Articles

Efficacy and mechanism of traditional Chinese medicine in relieving antibiotic-resistant bacterial diarrhea in children: study protocol for a randomized controlled trial

Bacterial infection is an important cause of diarrhea in children, potentially leading to malnutrition, growth and development disorders, and even death. Antibiotic abuse and resistance are widespread problems...

Authors: Chao-ran Bi, Wei Jing, Xiao-fei Xie and Yan-jing Liu

Stereotactic EEG-guided radiofrequency thermocoagulation versus anterior temporal lobectomy for mesial temporal lobe epilepsy with hippocampal sclerosis: study protocol for a randomised controlled trial

In this report, we aim to describe the design for the randomised controlled trial of Stereotactic electroencephalogram (EEG)-guided Radiofrequency Thermocoagulation versus Anterior Temporal Lobectomy for Mesia...

Authors: Yi-He Wang, Si-Chang Chen, Peng-Hu Wei, Kun Yang, Xiao-Tong Fan, Fei Meng, Jia-Lin Du, Lian-Kun Ren, Yong-Zhi Shan and Guo-Guang Zhao

Bilateral cervical plexus block for anterior cervical spine surgery: study protocol for a randomised placebo-controlled trial

There has been increasing focus to improve the quality of recovery following anterior cervical spine surgery (ACSS). Postoperative pain and nausea are the most common reasons for prolonged hospital stay and re...

Authors: Michael J. Mulcahy, Thananchayan Elalingam, Kevin Jang, Mario D’Souza and Matthew Tait

The role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trial

Tracheostomy is one of the most frequent techniques in intensive care units (ICU). Fiberoptic bronchoscopy (FB) is a safety measure when performing a percutaneous dilatational tracheostomy (PDT), but the contr...

Authors: José M. Añón, María Soledad Arellano, Manuel Pérez-Márquez, Claudia Díaz-Alvariño, José A. Márquez-Alonso, Jorge Rodríguez-Peláez, Kapil Nanwani-Nanwani, Ana Martín-Pellicer, Belén Civantos, Alba López-Fernández, Irene Seises, Jorge García-Nerín, Juan C. Figueira, Henar Casero, Javier Vejo, Alexander Agrifoglio…

Cost talk: protocol for a stepped-wedge cluster randomized trial of an intervention helping patients and urologic surgeons discuss costs of care for slow-growing prostate cancer during shared decision-making

Costs of care are important to patients making cancer treatment decisions, but clinicians often do not feel prepared to discuss treatment costs. We aim to (1) assess the impact of a conversation-based decision...

Authors: Mary C. Politi, Rachel C. Forcino, Katelyn Parrish, Marie-Anne Durand, A. James O’Malley and Glyn Elwyn

Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma (PREDICT-AEDH): study protocol for a randomized controlled trial

The expeditious surgical evacuation of acute epidural hematoma (AEDH) is an attainable gold standard and is often expected to have a good clinical outcome for patients with surgical indications. However, contr...

Authors: Chun Yang, Xianjian Huang, Junfeng Feng, Li Xie, Jiyuan Hui, Weiping Li and Jiyao Jiang

Survival analysis for AdVerse events with VarYing follow-up times (SAVVY)—estimation of adverse event risks

The SAVVY project aims to improve the analyses of adverse events (AEs), whether prespecified or emerging, in clinical trials through the use of survival techniques appropriately dealing with varying follow-up ...

Authors: Regina Stegherr, Claudia Schmoor, Jan Beyersmann, Kaspar Rufibach, Valentine Jehl, Andreas Brückner, Lewin Eisele, Thomas Künzel, Katrin Kupas, Frank Langer, Friedhelm Leverkus, Anja Loos, Christiane Norenberg, Florian Voss and Tim Friede

Improving analysis practice of continuous adverse event outcomes in randomised controlled trials - a distributional approach

Randomised controlled trials (RCTs) provide valuable information for developing harm profiles but current analysis practices to detect between-group differences are suboptimal. Drug trials routinely screen con...

Authors: Anca Chis Ster, Rachel Phillips, Odile Sauzet and Victoria Cornelius

Public access to protocols of contemporary cancer randomized clinical trials

Access to randomized clinical trial (RCT) protocols is necessary for the interpretation and reproducibility of the study results, but protocol availability has been lacking. We determined the prevalence of pro...

Authors: Christopher Babu, Loren Mell, Nancy Lee and Kaveh Zakeri

Recommendations for designing and analysing multi-arm non-inferiority trials: a review of methodology and current practice

Multi-arm non-inferiority (MANI) trials, here defined as non-inferiority trials with multiple experimental treatment arms, can be useful in situations where several viable treatments exist for a disease area o...

Authors: Jake Emmerson, Susan Todd and Julia M. Brown

The Retornus-2 study: impact of respiratory muscle training in subacute stroke patients with dysphagia, study protocol of a double-blind randomized controlled trial

Stroke can lead to varying degrees of oropharyngeal dysphagia, respiratory muscle dysfunction and even increase medical complications such as aspiration, malnutrition and death. Recent studies suggest that ins...

Authors: A. Guillen-Sola, M. Messaggi-Sartor, C. Ramírez-Fuentes, E. Marco and E. Duarte

The development of lived experience-centered word clouds to support research uncertainty gathering in degenerative cervical myelopathy: results from an engagement process and protocol for their evaluation, via a nested randomized controlled trial

AO Spine REsearch objectives and Common Data Elements for Degenerative Cervical Myelopathy [RECODE-DCM] is a multi-stakeholder consensus process aiming to promote research efficiency in DCM. It aims to establi...

Authors: Benjamin M. Davies, Oliver D. Mowforth, Danyal Z. Khan, Xiaoyu Yang, Sybil R. L. Stacpoole, Olesja Hazenbiller, Toto Gronlund, Lindsay Tetreault, Sukhvinder Kalsi-Ryan, Michelle L. Starkey, Iwan Sadler, Ellen Sarewitz, Delphine Houlton, Julia Carter, Evangeline Howard, Vafa Rahimi-Movaghar…

Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial

Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-ba...

Authors: Aziza Ajlan, Hassan Aleid, Tariq Zulfiquar Ali, Hala Joharji, Khalid Almeshari, Ahmed Mohammed Nazmi, Yaser Shah, Edward Devol, Dalal Alkortas, Zinah Alabdulkarim, Dieter Broering, Ibrahim Alahmadi, Asad Ullah, Anwar Alotaibi and Ahmed Aljedai

The effect of the mobile “blood pressure management application” on hypertension self-management enhancement: a randomized controlled trial

Self-management of hypertension is of great significance given its increasing incidence and its associated disabilities. In view of the increased use of mobile health in medicine, the present study evaluated t...

Authors: Ali Bozorgi, Hamed Hosseini, Hassan Eftekhar, Reza Majdzadeh, Ali Yoonessi, Ali Ramezankhani, Mehdi Mansouri and Mahnaz Ashoorkhani

A prospective, randomized, single-blinded, crossover trial to investigate the effect of a wearable device in addition to a daily symptom diary for the remote early detection of SARS-CoV-2 infections (COVID-RED): a structured summary of a study protocol for a randomized controlled trial

It is currently thought that most—but not all—individuals infected with SARS-CoV-2 develop symptoms, but that the infectious period starts on average two days before the first overt symptoms appear. It is esti...

Authors: Timo B. Brakenhoff, Billy Franks, Brianna Mae Goodale, Janneke van de Wijgert, Santiago Montes, Duco Veen, Eskild K. Fredslund, Theo Rispens, Lorenz Risch, Ariel V. Dowling, Amos A. Folarin, Patricia Bruijning, Richard Dobson, Tessa Heikamp, Paul Klaver, Maureen Cronin…

SUMMER Trial: mesh versus suture repair in small umbilical hernias in adults—a study protocol for a prospective randomized double-blind multicenter clinical trial

Small umbilical hernia repair is one of the most common surgical performances in general surgery. Yet, a gold standard procedure for the repair is still lacking today. There is an increasing evidence that mesh...

Authors: M. Melkemichel, S. Bringman, G. Granåsen and B. Widhe

Methods for conducting international Delphi surveys to optimise global participation in core outcome set development: a case study in gastric cancer informed by a comprehensive literature review

Core outcome sets (COS) should be relevant to key stakeholders and widely applicable and usable. Ideally, they are developed for international use to allow optimal data synthesis from trials. Electronic Delphi...

Authors: Bilal Alkhaffaf, Jane M. Blazeby, Aleksandra Metryka, Anne-Marie Glenny, Ademola Adeyeye, Paulo Matos Costa, Ismael Diez del Val, Suzanne S. Gisbertz, Ali Guner, Simon Law, Hyuk-Joon Lee, Ziyu Li, Koji Nakada, Rafael Mauricio Restrepo Nuñez, Daniel Reim, John V. Reynolds…

Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectivenes...

Authors: Lena Violetta Krämer, Nadine Eschrig, Lena Keinhorst, Luisa Schöchlin, Lisa Stephan, Malin Stiene and Jürgen Bengel

The impact of improved water supply on cholera and diarrhoeal diseases in Uvira, Democratic Republic of the Congo: a protocol for a pragmatic stepped-wedge cluster randomised trial and economic evaluation

Diarrhoeal disease remains a leading cause of mortality and morbidity worldwide. Cholera alone is estimated to cause 95,000 deaths per year, most of which occur in endemic settings with inadequate water access...

Authors: Karin Gallandat, Aurélie Jeandron, Ian Ross, Jaime Mufitini Saidi, Baron Bashige Rumedeka, Vercus Lumami Kapepula, Simon Cousens, Elizabeth Allen, Amy MacDougall and Oliver Cumming

Correction to: Is postoperative non-weight-bearing necessary? INWN Study protocol for a pragmatic randomised multicentre trial of operatively treated ankle fracture

Authors: Ramy Khojaly, Ruairí Mac Niocaill, Muhammad Shahab, Matthew Nagle, Colm Taylor, Fiachra E. Rowan and May Cleary

Using adalimumab serum concentration to choose a subsequent biological DMARD in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): study protocol for a fully blinded randomised superiority test-treatment trial

A substantial proportion of rheumatoid arthritis (RA) patients discontinues treatment with tumour necrosis factor inhibitors (TNFi) due to inefficacy or intolerance. After the failure of treatment with a TNFi,...

Authors: Maike H. M. Wientjes, Sadaf Atiqi, Gerrit Jan Wolbink, Michael T. Nurmohamed, Maarten Boers, Theo Rispens, Annick de Vries, Ronald F. van Vollenhoven, Bart J. F. van den Bemt and Alfons A. den Broeder

Effect of Baduanjin exercise intervention on cognitive function and quality of life in women with breast cancer receiving chemotherapy: study protocol of a randomized controlled trial

More than 50% cognitive impairment was reported by cancer patients before and after medical treatment. However, there are no effective interventions to manage the cognitive problem in women with breast cancer....

Authors: Xiao-Lin Wei, Ru-Zhen Yuan, Yong-Mei Jin, Shu Li, Ming-Yue Wang, Jie-Ting Jiang, Cai-Qin Wu and Kun-Peng Li

IMI2-PainCare-BioPain-RCT3: a randomized, double-blind, placebo-controlled, crossover, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by electroencephalography (EEG)

IMI2-PainCare-BioPain-RCT3 is one of four similarly designed clinical studies aiming at profiling a set of functional biomarkers of drug effects on the nociceptive system that could serve to accelerate the fut...

Authors: André Mouraux, Petra Bloms-Funke, Irmgard Boesl, Ombretta Caspani, Sonya C. Chapman, Giulia Di Stefano, Nanna Brix Finnerup, Luis Garcia-Larrea, Marcus Goetz, Anna Kostenko, Bernhard Pelz, Esther Pogatzki-Zahn, Karin Schubart, Alexandre Stouffs, Andrea Truini, Irene Tracey…

A community-based service enhancement model of training and employing Ear Health Facilitators to address the crisis in ear and hearing health of Aboriginal children in the Northern Territory, the Hearing for Learning Initiative (the HfLI): study protocol for a stepped-wedge cluster randomised trial

Almost all Aboriginal children in remote communities have persistent bilateral otitis media affecting hearing and learning throughout early childhood and school years, with consequences for social and educatio...

Authors: Kelvin Kong, Alan Cass, Amanda Jane Leach, Peter Stanley Morris, Amy Kimber, Jiunn-Yih Su and Victor Maduabuchi Oguoma

Recruiting hard-to-reach pregnant women at high psychosocial risk: strategies and costs from a randomised controlled trial

Recruiting participants to randomised controlled trials (RCTs) is often challenging, particularly when working with socially disadvantaged populations who are often termed ‘hard-to-reach’ in research. Here we ...

Authors: Alice MacLachlan, Karen Crawford, Shona Shinwell, Catherine Nixon and Marion Henderson

Effectiveness of a digitally supported care management programme to reduce unmet needs of family caregivers of people with dementia: study protocol for a cluster randomised controlled trial (GAIN)

Up to two-thirds of dementia care is provided by family caregivers who often experience high burden, little support and adverse health outcomes. Enabling and supporting family caregivers to provide care at hom...

Authors: Olga A. Klein, Melanie Boekholt, Dilshad Afrin, Christina Dornquast, Adina Dreier-Wolfgramm, Armin Keller, Bernhard Michalowsky, Ina Zwingmann, Stefan Teipel, Jochen René Thyrian, Ingo Kilimann and Wolfgang Hoffmann

An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial

Stroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences. The incidence of stroke rapidly inc...

Authors: Elvira Maranesi, Roberta Bevilacqua, Mirko Di Rosa, Giuseppe Pelliccioni, Valentina Di Donna, Riccardo Luzi, Micaela Morettini, Agnese Sbrollini, Elisa Casoni, Nadia Rinaldi, Renato Baldoni, Fabrizia Lattanzio, Laura Burattini and Giovanni R. Riccardi

The cerebral mechanism underlying the acupoints with specific effect for gallbladder stone disease: protocol for a randomized controlled task-fMRI trial

As it has been recorded in ancient Chinese classics, Yanglingquan (GB34) and Dannangxue (EX-LE6) are two important acupoints that can regulate the function of the gallbladder. Acupuncture at these two acupoint...

Authors: Ning Sun, Yuan-Fang Zhou, Jie Zhou, Wen-Wei Zuo, Xiang-Yin Ye, Xiao-Dong Deng, Zheng-Jie Li, Shi-Rui Cheng, Yu-Zhu Qu, Jun Zhou, Rui-Rui Sun and Fan-Rong Liang

Effects of seated lumbar rotation manipulation in treating degenerative lumbar instability: a protocol for a randomized controlled trial

Degenerative lumbar instability (DLI) is a common disease that causes low back pain (LBP) in clinic. It is difficult to completely recover from DLI, and it occurs repeatedly, which seriously affects the qualit...

Authors: Rui Xie, Long Liang, Kaiming Li, Jie Yu, Minshan Feng, Jiawen Zhan, Xu Wei, Kexin Yang, Zhefeng Jin, He Yin, Xin Chen, Xunlu Yin, Zhiwei Liu, Wenkang Dai and Liguo Zhu

Can patient decision aids reduce decisional conflict in a de-escalation of breast radiotherapy clinical trial? The PRIMETIME Study Within a Trial implemented using a cluster stepped-wedge trial design

For patients with early breast cancer considered at very-low risk of local relapse, risks of radiotherapy may outweigh the benefits. Decisions regarding treatment omission can lead to patient uncertainty (deci...

Authors: Indrani S. Bhattacharya, Joanne S. Haviland, Lesley Turner, Hilary Stobart, Ada Balasopoulou, Liba Stones, Anna M. Kirby, Cliona C. Kirwan, Charlotte E. Coles and Judith M. Bliss

Recruitment and retention rates in randomised controlled trials of exercise therapy in people with multimorbidity: a systematic review and meta-analysis

To quantify recruitment, retention and differential retention rates and associated trial, participant and intervention characteristics in randomised controlled trials (RCTs) evaluating the effect of exercise t...

Authors: Lasse K. Harris, Søren T. Skou, Carsten B. Juhl, Madalina Jäger and Alessio Bricca

Evaluating the clinical utility of early exome sequencing in diverse pediatric outpatient populations in the North Carolina Clinical Genomic Evaluation of Next-generation Exome Sequencing (NCGENES) 2 study: a randomized controlled trial

Exome sequencing (ES) has probable utility for shortening the diagnostic odyssey of children with suspected genetic disorders. This report describes the design and methods of a study evaluating the potential o...

Authors: Brooke S. Staley, Laura V. Milko, Margaret Waltz, Ida Griesemer, Lonna Mollison, Tracey L. Grant, Laura Farnan, Myra Roche, Angelo Navas, Alexandra Lightfoot, Ann Katherine M. Foreman, Julianne M. O’Daniel, Suzanne C. O’Neill, Feng-Chang Lin, Tamara S. Roman, Alicia Brandt…

The Brain in Motion II Study: study protocol for a randomized controlled trial of an aerobic exercise intervention for older adults at increased risk of dementia

There remains no effective intervention capable of reversing most cases of dementia. Current research is focused on prevention by addressing risk factors that are shared between cardiovascular disease and deme...

Authors: Renata L. Krüger, Cameron M. Clark, Adrienna M. Dyck, Todd J. Anderson, Fiona Clement, Patrick J. Hanly, Heather M. Hanson, Michael D. Hill, David B. Hogan, Jayna Holroyd-Leduc, R. Stewart Longman, Meghan McDonough, G. Bruce Pike, Jean M. Rawling, Tolulope Sajobi and Marc J. Poulin

Polyphosphate (PolyP) for alveolar cleft repair: study protocol for a pilot randomized controlled trial

Bone grafting is an important surgical procedure to restore missing bone in patients with alveolar cleft lip/palate, aiming to stabilize either sides of the maxillary segments by inducing new bone formation, a...

Authors: S. A. Alkaabi, D. S. Natsir Kalla, G. A. Alsabri, A. Fauzi, A. Tajrin, W. E. G. Müller, H. C. Schröder, X. G. Wang, T. Forouzanfar, M. N. Helder and M. Ruslin

Short-term effects of synchronized vs. non-synchronized NIPPV in preterm infants: study protocol for an unmasked randomized crossover trial

Non-invasive ventilation (NIV) has been recommended as the best respiratory support for preterm infants with respiratory distress syndrome (RDS). However, the best NIV technique to be used as first intention i...

Authors: Francesco Cresi, Federica Chiale, Elena Maggiora, Silvia Maria Borgione, Mattia Ferroglio, Federica Runfola, Giulia Maiocco, Chiara Peila, Enrico Bertino and Alessandra Coscia

Impact of a mobile phone-based interactive voice response software on tuberculosis treatment outcomes in Uganda (CFL-TB): a protocol for a randomized controlled trial

Throughout the last decade, tuberculosis (TB) treatment success has not surpassed 90%, the global target. The impact of mobile health interventions (MHIs) on TB treatment outcomes is unknown, especially in low...

Authors: Dathan Mirembe Byonanebye, Hope Mackline, Christine Sekaggya-Wiltshire, Agnes N. Kiragga, Mohammed Lamorde, Elizabeth Oseku, Rachel King and Rosalind Parkes-Ratanshi

Integrating pharmacists into aged care facilities to improve the quality use of medicine (PiRACF Study): protocol for a cluster randomised controlled trial

Medication management in residential aged care facilities is an ongoing concern. Numerous studies have reported high rates of inappropriate prescribing and medication use in aged care facilities, which contrib...

Authors: Sam Kosari, Jane Koerner, Mark Naunton, Gregory M. Peterson, Ibrahim Haider, Emily Lancsar, David Wright, Theo Niyonsenga and Rachel Davey

Evaluation of adherence monitoring system using evriMED with a differentiated response compared to standard of care among drug-sensitive TB patients in three provinces in South Africa: a protocol for a cluster randomised control trial

South Africa has achieved drug-susceptible TB (DS-TB) treatment success of only 77% among people with new and previously treated TB. Alternative approaches are required to improve medication adherence and trea...

Authors: Noriah Maraba, Catherine Orrell, Candice M. Chetty-Makkan, Kavindhran Velen, Rachel Mukora, Liesl Page-Shipp, Pren Naidoo, M. Thulani Mbatha, Katherine L. Fielding and Salome Charalambous

The quality of intervention reporting in trials of therapeutic exercise for hip osteoarthritis: a secondary analysis of a systematic review

Therapeutic exercise is recommended as a core treatment for hip osteoarthritis (HOA). Whilst it is widely accepted that exercise can improve pain and disability, optimal type and dose of exercise are yet to be...

Authors: Louise C. Burgess, Thomas W. Wainwright, Khara A. James, Johan von Heideken and Maura D. Iversen

Auricular acupressure for myopia prevention and control in children and its effect on choroid and retina: a randomized controlled trial protocol

Nowadays, because of the increasing incidence, the prevention and control of myopia has become an urgent issue. In China, auricular acupressure has been commonly used in the clinical treatment of myopia in chi...

Authors: Rong Han, Xie-he Kong, Feng Zhao, Yan-ting Yang, Xiao-qing Dong, Li Zeng, Zhi Chen, Yue Zhao, Guang Yang, Jue Hong, Xing-tao Zhou and Xiao-peng Ma

The cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trial

Many patients with chronic insomnia disorder (CID) have gastrointestinal (GI) symptoms. First-line insomnia medications do not treat GI problems. Acupuncture has a comprehensive regulative action on both CID a...

Authors: Wei Peng, Xiaojuan Hong, Yaru Huangfu, Zhao Sun, Wei Shen, Fen Feng, Liang Gong, Zhifu Shen, Baojun Guo, Leixiao Zhang, Yanan Wang, Ying Zhao, Tianmin Zhu, Youping Hu and Siyi Yu

SWE and SMI ultrasound techniques for monitoring needling treatment of ankylosing spondylitis: study protocol for a single-blinded randomized controlled trial

Ankylosing spondylitis (AS) is a high-incidence disease in young men that interferes with patients’ physical and mental wellbeing and overall quality of life (QoL). It is often accompanied by arthralgia, stiff...

Authors: Mengyu Wang, Wen Fu, Lingcui Meng, Jia Liu, Lihua Wu, Yingjun Peng and Ziping Li

Prophylaxis for patients at Risk to Eliminate Post-operative Atrial Fibrillation (PREP-AF trial): a protocol for a feasibility randomized controlled study

Postoperative atrial fibrillation (POAF) is a frequent adverse event after thoracic surgery with associated morbidity, mortality, and healthcare costs. It has been shown to be preventable with prophylactic ami...

Authors: Heather A. Smith, Salmaan Kanji, Diem T. T. Tran, Calum Redpath, Dean Ferguson, Tori Lenet, Greg Sigler, Sebastien Gilbert, Donna Maziak, Patrick Villeneuve, Sudhir Sundaresan and Andrew J. E. Seely

Assessing the efficacy of a stepped-care group treatment programme for borderline personality disorder: study protocol for a pragmatic trial

Borderline personality disorder (BPD) is a high prevalence and serious mental health disorder that has historically challenged the finite resources of health services. Despite empirical evidence supporting str...

Authors: Judy A. Pickard, Adam Finch, Elizabeth Huxley, Michelle L. Townsend, Stephanie Deuchar, Kate L. Lewis, Jason Pratt and Brin F. S. Grenyer

Maternal low-intensity psychosocial telemental interventions in response to COVID-19 in Qatar: study protocol for a randomized controlled trial

As COVID-19 is spreading, new psychological health problems are suspected to be emerging among pregnant women. Higher maternal mental health distress, including perinatal anxiety, depression, and COVID-19-spec...

Authors: Sarah Naja, Rowaida Elyamani, Mohamad Chehab, Mohamed Siddig, Abdullah Al Ibrahim, Tagreed Mohamad, Rajvir Singh and Iheb Bougmiza

Letter on “Sharing trial results directly with trial participants and other stakeholders after the SARS-CoV-2 pandemic hit the UK – experience from the ActWELL trial”

After the SARS-CoV-2 pandemic took hold in the UK, the ActWELL trial team’s plans to present the trial results to participants and other stakeholders had to change. Instead of face-face events, three online ev...

Authors: Hanne Bruhn, Annie S. Anderson, Amy Hickman, E. Jane Macaskill and Shaun Treweek

Patient-Reported OUtcome measures in key African languages to promote Diversity in research and clinical practice (PROUD)—protocol for a systematic review of measurement properties

Sub-Saharan Africa is a subcontinent with a proud cultural richness and diversity, yet inexplicably also a region with severe health care challenges and inequity. To challenge this health equity gap and reduce...

Authors: Martin Heine, Lidwine B. Mokkink, Chanel van Zyl, Wayne Derman and Susan Hanekom

A framework for handling missing accelerometer outcome data in trials

Accelerometers and other wearable devices are increasingly being used in clinical trials to provide an objective measure of the impact of an intervention on physical activity. Missing data are ubiquitous in th...

Authors: Mia S. Tackney, Derek G. Cook, Daniel Stahl, Khalida Ismail, Elizabeth Williamson and James Carpenter

Safety and efficacy of Ayurvedic interventions and Yoga on long term effects of COVID-19: A structured summary of a study protocol for a randomized controlled trial

Primary Objective

Authors: Babita Yadav, Amit Rai, Pallavi Suresh Mundada, Richa Singhal, B. C. S. Rao, Rakesh Rana and Narayanam Srikanth

Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial

Sepsis is associated with capillary leakage and vasodilatation and leads to hypotension and tissue hypoperfusion. Early plasma volume replacement is required to achieve haemodynamic stability (HDS) and maintai...

Authors: Gernot Marx, Kai Zacharowski, Carole Ichai, Karim Asehnoune, Vladimír Černý, Rolf Dembinski, Ricard Ferrer Roca, Dietmar Fries, Zsolt Molnar, Peter Rosenberger, Manuel Sanchez-Sanchez, Tobias Schürholz, Tamara Dehnhardt, Sonja Schmier, Elke von Kleist, Ute Brauer…