Ausgabe 1/2008
Inhalt (75 Artikel)
The ACTIVE (Acute Cholecystitis Trial Invasive Versus Endoscopic) study: Multicenter randomized, double-blind, controlled trial of laparoscopic (LC) versus open (LTC) surgery for acute cholecystitis (AC) in adults
Fausto Catena, Luca Ansaloni, Salomone Di Saverio, Filippo Gazzotti, Stefano Gagliardi, Federico Coccolini, Luigi D'Alessandro, Giorgio Ercolani, Carlo Talarico, Uberto A Bassi, Leonardo Leone, Filippo Calzolari, Antonio D Pinna
Workflow to improve patient recruitment for clinical trials within hospital information systems – a case-study
Martin Dugas, Matthias Lange, Wolfgang E Berdel, Carsten Müller-Tidow
A concept for trial institutions focussing on randomised controlled trials in surgery
Nuh N Rahbari, Markus K Diener, Lars Fischer, Moritz N Wente, Peter Kienle, Markus W Büchler, Christoph M Seiler
Improving the outcomes of primary care attenders with common mental disorders in developing countries: a cluster randomized controlled trial of a collaborative stepped care intervention in Goa, India
Vikram H Patel, Betty R Kirkwood, Sulochana Pednekar, Ricardo Araya, Michael King, Daniel Chisholm, Gregory Simon, Helen Weiss
Seminars may increase recruitment to randomised controlled trials: lessons learned from WISDOM
Bronwen J Paine, Nigel P Stocks, Alastair H MacLennan
Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial
Rathie Rajendram, Richard WJ Lee, Mike J Potts, Geoff E Rose, Rajni Jain, Jane M Olver, Fion Bremner, Steven Hurel, Anne Cook, Rao Gattamaneni, Marjorie Tomlinson, Nicholas Plowman, Catey Bunce, Sandra P Hollinghurst, Laura Kingston, Sue Jackson, Andrew D Dick, Nichola Rumsey, Olivia C Morris, Colin M Dayan, Jimmy M Uddin
Cluster-randomised controlled trial of community mobilisation in Mumbai slums to improve care during pregnancy, delivery, postpartum and for the newborn
Neena Shah More, Ujwala Bapat, Sushmita Das, Sarita Patil, Maya Porel, Leena Vaidya, Bhaveshree Koriya, Sarah Barnett, Anthony Costello, Armida Fernandez, David Osrin
Investigation of the effect of Interleukin-1 receptor antagonist (IL-1ra) on markers of inflammation in non-ST elevation acute coronary syndromes (The MRC-ILA-HEART Study)
David C Crossman, Allison C Morton, Julian P Gunn, John P Greenwood, Alistair S Hall, Keith AA Fox, Andrew J Lucking, Marcus D Flather, Belinda Lees, Claire E Foley
A study to assess changes in myocardial perfusion after treatment with spinal cord stimulation and percutaneous myocardial laser revascularisation; data from a randomised trial
Sadia N Khan, Duncan C McNab, Linda D Sharples, Carol J Freeman, Ian Hardy, David L Stone, Peter M Schofield
Efficacy of acupuncture for chronic low back pain: protocol for a randomized controlled trial
Daniel C Cherkin, Karen J Sherman, Charissa J Hogeboom, Janet H Erro, William E Barlow, Richard A Deyo, Andrew L Avins
Echocardiographic predictors of severe heart failure symptoms in hypertrophic cardiomyopathy patients with sinus rhythm
Fatih Bayrak, Gokhan Kahveci, Muzaffer Degertekin, Bulent Mutlu
What constitutes a "clinical trial"?: A survey of oncology professionals
James R Wright, Brenda Kowaleski, Jonathan Sussman
From multidimensional neuropsychological outcomes to a cognitive complication rate: The International Subarachnoid Aneurysm Trial
Richard B Scott, Fiona Eccles, Andrew Lloyd, Katherine Carpenter
Randomised controlled trial of thermostatic mixer valves in reducing bath hot tap water temperature in families with young children in social housing: A protocol
Denise Kendrick, Jane Stewart, Carol Coupland, Michael Hayes, Nick Hopkins, Debbie McCabe, Robert Murphy, George O'Donnell, Ceri Phillips, David Radford, Jackie Ryan, Sherie Smith, Lindsay Groom, Elizabeth Towner
Community based trial of home blood pressure monitoring with nurse-led telephone support in patients with stroke or transient ischaemic attack recently discharged from hospital
Sally Kerry, Hugh Markus, Teck Khong, Reena Doshi, Rachel Conroy, Pippa Oakeshott
Initial experience with a group presentation of study results to research participants
Andrew L Avins, Stephen Bent, Amy Padula, Suzanne Staccone, Evelyn Badua, Harley Goldberg
TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks' gestation
Sze M Ng, Mark A Turner, Carrol Gamble, Mohammed Didi, Suresh Victor, Alan M Weindling
Design of the P acemaker RE mote F ollow-up E valuation and R eview (PREFER) trial to assess the clinical value of the remote pacemaker interrogation in the management of pacemaker patients
Jane Chen, Bruce L Wilkoff, Wassim Choucair, Todd J Cohen, George H Crossley, W Ben Johnson, Luc R Mongeon, Gerald A Serwer, Lou Sherfesee
A randomized double-blind placebo-controlled trial to investigate the effects of nasal calcitonin on bone microarchitecture measured by high-resolution peripheral quantitative computerized tomography in postmenopausal women — Study protocol
Laura Richert, Brigitte Uebelhart, Marc Engelhardt, Moise Azria, René Rizzoli
Endorsement of the CONSORT Statement by high impact factor medical journals: a survey of journal editors and journal 'Instructions to Authors'
Sally Hopewell, Douglas G Altman, David Moher, Kenneth F Schulz
Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol
Lara R Fairall, Max O Bachmann, Merrick F Zwarenstein, Carl J Lombard, Kerry Uebel, Cloete van Vuuren, Dewald Steyn, Andrew Boulle, Eric D Bateman
An assessment of the quality of randomised controlled trials conducted in China
Dalu Zhang, Peng Yin, Nick Freemantle, Rachel Jordan, Nanshan Zhong, KK Cheng
Effectiveness of computer-tailored Smoking Cessation Advice in Primary Care (ESCAPE): a Randomised Trial
Hazel Gilbert, Irwin Nazareth, Stephen Sutton, Richard Morris, Christine Godfrey
Pearls and perils of an implantable defibrillator trial using a common control: implications for the design of future studies
Peter J Kudenchuk, Alfred P Hallstrom
The potential of Virtual Reality as anxiety management tool: a randomized controlled study in a sample of patients affected by Generalized Anxiety Disorder
Alessandra Gorini, Giuseppe Riva
Furberg Bengt D, Furberg Curt D: Evaluating Clinical Research – All that Glitters is not Gold
Desmond Julian
Keech A, Gebski V, Pike R: Interpreting and Reporting Clinical Trials. A guide to the CONSORT statement and the principles of randomised controlled trials
Stephen JW Evans
GALA: an international multicentre randomised trial comparing general anaesthesia versus local anaesthesia for carotid surgery
Michael J Gough, Andrew Bodenham, Michael Horrocks, Bridget Colam, Steff C Lewis, Peter M Rothwell, Adrian P Banning, David Torgerson, Moira Gough, Demosthenes Dellagrammaticas, Anne Leigh-Brown, Christos Liapis, Charles Warlow
GENetic and clinical Predictors Of treatment response in Depression: the GenPod randomised trial protocol
Laura Thomas, Jean Mulligan, Victoria Mason, Debbie Tallon, Nicola Wiles, Philip Cowen, David Nutt, Michael O'Donovan, Deborah Sharp, Tim Peters, Glyn Lewis
Competing risk and heterogeneity of treatment effect in clinical trials
David M Kent, Alawi Alsheikh-Ali, Rodney A Hayward
Do we want more cancer patients on clinical trials If so, what are the barriers to greater accrual
Andrew J Vickers
Efficacy of tibolone and raloxifene for the maintenance of skeletal muscle strength, bone mineral density, balance, body composition, cognitive function, mood/depression, anxiety and quality of life/well-being in late postmenopausal women ≥ 70 years: Study design of a randomized, double-blind, double-dummy, placebo-controlled, single-center trial
Didy E Jacobsen, Monique M Samson, Yvonne T van der Schouw, Diederick E Grobbee, Harald J J Verhaar
Study protocol for a three-armed randomized controlled trial to assess whether house screening can reduce exposure to malaria vectors and reduce malaria transmission in The Gambia
Matthew J Kirby, Paul J Milligan, David J Conway, Steve W Lindsay
Randomised, crossover clinical trial, in healthy volunteers, to compare the systemic availability of two topical intranasal budesonide formulations
Jaime Algorta, Maria Angeles Pena, Silvia Francisco, Zurine Abajo, Emilio Sanz
The SU.FOL.OM3 Study: a secondary prevention trial testing the impact of supplementation with folate and B-vitamins and/or Omega-3 PUFA on fatal and non fatal cardiovascular events, design, methods and participants characteristics
Pilar Galan, Serge Briancon, Jacque Blacher, Sébastien Czernichow, Serge Hercberg
Automated external cardioversion defibrillation monitoring in cardiac arrest: a randomized trial
Bakhtiar Ali, Heather Bloom, Emir Veledar, Dorothy House, Robert Norvel, Samuel C Dudley, A Maziar Zafari
The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke
Peter Sandercock, Richard Lindley, Joanna Wardlaw, Martin Dennis, Steff Lewis, Graham Venables, Adam Kobayashi, Anna Czlonkowska, Eivind Berge, Karsten Bruins Slot, Veronica Murray, Andre Peeters, Graeme Hankey, Karl Matz, Michael Brainin, Stefano Ricci, Maria Grazia Celani, Enrico Righetti, Teresa Cantisani, Gord Gubitz, Steve Phillips, Antonio Arauz, Kameshwar Prasad, Manuel Correia, Phillippe Lyrer
Effectiveness of the Austrian disease-management-programme for type 2 diabetes: study protocol of a cluster-randomized controlled trial
Andreas C Sönnichsen, Andreas Rinnerberger, Maria G Url, Henrike Winkler, Peter Kowatsch, Gert Klima, Bernhard Fürthauer, Raimund Weitgasser
Inefficacy of different strategies to improve guideline awareness – 5-year follow-up of the hypertension evaluation project (HEP)
Jens Hagemeister, Christian A Schneider, Holger Diedrichs, Diana Mebus, Holger Pfaff, Gernot Wassmer, Hans W Höpp
Clinical and cost-effectiveness analysis of an open label, single-centre, randomised trial of spinal cord stimulation (SCS) versus percutaneous myocardial laser revascularisation (PMR) in patients with refractory angina pectoris: The SPiRiT trial
M T Dyer, K A Goldsmith, S N Khan, L D Sharples, C Freeman, I Hardy, M J Buxton, P M Schofield
Multicenter double blind trial of autologous bone marrow mononuclear cell transplantation through intracoronary injection post acute myocardium infarction – MiHeart/AMI study
Hans F R Dohmann, Suzana A Silva, André L S Sousa, Alcione M S Braga, Rodrigo V C Branco, Andréa F Haddad, Mônica A Oliveira, Rodrigo C Moreira, Fabio A A Tuche, Cíntia M Peixoto, Bernardo R Tura, Radovan Borojevic, Jorge P Ribeiro, José C Nicolau, Antonio C Nóbrega, Antonio C C Carvalho
Design paper: The CapOpus trial: A randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis
Carsten Hjorthøj, Allan Fohlmann, Anne-Mette Larsen, Mette TR Madsen, Lone Vesterager, Christian Gluud, Mikkel C Arendt, Merete Nordentoft
The TEAM trial: Safety and efficacy of endovascular treatment of unruptured intracranial aneurysms in the prevention of aneurysmal hemorrhages: A randomized comparison with indefinite deferral of treatment in 2002 patients followed for 10 years
Jean Raymond, Andrew J Molyneux, Allan J Fox, S Claiborne Johnston, Jean-Paul Collet, Isabelle Rouleau
Rationale, design and methodology for a Prospective Randomized Study of graft patency in Off-pump and On-pump MultI-Vessel coronary artery bypasS Surgery (PROMISS) using multidetector computed tomography
Miguel Sousa Uva, Fernando Matias, Sara Cavaco, Manuel Pedro Magalhães
Informed consent for clinical trials in acute coronary syndromes and stroke following the European Clinical Trials Directive: investigators' experiences and attitudes
Piotr Iwanowski, Andrzej Budaj, Anna Członkowska, Wojciech Wąsek, Beata Kozłowska-Boszko, Urszula Olędzka, Wojciech Masełbas
Approaches to interim analysis of cancer randomised clinical trials with time to event endpoints: A survey from the Italian National Monitoring Centre for Clinical Trials
Irene Floriani, Nicole Rotmensz, Elena Albertazzi, Valter Torri, Marisa De Rosa, Carlo Tomino, Fillipo de Braud
Meta-analysis of trials comparing anastrozole and tamoxifen for adjuvant treatment of postmenopausal women with early breast cancer
Adnan Aydiner, Faruk Tas
Bright light in elderly subjects with nonseasonal major depressive disorder: a double blind randomised clinical trial using early morning bright blue light comparing dim red light treatment
Ritsaert Lieverse, Marjan M A Nielen, Dick J Veltman, Bernard M J Uitdehaag, Eus J W van Someren, Jan H Smit, Witte J G Hoogendijk
Non-invasive cardiac assessment in high risk patients (The GROUND study): rationale, objectives and design of a multi-center randomized controlled clinical trial
Alexander M de Vos, Annemarieke Rutten, Hester J van de Zaag-Loonen, Michiel L Bots, Riksta Dikkers, Robert A Buiskool, Willem P Mali, Daniel D Lubbers, Arend Mosterd, Mathias Prokop, Benno J Rensing, Maarten J Cramer, H Wouter van Es, Frans L Moll, Eric D van de Pavoordt, Pieter A Doevendans, Birgitta K Velthuis, Albert J Mackaay, Felix Zijlstra, Matthijs Oudkerk
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 review of RCTs in four medical journals to assess the use of imputation to overcome missing data in quality of life outcomes
Shona Fielding, Graeme Maclennan, Jonathan A Cook, Craig R Ramsay
A randomized comparative study of patients undergoing myocardial revascularization with or without cardiopulmonary bypass surgery: The MASS III Trial
Whady Hueb, Neuza H M Lopes, Bernard J Gersh, Cláudio C Castro, Felipe S Paulitsch, Sergio A Oliveira, Luis A Dallan, Alexandre C Hueb, Noedir A Stolf, José A F Ramires
Magnet therapy for the relief of pain and inflammation in rheumatoid arthritis (CAMBRA): A randomised placebo-controlled crossover trial
Stewart J Richmond
The VEPRO trial: A cross-over randomised controlled trial comparing 2 progressive lenses for patients with presbyopia
Isabelle Boutron, Caroline Touizer, Isabelle Pitrou, Carine Roy, Philippe Ravaud
European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial
Colin A Hutchison, Mark Cook, Nils Heyne, Katja Weisel, Lucinda Billingham, Arthur Bradwell, Paul Cockwell
A randomised, double-masked phase III/IV study of the efficacy and safety of Avastin® (Bevacizumab) intravitreal injections compared to standard therapy in subjects with choroidal neovascularisation secondary to age-related macular degeneration: clinical trial design
Praveen J Patel, Catey Bunce, Adnan Tufail
Randomized controlled trial to treat migraine with acupuncture: design and protocol
Ying Li, Fanrong Liang, Shuguang Yu, Xuguang Liu, Yong Tang, Xuguang Yang, Xiaoping Tian, Jie Yan, Guojie Sun, Xiaorong Chang, Hui Zheng, Hongxing Zhang, Tingting Ma
Perioperative oxygen fraction – effect on surgical site infection and pulmonary complications after abdominal surgery: a randomized clinical trial. Rationale and design of the PROXI-Trial
Christian S Meyhoff, Jørn Wetterslev, Lars N Jorgensen, Steen W Henneberg, Inger Simonsen, Therese Pulawska, Line R Walker, Nina Skovgaard, Kim Heltø, Peter Gocht-Jensen, Palle S Carlsson, Henrik Rask, Sharaf Karim, Charlotte G Carlsen, Frank S Jensen, Lars S Rasmussen
Study design and methods of the BoTULS trial: a randomised controlled trial to evaluate the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A
Helen Rodgers, Lisa Shaw, Christopher Price, Frederike van Wijck, Michael Barnes, Laura Graham, Gary Ford, Phil Shackley, Nick Steen
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
Philip Knebel, Lars Fischer, Eva Cremonese, Ruben Lopez-Benitez, Ulrike Stampfl, Boris Radeleff, Hans-Ulrich Kauczor, Markus W Büchler, Christoph M Seiler
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)
Noemi Lois, Jennifer Burr, John Norrie, Luke Vale, Jonathan Cook, Alison McDonald
Community-based randomised controlled trial evaluating falls and osteoporosis risk management strategies
PM Ciaschini, SE Straus, LR Dolovich, RA Goeree, KM Leung, CR Woods, GM Zimmerman, SR Majumdar, S Spadafora, LA Fera, HN Lee
ZAMSTAR, The Zambia South Africa TB and HIV Reduction study: Design of a 2 × 2 factorial community randomized trial
Helen M Ayles, Charalambos Sismanidis, Nulda Beyers, Richard J Hayes, Peter Godfrey-Faussett
Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units
Rhiannon T Edwards, Barry Hounsome, Pat Linck, Ian T Russell
VAST: Vertebral Artery Stenting Trial. Protocol for a randomised safety and feasibility trial
A Compter, HB van der Worp, WJ Schonewille, JA Vos, A Algra, TH Lo, WPThM Mali, FL Moll, LJ Kappelle
Reporting of clinical trials: a review of research funders' guidelines
Kerry Dwan, Carrol Gamble, Paula R Williamson, Douglas G Altman
Early intervention in panic: randomized controlled trial and cost-effectiveness analysis
Peter Meulenbeek, Godelief Willemse, Filip Smit, Anton van Balkom, Philip Spinhoven, Pim Cuijpers
Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design
Richard Sutton, Emanuel Kanal, Bruce L Wilkoff, David Bello, Roger Luechinger, Inge Jenniskens, Michael Hull, Torsten Sommer
Reporting of noninferiority and equivalence randomized trials for major prostaglandins: A systematic survey of the ophthalmology literature
Oghenowede Eyawo, Chia-Wen Lee, Beth Rachlis, Edward J Mills
Study Protocol: effects of acupuncture on hot flushes in perimenopausal and postmenopausal women – a multicenter randomized clinical trial
Kun-Hyung Kim, Kyung-Won Kang, Hee-Jung Jung, Ji-Eun Park, So-Young Jung, Jun-Yong Choi, Sun-Mi Choi
A randomized double blind crossover placebo-controlled clinical trial to assess the effects of a mouthwash containing chlorine dioxide on oral malodor
Kayoko Shinada, Masayuki Ueno, Chisato Konishi, Sachiko Takehara, Sayaka Yokoyama, Yoko Kawaguchi
Ultrasound enhanced prehospital thrombolysis using microbubbles infusion in patients with acute ST elevation myocardial infarction: Rationale and design of the Sonolysis study
Jeroen Slikkerveer, Pieter A Dijkmans, Gertjan T Sieswerda, Pieter AFM Doevendans, Arie PJ van Dijk, Freek WA Verheugt, Thomas R Porter, Otto Kamp
Community-based trial of screening for Chlamydia trachomatis to prevent pelvic inflammatory disease: the POPI (prevention of pelvic infection) trial
Pippa Oakeshott, Sally Kerry, Helen Atherton, Adamma Aghaizu, Sima Hay, David Taylor-Robinson, Ian Simms, Phillip Hay
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]
Fausto Catena, Luca Ansaloni, Augusto Lauro, Giorgio Ercolani, Luigi D'Alessandro, Antonio Pinna
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
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, John W Frank