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  1. Despite the importance of intervention fidelity in interpreting the outcomes of complex public health interventions, there is a lack of both reporting fidelity trial protocols and uniformity. In evaluating com...

    Authors: Larske M. Soepnel, Catherine E. Draper, Khuthala Mabetha, Cindy-Lee Dennis, Alessandra Prioreschi, Stephen Lye and Shane A. Norris
    Citation: Trials 2022 23:758
  2. Late-phase platform protocols (including basket, umbrella, multi-arm multi-stage (MAMS), and master protocols) are generally agreed to be more efficient than traditional two-arm clinical trial designs but are ...

    Authors: Sharon B. Love, Fay Cafferty, Claire Snowdon, Karen Carty, Joshua Savage, Philip Pallmann, Lucy McParland, Louise Brown, Lindsey Masters, Francesca Schiavone, Dominic Hague, Stephen Townsend, Claire Amos, Annabelle South, Kate Sturgeon, Ruth Langley…
    Citation: Trials 2022 23:757
  3. The number of interventions to improve recruitment and retention of participants in trials is rising, with a corresponding growth in randomised Studies Within Trials (SWATs) to evaluate their (cost-)effectiven...

    Authors: Victoria Shepherd, Fiona Wood, Katie Gillies, Abby O’Connell, Adam Martin and Kerenza Hood
    Citation: Trials 2022 23:756
  4. South Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high costs, p...

    Authors: Mirthe Muilwijk, Marie Loh, Sara Mahmood, Saranya Palaniswamy, Samreen Siddiqui, Wnurinham Silva, Gary S. Frost, Heather M. Gage, Marjo-Riitta Jarvelin, Ravindra P. Rannan-Eliya, Sajjad Ahmad, Sujeet Jha, Anuradhani Kasturiratne, Prasad Katulanda, Khadija I. Khawaja, Jaspal S. Kooner…
    Citation: Trials 2022 23:755
  5. Platform trials are well-known for their ability to investigate multiple arms on heterogeneous patient populations and their flexibility to add/drop treatment arms due to efficacy/lack of efficacy. Because of ...

    Authors: Guangyi Gao, Byron J. Gajewski, Jo Wick, Jonathan Beall, Jeffrey L. Saver and Caitlyn Meinzer
    Citation: Trials 2022 23:754
  6. To reduce the global burden of tobacco use, clinical guidelines support behavioral therapy and pharmacotherapy as preferred interventions for tobacco cessation. The evidence-based behavioral interventions has ...

    Authors: Priyanka Dhawan, Sonu Goel, Ashutosh Aggarwal, Abhishek Ghosh, Rajesh Vijayvergiya, Bikash Medhi, Dheeraj Khurana and Roshan Verma
    Citation: Trials 2022 23:753
  7. Recruitment for randomised controlled trials in palliative care can be challenging; disease progression and terminal illness underpin high rates of attrition. Research into participant decision-making in medic...

    Authors: Rebecca E. Olson, Alexandra Smith, Georgie Huggett, Phillip Good, Morgan Dudley and Janet Hardy
    Citation: Trials 2022 23:752
  8. Substantial data from high-income countries support early interventions in the form of evidence-based Coordinated Specialty Care (CSC) for people experiencing First Episode Psychosis (FEP) to ameliorate sympto...

    Authors: Franco Mascayano, Iruma Bello, Howard Andrews, Diego Arancibia, Tamara Arratia, María Soledad Burrone, Sarah Conover, Kim Fader, Maria Jose Jorquera, Mauricio Gomez, Sergio Malverde, Gonzalo Martínez-Alés, Jorge Ramírez, Gabriel Reginatto, Alexandra Restrepo-Henao, Robert A. Rosencheck…
    Citation: Trials 2022 23:751
  9. Functional constipation (FC) is a common functional gastrointestinal disorder, which brings many negative impacts to the children’s daily life. Pediatric Tuina has been proved to be a potential therapy for FC. Ho...

    Authors: Xinghe Zhang, Luan Hu, Li Li, Yuanwang Wang, Can Zhang, Jinyan Su, Hua Di, Qing Gao, Xiantao Tai and Taipin Guo
    Citation: Trials 2022 23:750
  10. Spinal cord stimulation (SCS) has shown to be an effective treatment for patients with persistent spinal pain syndrome type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important. On...

    Authors: Martijn R. Mons, Caro Edelbroek, Xander Zuidema, Katja Bürger, Lars Elzinga, Jessica de Vries, Sander van Kuijk, Elbert A. Joosten and Jan-Willem Kallewaard
    Citation: Trials 2022 23:749
  11. Ankle osteoarthritis (OA) is a debilitating health condition that is increasing in prevalence. Currently, there are no evidence-based guidelines for managing ankle OA. One of the current challenges to establis...

    Authors: Sultan Ayyadah Alanazi, Bill Vicenzino, Christiaan J. A. van Bergen, David J. Hunter, Erik A. Wikstrom, Hylton B. Menz, Yvonne M. Golightly and Michelle D. Smith
    Citation: Trials 2022 23:748
  12. Elevated patellofemoral joint stress has been associated with patellofemoral osteoarthritis (PFOA). Changes in lower limb kinematics, such as excessive femoral adduction and internal rotation and excessive rea...

    Authors: Larissa Rodrigues Souto, Paula Regina Mendes da Silva Serrão, Giulia Keppe Pisani, Bruna Mariana Tessarin, Hygor Ferreira da Silva, Eliane de Morais Machado, Tatiana de Oliveira Sato and Fábio Viadanna Serrão
    Citation: Trials 2022 23:746
  13. Overweight and obesity are typical risk factors for the increased prevalence and incidence of gout. The existing guidelines unequivocally indicated that exercise is highly advantageous for patients with gout. ...

    Authors: Ertao Jia, Haiqiong Zhu, Hongling Geng, Ruilin Liu, Xueqian Wo, Yaochi Zeng, Wukai Ma, Xueming Yao, Zhiying Zhan and Jianyong Zhang
    Citation: Trials 2022 23:745
  14. Acute-on-chronic liver failure (ACLF) represents a rising global healthcare burden, characterised by increasing prevalence among patients with decompensated cirrhosis who have a 28-day transplantation-free mor...

    Authors: Natalie LY Ngu, Edward Saxby, Thomas Worland, Patricia Anderson, Lisa Stothers, Anita Figredo, Jo Hunter, Alexander Elford, Phil Ha, Imogen Hartley, Andrew Roberts, Dean Seah, George Tambakis, Danny Liew, Benjamin Rogers, William Sievert…
    Citation: Trials 2022 23:744
  15. Axial involvement constitutes a specific domain of psoriatic arthritis (PsA). Interleukin (IL)-23 inhibitors have demonstrated improvement in axial PsA (axPsA) symptoms, but have not shown efficacy in treating...

    Authors: Dafna D. Gladman, Philip J. Mease, Paul Bird, Enrique R. Soriano, Soumya D. Chakravarty, May Shawi, Stephen Xu, Sean T. Quinn, Cinty Gong, Evan Leibowitz, Denis Poddubnyy, Lai-Shan Tam, Philip S. Helliwell, Arthur Kavanaugh, Atul Deodhar, Mikkel Østergaard…
    Citation: Trials 2022 23:743
  16. Pelvic organ prolapse (POP) is a common condition in women, where the downward descent of pelvic organs into the vagina causes symptoms which impacts quality of life. Vaginal pessaries offer an effective alter...

    Authors: Lucy Dwyer, Carol Bugge, Suzanne Hagen, Kirsteen Goodman, Wael Agur, Melanie Dembinsky, Margaret Graham, Karen Guerrero, Christine Hemming, Aethele Khunda, Doreen McClurg, Lynn Melone, Ranee Thakar and Rohna Kearney
    Citation: Trials 2022 23:742
  17. The prevalence of maternal depression and anxiety has increased during the COVID-19 pandemic, and pregnant individuals are experiencing concerningly elevated levels of mental health symptoms worldwide. Many in...

    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 23:741

    The Correction to this article has been published in Trials 2022 23:832

  18. Fibromyalgia is a form of chronic widespread pain that is defined as a syndrome of chronic symptoms of moderate to severe intensity, including diffuse pain, fatigue, sleep disturbance, cognitive impairment, an...

    Authors: Emilie Chipon, Jean-Luc Bosson, Laure Minier, Anne Dumolard, Antoine Vilotitch, David Crouzier and Caroline Maindet
    Citation: Trials 2022 23:740
  19. IMI2-PainCare-BioPain-RCT2 is one of four similarly designed clinical studies aiming at profiling a set of functional biomarkers of drug effects on specific compartments of the nociceptive system that could se...

    Authors: Caterina Leone, Giulia Di Stefano, Giuseppe Di Pietro, Petra Bloms-Funke, Irmgard Boesl, Ombretta Caspani, Sonya C. Chapman, Nanna Brix Finnerup, Luis Garcia-Larrea, Tom Li, Marcus Goetz, André Mouraux, Bernhard Pelz, Esther Pogatzki-Zahn, Andreas Schilder, Erik Schnetter…
    Citation: Trials 2022 23:739
  20. During restoration of poorly fitting complete dentures (CDs) in edentulous patients, liners are used to reconstruct the concave surfaces of CDs with a new base material. These relining materials are classified...

    Authors: Katsuhiko Kimoto, Suguru Kimoto, Noriyuki Hoshi, Yusuke Sato, Yoshikazu Yoneyama, Jun Takebe, Tetsuo Ichikawa, Hiroshi Murata, Masahiro Nishimura, Shunsuke Minakuchi and Yasuhiko Kawai
    Citation: Trials 2022 23:738
  21. Despite the intense global research endeavour to improve the treatment of patients with COVID-19, the current therapy remains insufficient, resulting in persisting high mortality. Severe cases are characterise...

    Authors: Sina M. Coldewey, Charles Neu, Frank Bloos, Philipp Baumbach, Ulrike Schumacher, Michael Bauer, Philipp Reuken and Andreas Stallmach
    Citation: Trials 2022 23:737
  22. At present, intraocular injection of anti-VEGF (vascular endothelial growth factor) drugs has replaced traditional laser therapy as the first-line treatment for DME (diabetic macular edema). However, ranibizum...

    Authors: Xuejing Mi, Xiaoya Gu and Xiaobing Yu
    Citation: Trials 2022 23:736
  23. The COVID-19 pandemic disrupted non-COVID critical care trials globally as intensive care units (ICUs) prioritized patient care and COVID-specific research. The international randomized controlled trial CYCLE (Cr...

    Authors: Julie C. Reid, Alex Molloy, Geoff Strong, Laurel Kelly, Heather O’Grady, Deborah Cook, Patrick M. Archambault, Ian Ball, Sue Berney, Karen E. A. Burns, Frederick D’Aragon, Erick Duan, Shane W. English, François Lamontagne, Amy M. Pastva, Bram Rochwerg…
    Citation: Trials 2022 23:735
  24. Recent studies have shown that nurses have been more affected by the COVID-19 pandemic than any other group of hospital workers in terms of anxiety, depression, and burnout. Several clinical studies had previo...

    Authors: Luca Bodini, Chiara Bonetto, Simone Cheli, Lidia Del Piccolo, Michela Rimondini, Alberto Rossi, Angela Carta, Stefano Porru, Francesco Amaddeo and Antonio Lasalvia
    Citation: Trials 2022 23:734
  25. Evidence of the benefits induced from resistance exercise on health markers of post-bariatric patients is limited. The study will investigate the effects of a resistance training (RT) program on muscle mass an...

    Authors: Karynne Grutter Lopes, Maria das Graças Coelho de Souza, Michelle da Costa Tavares Bezerra, Lucas Miranda Bessa, Paulo Farinatti, Eliete Bouskela, Miguel Madeira and Luiz Guilherme Kraemer-Aguiar
    Citation: Trials 2022 23:733
  26. Persistent pain and disability following rib fractures result in a large psycho-socio-economic impact for health-care system. Benefits of rib osteosynthesis are well documented in patients with flail chest tha...

    Authors: Jean Yaniss Perentes, Michel Christodoulou, Etienne Abdelnour-Berchtold, Wolfram Karenovics, Angèle Gayet-Ageron, Michel Gonzalez, Thorsten Krueger, Frédéric Triponez, Philippe Terrier and Benoît Bédat
    Citation: Trials 2022 23:732
  27. Medication non-adherence is a prevalent health problem in people with type 2 diabetes mellitus (T2DM). Interventions have previously been developed to improve medication adherence, but inconsistent outcomes ha...

    Authors: Marlous Langendoen-Gort, Hiyam Al-Jabr, Jacqueline G. Hugtenburg, Femke Rutters, Maartje de Wit, Debi Bhattacharya, Ameen Abu-Hanna, Andrew Farmer and Petra J. M. Elders
    Citation: Trials 2022 23:731
  28. Reproductive and sexual health (RSH) concerns are common and distressing for young adults diagnosed with breast and gynecologic cancer and their partners. This study evaluates the efficacy of a virtual couple-...

    Authors: Jessica R. Gorman, Karen S. Lyons, S. Marie Harvey, Chiara Acquati, John M. Salsman, Deborah A. Kashy, Julia H. Drizin, Ellie Smith, Lisa M. Flexner, Brandon Hayes-Lattin and Jennifer B. Reese
    Citation: Trials 2022 23:730
  29. High-intensity repetitive task-specific practice might be the most effective strategy to promote motor recovery after stroke, and electromechanical-assisted gait training represents one of the treatment option...

    Authors: Chi-Yeon Lim, Mun Jung Ko, Jin Won Lee, Soo Kyung Bok, Nam-Jong Paik, Yeon Gyo Nam and Bum Sun Kwon
    Citation: Trials 2022 23:729
  30. As of May 2022, Ontario has seen more than 1.3 million cases of COVID-19. While the majority of individuals will recover from infection within 4 weeks, a significant subset experience persistent and often debi...

    Authors: Simon Hatcher, Joel Werier, Nicole E. Edgar, James Booth, D. William J. Cameron, Vicente Corrales-Medina, Daniel Corsi, Juthaporn Cowan, Pierre Giguère, Mark Kaluzienski, Shawn Marshall, Tiago Mestre, Bryce Mulligan, Heather Orpana, Amanda Pontefract, Darlene Stafford…
    Citation: Trials 2022 23:728
  31. The number of people struggling with vulnerability to mental health difficulties is increasing worldwide, and there is a need for new interventions, to prevent more people from developing serious mental illnes...

    Authors: Chalotte Heinsvig Poulsen, Cecilie Høgh Egmose, Bea Kolbe Ebersbach, Carsten Hjorthøj and Lene Falgaard Eplov
    Citation: Trials 2022 23:727
  32. The standard procedure for the planning of transcatheter aortic valve replacement (TAVR) is the combination of echocardiography, coronary angiography, and cardiovascular computed tomography (TAVR-CT) for the e...

    Authors: Gert Klug, Sebastian Reinstadler, Felix Troger, Magdalena Holzknecht, Martin Reindl, Christina Tiller, Ivan Lechner, Priscilla Fink, Mathias Pamminger, Christian Kremser, Hanno Ulmer, Axel Bauer, Bernhard Metzler and Agnes Mayr
    Citation: Trials 2022 23:726
  33. Idiopathic pulmonary fibrosis is a critical disease with a poor prognosis. Although different studies have been conducted for the treatment of idiopathic pulmonary fibrosis, limited treatments are available. J...

    Authors: Shu-guang Yang, Xue-qing Yu, Jian-sheng Li, Yang Xie, Wei Zhang, Chengjun Ban, Jihong Feng, Lei Wu, Xuechao Lu, Limin Zhao, Yong Meng, Miao Zhou, Yong He and Weixian Luo
    Citation: Trials 2022 23:725
  34. Sexually active women aged 18 to 48 are within the population at risk for acquiring sexually transmitted infections. Some STIs can cause serious complications in women’s reproductive health. Accordingly, this ...

    Authors: Afsaneh Karami Juyani, Fatemeh Zarei, Shamsodin Niknami, Alireza Haydarni and Raziyeh Maasoumi
    Citation: Trials 2022 23:724
  35. As a type of local anaesthesia, retrobulbar nerve block is often used in vitrectomy, with patients remaining conscious during the operation. The increase in systolic blood pressure (SBP) caused by tension and ...

    Authors: Tianwei Qian, Qiaoyun Gong, Chong Chen, Xia Wu, Lin Xue, Ying Fan, Weijun Wang, Zhihua Zhang, Hui Cao and Xun Xu
    Citation: Trials 2022 23:723
  36. Pre-eclampsia is a complex pregnancy disorder, characterised by new or worsening hypertension associated with multi-organ dysfunction. Adverse outcomes include eclampsia, liver rupture, stroke, pulmonary oedem...

    Authors: Alice Hurrell, Jenie Sparkes, Kate Duhig, Paul T. Seed, Jenny Myers, Cheryl Battersby, Katherine Clark, Marcus Green, Rachael M. Hunter, Andrew H. Shennan, Lucy C. Chappell and Louise Webster
    Citation: Trials 2022 23:722
  37. Research has shown that internet-based cognitive behavioural therapy (iCBT) can be a very promising solution to increase access to and the dissemination of evidence-based treatments to all of the population in...

    Authors: Ladislav Timulak, Derek Richards, Louise Bhandal-Griffin, Patrick Healy, Juliana Azevedo, Graham Connon, Elaine Martin, Aoife Kearney, Conor O’Kelly, Angel Enrique, Nora Eilert, Sorcha O’Brien, Siobhan Harty, Alberto González-Robles, Elizabeth H. Eustis, David H. Barlow…
    Citation: Trials 2022 23:721
  38. Postoperative delirium in elderly patients is a common and costly complication after surgery. Propofol and sevoflurane are commonly used anesthetics during general anesthesia, and the sedative and anti-inflamm...

    Authors: Ji-hua Wang, Meng Lv, Hai-xia Zhang, Yang Gao, Ting-ting Chen, Tian-tian Wan and Yue-lan Wang
    Citation: Trials 2022 23:720
  39. Insertion of a central venous access device (CVAD) allows clinicians to easily access the circulation of a patient to administer life-saving interventions. Due to their invasive nature, CVADs are prone to comp...

    Authors: Marlena Ornowska, Hubert Wong, Yongdong Ouyang, Anish Mitra, Aaron White, Sue Willems, Jessica Wittmann and Steven Reynolds
    Citation: Trials 2022 23:719
  40. The standard of care for treating overweight and obesity is daily caloric restriction (DCR). While this approach produces modest weight loss, adherence to DCR declines over time and weight regain is common. In...

    Authors: Danielle M. Ostendorf, Ann E. Caldwell, Adnin Zaman, Zhaoxing Pan, Kristen Bing, Liza T. Wayland, Seth A. Creasy, Daniel H. Bessesen, Paul MacLean, Edward L. Melanson and Victoria A. Catenacci
    Citation: Trials 2022 23:718
  41. At present, effectively implementing smoking cessation programs in the health care system constitutes a major challenge. A unique opportunity to initiate smoking cessation focuses on smokers scheduled for surg...

    Authors: Christian D. Fankhauser, Andres Affentranger, Beatrice Cortonesi, Urs Jeker, Markus Gass, Fabrizio Minervini, Georg Jung, Corina Christmann, Christine Brambs, Milo A. Puhan and Ulrike Held
    Citation: Trials 2022 23:717
  42. Osteoarthritis (OA) is one of the most common disabilities in the elderly. When conservative management fails, total joint arthroplasty (TJA) is the treatment of choice for end-stage OA. Since quality and dura...

    Authors: André Strahl, Heiko Graichen, Holger Haas, Robert Hube, Carsten Perka, Tim Rolvien and Jan Hubert
    Citation: Trials 2022 23:716
  43. To date, there is no consensus on which anterior surgical technique is more cost-effective in treating cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with sin...

    Authors: Valérie N. E. Schuermans, Anouk Y. J. M. Smeets, Toon F. M. Boselie, Math J. J. M. Candel, Inez Curfs, Silvia M. A. A. Evers and Henk Van Santbrink
    Citation: Trials 2022 23:715
  44. The emergent outbreak of coronavirus disease (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has emphasized the requirement for therapeutic opportunities to overcome this pa...

    Authors: Anan Manomaipiboon, Kittisak Pholtawornkulchai, Sujaree Poopipatpab, Swangjit Suraamornkul, Jakravoot Maneerit, Wiroj Ruksakul, Uraporn Phumisantiphong and Thananda Trakarnvanich
    Citation: Trials 2022 23:714
  45. During reintegration to daily school life following psychiatric hospitalization, children and adolescents are confronted with various challenges and are at risk for rehospitalization. Tailored post-discharge s...

    Authors: Marlene Finkbeiner, Jan Kühnhausen, Johanna Schmid, Annette Conzelmann, Ute Dürrwächter, Lena-Marie Wahl, Augustin Kelava, Caterina Gawrilow and Tobias J. Renner
    Citation: Trials 2022 23:713
  46. For patients and their intimate partners, advanced cancer poses significant challenges that can negatively impact both individuals and their relationship. Prior studies have found evidence that couple-based co...

    Authors: Laura S. Porter, Katherine Ramos, Donald H. Baucom, Karen Steinhauser, Alaattin Erkanli, Timothy J. Strauman, S. Yousuf Zafar, Devon K. Check, Karena Leo, Evan Liu and Francis J. Keefe
    Citation: Trials 2022 23:712
  47. Core outcome sets are advocated as a means to standardize outcome reporting across randomized controlled trials (RCTs) and reduce selective outcome reporting. In 2005, the Prevention of Falls Network Europe (P...

    Authors: Alexandra M. B. Korall, Dawn Steliga, Sarah E. Lamb, Stephen R. Lord, Rasheda Rabbani and Kathryn M. Sibley
    Citation: Trials 2022 23:710
  48. An optimal bowel preparation can result in an improved colonoscopy. This study was to compare the effectiveness and safety of the use of a sports drink (Mizone) plus polyethylene glycol (PEG) solution with a w...

    Authors: Zhixin Zhang, Hui Gao, Xin Yuan, Cenqin Liu, Zhenfei Bao, Siyi Yu, Haofen Xie, Weihong Wang, Jiarong Xie and Lei Xu
    Citation: Trials 2022 23:709
  49. The alcohol-metabolizing enzyme aldehyde dehydrogenase 2 (ALDH2) is a carcinogenic acetaldehyde-degrading enzyme, and its low activity is a genetic constitution peculiar to East Asians. People with low alcohol de...

    Authors: Yukiko Owaki, Hisashi Yoshimoto, Go Saito, Takahiro Goto, Satoshi Kushio, Akihiro Nakamura, Yusuke Togo, Kazumasa Mori and Hideki Hokazono
    Citation: Trials 2022 23:708

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