Articles

The necessity of IIb dissection in T1–T2N0M0 oral squamous cell carcinoma: protocol for a randomized controlled trial

There is a growing debate on the relationship between health-related quality of life (HRQoL) and patient survival which has been going on for the last few decades. The greatest wish of clinicians is to extend ...

Authors: Lei Wang, Liang Wang, Xuefei Song, Chang Cui, Chunyue Ma, Bing Guo and Xingjun Qin

Enhanced recovery after surgery (ERAS) pathway for primary hip and knee arthroplasty: study protocol for a randomized controlled trial

With the substantially growing trend of the aging populations in China and the rest of the world, the number of total hip and total knee arthroplasty (THA and TKA) cases are increasing dramatically. It is impo...

Authors: Jingyi Li, Haibei Zhu and Ren Liao

Meeting abstracts from the 5th International Clinical Trials Methodology Conference (ICTMC 2019)

Authors:

Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2)

The Mesothelioma and Radical Surgery Trial (MARS 2) aims to evaluate a surgical procedure by comparing chemotherapy and surgery against chemotherapy alone. The pilot study for MARS 2 evaluated the viability of...

Authors: Clare Warnock, Karen Lord, Bethany Taylor and Angela Tod

Load monitoring on Pilates training: a study protocol for a randomized clinical trial

Currently there are campaigns to raise the awareness of the need to practice physical exercise with several objectives, mainly as a preventive measure. The Pilates method is a form of therapeutic exercise for ...

Authors: Allysiê Priscilla de Souza Cavina, Eduardo Pizzo Junior, Aryane Flauzino Machado, Taíse Mendes Biral, Carlos Marcelo Pastre and Franciele Marques Vanderlei

Effects of transcranial direct current stimulation on patients with disorders of consciousness after traumatic brain injury: study protocol for a randomized, double-blind controlled trial

Disorders of consciousness (DOC) after traumatic brain injury (TBI) raise the mortality of patients, restrict the rehabilitation of patients with TBI, and increase the physical and economic burden that TBI imp...

Authors: Shilin Li, Xiangli Dong, Weiming Sun, Na Zhao, Guohua Yu and Lang Shuai

Correction to: Prevention of Infections in Cardiac Surgery study (PICS): study protocol for a pragmatic cluster-randomized factorial crossover pilot trial

Following publication of the original article [1], we have been notified of a few mistakes in the “Sample size calculations” section, second paragraph.

Authors: Rachel B. van Oostveen, Alberto Romero-Palacios, Richard Whitlock, Shun Fu Lee, Stuart Connolly, Alex Carignan, C. David Mazer, Mark Loeb and Dominik Mertz

The trial to reduce antimicrobial use in nursing home residents with Alzheimer’s disease and other dementias: study protocol for a cluster randomized controlled trial

Infections are common in nursing home (NH) residents with advanced dementia but are often managed inappropriately. Antimicrobials are extensively prescribed, but frequently with insufficient evidence to suppor...

Authors: Andrea J. Loizeau, Erika M. C. D’Agata, Michele L. Shaffer, Laura C. Hanson, Ruth A. Anderson, Timothy Tsai, Daniel A. Habtemariam, Elaine H. Bergman, Ruth P. Carroll, Simon M. Cohen, Erin M. E. Scott, Erin Stevens, Jeremy D. Whyman, Elizabeth H. Bennert and Susan L. Mitchell

What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership: the PRioRiTy II (Prioritising Retention in Randomised Trials) study

One of the top three research priorities for the UK clinical trial community is to address the gap in evidence-based approaches to improving participant retention in randomised trials. Despite this, there is l...

Authors: Dan Brunsdon, Linda Biesty, Peter Brocklehurst, Valerie Brueton, Declan Devane, Jim Elliott, Sandra Galvin, Carrol Gamble, Heidi Gardner, Patricia Healy, Kerenza Hood, Joan Jordan, Doris Lanz, Beccy Maeso, Amanda Roberts, Imogen Skene…

The TREATT Trial (TRial to EvaluAte Tranexamic acid therapy in Thrombocytopenia): safety and efficacy of tranexamic acid in patients with haematological malignancies with severe thrombocytopenia: study protocol for a double-blind randomised controlled trial

Patients with haematological malignancies often develop thrombocytopenia as a consequence of either their disease or its treatment. Platelet transfusions are commonly given to raise a low platelet count and re...

Authors: Lise J. Estcourt, Zoe McQuilten, Gillian Powter, Claire Dyer, Eleanor Curnow, Erica M. Wood and Simon J. Stanworth

A randomised controlled trial exploring the impact of a dedicated health and social care professionals team in the emergency department on the quality, safety, clinical and cost-effectiveness of care for older adults: a study protocol

Older people are frequent emergency department (ED) users who present with complex issues that are linked to poorer health outcomes following the index visit, often have increased ED length of stay, and tend t...

Authors: Marica Cassarino, Katie Robinson, Íde O’Shaughnessy, Eimear Smalle, Stephen White, Collette Devlin, Rosie Quinn, Dominic Trépel, Fiona Boland, Marie E. Ward, Rosa McNamara, Margaret O’Connor, Gerard McCarthy, Damien Ryan and Rose Galvin

The effect of spinal manipulative therapy on heart rate variability and pain in patients with chronic neck pain: a randomized controlled trial

Recent experimental research has suggested that spinal manipulative therapy (SMT) may reduce pain through modulation of the ascending pain signals and/or the central pain-regulating mechanisms. People with per...

Authors: Anders Galaasen Bakken, Iben Axén, Andreas Eklund and Søren O’Neill

Harmonisation of Outcome Parameters and Evaluation (HOPE) for actinic keratosis: protocol for the development of a core outcome set

Actinic keratoses (AK) are common skin lesions that can progress to invasive squamous cell carcinoma of the skin. A variety of lesion- or field-targeted treatment options exist and their efficacy has been demo...

Authors: Markus V. Heppt, Theresa Steeb, Lutz Schmitz, Claus Garbe, Lars E. French, Ulrike Leiter and Carola Berking

Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial

Neuropathic pain is a common pain condition that has a major negative impact on health-related quality of life. However, despite decades of research, it remains difficult to treat neuropathic pain. Lacosamide ...

Authors: Malin E. Carmland, Melissa Kreutzfeldt, Jakob V. Holbech, Niels T. Andersen, Troels S. Jensen, Flemming W. Bach, Søren H. Sindrup and Nanna B. Finnerup

Frequency of Screening and SBT Technique Trial - North American Weaning Collaboration (FAST-NAWC): a protocol for a multicenter, factorial randomized trial

In critically ill patients receiving invasive mechanical ventilation (MV), research supports the use of daily screening to identify patients who are ready to undergo a spontaneous breathing trial (SBT) followe...

Authors: K. E. A. Burns, Leena Rizvi, Deborah J. Cook, Andrew J. E. Seely, Bram Rochwerg, Francois Lamontagne, John W. Devlin, Peter Dodek, Michael Mayette, Maged Tanios, Audrey Gouskos, Phyllis Kay, Susan Mitchell, Kenneth C. Kiedrowski and Nicholas S. Hill

Effects of neuromuscular training and strengthening of trunk and lower limbs muscles in women with Patellofemoral Pain: A protocol of randomized controlled clinical trial, blinded

Patellofemoral pain (PFP) often affects young women, and the etiology is multifactorial and poorly understood. Conservative intervention has been focused on risk factors or aggravating factors and is composed ...

Authors: Natália Camin Silva, Matheus de Castro Silva, Morisa Garcia Guimarães, Manoela Beatriz de Oliveira Nascimento and Lilian Ramiro Felicio

Comparison of the effect of three different protein content enteral diets on serum levels of proteins, nitrogen balance, and energy expenditure in critically ill infants: study protocol for a randomized controlled trial

Nutritional support is essential in the care of critically ill children since malnutrition in this population is associated with increased morbidity and mortality. Injury in patients admitted to pediatric inte...

Authors: Reyes Fernández, Javier Urbano, Ángel Carrillo, Ana Vivanco, María José Solana, Corsino Rey and Jesús López-Herce

The Salt Swap intervention to reduce salt intake in people with high blood pressure: protocol for a feasibility randomised controlled trial

High salt intake is a risk factor for hypertension and cardiovascular disease. Reducing salt intake has been shown to reduce blood pressure. Despite population-level interventions, including product reformulat...

Authors: Sarah Payne Riches, Carmen Piernas, Paul Aveyard, James P. Sheppard, Mike Rayner and Susan A. Jebb

Contributions of vitamin D in the management of depressive symptoms and cardiovascular risk factors: study protocol for a randomized, double-blind, placebo-controlled clinical trial

Depression is a major cause of chronic disability throughout the world and an important cardiovascular risk factor, increasing the relative risk of coronary artery disease as well as rates of cardiovascular mo...

Authors: Catarina Magalhães Porto, Tatiana de Paula Santana da Silva and Everton Botelho Sougey

The use of a machine-learning algorithm that predicts hypotension during surgery in combination with personalized treatment guidance: study protocol for a randomized clinical trial

Intraoperative hypotension is associated with increased morbidity and mortality. Current treatment is mostly reactive. The Hypotension Prediction Index (HPI) algorithm is able to predict hypotension minutes be...

Authors: M. Wijnberge, J. Schenk, L. E. Terwindt, M. P. Mulder, M. W. Hollmann, A. P. Vlaar, D. P. Veelo and B. F. Geerts

Social group and health care provider interventions to increase the demand for malaria rapid diagnostic test among community members in Ebonyi state, Nigeria: study protocol for a cluster randomized controlled trial

The World Health Organization recommended (in 2010) universal testing for suspected malaria, due to some fundamental changes in malaria trends such as the declining incidence of malaria in high-burden countrie...

Authors: Ugwu I. Omale, Benedict N. Azuogu, Chihurumnanya Alo, Ugochukwu C. Madubueze, Onyinyechukwu U. Oka, Kingsley C. Okeke, Ifeyinwa M. Okafor, Rowland Utulu, Uduak E. Akpan, Chijioke V. Iloke, Anthonia O. Nnubia, Ifeyinwa I. Eze, Ogechukwu C. Anene, Chukwuka R. Nnabu and Deborah C. Ibemesi

Effect of probiotic supplementation in nonalcoholic steatohepatitis patients: PROBILIVER TRIAL protocol

Recently factors in the relationship between gut microbiota, obesity, diabetes and the metabolic syndrome have been suggested in the development and progression of nonalcoholic steatohepatitis (NASH). In this ...

Authors: Amanda Souza Silva-Sperb, Helena Abadie Moraes, Bruna Concheski de Moura, Bruna Cherubini Alves, Juliana Paula Bruch-Bertani, Vittoria Zambon Azevedo and Valesca Dall’Alba

Development, acceptability, appropriateness and appeal of a cancer clinical trials implementation intervention for rural- and minority-serving urology practices

Few community urologists offer cancer patients the opportunity to participate in cancer clinical trials, despite national guidelines that recommend it, depriving an estimated 260,000 urological cancer patients...

Authors: Shellie Ellis, Mugur Geana, Tomas Griebling, Charles McWilliams, Jessie Gills, Kelly Stratton, Christine Mackay, Ariel Shifter, Andrew Zganjar and Brantley Thrasher

Cost analysis and efficacy of recruitment strategies used in a large pragmatic community-based clinical trial targeting low-income seniors: a comparative descriptive analysis

One of the most challenging parts of running clinical trials is recruiting enough participants. Our objective was to determine which recruitment strategies were effective in reaching specific subgroups.

Authors: Sravya Kakumanu, Braden J. Manns, Sophia Tran, Terry Saunders-Smith, Brenda R. Hemmelgarn, Marcello Tonelli, Ross Tsuyuki, Noah Ivers, Danielle Southern, Jeff Bakal and David J. T. Campbell

An electronic family health history tool to identify and manage patients at increased risk for colorectal cancer: protocol for a randomized controlled trial

Colorectal cancer is the fourth most commonly diagnosed cancer in the United States. Approximately 3–10% of the population has an increased risk for colorectal cancer due to family history and warrants more fr...

Authors: Karen M. Goldstein, Deborah A. Fisher, R. Ryanne Wu, Lori A. Orlando, Cynthia J. Coffman, Janet M. Grubber, Tejinder Rakhra-Burris, Virginia Wang, Maren T. Scheuner, Nina Sperber, Santanu K. Datta, Richard E. Nelson, Elizabeth Strawbridge, Dawn Provenzale, Elizabeth R. Hauser and Corrine I. Voils

Efficacy of intergrating vestibular rehabilitation and cognitive behaviour therapy in persons with persistent dizziness in primary care- a study protocol for a randomised controlled trial

Dizziness is a common complaint, and the symptom often persists, together with additional complaints. A treatment combining Vestibular Rehabilitation (VR) and Cognitive Behaviour Therapy (CBT) is suggested. Ho...

Authors: Lene Kristiansen, L. H. Magnussen, K. T. Wilhelmsen, S. Mæland, S. H. G. Nordahl, R. Clendaniel, A. Hovland and B. Juul-Kristensen

Online Social anxiety Cognitive therapy for Adolescents (OSCA): protocol for a randomised controlled trial

Adolescent social anxiety disorder (SAD) is common, impairing and persistent. There is a need to intervene early to avert its long-term consequences. Cognitive Therapy for SAD is the leading treatment for adul...

Authors: Eleanor Leigh and David M. Clark

Reducing Asthma Attacks in Children using Exhaled Nitric Oxide as a biomarker to inform treatment strategy: a randomised trial (RAACENO)

Childhood asthma is a common condition. Currently there is no validated objective test which can be used to guide asthma treatment in children. This study tests the hypothesis that the addition of fractional e...

Authors: S. Turner, S. C. Cotton, C. D. Emele, R. Thomas, S. Fielding, E. A. Gaillard, J. C. de Jongste, H. Morgan, A. R. Neilson, J. Norrie, M. Pijnenburg, D. Price and M. Thomas

Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols

Master protocols, classified as basket trials, umbrella trials, and platform trials, are novel designs that investigate multiple hypotheses through concurrent sub-studies (e.g., multiple treatments or populati...

Authors: Jay J. H Park, Ellie Siden, Michael J. Zoratti, Louis Dron, Ofir Harari, Joel Singer, Richard T. Lester, Kristian Thorlund and Edward J. Mills

A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials

Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known abo...

Authors: Anna Rosala-Hallas, Carrol Gamble, Jane Blazeby and Paula R. Williamson

The impact of surgeon and patient treatment preferences in an orthopaedic trauma surgery trial

Surgeon and patient treatment preferences are important threats to the internal and external validity of surgical trials such as PROFHER, which compared surgical versus non-surgical treatment for displaced fra...

Authors: Ada Keding, Helen Handoll, Stephen Brealey, Laura Jefferson, Catherine Hewitt, Belen Corbacho, David Torgerson and Amar Rangan

The effect of Baduanjin exercise on health-related physical fitness of college students: study protocol for a randomized controlled trial

Low health-related physical fitness in college students is a risk factor for future development of cardiovascular diseases at later stages in life, but appropriate exercise is one of the main determinant facto...

Authors: Fang Zhao, Shanshan Sun, Jian Xiong and Guohua Zheng

The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial

Conduct, anxiety, and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention for school-going ado...

Authors: Rachana Parikh, Daniel Michelson, Kanika Malik, Sachin Shinde, Helen A. Weiss, Adriaan Hoogendoorn, Jeroen Ruwaard, Madhuri Krishna, Rhea Sharma, Bhargav Bhat, Rooplata Sahu, Sonal Mathur, Paulomi Sudhir, Michael King, Pim Cuijpers, Bruce F. Chorpita…

Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial

Currently, there is limited evidence to guide intervention and service delivery coordination for youth who suffer a concussion and subsequently experience persistent post-concussive symptoms (PCS) (Lumba-Brown...

Authors: Carolyn A. McCarty, Douglas Zatzick, Teah Hoopes, Katelyn Payne, Rebecca Parrish and Frederick P. Rivara

Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes: what correlation between baseline and follow-up outcomes should we assume?

Patient-reported outcome measures (PROMs) are now frequently used in randomised controlled trials (RCTs) as primary endpoints. RCTs are longitudinal, and many have a baseline (PRE) assessment of the outcome an...

Authors: Stephen J. Walters, Richard M. Jacques, Inês Bonacho dos Anjos Henriques-Cadby, Jane Candlish, Nikki Totton and Mica Teo Shu Xian

Medial malleolus: Operative Or Non-operative (MOON) trial protocol - a prospective randomised controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fractures of the ankle

There are limited data reporting the outcome of patients with non-operatively managed medial malleolus fractures compared to those treated surgically in the presence of fibular stabilisation for unstable fract...

Authors: Thomas H. Carter, William M. Oliver, Catriona Graham, Andrew D. Duckworth and Timothy O. White

Manual acupuncture for the infertile female with polycystic ovary syndrome (PCOS): study protocol for a randomized sham-controlled trial

Polycystic ovary syndrome (PCOS) is one of the most common endocrine diseases for women. Acupuncture is widely used for the infertile female because of it is non-invasive and has fewer side effects, but the po...

Authors: Qiao Wang, Haiping Deng, Ke Cheng, Zouqin Huang, Xiuqi Yin, Yichen Zhou, Yiqin Yang, Weidong Shen, Ling Zhao and Xueyong Shen

The clinical effect of arrhythmia monitoring after myocardial infarction (BIO-GUARD|MI):study protocol for a randomized controlled trial

The increasing use of implantable cardiac monitors (ICMs) allows early documentation of asymptomatic cardiac arrhythmias that would previously have gone unnoticed. The addition of remote monitoring to cardiac ...

Authors: Christian Jons, Peter Sogaard, Steffen Behrens, Jürgen Schrader, Sascha Mrosk and Poul Erik Bloch Thomsen

Impact of deep water running in interval training (DWR-IT) on body composition, functional capacity, and quality of life in overweight adults: study protocol for a randomized controlled trial

Interval training in deep water running (DWR-IT) is a training method to improve cardiovascular fitness, functional health, and quality of life and to help control body weight. Its main advantages are the redu...

Authors: Bruna Pianna, Bianca Christianini Moreno, Caroline Aquino de Souza, Thais Fernanda Bôscoa, Guilherme Eleutério Alcalde, Silvia Regina Barrile, Camila Gimenes, Bruno Martinelli, Antonio Roberto Zamunér, Bruna Varanda Pessoa-Santos and Eduardo Aguilar Arca

Leucine-enriched essential amino acid supplementation in mechanically ventilated trauma patients: a feasibility study

Critically ill patients lose up to 2% of muscle mass per day. We assessed the feasibility of administering a leucine-enriched essential amino acid (L-EAA) supplement to mechanically ventilated trauma patients ...

Authors: L. Wandrag, S. J. Brett, G. S. Frost, M. To, E. Alves Loubo, N. C. Jackson, A. M. Umpleby, V. Bountziouka and M. Hickson

Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial

Myocardial damage in patients undergoing cardiac surgery increases both morbidity and mortality. Different protective strategies dealing with either preconditioning or postconditioning or assessing a single as...

Authors: Pascal Chiari, Michel Durand, Olivier Desebbe, Marc-Olivier Fischer, Diane Lena-Quintard, Jean-Charles Palao, Catherine Mercier, Géraldine Samson, Yvonne Varillon, Matteo Pozzi, Nathan Mewton, Delphine Maucort-Boulch, Michel Ovize and Jean-Luc Fellahi

Virtual training leads to real acute physical, cognitive, and neural benefits on healthy adults: study protocol for a randomized controlled trial

Keeping a certain level of physical activity has beneficial effects on the body itself but also, surprisingly, on cognition: specifically, physical high-intensity intermittent aerobic exercise (HIE) can show i...

Authors: Dalila Burin, Noriki Yamaya, Rie Ogitsu and Ryuta Kawashima

Is dangling of the lower leg after a free flap reconstruction necessary? Study protocol for a large multicenter randomized controlled study

Within the field of plastic surgery, free tissue transfer is common practice for knee and lower leg defects. Usually, after such free flap reconstruction, patients undergo a dangling protocol in the postoperat...

Authors: David D. Krijgh, Teun Teunis, Pascal P. A. Schellekens, Marc A. M. Mureau, Antonius J. M. Luijsterburg, Tallechien M. T. Tempelman, Eva S. J. van der Beek, Wiesje Maarse and J. Henk Coert

Correction to: Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial

Following publication of the original article [1], it has been brought to our attention that an error was slipped into the article’s title.

Authors: Marion Henderson, Anja Wittkowski, Emma McIntosh, Alex McConnachie, Katie Buston, Philip Wilson, Rachel Calam, Helen Minnis, Lucy Thompson, John O’Dowd, James Law, Elizabeth McGee and Daniel Wight

An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units

Good Clinical Practice guidelines issued in 2016 encourage risk-based approaches to monitoring clinical trials. This study compared current risk assessment and monitoring approaches in UK Clinical Trials Units...

Authors: Daniel Beever and Lizzie Swaby

N-acetylcysteine for cessation of tobacco smoking: rationale and study protocol for a randomised controlled trial

Tobacco smoking is a highly prevalent, addictive behaviour and a key public health priority. However available cessation therapies have low quit and high relapse rates, indicating an urgent need for more effec...

Authors: Lauren Arancini, Chiara C. Bortolasci, Seetal Dodd, Olivia M. Dean and Michael Berk

Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) in western Kenya: a study protocol of a cluster randomized trial

Hypertension is a major risk factor for cardiovascular disease (CVD), yet treatment and control rates for hypertension are very low in low- and middle-income countries (LMICs). Lack of effective referral netwo...

Authors: Tim Mercer, Benson Njuguna, Gerald S. Bloomfield, Jonathan Dick, Eric Finkelstein, Jemima Kamano, Ann Mwangi, Violet Naanyu, Sonak D. Pastakia, Thomas W. Valente, Rajesh Vedanthan and Constantine Akwanalo

Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for non-systematic adverse events

Adverse events (AEs) in clinical trials may be reported in multiple sources. Different methods for reporting adverse events across trials or across sources for a single trial may produce inconsistent informati...

Authors: Evan Mayo-Wilson, Nicole Fusco, Hwanhee Hong, Tianjing Li, Joseph K. Canner and Kay Dickersin

Interval-cohort designs and bias in the estimation of per-protocol effects: a simulation study

Randomized trials are considered the gold standard for making inferences about the causal effects of treatments. However, when protocol deviations occur, the baseline randomization of the trial is no longer su...

Authors: Jessica G. Young, Rajet Vatsa, Eleanor J. Murray and Miguel A. Hernán

Effects of different acupuncture treatment methods on mild cognitive impairment: a study protocol for a randomized controlled trial

Mild cognitive impairment (MCI) is an intermediate state between normal aging and Alzheimer’s disease, which is the world’s most common form of dementia. It is important to identify early and easily available ...

Authors: Jae-Hong Kim, Myoung-Rae Cho, Gwang-Cheon Park and Jeong-Soon Lee