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2. The likeness of fetal growth and newborn size across non-isolated populations in the INTERGROWTH-21st Project: the Fetal Growth Longitudinal Study and Newborn Cross-Sectional Study

Author

Villar, José, Papageorghiou, Aris T, Pang, Ruyan, Ohuma, Eric O, Ismail, Leila Cheikh, Barros, Fernando C, Lambert, Ann, Carvalho, Maria, Jaffer, Yasmin A, Bertino, Enrico, Gravett, Michael G, Altman, Doug G, Purwar, Manorama, Frederick, Ihunnaya O, Noble, Julia A, Victora, Cesar G, Bhutta, Zulfiqar A, and Kennedy, Stephen H

Published
2014
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3. International standards for newborn weight, length, and head circumference by gestational age and sex: the Newborn Cross-Sectional Study of the INTERGROWTH-21st Project

Author

Villar, José, Ismail, Leila Cheikh, Victora, Cesar G, Ohuma, Eric O, Bertino, Enrico, Altman, Doug G, Lambert, Ann, Papageorghiou, Aris T, Carvalho, Maria, Jaffer, Yasmin A, Gravett, Michael G, Purwar, Manorama, Frederick, Ihunnaya O, Noble, Alison J, Pang, Ruyan, Barros, Fernando C, Chumlea, Cameron, Bhutta, Zulfiqar A, and Kennedy, Stephen H

Published
2014
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6. Ten-year mortality, disease progression, and treatment-related side effects in men with localised prostate cancer from the ProtecT randomised controlled trial according to treatment received

Author

Neal, David E., Metcalfe, Chris, Donovan, Jenny L., Lane, J. Athene, Davis, Michael, Young, Grace J., Dutton, Susan J., Walsh, Eleanor I., Martin, Richard M., Peters, Tim. J., Turner, Emma L., Mason, Malcolm, Bryant, Richard, Bollina, Prasad, Catto, James, Doherty, Alan, Gillatt, David, Gnanapragasam, Vincent, Holding, Peter, Hughes, Owen, Kockelbergh, Roger, Kynaston, Howard, Oxley, Jon, Paul, Alan, Paez, Edgar, Rosario, Derek J., Rowe, Edward, Staffurth, John, Altman, Doug G., Hamdy, Freddie C., Peters, Tim J., Doble, Andrew, Powell, Philip, Prescott, Stephen, Rosario, Derek, Anderson, John B., Aning, Jonathan, Durkan, Garett, Koupparis, Anthony, Leung, Hing, Mariappan, Param, McNeill, Alan, Persad, Raj, Schwaibold, Hartwig, Tulloch, David, Wallace, Michael, Bonnington, Susan, Bradshaw, Lynne, Cooper, Deborah, Elliott, Emma, Herbert, Phillipa, Howson, Joanne, Jones, Amanda, Lennon, Teresa, Lyons, Norma, Moody, Hilary, Plumb, Claire, O'Sullivan, Tricia, Salter, Elizabeth, Thompson, Pauline, Tidball, Sarah, Blaikie, Jan, Gray, Catherine, Adam, Tonia, Askew, Sarah, Atkinson, Sharon, Baynes, Tim, Brain, Carole, Breen, Viv, Brunt, Sarah, Bryne, Sean, Bythem, Jo, Clarke, Jenny, Cloete, Jenny, Dark, Susan, Davis, Gill, Rue, Rachael De La, Denizot, Jane, Dewhurst, Elspeth, Dimes, Anna, Dixon, Nicola, Ebbs, Penny, Emmerson, Ingrid, Ferguson, Jill, Gadd, Ali, Geoghegan, Lisa, Grant, Alison, Grant, Collette, Godfrey, Rosemary, Goodwin, Louise, Hall, Susie, Hart, Liz, Harvey, Andrew, Hoult, Chloe, Hawkins, Sarah, Holling, Sharon, Innes, Alastair, Kilner, Sue, Marshall, Fiona, Mellen, Louise, Moore, Andrea, Napier, Sally, Needham, Julie, Pearse, Kevin, Pisa, Anna, Rees, Mark, Richards, Ellie, Robson, Lindsay, Roxburgh, Janet, Samuel, Nikki, Sharkey, Irene, Slater, Michael, Smith, Donna, Taggart, Pippa, Taylor, Helen, Taylor, Vicky, Thomas, Ayesha, Tomkies, Briony, Trewick, Nicola, Ward, Claire, Walker, Christy, Williams, Ayesha, Woodhouse, Colin, Wyber, Elizabeth, Bahl, Amit, Benson, Richard, Beresford, Mark, Ferguson, Catherine, Graham, John, Herbert, Chris, Howard, Grahame, James, Nick, Kirkbride, Peter, Law, Alastair, Loughrey, Carmel, McClaren, Duncan, Patterson, Helen, Pedley, Ian, Roberts, Trevor, Robinson, Angus, Russell, Simon, Symonds, Paul, Thanvi, Narottam, Vasanthan, Subramaniam, Wilson, Paula, Robinson, Mary, Bhattarai, Selina, Deshmukh, Neeta, Dormer, John, Fernando, Malee, Goepel, John, Griffiths, David, Grigor, Ken, Mayer, Nick, Varma, Murali, Warren, Anne, Appleby, Helen, Ash, Dominic, Aston, Dean, Bolton, Steven, Chalmers, Graham, Conway, John, Early, Nick, Geater, Tony, Goddall, Lynda, Heymann, Claire, Hicks, Deborah, Jones, Liza, Lamb, Susan, Lambert, Geoff, Lawrence, Gill, Lewis, Geraint, Lilley, John, MacLeod, Aileen, Massey, Pauline, McQueen, Alison, Moore, Rollo, Penketh, Lynda, Potterton, Janet, Roberts, Neil, Showler, Helen, Shuttleworth, Pam, Slade, Stephen, Steele, Alasdair, Swinscoe, James, Tiffany, Marie, Townley, John, Treeby, Jo, Weston, Michael, Wilkinson, Joyce, Williams, Lorraine, Wills, Lucy, Woodley, Owain, Yarrow, Sue, Brindle, Lucy, Davies, Linda, Dedman, Dan, Down, Elizabeth, Khazragui, Hanan, Noble, Sian, Taylor, Hilary, Tazewell, Marta, Wade, Julia, Walsh, Eleanor, Baker, Susan, Bellis-Sheldon, Elizabeth, Bougard, Chantal, Bowtell, Joanne, Brewer, Catherine, Burton, Chris, Charlton, Jennie, Christoforou, Nicholas, Clark, Rebecca, Coull, Susan, Croker, Christine, Currer, Rosemary, Daisey, Claire, Delaney, Gill, Donohue, Rose, Drew, Jane, Farmer, Rebecca, Fry, Susan, Haddow, Jean, Hale, Alex, Halpin, Susan, Harris, Belle, Hattrick, Barbara, Holmes, Sharon, Hunt, Helen, Jackson, Vicky, Johnson, Donna, Le Butt, Mandy, Leworthy, Jo, Liddiatt, Tanya, Martin, Alex, Mauree, Jainee, Moore, Susan, Moulam, Gill, Mutch, Jackie, Parker, Kathleen, Pawsey, Christopher, Purdie, Michelle, Robson, Teresa, Smith, Lynne, Stenton, Carole, Steuart-Feilding, Tom, Stott, Beth, Sully, Chris, Sutton, Caroline, Torrington, Carol, Wilkins, Zoe, Williams, Sharon, Wilson, Andrea, Weaver, Ashleigh, Albertsen, Peter, Adolfsson, Jan, Baum, Michael, McFarlane, Jon, Reid, Colette, Turner, Emma, Zietman, Anthony, Hill, Elizabeth, Ng, Siaw Yein, Williams, Naomi, Toole, Jessica, Davies, Charlotte, Hughes, Laura, Rowlands, Mari-Anne, Bell, Lindsey, Harrison, Sean, Mauree, Jainnee, Grant, Adrian, Roberts, Ian, Ashby, Deborah, Cowan, Richard, Fayers, Peter, Mellon, Killian, N’Dow, James, O’Brien, Tim, Sokhal, Michael, Dearnaley, David, Schröder, Fritz, Roberts, Tracy, and for the ProtecT Study Group, .

Subjects
Male, medicine.medical_specialty, Time Factors, Urology, medicine.medical_treatment, 030232 urology & nephrology, Urinary incontinence, Active monitoring, BTC (Bristol Trials Centre), Metastasis, law.invention, 03 medical and health sciences, Prostate cancer, 0302 clinical medicine, ProtecT trial, Randomized controlled trial, law, Internal medicine, Humans, Medicine, External beam radiotherapy, Watchful Waiting, Aged, Prostatectomy, Disease progression, Radiotherapy, business.industry, Prostatic Neoplasms, Middle Aged, medicine.disease, Radical prostatectomy, Treatment Outcome, 030220 oncology & carcinogenesis, Propensity score matching, Cohort, Disease Progression, BRTC, medicine.symptom, Sexual function, business, Literatur Kommentiert
Abstract

Background: The ProtecT trial reported intention-to-treat analysis of men with localised prostate cancer (PCa) randomly allocated to active monitoring (AM), radical prostatectomy, and external beam radiotherapy. Objective: To determine report outcomes according to treatment received in men in randomised and treatment choice cohorts. Design, Setting, and Participants: This study focuses on secondary care. Men with clinically localised prostate cancer at one of nine UK centres were invited to participate in the treatment trial comparing AM, radical prostatectomy, and radiotherapy. Intervention: Two cohorts included 1643 men who agreed to be randomised; 997 declined randomisation and chose treatment. Outcome Measurements and Statistical Analysis: Health-related quality of life impacts on urinary, bowel, and sexual function were assessed using patient-reported outcome measures. Analysis was carried out based on treatment received for each cohort and on pooled estimates using meta-analysis. Differences were estimated with adjustment for known prognostic factors using propensity scores. Results and Limitations: According to treatment received, more men receiving AM died of PCa (AM 1.85%, surgery 0.67%, radiotherapy 0.73%), whilst this difference remained consistent with chance in the randomised cohort (p = 0.08); stronger evidence was found in the exploratory analyses (randomised plus choice cohort) when AM was compared with the combined radical treatment group (p = 0.003). There was also strong evidence that metastasis (AM 5.6%, surgery 2.4%, radiotherapy 2.7%) and disease progression (AM 20.35%, surgery 5.87%, radiotherapy 6.62%) were more common in the AM group. Compared with AM, there were higher risks of sexual dysfunction (95% at 6 mo) and urinary incontinence (55% at 6 mo) after surgery, and of sexual dysfunction (88% at 6 mo) and bowel dysfunction (5% at 6 mo) after radiotherapy. The key limitations are the potential for bias when comparing groups defined by treatment received and outdating of the interventions being evaluated during the lengthy follow-up required in trials of screen-detected PCa. Conclusions: Analyses according to treatment received showed increased rates of disease-related events and lower rates of patient-reported harms in men managed by AM compared with men managed by radical treatment, and stronger evidence of greater PCa mortality in the AM group. Patient Summary: More than 90 out of every 100 men with localised prostate cancer do not die of prostate cancer within 10 yr, irrespective of whether treatment is by means of monitoring, surgery, or radiotherapy. Side effects on sexual and bladder function are much better after active monitoring, but the risks of spreading of prostate cancer are more common.

Published
2020

8. Erratum to ‘Ten-year Mortality, Disease Progression, and Treatment-related Side Effects in Men with Localised Prostate Cancer from the ProtecT Randomised Controlled Trial According to Treatment Received’ [European Urology 77 (2020) 320–330]

Author

Neal, David E., primary, Metcalfe, Chris, additional, Donovan, Jenny L., additional, Lane, J. Athene, additional, Davis, Michael, additional, Young, Grace J., additional, Dutton, Susan J., additional, Walsh, Eleanor I., additional, Martin, Richard M., additional, Peters, Tim. J., additional, Turner, Emma L., additional, Mason, Malcolm, additional, Bryant, Richard, additional, Bollina, Prasad, additional, Catto, James, additional, Doherty, Alan, additional, Gillatt, David, additional, Gnanapragasam, Vincent, additional, Holding, Peter, additional, Hughes, Owen, additional, Kockelbergh, Roger, additional, Kynaston, Howard, additional, Oxley, Jon, additional, Paul, Alan, additional, Paez, Edgar, additional, Rosario, Derek J., additional, Rowe, Edward, additional, Staffurth, John, additional, Altman, Doug G., additional, and Hamdy, Freddie C., additional

Published
2020
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10. Choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial - the development of the DELTA2 guidance

Author

Sones, William, Julious, Steven A, Rothwell, Joanne C, Ramsay, Craig R, Hampson, Lisa V, Emsley, Richard, Walters, Stephen J, Hewitt, Catherine Elizabeth, Bland, John Martin, Fergusson, Dean A, Berlin, Jesse A, Altman, Doug G, Vale, Luke D, and Cook, Jonathan A

Subjects
Randomised trial, lcsh:R5-920, Consensus, Delphi Technique, Sample size, Research, Correction, Effect size, Delphi, Target difference, Clinical Trial Protocols as Topic, Treatment Outcome, Data Interpretation, Statistical, Clinically important difference, Humans, Guidance, lcsh:Medicine (General), Numbers Needed To Treat, Randomized Controlled Trials as Topic
Abstract

Background A key step in the design of a randomised controlled trial is the estimation of the number of participants needed. The most common approach is to specify a target difference in the primary outcome between the randomised groups and then estimate the corresponding sample size. The sample size is chosen to provide reassurance that the trial will have high statistical power to detect the target difference at the planned statistical significance level. Alternative approaches are also available, though most still require specification of a target difference. The sample size has many implications for the conduct of the study, as well as incurring scientific and ethical aspects. Despite the critical role of the target difference for the primary outcome in the design of a randomised controlled trial (RCT), the manner in which it is determined has received little attention. This article reports the development of the DELTA2 guidance on the specification and reporting of the target difference for the primary outcome in a sample size calculation for a RCT. Methods The DELTA2 (Difference ELicitation in TriAls) project has five components comprising systematic literature reviews of recent methodological developments (stage 1) and existing funder guidance (stage 2), a Delphi study (stage 3), a 2-day consensus meeting bringing together researchers, funders and patient representatives (stage 4), and the preparation and dissemination of a guidance document (stage 5). Results The project started in April 2016. The literature search identified 28 articles of methodological developments relevant to a method for specifying a target difference. A Delphi study involving 69 participants, along with a 2-day consensus meeting were conducted. In addition, further engagement sessions were held at two international conferences. The main guidance text was finalised on April 18, 2018, after revision informed by feedback gathered from stages 2 and 3 and from funder representatives. Discussion The DELTA2 Delphi study identified a number of areas (such as practical recommendations and examples, greater coverage of different trial designs and statistical approaches) of particular interest amongst stakeholders which new guidance was desired to meet. New relevant references were identified by the review. Such findings influenced the scope, drafting and revision of the guidance. While not all suggestions could be accommodated, it is hoped that the process has led to a more useful and practical document. Electronic supplementary material The online version of this article (10.1186/s13063-018-2887-x) contains supplementary material, which is available to authorized users.

Published
2018

11. Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal

Author

Kent David M, Rothwell Peter M, Ioannidis John PA, Altman Doug G, and Hayward Rodney A

Subjects
Medicine (General), R5-920
Abstract

Abstract Mounting evidence suggests that there is frequently considerable variation in the risk of the outcome of interest in clinical trial populations. These differences in risk will often cause clinically important heterogeneity in treatment effects (HTE) across the trial population, such that the balance between treatment risks and benefits may differ substantially between large identifiable patient subgroups; the "average" benefit observed in the summary result may even be non-representative of the treatment effect for a typical patient in the trial. Conventional subgroup analyses, which examine whether specific patient characteristics modify the effects of treatment, are usually unable to detect even large variations in treatment benefit (and harm) across risk groups because they do not account for the fact that patients have multiple characteristics simultaneously that affect the likelihood of treatment benefit. Based upon recent evidence on optimal statistical approaches to assessing HTE, we propose a framework that prioritizes the analysis and reporting of multivariate risk-based HTE and suggests that other subgroup analyses should be explicitly labeled either as primary subgroup analyses (well-motivated by prior evidence and intended to produce clinically actionable results) or secondary (exploratory) subgroup analyses (performed to inform future research). A standardized and transparent approach to HTE assessment and reporting could substantially improve clinical trial utility and interpretability.

Published
2010
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12. Red blood cell transfusion and mortality in trauma patients: risk-stratified analysis of an observational study

Author

Perel, Pablo, Clayton, Tim, Altman, Doug G., Croft, Peter, Douglas, Ian, Hemingway, Harry, Hingorani, Aroon, Morley, Katherine I., Riley, Richard, Timmis, Adam, Van der Windt, Danielle, and Roberts, Ian

Subjects
Mortality -- Risk factors, Blood transfusion -- Statistics, Erythrocytes -- Health aspects, Wounds and injuries -- Statistics -- Care and treatment, Biological sciences
Abstract

Background: Haemorrhage is a common cause of death in trauma patients. Although transfusions are extensively used in the care of bleeding trauma patients, there is uncertainty about the balance of risks and benefits and how this balance depends on the baseline risk of death. Our objective was to evaluate the association of red blood cell (RBC) transfusion with mortality according to the predicted risk of death. Methods and Findings: A secondary analysis of the CRASH-2 trial (which originally evaluated the effect of tranexamic acid on mortality in trauma patients) was conducted. The trial included 20,127 trauma patients with significant bleeding from 274 hospitals in 40 countries. We evaluated the association of RBC transfusion with mortality in four strata of predicted risk of death: 50%. For this analysis the exposure considered was RBC transfusion, and the main outcome was death from all causes at 28 days. A total of 10,227 patients (50.8%) received at least one transfusion. We found strong evidence that the association of transfusion with all-cause mortality varied according to the predicted risk of death (p-value for interaction 50% predicted risk of death (OR 0.59, 95% CI 0.47-0.74, p Conclusions: The association of transfusion with all-cause mortality appears to vary according to the predicted risk of death. Transfusion may reduce mortality in patients at high risk of death but increase mortality in those at low risk. The effect of transfusion in low-risk patients should be further tested in a randomised trial. Trial registration: http://www.ClinicalTrials.gov NCT01746953 Please see later in the article for the Editors' Summary., Introduction Haemorrhage is a leading cause of death in trauma patients, responsible for approximately 30% to 40% of trauma-related deaths [1,2]. Although red blood cell (RBC) transfusion is often used [...]

Published
2014
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13. Methods for Evaluating Medical Tests and Biomarkers

Author

Gopalakrishna, Gowri, Langendam, Miranda, Scholten, Rob, Bossuyt, Patrick, Leeflang, Mariska, Noel-Storr, Anna, Thomas, James, Marshall, Iain, Wallace, Byron, Whiting, Penny, Davenport, Clare, GopalaKrishna, Gowri, de Salis, Isabel, Mallett, Sue, Wolff, Robert, Riley, Richard, Westwood, Marie, Kleinen, Jos, Collins, Gary, Reitsma, Hans, Moons, Karel, Zapf, Antonia, Hoyer, Annika, Kramer, Katharina, Kuss, Oliver, Ensor, J., Deeks, J. J., Martin, E. C., Riley, R. D., Rücker, Gerta, Steinhauser, Susanne, Schumacher, Martin, Ensor, Joie, Snell, Kym, Willis, Brian, Debray, Thomas, Deeks, Jon, di Ruffano, Lavinia Ferrante, Taylor-Phillips, Sian, Hyde, Chris, Taylor, Stuart A., Batnagar, Gauraang, Di Ruffano, Lavinia Ferrante, Seedat, Farah, Clarke, Aileen, Byron, Sarah, Nixon, Frances, Albrow, Rebecca, Walker, Thomas, Deakin, Carla, Zhelev, Zhivko, Hunt, Harriet, Yang, Yaling, Abel, Lucy, Buchanan, James, Fanshawe, Thomas, Shinkins, Bethany, Wynants, Laure, Verbakel, Jan, Van Huffel, Sabine, Timmerman, Dirk, Van Calster, Ben, Zwinderman, Aeliko, Oke, Jason, O’Sullivan, Jack, Perera, Rafael, Nicholson, Brian, Bromley, Hannah L., Roberts, Tracy E., Francis, Adele, Petrie, Denniis, Mann, G. Bruce, Malottki, Kinga, Smith, Holly, Billingham, Lucinda, Sitch, Alice, Gerke, Oke, Holm-Vilstrup, Mie, Segtnan, Eivind Antonsen, Halekoh, Ulrich, Høilund-Carlsen, Poul Flemming, Francq, Bernard G., Dinnes, Jac, Parkes, Julie, Gregory, Walter, Hewison, Jenny, Altman, Doug, Rosenberg, William, Selby, Peter, Asselineau, Julien, Perez, Paul, Paye, Aïssatou, Bessede, Emilie, Proust-Lima, Cécile, Naaktgeboren, Christiana, de Groot, Joris, Rutjes, Anne, Reitsma, Johannes, Ogundimu, Emmanuel, Cook, Jonathan, Le Manach, Yannick, Vergouwe, Yvonne, Pajouheshnia, Romin, Groenwold, Rolf, Moons, Karen, Peelen, Linda, Nieboer, Daan, De Cock, Bavo, Pencina, Micael J., Steyerberg, Ewout W., Cooper, Jennifer, Parsons, Nick, Stinton, Chris, Smith, Steve, Dickens, Andy, Jordan, Rachel, Enocson, Alexandra, Fitzmaurice, David, Adab, Peymane, Boachie, Charles, Vidmar, Gaj, Freeman, Karoline, Connock, Martin, Court, Rachel, Moons, Carl, Harris, Jessica, Mumford, Andrew, Plummer, Zoe, Lee, Kurtis, Reeves, Barnaby, Rogers, Chris, Verheyden, Veerle, Angelini, Gianni D., Murphy, Gavin J., Huddy, Jeremy, Ni, Melody, Good, Katherine, Cooke, Graham, Hanna, George, Ma, Jie, Moons, K. G. M. (Carl), de Groot, Joris A. H., Altman, Doug G., Reitsma, Johannes B., Collins, Gary S., Moons, Karel G. M., Altman, Douglas G., Kamarudin, Adina Najwa, Kolamunnage-Dona, Ruwanthi, Cox, Trevor, Borsci, Simone, Pérez, Teresa, Pardo, M.Carmen, Candela-Toha, Angel, Muriel, Alfonso, Zamora, Javier, Sanghera, Sabina, Mohiuddin, Syed, Martin, Richard, Donovan, Jenny, Coast, Joanna, Seo, Mikyung Kelly, Cairns, John, Mitchell, Elizabeth, Smith, Alison, Wright, Judy, Hall, Peter, Messenger, Michael, Calder, Nicola, Wickramasekera, Nyantara, Vinall-Collier, Karen, Lewington, Andrew, Damen, Johanna, Cairns, David, Hutchinson, Michelle, Sturgeon, Cathie, Mitchel, Liz, Kift, Rebecca, Christakoudi, Sofia, Rungall, Manohursingh, Mobillo, Paula, Montero, Rosa, Tsui, Tjir-Li, Kon, Sui Phin, Tucker, Beatriz, Sacks, Steven, Farmer, Chris, Strom, Terry, Chowdhury, Paramit, Rebollo-Mesa, Irene, Hernandez-Fuentes, Maria, Damen, Johanna A. A. G., Debray, Thomas P. A., Heus, Pauline, Hooft, Lotty, Scholten, Rob J. P. M., Schuit, Ewoud, Tzoulaki, Ioanna, Lassale, Camille M., Siontis, George C. M., Chiocchia, Virginia, Roberts, Corran, Schlüssel, Michael Maia, Gerry, Stephen, Black, James A., van der Schouw, Yvonne T., Peelen, Linda M., Spence, Graeme, McCartney, David, van den Bruel, Ann, Lasserson, Daniel, Hayward, Gail, Vach, Werner, de Jong, Antoinette, Burggraaff, Coreline, Hoekstra, Otto, Zijlstra, Josée, de Vet, Henrica, Graziadio, Sara, Allen, Joy, Johnston, Louise, O’Leary, Rachel, Power, Michael, Johnson, Louise, Waters, Ray, Simpson, John, Fanshawe, Thomas R., Phillips, Peter, Plumb, Andrew, Helbren, Emma, Halligan, Steve, Gale, Alastair, Sekula, Peggy, Sauerbrei, Willi, Forman, Julia R., Dutton, Susan J., Takwoingi, Yemisi, Hensor, Elizabeth M., Nichols, Thomas E., Kempf, Emmanuelle, Porcher, Raphael, de Beyer, Jennifer, Altman, Douglas, Hopewell, Sally, Dennis, John, Shields, Beverley, Jones, Angus, Henley, William, Pearson, Ewan, Hattersley, Andrew, Scheibler, Fueloep, Rummer, Anne, Sturtz, Sibylle, Großelfinger, Robert, Banister, Katie, Ramsay, Craig, Azuara-Blanco, Augusto, Burr, Jennifer, Kumarasamy, Manjula, Bourne, Rupert, Uchegbu, Ijeoma, Murphy, Jennifer, Carter, Alex, Murphy, Jen, Marti, Joachim, Eatock, Julie, Robotham, Julie, Dudareva, Maria, Gilchrist, Mark, Holmes, Alison, Monaghan, Phillip, Lord, Sarah, StJohn, Andrew, Sandberg, Sverre, Cobbaert, Christa, Lennartz, Lieselotte, Verhagen-Kamerbeek, Wilma, Ebert, Christoph, Horvath, Andrea, Jenniskens, Kevin, Peters, Jaime, Grigore, Bogdan, Ukoumunne, Obi, Levis, Brooke, Benedetti, Andrea, Levis, Alexander W., Ioannidis, John P. A., Shrier, Ian, Cuijpers, Pim, Gilbody, Simon, Kloda, Lorie A., McMillan, Dean, Patten, Scott B, Steele, Russell J., Ziegelstein, Roy C, Bombardier, Charles H., Osório, Flavia de Lima, Fann, Jesse R., Gjerdingen, Dwenda, Lamers, Femke, Lotrakul, Manote, Loureiro, Sonia R, Löwe, Bernd, Shaaban, Juwita, Stafford, Lesley, van Weert, Henk C. P. M., Whooley, Mary A., Williams, Linda S., Wittkampf, Karin A., Yeung, Albert S., Thombs, Brett D., Cooper, Chris, Nieto, Tom, Smith, Claire, Tucker, Olga, Dretzke, Janine, Beggs, Andrew, Rai, Nirmala, Bayliss, Sue, Stevens, Simon, Mallet, Sue, Sundar, Sudha, Hall, Emma, Porta, Nuria, Estelles, David Lorente, and de Bono, Johann

Subjects
Faecal Immunochemical Test, Chronic Obstructive Pulmonary Disorder, Circulate Tumour Cell Count, Apply Health Research, Meeting Abstracts, Faecal Immunochemical Test Result
Abstract

unKnown

Published
2017

14. The COMET initiative database: progress and activities update (2014)

Author

Gargon, Elizabeth, Williamson, Paula R., Altman, Doug G., Blazeby, Jane M., and Clarke, Mike

Subjects
Clinical Trials as Topic, Internet, Letter, Databases, Factual, Information Dissemination, International Cooperation, Core outcome set, Medicine (miscellaneous), Resources, Access to Information, Database, Humans, Pharmacology (medical), Cooperative Behavior, resources, database, Forecasting
Abstract

The COMET Initiative database is a repository of studies relevant to the development of core outcome sets (COS). Use of the website continues to increase, with more than 16,500 visits in 2014 (36 % increase over 2013), 12,257 unique visitors (47 % increase), 9780 new visitors (43 % increase) and a rise in the proportion of visits from outside the UK (8565 visits; 51 % of all visits). By December 2014, a total of 6588 searches had been completed, with 2383 in 2014 alone (11 % increase). The growing awareness of the need for COS is reflected in the website and database usage figures.

Published
2015

16. COMET V meeting summary

Author

Gorst, Sarah L, primary, Altman, Doug G, additional, Blazeby, Jane M, additional, Clarke, Mike, additional, Gargon, Elizabeth, additional, Tunis, Sean, additional, and Williamson, Paula R, additional

Published
2015
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18. Stem cell transplantation in traumatic spinal cord injury: a systematic review and meta-analysis of animal studies

Author

Altman, Doug G., Antonic, Ana, Sena, Emily S., Lees, Jennifer S., Wills, Taryn E., Skeers, Peta, Batchelor, Peter E., Macleod, Malcolm R., and Howells, David W.

Abstract

Spinal cord injury (SCI) is a devastating condition that causes substantial morbidity and mortality and for which no treatments are available. Stem cells offer some promise in the restoration of neurological function. We used systematic review, meta-analysis, and meta-regression to study the impact of stem cell biology and experimental design on motor and sensory outcomes following stem cell treatments in animal models of SCI. One hundred and fifty-six publications using 45 different stem cell preparations met our prespecified inclusion criteria. Only one publication used autologous stem cells. Overall, allogeneic stem cell treatment appears to improve both motor (effect size, 27.2%; 95% Confidence Interval [CI], 25.0%–29.4%; 312 comparisons in 5,628 animals) and sensory (effect size, 26.3%; 95% CI, 7.9%–44.7%; 23 comparisons in 473 animals) outcome. For sensory outcome, most heterogeneity between experiments was accounted for by facets of stem cell biology. Differentiation before implantation and intravenous route of delivery favoured better outcome. Stem cell implantation did not appear to improve sensory outcome in female animals and appeared to be enhanced by isoflurane anaesthesia. Biological plausibility was supported by the presence of a dose–response relationship. For motor outcome, facets of stem cell biology had little detectable effect. Instead most heterogeneity could be explained by the experimental modelling and the outcome measure used. The location of injury, method of injury induction, and presence of immunosuppression all had an impact. Reporting of measures to reduce bias was higher than has been seen in other neuroscience domains but were still suboptimal. Motor outcomes studies that did not report the blinded assessment of outcome gave inflated estimates of efficacy. Extensive recent preclinical literature suggests that stem-cell–based therapies may offer promise, however the impact of compromised internal validity and publication bias mean that efficacy is likely to be somewhat lower than reported here.

Published
2013

19. Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform

Author

Treweek, Shaun, primary, Altman, Doug G., additional, Bower, Peter, additional, Campbell, Marion, additional, Chalmers, Iain, additional, Cotton, Seonaidh, additional, Craig, Peter, additional, Crosby, David, additional, Davidson, Peter, additional, Devane, Declan, additional, Duley, Lelia, additional, Dunn, Janet, additional, Elbourne, Diana, additional, Farrell, Barbara, additional, Gamble, Carrol, additional, Gillies, Katie, additional, Hood, Kerry, additional, Lang, Trudie, additional, Littleford, Roberta, additional, Loudon, Kirsty, additional, McDonald, Alison, additional, McPherson, Gladys, additional, Nelson, Annmarie, additional, Norrie, John, additional, Ramsay, Craig, additional, Sandercock, Peter, additional, Shanahan, Daniel R, additional, Summerskill, William, additional, Sydes, Matt, additional, Williamson, Paula, additional, and Clarke, Mike, additional

Published
2015
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21. COMET IV meeting summary

Author

Gargon, Elizabeth, primary, Altman, Doug G, additional, Blazeby, Jane M, additional, Clarke, Mike, additional, and Williamson, Paula R, additional

Published
2015
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22. The Distribution of Clinical Phenotypes of Preterm Birth Syndrome

Author

Barros, Fernando C., primary, Papageorghiou, Aris T., additional, Victora, Cesar G., additional, Noble, Julia A., additional, Pang, Ruyan, additional, Iams, Jay, additional, Cheikh Ismail, Leila, additional, Goldenberg, Robert L., additional, Lambert, Ann, additional, Kramer, Michael S., additional, Carvalho, Maria, additional, Conde-Agudelo, Agustin, additional, Jaffer, Yasmin A., additional, Bertino, Enrico, additional, Gravett, Michael G., additional, Altman, Doug G., additional, Ohuma, Eric O., additional, Purwar, Manorama, additional, Frederick, Ihunnaya O., additional, Bhutta, Zulfiqar A., additional, Kennedy, Stephen H., additional, and Villar, José, additional

Published
2015
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28. Consensus-based recommendations for investigating clinical heterogeneity in systematic reviews.

Author

Gagnier, Joel J., Morgenstern, Hal, Altman, Doug G., Berlin, Jesse, Chang, Stephanie, McCulloch, Peter, Sun, Xin, and Moher, David

Subjects
VISUAL aids, FOCUS groups, DECISION making, PROBLEM solving
Abstract

Background: Critics of systematic reviews have argued that these studies often fail to inform clinical decision making because their results are far too general, that the data are sparse, such that findings cannot be applied to individual patients or for other decision making. While there is some consensus on methods for investigating statistical and methodological heterogeneity, little attention has been paid to clinical aspects of heterogeneity. Clinical heterogeneity, true effect heterogeneity, can be defined as variability among studies in the participants, the types or timing of outcome measurements, and the intervention characteristics. The objective of this project was to develop recommendations for investigating clinical heterogeneity in systematic reviews. Methods: We used a modified Delphi technique with three phases: (1) pre-meeting item generation; (2) face-to -face consensus meeting in the form of a modified Delphi process; and (3) post-meeting feedback. We identified and invited potential participants with expertise in systematic review methodology, systematic review reporting, or statistical aspects of meta-analyses, or those who published papers on clinical heterogeneity. Results: Between April and June of 2011, we conducted phone calls with participants. In June 2011 we held the face-to-face focus group meeting in Ann Arbor, Michigan. First, we agreed upon a definition of clinical heterogeneity: Variations in the treatment effect that are due to differences in clinically related characteristics. Next, we discussed and generated recommendations in the following 12 categories related to investigating clinical heterogeneity: the systematic review team, planning investigations, rationale for choice of variables, types of clinical variables, the role of statistical heterogeneity, the use of plotting and visual aids, dealing with outlier studies, the number of investigations or variables, the role of the best evidence synthesis, types of statistical methods, the interpretation of findings, and reporting. Conclusions: Clinical heterogeneity is common in systematic reviews. Our recommendations can help guide systematic reviewers in conducting valid and reliable investigations of clinical heterogeneity. Findings of these investigations may allow for increased applicability of findings of systematic reviews to the management of individual patients. [ABSTRACT FROM AUTHOR]

Published
2013
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29. The likeness of fetal growth and newborn size across non-isolated populations in the INTERGROWTH-21stProject: the Fetal Growth Longitudinal Study and Newborn Cross-Sectional Study

Author

Villar, José, Papageorghiou, Aris T, Pang, Ruyan, Ohuma, Eric O, Ismail, Leila Cheikh, Barros, Fernando C, Lambert, Ann, Carvalho, Maria, Jaffer, Yasmin A, Bertino, Enrico, Gravett, Michael G, Altman, Doug G, Purwar, Manorama, Frederick, Ihunnaya O, Noble, Julia A, Victora, Cesar G, Bhutta, Zulfiqar A, and Kennedy, Stephen H

Abstract

Large differences exist in size at birth and in rates of impaired fetal growth worldwide. The relative effects of nutrition, disease, the environment, and genetics on these differences are often debated. In clinical practice, various references are often used to assess fetal growth and newborn size across populations and ethnic origins, whereas international standards for assessing growth in infants and children have been established. In the INTERGROWTH-21stProject, our aim was to assess fetal growth and newborn size in eight geographically defined urban populations in which the health and nutrition needs of mothers were met and adequate antenatal care was provided.

Published
2014
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30. Evaluation of the Ages and Stages Questionnaires in identifying children with neurosensory disability in the Magpie Trial follow-up study.

Author

Ly-Mee Yu, Hey, Edmund, Doyle, Lex W., Farrell, Barbara, Spark, Patsy, Altman, Doug G., and Duley, Lelia

Subjects
ADULT-child relationships, NEUROSECRETION, NERVOUS system, NEUROHEMAL organs, CLINICAL trials, DISABILITIES, CONFIDENCE intervals, CONFIDENCE in children, CHILD psychology
Abstract

Aim: To evaluate performance of the Ages and Stages Questionnaires (full ASQ), and a shortened version (short ASQ), in detecting children with severe neurosensory disability in the Magpie Trial follow-up study. Methods: All children, born to women in the Magpie Trial and selected for follow-up, with a completed full 30 items and/or short 9-items ASQ were included in this analysis. Sensitivity and specificity, corrected for verification bias, were computed to assess detection ability. Results: Of the 2046 children who completed a full ASQ, 406 (19.8%) failed the assessment, 54 of whom had confirmed neurosensory disability. Adjusted sensitivity and specificity (95% confidence intervals) were 87.4% (62.9–96.6%), and 82.3% (80.5–83.9%), respectively. Two of the five domains in the full ASQ (Fine Motor and Problem Solving) contributed little to detection ability. Sensitivity and specificity for the short ASQ were 69.2% and 95.7%, respectively. Conclusions: Sensitivity of the full ASQ for severe neurosensory disability is generally good, and does not appear to be much reduced by restricting questions to three out of the five domains. The short ASQ reported here reduced performance, although this might be improved by a different choice of questions or scoring system. [ABSTRACT FROM AUTHOR]

Published
2007
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32. Ten-year Mortality, Disease Progression, and Treatment-related Side Effects in Men with Localised Prostate Cancer from the ProtecT Randomised Controlled Trial According to Treatment Received.

Author

Neal DE, Metcalfe C, Donovan JL, Lane JA, Davis M, Young GJ, Dutton SJ, Walsh EI, Martin RM, Peters TJ, Turner EL, Mason M, Bryant R, Bollina P, Catto J, Doherty A, Gillatt D, Gnanapragasam V, Holding P, Hughes O, Kockelbergh R, Kynaston H, Oxley J, Paul A, Paez E, Rosario DJ, Rowe E, Staffurth J, Altman DG, and Hamdy FC

Subjects
Aged, Disease Progression, Humans, Male, Middle Aged, Prostatectomy adverse effects, Prostatic Neoplasms pathology, Radiotherapy adverse effects, Radiotherapy methods, Time Factors, Treatment Outcome, Watchful Waiting, Prostatic Neoplasms mortality, Prostatic Neoplasms therapy
Abstract

Background: The ProtecT trial reported intention-to-treat analysis of men with localised prostate cancer (PCa) randomly allocated to active monitoring (AM), radical prostatectomy, and external beam radiotherapy., Objective: To determine report outcomes according to treatment received in men in randomised and treatment choice cohorts., Design, Setting, and Participants: This study focuses on secondary care. Men with clinically localised prostate cancer at one of nine UK centres were invited to participate in the treatment trial comparing AM, radical prostatectomy, and radiotherapy., Intervention: Two cohorts included 1643 men who agreed to be randomised; 997 declined randomisation and chose treatment., Outcome Measurements and Statistical Analysis: Health-related quality of life impacts on urinary, bowel, and sexual function were assessed using patient-reported outcome measures. Analysis was carried out based on treatment received for each cohort and on pooled estimates using meta-analysis. Differences were estimated with adjustment for known prognostic factors using propensity scores., Results and Limitations: According to treatment received, more men receiving AM died of PCa (AM 1.85%, surgery 0.67%, radiotherapy 0.73%), whilst this difference remained consistent with chance in the randomised cohort (p=0.08); stronger evidence was found in the exploratory analyses (randomised plus choice cohort) when AM was compared with the combined radical treatment group (p=0.003). There was also strong evidence that metastasis (AM 5.6%, surgery 2.4%, radiotherapy 2.7%) and disease progression (AM 20.35%, surgery 5.87%, radiotherapy 6.62%) were more common in the AM group. Compared with AM, there were higher risks of sexual dysfunction (95% at 6mo) and urinary incontinence (55% at 6mo) after surgery, and of sexual dysfunction (88% at 6mo) and bowel dysfunction (5% at 6mo) after radiotherapy. The key limitations are the potential for bias when comparing groups defined by treatment received and outdating of the interventions being evaluated during the lengthy follow-up required in trials of screen-detected PCa., Conclusions: Analyses according to treatment received showed increased rates of disease-related events and lower rates of patient-reported harms in men managed by AM compared with men managed by radical treatment, and stronger evidence of greater PCa mortality in the AM group., Patient Summary: More than 90 out of every 100 men with localised prostate cancer do not die of prostate cancer within 10yr, irrespective of whether treatment is by means of monitoring, surgery, or radiotherapy. Side effects on sexual and bladder function are much better after active monitoring, but the risks of spreading of prostate cancer are more common., (Copyright © 2019 The Author(s). Published by Elsevier B.V. All rights reserved.)

Published
2020
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33. Erratum to: Methods for evaluating medical tests and biomarkers.

Author

Gopalakrishna G, Langendam M, Scholten R, Bossuyt P, Leeflang M, Noel-Storr A, Thomas J, Marshall I, Wallace B, Whiting P, Davenport C, Leeflang M, GopalaKrishna G, de Salis I, Mallett S, Wolff R, Whiting P, Riley R, Westwood M, Kleinen J, Collins G, Reitsma H, Moons K, Zapf A, Hoyer A, Kramer K, Kuss O, Ensor J, Deeks JJ, Martin EC, Riley RD, Rücker G, Steinhauser S, Schumacher M, Riley R, Ensor J, Snell K, Willis B, Debray T, Moons K, Deeks J, Collins G, di Ruffano LF, Willis B, Davenport C, Mallett S, Taylor-Phillips S, Hyde C, Deeks J, Mallett S, Taylor SA, Batnagar G, Taylor-Phillips S, Di Ruffano LF, Seedat F, Clarke A, Deeks J, Byron S, Nixon F, Albrow R, Walker T, Deakin C, Hyde C, Zhelev Z, Hunt H, di Ruffano LF, Yang Y, Abel L, Buchanan J, Fanshawe T, Shinkins B, Wynants L, Verbakel J, Van Huffel S, Timmerman D, Van Calster B, Leeflang M, Zwinderman A, Bossuyt P, Oke J, O'Sullivan J, Perera R, Nicholson B, Bromley HL, Roberts TE, Francis A, Petrie D, Mann GB, Malottki K, Smith H, Deeks J, Billingham L, Sitch A, Mallett S, Deeks J, Gerke O, Holm-Vilstrup M, Segtnan EA, Halekoh U, Høilund-Carlsen PF, Francq BG, Deeks J, Sitch A, Dinnes J, Parkes J, Gregory W, Hewison J, Altman D, Rosenberg W, Selby P, Asselineau J, Perez P, Paye A, Bessede E, Proust-Lima C, Naaktgeboren C, de Groot J, Rutjes A, Bossuyt P, Reitsma J, Moons K, Collins G, Ogundimu E, Cook J, Le Manach Y, Altman D, Wynants L, Vergouwe Y, Van Huffel S, Timmerman D, Van Calster B, Pajouheshnia R, Groenwold R, Moons K, Reitsma J, Peelen L, Van Calster B, Nieboer D, Vergouwe Y, De Cock B, Pencina MJ, Steyerberg EW, Cooper J, Taylor-Phillips S, Parsons N, Stinton C, Smith S, Dickens A, Jordan R, Enocson A, Fitzmaurice D, Sitch A, Adab P, Francq BG, Boachie C, Vidmar G, Freeman K, Connock M, Taylor-Phillips S, Court R, Clarke A, de Groot J, Naaktgeboren C, Reitsma H, Moons C, Harris J, Mumford A, Plummer Z, Lee K, Reeves B, Rogers C, Verheyden V, Angelini GD, Murphy GJ, Huddy J, Ni M, Good K, Cooke G, Bossuyt P, Hanna G, Ma J, Altman D, Collins G, Moons KGMC, de Groot JAH, Mallett S, Altman DG, Reitsma JB, Collins GS, Moons KGM, Altman DG, Reitsma JB, Collins GS, Kamarudin AN, Kolamunnage-Dona R, Cox T, Ni M, Huddy J, Borsci S, Hanna G, Pérez T, Pardo MC, Candela-Toha A, Muriel A, Zamora J, Sanghera S, Mohiuddin S, Martin R, Donovan J, Coast J, Seo MK, Cairns J, Mitchell E, Smith A, Wright J, Hall P, Messenger M, Calder N, Wickramasekera N, Vinall-Collier K, Lewington A, Pajouheshnia R, Damen J, Groenwold R, Moons K, Peelen L, Messenger M, Cairns D, Smith A, Hutchinson M, Wright J, Hall P, Calder N, Sturgeon C, Mitchel L, Kift R, Christakoudi S, Rungall M, Mobillo P, Montero R, Tsui TL, Kon SP, Tucker B, Sacks S, Farmer C, Strom T, Chowdhury P, Rebollo-Mesa I, Hernandez-Fuentes M, Damen JAAG, Debray TPA, Heus P, Hooft L, Moons KGM, Pajouheshnia R, Reitsma JB, Scholten RJPM, Damen JAAG, Hooft L, Schuit E, Debray TPA, Collins GS, Tzoulaki I, Lassale CM, Siontis GCM, Chiocchia V, Roberts C, Schlüssel MM, Gerry S, Black JA, Heus P, van der Schouw YT, Peelen LM, Moons KGM, Damen JAAG, Debray TPA, Heus P, Hooft L, Moons KGM, Pajouheshnia R, Reitsma JB, Scholten RJPM, Ma J, Altman D, Collins G, Spence G, McCartney D, van den Bruel A, Lasserson D, Hayward G, Vach W, de Jong A, Burggraaff C, Hoekstra O, Zijlstra J, de Vet H, Hunt H, Hyde C, Graziadio S, Allen J, Johnston L, O'Leary R, Power M, Allen J, Graziadio S, Johnson L, O'Leary R, Power M, Waters R, Simpson J, Johnston L, Allen J, Graziadio S, O'Leary R, Waters R, Power M, Mallett S, Fanshawe TR, Phillips P, Plumb A, Helbren E, Halligan S, Taylor SA, Gale A, Mallett S, Sekula P, Altman DG, Sauerbrei W, Mallett S, Fanshawe TR, Forman JR, Dutton SJ, Takwoingi Y, Hensor EM, Nichols TE, Shinkins B, Yang Y, Abel L, Di Ruffano LF, Fanshawe T, Kempf E, Porcher R, de Beyer J, Moons K, Altman D, Reitsma H, Hopewell S, Sauerbrei W, Collins G, Dennis J, Shields B, Jones A, Henley W, Pearson E, Hattersley A, Heus P, Damen JAAG, Pajouheshnia R, Scholten RJPM, Reitsma JB, Collins GS, Altman DG, Moons KGM, Hooft L, Shields B, Dennis J, Jones A, Henley W, Pearson E, Hattersley A, Scheibler F, Rummer A, Sturtz S, Großelfinger R, Banister K, Ramsay C, Azuara-Blanco A, Cook J, Boachie C, Burr J, Kumarasamy M, Bourne R, Uchegbu I, Borsci S, Murphy J, Hanna G, Uchegbu I, Carter A, Murphy J, Ni M, Marti J, Eatock J, Uchegbu I, Robotham J, Dudareva M, Gilchrist M, Holmes A, Uchegbu I, Borsci S, Monaghan P, Lord S, StJohn A, Sandberg S, Cobbaert C, Lennartz L, Verhagen-Kamerbeek W, Ebert C, Bossuyt P, Horvath A, Jenniskens K, Naaktgeboren C, Reitsma J, Moons K, de Groot J, Hyde C, Peters J, Grigore B, Peters J, Hyde C, Hyde C, Ukoumunne O, Peters J, Zhelev Z, Levis B, Benedetti A, Levis AW, Ioannidis JPA, Shrier I, Cuijpers P, Gilbody S, Kloda LA, McMillan D, Patten SB, Steele RJ, Ziegelstein RC, Bombardier CH, Osório FL, Fann JR, Gjerdingen D, Lamers F, Lotrakul M, Loureiro SR, Löwe B, Shaaban J, Stafford L, van Weert HCPM, Whooley MA, Williams LS, Wittkampf KA, Yeung AS, Thombs BD, Peters J, Cooper C, Buchanan J, Nieto T, Smith C, Tucker O, Dretzke J, Beggs A, Rai N, Davenport C, Bayliss S, Stevens S, Snell K, Mallet S, Deeks J, Sundar S, Hall E, Porta N, Estelles DL, and de Bono J

Abstract

[This corrects the article DOI: 10.1186/s41512-016-0001-y.].

Published
2017
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34. Inconsistency between direct and indirect comparisons of competing interventions: meta-epidemiological study.

Author

Song F, Xiong T, Parekh-Bhurke S, Loke YK, Sutton AJ, Eastwood AJ, Holland R, Chen YF, Glenny AM, Deeks JJ, and Altman DG

Subjects
Bias, Humans, Reproducibility of Results, Research Design, Review Literature as Topic, Treatment Outcome, Comparative Effectiveness Research, Epidemiologic Studies, Meta-Analysis as Topic, Randomized Controlled Trials as Topic
Abstract

Objective: To investigate the agreement between direct and indirect comparisons of competing healthcare interventions., Design: Meta-epidemiological study based on sample of meta-analyses of randomised controlled trials. Data sources Cochrane Database of Systematic Reviews and PubMed. Inclusion criteria Systematic reviews that provided sufficient data for both direct comparison and independent indirect comparisons of two interventions on the basis of a common comparator and in which the odds ratio could be used as the outcome statistic., Main Outcome Measure: Inconsistency measured by the difference in the log odds ratio between the direct and indirect methods., Results: The study included 112 independent trial networks (including 1552 trials with 478,775 patients in total) that allowed both direct and indirect comparison of two interventions. Indirect comparison had already been explicitly done in only 13 of the 85 Cochrane reviews included. The inconsistency between the direct and indirect comparison was statistically significant in 16 cases (14%, 95% confidence interval 9% to 22%). The statistically significant inconsistency was associated with fewer trials, subjectively assessed outcomes, and statistically significant effects of treatment in either direct or indirect comparisons. Owing to considerable inconsistency, many (14/39) of the statistically significant effects by direct comparison became non-significant when the direct and indirect estimates were combined., Conclusions: Significant inconsistency between direct and indirect comparisons may be more prevalent than previously observed. Direct and indirect estimates should be combined in mixed treatment comparisons only after adequate assessment of the consistency of the evidence.

Published
2011
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