Articles

ABBaH teens: Activity Breaks for Brain Health in adolescents: study protocol for a randomized crossover trial

Physical activity breaks are widely being implemented in school settings as a solution to increase academic performance and reduce sitting time. However, the underlying physiological mechanisms suggested to im...

Authors: Emerald G. Heiland, Karin Kjellenberg, Olga Tarassova, Maria Fernström, Gisela Nyberg, Maria M. Ekblom, Björg Helgadottir and Örjan Ekblom

DUbbing Language-therapy CINEma-based in Aphasia post-Stroke (DULCINEA): study protocol for a randomized crossover pilot trial

Communication is one of the most important predictors of social reintegration after stroke. Approximately 15–42% of stroke survivors experience post-stroke aphasia. Helping people recover from aphasia is one o...

Authors: Blanca Fuentes, Lydia de la Fuente-Gómez, Cristian Sempere-Iborra, Celia Delgado-Fernández, Aida Tarifa-Rodríguez, María Alonso de Leciñana, Elena de Celis-Ruiz, Raquel Gutiérrez-Zúñiga, José López-Tàppero, Marta Martín Alonso, Sylvia Pastor-Yborra, Ricardo Rigual, Gerardo Ruiz-Ares, Jorge Rodríguez-Pardo, Javier Virués-Ortega, Alberto M. Borobia…

Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol

The coronavirus disease 2019 (COVID-19) pandemic continues to affect the globe. After 18 months of the SARS-CoV-2 emergence, clinicians have clearly defined a subgroup of patients with lasting, disabling sympt...

Authors: Francisco Mera Cordero, Sara Bonet Monne, Jesús Almeda Ortega, Ana García-Sangenís, Oriol Cunillera Puèrtolas, Sara Contreras-Martos, Gemma Alvarez Muñoz, Ramon Monfà Escolà, Marina Balanzó Joué, Rosa Morros Pedrós and Betlem Salvador-Gonzalez

Fasting before living-kidney donation: effect on donor well-being and postoperative recovery: study protocol of a multicenter randomized controlled trial

One of the main effectors on the quality of life of living-kidney donors is postoperative fatigue. Caloric restriction (CR) and short-term fasting (STF) are associated with improved fitness and increased resis...

Authors: C. A. J. Oudmaijer, R. C. Minnee, R. A. Pol, W. M. C. van den Boogaard, D. S. J. Komninos, J. van de Wetering, M. H. van Heugten, E. J. Hoorn, J. S. F. Sanders, J. H. J. Hoeijmakers, W. P. Vermeij and J. N. M. IJzermans

Guided meditation for vision acuity training on adolescent myopia: study protocol for an open-label, prospective, multicenter, randomized controlled trial

Currently, the population with myopia climbs steadily, and is developing toward younger age, posing a great concern to the health of adolescents. Myopia in severe cases can cause irreversible consequences such...

Authors: Yibo Li, Lili Zhu, Raoying Wang, Xingyue Yang, Xinqi Jiang and Tao Lu

The effect of low-intensity whole-body vibration with or without high-intensity resistance and impact training on risk factors for proximal femur fragility fracture in postmenopausal women with low bone mass: study protocol for the VIBMOR randomized controlled trial

The prevailing medical opinion is that medication is the primary (some might argue, only) effective intervention for osteoporosis. It is nevertheless recognized that osteoporosis medications are not universall...

Authors: Belinda Beck, Clinton Rubin, Amy Harding, Sanjoy Paul and Mark Forwood

Statistical analysis plan for the Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian, fallopian tube or primary peritoneal cancer (of clear cell, endometrioid and high-grade serous type, and carcinosarcoma) trial (DICE)

Treatment for ovarian cancer includes platinum-based chemotherapy, but many women become resistant to chemotherapy, becoming platinum-resistant. Standard of care for these women is weekly paclitaxel chemothera...

Authors: Consuelo Nóhpal de la Rosa, Jonathan Krell, Emily Day, Aaron Clarke, Meena Reddi, Lee Webber and Francesca Fiorentino

Testing the efficacy of a couple-focused, tailored eHealth intervention for symptom self-management among men with prostate cancer and their partners: the study protocol

Men with localized prostate cancer often experience urinary, sexual, bowel, and hormonal symptoms; general distress; pain; fatigue; and sleep disturbance. For men in an intimate relationship, these symptoms di...

Authors: Lixin Song, Matthew E. Nielsen, Ronald C. Chen, Christine Rini, Thomas C. Keyserling, Eno Idiagbonya, Gail P. Fuller, Laurel Northouse, Mary H. Palmer and Xianming Tan

Efficacy of acupuncture and its influence on the emotional network in adult insomnia patients: protocol for a randomized controlled clinical trial

Insomnia disorder (ID) is characterized by dissatisfaction with the quantity or quality of sleep and is often accompanied by negative emotions such as anxiety and depression. Patients with insomnia become trap...

Authors: Tongfei Jiang, Qi Zhang, Fang Yuan, Fan Zhang and Jing Guo

Efficacy and safety of Xiaoyao pills for mild to moderate depression: study protocol for a randomized controlled trial

Depression is one of the most frequent and severe psychiatric conditions. Many chemical drugs to treat depression are associated with adverse reactions and have shortcomings. Traditional Chinese medicine is of...

Authors: Zhe Xue, Zhen Huang, Shu-li Cheng, Xi-hong Wang, Xuan Zhou, Qing-yu Ma and Jia-xu Chen

Acupuncture for prostatectomy incontinence: study protocol for a multicenter single-blind randomized parallel controlled trial

Urinary incontinence is a common complication post radical prostatectomy. Acupuncture is considered an effective treatment for post-prostatectomy incontinence (PPI), but the evidence is still limited. We propo...

Authors: Yao Zhang, Shanqi Guo, Chaoran Wang, Xiaodi Liu, Yan Liu, Hongcai Shang, Peiying Yang, Liang Wang, Jingbo Zhai, Xiaojiang Li and Yingjie Jia

Effect of different conditioning methods of traditional Chinese health exercise on lung function in healthy middle-aged and elderly people: study protocol for a randomized controlled trial

Lung function is highly age-dependent as it decreases in varying degrees with age, even in healthy people. Decreased lung function results in less elastic lung tissue, reduced chest wall compliance, reduced ar...

Authors: Wenlong Li, Yapei Song, Qiuping Xiang, Xinlei Wang, Xiaoyun Wei and Tonggang Fan

Social Mobile Approaches to Reducing Weight (SMART) 2.0: protocol of a randomized controlled trial among young adults in university settings

Excess weight gain in young adulthood is associated with future weight gain and increased risk of chronic disease. Although multimodal, technology-based weight-loss interventions have the potential to promote ...

Authors: Shadia J. Mansour-Assi, Natalie M. Golaszewski, Victoria Lawhun Costello, David Wing, Hailey Persinger, Aaron Coleman, Leslie Lytle, Britta A. Larsen, Sonia Jain, Nadir Weibel, Cheryl L. Rock, Kevin Patrick, Eric Hekler and Job G. Godino

Effect of low-load resistance training with different degrees of blood flow restriction in patients with knee osteoarthritis: study protocol for a randomized trial

Knee osteoarthritis (KOA) is a common degenerative disease that causes pain, functional impairment, and reduced quality of life. Resistance training is considered as an effective approach to reduce the risk of...

Authors: Hao-Nan Wang, Yan Chen, Lin Cheng, Shen-Tao Wang, De-Xin Hu, Li-Na Wang and Guo-Xin Ni

Impact of telelactation services on breastfeeding outcomes among Black and Latinx parents: protocol for the Tele-MILC randomized controlled trial

Breastfeeding offers many medical and neurodevelopmental advantages for birthing parents and infants; however, the majority of parents stop breastfeeding before it is recommended. Professional lactation suppor...

Authors: Lori Uscher-Pines, Jill Demirci, Molly Waymouth, Rebecca Lawrence, Amanda Parks, Ateev Mehrotra, Kristin Ray, Maria DeYoreo and Kandice Kapinos

Low-dose corticosteroid therapy for cardiogenic shock in adults (COCCA): study protocol for a randomized controlled trial

Cardiogenic shock (CS) is a life-threatening condition characterized by circulatory insufficiency caused by an acute dysfunction of the heart pump. The pathophysiological approach to CS has recently been enric...

Authors: Armand Mekontso Dessap, François Bagate, Clément Delmas, Tristan Morichau-Beauchant, Bernard Cholley, Alain Cariou, Benoit Lattuca, Mouhamed Moussa, Nicolas Mongardon, Damien Fard, Matthieu Schmidt, Adrien Bouglé, Mathieu Kerneis, Emmanuel Vivier, François Roubille, Matthieu Duprey…

Does serum progesterone level impact the ongoing pregnancy rate in frozen embryo transfer under artificial preparation with vaginal progesterone? Study protocol for a randomized controlled trial

In previous retrospective studies, low serum progesterone level on the embryo transfer day is associated with lower clinical pregnancy and ongoing pregnancy rates. Whether adding progesterone in low serum prog...

Authors: Lin Haiyan, Yang Gang, Li Yu, Li Lin, Chen Xiaoli and Zhang Qingxue

Nutritional support and prophylaxis of azithromycin for pregnant women to improve birth outcomes in peri-urban slums of Karachi, Pakistan—a protocol of multi-arm assessor-blinded randomized controlled trial (Mumta PW trial)

Maternal undernutrition is critical in the etiology of poor perinatal outcomes and accounts for 20% of small-for-gestational-age (SGA) births. High levels of food insecurity, antenatal undernourishment, and ch...

Authors: Ameer Muhammad, Zoha Zahid Fazal, Benazir Baloch, Imran Nisar, Fyezah Jehan and Yasir Shafiq

Efficacy of Chinese herbal medicine Jiangniaosuan formula for treatment of hyperuricemia: study protocol for a double-blinded non-inferiority randomized controlled clinical trial

Jiangniaosuan formula (JNSF) is commonly used in China for treating hyperuricemia, but there is little research-based evidence to support its use. This randomized controlled trial aims to assess the efficacy a...

Authors: Yafang Guo, Hong Lu, Jing Gan, Dongdong Li, Jiandong Gao and Changming Zhang

The effect of passive mobilization associated with blood flow restriction and combined with electrical stimulation on cardiorespiratory safety, neuromuscular adaptations, physical function, and quality of life in comatose patients in an ICU: a randomized controlled clinical trial

Intensive care unit-acquired atrophy and weakness are associated with high mortality, a reduction in physical function, and quality of life. Passive mobilization (PM) and neuromuscular electrical stimulation w...

Authors: Thaís Marina Pires de Campos Biazon, Cleiton Augusto Libardi, Jose Carlos Bonjorno Junior, Flávia Rossi Caruso, Tamara Rodrigues da Silva Destro, Naiara Garcia Molina, Audrey Borghi-Silva and Renata Gonçalves Mendes

Correction to: Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy—PREVED study: study protocol for a randomized controlled trial

Authors: Houria E. L. Ouazzani, Steeve Rouillon, Nicolas Venisse, Lynda Sifer-Rivière, Antoine Dupuis, Guillaume Cambien, Sarah Ayraud-Thevenot, Anne-Sophie Gourgues, Pascale Pierre-Eugène, Fabrice Pierre, Sylvie Rabouan, Virginie Migeot and Marion Albouy-Llaty

Correction to: Efficacy of Guizhi Fuling Wan for primary dysmenorrhea: protocol for a randomized controlled trial

Authors: Yun Du, Yatong Li, Xianyun Fu, Chenjie Li and Yanan Luo

E-nergEYEze, a vision-specific eHealth intervention based on cognitive behavioral therapy and self-management to reduce fatigue in adults with visual impairment: study protocol for a randomized controlled trial

More than half of the adults with visual impairment experience severe symptoms of fatigue, with a negative impact on daily life. Since there is no evidence-based treatment to reduce fatigue in adults with visu...

Authors: Manon H. J. Veldman, Hilde P. A. van der Aa, Christina Bode, Hans Knoop, Carel T. J. Hulshof, Marc Koopmanschap, Edwin Stavleu, Ger H. M. B. van Rens and Ruth M. A. van Nispen

Ultrasound-guided erector spinae plane catheter versus video-assisted paravertebral catheter placement in minimally invasive thoracic surgery: comparing continuous infusion analgesic techniques on early quality of recovery, respiratory function and chronic persistent surgical pain: study protocol for a double-blinded randomised controlled trial

Compared to conventional thoracotomy, minimally invasive thoracic surgery (MITS) can reduce postoperative pain, reduce tissue trauma and contribute to better recovery. However, it still causes significant acut...

Authors: Aneurin Moorthy, Aisling Ni Eochagain, Eamon Dempsey and Donal Buggy

Examining transcranial random noise stimulation as an add-on treatment for persistent symptoms in schizophrenia (STIM’Zo): a study protocol for a multicentre, double-blind, randomized sham-controlled clinical trial

One out of three patients with schizophrenia failed to respond adequately to antipsychotics and continue to experience debilitating symptoms such as auditory hallucinations and negative symptoms. The developme...

Authors: Jerome Brunelin, Marine Mondino, Julie Haesebaert, Jerome Attal, Michel Benoit, Marie Chupin, Sonia Dollfus, Wissam El-Hage, Filipe Galvao, Renaud Jardri, Pierre Michel Llorca, Laurent Magaud, Marion Plaze, Anne Marie Schott-Pethelaz, Marie-Françoise Suaud-Chagny, David Szekely…

Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children

Gestational diabetes (GDM) impacts 8–18% of pregnancies and greatly increases both maternal and child risk of developing non-communicable diseases such as type 2 diabetes and obesity. Whilst lifestyle interven...

Authors: Sharleen L. O’Reilly, Christy Burden, Cristina Campoy, Fionnuala M. McAuliffe, Helena Teede, Jesper Andresen, Karen J. Campbell, Aisling A. Geraghty, Cheryce L. Harrison, Rachel Laws, Jane E. Norman, Helle T. Maindal, Karsten Vrangbæk, Ricardo Segurado, Vincent L. Versace and Timothy C. Skinner

Protocol for the Metformin Aneurysm Trial (MAT): a placebo-controlled randomised trial testing whether metformin reduces the risk of serious complications of abdominal aortic aneurysm

Multiple observational studies have associated metformin prescription with reduced progression of abdominal aortic aneurysm (AAA). The Metformin Aneurysm Trial (MAT) will test whether metformin reduces the ris...

Authors: Jonathan Golledge, Clare Arnott, Joseph Moxon, Helen Monaghan, Richard Norman, Dylan Morris, Qiang Li, Greg Jones, Justin Roake, Matt Bown and Bruce Neal

Methodological approaches for conducting follow-up research with clinical trial participants: a scoping review and expert interviews

Evidence-based establishment and implementation of best principles, laws and ordinances that regulate clinical research depend on the consultation and involvement of trial participants. Yet, guidance on method...

Authors: Aita Signorell, Jasmina Saric, Christian Appenzeller-Herzog, Hannah Ewald, Christian Burri, Martin Goetz and Jana Gerold

Prevention of child mental health problems through parenting interventions in Southeastern Europe (RISE): study protocol for a multi-site randomised controlled trial

Childhood adversities, such as poor parental practices, exposure to violence, and risk behaviours strongly impact children’s future mental and behavioural problems. Adversities affect families living in disadv...

Authors: Diana Tăut, Adriana Băban, Inga Frantz, Ingrid Dănilă, Jamie M. Lachman, Nina Heinrichs, Catherine L. Ward, Frances Gardner, Xiangming Fang, Judy Hutchings, Marija Raleva, Galina Lesco, Hugh Murphy and Heather Foran

A comparative study of R functions for clustered data analysis

Clustered or correlated outcome data is common in medical research studies, such as the analysis of national or international disease registries, or cluster-randomized trials, where groups of trial participant...

Authors: Wei Wang and Michael O. Harhay

A mechanism-based proof of concept study on the effects of duloxetine in patients with painful knee osteoarthritis

The global burden of osteoarthritis (OA) is steadily increasing due to demographic and lifestyle changes. The nervous system can undergo peripheral and central neuroplastic changes (sensitization) in patients ...

Authors: Nadia Ammitzbøll, Lars Arendt-Nielsen, Davide Bertoli, Christina Brock, Anne Estrup Olesen, Andreas Kappel, Asbjørn Mohr Drewes and Kristian Kjær Petersen

Balloon pulmonary angioplasty combined with riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (PRACTICE study): study protocol for a randomized controlled trial

Management of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) remains a clinical challenge. Currently, riociguat, a soluble guanylate-cyclase stimulator is recommended by international guideli...

Authors: Qin-Hua Zhao, Su-Gang Gong, Jing He, Ping Yuan, Wen-Hui Wu, Ci-Jun Luo, Rong Jiang, Rui Zhang, Hong-Ling Qiu, Hui-Ting Li, Yuan Li, Jin-Ming Liu and Lan Wang

The CombinADO study to assess the impact of a combination intervention strategy on viral suppression, antiretroviral therapy adherence, and retention in HIV care among adolescents and young people living with HIV: protocol for a cluster-randomized controlled trial

Adolescents and youth living with HIV (AYAHIV) have worse HIV outcomes than other age groups, particularly in sub-Saharan Africa (SSA). AYAHIV in SSA face formidable health system, interpersonal- and individua...

Authors: Phepo Mogoba, Maia Lesosky, Allison Zerbe, Joana Falcao, Claude Ann Mellins, Christopher Desmond, Carlos Arnaldo, Bill Kapogiannis, Landon Myer and Elaine J. Abrams

Evaluation of efficacy and safety of Qiangzhu-qinggan formula as an adjunctive therapy in adult patients with severe influenza: study protocol for a randomized parallel placebo-controlled double-blind multicenter trial

Influenza can fall into three categories according to severity: mild influenza, severe influenza, and critical influenza. Severe influenza can result in critical illness and sometimes death particularly in pat...

Authors: Lei Qiu, Xian-wei Wu, Shao-yan Zhang, Ming Yang, Shun-xian Zhang, Ji-you Fu, Cui Li, Zhi-jie Zhang, Pei-yong Zheng and Zhen-hui Lu

Robotic versus Open Pancreatoduodenectomy for Pancreatic and Periampullary Tumors (PORTAL): a study protocol for a multicenter phase III non-inferiority randomized controlled trial

Pancreatoduodenectomy is a complex and challenging procedure that requires meticulous tissue dissection and proficient suturing skills. Minimally invasive surgery with the utilization of robotic platforms has ...

Authors: Jiabin Jin, Yusheng Shi, Mengmin Chen, Jianfeng Qian, Kai Qin, Zhen Wang, Wei Chen, Weiwei Jin, Fengchun Lu, Zheyong Li, Zehua Wu, Li Jian, Bing Han, Xiao Liang, Chuandong Sun, Zheng Wu…

Study protocol of a randomized controlled clinical trial investigating the effects of omega-3 supplementation on endothelial function, vascular structure, and metabolic parameters in adolescents with type 1 diabetes

Type 1 diabetes is a main health burden with several related comorbidities. It has been shown that endothelial function, vascular structure, and metabolic parameters are considerably disrupted in patients with...

Authors: Masoud Khorshidi, Aliakbar Sayyari, Beheshteh Olang, Mohammad Reza Alaei, Sakineh Shab-Bidar, Mitra Khalili, Masoud Salehi and Naheed Aryaeian

Protocol of investigation into reporting quality of RCT abstracts on COVID-19 pursuant to CONSORT (CoCo study)—a review

In 2020, the COVID-19 pandemic developed into a global crisis, the enormity and urgency of which accelerated research activities in the field. At the same time, manuscripts describing these research projects u...

Authors: Sabrina Tulka, Christine Baulig and Stephanie Knippschild

Correction to: Much ado about something: a response to “COVID-19: underpowered randomised trials, or no randomised trials?”

Authors: Noah A. Haber, Sarah E. Wieten, Emily R. Smith and David Nunan

Effect of oral intake of royal jelly on endothelium function in hemodialysis patients: study protocol for multicenter, double-blind, randomized control trial

Hemodialysis (HD) is a common renal replacement therapy for patients with renal failure. Cardiovascular and cerebrovascular diseases are known to shorten survival periods and worsen the quality of life of HD p...

Authors: Kojiro Ohba, Yasuyoshi Miyata, Takeaki Shinzato, Satoshi Funakoshi, Kanenori Maeda, Tomohiro Matsuo, Kensuke Mitsunari, Yasushi Mochizuki, Tomoya Nishino and Hideki Sakai

Promoting Independence Through quality dementia Care at Home (PITCH): a research protocol for a stepped-wedge cluster-randomised controlled trial

Home care service providers are increasingly supporting clients living with dementia. Targeted and comprehensive dementia-specific training for home care staff is necessary to meet this need. This study evalua...

Authors: Steven Savvas, Anita M. Y. Goh, Frances Batchelor, Colleen Doyle, Erica Wise, Esther Tan, Anita Panayiotou, Sue Malta, Margaret Winbolt, Phillip Clarke, Jason Burton, Lee-Fay Low, Samantha M. Loi, Anne Fairhall, Meg Polacsek, Jay Stiles…

A cross-sectional survey of potential factors, motivations, and barriers influencing research participation and retention among people who use drugs in the rural USA

Despite high morbidity and mortality among people who use drugs (PWUD) in rural America, most research is conducted within urban areas. Our objective was to describe influencing factors, motivations, and barri...

Authors: Angela T. Hetrick, April M. Young, Miriam R. Elman, Sarann Bielavitz, Rhonda L. Alexander, Morgan Brown, Elizabeth Needham Waddell, P. Todd Korthuis and Kathryn E. Lancaster

Augmenting an online self-directed intervention for gambling disorder with a single motivational interview: study protocol for a randomized controlled trial

Despite the success of gold standard cognitive-behavioral therapy for problem and disordered gambling, the majority of individuals with gambling problems do not seek or receive professional treatment. Thus, th...

Authors: Brad W. Brazeau, David C. Hodgins, John A. Cunningham, Kylie Bennett and Anthony Bennett

Comparison of extended reality and conventional methods of basic life support training: protocol for a multinational, pragmatic, noninferiority, randomised clinical trial (XR BLS trial)

Conventional cardiopulmonary resuscitation (CPR) training for the general public involves the use of a manikin and a training video, which has limitations related to a lack of realism and immersion. To overcom...

Authors: Dong Keon Lee, Chang Woo Im, You Hwan Jo, Todd Chang, Joo Lee Song, Cindy Luu, Ralph Mackinnon, Suresh Pillai, Chuen Neng Lee, Sanghoon Jheon, Soyeon Ahn and Seung Hyun Won

SIroliMus coated angioPlasty versus plain balloon angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION): study protocol for a randomized controlled trial

Percutaneous transluminal angioplasty is the current standard treatment for arteriovenous fistula (AVF) stenosis. The mid- and long-term patency with plain balloon angioplasty (PBA) is however far from satisfa...

Authors: Suh Chien Pang, Ru Yu Tan, Edward Choke, Jackie Ho, Kiang Hiong Tay, Apoorva Gogna, Farah G. Irani, Kun Da Zhuang, Luke Toh, Shaun Chan, Pradesh Krishnan, Kristen A. Lee, Sum Leong, Richard Lo, Ankur Patel, Bien Soo Tan…

Promoting physical activity and health in Hong Kong primary school children through a blended physical literacy intervention: protocol and baseline characteristics of the “Stand+Move” randomized controlled trial

Children predominantly remain sedentary in a traditional classroom. This study aimed to demonstrate the design and baseline characteristics of a three-armed intervention program that targeted enhancements in c...

Authors: Ming Hui Li, Cindy Hui Ping Sit, Stephen Heung Sang Wong, Yun Kwok Wing, Ching Kong Ng and Raymond Kim Wai Sum

INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial

Early intensive blood pressure (BP) lowering remains the most promising treatment for acute intracerebral hemorrhage (ICH), despite discordant results between clinical trials and potential variation in the tre...

Authors: Lili Song, Xin Hu, Lu Ma, Xiaoying Chen, Menglu Ouyang, Laurent Billot, Qiang Li, Paula Muñoz-Venturelli, Carlos Abanto, Octavio Marques Pontes-Neto, Arauz Antonio, Mohammad Wasay, Asita de Silva, Nguyen Huy Thang, Jeyaraj Durai Pandian, Kolawole Wasiu Wahab…

Comparison of intradialytic neuromuscular electrical stimulation and oral nutritional supplements in hemodialysis patients: study protocol for a multicenter, parallel-group, randomized controlled trial in Korea

The prevalence of sarcopenia increases as renal function decreases, and a considerable number of hemodialysis (HD) patients have sarcopenia. Exercise and nutritional support are established interventions to pr...

Authors: Mi-yeon Yu, Jae Hyeon Park, Yong Chul Kim, Jae Yoon Park and Ran-hui Cha

Correction to: Metacognitive therapy and work-focused interventions for patients on sick leave due to anxiety and depression: study protocol for a randomised controlled wait-list trial

Authors: Kenneth Sandin, Ragne G. H. Gjengedal, Kåre Osnes, Marit Hannisdal, Torkil Berge, Jonas S. R. Leversen, Lars G. Røv, Silje Endresen Reme, Suzanne Lagerveld, Roland Blonk, Hans M. Nordahl, Gemma Shields, Adrian Wells and Odin Hjemdal

A survey of knowledge, perceptions and use of core outcome sets among clinical trialists

Core outcome sets (COS) are standardised sets of outcomes, which represent the minimum outcomes that should be measured and reported in clinical trials. COS can enhance comparability across health trials by re...

Authors: Chiara Bellucci, Karen Hughes, Elaine Toomey, Paula R. Williamson and Karen Matvienko-Sikar

Cast OFF-2: 1 week of plaster cast immobilization for non-reduced distal radius fractures—a study protocol for an implementation study

The distal radius fracture (DRF) is a common fracture, with the majority of these fractures being stable. Of all diagnosed fractures, 17% is a DRF, of which a large part is extra-articular and one-third is non...

Authors: Emily Boersma, Erik van de Krol, Tjarda Tromp, Maria Nijhuis - van der Sanden and Michael Edwards