Articles

Cognitive effectiveness of high-intensity interval training for individuals with methamphetamine dependence: a study protocol for randomised controlled trial

Cognitive deficit is a common syndrome of methamphetamine (MA) dependence. It is related to decision-making, control ability, and social functioning. High-intensity interval training (HIIT) is a training techn...

Authors: Shen Menglu, Yang Suyong, Wang Xiaoyan, Wolfgang I. Schöllhorn and Zhu Dong

RAPIDIRON: Reducing Anaemia in Pregnancy in India—a 3-arm, randomized-controlled trial comparing the effectiveness of oral iron with single-dose intravenous iron in the treatment of iron deficiency anaemia in pregnant women and reducing low birth weight deliveries

Anaemia is a worldwide problem and iron deficiency is the most common cause. In pregnancy, anaemia increases the risk of adverse maternal, foetal and neonatal outcomes.

Authors: Richard J. Derman, Shivaprasad S. Goudar, Simal Thind, Sudhir Bhandari, Zubair Aghai, Michael Auerbach, Rupsa Boelig, Umesh S. Charantimath, Rosemary Frasso, M. S. Ganachari, Kusum Lata Gaur, Michael K. Georgieff, Frances Jaeger, S Yogeshkumar, Parth Lalakia, Benjamin Leiby…

Effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain: statistical analysis plan for a randomised controlled trial

This paper describes the statistical analysis plan for a randomised controlled trial of a Healthy Lifestyle Program (HeLP) for low back pain targeting multiple health risks and behaviours, weight, physical act...

Authors: Emma Robson, Steven J. Kamper, Alix Hall, Hopin Lee, Simon Davidson, Priscilla Viana da Silva, Connor Gleadhill and Christopher M. Williams

Transcranial direct current stimulation (tDCS) in addition to walking training on walking, mobility, and reduction of falls in Parkinson’s disease: study protocol for a randomized clinical trial

Transcranial direct current stimulation (tDCS) has the potential to modulate cortical excitability and enhance the effects of walking training in people with Parkinson’s disease. This study will examine the ef...

Authors: Lucas Rodrigues Nascimento, Ester Miyuki Nakamura-Palacios, Augusto Boening, Daniel Lyrio Cabral, Alessandra Swarowsky, Guilherme Peixoto Tinoco Arêas, Wellingson Silva Paiva and Fernando Zanela da Silva Arêas

Correction to: A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPal^TM): study protocol for a multisite randomized controlled trial

Authors: Jennifer A. Rabbitts, Chuan Zhou, Rocio de la Vega, Homer Aalfs, Caitlin B. Murray and Tonya M. Palermo

Altering Dynamics of Autonomic Processing Therapy (ADAPT) trial: a novel, targeted treatment for reducing anxiety in joint hypermobility

Hypermobility is a poorly recognised and understood musculoskeletal disorder thought to affect around 20% of the population. Hypermobility is associated with reduced physiological and psychological functioning...

Authors: Geoff Davies, Jenny L. L. Csecs, Heather Ball, Jess Dare, Stephen Bremner, Robin Hosking, Hugo D. Critchley, Nick Grey and Jessica A. Eccles

Assessing the fidelity of a peer-led chronic pain management program (PAP)

Intervention fidelity is the core component of a well-designed clinical trial and processes that are used to ensure that the study intervention is delivered as planned. It affects the design and implementation...

Authors: Mimi M. Y. Tse, Shuk Kwan Tang, Shamay Ng, Yajie Li, Daphne Sze Ki Cheung and Rick Yiu Cho Kwan

Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate-to-severe ARDS—a randomized, placebo-controlled, double-blind trial

Acute respiratory distress syndrome (ARDS) is a complex clinical diagnosis with various possible etiologies. One common feature, however, is pulmonary permeability edema, which leads to an increased alveolar d...

Authors: Benedikt Schmid, Markus Kredel, Roman Ullrich, Katharina Krenn, Rudolf Lucas, Klaus Markstaller, Bernhard Fischer, Peter Kranke, Patrick Meybohm, Bernhard Zwißler and Sandra Frank

Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial

Colorectal cancer is one the most common cancers in the western world with increasing incidence. Approximately 50% of the patients develop liver metastases. Resection of liver metastases is the treatment of ch...

Authors: Sheraz Yaqub, Bjørn Atle Bjørnbeth, Jon-Helge Angelsen, Claus Wilki Fristrup, Jon Erik Grønbech, Oskar Hemmingsson, Bengt Isaksson, Ingebjørg Soterud Juel, Peter Nørgaard Larsen, Gert Lindell, Frank Viborg Mortensen, Kim Erlend Mortensen, Magnus Rizell, Per Sandström, Oddvar Mathias Sandvik, Ernesto Sparrelid…

Efficacy of a transdiagnostic ecological momentary intervention for improving self-esteem (SELFIE) in youth exposed to childhood adversity: study protocol for a multi-center randomized controlled trial

Targeting low self-esteem in youth exposed to childhood adversity is a promising strategy for preventing adult mental disorder, but psychological help remains difficult to access and accept for youth, calling ...

Authors: Maud Daemen, Mary Rose Postma, Ramon Lindauer, Iris Hoes-van der Meulen, Dorien Nieman, Philippe Delespaul, Josefien Johanna Froukje Breedvelt, Mark van der Gaag, Wolfgang Viechtbauer, Koen Schruers, David van den Berg, Claudi Bockting, Therese van Amelsvoort and Ulrich Reininghaus

Evaluation of the “Let’s Get Organized” group intervention to improve time management: protocol for a multi-centre randomised controlled trial

Time management skills are essential for living in modern society. People with mental or neurodevelopmental disorders typically have cognitive limitations, including affected time management, which might lead ...

Authors: Marie Holmefur, Afsaneh Roshanay, Suzanne White, Gunnel Janeslätt, Elin Vimefall and Kajsa Lidström-Holmqvist

ACTION-1: study protocol for a randomised controlled trial on ACT-guided heparinization during open abdominal aortic aneurysm repair

Heparin is used worldwide for 70 years during all non-cardiac arterial procedures (NCAP) to reduce thrombo-embolic complications (TEC). But heparin also increases blood loss causing possible harm for the patie...

Authors: Arno M. Wiersema, Liliane C. Roosendaal, Mark J. W. Koelemaij, Jan G. P. Tijssen, Susan van Dieren, Jan D. Blankensteijn, E. Sebastian Debus, Saskia Middeldorp, Jan M. M. Heyligers, Ymke S. Fokma, Michel M. P. J. Reijnen and Vincent Jongkind

Effects of Hydroxychloroquine on endOthelial function in eLDerly with sleep apnea (HOLD): study protocol for a randomized clinical trial

Sleep apnea and coronary artery disease are prevalent and relevant diseases. The mechanism by which sleep apnea leads to coronary artery disease remains unclear. Intermittent hypoxia, caused by sleep apnea, le...

Authors: Leticia Maria Tedesco Silva, Antonio Cortes, Beatriz Rossi, Liliana Boll, Gustavo Waclawosky, Bruna Eibel, Sandro Cadaval Gonçalves, Maria Claudia Irigoyen and Denis Martinez

Early skin contact combined with mother’s breastfeeding to shorten the process of premature infants ≤ 30 weeks of gestation to achieve full oral feeding: the study protocol of a randomized controlled trial

Most hospitalized preterm infants experience difficulties in transitioning from tube feeding to full oral feeding. Interventions to promote full oral feeding in preterm infants in the neonatal intensive care u...

Authors: Liling Li, Li Wang, Conway Niu, Chan Liu, Tianchan Lv, Futing Ji, Ling Yu, Weili Yan, Ya Lan Dou, Yin Wang, Yun Cao, Guoying Huang and Xiaojing Hu

DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population

Financial toxicity, the material and psychological burden of the cost of treatment, affects 30–50% of people with cancer, even those with health insurance. The burden of treatment cost can affect treatment adh...

Authors: Lauren M. Hamel, David W. Dougherty, Seongho Kim, Elisabeth I. Heath, Lorna Mabunda, Eyouab Tadesse, RaeAnn Hill and Susan Eggly

Improving time to palliative care review with predictive modeling in an inpatient adult population: study protocol for a stepped-wedge, pragmatic randomized controlled trial

Palliative care is a medical specialty centered on improving the quality of life (QOL) of patients with complex or life-threatening illnesses. The need for palliative care is increasing and with that the rigor...

Authors: Patrick M. Wilson, Lindsey M. Philpot, Priya Ramar, Curtis B. Storlie, Jacob Strand, Alisha A. Morgan, Shusaku W. Asai, Jon O. Ebbert, Vitaly D. Herasevich, Jalal Soleimani and Brian W. Pickering

Four-factor prothrombin complex concentrate to reduce allogenic blood product transfusion in patients with major trauma, the PROCOAG trial: study protocol for a randomized multicenter double-blind superiority study

Optimal management of severe trauma patients with active hemorrhage relies on adequate initial resuscitation. Early administration of coagulation factors improves post-traumatic coagulation disorders, and four...

Authors: Pierre Bouzat, Jean-Luc Bosson, Jean-Stéphane David, Bruno Riou, Jacques Duranteau and Jean-François Payen

ISOlation Procedure vs. conventional procedure during Distal Pancreatectomy (ISOP-DP trial): study protocol for a randomized controlled trial

Radical antegrade modular pancreatosplenectomy (RAMPS) is an isolation procedure in pancreatosplenectomy for pancreatic body/tail cancer. Connective tissues around the bifurcation of the celiac axis are dissec...

Authors: Ken-ichi Okada, Manabu Kawai, Seiko Hirono, Masayuki Sho, Masaji Tani, Ippei Matsumoto, Suguru Yamada, Ryosuke Amano, Hirochika Toyama, Yo-ichi Yamashita, Takeshi Gocho, Kazuto Shibuya, Minako Nagai, Hiromitsu Maehira, Keiko Kamei, Go Ohira…

Epidural morphine in COVID ARDS patients with high respiratory drive: a structured summary of a study protocol for a randomised controlled trial

We aim to study the effect of epidural morphine as a means to reduce high respiratory drive in COVID 19 patients on non-invasive ventilation (NIV)—primary end point—and to study its effect on respiratory param...

Authors: Swagata Tripathy and P. Bhaskar Rao

Employing a mobile health decision aid to improve decision-making for patients with advanced prostate cancer and their decision partners/proxies: the CHAMPION randomized controlled trial study design

Metastatic prostate cancer remains a lethal malignancy that warrants novel supportive interventions for patients and their decision partners and proxies. Decision aids have been applied primarily to patients w...

Authors: Lourdes R. Carhuapoma, Winter M. Thayer, Catherine E. Elmore, Jane Gildersleeve, Tanmay Singh, Farah Shaukat, Melissa K. Uveges, Tamryn Gray, Crystal Chu, Daniel Song, Patricia J. Hollen, Jennifer Wenzel and Randy A. Jones

Stepped care for depression at integrated chronic care centers (IC3) in Malawi: study protocol for a stepped-wedge cluster randomized controlled trial

Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease—including HIV/AIDS. Additionally, depression is a leading cause of disability in the c...

Authors: Ryan K. McBain, Owen Mwale, Todd Ruderman, Waste Kayira, Emilia Connolly, Mark Chalamanda, Chiyembekezo Kachimanga, Brown David Khongo, Jesse Wilson, Emily Wroe, Giuseppe Raviola, Stephanie Smith, Sarah Coleman, Ksakrad Kelly, Amruta Houde, Mahlet G. Tebeka…

The impact of i-PUSH on maternal and child health care utilization, health outcomes, and financial protection: study protocol for a cluster randomized controlled trial based on financial and health diaries data

Universal Health Coverage ensures access to quality health services for all, with no financial hardship when accessing the needed services. Nevertheless, access to quality health services is marred by substant...

Authors: Amanuel Abajobir, Richard de Groot, Caroline Wainaina, Anne Njeri, Daniel Maina, Silvia Njoki, Nelson Mbaya, Hermann Pythagore Pierre Donfouet, Menno Pradhan, Wendy Janssens and Estelle M. Sidze

Vaccine trials during a pandemic: potential approaches to ethical dilemmas

Ever since the emergence of the coronavirus disease 2019 (COVID-19), global public health infrastructures and systems, along with community-wide collaboration and service, have risen to an unprecedented challe...

Authors: Manaf Alqahtani, Saad I. Mallah, Nigel Stevenson and Sally Doherty

Multi-centre, randomised non-inferiority trial of early treatment versus expectant management of patent ductus arteriosus in preterm infants (the BeNeDuctus trial): statistical analysis plan

Controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants. A persistent PDA is associated with neonatal mortality and morbidity, but causality remains unproven. Alt...

Authors: Tim Hundscheid, Rogier Donders, Wes Onland, Elisabeth M. W. Kooi, Daniel C. Vijlbrief, Willem B. de Vries, Debbie H. G. M. Nuytemans, Bart van Overmeire, Antonius L. Mulder and Willem P. de Boode

Simple compared to covariate-constrained randomization methods in balancing baseline characteristics: a case study of randomly allocating 72 hemodialysis centers in a cluster trial

Some parallel-group cluster-randomized trials use covariate-constrained rather than simple randomization. This is done to increase the chance of balancing the groups on cluster- and patient-level baseline char...

Authors: Ahmed A. Al-Jaishi, Stephanie N. Dixon, Eric McArthur, P. J. Devereaux, Lehana Thabane and Amit X. Garg

Optimizing nutrition and oral health for caregivers—intervention protocol

The focus of care has shifted from institutional care to home care. Family caregivers provide the majority of home care that allows an opportunity for their care recipients to live at home and avoid costly ins...

Authors: Irma Nykänen, Tarja Välimäki, Liisa Suominen and Ursula Schwab

Improving the continuity and coordination of ambulatory care through feedback and facilitated dialogue—a study protocol for a cluster-randomised trial to evaluate the ACD study (Accountable Care in Germany)

Patients in Germany are free to seek care from any office-based physician and can always ask for multiple opinions on a diagnosis or treatment. The high density of physicians and the freedom to choose among th...

Authors: Leonie Sundmacher, Ronja Flemming, Verena Leve, Isabel Geiger, Sebastian Franke, Thomas Czihal, Clemens Krause, Birgitt Wiese, Frank Meyer, Matthias Brittner, Johannes Pollmanns, Johannes Martin, Paul Brandenburg, Annemarie Schultz, Emmanuelle Brua, Udo Schneider…

Kabasura Kudineer (KSK), a poly-herbal Siddha medicine, reduced SARS-CoV-2 viral load in asymptomatic COVID-19 individuals as compared to vitamin C and zinc supplementation: findings from a prospective, exploratory, open-labeled, comparative, randomized controlled trial, Tamil Nadu, India

Despite several ongoing efforts in biomedicine and traditional medicine, there are no drugs or vaccines for coronavirus disease 2019 (COVID-19) as of May 2020; Kabasura Kudineer (KSK), a polyherbal formulation...

Authors: S. Natarajan, C. Anbarasi, P. Sathiyarajeswaran, P. Manickam, S. Geetha, R. Kathiravan, P. Prathiba, M. Pitchiahkumar, P. Parthiban, K. Kanakavalli and P. Balaji

Comprehensive support for families with parental cancer (Family-SCOUT), evaluation of a complex intervention: study protocol for a non-randomized controlled trial

Families with minor children affected by parental cancer are at risk of considerable emotional and organizational stress that can severely burden all family members. So far, there has been a lack of comprehens...

Authors: Marc Dohmen, Andrea Petermann-Meyer, Daniel Blei, Rebecca Bremen, Evamarie Brock-Midding, Manuela Brüne, Franziska Geiser, Burkhard Haastert, Sarah Maria Halbach, Christian Heuser, Steffen Holsteg, Lina Heier, Andrea Icks, Andre Karger, Joseph Montalbo, Hannah Nakata…

BiCyCLE NMES—neuromuscular electrical stimulation in the perioperative treatment of sarcopenia and myosteatosis in advanced rectal cancer patients: design and methodology of a phase II randomised controlled trial

Colorectal cancer is associated with secondary sarcopenia (muscle loss) and myosteatosis (fatty infiltration of muscle) and patients who exhibit these host characteristics have poorer outcomes following surger...

Authors: Edward T. Pring, Laura E. Gould, George Malietzis, Philip Lung, Mina Bharal, Tutu Fadodun, Paul Bassett, Mani Naghibi, Claire Taylor, Ioanna Drami, Deeptika Chauhan, Tamsyn Street, Nader K. Francis, Thanos Athanasiou, John M. Saxton and John T. Jenkins

Normalising comparative effectiveness trials as clinical practice

There is a lack of high-quality evidence underpinning many contemporary clinical practice guidelines embedded in the healthcare systems, leading to treatment uncertainty and practice variation in most medical ...

Authors: Tom Briffa, Tanya Symons, Nikolajs Zeps, Nicola Straiton, William Odita Tarnow-Mordi, John Simes, Ian A. Harris, Melinda Cruz, Steven A. Webb, Edward Litton, Alistair Nichol and Christopher M. Williams

Electro-acupuncture for irritable bowel syndrome patients: study protocol for a single-blinded randomized sham-controlled clinical trial

Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders in clinical practice. IBS diagnosis is based on symptoms defined by abdominal pain or discomfort associated with d...

Authors: Linda L. D. Zhong, Tsz Fung Lam, Wei Yang, Ya Zheng, Zipan Lyu and Zhaoxiang Bian

Prophylactic potential of honey and Nigella sativa L. against hospital and community-based SARS-CoV-2 spread: a structured summary of a study protocol for a randomised controlled trial

Considering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS.

Authors: Sohaib Ashraf, Shoaib Ashraf, Rutaba Akmal, Moneeb Ashraf, Larab Kalsoom, Aadil Maqsood, Muhammad Ahmad Imran, Iqra Farooq, Sidra Ashraf, Uzma Nasim Siddiqui, Muhammad Ghufran, Muhammad Kiwan Akram, Nighat Majeed, Sundas Rafique, Zaigham Habib, Muhammad Sarmad Shahab…

Total or partial tonsillar resection (tonsillectomy or tonsillotomy) to change the quality of life for adults with recurrent or chronic tonsillitis: study protocol for a randomised controlled trial

Tonsillar surgery has been used for decades to treat recurrent and chronic tonsillitis in adults. Recurrent and chronic tonsillitis result in disturbing symptoms, treatment costs, sick leave, and impaired qual...

Authors: Aleksi Laajala, Paulus Tokola, Timo J. Autio, Timo Koskenkorva, Mikko Tastula, Pasi Ohtonen, Esa Läärä and Olli-Pekka Alho

Optimization of Nutrition And Medication (OptiNAM) for acutely admitted older patients: protocol for a randomized single-blinded controlled trial

Internationally, older patients (≥65 years) account for more than 40% of acute admissions. Older patients admitted to the emergency department (ED) are frequently malnourished and exposed to inappropriate medi...

Authors: Aino L. Andersen, Morten B. Houlind, Rikke L. Nielsen, Lillian M. Jørgensen, Charlotte Treldal, Morten Damgaard, Anne Kathrine Bengaard, Helle Gybel Juul-Larsen, Louise Bolvig Laursen, Esben Iversen, Marie Kruse, Anne M. L. Pedersen, Mads Hornum, Anne M. Beck, Mette M. Pedersen, Mikkel Z. Ankarfeldt…

Correction to: Making large-scale surgical trials possible: collaboration and the role of surgical trainees

Authors: Marcus Jepson, Michelle Lazaroo, Samir Pathak, Natalie Blencowe, Jane Collingwood, Madeleine Clout, Giles Toogood and Jane Blazeby

The novel effectiveness of Tai Chi on cardiopulmonary fitness among stroke patients in the recovery phase: a study protocol for a randomized controlled trial

Stroke is the leading cause of death worldwide. China faces a similar risk of stroke as developed countries because of considerable changes in lifestyle, such as overeating and smoking. Tai Chi is a traditiona...

Authors: Tianyang Tan, Yanyan Meng, Xinyu Li, Ruina Bai, Chengchao Wang, Jiaxuan Lyu, Kang Yan, Meng Liu, Chaoyang Zhang and Yulong Wei

Analysis of contamination in cluster randomized trials of malaria interventions

In cluster randomized trials (CRTs) of interventions against malaria, mosquito movement between households ultimately leads to contamination between intervention and control arms, unless they are separated by ...

Authors: Lea Multerer, Tracy R. Glass, Fiona Vanobberghen and Thomas Smith

Standardised Outcomes in Nephrology – Chronic Kidney Disease (SONG-CKD): a protocol for establishing a core outcome set for adults with chronic kidney disease who do not require kidney replacement therapy

Globally, over 1.2 million people die from chronic kidney disease (CKD) every year. Patients with CKD are up to 10 times more likely to die prematurely than progress to kidney failure requiring kidney replacem...

Authors: Nicole Evangelidis, Benedicte Sautenet, Magdalena Madero, Allison Tong, Gloria Ashuntantang, Laura Cortes Sanabria, Ian H. de Boer, Samuel Fung, Daniel Gallego, Andrew S. Levey, Adeera Levin, Eduardo Lorca, Ikechi G. Okpechi, Patrick Rossignol, Laura Sola, Tim Usherwood…

Co-production of randomized clinical trials with patients: a case study in autologous hematopoietic stem cell transplant for patients with scleroderma

Increasingly, it is argued that clinical trials struggle to recruit participants because they do not respond to key questions or study treatments that patients will be willing or able to use. This study explor...

Authors: Magda Aguiar, Tracey-Lea Laba, Sarah Munro, Tiasha Burch, Jennifer Beckett, K. Julia Kaal, Nick Bansback, Marie Hudson and Mark Harrison

Electroacupuncture for postoperative ileus after laparoscopic surgery on colorectal cancer: study protocol for a randomized controlled trial

Postoperative ileus (POI) occurs in almost all patients after abdominal laparoscopic surgery, resulting in complications and increasing the length of hospitalization. Electroacupuncture has been used as an alt...

Authors: Jia-Kai Shao, Qian Liu, Wei Pei, Yu Wang, Na-Na Yang, Ling-Yu Qi, Jin Huang, Jing-Wen Yang and Cun-zhi Liu

Correction to: Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes

Authors: Jennifer L. Bell, Samir Gupta, Edmund Juszczak, Pollyanna Hardy and Louise Linsell

Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial

Recently, the first randomized trials comparing minimally invasive distal pancreatectomy (MIDP) with open distal pancreatectomy (ODP) for non-malignant and malignant disease showed a 2-day reduction in time to...

Authors: Jony van Hilst, Maarten Korrel, Sanne Lof, Thijs de Rooij, Frederique Vissers, Bilal Al-Sarireh, Adnan Alseidi, Adrian C. Bateman, Bergthor Björnsson, Ugo Boggi, Svein Olav Bratlie, Olivier Busch, Giovanni Butturini, Riccardo Casadei, Frederike Dijk, Safi Dokmak…

Operative treatment of cervical radiculopathy: anterior cervical decompression and fusion compared with posterior foraminotomy: study protocol for a randomized controlled trial

Cervical radiculopathy is the most common disease in the cervical spine, affecting patients around 50–55 year of age. An operative treatment is common clinical praxis when non-operative treatment fails. The co...

Authors: Marek Holy, Anna MacDowall, Freyr Gauti Sigmundsson and Class Olerud

Endoscopic sinus surgery (ESS) to change quality of life for adults with recurrent rhinosinusitis: study protocol for a randomized controlled trial

Endoscopic sinus surgery (ESS) has been used for decades to treat recurrent acute rhinosinusitis episodes (RARS) in adults. RARS results in infectious symptoms, antibiotic courses, sick leaves, and impaired qu...

Authors: Heidi M. Kaski, Antti Alakärppä, Ulla Lantto, Aleksi Laajala, Paulus Tokola, Tomi Penna, Pasi Ohtonen and Olli-Pekka Alho

Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19

Many non-COVID-19 trials were disrupted in 2020 and either struggled to recruit participants or stopped recruiting altogether. In December 2019, just before the pandemic, we were awarded a grant to conduct a r...

Authors: Shakira Milton, Jennifer McIntosh, Lucy Boyd, Napin Karnchanachari, Finlay Macrae and Jon David Emery

Effects of proximal priority and distal priority robotic priming techniques with impairment-oriented training of upper limb functions in patients with chronic stroke: study protocol for a single-blind, randomized controlled trial

The sequence of establishing a proximal stability or function before facilitation of the distal body part has long been recognized in stroke rehabilitation practice but lacks scientific evidence. This study pl...

Authors: Yi-chen Lee, Yi-chun Li, Keh-chung Lin, Chia-ling Chen, Yi-hsuan Wu, Chihchieh Kuo, Yi-ping Yeh and Ting-xuan Liu

The future is now: our experience starting a remote clinical trial during the beginning of the COVID-19 pandemic

The World Health Organization declared the outbreak of SARS-CoV-2 a pandemic on February 11, 2020. This organism causes COVID-19 disease and the rapid rise in cases and geographic spread strained healthcare sy...

Authors: Hans H. Liu, Michael D. Ezekowitz, Michele Columbo, Oneib Khan, Jack Martin, Judith Spahr, David Yaron, Lisa Cushinotto and Luciano Kapelusznik

Correction to: The Treatment In Morning versus Evening (TIME) study: analysis of recruitment, follow-up and retention rates post-recruitment

Authors: David A. Rorie, Robert W. V. Flynn, Isla S. Mackenzie, Thomas M. MacDonald and Amy Rogers

Correction to: The role of machine learning in clinical research: transforming the future of evidence generation

Authors: E. Hope Weissler, Tristan Naumann, Tomas Andersson, Rajesh Ranganath, Olivier Elemento, Yuan Luo, Daniel F. Freitag, James Benoit, Michael C. Hughes, Faisal Khan, Paul Slater, Khader Shameer, Matthew Roe, Emmette Hutchison, Scott H. Kollins, Uli Broedl…