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  1. Despite substantial awareness that certain groups (e.g. ethnic minorities) are under-represented and under-served in trials, limited progress has been made in addressing this. As well as a public service and e...

    Authors: Lydia Morris, Jo Dumville, Shaun Treweek, Nasima Miah, Ffion Curtis and Peter Bower
    Citation: Trials 2022 23:867
  2. Visits to the emergency department (ED) are inflection points in patients’ illness trajectories and are an underutilized setting to engage seriously ill patients in conversations about their goals of care. We ...

    Authors: Thidathit Prachanukool, Susan D. Block, Donna Berry, Rachel S. Lee, Sarah Rossmassler, Mohammad A. Hasdianda, Wei Wang, Rebecca Sudore, Mara A. Schonberg, James A. Tulsky and Kei Ouchi
    Citation: Trials 2022 23:866
  3. In the ongoing COVID-19 pandemic, advanced age is a risk factor for a severe clinical course of SARS-CoV-2 infection. Thus, older people may benefit in particular from booster doses with potent vaccines and re...

    Authors: Julia M. Neuhann, Jannik Stemler, Antonio Carcas, Jesús Frías-Iniesta, Ullrich Bethe, Sarah Heringer, Lea Tischmann, Marouan Zarrouk, Arnd Cüppers, Franz König, Martin Posch and Oliver A. Cornely
    Citation: Trials 2022 23:865
  4. Rifampicin-resistant tuberculosis (RR-TB) remains an important global health problem. Ideally, the complete drug-resistance profile guides individualized treatment for all RR-TB patients, but this is only prac...

    Authors: Annelies Van Rie, Elise De Vos, Emilyn Costa, Lennert Verboven, Felex Ndebele, Tim H. Heupink, Steven Abrams, Boitumelo Fanampe, Anneke Van der Spoel Van Dyk, Salome Charalambous, Gavin Churchyard and Rob Warren
    Citation: Trials 2022 23:864
  5. The way information about potential harms of trial intervention is shared within participant information leaflets (PILs) varies widely and can cause subjective ‘nocebo’ harms. This study aimed to develop princ...

    Authors: Martina Svobodova, Nina Jacob, Kerry Hood, Katie Gillies, Rachel Hale, Jennifer Bostock, Peter Bower, Adrian Edwards, Penelope Farthing, Sarah Rawlinson, Shaun Treweek and Jeremy Howick
    Citation: Trials 2022 23:863
  6. The COVID-19 pandemic forced many research teams to adjust the way they conduct studies, including moving to remote delivery of some or all of their recruitment and data collection processes. The Montreal Cogn...

    Authors: Caroline Brundle, Anne Heaven and Andrew Clegg
    Citation: Trials 2022 23:862
  7. Bariatric surgery has adverse effects on the muscular-skeletal system with loss of bone mass and muscle mass and an increase in the risk of fracture. Zoledronic acid is widely used in osteoporosis and prevents...

    Authors: Søren Gam, Bibi Gram, Claus Bogh Juhl, Anne Pernille Hermann and Stinus Gadegaard Hansen
    Citation: Trials 2022 23:861
  8. Shift work is considered a risk factor for a number of chronic health conditions including obesity. Weight reduction in obese patients lowers the risk for cardiovascular disease, diabetes, certain cancers, and...

    Authors: Piumika Sooriyaarachchi, Ranil Jayawardena, Toby Pavey and Neil A. King
    Citation: Trials 2022 23:860
  9. The complexity of past trauma and ongoing post-migration stressors challenges the existing mental health treatment for trauma-affected refugees. Therefore, interventions are needed to accommodate these complex...

    Authors: Maja Bruhn, Henriette Laugesen, Matilde Kromann-Larsen, Cathrine Selnes Trevino, Lene Eplov, Carsten Hjorthøj and Jessica Carlsson
    Citation: Trials 2022 23:859
  10. The clinical trial landscape has evolved over the last two decades, shaped by advances in therapeutics and drug development and innovation in trial design and methods. The tracking of such changes became possi...

    Authors: Gillian Gresham, Jill L. Meinert, Arthur G. Gresham, Steven Piantadosi and Curtis L. Meinert
    Citation: Trials 2022 23:858
  11. For the design and analysis of clinical trials with time-to-event outcomes, the Cox proportional hazards model and the logrank test have been the cornerstone methods for many decades. Increasingly, the key ass...

    Authors: Kim M. Jachno, Stephane Heritier, Robyn L. Woods, Suzanne Mahady, Andrew Chan, Andrew Tonkin, Anne Murray, John J. McNeil and Rory Wolfe
    Citation: Trials 2022 23:857
  12. The COVID-19 pandemic significantly impacted the conduct of clinical trials through delay, interruption or cancellation. Decentralised methods in clinical trials could help to continue trials during a pandemic...

    Authors: Arnela Suman, Jasmijn van Es, Helga Gardarsdottir, Diederick E. Grobbee, Kimberly Hawkins, Megan A. Heath, Isla S. Mackenzie, Ghislaine van Thiel and Mira G. P. Zuidgeest
    Citation: Trials 2022 23:856
  13. To date, no medication has slowed the progression of Parkinson’s disease (PD). Preclinical, epidemiological, and experimental data on humans all support many benefits of endurance exercise among persons with P...

    Authors: Charity G. Patterson, Elizabeth Joslin, Alexandra B. Gil, Wendy Spigle, Todd Nemet, Lana Chahine, Cory L. Christiansen, Ed Melanson, Wendy M. Kohrt, Martina Mancini, Deborah Josbeno, Katherine Balfany, Garett Griffith, Mac Kenzie Dunlap, Guillaume Lamotte, Erin Suttman…
    Citation: Trials 2022 23:855
  14. Obsessive-compulsive disorder (OCD) is a debilitating psychiatric disorder which affects up to 3% of children and adolescents. OCD in children and adolescents is generally treated with cognitive behavioural th...

    Authors: Markus Harboe Olsen, Julie Hagstrøm, Nicole Nadine Lønfeldt, Camilla Uhre, Valdemar Uhre, Linea Pretzmann, Sofie Heidenheim Christensen, Christine Thoustrup, Nicoline Løcke Jepsen Korsbjerg, Anna-Rosa Cecilie Mora-Jensen, Melanie Ritter, Janus Engstrøm, Jane Lindschou, Hartwig Roman Siebner, Frank Verhulst, Pia Jeppesen…
    Citation: Trials 2022 23:854
  15. Authors: Susanne G. R. Klotz, Gesche Ketels, Christian A. Behrendt, Hans-Helmut Konig, Sebastian Kohlmann, Bernd Lowe, Johannes Petersen, Sina Stock, Eik Vettorazzi, Antonia Zapf, Inke Zastrow, Christian Zollner, Hermann Reichenspurner and Evaldas Girdauskas
    Citation: Trials 2022 23:853

    The original article was published in Trials 2022 23:528

  16. Authors: Alaa Abouhajar, Lisa Alcock, Theophile Bigirumurame, Penny Bradley, Laura Brown, Ian Campbell, Silvia Del Din, Julie Faitg, Gavin Falkous, Grainne S. Gorman, Rachel Lakey, Robert McFarland, Jane Newman, Lynn Rochester, Vicky Ryan, Hesther Smith…
    Citation: Trials 2022 23:852

    The original article was published in Trials 2022 23:789

  17. Many people with psychotic disorders experience symptoms of post-traumatic stress disorder (PTSD). In recent years, several trauma-focused therapies (TFTs), including cognitive restructuring (CR), prolonged ex...

    Authors: Simone R. Burger, Tineke van der Linden, Amy Hardy, Paul de Bont, Berber van der Vleugel, Anton B. P. Staring, Carlijn de Roos, Catherine van Zelst, Jennifer D. Gottlieb, Kim T. Mueser, Agnes van Minnen, Ad de Jongh, Machteld Marcelis, Mark van der Gaag and David van den Berg
    Citation: Trials 2022 23:851
  18. Self-management support is increasingly viewed as an integral part of chronic condition management in adolescence. It is well recognized that markers of chronic illness control deteriorate during adolescence. ...

    Authors: Jaunna Gauci, Jacqueline Bloomfield, Sharon Lawn, Susan Towns, Annabelle Hobbs and Katharine Steinbeck
    Citation: Trials 2022 23:850
  19. Men who present to the emergency department (ED) with self-harm are at high risk of dying by suicide, with 2.7% of men dying in the year following their presentation, more than double the rate for women (1.2%)...

    Authors: Simon Hatcher, Marnin J. Heisel, Oydeji Ayonrinde, Daniel Corsi, Nicole E. Edgar, Sidney H. Kennedy, Sakina J. Rizvi, Ayal Schaffer and Mark Sinyor
    Citation: Trials 2022 23:849

    The Study protocol to this article has been published in Trials 2020 21:925

  20. Cardiotocography (CTG) is a screening test used to detect fetal hypoxia in labour. It has a high false positive rate resulting in many potentially unnecessary caesarean sections. Fetal blood sampling (FBS) is ...

    Authors: D. J. Murphy, Y. Shahabuddin, S. Yambasu, K. O’Donoghue, D. Devane, A. Cotter, G. Gaffney, L. A. Burke, E. J. Molloy and F. Boland
    Citation: Trials 2022 23:848
  21. Acute and everyday stress is substantial for the development of mental and physical diseases, therefore it is crucial to get a better understanding of its pathogenesis. Different methods (e.g., Ambulatory Asse...

    Authors: Daniel Schleicher, Angelika Ecker, Martin Kocur, Irina Jarvers, Colin Nash, Leonie Götz, Alexandra H. Otto, Stephanie Kandsperger and Romuald Brunner
    Citation: Trials 2022 23:847
  22. Enteral feeding intolerance, energy-protein malnutrition, and muscle wasting are common conditions in the critical care setting. The primary aim of this study was to investigate the effect of synbiotic supplem...

    Authors: Najmeh Seifi, Reza Rezvani, Alireza Sedaghat, Mohsen Nematy, Majid Khadem-Rezaiyan and Mohammad Safarian
    Citation: Trials 2022 23:846
  23. Plantar fasciopathy is the most common reason for complaints of plantar heel pain and one of the most prevalent musculoskeletal conditions with a reported lifetime incidence of 10%. The condition is normally c...

    Authors: Stefan Møller, Henrik Riel, Jens Wester, Ane Simony, Bjarke Viberg and Carsten Jensen
    Citation: Trials 2022 23:845
  24. Different coping strategies have been associated with various effects on infertile couples’ mental health. Considering the close interaction between couples, the present study aims to develop coping strategies...

    Authors: Marzie Reisi, Ashraf Kazemi and Mohammad Reza Abedi
    Citation: Trials 2022 23:844
  25. Recruitment of adults lacking the capacity to consent to trials requires the involvement of an alternative ‘proxy’ decision-maker, usually a family member. This can be challenging for family members, with some...

    Authors: Victoria Shepherd, Kerenza Hood, Katie Gillies and Fiona Wood
    Citation: Trials 2022 23:843
  26. Physical activity (PA) is a key behaviour for patients with type 2 diabetes (T2DM). However, healthcare professionals’ (HCP) recommendations (walking advice), which are short-term and individually focused, did...

    Authors: Guillem Jabardo-Camprubí, Judit Bort-Roig, Rafel Donat-Roca, Raimon Milà-Villarroel, Mercè Sitjà-Rabert, Jim McKenna and Anna Puig-Ribera
    Citation: Trials 2022 23:842
  27. Diabetes self-management education and support (DSMES) programs have struggled to deliver sustainable, effective support for adults with diabetes (AWDs) to improve self-management behaviors, achieve glycemic g...

    Authors: Denise J. Deverts, Michele Heisler, Edith C. Kieffer, Gretchen A. Piatt, Felix Valbuena, Jonathan G. Yabes, Claudia Guajardo, Deliana Ilarraza-Montalvo, Gloria Palmisano, Glory Koerbel and Ann-Marie Rosland
    Citation: Trials 2022 23:841
  28. Job loss after a cancer diagnosis can lead to long-term financial toxicity and its attendant adverse clinical consequences, including decreased treatment adherence. Among women undergoing (neo)adjuvant chemoth...

    Authors: Victoria S. Blinder, Sujata Patil, Jackie Finik, Della Makower, Monica Muppidi, Wendy G. Lichtenthal, Patricia A. Parker, Maria Claros, Jennifer Suarez, Bharat Narang and Francesca Gany
    Citation: Trials 2022 23:840
  29. Almost half of the patients with cancer report cancer-related financial hardship, termed “financial toxicity” (FT), which affects health-related quality of life, care retention, and, in extreme cases, mortalit...

    Authors: Stephanie B. Wheeler, Caitlin B. Biddell, Michelle L. Manning, Mindy S. Gellin, Neda R. Padilla, Lisa P. Spees, Cynthia D. Rogers, Julia Rodriguez-O’Donnell, Cleo Samuel-Ryals, Sarah A. Birken, Katherine E. Reeder-Hayes, Victoria M. Petermann, Allison M. Deal and Donald L. Rosenstein
    Citation: Trials 2022 23:839
  30. International guidelines recommend delayed umbilical cord clamping (DCC) up to 1 min in preterm infants, unless the condition of the infant requires immediate resuscitation. However, clamping the cord prior to...

    Authors: Ronny Knol, Emma Brouwer, Thomas van den Akker, Philip L. J. DeKoninck, Enrico Lopriore, Wes Onland, Marijn J. Vermeulen, M. Elske van den Akker–van Marle, Leti van Bodegom–Vos, Willem P. de Boode, Anton H. van Kaam, Irwin K. M. Reiss, Graeme R. Polglase, G. Jeroen Hutten, Sandra A. Prins, Estelle E. M. Mulder…
    Citation: Trials 2022 23:838
  31. The purpose of this study is to explore whether electrical impedance tomography (EIT)-guided individualized positive end-expiratory pressure (PEEP) can reduce the incidence of pulmonary complications within 1 ...

    Authors: Zihao Zhang, Lianqin Zhang, Jiang Zhu, Jun Dong and Hairui Liu
    Citation: Trials 2022 23:837
  32. The sources of information on clinical trial monitoring do not give information in an accessible language and do not give detailed guidance. In order to enable communication and to build clinical trial monitor...

    Authors: Sharon B. Love, Victoria Yorke-Edwards, Elizabeth Ward, Rebecca Haydock, Katie Keen, Katie Biggs, Gosala Gopalakrishnan, Lucy Marsh, Lydia O’Sullivan, Lisa Fox, Estelle Payerne, Kerenza Hood and Garry Meakin
    Citation: Trials 2022 23:836
  33. Neurosyphilis may cause irreversible neurological sequelae. First-line treatment consists of penicillin G, with ceftriaxone being an alternative treatment in patients allergic to penicillin. The lack of clinic...

    Authors: Fang-Zhi Du, Min-Zhi Wu, Xu Zhang, Rui-Li Zhang and Qian-Qiu Wang
    Citation: Trials 2022 23:835
  34. Cervical cancer is considered preventable disease, though it is the second largest killer of women’s cancer in low and middle-income countries. Despite the government’s attempts to broaden screening facilities...

    Authors: Gerezgiher Buruh Abera, Solomon Mekonen Abebe and Abebaw Gebeyehu Worku
    Citation: Trials 2022 23:834
  35. The COVID-19 pandemic has had a devastating impact on individuals and multiple aspects of our society including healthcare and clinical research. The silver lining is that the pandemic also served as a catalys...

    Authors: Lada Leyens, Tracy Simkins and Nafsika Kronidou Horst
    Citation: Trials 2022 23:833
  36. Authors: E. Bailin Xie, Kaeley M. Simpson, Kristin A. Reynolds, Ryan J. Giuliano, Jennifer L. P. Protudjer, Melanie Soderstrom, Shannon Sauer-Zavala, Gerald F. Giesbrecht, Catherine Lebel, Anna L. Mackinnon, Charlie Rioux, Lara Penner-Goeke, Makayla Freeman, Marlee R. Salisbury, Lianne Tomfohr-Madsen and Leslie E. Roos
    Citation: Trials 2022 23:832

    The original article was published in Trials 2022 23:741

  37. Around one fourth of patients with colorectal cancer present themselves with distant metastases at the time of diagnosis, and one additional one fifth of the patients will develop distant metastases during the...

    Authors: Veronica Reivell, Helga Hagman, Johan Haux, Carl Jorns, Per Lindnér and Helena Taflin
    Citation: Trials 2022 23:831
  38. In blended therapy, face-to-face psychotherapy and Internet-based interventions are combined. Blended therapy may be advantageous for patients and psychotherapists. However, most blended interventions focus on...

    Authors: Carmen Schaeuffele, Manuel Heinrich, Solveig Behr, Friederike Fenski, Leona Hammelrath, Pavle Zagorscak, Alessa Jansen, Steffi Pohl, Johanna Boettcher and Christine Knaevelsrud
    Citation: Trials 2022 23:830
  39. Advance care planning (ACP) is a process involving conversations between patients, loved ones, and healthcare providers that consider patient preferences for the types of medical therapies received at the end ...

    Authors: Lauren J. Van Scoy, Benjamin H. Levi, Cindy Bramble, William Calo, Vernon M. Chinchilli, Lindsey Currin, Denise Grant, Christopher Hollenbeak, Maria Katsaros, Sara Marlin, Allison M. Scott, Amy Tucci, Erika VanDyke, Emily Wasserman, Pamela Witt and Michael J. Green
    Citation: Trials 2022 23:829
  40. Dyspnea is common and severe in intensive care unit (ICU) patients managed for acute respiratory failure. Dyspnea appears to be associated with impaired prognosis and neuropsychological sequels. Pain and dyspn...

    Authors: Alexandre Demoule, Robin Deleris, Côme Bureau, Said Lebbah, Maxens Decavèle, Martin Dres, Thomas Similowski and Agnes Dechartres
    Citation: Trials 2022 23:828
  41. The Center for Disease Control and Prevention’s National Diabetes Prevention Program (NDPP) aims to help individuals with prediabetes avoid progression to type 2 diabetes mellitus (T2DM) through weight loss. S...

    Authors: Dina H. Griauzde, Alison O’Brien, William S. Yancy Jr., Caroline R. Richardson, Jamie Krinock, Melissa DeJonckheere, Deanna J. M. Isaman, Kaitlyn Vanias, Samuel Shopinski and Laura R. Saslow
    Citation: Trials 2022 23:827
  42. Working memory deficits are one of the core and most characteristic clinical features of cognitive impairment in schizophrenia. Cognitive training can improve the cognitive function of patients with schizophre...

    Authors: Xiaolin Zhu, Chao Huang, Hongzhen Fan, Fengmei Fan, Yanli Zhao, Meihong Xiu, Yunhui Wang, Yajun Li, Yunlong Tan, Zhiren Wang and Shuping Tan
    Citation: Trials 2022 23:826
  43. Traumatic hemorrhagic shock (THS) is the main cause of death in trauma patients with high mortality. Rapid control of the source of bleeding and early resuscitation are crucial to clinical treatment. Guideline...

    Authors: Jizhe Zhang, Dong Han, Kun Zhang, Weiqiang Guan, Li Li and Zhengtao Gu
    Citation: Trials 2022 23:825
  44. This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS2 trial of patient navigators for children with chronic kidney disease (CKD) experiencing soci...

    Authors: Anita van Zwieten, Elizabeth G. Ryan, Patrina Caldwell, Kirsten Howard, Allison Tong, Jonathan C. Craig, Stephen I. Alexander, Martin Howell, Armando Teixeira-Pinto, Carmel M. Hawley, Shilpanjali Jesudason, Amanda Walker, Fiona Mackie, Sean E. Kennedy, Steven McTaggart, Hugh J. McCarthy…
    Citation: Trials 2022 23:824

    The Study protocol to this article has been published in BMC Nephrology 2019 20:134

  45. Understanding public and patient attitudes to clinical research is paramount to successful recruitment. The COVID-19 pandemic has led to additional hurdles in achieving this. Our aim is to understand the curre...

    Authors: Dalia Abdulhussein, Timothy E. Yap, Haider Manzar, Serge Miodragovic and Francesca Cordeiro
    Citation: Trials 2022 23:823
  46. Major depressive disorder (MDD) is a leading cause of disability worldwide. The current treatments are ineffective in approximately one-third of patients, resulting in a large economic burden and reduced quali...

    Authors: Julia R. Plank, Stephanie C. Glover, Ben D. Moloney, Nicholas R. Hoeh, Frederick Sundram, Rachael L. Sumner, Suresh Muthukumaraswamy and Joanne C. Lin
    Citation: Trials 2022 23:822
  47. Sri Lanka is faced with the challenge of managing a large population with diabetes mellitus by 2030. Psychological stress plays a major role in disease outcome by exerting physiological, psychological and soci...

    Authors: K. P. C. Dalpatadu, P. Galappatthy, P. Katulanda and S. Jayasinghe
    Citation: Trials 2022 23:821
  48. Mental illness has an estimated financial burden on the Danish economy of 3.4% of the gross national product every year due to lost productivity, social benefits, and healthcare costs, and approximately 50% of...

    Authors: Thomas Nordahl Christensen, Chalotte Heinsvig Poulsen, Bea Kolbe Ebersbach and Lene Falgaard Eplov
    Citation: Trials 2022 23:820
  49. Cancer survivors frequently develop cognitive impairment, which negatively affects their quality of life and emotional well-being. This study compares the effectiveness of a well-established treatment (neurops...

    Authors: Francisco García-Torres, Adrián Tejero-Perea, Ángel Gómez-Solís, Rosario Castillo-Mayén, Maria José Jaén-Moreno, Bárbara Luque, Mario Gálvez-Lara, Araceli Sánchez-Raya, Marcin Jablonski, Beatriz Rodríguez-Alonso and Enrique Aranda
    Citation: Trials 2022 23:819
  50. Authors: Valérie Martel-Laferrière, Daniel J. Feaster, Lisa R. Metsch, Bruce R. Schackman, Christine Loignon, Bohdan Nosyk, Hansel Tookes, Czarina N. Behrends, Nelson Arruda, Oluleye Adigun, Marie-Eve Goyer, Michael A. Kolber, Jean-Francois Mary, Allan E. Rodriguez, Iveth G. Yanez, Yue Pan…
    Citation: Trials 2022 23:815

    The original article was published in Trials 2022 23:341

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