Articles

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

In the developmental stage of laparoscopic cholecystectomy (LC) it was considered 'unsafe' or 'technically difficult' to perform laparoscopic cholecystectomy for acute cholecystitis (AC). With increasing exper...

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

Outcome based subgroup analysis: a neglected concern

A subgroup of clinical trial subjects identified by baseline characteristics is a proper subgroup while a subgroup determined by post randomization events or measures is an improper subgroup. Both types of sub...

Authors: Karim F Hirji and Morten W Fagerland

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

The incidence of gallstones and gallbladder sludge is known to be higher in patients after gastrectomy than in general population. This higher incidence is probably related to surgical dissection of the vagus ...

Authors: 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 and Renato Moretti

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

One third to two thirds of people with schizophrenia have persistent psychotic symptoms despite clozapine treatment. Under real-world circumstances, the need to provide effective therapeutic interventions to p...

Authors: 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…

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

Amlexanox has been developed as a 5 percent topical oral paste for the treatment of patients with recurrent aphthous stomatitis (RAS) in most European countries. However, it is not yet available in China and h...

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

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

The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention.

Authors: Morgane Ethgen, Isabelle Boutron, Philippe Gabriel Steg, Carine Roy and Philippe Ravaud

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

Medication errors are an important cause of morbidity and mortality in primary care.

Authors: 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 and Aziz Sheikh

Design, analysis, and presentation of crossover trials

Although crossover trials enjoy wide use, standards for analysis and reporting have not been established. We reviewed methodological aspects and quality of reporting in a representative sample of published cro...

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

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

Telephone quit lines are accessible to many smokers and are used to engage motivated smokers to make quit attempts. Smoking cessation counselling provided via telephone can either be reactive (i.e. primarily i...

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

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

Many studies have already reported encouraging results in the prophylactic therapy of migraine by acupuncture, but there seems to be a lack of high quality randomized controlled trials from China. We design an...

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

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

Fibromyalgia is a prevalent and disabling disorder characterized by widespread pain and other symptoms such as insomnia, fatigue or depression. Catastrophization is considered a key clinical symptom in fibromy...

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

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

Anorexia nervosa is a serious eating disorder leading to high morbidity and mortality as a result of both malnutrition and suicide. The seriousness of the disorder requires extensive knowledge of effective tre...

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

Rationale and design: telepsychology service delivery for depressed elderly veterans

Older adults who live in rural areas experience significant disparities in health status and access to mental health care. "Telepsychology," (also referred to as "telepsychiatry," or "telemental health") repre...

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

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

To speed up the evaluation of new therapies, the multi-arm, multi-stage trial design was suggested previously by the authors.

Authors: FM-S Barthel, MKB Parmar and P Royston

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

The prevalence of depression in patients with acute coronary syndrome, i.e. myocardial infarction and unstable angina, is higher than in the general population. The prevalence of anxiety is higher as well. Bot...

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

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

Many studies have attempted to determine the "best" anaesthetic technique for neurosurgical procedures in patients without intracranial hypertension. So far, no study comparing intravenous (IA) with volatile-base...

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

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

Depression Care for People with Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depressio...

Authors: Jane Walker, Jim Cassidy and Michael Sharpe

Towards agreement on best practice for publishing raw clinical trial data

Many research-funding agencies now require open access to the results of research they have funded, and some also require that researchers make available the raw data generated from that research. Similarly, t...

Authors: Iain Hrynaszkiewicz and Douglas G Altman

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

Tourette Syndrome (TS) is a neurological condition presenting chronic motor and phonic tics, and important degree of comorbidity. Considered an uncommon illness, it first becomes apparent during childhood. Cur...

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

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

The motivations of clinicians to participate in clinical trials have been little studied. This project explored the potential role of payment for participation in publicly funded clinical trials in the UK. The...

Authors: James Raftery, Christine Kerr, Sheila Hawker and John Powell

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

Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex a...

Authors: Andrew J Vickers and Peter T Scardino

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

Hypertension affects 29% of the adult U.S. population and is a leading cause of heart disease, stroke, and kidney failure. Despite numerous effective treatments, only 53% of people with hypertension are at goa...

Authors: 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 and Laura P Svetkey

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

Metformin has had a 'black box' contraindication in diabetic patients with heart failure (HF), but many believe it to be the treatment of choice in this setting. Therefore, we attempted to conduct a pilot stud...

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

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

Non-pharmacological, non-surgical interventions are recommended as the first line of treatment for osteoarthritis (OA) of the hip and knee. There is evidence that exercise therapy is effective for reducing pai...

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

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

Almost 50% of Americans have elevated low-density lipoprotein cholesterol (LDL-C). The behaviors required to lower LDL-C levels may be difficult to adhere to if they are inconsistent with spouses' health pract...

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

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

Randomised evaluations of surgical interventions are rare; some interventions have been widely adopted without rigorous evaluation. Unlike other medical areas, the randomised controlled trial (RCT) design has ...

Authors: Jonathan A Cook

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

Laparoscopy-assisted vaginal hysterectomy is one of the definite methods for the treatment of symptomatic uterine fibroids with lesser intraoperative bleeding and shorter hospitalization compared with abdomina...

Authors: 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 and Soon-Beom Kang

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

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

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

An abundance of literature is dedicated to research for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Most, is in the area of pharmacological therapies with less emphasis in psychotherapy a...

Authors: Fay Karpouzis, Henry Pollard and Rod Bonello

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

The Tehran Lipid and Glucose Study (TLGS) is a long term integrated community-based program for prevention of non-communicable disorders (NCD) by development of a healthy lifestyle and reduction of NCD risk fa...

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

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

There is no recommendation to screen ferritin level in blood donors, even though several studies have noted the high prevalence of iron deficiency after blood donation, particularly among menstruating females....

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

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

Depression is one of the most common reasons for consulting in primary care. Acupuncture is a popular complementary therapy choice for depression but its evidence base is poor with more robust high quality tri...

Authors: Sylvia Schroer and Hugh MacPherson

Readers as research detectives

Flaws in research papers are common but it may require arduous detective work to unravel them. Checklists are helpful, but many inconsistencies will only be revealed through repeated cross-checks of every litt...

Authors: Peter C Gøtzsche

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

Assessing the quality of included trials is a central part of a systematic review. Many check-list type of instruments for doing this exist. Using a trial of antibiotic treatment for acute otitis media, Burke ...

Authors: Karim F Hirji

Protocol of a randomized controlled trial of the effectiveness of physician education and activation versus two rehabilitation programs for the treatment of Whiplash-associated Disorders: The University Health Network Whiplash Intervention Trial

Whiplash injuries are an important public health problem that is associated with significant disability and high health care utilization. Recent cohort studies suggest that physician care may be the most effec...

Authors: Pierre Côté, J David Cassidy, Simon Carette, Eleanor Boyle, Heather M Shearer, Maja Stupar, Carlo Ammendolia, Gabrielle van der Velde, Jill A Hayden, Xiaoqing Yang, Maurits van Tulder and John W Frank

Prospective controlled randomized trial on prevention of postoperative abdominal adhesions by Icodextrin 4% solution after laparotomic operation for small bowel obstruction caused by adherences [POPA study: Prevention of Postoperative Adhesions on behalf of the World Society of Emergency Surgery]

Adhesive small intestine occlusion [ASIO] is an important cause of hospital admission placing a substantial burden on healthcare systems worldwide. Often times, ASIO is associated with significant morbidity an...

Authors: Fausto Catena, Luca Ansaloni, Augusto Lauro, Giorgio Ercolani, Luigi D'Alessandro and Antonio Pinna

Community-based trial of screening for Chlamydia trachomatis to prevent pelvic inflammatory disease: the POPI (prevention of pelvic infection) trial

Pelvic inflammatory disease (PID) is common and can lead to tubal factor infertility, ectopic pregnancy or chronic pelvic pain. Despite major UK government investment in the National Chlamydia Screening Progra...

Authors: Pippa Oakeshott, Sally Kerry, Helen Atherton, Adamma Aghaizu, Sima Hay, David Taylor-Robinson, Ian Simms and Phillip Hay

Ultrasound enhanced prehospital thrombolysis using microbubbles infusion in patients with acute ST elevation myocardial infarction: Rationale and design of the Sonolysis study

Experimental studies have shown that ultrasound contrast agents enhance the effectiveness of thrombolytic agents in the presence of ultrasound in vitro and in vivo. Recently, we have launched a clinical pilot stu...

Authors: Jeroen Slikkerveer, Pieter A Dijkmans, Gertjan T Sieswerda, Pieter AFM Doevendans, Arie PJ van Dijk, Freek WA Verheugt, Thomas R Porter and Otto Kamp

A randomized double blind crossover placebo-controlled clinical trial to assess the effects of a mouthwash containing chlorine dioxide on oral malodor

Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO₂), however, its clinical efficacies on oral malodor have been evaluated only with organoleptic measurem...

Authors: Kayoko Shinada, Masayuki Ueno, Chisato Konishi, Sachiko Takehara, Sayaka Yokoyama and Yoko Kawaguchi

Study Protocol: effects of acupuncture on hot flushes in perimenopausal and postmenopausal women – a multicenter randomized clinical trial

Hot flushes are the most frequent climacteric symptom and a major cause of suffering among menopausal women. The condition negatively influences many aspects of women's lives. To date, conventional hormone rep...

Authors: Kun-Hyung Kim, Kyung-Won Kang, Hee-Jung Jung, Ji-Eun Park, So-Young Jung, Jun-Yong Choi and Sun-Mi Choi

Reporting of noninferiority and equivalence randomized trials for major prostaglandins: A systematic survey of the ophthalmology literature

Standards for reporting clinical trials have improved the transparency of patient-important research. The Consolidated Standards of Reporting Trials (CONSORT) published an extension to address noninferiority a...

Authors: Oghenowede Eyawo, Chia-Wen Lee, Beth Rachlis and Edward J Mills

Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design

Magnetic Resonance Imaging (MRI) of patients with implanted cardiac devices is currently considered hazardous due to potential for electromagnetic interference to the patient and pacemaker system. With approxi...

Authors: Richard Sutton, Emanuel Kanal, Bruce L Wilkoff, David Bello, Roger Luechinger, Inge Jenniskens, Michael Hull and Torsten Sommer

Early intervention in panic: randomized controlled trial and cost-effectiveness analysis

Panic disorder (PD) is a common, severe and persistent mental disorder, associated with a high degree of distress and occupational and social disability. A substantial proportion of the population experiences ...

Authors: Peter Meulenbeek, Godelief Willemse, Filip Smit, Anton van Balkom, Philip Spinhoven and Pim Cuijpers

Reporting of clinical trials: a review of research funders' guidelines

Randomised controlled trials (RCTs) represent the gold standard methodological design to evaluate the effectiveness of an intervention in humans but they are subject to bias, including study publication bias a...

Authors: Kerry Dwan, Carrol Gamble, Paula R Williamson and Douglas G Altman

VAST: Vertebral Artery Stenting Trial. Protocol for a randomised safety and feasibility trial

Twenty to 30 percent of all transient ischaemic attacks and ischaemic strokes involve tissue supplied by the vertebrobasilar circulation. Atherosclerotic stenosis ≥ 50% in the vertebral artery accounts for ver...

Authors: A Compter, HB van der Worp, WJ Schonewille, JA Vos, A Algra, TH Lo, WPThM Mali, FL Moll and LJ Kappelle

Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units

There is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigo...

Authors: Rhiannon T Edwards, Barry Hounsome, Pat Linck and Ian T Russell

ZAMSTAR, The Zambia South Africa TB and HIV Reduction study: Design of a 2 × 2 factorial community randomized trial

TB and HIV form a deadly synergy in much of the developing world, especially Africa. Interventions to reduce the impact of these diseases at community level are urgently needed. This paper presents the design ...

Authors: Helen M Ayles, Charalambos Sismanidis, Nulda Beyers, Richard J Hayes and Peter Godfrey-Faussett

Community-based randomised controlled trial evaluating falls and osteoporosis risk management strategies

Osteoporosis-related fractures are a significant public health concern. Interventions that increase detection and treatment of osteoporosis, as well as prevention of fractures and falls, are substantially unde...

Authors: PM Ciaschini, SE Straus, LR Dolovich, RA Goeree, KM Leung, CR Woods, GM Zimmerman, SR Majumdar, S Spadafora, LA Fera and HN Lee

Clinical and cost-effectiveness of internal limiting membrane peeling for patients with idiopathic full thickness macular hole. Protocol for a Randomised Controlled Trial: FILMS (Full-thickness macular hole and Internal Limiting Membrane peeling Study)

A full-thickness macular hole (FTMH) is a common retinal condition associated with impaired vision. Randomised controlled trials (RCTs) have demonstrated that surgery, by means of pars plana vitrectomy and pos...

Authors: Noemi Lois, Jennifer Burr, John Norrie, Luke Vale, Jonathan Cook and Alison McDonald

Protocol of an expertise based randomized trial comparing surgical Venae Sectio versus radiological Puncture of Vena Subclavia for insertion of Totally Implantable Access Port in oncological patients

Totally Implantable Access Ports (TIAP) are being extensively used world-wide and can be expected to gain further importance with the introduction of new neoadjuvant and adjuvant treatments in oncology. Two di...

Authors: Philip Knebel, Lars Fischer, Eva Cremonese, Ruben Lopez-Benitez, Ulrike Stampfl, Boris Radeleff, Hans-Ulrich Kauczor, Markus W Büchler and Christoph M Seiler