Issue Special Issue 1/2015
Abstracts of the 4th Meeting of the Core Outcome Measures in Effectiveness Trials (COMET) Initiative
Content (41 Articles)
COMET IV meeting summary
Elizabeth Gargon, Doug G Altman, Jane M Blazeby, Mike Clarke, Paula R Williamson
A survey of core outcome set developers
Elizabeth Gargon, Bridget Young, Paula R Williamson
Assessment of patients' and caregiver’s perceived need to start actively participated outcome measures in neurological research
MG Celani, R Papetti, C Piersanti, S Macone, A Sgoifo, M Bianchi, A Bignamini, T Cantisani, K Mahan
Qualitative systematic reviews to increase the volume and diversity of patient perspectives included in the development of core outcome sets. Tuberculosis: a pilot study
Lucy Elizabeth Hoppe
Towards a shared vision for measureable and meaningful health outcomes for children and young people with neurodisability: qualitative research, Delphi survey, systematic review, and stakeholder prioritisation
Christopher Morris, Astrid Janssens, Amanda Allard, Joanne Thompson Coon, Valerie Shilling, Richard Tomlinson, Jane Williams, Andrew Fellowes, Morwenna Rogers, Karen Allen, Bryony Beresford, Colin Green, Crispin Jenkinson, Alan Tennant, Stuart Logan
Core outcome set to assess effectiveness in multimodal pain therapy – preliminary results of an interdisciplinary online survey
Christian Kopkow, Stefanie Deckert, Jochen Schmitt, Rainer Sabatowski, Ulrike Kaiser
Core outcome measures in perioperative and anaesthetic care
Oliver Boney, Ramani Moonesinghe, Mike Grocott
BISON (Bloodstream Infections and Sepsis Outcomes measurement Network) initiative: an ESGBIS proposal
Luigia Scudeller, Jesús Rodríguez Baño, Winfried V Kern
Outcomes reported in trials of methods for the induction of labour
Nancy Medley, Zarko Alfirevic, Deborah M Caldwell, Sofia Dias, Therese Dowswell, Edna Keeney, Leanne Jones, Kate Navaratnam, Nicky Welton
EvaLuation of Interventions for informed Consent for randomIsed controlled Trials (ELICIT): developing a core outcome set
Katie Gillies, Cynthia Fraser, Vikki Entwistle, Shaun Treweek, Paula Williamson, Marion Campbell
Treatment of deep caries lesions: a multi-center randomised controlled trial using a comprehensive set of outcome parameters
Falk Schwendicke, Sebastian Paris, Hardy Schweigel
Reported outcomes in phase II studies of newly-diagnosed pulmonary tuberculosis
Laura J Bonnett, Geraint Davies
Do outcome measures used in neurological clinical research realistically represent the needs and the expectations of patients and their care givers?
MG Celani, MC Bassi, A Bignamini, P Candelaresi, M Carlini, M Cecconi, M Congedo, C Cusi, S Cuzzubbo, D Guerra, S Macone, M Melis, C Motto, K Nardi, V Oppo, R Papetti, C Piersanti, V Piras, A Serafini, AL Sgoifo, E Susani, L Tremolizzo, TA Cantisani
Focus group in Multiple Sclerosis as a tool to increase active patient involvement. A preliminary experience
Annalisa Sgoifo, A Bignamini, M Celani, L La Mantia, M Esposito, R Marazzi, V Prone, A Protti, V Sangalli, E Agostoni
Developing meaningful public involvement in a cancer clinical trials unit
Jessica Baillie, Jim Fitzgibbon, Natalie Simon, Annmarie Nelson
Core outcomes set for studies on primary prevention of preterm birth
Janneke van‘t Hooft, James M.N. Duffy, George R. Saade, Zarko Alfirevic, S Meher, Ben Willem J. Mol, Khalid S. Khan
The development of a colorectal cancer surgery core outcome set
AGK McNair, RN Whistance, RO Forsythe, R Macefield, J Rees, JE Jones, G Smith, AM Pullyblank, KNL Avery, ST Brookes, MG Thomas, PA Sylvester, A Russell, A Oliver, D Morton, R Kennedy, DG Jayne, R Huxtable, R Hackett, S Dutton, MG Coleman, M Card, J Brown, JM Blazeby
TACT: Research Partner involvement in a cancer clinical trials unit and academic research centre; evaluating its impact
Noreen Hopewell-Kelly, Jim Fitzgibbon, Jessica Baillie, Annmarie Nelson
Systematic review of Goal Attainment Scaling as an outcome measure in drug trials
Charlotte M.W. Gaasterland, Marijke C. Jansen-van der Weide, Johanna H. van der Lee
Development of a method to involve patients in the determination and appraisal of outcomes in clinical trials
Charlotte M.W. Gaasterland, Marijke C. Jansen-van der Weide, Johanna H. van der Lee
Making core outcomes more clinically meaningful: 2-for-the-price-of-1 with a distributional approach
Janet L Peacock, Jessica W Lo, Odile Sauzet
Usability and consistency of harm information in drug product descriptions: a matched comparison of data between the United States (US) and Europe
Victoria R Cornelius, Kun Liu, Janet Peacock, Odile Sauzet
TINNET COST Action BM1306: an international standard for outcome measurements in clinical trials of tinnitus
Deborah Hall, Alain Londero, Winifred Schlee
Achieving consensus over the assessment of clinical signs in eczema trials
Kim S Thomas, Jochen Schmitt, Phyllis I Spuls, Eric Simpson, Masutaka Furue, Stefanie Deckert, Christian Apfelbacher, Joanne Chalmers, Hywel C Williams
UK validation of the Tinnitus Functional Index (TFI) in a large research population
Kathryn Fackrell, Deborah A Hall, Johanna G Barry, Derek J Hoare
Complexity, context and considerations for treatment in CFS/ME: children’s versus health professional’s conceptual model
Roxanne Potgieter, Aarti Patel, Lucy Beasant, Kirstie L Haywood, Debbie Johnson, Alison Shaw, Esther Crawley
The primary outcomes and power calculations in clinical RCTs in urogynecology - need for improvement?
Marianne Koch, Paul Riss, Wolfgang Umek, Engelbert Hanzal
Development of a core outcome set based on Case Report Form (CRF) to assess laboratory biomarkers and clinical parameters in Onco-Hematology area
Mariangela Vanalli, Francesca Rio
Completeness of outcome description in studies for low back pain rehabilitation interventions: a survey of trials included in Cochrane reviews
Greta Castellini, Silvia Gianola, Pamela Frigerio, Michela Agostini, Rosa Bolotta, Davide Corbetta, Monica Gasparini, Paolo Gozzer, Erica Guariento, Linda Li, Valentina Pecoraro, Valeria Sirtori, Andrea Turolla, Lorenzo Moja
Development of core outcome set for pediatric health conditions: a systematic review
Mufiza Kapadia, Winnie Chan, Thivia Jegathesan, Martin Offringa
A comprehensive survey of hearing questionnaires: how many are there, what do they measure, and how have they been validated?
Michael A Akeroyd, Kay Wright-Whyte, Jack A Holman, William M Whitmer
Measuring patient outcome using data capture by mobile app
Carol Fawkes, Robert Froud, Dawn Carnes
PARTNERS2: a protocol for the development of a core outcome set for use in mental health trials involving people with schizophrenia or bipolar disorder in a community setting
Thomas Keeley, Humera Khan, Vanessa Pinfold, Paula Williamson, Jonathan Mathers, Linda Davies, Ruth Sayers, Elizabeth England, Siobhan Reilly, Richard Byng, Linda Gask, Mike Clark, Peter Huxley, Peter Lewis, Maximillian Birchwood, Melanie Calvert
The concept of physical limitations in knee osteoarthritis – the view of patients and health professionals
Louise Klokker, Richard H Osborne, Eva Ejlersen Waehrens, Ole Norgaard, Elisabeth Bandak, Henning Bliddal, Marius Henriksen
The development of a measure of participation in adults with hearing loss: a qualitative study of expert views
Eithne Heffernan, Neil Coulson, Helen Henshaw, Johanna Barry, Melanie Ferguson
Interventions for caries in primary teeth; mapping reported outcomes in clinical trials over the last 30 years
Nicola P T Innes, Felicity Borrie, Neeraj Gugnani, Alex Keightley, Thomas J Lamont, Zoe Marshman, Ruth Santamaria, Falk Schwendicke
Outcome measures in Cochrane reviews and protocols for the prevention and treatment of periodontal disease
Thomas J Lamont, Jan E Clarkson, Craig R Ramsay
The CONSENSUS Study: Preliminary results of a mixed methods study to develop a core outcome set for late phase clinical trials in Oropharyngeal Cancer
Aoife M I Waters, Catrin Tudur Smith, Bridget Young, Terry M Jones
How do clinical researchers’ and patients’ preferences influence study hypotheses and reported outcome results for clinical randomised controlled trials? A critical appraisal
Paola Rosati, Roberto D’Amico, Gabriella Ricciotti, Giuseppina Testa, Rita Inglese, Ferruccio Giustini, Ersilia Fiscarelli, Marco Zazza, Cecilia Carlino, Valerio Balassone, Roberto Fiorito, Franz Porzsolt
The COVenT study: developing a core outcome set for mechanical ventilation trials
Bronagh Blackwood, Suzanne Ringrow, Danny McAuley, Mike Clarke
Consensus on the need for a hierarchical list of patient-reported pain outcomes for meta-analyses of knee osteoarthritis trials
Louise Klokker, Lara J Maxwell, Peter Juni, David Tovey, Paula R Williamson, Maarten Boers, Niti Goel, Rachelle Buchbinder, Lyn March, Caroline B Terwee, Jasvinder A Singh, Peter Tugwell, Robin Christensen