Trials

No short-cut in assessing trial quality: a case study

Karim F Hirji

Readers as research detectives

Peter C Gøtzsche

Acupuncture, or non-directive counselling versus usual care for the treatment of depression: a pilot study

Sylvia Schroer, Hugh MacPherson

The impact of iron supplementation efficiency in female blood donors with a decreased ferritin level and no anaemia. Rationale and design of a randomised controlled trial: a study protocol

Baptiste Pedrazzini, Sophie Waldvogel, Jacques Cornuz, Paul Vaucher, Raphael Bize, Jean-Daniel Tissot, Alain Pecoud, Bernard Favrat

Prevention of non-communicable disease in a population in nutrition transition: Tehran Lipid and Glucose Study phase II

Fereidoun Azizi, Arash Ghanbarian, Amir Abbas Momenan, Farzad Hadaegh, Parvin Mirmiran, Mehdi Hedayati, Yadollah Mehrabi, Saleh Zahedi-Asl

A randomised controlled trial of the Neuro Emotional Technique (NET) for childhood Attention Deficit Hyperactivity Disorder (ADHD): a protocol

Fay Karpouzis, Henry Pollard, Rod Bonello

Erratum to: A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics

Caroline Laurence, Angela Gialamas, Lisa Yelland, Tanya Bubner, Philip Ryan, Kristyn Willson, Briony Glastonbury, Janice Gill, Mark Shephard, Justin Beilby

A randomized prospective trial of the postoperative quality of life between laparoscopic uterine artery ligation and laparoscopy-assisted vaginal hysterectomy for the treatment of symptomatic uterine fibroids: clinical trial design

Hee Seung Kim, Jae Weon Kim, Mi-Kyung Kim, Hyun Hoon Chung, Taek Sang Lee, Yong-Tark Jeon, Yong Beom Kim, Hye Won Jeon, Young Ho Yun, Noh Hyun Park, Yong Sang Song, Soon-Beom Kang

The challenges faced in the design, conduct and analysis of surgical randomised controlled trials

Jonathan A Cook

Study protocol: Couples Partnering for Lipid Enhancing Strategies (CouPLES) – a randomized, controlled trial

Corrine I Voils, William S Yancy Jr, Stacey Kovac, Cynthia J Coffman, Morris Weinberger, Eugene Z Oddone, Amy Jeffreys, Santanu Datta, Hayden B Bosworth

Exercise therapy, manual therapy, or both, for osteoarthritis of the hip or knee: a factorial randomised controlled trial protocol

J Haxby Abbott, M Clare Robertson, Joanne E McKenzie, G David Baxter, Jean-Claude Theis, A John Campbell

Metformin treatment in diabetes and heart failure: when academic equipoise meets clinical reality

Dean T Eurich, Ross T Tsuyuki, Sumit R Majumdar, Finlay A McAlister, Richard Lewanczuk, Marcelo C Shibata, Jeffrey A Johnson

Hypertension Improvement Project (HIP): study protocol and implementation challenges

Rowena J Dolor, William S Yancy Jr, William F Owen, David B Matchar, Gregory P Samsa, Kathryn I Pollak, Pao-Hwa Lin, Jamy D Ard, Maxwell Prempeh, Heather L McGuire, Bryan C Batch, William Fan, Laura P Svetkey

The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

Andrew J Vickers, Peter T Scardino

Paying clinicians to join clinical trials: a review of guidelines and interview study of trialists

James Raftery, Christine Kerr, Sheila Hawker, John Powell

New therapeutic approach to Tourette Syndrome in children based on a randomized placebo-controlled double-blind phase IV study of the effectiveness and safety of magnesium and vitamin B6

Rafael Garcia-Lopez, Emilio Perea-Milla, Cesar Ruiz Garcia, Francisco Rivas-Ruiz, Julio Romero-Gonzalez, Jose L Moreno, Vicente Faus, Guadalupe del Castillo Aguas, Juan C Ramos Diaz

Towards agreement on best practice for publishing raw clinical trial data

Iain Hrynaszkiewicz, Douglas G Altman

The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2): a randomised trial to determine the effectiveness and cost-effectiveness of adding a complex intervention for major depressive disorder to usual care for cancer patients

Jane Walker, Jim Cassidy, Michael Sharpe

Anaesthesiological strategies in elective craniotomy: randomized, equivalence, open trial – The NeuroMorfeo trial

Giuseppe Citerio, Maria Grazia Franzosi, Roberto Latini, Serge Masson, Simona Barlera, Stefano Guzzetti, Antonio Pesenti

Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD)

Baiba Hedegaard Hansen, Jamal Abed Hanash, Alice Rasmussen, Jørgen Fischer Hansen, Morten Birket-Smith

How do multi-stage, multi-arm trials compare to the traditional two-arm parallel group design – a reanalysis of 4 trials

FM-S Barthel, MKB Parmar, P Royston

Rationale and design: telepsychology service delivery for depressed elderly veterans

Leonard E Egede, Christopher B Frueh, Lisa K Richardson, Ronald Acierno, Patrick D Mauldin, Rebecca G Knapp, Carl Lejuez

The ANTOP study: focal psychodynamic psychotherapy, cognitive-behavioural therapy, and treatment-as-usual in outpatients with anorexia nervosa - a randomized controlled trial

Beate Wild, Hans-Christoph Friederich, Gaby Gross, Martin Teufel, Wolfgang Herzog, Katrin E Giel, Martina de Zwaan, Henning Schauenburg, Carmen Schade-Brittinger, Helmut Schäfer, Stephan Zipfel

Effectiveness of the psychological and pharmacological treatment of catastrophization in patients with fibromyalgia: a randomized controlled trial

Javier García-Campayo, Antoni Serrano-Blanco, Baltasar Rodero, Rosa Magallón, Marta Alda, Eva Andrés, Juan V Luciano, Yolanda López del Hoyo

The design and protocol of acupuncture for migraine prophylaxis: A multicenter randomized controlled trial

Yan Zhang, Linpeng Wang, Huilin Liu, Nan Li, Jingdao Li, Jinghong Yi

Protocol for the Proactive Or Reactive Telephone Smoking CeSsation Support (PORTSSS) trial

Tim Coleman, Andy McEwen, Linda Bauld, Janet Ferguson, Paula Lorgelly, Sarah Lewis

Design, analysis, and presentation of crossover trials

Edward J Mills, An-Wen Chan, Ping Wu, Andy Vail, Gordon H Guyatt, Douglas G Altman

Protocol for the PINCER trial: a cluster randomised trial comparing the effectiveness of a pharmacist-led IT-based intervention with simple feedback in reducing rates of clinically important errors in medicines management in general practices

Anthony J Avery, Sarah Rodgers, Judith A Cantrill, Sarah Armstrong, Rachel Elliott, Rachel Howard, Denise Kendrick, Caroline J Morris, Scott A Murray, Robin J Prescott, Kathrin Cresswell, Aziz Sheikh

Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention

Morgane Ethgen, Isabelle Boutron, Philippe Gabriel Steg, Carine Roy, Philippe Ravaud

A clinical evaluation of amlexanox oral adhesive pellicles in the treatment of recurrent aphthous stomatitis and comparison with amlexanox oral tablets: a randomized, placebo controlled, blinded, multicenter clinical trial

Wenxia Meng, Yi Dong, Jie Liu, Zhi Wang, Xiaobo Zhong, Ruiyang Chen, Hongmei Zhou, Mei Lin, Lu Jiang, Feng Gao, Tao Xu, Qianming Chen, Xin Zeng

Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia

Michela Nosè, Simone Accordini, Paola Artioli, Francesco Barale, Corrado Barbui, Rossella Beneduce, Domenico Berardi, Gerardo Bertolazzi, Bruno Biancosino, Alfredo Bisogno, Raffaella Bivi, Filippo Bogetto, Marianna Boso, Alberto Bozzani, Piera Bucolo, Marcello Casale, Liliana Cascone, Luisa Ciammella, Alessia Cicolini, Gabriele Cipresso, Andrea Cipriani, Paola Colombo, Barbara Dal Santo, Michele De Francesco, Giorgio Di Lorenzo, Walter Di Munzio, Giuseppe Ducci, Arcadio Erlicher, Eleonora Esposito, Luigi Ferrannini, Farida Ferrato, Antonio Ferro, Nicoletta Fragomeno, Vincenzo Fricchione Parise, Maria Frova, Francesco Gardellin, Nicola Garzotto, Andrea Giambartolomei, Giancarlo Giupponi, Luigi Grassi, Natalia Grazian, Lorella Grecu, Gualtiero Guerrini, Francesco Laddomada, Ermanna Lazzarin, Camilla Lintas, Francesca Malchiodi, Lara Malvini, Livio Marchiaro, Alessandra Marsilio, Massimo Carlo Mauri, Antonio Mautone, Marco Menchetti, Giuseppe Migliorini, Marco Mollica, Daniele Moretti, Serena Mulè, Stylianos Nicholau, Flavio Nosè, Guglielmo Occhionero, Anna Maria Pacilli, Stefania Pecchioli, Mauro Percudani, Ennio Piantato, Carlo Piazza, Francesco Pontarollo, Roger Pycha, Roberto Quartesan, Luciana Rillosi, Francesco Risso, Raffella Rizzo, Paola Rocca, Stefania Roma, Matteo Rossattini, Giuseppe Rossi, Giovanni Rossi, Alessandra Sala, Claudio Santilli, Giuseppe Saraò, Antonio Sarnicola, Francesca Sartore, Silvio Scarone, Tiziana Sciarma, Alberto Siracusano, Stefania Strizzolo, Michele Tansella, Gino Targa, Annamarie Tasser, Rodolfo Tomasi, Rossana Travaglini, Antonio Veronese, Simona Ziero

The CHOLEGAS study: multicentric randomized, blinded, controlled trial of gastrectomy plus prophylactic cholecystectomy versus gastrectomy only, in adults submitted to Gastric cancer surgery with curative intent

Marco Farsi, Marco Bernini, Lapo Bencini, Egidio Miranda, Roberto Manetti, Giovanni de Manzoni, Giuseppe Verlato, Daniele Marrelli, Corrado Pedrazzani, Francesco Roviello, Alberto Marchet, Luigi Cristadoro, Leonardo Gerard, Renato Moretti

Outcome based subgroup analysis: a neglected concern

Karim F Hirji, Morten W Fagerland

The HAC Trial (Harmonic for Acute Cholecystitis) Study. Randomized, double-blind, controlled trial of Harmonic(H) versus Monopolar Diathermy (M) for laparoscopic cholecystectomy (LC) for acute cholecystitis (AC) in adults

Fausto Catena, Luca Ansaloni, Salomone Di Saverio, Filippo Gazzotti, Federico Coccolini, Antonio Daniele Pinna

Over 50 years of trial in Acta Psychiatrica Scandinavica: a survey

Hosam E Matar, Muhammad Q Almerie, Muhammad O Al Marhi, Clive E Adams

VITA-D: Cholecalciferol substitution in vitamin D deficient kidney transplant recipients: A randomized, placebo-controlled study to evaluate the post-transplant outcome

Ursula Thiem, Georg Heinze, Rudolf Segel, Thomas Perkmann, Franz Kainberger, Ferdinand Mühlbacher, Walter Hörl, Kyra Borchhardt

Making trials matter: pragmatic and explanatory trials and the problem of applicability

Shaun Treweek, Merrick Zwarenstein

Rationale, design, and baseline characteristics of the Acetylcystein for Contrast-Induced nephropaThy (ACT) Trial: a pragmatic randomized controlled trial to evaluate the efficacy of acetylcysteine for the prevention of contrast-induced nephropathy

Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial

Matthew R Sydes, Mahesh KB Parmar, Nicholas D James, Noel W Clarke, David P Dearnaley, Malcolm D Mason, Rachel C Morgan, Karen Sanders, Patrick Royston

LOST to follow-up Information in Trials (LOST-IT): a protocol on the potential impact

Elie A Akl, Matthias Briel, John J You, Francois Lamontagne, Azim Gangji, Tali Cukierman-Yaffe, Mohamad Alshurafa, Xin Sun, Kara A Nerenberg, Bradley C Johnston, Claudio Vera, Edward J Mills, Dirk Bassler, Arturo Salazar, Neera Bhatnagar, Jason W Busse, Zara Khalid, SD Walter, Deborah J Cook, Holger J Schünemann, Douglas G Altman, Gordon H Guyatt

Antiretroviral effect of lovastatin on HIV-1-infected individuals without highly active antiretroviral therapy (The LIVE study): a phase-II randomized clinical trial

Carlos J Montoya, Fabian Jaimes, Edwin A Higuita, Sandra Convers-Páez, Santiago Estrada, Francisco Gutierrez, Pedro Amariles, Newar Giraldo, Cristina Peñaloza, Maria T Rugeles

Design of the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study to assess the ability of remote monitoring to treat and triage patients more effectively

Maurizio Marzegalli, Maurizio Landolina, Maurizio Lunati, Giovanni B Perego, Alessia Pappone, Giuseppe Guenzati, Carlo Campana, Maria Frigerio, Gianfranco Parati, Antonio Curnis, Irene Colangelo, Sergio Valsecchi

Dealing with heterogeneity of treatment effects: is the literature up to the challenge?

Nicole B Gabler, Naihua Duan, Diana Liao, Joann G Elmore, Theodore G Ganiats, Richard L Kravitz

Does a monetary incentive improve the response to a postal questionnaire in a randomised controlled trial? The MINT incentive study

Simon Gates, Mark A Williams, Emma Withers, Esther Williamson, Shahrul Mt-Isa, Sarah E Lamb

N-acetylcysteine does not prevent contrast-induced nephropathy after cardiac catheterization in patients with diabetes mellitus and chronic kidney disease: a randomized clinical trial

Manouchehr Amini, Mojtaba Salarifar, Alireza Amirbaigloo, Farzad Masoudkabir, Fatemeh Esfahani

Randomized trials published in some Chinese journals: how many are randomized?

Taixiang Wu, Youping Li, Zhaoxiang Bian, Guanjian Liu, David Moher

The impact of avoiding cardiopulmonary by-pass during coronary artery bypass surgery in elderly patients: the Danish On-pump Off-pump Randomisation Study (DOORS)

Kim Houlind, Bo Juul Kjeldsen, Susanne Nørgaard Madsen, Bodil Steen Rasmussen, Susanne Juel Holme, Thomas Andersen Schmidt, Poul Erik Haahr, Poul Erik Mortensen

Against pragmatism: on efficacy, effectiveness and the real world

David M Kent, Georgios Kitsios

Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

Matthias Briel, Melanie Lane, Victor M Montori, Dirk Bassler, Paul Glasziou, German Malaga, Elie A Akl, Ignacio Ferreira-Gonzalez, Pablo Alonso-Coello, Gerard Urrutia, Regina Kunz, Carolina Ruiz Culebro, Suzana Alves da Silva, David N Flynn, Mohamed B Elamin, Brigitte Strahm, M Hassan Murad, Benjamin Djulbegovic, Neill KJ Adhikari, Edward J Mills, Femida Gwadry-Sridhar, Haresh Kirpalani, Heloisa P Soares, Nisrin O Abu Elnour, John J You, Paul J Karanicolas, Heiner C Bucher, Julianna F Lampropulos, Alain J Nordmann, Karen EA Burns, Sohail M Mulla, Heike Raatz, Amit Sood, Jagdeep Kaur, Clare R Bankhead, Rebecca J Mullan, Kara A Nerenberg, Per Olav Vandvik, Fernando Coto-Yglesias, Holger Schünemann, Fabio Tuche, Pedro Paulo M Chrispim, Deborah J Cook, Kristina Lutz, Christine M Ribic, Noah Vale, Patricia J Erwin, Rafael Perera, Qi Zhou, Diane Heels-Ansdell, Tim Ramsay, Stephen D Walter, Gordon H Guyatt

Intravenous fluid restriction after major abdominal surgery: a randomized blinded clinical trial

Hester Vermeulen, Jan Hofland, Dink A Legemate, Dirk T Ubbink

Effect of osteosynthesis, primary hemiarthroplasty, and non-surgical management for displaced four-part fractures of the proximal humerus in elderly: a multi-centre, randomised clinical trial

Stig Brorson, Bo Sanderhoff Olsen, Lars Henrik Frich, Steen Lund Jensen, Hans Viggo Johannsen, Anne Kathrine Sørensen, Asbjørn Hrobjartsson

A review of reporting of participant recruitment and retention in RCTs in six major journals

Merran Toerien, Sara T Brookes, Chris Metcalfe, Isabel de Salis, Zelda Tomlin, Tim J Peters, Jonathan Sterne, Jenny L Donovan

The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) Prisons Project Study: protocol for a randomised controlled trial comparing methadone and buprenorphine for opiate detoxification

Laura Sheard, Nat MJ Wright, Clive E Adams, Nicole Bound, Bruno Rushforth, Roger Hart, Charlotte NE Tompkins

Acupuncture for persistent allergic rhinitis: a multi-centre, randomised, controlled trial protocol

Jong-In Kim, Myeong Soo Lee, So-Young Jung, Jun-Yong Choi, Sanghoon Lee, Jeong-Min Ko, Hong Zhao, Jiping Zhao, Ae-Ran Kim, Mi-Suk Shin, Kyung-Won Kang, Hee-Jung Jung, Tae-Hun Kim, Baoyan Liu, Sun-Mi Choi

Can you believe what you read in the papers?

Mike Clarke

Compliance of clinical trial registries with the World Health Organization minimum data set: a survey

Lorenzo P Moja, Ivan Moschetti, Munira Nurbhai, Anna Compagnoni, Alessandro Liberati, Jeremy M Grimshaw, An-Wen Chan, Kay Dickersin, Karmela Krleza-Jeric, David Moher, Ida Sim, Jimmy Volmink

DOMINO-AD protocol: donepezil and memantine in moderate to severe Alzheimer's disease – a multicentre RCT

Rob Jones, Bart Sheehan, Patrick Phillips, Ed Juszczak, Jessica Adams, Ashley Baldwin, Clive Ballard, Sube Banerjee, Bob Barber, Peter Bentham, Richard Brown, Alistair Burns, Tom Dening, David Findlay, Richard Gray, Mary Griffin, Clive Holmes, Alan Hughes, Robin Jacoby, Tony Johnson, Roy Jones, Martin Knapp, James Lindesay, Ian McKeith, Rupert McShane, Ajay Macharouthu, John O'Brien, Caroline Onions, Peter Passmore, James Raftery, Craig Ritchie, Rob Howard

Perioperative management in distal pancreatectomy: results of a survey in 23 European participating centres of the DISPACT trial and a review of literature

Helge Bruns, Nuh N Rahbari, Thorsten Löffler, Markus K Diener, Christoph M Seiler, Matthias Glanemann, Giovanni Butturini, Christoph Schuhmacher, Inga Rossion, Markus W Büchler, Tido Junghans

Implementation of Internet-based preventive interventions for depression and anxiety: role of support? The design of a randomized controlled trial

Tara Donker, Annemieke van Straten, Heleen Riper, Isaac Marks, Gerhard Andersson, Pim Cuijpers

RADAR – A ra ndomised, multi-centre, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with haemod ynamically relevant atherosclerotic renal ar tery stenosis

Uwe Schwarzwälder, Michael Hauk, Thomas Zeller

Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study

Monica Taljaard, Charles Weijer, Jeremy M Grimshaw, Judith Belle Brown, Ariella Binik, Robert Boruch, Jamie C Brehaut, Shazia H Chaudhry, Martin P Eccles, Andrew McRae, Raphael Saginur, Merrick Zwarenstein, Allan Donner

Clinical e valuation of magnetic resonance imaging in coronary heart disease: The CE-MARC study

John P Greenwood, Neil Maredia, Aleksandra Radjenovic, Julia M Brown, Jane Nixon, Amanda J Farrin, Catherine Dickinson, John F Younger, John P Ridgway, Mark Sculpher, Stephen G Ball, Sven Plein

Evaluation of an online Diabetes Needs Assessment Tool (DNAT) for health professionals: a randomised controlled trial

Sara Schroter, Dean Jenkins, Rebecca Playle, Kieran Walsh, Courtenay Probert, Thomas Kellner, Gerhard Arnhofer, David Owens

Reminiscence groups for people with dementia and their family carers: pragmatic eight-centre randomised trial of joint reminiscence and maintenance versus usual treatment: a protocol

Robert T Woods, Errollyn Bruce, Rhiannon T Edwards, Barry Hounsome, John Keady, Esme D Moniz-Cook, Martin Orrell, Ian T Russell

Periodontal treatment to improve glycaemic control in diabetic patients: study protocol of the randomized, controlled DIAPERIO trial

Jean-Noel Vergnes, Elise Arrivé, Pierre Gourdy, Hélène Hanaire, Vincent Rigalleau, Henri Gin, Cyril Sédarat, Georges Dorignac, Christophe Bou, Michel Sixou, Cathy Nabet

Rationale and design of the participant, investigator, observer, and data-analyst-blinded randomized AGENDA trial on associations between gene-polymorphisms, endophenotypes for depression and antidepressive intervention: the effect of escitalopram versus placebo on the combined dexamethasone-corticotrophine releasing hormone test and other potential endophenotypes in healthy first-degree relatives of persons with depression

Ulla Knorr, Maj Vinberg, Marianne Klose, Ulla Feldt-Rasmussen, Linda Hilsted, Anders Gade, Eva Haastrup, Olaf Paulson, Jørn Wetterslev, Christian Gluud, Ulrik Gether, Lars Kessing

Exercise therapy, quality of life, and activities of daily living in patients with Parkinson disease: a small scale quasi-randomised trial

Bahram Yousefi, Vahid Tadibi, Ali Fathollahzadeh Khoei, Ali Montazeri

Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial

Frank Peters-Klimm, Stephen Campbell, Thomas Müller-Tasch, Dieter Schellberg, Goetz Gelbrich, Wolfgang Herzog, Joachim Szecsenyi

Rapid reduction versus abrupt quitting for smokers who want to stop soon: a randomised controlled non-inferiority trial

Nicola Lindson, Paul Aveyard, Jackie T Ingram, Jennie Inglis, Jane Beach, Robert West, Susan Michie

Efficacy of prescribed injectable diacetylmorphine in the Andalusian trial: Bayesian analysis of responders and non-responders according to a multi domain outcome index

Emilio Perea-Milla, Luis Carlos Silva Ayçaguer, Joan Carles March Cerdà, Francisco González Saiz, Francisco Rivas-Ruiz, Alina Danet, Manuel Romero Vallecillo, Eugenia Oviedo-Joekes

Promoting smoking cessation in Bangladeshi and Pakistani male adults: design of a pilot cluster randomised controlled trial of trained community smoking cessation workers

Rachna A Begh, Paul Aveyard, Penney Upton, Raj S Bhopal, Martin White, Amanda Amos, Robin J Prescott, Raman Bedi, Pelham Barton, Monica Fletcher, Paramjit Gill, Qaim Zaidi, Aziz Sheikh

Protocol for a randomized controlled trial on risk adapted damage control orthopedic surgery of femur shaft fractures in multiple trauma patients

Dieter Rixen, Eva Steinhausen, Stefan Sauerland, Rolf Lefering, Matthias Meier, Marc G Maegele, Bertil Bouillon, Edmund A M Neugebauer

A phase II clinical trial to assess the safety of clonidine in acute organophosphorus pesticide poisoning

Polwattage M S Perera, Shaluka F Jayamanna, Raja Hettiarachchi, Chandana Abeysinghe, Harindra Karunatilake, Andrew H Dawson, Nick A Buckley

Efficacy and safety of bilateral continuous theta burst stimulation (cTBS) for the treatment of chronic tinnitus: design of a three-armed randomized controlled trial

Carola Arfeller, Reinhard Vonthein, Stefan K Plontke, Christian Plewnia

Acupuncture as a treatment for functional dyspepsia: design and methods of a randomized controlled trial

Hui Zheng, Xiao-ping Tian, Ying Li, Fan-rong Liang, Shu-guang Yu, Xu-guang Liu, Yong Tang, Xu-guang Yang, Jie Yan, Guo-jie Sun, Xiao-rong Chang, Hong-xing Zhang, Ting-ting Ma, Shu-yuan Yu

Barriers encountered during enrollment in an internet-mediated randomized controlled trial

Lorraine R Buis, Adrienne W Janney, Michael L Hess, Silas A Culver, Caroline R Richardson

The efficacy of surgical decompression before 24 hours versus 24 to 72 hours in patients with spinal cord injury from T1 to L1 – with specific consideration on ethics: a randomized controlled trial

Vafa Rahimi-Movaghar, Soheil Saadat, Alexander R Vaccaro, Seyed Mohammad Ghodsi, Mohammad Samadian, Arya Sheykhmozaffari, Seyed Mohammad Safdari, Bahram Keshmirian

Psychoeducation versus treatment as usual in diabetic patients with subthreshold depression: preliminary results of a randomized controlled trial

Mirjana Pibernik-Okanovic, Drazen Begic, Dea Ajdukovic, Natasa Andrijasevic, Zeljko Metelko

Performance-based readability testing of participant information for a Phase 3 IVF trial

Peter Knapp, DK Raynor, Jonathan Silcock, Brian Parkinson

Cost-minimization analysis in a blind randomized trial on small-incision versus laparoscopic cholecystectomy from a societal perspective: sick leave outweighs efforts in hospital savings

Frederik Keus, Trudy de Jonge, Hein G Gooszen, Erik Buskens, Cornelis JHM van Laarhoven

Wean Earlier and Automatically with New technology (the WEAN study): a protocol of a multicentre, pilot randomized controlled trial

Karen EA Burns, Maureen O Meade, Martin R Lessard, Sean P Keenan, Francois Lellouche

Design, statistical analysis and sample size calculation of a phase IIb/III study of linagliptin versus voglibose and placebo

Yoshiharu Horie, Naoyuki Hayashi, Klaus Dugi, Masahiro Takeuchi

REFINE (Reducing Falls in In-patient Elderly) - a randomised controlled trial

Catherine D Vass, Opinder Sahota, Avril Drummond, Denise Kendrick, John Gladman, Tracey Sach, Mark Avis, Matthew Grainge

Structured information during the ICU stay to reduce anxiety: study protocol of a multicenter randomized controlled trial

Steffen Fleischer, Almuth Berg, Thomas R Neubert, Michael Koller, Johann Behrens, Ralf Becker, Annegret Horbach, Joachim Radke, Mathias Rothmund, Oliver Kuss

QUARITE (quality of care, risk management and technology in obstetrics): a cluster-randomized trial of a multifaceted intervention to improve emergency obstetric care in Senegal and Mali

Alexandre Dumont, Pierre Fournier, William Fraser, Slim Haddad, Mamadou Traore, Idrissa Diop, Mouhamadou Gueye, Alioune Gaye, François Couturier, Jean-Charles Pasquier, François Beaudoin, André Lalonde, Marie Hatem, Michal Abrahamowicz

Incorporating multiple interventions in meta-analysis: an evaluation of the mixed treatment comparison with the adjusted indirect comparison

Christopher O'Regan, Isabella Ghement, Oghenowede Eyawo, Gordon H Guyatt, Edward J Mills

The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol

Richard T Lester, Edward J Mills, Antony Kariri, Paul Ritvo, Michael Chung, William Jack, James Habyarimana, Sarah Karanja, Samson Barasa, Rosemary Nguti, Benson Estambale, Elizabeth Ngugi, T Blake Ball, Lehana Thabane, Joshua Kimani, Lawrence Gelmon, Marta Ackers, Francis A Plummer

The Irish DAFNE Study Protocol: A cluster randomised trial of group versus individual follow-up after structured education for Type 1 diabetes

Seán F Dinneen, Mary Clare O' Hara, Molly Byrne, John Newell, Lisa Daly, Donal O' Shea, Diarmuid Smith

The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique

Giel G Koning, Hans JP de Schipper, Henk JM Oostvogel, Michiel HJ Verhofstad, Pieter G Gerritsen, Kees CJHM van Laarhoven, Patrick WHE Vriens

Intracoronary versus intravenous abciximab in ST-segment elevation myocardial infarction: rationale and design of the CICERO trial in patients undergoing primary percutaneous coronary intervention with thrombus aspiration

Youlan L Gu, Marieke L Fokkema, Marthe A Kampinga, Bart JGL de Smet, Eng S Tan, Ad FM van den Heuvel, Felix Zijlstra

A randomized, controlled, prospective trial to evaluate the haemostatic effect of Lyostypt versus Surgicel in arterial bypass anastomosis: "COBBANA" trial

Petra Baumann, Hardy Schumacher, Johannes Hüsing, Steffen Luntz, Hanns-Peter Knaebel

The third Symptom Management Research Trial in Oncology (SMaRT Oncology-3): a randomised trial to determine the efficacy of adding a complex intervention for major depressive disorder (Depression Care for People with Lung Cancer) to usual care, compared to usual care alone in patients with lung cancer

Jane Walker, Jim Cassidy, Michael Sharpe

Prevention of depression and anxiety in adolescents: A randomized controlled trial testing the efficacy and mechanisms of Internet-based self-help problem-solving therapy

Willemijn Hoek, Josien Schuurmans, Hans M Koot, Pim Cuijpers

IVC CLAMP: infrahepatic inferior vena cava clamping during hepatectomy - a randomised controlled trial in an interdisciplinary setting

Nuh N Rahbari, Johannes B Zimmermann, Moritz Koch, Thomas Bruckner, Thomas Schmidt, Heike Elbers, Christoph Reissfelder, Markus A Weigand, Markus W Büchler, Jürgen Weitz

Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

Christine Kubiak, Fernando de Andres-Trelles, Wolfgang Kuchinke, Karl-Heinz Huemer, Steffen Thirstrup, Kate Whitfield, Christian Libersa, Béatrice Barraud, Xina Grählert, Gabriele Dreier, Ruth Grychtol, Zsuzsa Temesvari, Gyorgy Blasko, Gabriella Kardos, Timothy O'Brien, Margaret Cooney, Siobhan Gaynor, Arrigo Schieppati, Nuria Sanz, Raquel Hernandez, Charlotte Asker-Hagelberg, Hanna Johansson, Sue Bourne, Jane Byrne, Adeeba Asghar, Jean-Marc Husson, Christian Gluud, Jacques Demotes-Mainard

Effectiveness of focused structural massage and relaxation massage for chronic low back pain: protocol for a randomized controlled trial

Daniel C Cherkin, Karen J Sherman, Janet Kahn, Janet H Erro, Richard A Deyo, Sebastien J Haneuse, Andrea J Cook

Comparison of embedded and added motor imagery training in patients after stroke: study protocol of a randomised controlled pilot trial using a mixed methods approach

Corina Schuster, Jenny Butler, Brian Andrews, Udo Kischka, Thierry Ettlin

Efficacies of the new Paclitaxel-eluting Coroflex Please™ Stent in percutaneous coronary intervention; comparison of efficacy between Coroflex Please™ and Taxus™ (ECO-PLEASANT) trial: study rationale and design

Jae-Bin Seo, Hui-Kyung Jeon, Kyung-Woo Park, Jong-Seon Park, Jang-Ho Bae, Sang-Wook Kim, Keon-Woong Moon, Jae-Woong Choi, Sang-Gon Lee, Woo-Young Chung, Tae-Jin Youn, Soo-Joong Kim, Doo-Il Kim, Byung-Ok Kim, Min-Su Hyon, Keum-Soo Park, Tae-Joon Cha, Hweung-Kon Hwang, Seung-Ho Hur, Hyo-Soo Kim

Microbicides Development Programme: design of a phase III trial to measure the efficacy of the vaginal microbicide PRO 2000/5 for HIV prevention

Andrew Nunn, Sheena McCormack, Angela M Crook, Robert Pool, Clare Rutterford, Richard Hayes

The impact of networks on clinical trials in the United Kingdom

Sze May Ng, Alan Michael Weindling

Subgroup Analysis of Trials Is Rarely Easy (SATIRE): a study protocol for a systematic review to characterize the analysis, reporting, and claim of subgroup effects in randomized trials

Xin Sun, Matthias Briel, Jason W Busse, Elie A Akl, John J You, Filip Mejza, Malgorzata Bala, Natalia Diaz-Granados, Dirk Bassler, Dominik Mertz, Sadeesh K Srinathan, Per Olav Vandvik, German Malaga, Mohamed Alshurafa, Philipp Dahm, Pablo Alonso-Coello, Diane M Heels-Ansdell, Neera Bhatnagar, Bradley C Johnston, Li Wang, Stephen D Walter, Douglas G Altman, Gordon H Guyatt

Prednisolone Trial: Study protocol for a randomised controlled trial of prednisolone for women with idiopathic recurrent miscarriage and raised levels of uterine natural killer (uNK) cells in the endometrium

Ai-Wei Tang, Zarko Alfirevic, Mark A Turner, Jo Drury, Siobhan Quenby

Cost-effectiveness of postural exercise therapy versus physiotherapy in computer screen-workers with early non-specific work-related upper limb disorders (WRULD); a randomized controlled trial

Marjon D van Eijsden, Sylvia A Gerhards, Rob A de Bie, Johan L Severens

Clinical trial to assess the effect of physical exercise on endothelial function and insulin resistance in pregnant women

Robinson Ramírez-Vélez, Ana C Aguilar, Mildrey Mosquera, Ronald G Garcia, Laura M Reyes, Patricio López-Jaramillo

The Toronto prehospital hypertonic resuscitation-head injury and multi organ dysfunction trial (TOPHR HIT) - Methods and data collection tools

Laurie J Morrison, Sandro B Rizoli, Brian Schwartz, Shawn G Rhind, Merita Simitciu, Tyrone Perreira, Russell MacDonald, Anna Trompeo, Donald T Stuss, Sandra E Black, Alex Kiss, Andrew J Baker

Quality of reporting of randomized controlled trials in polycystic ovary syndrome

Anna Partsinevelou, Elias Zintzaras

Does point of care prothrombin time measurement reduce the transfusion of fresh frozen plasma in patients undergoing major surgery? The POC-OP randomized-controlled trial

Natalie Urwyler, Sven Trelle, Lorenz Theiler, Peter Jüni, Lukas P Staub, Cedric Luyet, Lorenzo Alberio, Kay Stricker, Robert Greif

When worlds collide

Clive E Adams, Mauricio Silva de Lima

The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury

Haleema Shakur, Peter Andrews, Toomas Asser, Laura Balica, Cristian Boeriu, Juan Diego Ciro Quintero, Yashbir Dewan, Patrick Druwé, Olivia Fletcher, Chris Frost, Bennie Hartzenberg, Jorge Mejia Mantilla, Francisco Murillo-Cabezas, Jan Pachl, Ramalingam R Ravi, Indrek Rätsep, Cristina Sampaio, Manmohan Singh, Petr Svoboda, Ian Roberts

Response to: The BRAIN TRIAL: a randomised, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury

Vincent F Simmon

Response to: The BRAIN TRIAL: a randomized, placebo controlled trial of a Bradykinin B2 receptor antagonist (Anatibant) in patients with traumatic brain injury - authors' reply

Ian Roberts, Haleema Shakur

Acupuncture for dry eye: a randomised controlled trial protocol

Tae-Hun Kim, Jong-In Kim, Mi-Suk Shin, Myeong Soo Lee, Jun-Yong Choi, So-Yong Jung, Ae-Ran Kim, Jae-Uk Seol, Sun-Mi Choi

Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice

Laurie J Pencille, Megan E Campbell, Holly K Van Houten, Nilay D Shah, Rebecca J Mullan, Brian A Swiglo, Maggie Breslin, Rebecca L Kesman, Sidna M Tulledge-Scheitel, Thomas M Jaeger, Ruth E Johnson, Gregory A Bartel, Robert A Wermers, L Joseph Melton III, Victor M Montori

The PACE Study: A randomised clinical trial of cognitive activity (CA) for older adults with mild cognitive impairment (MCI)

Mandy R Vidovich, Nicola T Lautenschlager, Leon Flicker, Linda Clare, Osvaldo P Almeida

SWiss Atorvastatin and Interferon Beta-1b Trial In Multiple Sclerosis (SWABIMS) - rationale, design and methodology

Christian P Kamm, Heinrich P Mattle

Association of trial registration with the results and conclusions of published trials of new oncology drugs

Nicolas Rasmussen, Kirby Lee, Lisa Bero

Baseline hospital performance and the impact of medical emergency teams: Modelling vs. conventional subgroup analysis

Jack Chen, Arthas Flabouris, Rinaldo Bellomo, Ken Hillman, Simon Finfer

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state) - A prospective multicenter randomized controlled clinical trial using a comprehensive cohort design

Maximilian Moergel, Antje Jahn-Eimermacher, Frank Krummenauer, Torsten E Reichert, Wilfried Wagner, Thomas G Wendt, Jochen A Werner, Bilal Al-Nawas

Screening asymptomatic patients with diabetes for unknown coronary artery disease: Does it reduce risk? An open-label randomized trial comparing a strategy based on exercise testing aimed at revascularization with management based on pharmacological/behavioural treatment of traditional risk factors. DADDY-D Trial (Does coronary Atherosclerosis Deserve to be Diagnosed and treated early in Diabetics?)

Fabrizio Turrini, Roberto Messora, Paolo Giovanardi, Stefano Tondi, Paolo Magnavacchi, Rita Cavani, Giandomenico Tosoni, Carlo Cappelli, Elisa Pellegrini, Stefania Romano, Augusto Baldini, Romeo Giulietto Zennaro, Marco Bondi

Rationale and design of WEBCARE: A randomized, controlled, web-based behavioral intervention trial in cardioverter-defibrillator patients to reduce anxiety and device concerns and enhance quality of life

Susanne S Pedersen, Viola Spek, Dominic AMJ Theuns, Marco Alings, Pepijn van der Voort, Luc Jordaens, Pim Cuijpers, Johan Denollet, Krista C van den Broek

The GYMSSA trial: a prospective randomized trial comparing gastrectomy, metastasectomy plus systemic therapy versus systemic therapy alone

Sid P Kerkar, Clinton D Kemp, Austin Duffy, Udai S Kammula, David S Schrump, King F Kwong, Martha Quezado, Barry R Goldspiel, Aradhana Venkatesan, Ann Berger, Melissa Walker, Mary Ann Toomey, Seth M Steinberg, Guiseppe Giaccone, Steven A Rosenberg, Itzhak Avital

Study on the evaluation of the clinical effects of traditional chinese medicine in heart failure by complex intervention: protocol of SECETCM-HF

Jingyuan Mao, Yazhu Hou, Hongcai Shang, Henghe Wang, Xianliang Wang, Yingqiang Zhao, Tianfu Niu, Jinrong Cui, Guangping Li, Qian Lin, Le Shi, Xiuli Jia, Ruihong Fan, Baohe Wang, Hongwu Wang, Jishou Ruan

Improved quality monitoring of multi-center acupuncture clinical trials in China

Ling Zhao, Fan-rong Liang, Ying Li, Fu-wen Zhang, Hui Zheng, Xi Wu