Articles

Breast MRI in nonpalpable breast lesions: a randomized trial with diagnostic and therapeutic outcome – MONET – study

In recent years there has been an increasing interest in MRI as a non-invasive diagnostic modality for the work-up of suspicious breast lesions. The additional value of Breast MRI lies mainly in its capacity t...

Authors: Nicky HGM Peters, Inne HM Borel Rinkes, Willem PTM Mali, Maurice AAJ van den Bosch, Remmert K Storm, Peter W Plaisier, Erwin de Boer, Adriaan J van Overbeeke and Petra HM Peeters

Standardising outcomes for clinical trials and systematic reviews

Authors: Mike Clarke

OMERACT: An international initiative to improve outcome measurement in rheumatology

OMERACT is the acronym for an international, informally organized network initiated in 1992 aimed at improving outcome measurement in rheumatology. Chaired by an executive committee, it organizes consensus con...

Authors: Peter Tugwell, Maarten Boers, Peter Brooks, Lee Simon, Vibeke Strand and Leanne Idzerda

Marketing and clinical trials: a case study

Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigoro...

Authors: David Francis, Ian Roberts, Diana R Elbourne, Haleema Shakur, Rosemary C Knight, Jo Garcia, Claire Snowdon, Vikki A Entwistle, Alison M McDonald, Adrian M Grant and Marion K Campbell

Figures in clinical trial reports: current practice & scope for improvement

Most clinical trial publications include figures, but there is little guidance on what results should be displayed as figures and how.

Authors: Stuart J Pocock, Thomas G Travison and Lisa M Wruck

Comparison of different dosing regimens (once weekly vs. twice weekly, and once weekly vs. once every two weeks) with epoetin delta in patients with chronic kidney disease: a randomized controlled trial

Anaemia is a common complication of chronic kidney disease and prevalence increases with declining renal function. Renal anaemia has significant implications for the well-being and quality of life of patients ...

Authors: Iain C Macdougall

Multiple treatment comparisons in epilepsy monotherapy trials

The choice of antiepileptic drug for an individual should be based upon the highest quality evidence regarding potential benefits and harms of the available treatments. Systematic reviews and meta-analysis of ...

Authors: Catrin Tudur Smith, Anthony G Marson, David W Chadwick and Paula R Williamson

VERTOS II: Percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial

The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is gaining popularity a...

Authors: CAH Klazen, HJJ Verhaar, LEH Lampmann, JR Juttmann, MC Blonk, FH Jansen, AV Tielbeek, MC Schoemaker, E Buskens, Y van der Graaf, X Janssens, H Fransen, KJ van Everdingen, AF Muller, WPThM Mali and PNM Lohle

Design of a multicentre randomized trial to evaluate CT colonography versus colonoscopy or barium enema for diagnosis of colonic cancer in older symptomatic patients: The SIGGAR study

The standard whole-colon tests used to investigate patients with symptoms of colorectal cancer are barium enema and colonoscopy. Colonoscopy is the reference test but is technically difficult, resource intensi...

Authors: Steve Halligan, Richard J Lilford, Jane Wardle, Dion Morton, Pauline Rogers, Katherine Wooldrage, Rob Edwards, Reshma Kanani, Urvi Shah and Wendy Atkin

Responder analyses and the assessment of a clinically relevant treatment effect

Ideally, a clinical trial should be able to demonstrate not only a statistically significant improvement in the primary efficacy endpoint, but also that the magnitude of the effect is clinically relevant. One ...

Authors: Steven M Snapinn and Qi Jiang

Do trialists endorse clinical trial registration? Survey of a Pubmed sample

Despite intense interest in trial registration, there is a wide gap between theoretical postulates on trial registration and its implementation worldwide.

Authors: Ludovic Reveiz, Karmela Krleža-Jerić, An-Wen Chan and Sylvia De Aguiar

Acute cholecystitis – early laparoskopic surgery versus antibiotic therapy and delayed elective cholecystectomy: ACDC-study

Acute cholecystitis occurs frequently in the elderly and in patients with gall stones. Most cases of severe or recurrent cholecystitis eventually require surgery, usually laparoscopic cholecystectomy in the We...

Authors: Kilian Weigand, Jörg Köninger, Jens Encke, Markus W Büchler, Wolfgang Stremmel and Carsten N Gutt

A cluster randomized trial evaluating electronic prescribing in an ambulatory care setting

Medication errors, adverse drug events and potential adverse drug events are common and serious in terms of the harms and costs that they impose on the health system and those who use it. Errors resulting in p...

Authors: Merrick F Zwarenstein, Katie N Dainty, Sherman Quan, Alex Kiss and Neill KJ Adhikari

Safety and efficacy of botox injection in alleviating post-operative pain and improving quality of life in lower extremity limb lengthening and deformity correction

Distraction osteogenesis is the standard treatment for the management of lower limb length discrepancy of more than 3 cm and bone loss secondary to congenital anomalies, trauma or infection. This technique con...

Authors: Reggie C Hamdy, Kathleen Montpetit, Joanne Ruck-Gibis, Kelly Thorstad, Ellen Raney, Michael Aiona, Robert Platt, Allen Finley, William Mackenzie, James McCarthy and Unni Narayanan

Double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch: PATHON

Diabetes Mellitus constitutes one of the most important public health problems due to its high prevalence and enormous social and economic consequences. Diabetic foot ulcers are one of the chronic complication...

Authors: Sandra Y Silva, Ligia C Rueda, Gustavo A Márquez, Marcos López, Daniel J Smith, Carlos A Calderón, Juan C Castillo, Jaime Matute, Christian F Rueda-Clausen, Arturo Orduz, Federico A Silva, Piyaporn Kampeerapappun, Mahesh Bhide and Patricio López-Jaramillo

Randomised trial of glutamine and selenium supplemented parenteral nutrition for critically ill patients. Protocol Version 9, 19 February 2007 known as SIGNET (Scottish Intensive care Glutamine or seleNium Evaluative Trial)

Mortality rates in the Intensive Care Unit and subsequent hospital mortality rates in the UK remain high. Infections in Intensive Care are associated with a 2–3 times increased risk of death. It is thought tha...

Authors: Peter JD Andrews, Alison Avenell, David W Noble, Marion K Campbell, Claire G Battison, Bernard L Croal, William G Simpson, John Norrie, Luke D Vale, Jonathon Cook, Robyn de Verteuil and Anne C Milne

Early loading of plalatal implants (ortho-type II) a prospective multicenter randomized controlled clinical trial

In orthodontic treatment, anchorage control is a fundamental aspect. Usually conventional mechanism for orthodontic anchorage control can be either extraoral or intraoral that is headgear or intermaxillary ela...

Authors: Britta A Jung, Heinrich Wehrbein, Werner Hopfenmüller, Winfried Harzer, Tomasz Gedrange, Peter Diedrich and Martin Kunkel

Structuring communication relationships for interprofessional teamwork (SCRIPT): a cluster randomized controlled trial

Despite a burgeoning interest in using interprofessional approaches to promote effective collaboration in health care, systematic reviews find scant evidence of benefit. This protocol describes the first clust...

Authors: Merrick Zwarenstein, Scott Reeves, Ann Russell, Chris Kenaszchuk, Lesley Gotlib Conn, Karen-Lee Miller, Lorelei Lingard and Kevin E Thorpe

Comparison of total parathyroidectomy without autotransplantation and without thymectomy versus total parathyroidectomy with autotransplantation and with thymectomy for secondary hyperparathyroidism: TOPAR PILOT-Trial

Secondary hyperparathyroidism (sHPT) is common in patients with chronic renal failure. Despite the initiation of new therapeutic agents, several patients will require parathyroidectomy (PTX). Total PTX with au...

Authors: Katja Schlosser, Johannes A Veit, Stefan Witte, Emilio Domínguez Fernández, Norbert Victor, Hans-Peter Knaebel, Christoph M Seiler and Matthias Rothmund

Aspirin and Simvastatin Combination for Cardiovascular Events Prevention Trial in Diabetes (ACCEPT-D): design of a randomized study of the efficacy of low-dose aspirin in the prevention of cardiovascular events in subjects with diabetes mellitus treated with statins

Despite the high cardiovascular risk, evidence of efficacy of preventive strategies in individuals with diabetes is scant. In particular, recommendations on the use of aspirin in patients with diabetes mostly ...

Authors: Giorgia De Berardis, Michele Sacco, Virgilio Evangelista, Alessandro Filippi, Carlo B Giorda, Gianni Tognoni, Umberto Valentini and Antonio Nicolucci

PROUD: Effects of preoperative long-term immunonutrition in patients listed for liver transplantation

Patients with end stage liver disease are characteristically malnourished which is associated with poor outcome. Formulas enriched with arginine, ω-3 fatty acids, and nucleotides, "immunonutrients", potentiall...

Authors: Arash Nickkholgh, Heinz Schneider, Jens Encke, Markus W Büchler, Jan Schmidt and Peter Schemmer

Is looped nasogastric tube feeding more effective than conventional nasogastric tube feeding for dysphagia in acute stroke?

Dysphagia occurs in up to 50% of patients admitted to hospital with acute strokes with up to 27% remaining by seven days. Up to 8% continue to have swallowing problems six months after their stroke with 1.7% s...

Authors: Jessica R Beavan, Simon Conroy, Jo Leonardi-Bee, Tim Bowling, Catherine Gaynor, John Gladman, Dawn Good, Peter Gorman, Rowan Harwood, Jan Riley, Tracey Sach and Wayne Sunman

Telecare motivational interviewing for diabetes patient education and support: a randomised controlled trial based in primary care comparing nurse and peer supporter delivery

There is increasing interest in developing peer-led and 'expert patient'-type interventions, particularly to meet the support and informational needs of those with long term conditions, leading to improved cli...

Authors: Jeremy Dale, Isabela Caramlau, Andrea Docherty, Jackie Sturt and Hilary Hearnshaw

Outcome measurement in clinical trials for ulcerative colitis: towards standardisation

Clinical trials on novel drug therapies require clear criteria for patient selection and agreed definitions of disease remission. This principle has been successfully applied in the field of rheumatology where...

Authors: Rachel M Cooney, Bryan F Warren, Douglas G Altman, Maria T Abreu and Simon PL Travis

Practical methods for incorporating summary time-to-event data into meta-analysis

In systematic reviews and meta-analyses, time-to-event outcomes are most appropriately analysed using hazard ratios (HRs). In the absence of individual patient data (IPD), methods are available to obtain HRs a...

Authors: Jayne F Tierney, Lesley A Stewart, Davina Ghersi, Sarah Burdett and Matthew R Sydes

Silent cerebral infarct after cardiac catheterization as detected by diffusion weighted Magnetic Resonance Imaging: a randomized comparison of radial and femoral arterial approaches

Cerebral microembolism detected by transcranial Doppler (TCD) occurs systematically during cardiac catheterization, but its clinical relevance, remains unknown. Studies suggest that asymptomatic embolic cerebr...

Authors: Michèle Hamon, Francesco Burzotta, Catherine Oppenheim, Rémy Morello, Fausto Viader and Martial Hamon

Method for evaluating prediction models that apply the results of randomized trials to individual patients

The clinical significance of a treatment effect demonstrated in a randomized trial is typically assessed by reference to differences in event rates at the group level. An alternative is to make individualized ...

Authors: Andrew J Vickers, Michael W Kattan and Daniel J Sargent

Decisions by regulatory agencies: are they evidence-based?

Contradictory statements about the non-steroidal anti-inflammatory drugs from the European Medicines Agency and the United States Food and Drug Administration have raised questions about whether regulatory dec...

Authors: Curt D Furberg

Importance of competing risks in the analysis of anti-epileptic drug failure

Retention time (time to treatment failure) is a commonly used outcome in antiepileptic drug (AED) studies.

Authors: Paula R Williamson, Catrin Tudur Smith, Josemir W Sander and Anthony G Marson

Evaluation of two formulations of adjuvanted RTS, S malaria vaccine in children aged 3 to 5 years living in a malaria-endemic region of Mozambique: a Phase I/IIb randomized double-blind bridging trial

Previous trials of the RTS, S malaria candidate vaccine have shown that this vaccine is safe, tolerated and immunogenic. The development plan for this vaccine aims at administering it in the first year of life...

Authors: Eusebio V Macete, Jahit Sacarlal, John J Aponte, Amanda Leach, Margarita M Navia, Jessica Milman, Caterina Guinovart, Inacio Mandomando, Yolanda López-Púa, Marc Lievens, Alex Owusu-Ofori, Marie-Claude Dubois, Conor P Cahill, Marguerite Koutsoukos, Marla Sillman, Ricardo Thompson…

"Me's me and you's you": Exploring patients' perspectives of single patient (n-of-1) trials in the UK

The n-of-1 trial offers a more methodologically sound approach to determining optimum treatment for an individual patient than "trials of therapy" routinely conducted in clinical practice. However, such method...

Authors: Sara T Brookes, Lucy Biddle, Charlotte Paterson, Gillian Woolhead and Paul Dieppe

Application and investigation of a bound for outcome reporting bias

Direct empirical evidence for the existence of outcome reporting bias is accumulating and this source of bias is recognised as a potential threat to the validity of meta-analysis of randomised clinical trials.

Authors: Paula R Williamson and Carrol Gamble

Phase II study of two dose schedules of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in anemic patients with advanced non-small cell lung cancer (NSCLC) receiving chemotherapy

C.E.R.A. (Continuous Erythropoietin Receptor Activator) is an innovative agent with unique erythropoietin receptor activity and prolonged half-life. This study evaluated C.E.R.A. once weekly (QW) or once every...

Authors: Vera Hirsh, John Glaspy, Paul Mainwaring, Christian Manegold, Rodryg Ramlau and Joseph E Eid

Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years

The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study.

Authors: Christian Gluud and Dimitrinka Nikolova

Continuity and change?: Exploring reactions to a guided self-management intervention in a randomised controlled trial for IBS with reference to prior experience of managing a long term condition

Self-care interventions are promoted as effective strategies for improving the quality of life and health outcomes for individuals with long-term health conditions. Outcome measures used in evaluations using R...

Authors: Anne Rogers, Victoria Lee and Anne Kennedy

Handheld computers for data entry: high tech has its problems too

The use of handheld computers in medicine has increased in the last decade, they are now used in a variety of clinical settings. There is an underlying assumption that electronic data capture is more accurate ...

Authors: Tania M Shelby-James, Amy P Abernethy, Andrew McAlindon and David C Currow

Does it matter if clinicians recruiting for a trial don't understand what the trial is really about? Qualitative study of surgeons' experiences of participation in a pragmatic multi-centre RCT

Qualitative methods are increasingly used to study the process of clinical trials and patients understanding of the rationale for trials, randomisation and reasons for taking part or refusing. Patients' unders...

Authors: Sue Ziebland, Katie Featherstone, Claire Snowdon, Karen Barker, Helen Frost and Jeremy Fairbank

Feasibility study to inform the design of a UK multi-centre randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis of the leg

This paper describes the results of a feasibility study for a randomised controlled trial (RCT).

Authors: Kim S Thomas, Neil H Cox, Boki SP Savelyich, Debbie Shipley, Sarah Meredith, Andrew Nunn, Nick Reynolds and Hywel C Williams

M ulticenter randomi zed trial of cell the rapy in car diopat hies – MiHeart Study

Cardiovascular diseases are the major cause of death in the world. Current treatments have not been able to reverse this scenario, creating the need for the development of new therapies. Cell therapies have em...

Authors: Bernardo R Tura, Helena F Martino, Luis H Gowdak, Ricardo Ribeiro dos Santos, Hans F Dohmann, José E Krieger, Gilson Feitosa, Fábio Vilas-Boas, Sérgio A Oliveira, Suzana A Silva, Augusto Z Bozza, Radovan Borojevic and Antonio C Campos de Carvalho

The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) prisons project pilot study: protocol for a randomised controlled trial comparing dihydrocodeine and buprenorphine for opiate detoxification

In the United Kingdom (UK), there is an extensive market for the class 'A' drug heroin. Many heroin users spend time in prison. People addicted to heroin often require prescribed medication when attempting to ...

Authors: Laura Sheard, Clive E Adams, Nat MJ Wright, Hany El-Sayeh, Richard Dalton and Charlotte NE Tompkins

Comparison of the efficacy and safety of rosuvastatin 10 mg and atorvastatin 20 mg in high-risk patients with hypercholesterolemia – Prospective study to evaluate the Use of Low doses of the Statins Atorvastatin and Rosuvastatin (PULSAR)

Many patients at high risk of cardiovascular disease do not achieve recommended low-density lipoprotein cholesterol (LDL-C) goals. This study compared the efficacy and safety of low doses of rosuvastatin (10 m...

Authors: Michael B Clearfield, John Amerena, Jean-Pierre Bassand, Hugo R Hernández García, Sam S Miller, Froukje FM Sosef, Michael K Palmer and Brian S Bryzinski

Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study

Securing and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial neg...

Authors: Claire Snowdon, Diana R Elbourne, Jo Garcia, Marion K Campbell, Vikki A Entwistle, David Francis, Adrian M Grant, Rosemary C Knight, Alison M McDonald and Ian Roberts

Fracture risk and the use of a diuretic (indapamide sr) ± perindopril: a substudy of the Hypertension in the Very Elderly Trial (HYVET)

The Hypertension in the Very Elderly Trial (HYVET) is a placebo controlled double blind trial of treating hypertension with indapamide Slow Release (SR) ± perindopril in subjects over the age of 80 years. The ...

Authors: Christopher J Bulpitt, Ruth Peters, Jan A Staessen, Lutgarde Thijs, Marie-Christine De Vernejoul, Astrid E Fletcher and Nigel S Beckett

Duty, desire or indifference? A qualitative study of patient decisions about recruitment to an epilepsy treatment trial

Epilepsy is a common neurological condition, in which drugs are the mainstay of treatment and drugs trials are commonplace. Understanding why patients might or might not opt to participate in epilepsy drug tri...

Authors: Krysia Canvin and Ann Jacoby

Acetylsalicylic acid as an adjuvant therapy for schizophrenia

Findings from both epidemiological and basic research point to the possibility that NSAIDS impede the deterioration in schizophrenia.

Authors: Wijnand Laan, Jean-Paul Selten, René S Kahn, Anne-Margriet Huisman, Cobi J Heijnen, Diederick E Grobbee and Huibert Burger

Selecting patients for randomized trials: a systematic approach based on risk group

A key aspect of randomized trial design is the choice of risk group. Some trials include patients from the entire at-risk population, others accrue only patients deemed to be at increased risk. We present a si...

Authors: Andrew J Vickers, Barry S Kramer and Stuart G Baker

Hemicraniectomy after middle cerebral artery infarction with life-threatening Edema trial (HAMLET). Protocol for a randomised controlled trial of decompressive surgery in space-occupying hemispheric infarction

Patients with a hemispheric infarct and massive space-occupying brain oedema have a poor prognosis. Despite maximal conservative treatment, the case fatality rate may be as high as 80%, and most survivors are ...

Authors: Jeannette Hofmeijer, G Johan Amelink, Ale Algra, Jan van Gijn, Malcolm R Macleod, L Jaap Kappelle and H Bart van der Worp

A randomized, double blind, cross-over, placebo-controlled clinical trial to assess the effects of Candesartan on the insulin sensitivity on non diabetic, non hypertense subjects with dysglyce mia and abdominal obesity. "ARAMIA"

The raising prevalence of type-2 diabetes mellitus and obesity has been recognized as a major problem for public health, affecting both developed and developing countries. Impaired fasting plasma glucose has b...

Authors: Patricio López-Jaramillo, Lina P Pradilla, Vicente Lahera, Federico A Silva Sieger, Christian F Rueda-Clausen and Gustavo A Márquez

Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery

Annually, more than 90000 surgical procedures of the thyroid gland are performed in Germany. Strategies aimed at reducing the duration of the surgical procedure are relevant to patients and the health care sys...

Authors: CM Seiler, BE Fröhlich, JA Veit, E Gazyakan, MN Wente, C Wollermann, A Deckert, S Witte, N Victor, MW Buchler and HP Knaebel

Factors associated with compliance and non-compliance by physicians in a large-scale randomized clinical trial

In order to minimize the amount of incomplete follow-up data, reducing the non-compliance of participating physicians is one of the key issues for the data coordinating center in a multi-center trial. Identify...

Authors: Koji Oba, Satoshi Morita, Mahbubur Rahman and Junichi Sakamoto