Articles

UVR-sensor wearable device intervention to improve sun behaviors and reduce sunburns in melanoma survivors: study protocol of a parallel-group randomized controlled trial

Individuals who have been diagnosed with melanoma have more than a 9-fold increased risk of developing another melanoma. Ultraviolet radiation (UVR) exposure following a melanoma diagnosis can be modified to r...

Authors: Rachel I. Vogel, Rebekah H. Nagler, Rehana L. Ahmed, Katherine Brown, Xianghua Luo, Brian C. Martinson and DeAnn Lazovich

Individualized hemodynamic optimization guided by indirect measurement of the respiratory exchange ratio in major surgery: study protocol for a randomized controlled trial (the OPHIQUE study)

Observational studies have suggested that a high respiratory exchange ratio (RER) is associated with the occurrence of postoperative complications. The study’s primary objective is to demonstrate that the inci...

Authors: Stéphane Bar, Pierre Boivin, Younes El Amine, Richard Descamps, Mouhamed Moussa, Osama Abou Arab, Marc-Olivier Fischer, Hervé Dupont, Emmanuel Lorne and Pierre-Grégoire Guinot

Corticosteroids versus clobazam in epileptic encephalopathy with ESES: a European multicentre randomised controlled clinical trial (RESCUE ESES*)

Epileptic encephalopathy with electrical status epilepticus in sleep (ESES) is an epilepsy syndrome occurring almost exclusively in children, usually at an age between 4 and 12 years. It is characterised by ab...

Authors: Bart van den Munckhof, Alexis Arzimanoglou, Emilio Perucca, Heleen C. van Teeseling, Frans S. S. Leijten, Kees P. J. Braun and Floor E. Jansen

Point-of-care molecular testing and antiviral treatment of influenza in residents of homeless shelters in Seattle, WA: study protocol for a stepped-wedge cluster-randomized controlled trial

Influenza is an important public health problem, but data on the impact of influenza among homeless shelter residents are limited. The primary aim of this study is to evaluate whether on-site testing and antiv...

Authors: Kira L. Newman, Julia H. Rogers, Denise McCulloch, Naomi Wilcox, Janet A. Englund, Michael Boeckh, Timothy M. Uyeki, Michael L. Jackson, Lea Starita, James P. Hughes and Helen Y. Chu

Oral corticosteroids for post-infectious cough in adults: study protocol for a double-blind randomized placebo-controlled trial in Swiss family practices (OSPIC trial)

Cough is a common reason for patients to visit general practices. So-called post-infectious cough is defined as lasting 3 to 8 weeks after an upper respiratory tract infection. It can be disabling in daily act...

Authors: Christoph Merlo, Stefan Essig, D. Oana Brancati-Badarau, Jörg Daniel Leuppi, Benjamin Speich, Tobias E. Erlanger, Lars G. Hemkens and Andreas Zeller

Developing and testing the effectiveness of a novel online integrated treatment for problem gambling and tobacco smoking: a protocol for an open-label randomized controlled trial

Gambling and tobacco smoking are highly comorbid among North American adults. However, there is a paucity of treatment options that are integrated (i.e. targeting both gambling and tobacco smoking simultaneous...

Authors: Elena Bilevicius, Alanna Single, Chris Baumgartner, Van Bui, Tyler Kempe, Michael P. Schaub, Sherry H. Stewart, James MacKillop, David C. Hodgins, Jeffrey D. Wardell, Roisin O’Connor, Jennifer Read, Heather Hadjistavropoulos, Christopher Sundstrom and Matthew T. Keough

Effects of tibial and parasacral nerve electrostimulation techniques on women with poststroke overactive bladder: study protocol for a randomized controlled trial

Neurogenic bladder (NB) can affect people after stroke episodes. NB features changes in the normal voiding pattern at the bladder filling and emptying phases. Overactive NB is characterized by urgency symptoms...

Authors: Thais Alves Candido, Bruna Miranda Ribeiro, Cristiane Rodrigues Cardoso de Araújo, Rogério de Melo Costa Pinto, Ana Paula Magalhães Resende and Vanessa Santos Pereira-Baldon

Glasgow Early Treatment Arm Favirpiravir (GETAFIX) for adults with early stage COVID-19: A structured summary of a study protocol for a randomised controlled trial

The GETAFIX trial will test the hypothesis that favipiravir is a more effective treatment for COVID-19 infection in patients who have early stage disease, compared to current standard of care. This study will ...

Authors: Catherine R. Hanna, Kevin G. Blyth, Glenn Burley, Samantha Carmichael, Carol Evans, Samantha Hinsley, Ibrahim Khadra, Saye Khoo, Liz-Anne Lewsley, Robert R. Jones, Raman Sharma, Andrea Taladriz-Sender, Emma C. Thomson and Janet T. Scott

Zilucoplan in patients with acute hypoxic respiratory failure due to COVID-19 (ZILU-COV): A structured summary of a study protocol for a randomised controlled trial

Zilucoplan (complement C5 inhibitor) has profound effects on inhibiting acute lung injury post COVID-19, and can promote lung repair mechanisms that lead to improvement in lung oxygenation parameters. The purp...

Authors: Jozefien Declercq, Cedric Bosteels, Karel Van Damme, Elisabeth De Leeuw, Bastiaan Maes, Ans Vandecauter, Stefanie Vermeersch, Anja Delporte, Bénédicte Demeyere, Marnik Vuylsteke, Marianna Lalla, Trevor Smart, Laurent Detalle, René Bouw, Johannes Streffer, Thibo Degeeter…

Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention (eMBI) on maternal mental health during pregnancy: the mindmom study protocol for a randomized controlled clinical trial

Mental disorders are common during the peripartum period and may have far-reaching consequences for both mother and child. Unfortunately, most antenatal care systems do not provide any structured screening for...

Authors: Mitho Müller, Lina Maria Matthies, Maren Goetz, Harald Abele, Sara Yvonne Brucker, Armin Bauer, Johanna Graf, Stephan Zipfel, Lena Hasemann, Markus Wallwiener and Stephanie Wallwiener

Clinical trials with cannabis medicines—guidance for ethics committees, governance officers and researchers to streamline ethics applications and ensuring patient safety: considerations from the Australian experience

With cannabis medicines now obtaining legal status in many international jurisdictions (generally on the authorisation of a medical professional), a rapid increase in consumer demand for access to cannabis as ...

Authors: Jennifer H. Martin, Courtney Hill, Anna Walsh, Daryl Efron, Kaitlyn Taylor, Michael Kennedy, Rachel Galettis, Paul Lightfoot, Julie Hanson, Helen Irving, Meera Agar and Judith Lacey

Digital crowdsourced intervention to promote HIV testing among MSM in China: study protocol for a cluster randomized controlled trial

Men who have sex with men (MSM) are an important HIV key population in China. However, HIV testing rates among MSM remain suboptimal. Digital crowdsourced media interventions may be a useful tool to reach this...

Authors: Ci Ren, Joseph D. Tucker, Weiming Tang, Xiaorun Tao, Meizhen Liao, Guoyong Wang, Kedi Jiao, Zece Xu, Zhe Zhao, Yu Yan, Yuxi Lin, Chuanxi Li, Lin Wang, Yijun Li, Dianmin Kang and Wei Ma

Analysis and reporting of stratified cluster randomized trials—a systematic survey

In order to correctly assess the effect of intervention from stratified cluster randomized trials (CRTs), it is necessary to adjust for both clustering and stratification, as failure to do so leads to misleadi...

Authors: Sayem Borhan, Alexandra Papaioannou, Jinhui Ma, Jonathan Adachi and Lehana Thabane

CovEMERALD: Assessing the feasibility and preliminary effectiveness of remotely delivered Eye Movement Desensitisation and Reprocessing following Covid-19 related critical illness: A structured summary of a study protocol for a randomised controlled trial

Primary Objective: To determine the feasibility of delivering a protocolised, remote, online, Eye Movement Desensitisation and Reprocessing (EMDR) intervention, within 12-weeks of hospital discharge, for adult su...

Authors: Andrew Bates, Sophie Rushbrook, Elan Shapiro, Michael Grocott and Rebecca Cusack

Case management after acquired brain injury compared to care as usual: study protocol for a 2-year pragmatic randomized controlled superiority trial with two parallel groups

People with acquired brain injury may suffer from cognitive, emotional and behavioural changes in the long term. Continuity of care is often lacking, leading to a variety of unmet needs and hindering psychosoc...

Authors: Annemarie P. M. Stiekema, Christine Resch, Mireille Donkervoort, Natska Jansen, Kitty H. M. Jurrius, Judith M. Zadoks and Caroline M. van Heugten

Correction to: Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial

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

Authors: Christina M. Eckhardt, Matthew J. Cummings, Kartik N. Rajagopalan, Sarah Borden, Zachary C. Bitan, Allison Wolf, Alex Kantor, Thomas Briese, Benjamin J. Meyer, Samuel D. Jacobson, Dawn Scotto, Nischay Mishra, Neena M. Philip, Brie A. Stotler, Joseph Schwartz, Beth Shaz…

Assessing effectiveness and implementation of a perioperative enhanced recovery protocol for children undergoing surgery: study protocol for a prospective, stepped-wedge, cluster, randomized, controlled clinical trial

Perioperative enhanced recovery protocols (ERPs) have been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but evidence for pediatric population...

Authors: Mehul V. Raval, Erin Wymore, Martha-Conley E. Ingram, Yao Tian, Julie K. Johnson and Jane L. Holl

The BEACON study: protocol for a cohort study as part of an evaluation of the effectiveness of smartphone-assisted problem-solving therapy in men who present with intentional self-harm to emergency departments in Ontario

Patients who present to emergency departments after intentional self-harm are at an increased risk of dying by suicide. This applies particularly to men, who represent nearly two-thirds of those who die by sui...

Authors: Simon Hatcher, Marnin Heisel, Oyedeji Ayonrinde, Julie K. Campbell, Ian Colman, Daniel J. Corsi, Nicole E. Edgar, Lindsay Gillett, Sidney H. Kennedy, Sophia Lakatoo Hunt, Paul Links, Sarah MacLean, Viraj Mehta, Christopher Mushquash, Alicia Raimundo, Sakina J. Rizvi…

Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide: study protocol for a randomized controlled trial in veterans

At least 17 veterans die every day from suicide. Although existing treatments such as brief cognitive behavioral therapy (BCBT) have been found to reduce suicide attempts in military personnel, a number of pat...

Authors: Melanie L. Bozzay, Jennifer M. Primack, Hannah R. Swearingen, Jennifer Barredo and Noah S. Philip

Effectiveness and tolerability of repetitive transcranial magnetic stimulation for preventive treatment of episodic migraine: a single-centre, randomised, double-blind, sham-controlled phase 2 trial (Magnet-EM)

This is a phase II randomised, double-blind, sham-controlled trial to evaluate the effectiveness and tolerability of repetitive transcranial magnetic stimulation for preventive treatment of episodic migraine a...

Authors: Nabil Izzaatie Mohamad Safiai, Nur Ain Amir, Hamidon Basri, Liyana Najwa Inche Mat, Fan Kee Hoo, Abdul Hanif Khan Yusof Khan, Wei Chao Loh, Peck Kee Chia, Vasudevan Ramachandran, Hazwan Mat Din, Intan Nureslyna Samsudin, Aaron Fernandez, Mohd Hazmi Mohamed, Siew Mooi Ching, Hasnur Zaman Hashim and Wan Aliaa Wan Sulaiman

A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©

Epilepsy extends far beyond seizures; up to 80% of children with epilepsy (CWE) may have comorbid cognitive or mental health problems, and up to 50% of parents of CWE are at risk for major depression. Past res...

Authors: Klajdi Puka, Karen Bax, Andrea Andrade, Margo Devries-Rizzo, Hema Gangam, Simon Levin, Maryam N. Nouri, Asuri N. Prasad, Mary Secco, Guangyong Zou and Kathy N. Speechley

Measuring effects on intima-media thickness: an evaluation of rosuvastatin in Chinese subjects with subclinical atherosclerosis—design, rationale, and methodology of the METEOR-China study

The beneficial effect of statins on atherosclerosis and cardiovascular outcomes has been well established. The Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin (METEOR) global study d...

Authors: Yilong Wang, Anxin Wang, Hongwei Li, Zhanquan Li, Bo Hu, Xiaogang Li, Huaguang Zheng, Lu Fu, Hongtao Hu, Zhiyu Nie, Yulin Qin, Bilian Zhao, Di Wei, Björn W. Karlson, Michiel L. Bots, Yundai Chen…

Cov-hep study: heparin in standard anticoagulation based on citrate for continuous veno-venous hemodialysis in patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial

The primary objective is to test if heparin added to a standard regional anticoagulation protocol based on citrate is able to reduce dialysis circuit losses by clotting without increasing the risk of thrombocy...

Authors: Paulo Ricardo Gessolo Lins, Claudia Coimbra César de Albuquerque, Camila Fernandes Assis, Bruna Cristine Duarte Rodrigues, Beatriz Pinto e Siqueira Campos, Eduardo de Oliveira Valle, Carla Paulina Sandoval Cabrera, Jeison de Oliveira Gois, Gabriela Cardoso Segura, Fernando Louzada Strufaldi, Lorena Catelan Mainardes, Rayra Gomes Ribeiro, Daniela Del Pilar Via Reque Cortes, Luciana Gil Lutf, Márcia Fernanda Arantes de Oliveira, Gabriel Teixeira Montezuma Sales…

The effect of surfactant on clinical outcome of patients with COVID-19 under mechanical ventilation: A structured summary of a study protocol for a randomised controlled trial

Assessing the effect of surfactant on clinical outcome in patients with COVID-19 under mechanical ventilation

Authors: Ali Dabbagh, Samira Rajaei, Mehdi Ghahremani, Mohammad Fathi, Nilofar Massoudi, Sasan Tavana, Kamal Fani, Navid Nooraee, Nasser Malekpour Alamdari, Sara Besharat, Arash Najafi Abrandabadi, Ali Pirsalehi and Mohammad Ali Khabiri Khatiri

Negative pressure wound therapy (NPWT) on closed incisions to prevent surgical site infection in high-risk patients in hepatopancreatobiliary surgery: study protocol for a randomized controlled trial—the NP-SSI trial

Incisional surgical site infections (iSSI) in hepatopancreatobiliary (HPB) surgery usually lead to prolonged hospital stays, consume valuable resources, and impact on patients’ outcome. Prophylactic closed inc...

Authors: Frank W. Brennfleck, Lena Linsenmeier, Henrik H.G. Junger, Katharina M. Schmidt, Jens M. Werner, Daniel Woehl, Florian Zeman, Ingrid Mutzbauer, James A. Hutchinson, Edward K. Geissler, Hans J. Schlitt and Stefan M. Brunner

Analysis of multicenter clinical trials with very low event rates

In a five-arm randomized clinical trial (RCT) with stratified randomization across 54 sites, we encountered low primary outcome event proportions, resulting in multiple sites with zero events either overall or...

Authors: Jiyu Kim, Andrea B. Troxel, Scott D. Halpern, Kevin G. Volpp, Brennan C. Kahan, Tim P. Morris and Michael O. Harhay

Process evaluation within pragmatic randomised controlled trials: what is it, why is it done, and can we find it?—a systematic review

Process evaluations are increasingly conducted within pragmatic randomised controlled trials (RCTs) of health services interventions and provide vital information to enhance understanding of RCT findings. Howe...

Authors: Caroline French, Hilary Pinnock, Gordon Forbes, Imogen Skene and Stephanie J. C. Taylor

Acupuncture for chronic stable angina pectoris based on the theory of Meridian-Viscera Association: study protocol for a multicenter randomized controlled trial

Acupuncture has long been used to treat chronic stable angina pectoris (CSAP), but the acupuncture prescription for CSAP varies. This trial will compare the therapeutic effects between the acupoints on the Hea...

Authors: Zhaoxuan He, Yi Yang, Qiao Wen, Tao Yin, Zhengjie Li, Peihong Ma, Hui Zheng, Yunhong Yang, Yongliang Jiang, Jianqiao Fang, Lei Lan and Fang Zeng

A collaborative care psychosocial intervention to improve late life depression in socioeconomically deprived areas of Guarulhos, Brazil: the PROACTIVE cluster randomised controlled trial protocol

The elderly population has been growing in most low- and middle-income countries (LMIC), and depression is a common condition among these populations. The lack of integration between mental health and primary ...

Authors: Marcia Scazufca, Carina Akemi Nakamura, Tim J. Peters, Maiara Garcia Henrique, Antônio Seabra, Ehidee Gomez La Rotta, Renato M. Franzin, Daniele Ferreira Martins, Pepijn Van de Ven, William Hollingworth and Ricardo Araya

Effects of strategies to improve general practitioner-nurse collaboration and communication in regard to hospital admissions of nursing home residents (interprof ACT): study protocol for a cluster randomised controlled trial

In Germany, up to 50% of nursing home residents are admitted to a hospital at least once a year. It is often unclear whether this is beneficial or even harmful. Successful interprofessional collaboration and c...

Authors: Christiane Müller, Berit Hesjedal-Streller, Nina Fleischmann, Britta Tetzlaff, Tina Mallon, Martin Scherer, Sascha Köpke, Katrin Balzer, Linda Gärtner, Indre Maurer, Tim Friede, Hans-Helmut König and Eva Hummers

The rescue intervention strategy for asthma patients under severe air pollution: a protocol for a single-centre prospective randomized controlled trial

Asthma is a common chronic airway inflammatory disease. Exacerbations of asthma not only accelerate the progression of the disease but also increase the incidence of hospitalization and death. Studies have sho...

Authors: Xiaoyu Yang, Junjun Huang, Yan Hu, Cuiyan Guo, Xi Wang, Zhao Yang, Tianyu Zhou and Guangfa Wang

Evaluation of the efficacy and safety of fire needle compared to filiform needle on knee osteoarthritis: study protocol for a randomized controlled trial

Knee osteoarthritis is a common clinical chronic degenerative disease associated with high morbidity and long-term disability. Previous studies have confirmed the efficacy of acupuncture on knee osteoarthritis...

Authors: Yuanjie Gao, Lu Liu, Bin Li, Jing Guo, Huilin Liu, Shaosong Wang, Fan Zhang, Xu Ji, Yuanbo Fu, Yizhan Wang, Jingqing Sun and Fang Yuan

Effectiveness of theta and gamma electroacupuncture for post-stroke patients on working memory and electrophysiology: study protocol for a double-center, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial

Practitioners of complementary and alternative medicine have suggested that electroacupuncture (EA) could improve post-stroke cognitive impairment, based on the clinical evidence. This study protocol is aimed ...

Authors: Jing-Jing Xu, Meng Ren, Jing-Jun Zhao, Jia-Jia Wu, Si-Cong Zhang, Yan-Biao Zhong, Shu-Tian Xu, Zhong-Yao Cao, Zhi-Qing Zhou, Yuan-Li Li and Chun-Lei Shan

A study protocol for HEalth-Related quality of life-intervention in survivors of Breast and other cancers experiencing cancer-related fatigue using TraditionAL Chinese Medicine: the HERBAL trial

Cancer-related fatigue (CRF) is a debilitating condition which commonly affects cancer survivors. The management of CRF remains a challenge due to the lack of effective pharmacological interventions. Tradition...

Authors: Ning Yi Yap, Wei Sheng Loo, Huang Fang Zheng, Quan Ming Tan, Tze Kiat Tan, Leona Yan Peng Quek, Chia Jie Tan, Yi Long Toh, Chiu Chin Ng, Seng Kok Ang, Veronique Kiak Mien Tan, Han Kiat Ho, Lita Chew, Kiley Wei-Jen Loh, Tira Jing Ying Tan and Alexandre Chan

Efficacy of Tong-Xie-Yao-Fang granule and its impact on whole transcriptome profiling in diarrhea-predominant irritable bowel syndrome patients: study protocol for a randomized controlled trial

Irritable bowel syndrome (IBS) is one kind of common functional bowel disease with obscure pathogenesis, and exploration about whole transcriptome profiling in IBS-D is still negligible. Conventional medicatio...

Authors: Yan Wang, Yong-quan Huang, Shui-lian Zhu, Chang-rong Zhang, Xin-lin Chen, Qiu-ke Hou and Feng-bin Liu

Parental perspectives long term after neonatal clinical trial participation: a survey

Although recruiting newborns is ethically challenging, clinical trials remain essential to improve neonatal care. There is a lack of empirical data on the parental perspectives following participation of their...

Authors: Thomas Salaets, Emilie Lavrysen, Anne Smits, Sophie Vanhaesebrouck, Maissa Rayyan, Els Ortibus, Jaan Toelen, Laurence Claes and Karel Allegaert

Salivary and Nasal Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses (BBCovid): A structured summary of a study protocol for a randomised controlled trial

- To describe the evolution of the SARS-CoV-2 salivary viral load of patients infected with Covid-19, performing 7 days of tri-daily mouthwashes with and without antivirals.

Authors: Florence Carrouel, Stéphane Viennot, Martine Valette, Jean-Marie Cohen, Claude Dussart and Denis Bourgeois

Hyperimmune anti-COVID-19 IVIG (C-IVIG) Therapy for Passive Immunization of Severe and Critically Ill COVID-19 Patients: A structured summary of a study protocol for a randomised controlled trial

The aim of this trial is to investigate the safety and clinical efficacy of passive immunization therapy through Hyperimmune anti-COVID-19 Intravenous Immunoglobulin (C-IVIG: 5% liquid formulation), on severe ...

Authors: Shaukat Ali, Shobha Luxmi, Fatima Anjum, Sheikh Muhammad Muhaymin, Syed Muneeb Uddin, Ayesha Ali, Mir Rashid Ali, Sohaib Tauheed, Mujtaba Khan, Mohsin Bajwa, Saif Ullah Baig, Elisha Shalim, Iqra Ahmed, Abdul Samad Khan and Saeed Quraishy

A Trial of Favipiravir and Hydroxychloroquine combination in Adults Hospitalized with moderate and severe Covid-19: A structured summary of a study protocol for a randomised controlled trial

The selected combination was based on limited evidence clinically and in vitro on the efficacy of the Favipiravir and Hydroxychloroquine in SARS-CoV-2. The two medications were listed in many guidelines as tre...

Authors: Mohammad Bosaeed, Ebrahim Mahmoud, Mohammad Hussein, Ahmad Alharbi, Abdulrahman Alsaedy, Adel Alothman, Majed Aljeraisy, Hajar Alqahtani, Marwan Nashabat, Badriah Almutairi, Manar Almaghaslah, Omar Aldibasi, Sameera AlJohani, Abderrezak Bouchama, Yaseen Arabi and Ahmad Alaskar

First-line support for assistance in breathing in children: statistical and health economic analysis plan for the FIRST-ABC trial

The FIRST-ABC trial comprises of two pragmatic, multicentre, parallel groups, non-inferiority randomised clinical trials designed to evaluate the clinical non-inferiority of first-line use of high flow nasal c...

Authors: Izabella Orzechowska, M. Zia Sadique, Karen Thomas, Peter Davis, Kevin P. Morris, Paul R. Mouncey, Mark J. Peters, Alvin Richards-Belle, Lyvonne N. Tume, Padmanabhan Ramnarayan and David A. Harrison

Atorvastatin and Aspirin as Adjuvant Therapy in Patients with SARS-CoV-2 Infection: A structured summary of a study protocol for a randomised controlled trial

To assess the impact of adding statin (atorvastatin) and/or aspirin on clinical deterioration in patients infected with SARS-CoV-2 who require hospitalisation. The safety of these drugs in COVID-19 patients wi...

Authors: Nirmal Ghati, Ambuj Roy, Sushma Bhatnagar, Sumit Bhati, Sudha Bhushan, Manjit Mahendran, Abhishek Thakur, Pawan Tiwari, Tanima Dwivedi, Kalaivani Mani, Ritu Gupta, Anant Mohan, Rakesh Garg, Anita Saxena, Randeep Guleria and Siddharthan Deepti

Stuck-moving needle acupuncture myofascial trigger point to treat idiopathic frozen shoulder: study protocol for a randomized controlled trial

There are evidence for the efficacy of acupuncture treatment for chronic shoulder pain, however, it remains unclear the best acupuncture modes for effective treatment. We compared the effect of the myofascial ...

Authors: Yang Bai, Ying Wang, Bo Chen, Yinan Qin, Qianqian Lei, Hailong Zhao, Jingbao Lu, Qian Fan, Yali Wang, Hongbo Song, Maomao Cheng, Wei Wang, Shengen Hu, Yuan Hao Du and Tian Xia

Combined HIV Adolescent Prevention Study (CHAPS): comparison of HIV pre-exposure prophylaxis regimens for adolescents in sub-Saharan Africa—study protocol for a mixed-methods study including a randomised controlled trial

HIV remains a major public health issue, especially in Eastern and Southern Africa. Pre-exposure prophylaxis is highly effective when adhered to, but its effectiveness is limited by cost, user acceptability an...

Authors: S. Nash, J. Dietrich, A. S. Ssemata, C. Herrera, K. O’Hagan, L. Else, F. Chiodi, C. Kelly, R. Shattock, M. Chirenje, L. Lebina, S. Khoo, L-G Bekker, H. A. Weiss, C. Gray, L. Stranix-Chibanda…

Practicing outcome-based medical care using pragmatic care trials

The current separation between medical research and care is an obstacle to essential aspects of good medical practice: the verification that care interventions actually deliver the good outcomes they promise, ...

Authors: Tim E. Darsaut and Jean Raymond

Prospective reporting of statistical analysis plans for randomised controlled trials

Authors: Karla Hemming, Anna Kearney, Carrol Gamble, Tianjing Li, Peter Jüni, An-Wen Chan and Matthew R. Sydes

Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial

Primary Objective: To evaluate the efficacy and safety of oral administration of imatinib combined with the Best Conventional Care (BCC) versus placebo plus BCC in hospitalized patients with COVID-19.

Authors: Ashkan Emadi, Joel V. Chua, Rohit Talwani, Søren M. Bentzen and John Baddley

Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects

Clearly structured and comprehensive protocols are an essential component to ensure safety of participants, data validity, successful conduct, and credibility of results of randomized clinical trials (RCTs). F...

Authors: Dmitry Gryaznov, Ayodele Odutayo, Belinda von Niederhäusern, Benjamin Speich, Benjamin Kasenda, Elena Ojeda-Ruiz, Anette Blümle, Stefan Schandelmaier, Dominik Mertz, Yuki Tomonaga, Alain Amstutz, Christiane Pauli-Magnus, Viktoria Gloy, Karin Bischoff, Katharina Wollmann, Laura Rehner…

A technology-enhanced model of care for transitional palliative care versus attention control for adult family caregivers in rural or medically underserved areas: study protocol for a randomized controlled trial

Transitioning care from hospital to home is associated with risks of adverse events and poor continuity of care. These transitions are even more challenging when new approaches to care, such as palliative care...

Authors: Diane E. Holland, Catherine E. Vanderboom, Jay Mandrekar, Bijan J. Borah, Ann Marie Dose, Cory J. Ingram and Joan M. Griffin

Early recognition and response to increases in surgical site infections using optimized statistical process control charts—the Early 2RIS Trial: a multicenter cluster randomized controlled trial with stepped wedge design

Surgical site infections (SSIs) cause significant patient suffering. Surveillance and feedback of SSI rates is an evidence-based strategy to reduce SSIs, but traditional surveillance methods are slow and prone...

Authors: Deverick J. Anderson, Iulian Ilieş, Katherine Foy, Nicole Nehls, James C. Benneyan, Yuliya Lokhnygina and Arthur W. Baker

Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial

Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll st...

Authors: Leah Bührmann, Josien Schuurmans, Jeroen Ruwaard, Margot Fleuren, Anne Etzelmüller, Jordi Piera-Jiménez, Tracy Finch, Tim Rapley, Sebastian Potthoff, Bruno Aouizerate, Philip J. Batterham, Alison Calear, Helen Christensen, Claus Duedal Pedersen, David Daniel Ebert, Erik Van der Eycken…