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51. Core competencies for scientific editors of biomedical journals: consensus statement

Author

Moher, David, Galipeau, James, Alam, Sabina, Barbour, Virginia, Bartolomeos, Kidist, Baskin, Patricia, Bell-Syer, Sally, Cobey, Kelly D, Chan, Leighton, Clark, Jocalyn, Deeks, Jon, Flanagin, Annette, Garner, Paul, Glenny, Anne-Marie, and Groves, Trish

Subjects
Biomedical journal, Scientific editor, Expert consensus, Editor role, Delphi, Core competencies
Abstract

Background Scientific editors are responsible for deciding which articles to publish in their journals. However, we have not found documentation of their required knowledge, skills, and characteristics, or the existence of any formal core competencies for this role. Methods We describe the development of a minimum set of core competencies for scientific editors of biomedical journals. Results The 14 key core competencies are divided into three major areas, and each competency has a list of associated elements or descriptions of more specific knowledge, skills, and characteristics that contribute to its fulfillment. Conclusions We believe that these core competencies are a baseline of the knowledge, skills, and characteristics needed to perform competently the duties of a scientific editor at a biomedical journal.

Published
2017

52. Variation in the Observed Effect of Xpert MTB/RIF Testing for Tuberculosis on Mortality - A Systematic Review and Analysis of Trial Design Considerations

Author

Ochodo, Eleanor, primary, Kalema, Nelson, additional, Schumacher, Samuel, additional, Steingart, Karen, additional, Young, Taryn, additional, Mallett, Susan, additional, Deeks, Jon, additional, Cobelens, Frank, additional, Bossuyt, Patrick M., additional, Nicol, Mark P., additional, and Cattamanchi, Adithya, additional

Published
2019
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54. PET-PANC:multicentre prospective diagnostic accuracy and health economic analysis study of the impact of combined modality 18fluorine-2-fluoro-2-deoxy-d-glucose positron emission tomography with computed tomography scanning in the diagnosis and management of pancreatic cancer

Author

Ghaneh, Paula, Hanson, Robert, Titman, Andrew, Lancaster, Gillian Ann, Plumpton, Catrin, Lloyd-Williams, Huw, Yeo, Seow Tien, Edwards, Rhiannon Tudor, Johnson, Colin, Abu Hilal, Mohammed, Higginson, Antony P, Armstrong, Tom, Smith, Andrew, Scarsbrook, Andrew, McKay, Colin, Carter, Ross, Sutcliffe, Robert P, Bramhall, Simon, Kocher, Hemant M, Cunningham, David, Pereira, Stephen P, Davidson, Brian, Chang, David, Khan, Saboor, Zealley, Ian, Sarker, Debashis, Al Sarireh, Bilal, Charnley, Richard, Lobo, Dileep, Nicolson, Marianne, Halloran, Christopher, Raraty, Michael, Sutton, Robert, Vinjamuri, Sobhan, Evans, Jonathan, Campbell, Fiona, Deeks, Jon, Sanghera, Bal, Wong, Wai-Lup, Neoptolemos, John P, Ghaneh, Paula, Hanson, Robert, Titman, Andrew, Lancaster, Gillian Ann, Plumpton, Catrin, Lloyd-Williams, Huw, Yeo, Seow Tien, Edwards, Rhiannon Tudor, Johnson, Colin, Abu Hilal, Mohammed, Higginson, Antony P, Armstrong, Tom, Smith, Andrew, Scarsbrook, Andrew, McKay, Colin, Carter, Ross, Sutcliffe, Robert P, Bramhall, Simon, Kocher, Hemant M, Cunningham, David, Pereira, Stephen P, Davidson, Brian, Chang, David, Khan, Saboor, Zealley, Ian, Sarker, Debashis, Al Sarireh, Bilal, Charnley, Richard, Lobo, Dileep, Nicolson, Marianne, Halloran, Christopher, Raraty, Michael, Sutton, Robert, Vinjamuri, Sobhan, Evans, Jonathan, Campbell, Fiona, Deeks, Jon, Sanghera, Bal, Wong, Wai-Lup, and Neoptolemos, John P

Abstract

BACKGROUND: Pancreatic cancer diagnosis and staging can be difficult in 10-20% of patients. Positron emission tomography (PET)/computed tomography (CT) adds precise anatomical localisation to functional data. The use of PET/CT may add further value to the diagnosis and staging of pancreatic cancer. OBJECTIVE: To determine the incremental diagnostic accuracy and impact of PET/CT in addition to standard diagnostic work-up in patients with suspected pancreatic cancer. DESIGN: A multicentre prospective diagnostic accuracy and clinical value study of PET/CT in suspected pancreatic malignancy. PARTICIPANTS: Patients with suspected pancreatic malignancy. INTERVENTIONS: All patients to undergo PET/CT following standard diagnostic work-up. MAIN OUTCOME MEASURES: The primary outcome was the incremental diagnostic value of PET/CT in addition to standard diagnostic work-up with multidetector computed tomography (MDCT). Secondary outcomes were (1) changes in patients' diagnosis, staging and management as a result of PET/CT; (2) changes in the costs and effectiveness of patient management as a result of PET/CT; (3) the incremental diagnostic value of PET/CT in chronic pancreatitis; (4) the identification of groups of patients who would benefit most from PET/CT; and (5) the incremental diagnostic value of PET/CT in other pancreatic tumours. RESULTS: Between 2011 and 2013, 589 patients with suspected pancreatic cancer underwent MDCT and PET/CT, with 550 patients having complete data and in-range PET/CT. Sensitivity and specificity for the diagnosis of pancreatic cancer were 88.5% and 70.6%, respectively, for MDCT and 92.7% and 75.8%, respectively, for PET/CT. The maximum standardised uptake value (SUVmax.) for a pancreatic cancer diagnosis was 7.5. PET/CT demonstrated a significant improvement in relative sensitivity (p = 0.01) and specificity (p = 0.023) compared with MDCT. Incremental likelihood ratios demonstrated that PET/CT significantly improved diagnostic accuracy in all sce

Published
2018

55. 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

56. Refining Ovarian Cancer Test accuracy Scores (ROCkeTS): protocol for a prospective longitudinal test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer

Author

Sundar, Sudha, Rick, Caroline, Dowling, Francis, Au, Pui, Snell, Kym, Rai, Nirmala, Champaneria, Rita, Stobart, Hilary, Neal, Richard, Davenport, Clare, Mallett, Susan, Sutton, Andrew, Kehoe, Sean, Timmerman, Dirk, Bourne, Tom, Van Calster, Ben, Gentry-Maharaj, Aleksandra, Menon, Usha, and Deeks, Jon

Subjects
Adult, Adolescent, Risk Assessment, Sensitivity and Specificity, Severity of Illness Index, Young Adult, Obstetrics and Gynaecology, Protocol, Humans, Longitudinal Studies, Prospective Studies, Aged, Ultrasonography, Aged, 80 and over, Ovarian Neoplasms, GYNAECOLOGY, Middle Aged, United Kingdom, Research Design, CA-125 Antigen, Female
Abstract

Introduction Ovarian cancer (OC) is associated with non-specific symptoms such as bloating, making accurate diagnosis challenging: only 1 in 3 women with OC presents through primary care referral. National Institute for Health and Care Excellence guidelines recommends sequential testing with CA125 and routine ultrasound in primary care. However, these diagnostic tests have limited sensitivity or specificity. Improving accurate triage in women with vague symptoms is likely to improve mortality by streamlining referral and care pathways. The Refining Ovarian Cancer Test Accuracy Scores (ROCkeTS; HTA 13/13/01) project will derive and validate new tests/risk prediction models that estimate the probability of having OC in women with symptoms. This protocol refers to the prospective study only (phase III). Methods and analysis ROCkeTS comprises four parallel phases. The full ROCkeTS protocol can be found at http://www.birmingham.ac.uk/ROCKETS. Phase III is a prospective test accuracy study. The study will recruit 2450 patients from 15 UK sites. Recruited patients complete symptom and anxiety questionnaires, donate a serum sample and undergo ultrasound scored as per International Ovarian Tumour Analysis (IOTA) criteria. Recruitment is at rapid access clinics, emergency departments and elective clinics. Models to be evaluated include those based on ultrasound derived by the IOTA group and novel models derived from analysis of existing data sets. Estimates of sensitivity, specificity, c-statistic (area under receiver operating curve), positive predictive value and negative predictive value of diagnostic tests are evaluated and a calibration plot for models will be presented. ROCkeTS has received ethical approval from the NHS West Midlands REC (14/WM/1241) and is registered on the controlled trials website (ISRCTN17160843) and the National Institute of Health Research Cancer and Reproductive Health portfolios.

Published
2016

59. Defining the major health modifiers causing atrial fibrillation: a roadmap to underpin personalized prevention and treatment

Author

Fabritz, Larissa Guasch, Eduard Antoniades, Charalambos and Bardinet, Isabel Benninger, Gerlinde Betts, Tim R. Brand, Eva Breithardt, Guenter Bucklar-Suchankova, Gabriela Camm, A. John Cartlidge, David Casadei, Barbara Chua, Winnie W. L. and Crijns, Harry J. G. M. Deeks, Jon Hatem, Stephane and Hidden-Lucet, Francoise Kaeaeb, Stefan Maniadakis, Nikos and Martin, Stephan Mont, Lluis Reinecke, Holger Sinner, Moritz F. Schotten, Ulrich Southwood, Taunton Stoll, Monika and Vardas, Panos Wakili, Reza West, Andy Ziegler, Andre and Kirchhof, Paulus

Abstract

Despite remarkable advances in antiarrhythmic drugs, ablation procedures, and stroke-prevention strategies, atrial fibrillation (AF) remains an important cause of death and disability in middle-aged and elderly individuals. Unstructured management of patients with AF sharply contrasts with our detailed, although incomplete, knowledge of the mechanisms that cause AF and its complications. Altered calcium homeostasis, atrial fibrosis and ageing, ion-channel dysfunction, autonomic imbalance, fat-cell infiltration, and oxidative stress, in addition to a susceptible genetic background, contribute to the promotion, maintenance, and progression of AF. However, clinical management of patients with AF is currently guided by stroke risk parameters, AF pattern, and symptoms. In response to this apparent disconnect between the known pathophysiology of AF and clinical management, we propose a roadmap to develop a set of clinical markers that reflect the major causes of AF in patients. Thereby, the insights into the mechanisms causing AF will be transformed into a format that can underpin future personalized strategies to prevent and treat AF, ultimately informing better patient care.

Published
2016

60. Development and validation of Prediction models for Risks of complications in Early-onset Pre-eclampsia (PREP): a prospective cohort study

Author

Thangaratinam, Shakila, primary, Allotey, John, additional, Marlin, Nadine, additional, Mol, Ben W, additional, Von Dadelszen, Peter, additional, Ganzevoort, Wessel, additional, Akkermans, Joost, additional, Ahmed, Asif, additional, Daniels, Jane, additional, Deeks, Jon, additional, Ismail, Khaled, additional, Barnard, Ann Marie, additional, Dodds, Julie, additional, Kerry, Sally, additional, Moons, Carl, additional, Riley, Richard D, additional, and Khan, Khalid S, additional

Published
2017
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61. Development and validation of Prediction models for Risks of complications in Early-onset Pre-eclampsia (PREP) : a prospective cohort study

Author

Thangaratinam, Shakila, Allotey, John, Marlin, Nadine, Mol, Ben W., von Dadelszen, Peter, Ganzevoort, Wessel, Akkermans, Joost, Ahmed, Asif, Daniels, Jane, Deeks, Jon, Ismail, Khaled, Barnard, Ann Marie, Dodds, Julie, Kerry, Sally, Riley, Richard D., Khan, Khalid S, Moons, KGM, Thangaratinam, Shakila, Allotey, John, Marlin, Nadine, Mol, Ben W., von Dadelszen, Peter, Ganzevoort, Wessel, Akkermans, Joost, Ahmed, Asif, Daniels, Jane, Deeks, Jon, Ismail, Khaled, Barnard, Ann Marie, Dodds, Julie, Kerry, Sally, Riley, Richard D., Khan, Khalid S, and Moons, KGM

Published
2017

62. Development and validation of Prediction models for Risks of complications in Early-onset Pre-eclampsia (PREP):a prospective cohort study

Author

Thangaratinam, Shakila, Allotey, John, Marlin, Nadine, Mol, Ben W., von Dadelszen, Peter, Ganzevoort, Wessel, Akkermans, Joost, Ahmed, Asif, Daniels, Jane, Deeks, Jon, Ismail, Khaled, Barnard, Ann Marie, Dodds, Julie, Kerry, Sally, Moons, Carl, Riley, Richard D., Khan, Khalid S., Thangaratinam, Shakila, Allotey, John, Marlin, Nadine, Mol, Ben W., von Dadelszen, Peter, Ganzevoort, Wessel, Akkermans, Joost, Ahmed, Asif, Daniels, Jane, Deeks, Jon, Ismail, Khaled, Barnard, Ann Marie, Dodds, Julie, Kerry, Sally, Moons, Carl, Riley, Richard D., and Khan, Khalid S.

Abstract

Background: The prognosis of early-onset pre-eclampsia (before 34 weeks’ gestation) is variable. Accurate prediction of complications is required to plan appropriate management in high-risk women. Objective: To develop and validate prediction models for outcomes in early-onset pre-eclampsia. Design: Prospective cohort for model development, with validation in two external data sets. Setting: Model development: 53 obstetric units in the UK. Model transportability: PIERS (Pre-eclampsia Integrated Estimate of RiSk for mothers) and PETRA (Pre-Eclampsia TRial Amsterdam) studies. Participants: Pregnant women with early-onset pre-eclampsia. Sample size: Nine hundred and forty-six women in the model development data set and 850 women (634 in PIERS, 216 in PETRA) in the transportability (external validation) data sets. Predictors: The predictors were identified from systematic reviews of tests to predict complications in pre-eclampsia and were prioritised by Delphi survey. Main outcome measures: The primary outcome was the composite of adverse maternal outcomes established using Delphi surveys. The secondary outcome was the composite of fetal and neonatal complications. Analysis: We developed two prediction models: a logistic regression model (PREP-L) to assess the overall risk of any maternal outcome until postnatal discharge and a survival analysis model (PREP-S) to obtain individual risk estimates at daily intervals from diagnosis until 34 weeks. Shrinkage was used to adjust for overoptimism of predictor effects. For internal validation (of the full models in the development data) and external validation (of the reduced models in the transportability data), we computed the ability of the models to discriminate between those with and without poor outcomes (c-statistic), and the agreement between predicted and observed risk (calibration slope). Results: The PREP-L model included maternal age, gestational age at diagnosis, medical history, systolic blood pressure, urine prot

Published
2017

63. An international survey and modified Delphi process revealed editors' perceptions, training needs, and ratings of competency-related statements for the development of core competencies for scientific editors of biomedical journals

Author

Galipeau, James, Cobey, Kelly, Barbour, Ginny, Baskin, Patricia, Bell-Syer, Sally, Deeks, Jon, Garner, Paul, Shamseer, Larissa, Straus, Sharon, Tugwell, Peter, Winker, Margaret, Moher, David, Galipeau, James, Cobey, Kelly, Barbour, Ginny, Baskin, Patricia, Bell-Syer, Sally, Deeks, Jon, Garner, Paul, Shamseer, Larissa, Straus, Sharon, Tugwell, Peter, Winker, Margaret, and Moher, David

Abstract

Background: Scientific editors (i.e., those who make decisions on the content and policies of a journal) have a central role in the editorial process at biomedical journals. However, very little is known about the training needs of these editors or what competencies are required to perform effectively in this role. Methods: We conducted a survey of perceptions and training needs among scientific editors from major editorial organizations around the world, followed by a modified Delphi process in which we invited the same scientific editors to rate the importance of competency-related statements obtained from a previous scoping review. Results: A total of 148 participants completed the survey of perceptions and training needs. At least 80% of participants agreed on six of the 38 skill and expertise-related statements presented to them as being important or very important to their role as scientific editors. At least 80% agreed on three of the 38 statements as necessary skills they perceived themselves as possessing (well or very well). The top five items on participants’ list of top training needs were training in statistics, research methods, publication ethics, recruiting and dealing with peer reviewers, and indexing of journals. The three rounds of the Delphi were completed by 83, 83, and 73 participants, respectively, which ultimately produced a list of 23 “highly rated” competency-related statements and another 86 “included” items. Conclusion: Both the survey and the modified Delphi process will be critical for understanding knowledge and training gaps among scientific editors when designing curriculum around core competencies in the future.

Published
2017

64. Development and validation of Prediction models for Risks of complications in Early-onset Pre-eclampsia (PREP): a prospective cohort study

Author

Epi Methoden, Child Health, Cancer, Circulatory Health, JC onderzoeksprogramma Methodologie, Thangaratinam, Shakila, Allotey, John, Marlin, Nadine, Mol, Ben W., von Dadelszen, Peter, Ganzevoort, Wessel, Akkermans, Joost, Ahmed, Asif, Daniels, Jane, Deeks, Jon, Ismail, Khaled, Barnard, Ann Marie, Dodds, Julie, Kerry, Sally, Riley, Richard D., Khan, Khalid S, Moons, KGM, Epi Methoden, Child Health, Cancer, Circulatory Health, JC onderzoeksprogramma Methodologie, Thangaratinam, Shakila, Allotey, John, Marlin, Nadine, Mol, Ben W., von Dadelszen, Peter, Ganzevoort, Wessel, Akkermans, Joost, Ahmed, Asif, Daniels, Jane, Deeks, Jon, Ismail, Khaled, Barnard, Ann Marie, Dodds, Julie, Kerry, Sally, Riley, Richard D., Khan, Khalid S, and Moons, KGM

Published
2017

65. Development and validation of prediction models for risk of adverse outcomes in women with early-onset pre-eclampsia: protocol of the prospective cohort PREP study

Author

Allotey, John, primary, Marlin, Nadine, additional, Mol, Ben W., additional, Von Dadelszen, Peter, additional, Ganzevoort, Wessel, additional, Akkermans, Joost, additional, Ahmed, Asif, additional, Daniels, Jane, additional, Deeks, Jon, additional, Ismail, Khaled, additional, Barnard, Ann Marie, additional, Dodds, Julie, additional, Kerry, Sally, additional, Moons, Carl, additional, Khan, Khalid S., additional, Riley, Richard D., additional, and Thangaratinam, Shakila, additional

Published
2017
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66. A scoping review of competencies for scientific editors of biomedical journals

Author

Galipeau, James, Barbour, Ginny, Baskin, Patricia, Bell-Syer, Sally, Cobey, Kelly, Cumpston, Miranda, Deeks, Jon, Garner, Paul, MacLehose, Harriet, Shamseer, Larissa, Straus, Sharon, Tugwell, Peter, Wager, Elizabeth (Liz), Winker, Margaret, Moher, David, Galipeau, James, Barbour, Ginny, Baskin, Patricia, Bell-Syer, Sally, Cobey, Kelly, Cumpston, Miranda, Deeks, Jon, Garner, Paul, MacLehose, Harriet, Shamseer, Larissa, Straus, Sharon, Tugwell, Peter, Wager, Elizabeth (Liz), Winker, Margaret, and Moher, David

Abstract

Background - Biomedical journals are the main route for disseminating the results of health-related research. Despite this, their editors operate largely without formal training or certification. To our knowledge, no body of literature systematically identifying core competencies for scientific editors of biomedical journals exists. Therefore, we aimed to conduct a scoping review to determine what is known on the competency requirements for scientific editors of biomedical journals. Methods - We searched the MEDLINE®, Cochrane Library, Embase®, CINAHL, PsycINFO, and ERIC databases (from inception to November 2014) and conducted a grey literature search for research and non-research articles with competency-related statements (i.e. competencies, knowledge, skills, behaviors, and tasks) pertaining to the role of scientific editors of peer-reviewed health-related journals. We also conducted an environmental scan, searched the results of a previous environmental scan, and searched the websites of existing networks, major biomedical journal publishers, and organizations that offer resources for editors. Results - A total of 225 full-text publications were included, 25 of which were research articles. We extracted a total of 1,566 statements possibly related to core competencies for scientific editors of biomedical journals from these publications. We then collated overlapping or duplicate statements which produced a list of 203 unique statements. Finally, we grouped these statements into seven emergent themes: (1) dealing with authors; (2) dealing with peer reviewers; (3) journal publishing; (4) journal promotion; (5) editing; (6) ethics and integrity, and; (7) qualities and characteristics of editors. Discussion - To our knowledge, this scoping review is the first attempt to systematically identify possible competencies of editors. Limitations are that: (1) we may not have captured all aspects of a biomedical editor’s work in our searches; (2

Published
2016

67. Stratified medicine in European Medicines Agency licensing: a systematic review of predictive biomarkers

Author

Malottki, Kinga, Biswas, Mousumi, Deeks, Jon, Riley, Richard, Craddock, Charles, Johnson, Philip, and Billingham, Lucinda

Abstract

Objectives: Stratified medicine is often heralded as the future of clinical practice. Key part of stratified medicine is the use of predictive biomarkers, which identify patient subgroups most likely to benefit (or least likely to experience harm) from an intervention. We investigated how many and what predictive biomarkers are currently included in European Medicines Agency (EMA) licensing.Setting: EMA licensing. Participants: Indications and contraindications of all drugs considered by the EMA and published in 883 European Public Assessment Reports and Pending Decisions.Primary and secondary outcome measures: Data were collected on: the type of the biomarker, whether it selected a subgroup of patients based on efficacy or toxicity, therapeutic area, marketing status, date of licensing decision, date of inclusion of the biomarker in the indication or contraindication and on orphan designation.Results: 49 biomarker–indication–drug (B-I-D) combinations were identified over 16 years, which included 37 biomarkers and 41 different drugs. All identified biomarkers were molecular. Six drugs (relating to 10 B-I-D combinations) had an orphan designation at the time of licensing. The identified B-ID combinations were mainly used in cancer and HIV treatment, and also in hepatitis C and three other indications (cystic fibrosis, hyperlipoproteinaemia type I and methemoglobinaemia). In 45 B-I-D combinations, biomarkers were used as predictive of drug efficacy and in four of drug toxicity. It appeared that there was an increase in the number of B-I-D combinations introduced each year; however, the numbers were too small to identify any trends.Conclusions: Given the large body of literature documenting research into potential predictive biomarkers and extensive investment into stratified medicine, we identified relatively few predictive biomarkers included in licensing. These were also limited to a small number of clinical areas. This might suggest a need for improvement in methods of translation from laboratory findings to clinical practice.

Published
2014
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68. QUADAS-2: an updated quality assessment tool for diagnostic accuracy studies

Author

Raatz, Heike, Whiting, Penny, Westwood, Marie, Rutjes, Anne W., Mallett, Susan, Leeflang, Mariska, Reitsma, Johannes B., Deeks, Jon, Sterne, Jonathan, and Bossuyt, Patrick

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Background: QUADAS was developed in 2003 to assess the quality of diagnostic test accuracy (DTA) studies included in systematic reviews [ref:1]. Its 14 items assess risk of bias, variability and reporting quality. Personal experience, anecdotal reports, and feedback via Cochrane suggested [for full text, please go to the a.m. URL], EbM & Individualisierte Medizin; 12. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin

Published
2011

69. A scoping review of competencies for scientific editors of biomedical journals

Author

Galipeau, James, primary, Barbour, Virginia, additional, Baskin, Patricia, additional, Bell-Syer, Sally, additional, Cobey, Kelly, additional, Cumpston, Miranda, additional, Deeks, Jon, additional, Garner, Paul, additional, MacLehose, Harriet, additional, Shamseer, Larissa, additional, Straus, Sharon, additional, Tugwell, Peter, additional, Wager, Elizabeth, additional, Winker, Margaret, additional, and Moher, David, additional

Published
2016
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70. 782: Development and validation of a prediction model for the risk of adverse outcomes in women with early onset preeclampsia (PREP): prospective cohort study

Author

Allotey, John, primary, Thangaratinam, Shakila, additional, Marlin, Nadine, additional, Mol, Ben, additional, Von Dadelszen, Peter, additional, Ganzevoort, Wessel, additional, Akkermans, Joost, additional, Ahmed, Asif, additional, Daniels, Jane, additional, Deeks, Jon, additional, Ismail, Khaled, additional, Barnard, Ann Marie, additional, Dodds, Julie, additional, Kerry, Sally, additional, Moons, Carl, additional, Riley, Richard D., additional, and Khan, Khalid S., additional

Published
2016
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71. Defining the major health modifiers causing atrial fibrillation: a roadmap to underpin personalized prevention and treatment

Author

Fabritz, Larissa, primary, Guasch, Eduard, additional, Antoniades, Charalambos, additional, Bardinet, Isabel, additional, Benninger, Gerlinde, additional, Betts, Tim R., additional, Brand, Eva, additional, Breithardt, Günter, additional, Bucklar-Suchankova, Gabriela, additional, Camm, A. John, additional, Cartlidge, David, additional, Casadei, Barbara, additional, Chua, Winnie W. L., additional, Crijns, Harry J. G. M., additional, Deeks, Jon, additional, Hatem, Stéphane, additional, Hidden-Lucet, Françoise, additional, Kääb, Stefan, additional, Maniadakis, Nikos, additional, Martin, Stephan, additional, Mont, Lluis, additional, Reinecke, Holger, additional, Sinner, Moritz F., additional, Schotten, Ulrich, additional, Southwood, Taunton, additional, Stoll, Monika, additional, Vardas, Panos, additional, Wakili, Reza, additional, West, Andy, additional, Ziegler, André, additional, and Kirchhof, Paulus, additional

Published
2015
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74. Further advances in diagnosis of adrenal cancer: a high-throughput urinary steroid profiling method using liquid chromatography tandem mass spectrometry (LC-MS/MS)

Author

Taylor, Angela, primary, Bancos, Irina, additional, Chortis, Vasileios, additional, Lang, Katharina, additional, O'Neil, Donna, additional, Hughes, Beverly, additional, Jenkinson, Carl, additional, Deeks, Jon, additional, Shackleton, Cedric, additional, Biehl, Michael, additional, and Arlt, Wiebke, additional

Published
2015
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76. The eGFR-C study: accuracy of glomerular filtration rate (GFR) estimation using creatinine and cystatin C and albuminuria for monitoring disease progression in patients with stage 3 chronic kidney disease - prospective longitudinal study in a multiethnic population

Author

Lamb, Edmund J, primary, Brettell, Elizabeth A, additional, Cockwell, Paul, additional, Dalton, Neil, additional, Deeks, Jon J, additional, Harris, Kevin, additional, Higgins, Tracy, additional, Kalra, Philip A, additional, Khunti, Kamlesh, additional, Loud, Fiona, additional, Ottridge, Ryan S, additional, Sharpe, Claire C, additional, Sitch, Alice J, additional, Stevens, Paul E, additional, Sutton, Andrew J, additional, and Taal, Maarten W, additional

Published
2014
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81. Bypass versus angio plasty in severe ischaemia of the leg - 2 (BASIL-2) trial: study protocol for a randomised controlled trial.

Author

Popplewell, Matthew A., Davies, Huw, Jarrett, Hugh, Bate, Gareth, Grant, Margaret, Patel, Smitaa, Mehta, Samir, Andronis, Lazaros, Roberts, Tracy, Deeks, Jon, Bradbury, Andrew, and BASIL-2 Trial Investigators

Subjects
ISCHEMIA treatment, CORONARY artery bypass, ANGIOPLASTY, HEALTH outcome assessment, DISEASES of the anatomical extremities, COMPARATIVE studies, LEG, RESEARCH methodology, MEDICAL cooperation, RESEARCH protocols, RESEARCH, SAMPLE size (Statistics), EVALUATION research, RANDOMIZED controlled trials
Abstract

Background: Severe limb ischaemia is defined by ischaemic rest/night pain, tissue loss, or both, secondary to arterial insufficiency and is increasingly caused by infra-popliteal (below the knee) disease, mainly as a result of the increasing worldwide prevalence of diabetes. Currently, it is unknown whether vein bypass surgery or the best endovascular treatment (angioplasty or stenting) represents the optimal revascularisation strategy in terms of amputation-free survival, overall survival, relief of symptoms, quality of life and cost-effective use of health care resources.Methods/design: The Bypass vs. Angioplasty in Severe Ischaemia of the Leg - 2 Trial is a UK National Institute of Health Research, Health Technology Assessment funded, multi-centre randomised controlled trial that compares, at the point of clinical equipoise, the clinical and cost-effectiveness of a 'vein bypass first' and a 'best endovascular treatment first' revascularisation strategy for severe limb ischaemia due to infra-popliteal disease. The primary clinical outcome is amputation-free survival defined as the time to major (above the ankle) amputation of the trial limb or death from any cause. The primary outcome for the cost-effectiveness analysis is cost per quality-adjusted life year. Secondary outcomes include overall survival, quality of life, in-hospital mortality and morbidity, repeat and crossover interventions, healing of tissue loss and haemodynamic changes following revascularisation. Sample size is estimated at 600 patients. An economic evaluation will be conducted from the perspective of the National Health Service and comprise a 'within-study' analysis, based on prospectively collected trial data and a 'model-based' analysis, which will extrapolate and compare costs and effects beyond the study follow-up period.Discussion: The BASIL-2 trial is designed to be pragmatic and represent current practice within the United Kingdom. Patients with severe limb ischaemia can only be randomised into the trial where clinical equipose exists. The advent of hybrid operating procedures should not be a barrier to randomisation, should a patient require inflow correction prior to tibial revascularisation.Trial Registration: Isrctn: 27728689 Date of registration: 12 May 2014. [ABSTRACT FROM AUTHOR]

Published
2016
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85. Methods Used in Economic Evaluations of Chronic Kidney Disease Testing — A Systematic Review.

Author

Sutton, Andrew J., Breheny, Katie, Deeks, Jon, Khunti, Kamlesh, Sharpe, Claire, Ottridge, Ryan S., Stevens, Paul E., Cockwell, Paul, Kalra, Philp A., Lamb, Edmund J., and null, null

Subjects
KIDNEY disease diagnosis, MEDICAL economics, DISEASE prevalence, MEDICAL screening, SYSTEMATIC reviews, KIDNEY diseases, PATIENTS
Abstract

Background: The prevalence of chronic kidney disease (CKD) is high in general populations around the world. Targeted testing and screening for CKD are often conducted to help identify individuals that may benefit from treatment to ameliorate or prevent their disease progression. Aims: This systematic review examines the methods used in economic evaluations of testing and screening in CKD, with a particular focus on whether test accuracy has been considered, and how analysis has incorporated issues that may be important to the patient, such as the impact of testing on quality of life and the costs they incur. Methods: Articles that described model-based economic evaluations of patient testing interventions focused on CKD were identified through the searching of electronic databases and the hand searching of the bibliographies of the included studies. Results: The initial electronic searches identified 2,671 papers of which 21 were included in the final review. Eighteen studies focused on proteinuria, three evaluated glomerular filtration rate testing and one included both tests. The full impact of inaccurate test results was frequently not considered in economic evaluations in this setting as a societal perspective was rarely adopted. The impact of false positive tests on patients in terms of the costs incurred in re-attending for repeat testing, and the anxiety associated with a positive test was almost always overlooked. In one study where the impact of a false positive test on patient quality of life was examined in sensitivity analysis, it had a significant impact on the conclusions drawn from the model. Conclusion: Future economic evaluations of kidney function testing should examine testing and monitoring pathways from the perspective of patients, to ensure that issues that are important to patients, such as the possibility of inaccurate test results, are properly considered in the analysis. [ABSTRACT FROM AUTHOR]

Published
2015
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88. Defining the major health modifiers causing atrial fibrillation: a roadmap to underpin personalized prevention and treatment

Author

Fabritz, Larissa, Guasch, Eduard, Antoniades, Charalambos, Bardinet, Isabel, Benninger, Gerlinde, Betts, Tim R., Brand, Eva, Breithardt, Günter, Bucklar-Suchankova, Gabriela, Camm, A. John, Cartlidge, David, Casadei, Barbara, Chua, Winnie W. L., Crijns, Harry J. G. M., Deeks, Jon, Hatem, Stéphane, Hidden-Lucet, Françoise, Kääb, Stefan, Maniadakis, Nikos, Martin, Stephan, Mont, Lluis, Reinecke, Holger, Sinner, Moritz F., Schotten, Ulrich, Southwood, Taunton, Stoll, Monika, Vardas, Panos, Wakili, Reza, West, Andy, Ziegler, André, and Kirchhof, Paulus

Abstract

To bridge the current gap between the known mechanisms of atrial fibrillation (AF) and the clinical management of patients with this arrhythmia, Fabritz and colleagues propose a roadmap to develop a set of clinical markers that reflect the major causes of AF in patients. A new, mechanism-based classification of AF can provide the basis for personalized prevention and management.

Published
2016
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92. An update of the Cochrane systematic review ofHelicobacter pylorieradication therapy in nonulcer dyspepsia: resolving the discrepancy between systematic reviews.

Author

Moayyedi, Paul, Deeks, Jon, Tailey, Nicholas J., Delaney, Brendan, and Forman, David

Subjects
*HELICOBACTER pylori, *INDIGESTION, *CLINICAL trials, *SYSTEMATIC reviews, *METHODOLOGY, *THERAPEUTICS
Abstract

OBJECTIVES: A Cochrane systematic review on the efficacy of Helicobacter pylon (H. pylon) eradication therapy in nonulcer dyspepsia concluded that this intervention had a small but statistically significant effect in curing symptoms. A systematic review in the Annals of Internal Medicine suggested that there was no statistically significant effect of H. pylon eradication therapy on nonulcer dyspepsia symptoms. We updated the Cochrane review and explored reasons for these discrepant results. METHODS: In our update of the Cochrane review we included randomized controlled trials evaluating H. pylon eradication in nonulcer dyspepsia published up to September, 2002. A statistician and the lead author of two negative randomized controlled trials explored reasons for the differences between the Cochrane and Annals systematic reviews according to the review methodology, data analyzed, and statistical methods. Sensitivity analyses were undertaken to evaluate which differences had an impact on the review conclusions. RESULTS: The updated review identified 12 trials evaluating H. pylon eradication versus placebo antibiotics in 2903 patients. H. pylon eradication reduced nonulcer dyspepsia (nonulcer dyspepsia relative risk = 0.91; 95% CI = 0.86-0.95). We identified five differences in methodology between the Cochrane and Annals reviews. The Annals review included all dual, triple, and quadruple H. pylon eradication therapies searched until December, 1999; did not contact authors for further information; included abstracts; and assumed that dropouts were treatment failures. The Cochrane review included only those therapies proved to be successful in eradicating H. pylon; searched until May, 2000; contacted authors for further information; included abstracts only if further information was available; and excluded dropouts from the analysis. Not including trials published in 2000 reduced the number of trials in the review and the number of patients evaluated, changing the conclusions from evidence of benefit to benefit not being proved. The method of statistical analysis did not alter conclusions when all studies were included. CONCLUSIONS: The results of systematic reviews in a rapidly developing field depend on inclusion of all relevant studies. There is evidence for a small benefit of eradicating H. pylon in nonulcer dyspepsia, and this is confirmed by updating the Cochrane systematic review. [ABSTRACT FROM AUTHOR]

Published
2003
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93. Refining Ovarian Cancer Test accuracy Scores: A multicentre, prospective cohort study investigating diagnostic accuracy among women with symptoms of suspected ovarian cancer (the ROCkeTS study): Results for post-menopausal women.

Author

Sundar, Sudha, Agarwal, Ridhi, Deeks, Jon, Mallett, Sue, Scandrett, Katie, Davenport, Clare, Rick, Caroline, Kehoe, Sean, Timmerman, Dirk, Bourne, Tom, Stobart, Hilary, Neal, Richard, Menon, Usha, Gentry-Maharaj, Aleksandra, Sturdy, Lauren, and Ottridge, Ryan

Subjects
*OVARIAN cancer, *POSTMENOPAUSE, *COHORT analysis, *LONGITUDINAL method, *TEST scoring
Published
2024
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95. The eGFR-C study: accuracy of glomerular filtration rate (GFR) estimation using creatinine and cystatin C and albuminuria for monitoring disease progression in patients with stage 3 chronic kidney disease - prospective longitudinal study in a multiethnic population

Author

Lamb, Edmund J., Brettell, Elizabeth A., Cockwell, Paul, Dalton, Neil, Deeks, Jon J., Harris, Kevin, Higgins, Tracy, Kalra, Philip A., Khunti, Kamlesh, Loud, Fiona, Ottridge, Ryan S., Sharpe, Claire C., Sitch, Alice J., Stevens, Paul E., Sutton, Andrew J., and Taal, Maarten W.

Subjects
Adult, Male, Adolescent, Iohexol, Comorbidity, urologic and male genital diseases, Sensitivity and Specificity, HT, Study Protocol, Young Adult, Age Distribution, RA0421, Albuminuria, Humans, Longitudinal Studies, Prospective Studies, Cystatin C, Renal Insufficiency, Chronic, Sex Distribution, reproductive and urinary physiology, Aged, urogenital system, Reproducibility of Results, Kidney disease, Middle Aged, United Kingdom, female genital diseases and pregnancy complications, Causality, Research Design, Nephrology, Creatinine, Disease Progression, Female, Glomerular filtration rate, Biological variation
Abstract

Background: Uncertainty exists regarding the optimal method to estimate glomerular filtration rate (GFR) for disease detection and monitoring. Widely used GFR estimates have not been validated in British ethnic minority populations. Methods/design. Iohexol measured GFR will be the reference against which each estimating equation will be compared. The estimating equations will be based upon serum creatinine and/or cystatin C. The eGFR-C study has 5 components:.1) A prospective longitudinal cohort study of 1300 adults with stage 3 chronic kidney disease followed for 3 years with reference (measured) GFR and test (estimated GFR [eGFR] and urinary albumin-to-creatinine ratio) measurements at baseline and 3 years. Test measurements will also be undertaken every 6 months. The study population will include a representative sample of South-Asians and African-Caribbeans. People with diabetes and proteinuria (ACR ≥30 mg/mmol) will comprise 20-30% of the study cohort.2) A sub-study of patterns of disease progression of 375 people (125 each of Caucasian, Asian and African-Caribbean origin; in each case containing subjects at high and low risk of renal progression). Additional reference GFR measurements will be undertaken after 1 and 2 years to enable a model of disease progression and error to be built.3) A biological variability study to establish reference change values for reference and test measures.4) A modelling study of the performance of monitoring strategies on detecting progression, utilising estimates of accuracy, patterns of disease progression and estimates of measurement error from studies 1), 2) and 3).5) A comprehensive cost database for each diagnostic approach will be developed to enable cost-effectiveness modelling of the optimal strategy.The performance of the estimating equations will be evaluated by assessing bias, precision and accuracy. Data will be modelled as a linear function of time utilising all available (maximum 7) time points compared with the difference between baseline and final reference values. The percentage of participants demonstrating large error with the respective estimating equations will be compared. Predictive value of GFR estimates and albumin-to-creatinine ratio will be compared amongst subjects that do or do not show progressive kidney function decline. Discussion. The eGFR-C study will provide evidence to inform the optimal GFR estimate to be used in clinical practice. Trial registration. ISRCTN42955626.

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96. PET-PANC: multicentre prospective diagnostic accuracy and health economic analysis study of the impact of combined modality 18fluorine-2-fluoro-2-deoxy-d-glucose positron emission tomography with computed tomography scanning in the diagnosis and management of pancreatic cancer

Author

Ghaneh, Paula, Hanson, Robert, Titman, Andrew, Lancaster, Gill, Plumpton, Catrin, Lloyd-Williams, Huw, Tien Yeo, Seow, Edwards, Rhiannon T., Johnson, Colin, Hilal, Mohammed Abul., Higginson, Antony P., Armstrong, Tom, Smith, Andrew, Scarsbrook, Andrew, McKay, Colin, Carter, Ross, Sutcliffe, Robert P., Bramhall, Simon, Kocher, Hemant M., Cunningham, David, Pereira, Stephen P., Davidson, Brian, Chang, David, Khan, Saboor, Zealley, Ian, Sarker, Debashis, Al Sarireh, Bilal, Charnley, Richard, Lobo, Dileep N., Nicolson, Marianne, Halloran, Christopher, Raraty, Michael, Sutton, Robert, Vinjamuri, Sobhan, Evans, Jonathan, Campbell, Fiona, Deeks, Jon, Sanghera, Bal, Wong, Wai-Lup, Neoptolemos, John P., Ghaneh, Paula, Hanson, Robert, Titman, Andrew, Lancaster, Gill, Plumpton, Catrin, Lloyd-Williams, Huw, Tien Yeo, Seow, Edwards, Rhiannon T., Johnson, Colin, Hilal, Mohammed Abul., Higginson, Antony P., Armstrong, Tom, Smith, Andrew, Scarsbrook, Andrew, McKay, Colin, Carter, Ross, Sutcliffe, Robert P., Bramhall, Simon, Kocher, Hemant M., Cunningham, David, Pereira, Stephen P., Davidson, Brian, Chang, David, Khan, Saboor, Zealley, Ian, Sarker, Debashis, Al Sarireh, Bilal, Charnley, Richard, Lobo, Dileep N., Nicolson, Marianne, Halloran, Christopher, Raraty, Michael, Sutton, Robert, Vinjamuri, Sobhan, Evans, Jonathan, Campbell, Fiona, Deeks, Jon, Sanghera, Bal, Wong, Wai-Lup, and Neoptolemos, John P.

Abstract

Background: Pancreatic cancer diagnosis and staging can be difficult in 10–20% of patients. Positron emission tomography (PET)/computed tomography (CT) adds precise anatomical localisation to functional data. The use of PET/CT may add further value to the diagnosis and staging of pancreatic cancer. Objective: To determine the incremental diagnostic accuracy and impact of PET/CT in addition to standard diagnostic work-up in patients with suspected pancreatic cancer. Design: A multicentre prospective diagnostic accuracy and clinical value study of PET/CT in suspected pancreatic malignancy. Participants: Patients with suspected pancreatic malignancy. Interventions: All patients to undergo PET/CT following standard diagnostic work-up. Main outcome measures: The primary outcome was the incremental diagnostic value of PET/CT in addition to standard diagnostic work-up with multidetector computed tomography (MDCT). Secondary outcomes were (1) changes in patients’ diagnosis, staging and management as a result of PET/CT; (2) changes in the costs and effectiveness of patient management as a result of PET/CT; (3) the incremental diagnostic value of PET/CT in chronic pancreatitis; (4) the identification of groups of patients who would benefit most from PET/CT; and (5) the incremental diagnostic value of PET/CT in other pancreatic tumours. Results: Between 2011 and 2013, 589 patients with suspected pancreatic cancer underwent MDCT and PET/CT, with 550 patients having complete data and in-range PET/CT. Sensitivity and specificity for the diagnosis of pancreatic cancer were 88.5% and 70.6%, respectively, for MDCT and 92.7% and 75.8%, respectively, for PET/CT. The maximum standardised uptake value (SUVmax.) for a pancreatic cancer diagnosis was 7.5. PET/CT demonstrated a significant improvement in relative sensitivity (p = 0.01) and specificity (p = 0.023) compared with MDCT. Incremental likelihood ratios demonstrated that PET/CT significantly improved diagnostic accuracy in all sce

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98. Developing a Diagnostic Multivariable Prediction Model for Urinary Tract Cancer in Patients Referred with Haematuria: Results from the IDENTIFY Collaborative Study

Author

Sinan Khadhouri, Kevin M. Gallagher, Kenneth R. MacKenzie, Taimur T. Shah, Chuanyu Gao, Sacha Moore, Eleanor F. Zimmermann, Eric Edison, Matthew Jefferies, Arjun Nambiar, Thineskrishna Anbarasan, Miles P. Mannas, Taeweon Lee, Giancarlo Marra, Juan Gómez Rivas, Gautier Marcq, Mark A. Assmus, Taha Uçar, Francesco Claps, Matteo Boltri, Giuseppe La Montagna, Tara Burnhope, Nkwam Nkwam, Tomas Austin, Nicholas E. Boxall, Alison P. Downey, Troy A. Sukhu, Marta Antón-Juanilla, Sonpreet Rai, Yew-Fung Chin, Madeline Moore, Tamsin Drake, James S.A. Green, Beatriz Goulao, Graeme MacLennan, Matthew Nielsen, John S. McGrath, Veeru Kasivisvanathan, Aasem Chaudry, Abhishek Sharma, Adam Bennett, Adnan Ahmad, Ahmed Abroaf, Ahmed Musa Suliman, Aimee Lloyd, Alastair McKay, Albert Wong, Alberto Silva, Alexandre Schneider, Alison MacKay, Allen Knight, Alkiviadis Grigorakis, Amar Bdesha, Amy Nagle, Ana Cebola, Ananda Kumar Dhanasekaran, Andraž Kondža, André Barcelos, Andrea Benedetto Galosi, Andrea Ebur, Andrea Minervini, Andrew Russell, Andrew Webb, Ángel García de Jalón, Ankit Desai, Anna Katarzyna Czech, Anna Mainwaring, Anthony Adimonye, Arighno Das, Arnaldo Figueiredo, Arnauld Villers, Artur Leminski, Arvinda Chippagiri, Asim Ahmed Lal, Asıf Yıldırım, Athanasios Marios Voulgaris, Audrey Uzan, Aye Moh Moh Oo, Ayman Younis, Bachar Zelhof, Bashir Mukhtar, Ben Ayres, Ben Challacombe, Benedict Sherwood, Benjamin Ristau, Billy Lai, Brechtje Nellensteijn, Brielle Schreiter, Carlo Trombetta, Catherine Dowling, Catherine Hobbs, Cayo Augusto Estigarribia Benitez, Cédric Lebacle, Cherrie Wing Yin Ho, Chi-Fai Ng, Chloe Mount, Chon Meng Lam, Chris Blick, Christian Brown, Christopher Gallegos, Claire Higgs, Clíodhna Browne, Conor McCann, Cristina Plaza Alonso, Daniel Beder, Daniel Cohen, Daniel Gordon, Daniel Wilby, Danny Gordon, David Hrouda, David Hua Wu Lau, Dávid Karsza, David Mak, David Martin-Way, Denula Suthaharan, Dhruv Patel, Diego M Carrion, Donald Nyanhongo, Edward Bass, Edward Mains, Edwin Chau, Elba Canelon Castillo, Elizabeth Day, Elsayed Desouky, Emily Gaines, Emma Papworth, Emrah Yuruk, Enes Kilic, Eoin Dinneen, Erika Palagonia, Evanguelos Xylinas, Faizan Khawaja, Fernando Cimarra, Florian Bardet, Francesca Kum, Francesca Peters, Gábor Kovács, Geroge Tanasescu, Giles Hellawell, Giovanni Tasso, Gitte Lam, Giuseppe Pizzuto, Gordan Lenart, Günal Özgür, Hai Bi, Hannah Lyons, Hannah Warren, Hashim Ahmed, Helen Simpson, Helena Burden, Helena Gresty, Hernado Rios Pita, Holly Clarke, Hosam Serag, Howard Kynaston, Hugh Crawford-Smith, Hugh Mostafid, Hugo Otaola-Arca, Hui Fen Koo, Ibrahim Ibrahim, Idir Ouzaid, Ignacio Puche-Sanz, Igor Tomašković, Ilker Tinay, Iqbal Sahibzada, Isaac Thangasamy, Iván Revelo Cadena, Jacques Irani, Jakub Udzik, James Brittain, James Catto, James Green, James Tweedle, Jamie Borrego Hernando, Jamie Leask, Jas Kalsi, Jason Frankel, Jason Toniolo, Jay D. Raman, Jean Courcier, Jeevan Kumaradeevan, Jennifer Clark, Jennifer Jones, Jeremy Yuen-Chun Teoh, John Iacovou, John Kelly, John P. Selph, Jonathan Aning, Jon Deeks, Jonathan Cobley, Jonathan Olivier, Jonny Maw, José Antonio Herranz-Yagüe, Jose Ignacio Nolazco, Jose Manuel Cózar-Olmo, Joseph Bagley, Joseph Jelski, Joseph Norris, Joseph Testa, Joshua Meeks, Juan Hernandez, Juan Luis Vásquez, Karen Randhawa, Karishma Dhera, Katarzyna Gronostaj, Kathleen Houlton, Kathleen Lehman, Kathryn Gillams, Kelvin Adasonla, Kevin Brown, Kevin Murtagh, Kiki Mistry, Kim Davenport, Kosuke Kitamura, Laura Derbyshire, Laurence Clarke, Lawrie Morton, Levin Martinez, Louise Goldsmith, Louise Paramore, Luc Cormier, Lucio Dell'Atti, Lucy Simmons, Luis Martinez-Piñeiro, Luis Rico, Luke Chan, Luke Forster, Lulin Ma, Maria Camacho Gallego, Maria José Freire, Mark Emberton, Mark Feneley, Marta Viridiana Muñoz Rivero, Matea Pirša, Matteo Tallè, Matthew Crockett, Matthew Liew, Matthew Trail, Max Peters, Meghan Cooper, Meghana Kulkarni, Michael Ager, Ming He, Mo Li, Mohamed Omran Breish, Mohamed Tarin, Mohammed Aldiwani, Mudit Matanhelia, Muhammad Pasha, Mustafa Kaan Akalın, Nasreen Abdullah, Nathan Hale, Neha Gadiyar, Neil Kocher, Nicholas Bullock, Nicholas Campain, Nicola Pavan, Nihad Al-Ibraheem, Nikita Bhatt, Nishant Bedi, Nitin Shrotri, Niyati Lobo, Olga Balderas, Omar Kouli, Otakar Capoun, Pablo Oteo Manjavacas, Paolo Gontero, Paramananthan Mariappan, Patricio Garcia Marchiñena, Paul Erotocritou, Paul Sweeney, Paula Planelles, Peter Acher, Peter C. Black, Peter K Osei-Bonsu, Peter Østergren, Peter Smith, Peter-Paul Michiel Willemse, Piotr L. Chlosta, Qurrat Ul Ain, Rachel Barratt, Rachel Esler, Raihan Khalid, Ray Hsu, Remigiusz Stamirowski, Reshma Mangat, Ricardo Cruz, Ricky Ellis, Robert Adams, Robert Hessell, Robert J.A. Oomen, Robert McConkey, Robert Ritchie, Roberto Jarimba, Rohit Chahal, Rosado Mario Andres, Rosalyn Hawkins, Rotimi David, Rustom P. Manecksha, Sachin Agrawal, Syed Sami Hamid, Samuel Deem, Sanchia Goonewardene, Satchi Kuchibhotla Swami, Satoshi Hori, Shahid Khan, Shakeel Mohammud Inder, Shanthi Sangaralingam, Shekhar Marathe, Sheliyan Raveenthiran, Shigeo Horie, Shomik Sengupta, Sian Parson, Sidney Parker, Simon Hawlina, Simon Williams, Simone Mazzoli, Slawomir Grzegorz Kata, Sofia Pinheiro Lopes, Sónia Ramos, Sophie Rintoul-Hoad, Sorcha O'Meara, Steve Morris, Stacey Turner, Stefano Venturini, Stephanos Almpanis, Steven Joniau, Sunjay Jain, Susan Mallett, Sven Nikles, null Shahzad, Sylvia Yan, Tarq Toma, Teresa Cabañuz Plo, Thierry Bonnin, Tim Muilwijk, Tim Wollin, Timothy Shun Man Chu, Timson Appanna, Tom Brophy, Tom Ellul, Tomaž Smrkolj, Tracey Rowe, Troy Sukhu, Trushar Patel, Tullika Garg, Turhan Çaşkurlu, Uros Bele, Usman Haroon, Víctor Crespo-Atín, Victor Parejo Cortes, Victoria Capapé Poves, Vincent Gnanapragasam, Vineet Gauhar, Vinnie During, Vivek Kumar, Vojtech Fiala, Wasim Mahmalji, Wayne Lam, Yew Fung Chin, Yigit Filtekin, Yih Chyn Phan, Youssed Ibrahim, Zachary A Glaser, Zainal Adwin Abiddin, Zijian Qin, Zsuzsanna Zotter, Zulkifli Zainuddin, Khadhouri, Sinan, Gallagher, Kevin M., Mackenzie, Kenneth R., Shah, Taimur T., Gao, Chuanyu, Moore, Sacha, Zimmermann, Eleanor F., Edison, Eric, Jefferies, Matthew, Nambiar, Arjun, Anbarasan, Thineskrishna, Mannas, Miles P., Lee, Taeweon, Marra, Giancarlo, Gómez Rivas, Juan, Marcq, Gautier, Assmus, Mark A., Uçar, Taha, Claps, Francesco, Boltri, Matteo, La Montagna, Giuseppe, Burnhope, Tara, Nkwam, Nkwam, Austin, Toma, Boxall, Nicholas E., Downey, Alison P., Sukhu, Troy A., Antón-Juanilla, Marta, Rai, Sonpreet, Chin, Yew-Fung, Moore, Madeline, Drake, Tamsin, Green, James S. A., Goulao, Beatriz, Maclennan, Graeme, Nielsen, Matthew, Mcgrath, John S., Kasivisvanathan, Veeru, Chaudry, Aasem, Sharma, Abhishek, Bennett, Adam, Ahmad, Adnan, Abroaf, Ahmed, Suliman, Ahmed Musa, Lloyd, Aimee, Mckay, Alastair, Wong, Albert, Silva, Alberto, Schneider, Alexandre, Mackay, Alison, Knight, Allen, Grigorakis, Alkiviadi, Bdesha, Amar, Nagle, Amy, Cebola, Ana, Dhanasekaran, Ananda Kumar, Kondža, Andraž, Barcelos, André, Galosi, Andrea Benedetto, Ebur, Andrea, Minervini, Andrea, Russell, Andrew, Webb, Andrew, de Jalón, Ángel García, Desai, Ankit, Czech, Anna Katarzyna, Mainwaring, Anna, Adimonye, Anthony, Das, Arighno, Figueiredo, Arnaldo, Villers, Arnauld, Leminski, Artur, Chippagiri, Arvinda, Lal, Asim Ahmed, Yıldırım, Asıf, Voulgaris, Athanasios Mario, Uzan, Audrey, Oo, Aye Moh Moh, Younis, Ayman, Zelhof, Bachar, Mukhtar, Bashir, Ayres, Ben, Challacombe, Ben, Sherwood, Benedict, Ristau, Benjamin, Lai, Billy, Nellensteijn, Brechtje, Schreiter, Brielle, Trombetta, Carlo, Dowling, Catherine, Hobbs, Catherine, Benitez, Cayo Augusto Estigarribia, Lebacle, Cédric, Ho, Cherrie Wing Yin, Ng, Chi-Fai, Mount, Chloe, Lam, Chon Meng, Blick, Chri, Brown, Christian, Gallegos, Christopher, Higgs, Claire, Browne, Clíodhna, Mccann, Conor, Plaza Alonso, Cristina, Beder, Daniel, Cohen, Daniel, Gordon, Daniel, Wilby, Daniel, Gordon, Danny, Hrouda, David, Lau, David Hua Wu, Karsza, Dávid, Mak, David, Martin-Way, David, Suthaharan, Denula, Patel, Dhruv, Carrion, Diego M, Nyanhongo, Donald, Bass, Edward, Mains, Edward, Chau, Edwin, Canelon Castillo, Elba, Day, Elizabeth, Desouky, Elsayed, Gaines, Emily, Papworth, Emma, Yuruk, Emrah, Kilic, Ene, Dinneen, Eoin, Palagonia, Erika, Xylinas, Evanguelo, Khawaja, Faizan, Cimarra, Fernando, Bardet, Florian, Kum, Francesca, Peters, Francesca, Kovács, Gábor, Tanasescu, Geroge, Hellawell, Gile, Tasso, Giovanni, Lam, Gitte, Pizzuto, Giuseppe, Lenart, Gordan, Özgür, Günal, Bi, Hai, Lyons, Hannah, Warren, Hannah, Ahmed, Hashim, Simpson, Helen, Burden, Helena, Gresty, Helena, Rios Pita, Hernado, Clarke, Holly, Serag, Hosam, Kynaston, Howard, Crawford-Smith, Hugh, Mostafid, Hugh, Otaola-Arca, Hugo, Koo, Hui Fen, Ibrahim, Ibrahim, Ouzaid, Idir, Puche-Sanz, Ignacio, Tomašković, Igor, Tinay, Ilker, Sahibzada, Iqbal, Thangasamy, Isaac, Cadena, Iván Revelo, Irani, Jacque, Udzik, Jakub, Brittain, Jame, Catto, Jame, Green, Jame, Tweedle, Jame, Hernando, Jamie Borrego, Leask, Jamie, Kalsi, Ja, Frankel, Jason, Toniolo, Jason, Raman, Jay D., Courcier, Jean, Kumaradeevan, Jeevan, Clark, Jennifer, Jones, Jennifer, Teoh, Jeremy Yuen-Chun, Iacovou, John, Kelly, John, Selph, John P., Aning, Jonathan, Deeks, Jon, Cobley, Jonathan, Olivier, Jonathan, Maw, Jonny, Herranz-Yagüe, José Antonio, Nolazco, Jose Ignacio, Cózar-Olmo, Jose Manuel, Bagley, Joseph, Jelski, Joseph, Norris, Joseph, Testa, Joseph, Meeks, Joshua, Hernandez, Juan, Vásquez, Juan Lui, Randhawa, Karen, Dhera, Karishma, Gronostaj, Katarzyna, Houlton, Kathleen, Lehman, Kathleen, Gillams, Kathryn, Adasonla, Kelvin, Brown, Kevin, Murtagh, Kevin, Mistry, Kiki, Davenport, Kim, Kitamura, Kosuke, Derbyshire, Laura, Clarke, Laurence, Morton, Lawrie, Martinez, Levin, Goldsmith, Louise, Paramore, Louise, Cormier, Luc, Dell'Atti, Lucio, Simmons, Lucy, Martinez-Piñeiro, Lui, Rico, Lui, Chan, Luke, Forster, Luke, Ma, Lulin, Gallego, Maria Camacho, Freire, Maria José, Emberton, Mark, Feneley, Mark, Rivero, Marta Viridiana Muñoz, Pirša, Matea, Tallè, Matteo, Crockett, Matthew, Liew, Matthew, Trail, Matthew, Peters, Max, Cooper, Meghan, Kulkarni, Meghana, Ager, Michael, He, Ming, Li, Mo, Omran Breish, Mohamed, Tarin, Mohamed, Aldiwani, Mohammed, Matanhelia, Mudit, Pasha, Muhammad, Akalın, Mustafa Kaan, Abdullah, Nasreen, Hale, Nathan, Gadiyar, Neha, Kocher, Neil, Bullock, Nichola, Campain, Nichola, Pavan, Nicola, Al-Ibraheem, Nihad, Bhatt, Nikita, Bedi, Nishant, Shrotri, Nitin, Lobo, Niyati, Balderas, Olga, Kouli, Omar, Capoun, Otakar, Oteo Manjavacas, Pablo, Gontero, Paolo, Mariappan, Paramananthan, Marchiñena, Patricio Garcia, Erotocritou, Paul, Sweeney, Paul, Planelles, Paula, Acher, Peter, Black, Peter C., Osei-Bonsu, Peter K, Østergren, Peter, Smith, Peter, Willemse, Peter-Paul Michiel, Chlosta, Piotr L., Ul Ain, Qurrat, Barratt, Rachel, Esler, Rachel, Khalid, Raihan, Hsu, Ray, Stamirowski, Remigiusz, Mangat, Reshma, Cruz, Ricardo, Ellis, Ricky, Adams, Robert, Hessell, Robert, Oomen, Robert J. A., Mcconkey, Robert, Ritchie, Robert, Jarimba, Roberto, Chahal, Rohit, Andres, Rosado Mario, Hawkins, Rosalyn, David, Rotimi, Manecksha, Rustom P., Agrawal, Sachin, Hamid, Syed Sami, Deem, Samuel, Goonewardene, Sanchia, Swami, Satchi Kuchibhotla, Hori, Satoshi, Khan, Shahid, Mohammud Inder, Shakeel, Sangaralingam, Shanthi, Marathe, Shekhar, Raveenthiran, Sheliyan, Horie, Shigeo, Sengupta, Shomik, Parson, Sian, Parker, Sidney, Hawlina, Simon, Williams, Simon, Mazzoli, Simone, Grzegorz Kata, Slawomir, Pinheiro Lopes, Sofia, Ramos, Sónia, Rintoul-Hoad, Sophie, O'Meara, Sorcha, Morris, Steve, Turner, Stacey, Venturini, Stefano, Almpanis, Stephano, Joniau, Steven, Jain, Sunjay, Mallett, Susan, Nikles, Sven, Shahzad, Null, Yan, Sylvia, Toma, Tarq, Cabañuz Plo, Teresa, Bonnin, Thierry, Muilwijk, Tim, Wollin, Tim, Chu, Timothy Shun Man, Appanna, Timson, Brophy, Tom, Ellul, Tom, Smrkolj, Tomaž, Rowe, Tracey, Sukhu, Troy, Patel, Trushar, Garg, Tullika, Çaşkurlu, Turhan, Bele, Uro, Haroon, Usman, Crespo-Atín, Víctor, Parejo Cortes, Victor, Capapé Poves, Victoria, Gnanapragasam, Vincent, Gauhar, Vineet, During, Vinnie, Kumar, Vivek, Fiala, Vojtech, Mahmalji, Wasim, Lam, Wayne, Fung Chin, Yew, Filtekin, Yigit, Chyn Phan, Yih, Ibrahim, Youssed, Glaser, Zachary A, Abiddin, Zainal Adwin, Qin, Zijian, Zotter, Zsuzsanna, and Zainuddin, Zulkifli

Subjects
Renal cancer, Prostate cancer, Risk factors, Urology, Bladder cancer, Urothelial cancer, Risk factor, Urinary tract cancer, Haematuria, Risk Calculator
Abstract

Background: Patient factors associated with urinary tract cancer can be used to risk stratify patients referred with haematuria, prioritising those with a higher risk of cancer for prompt investigation. Objective: To develop a prediction model for urinary tract cancer in patients referred with haematuria. Design, setting, and participants: A prospective observational study was conducted in 10 282 patients from 110 hospitals across 26 countries, aged ≥16 yr and referred to secondary care with haematuria. Patients with a known or previous urological malignancy were excluded. Outcome measurements and statistical analysis: The primary outcomes were the presence or absence of urinary tract cancer (bladder cancer, upper tract urothelial cancer [UTUC], and renal cancer). Mixed-effect multivariable logistic regression was performed with site and country as random effects and clinically important patient-level candidate predictors, chosen a priori, as fixed effects. Predictors were selected primarily using clinical reasoning, in addition to backward stepwise selection. Calibration and discrimination were calculated, and bootstrap validation was performed to calculate optimism. Results and limitations: The unadjusted prevalence was 17.2% (n = 1763) for bladder cancer, 1.20% (n = 123) for UTUC, and 1.00% (n = 103) for renal cancer. The final model included predictors of increased risk (visible haematuria, age, smoking history, male sex, and family history) and reduced risk (previous haematuria investigations, urinary tract infection, dysuria/suprapubic pain, anticoagulation, catheter use, and previous pelvic radiotherapy). The area under the receiver operating characteristic curve of the final model was 0.86 (95% confidence interval 0.85-0.87). The model is limited to patients without previous urological malignancy. Conclusions: This cancer prediction model is the first to consider established and novel urinary tract cancer diagnostic markers. It can be used in secondary care for risk stratifying patients and aid the clinician's decision-making process in prioritising patients for investigation. Patient summary: We have developed a tool that uses a person's characteristics to determine the risk of cancer if that person develops blood in the urine (haematuria). This can be used to help prioritise patients for further investigation.

Published
2022

99. Diagnostic performance of ultrasound vs. ultrasound-guided FNAc in thyroid nodules: data from the ElaTION trial.

Author

Mehanna H, Nankivell P, Boelaert K, Woolley R, Sharma N, Sidhu PS, Madani G, Da Forno P, Moreman C, Palmer A, Fulton-Lieuw T, Taylor J, Rajaguru K, Bekker J, Vaidhyanath R, Rehman T, and Deeks J

Abstract

Introduction: ElaTION is a large multi-centre pragmatic randomised controlled trial, performed in 18 secondary/tertiary hospitals across England, comparing elastography ultrasound-guided fine needle aspiration cytology (EUS-FNAC) with ultrasound-guided FNAC (US-FNAC) alone in the diagnostic assessment of thyroid nodules. Secondary trial outcomes, reported here, assessed the accuracy of ultrasound-alone (US) compared with US-guided FNAC to inform and update current practice guidelines., Methods: Adults with single or multiple thyroid nodules who had not undergone previous FNAC were eligible. Radiologists assessed all thyroid nodules using US alone, thereby enabling assessment of its accuracy (sensitivity and specificity) versus US-FNAC., Results: Of the 982 participants, a final definitive diagnosis was obtained in 688, who were included in the final analyses. The sensitivity of US-alone was the same as US-FNAC (0.91, [95% CI 0.85, 0.97] vs 0.87 [95%CI 0.80-0.95], p=0.37). US alone had statistically significant lower specificity than US-FNAC alone (0.48 vs 0.67 respectively, p<0.0001). The malignancy rate on histology in a nodule classified as benign on ultrasound (U2) was 9/263 (3.42%) and on cytology (Thy2) was 15/353 (4.25%), whereas the malignancy rate in a nodule that was benign on both (U2, Thy2) was 3/210 (1.43%). Malignancy risk for U3, U4, and U5 nodules was 68/304 (22.4%), 43/83 (51.8%), and 29/38 (76.3%) respectively (p<0.0001). Yet 80/982 (8%) patients were discharged despite having U3-U5 scans with Thy1 (non-diagnostic) FNAC and no definitive diagnosis.Malignancy risk was higher in smaller nodules: <10mm 23/60 (38.3%), 10-20mm 46/162 (28.4 %), and >20mm 80/466 (17.2%) (p<0.0001). Nodules with indeterminate cytology with atypical features (Thy3a) carried a similar malignancy risk to those with indeterminate cytology (Thy3/3f): 27/95 (28.4%) versus 42/113 (37.2%) respectively (p=0.18)., Conclusion: Ultrasound alone appears to be an effective diagnostic modality in thyroid nodules, confirming the recommendations of recent guidelines and the BTA classification. However, findings also suggest caution regarding existing recommendations for conservative management of non-diagnostic (Thy1/Bethesda I) and atypical (Thy3a/Bethesda III) nodules. In those cases, ultrasound (U3-5) features may help identify high-risk subgroups for more proactive management., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society.)

Published
2024
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100. Symptom-triggered testing detects early stage and low volume resectable advanced stage ovarian cancer.

Author

Kwong FLA, Kristunas C, Davenport C, Deeks J, Mallett S, Agarwal R, Kehoe S, Timmerman D, Bourne T, Stobart H, Neal R, Menon U, Gentry-Maharaj A, Brenton J, Rosenfeld N, Sturdy L, Ottridge R, and Sundar SS

Abstract

Objective: Symptom-triggered testing for ovarian cancer was introduced to the UK whereby symptomatic women undergo an ultrasound scan and serum CA125, and are referred to hospital within 2 weeks if these are abnormal. The potential value of symptom-triggered testing in the detection of early-stage disease or low tumor burden remains unclear in women with high grade serous ovarian cancer. In this descriptive study, we report on the International Federation of Gynecology and Obstetrics (FIGO) stage, disease distribution, and complete cytoreduction rates in women presenting via the fast-track pathway and who were diagnosed with high grade serous ovarian cancer., Methods: We analyzed the dataset from Refining Ovarian Cancer Test accuracy Scores (ROCkeTS), a single-arm prospective diagnostic test accuracy study recruiting from 24 hospitals in the UK. The aim of ROCkeTS is to validate risk prediction models in symptomatic women. We undertook an opportunistic analysis for women recruited between June 2015 to July 2022 and who were diagnosed with high grade serous ovarian cancer via the fast-track pathway. Women presenting with symptoms suspicious for ovarian cancer receive a CA125 blood test and an ultrasound scan if the CA125 level is abnormal. If either of these is abnormal, women are referred to secondary care within 2 weeks. Histology details were available on all women who underwent surgery or biopsy within 3 months of recruitment. Women who did not undergo surgery or biopsy at 3 months were followed up for 12 months as per the national guidelines in the UK. In this descriptive study, we report on patient demographics (age and menopausal status), WHO performance status, FIGO stage at diagnosis, disease distribution (low/pelvic confined, moderate/extending to mid-abdomen, high/extending to upper abdomen) and complete cytoreduction rates in women who underwent surgery., Results: Of 1741 participants recruited via the fast-track pathway, 119 (6.8%) were diagnosed with high grade serous ovarian cancer. The median age was 63 years (range 32-89). Of these, 112 (94.1%) patients had a performance status of 0 and 1, 30 (25.2%) were diagnosed with stages I/II, and the disease distribution was low-to-moderate in 77 (64.7%). Complete and optimal cytoreduction were achieved in 73 (61.3%) and 18 (15.1%). The extent of disease was low in 43 of 119 (36.1%), moderate in 34 of 119 (28.6%), high in 32 of 119 (26.9%), and not available in 10 of 119 (8.4%). Nearly two thirds, that is 78 of 119 (65.5%) women with high grade serous ovarian cancer, underwent primary debulking surgery, 36 of 119 (30.3%) received neoadjuvant chemotherapy followed by interval debulking surgery, and 5 of 119 (4.2%) women did not undergo surgery., Conclusion: Our results demonstrate that one in four women identified with high grade serous ovarian cancer through the fast-track pathway following symptom-triggered testing was diagnosed with early-stage disease. Symptom-triggered testing may help identify women with a low disease burden, potentially contributing to high complete cytoreduction rates., Competing Interests: Competing interests: SS has received honoraria from AstraZeneca, GSK, Mercke, Immunogen and research funding from AoA diagnostics. UM had stock ownership awarded by University College London (UCL) between until October 2021 in Abcodia, which holds the license for ROCA. She has received grants and AGM has been funded by grants from the Medical Research Council (MRC), Cancer Research UK, National Institute for Health Research (NIHR) and The Eve Appeal. UM has also received grants from UK Innovate and National Health and Medical Research Council (NHMRC), Australia and salary support from UCL Hospital Biomedical Research Centre. UM and AGM report funded research collaborations with industry - iLOF (intelligent Lab on Fiber), RNA Guardian, Micronoma, Mercy BioAnalytics and academics - Cambridge University, QIMR Berghofer Medical Research Institute, Imperial College London, University of Innsbruck and Dana Farber USA. UM holds patent number EP10178345.4 for Breast Cancer Diagnostics. AGM is a member of ACED Gynaecological Cancer Working Group and is ACED Co-Director Research Domain Trials. All other authors report no conflict of interest., (© IGCS and ESGO 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)

Published
2024
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