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2. Response to Mepolizumab Treatment in Patients with Severe Eosinophilic Asthma and Atopic Phenotypes

Author

Prazma CM, Idzko M, Douglass JA, Bourdin A, Mallett S, Albers FC, and Yancey SW

Subjects
allergens and epitopes, eosinophils, asthma, asthma treatments, biologics, Immunologic diseases. Allergy, RC581-607
Abstract

Charlene M Prazma,1 Marco Idzko,2,3 Jo Anne Douglass,4 Arnaud Bourdin,5,6 Stephen Mallett,7 Frank C Albers,8 Steven W Yancey1 1Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA; 2Division of Pneumology, Medical University of Vienna, Vienna, Austria; 3Department of Pneumology, University Hospital Freiburg, Freiburg, Germany; 4The Royal Melbourne Hospital and University of Melbourne, Melbourne, VIC, Australia; 5Departement de Pneumologie et Addictologie, Hôpital Arnaud de Villeneuve, CHU Montpellier, Montpellier, France; 6PhyMedExp, University of Montpellier, Montpellier, France; 7Clinical Statistics, GSK, Uxbridge, Middlesex, UK; 8Respiratory Medical Franchise, GSK, Research Triangle Park, NC, USACorrespondence: Charlene M PrazmaRespiratory Therapeutic Area, GSK, 5 Moore Drive, PO Box 13398, Research Triangle Park, NC, 27709, USATel +1 919 483 9013Email charlene.m.prazma@gsk.comPurpose: Improved understanding of characteristics that may influence treatment response across phenotypes may help guide treatment decisions.Patients and Methods: This was a post hoc analysis of MENSA, a multicenter, randomized, double-blind, placebo-controlled trial (NCT01691521). Patients aged ≥ 12 years with severe eosinophilic asthma received mepolizumab (75 mg intravenously or 100 mg subcutaneously) or placebo, plus standard of care, every 4 weeks for 32 weeks. Outcomes assessed were the annualized rate of clinically significant exacerbations and change from baseline in Asthma Control Questionnaire (ACQ)-5 score. Subgroup analyses were performed by baseline blood eosinophil count (< 150, ≥ 150– 300, ≥ 300 cells/μL) within atopic subgroups (non-atopic [specific immunoglobulin E < 0.35 kU/L], atopic [≥ 0.35– 17.5 kU/L], strongly atopic [> 17.5 kU/L]), and by house dust mite (HDM) sensitivity.Results: Of 576 patients analyzed, 272 were non-atopic, 181 were atopic and 94 were strongly atopic; 29 had missing atopy data. In patients with blood eosinophil counts ≥ 300 cells/μL, mepolizumab versus placebo reduced clinically significant exacerbations by 74%, 43% and 25% in the non-atopic, atopic and strongly atopic subgroups. Similar reductions were observed in all atopic subgroups in other blood eosinophil count categories where there were sufficient patient numbers for analysis, except for non-atopic patients with baseline blood eosinophil counts of < 150 cells/μL. Improvements in ACQ-5 scores of – 0.75, – 0.73 and – 0.78 with mepolizumab versus placebo were observed in non-atopic, atopic and strongly atopic patients with blood eosinophil counts ≥ 300 cells/μL; consistent improvements in ACQ-5 were not observed in patients with blood eosinophil counts < 150 or ≥ 150– 300 cells/μL. Reductions in clinically significant exacerbations with mepolizumab versus placebo were also observed irrespective of sensitivity to HDMs.Conclusion: Mepolizumab was associated with a trend for reductions in clinically significant exacerbations and improved asthma control versus placebo in patients with severe eosinophilic asthma, irrespective of atopic status or HDM sensitivity.Keywords: allergens and epitopes, eosinophils, asthma, asthma treatments, biologics

Published
2021

8. School stress in children

Author

Mallett, S.

Subjects
370, LB Theory and practice of education
Abstract

Most of us can empathise with feeling stressed. Each of us has our own unique interpretation of what stress is and our own understanding of what stress feels like. We each feel stress from a variety of sources and for a variety of reasons. We all have different coping strategies, which may or may not be effective. It is likely we learned our coping strategies in childhood; children who cope successfully with stress are likely to become adults who cope with stress successfully. Stress is not necessarily a 'bad thing': it can have many positive benefits. But too much stress, or coping ineffectively with repeated stress over long periods of time can have harmful effects on physical and psychological well being. This research investigates stress in school children, focusing specifically on school stress and everyday stressors inherent in schooling. It lets the pupils taking part in the research define their own stress and set the agenda for the research. How the pupils define their stress, their assessment of what is stressful for them in their life at school and how it makes them feel are all accepted unconditionally, and I have endeavoured to be non-judgemental in processing the information about stress disclosed to me by these pupils. The research was conducted over a two year period (1993-1994), at the eleven to sixteen comprehensive school where the author is employed. The data were collected by means of questionnaire, semi-structured interview and pupils' own personal writing and 'stress diaries'. After piloting, the first questionnaire was issued in January 1993 to one hundred and eighty volunteers in every form and every year group in the school (six questionnaires to each of the thirty tutor groups in the school). Of these questionnaires, 167 were returned (92.8%). The questionnaire asked respondents who would be prepared to be interviewed at a later stage, to identify themselves. Forty-five pupils volunteered. From these volunteers I selected pupils who had indicated that they had experienced feeling stress at school at some time on their questionnaire. I tried to keep a balance between males and females wherever possible, and to choose volunteers from across the age range. There were ten male and eleven female interviewees in the final selection one male and one female from year seven; one male and two females from year eight; two males and two females from year nine; and three males and three females from years ten and eleven respectively. The process was repeated again in 1994. Of the one hundred and eighty questionnaires issued in 1994, one hundred and forty three were returned (79%). Possible explanations for the difference in the number of questionnaires returned are discussed in Chapter 6. The same volunteers were interviewed in 1994 as in 1993, with the addition of two new volunteers, one male and one female, from year seven. The questionnaires and interviews were issued and conducted during the same time periods in both years. This was deliberately done to maintain consistency, to confirm the data collected in 1993 and to highlight any periods during the school year when pupils reported feeling more stress than at other times. This was successful as much of the data collected in 1994 does confirm the findings of 1993, and helps to build up a remarkably consistent picture of how pupils perceive stress at school. Originally, the author had planned to repeat the research method for a third year, but it was felt unnecessary to do this due to the corroborative nature of the data already collected. I have presented the results of each year separately rather than amalgamated the two sets of data, not only to emphasise this correlation but also because I wished to present as detailed a picture as possible of the stressful aspects of school life as perceived by the pupils, and although much of it is similar, none of it is the same. Each pupil has offered their own unique interpretation of the stressful school experiences he/she has encountered, and I felt it was important to include them all as equally important and valid in order to preserve the aims and integrity of the research. It would be impossible to amalgamate the data without trivialising the disparity of the experiences being disclosed to me. The main findings of this research suggest that there is a diverse, but ultimately exhaustive, range of school experiences pupils describe as being stressful for them. Most of these experiences can be categorised into domains relating to stressors which are curriculum generated; stressors which are the result of conflict in relationships with peers, teachers and/or family members; everyday life stressors not necessarily associated directly with school and a range of individually unique ‘one off’ stressors ...

Published
1997

10. Causes of death in patients with chronic kidney disease: insights from the ASCEND-D and ASCEND-ND cardiovascular outcomes trials

Author

Singh, A K, primary, Acharya, A, additional, Carroll, K, additional, Lopes, R D, additional, McCausland, F R, additional, Mulloy, L, additional, Perkovic, V, additional, Solomon, S, additional, Waikar, S S, additional, Wanner, C, additional, Wong, M G, additional, Cobitz, A R, additional, Mallett, S A, additional, Shaddinger, B C, additional, and McMurray, J J V, additional

Published
2022
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11. CO2 Indirect Treatment Comparison between Daprodustat and Roxadustat in Non-Dialysis Patients with Anemia Associated with Chronic Kidney Disease: An Analysis of Energy/Fatigue as Measured by the SF-36 Vitality Score

Author

Singh, A, primary, Sackeyfio, A, additional, Lopes, RD, additional, Kovesdy, CP, additional, Dasgupta, I, additional, Wheeler, DC, additional, Cases, A, additional, Wiecek, A, additional, Mallett, S, additional, Ballew, N, additional, Israni, RK, additional, Keeley, T, additional, Garcia-Horton, V, additional, Ayyagari, R, additional, Refoios Camejo, R, additional, and Johansen, KL, additional

Published
2022
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12. Predictors of Close Family Relationships over One Year among Homeless Young People

Author

Milburn, N.G, Jane Rotheram-Borus, M., Batterham, P., Brumback, B., Rosenthal, D., and Mallett, S.

Abstract

Predictors of perceived family bonds were examined among homeless young people who initially left home one year earlier. Newly homeless young people aged 12-20 years who had recently left home were recruited in Los Angeles County, United States (n=201) and Melbourne, Australia (n=124) and followed longitudinally at 3, 6, and 12 months (follow-up rates ranging from 72% to 86% overall). These homeless young people varied substantially in their bonds to their families. Family bonds at one year were predicted in multivariate regression analyses by having significantly fewer problem behaviours when leaving home and decreasing rates of problem behaviours over the next year. Having more emotional support and more instrumental financial support were also significantly associated with greater family bonds one year later. These results suggest that efforts to reunite families may be a viable intervention strategy for newly homeless young people.

Published
2005
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16. Intraoperative transfusion practices in Europe

Author

Meier, J., Filipescu, D., Kozek-Langenecker, S., Llau Pitarch, J., Mallett, S., Martus, P., Matot, I., Accurso, Giuseppe, Ahrens, Norbert, Akan, Mert, Åkeröy, Kristin, Aksoy, Omur, Alanoğlu, Zekeriyye, Alfredo, Merten, Alkis, Neslihan, Almeida, Valentina, Alousi, Mohammed, Alves, Claudia, Amaral, Joana, Ambrosi, Xavier, Ana, Izquierdo, Anastase, Denisa, Andersson, Mona, Andreou, Antonis, Anthopoulos, Georgios, Apanaviciute, Daiva, Arbelaez, Alejandro, Arcade, Anne-Laure, Arion-Balescu, Carmen, Arun, Oguzhan, Azenha, Marta, Bacalbasa, Nicolae, Baeten, Wannes, Balandin, Alina, Barquero López, Marta, Barsan, Victoria, Bascuas, Begona, Basora, Misericordia, Baumann, Holger, Bayer, Andreas, Bell, Andrea, Belmonte Cuenca, Julio, Bengisun, Zuleyha Kazak, Bento, Carlos, Beran, Maud, Bermudez Lopez, Maria, Bernardino, Ana, Berthelsen, Kasper Gymoese, Bigat, Zekiye, Bilshiene, Diana, Bilska, Marcela, Bisbe Vives, Elvira, Biscioni, Tamara, Björn, Heyse, Blom, Tommi, Bogdan Prodan, Alexandru, Bogdanovic Dvorscak, Matea, Boisson, Matthieu, Bolten, Jens, Bona, Francesco, Borg, Francis, Boros, Cristian, Borys, Michał, Boveroux, Pierre, Boztug Uz, Neval, Brettner, Florian, Brisard, Laurent, Britta, De Waal, Browne, Gail, Budow, Kristin, Buerkle, Hartmut, Buggy, Donal, Cain, Alistair, Calancea, Esenia, Calarasu, Florenta, Calder, Verity, Camci, Ali Emre, Campiglia, Laura, Campos, Beatriz, Camps, Angela, Carlos, Delgado, Carreira, Claudia, Carrilho, Alexandre, Carvalho, Peter, Cassinello, Concepcion, Cattan, Anat, Cenni, Leonardo, Cerny, Vladimir, Ceyda Meço, Başak, Chesov, Ion, Chishti, Ahmed, Chupin, Anne-Marie, Cikova, Andrea, Cindea, Iulia, Cintula, Daniel, Ciobanasu, Roxana, Clements, Deborah, Cobiletchi, Serghei, Coburn, Mark, Coghlan, Liz, Collyer, Thomas, Copotoiu, Sanda Maria, Copotoiu, Ruxandra, Corneci, Dan, Cortegiani, Andrea, Coskunfirat, O.Koray, Costea, Dan, Czuczwar, Mirosław, Davies, Katy, De Baerdemaeker, Luc, De Hert, Stefan, Debernardi, Felicino, Decagny, Sylvie, Deger Coskunfirat, Nesil, Diana, Toma, Diana, Gómez Martinez, Dias, Sandra, Dickinson, Matthew, Dobisova, Anna, Dragan, Anca, Droc, Gabriela, Duarte, Sonia, Dunk, Nigel, Ekelund, Kim, Ekmekçi, Perihan, Elena, Ciobanu, Ellimah, Tracey, Espie, Laura, Everett, Lynn, Ferguson, Andrew, Fernandes, Melissa, Fernández, J.A., Ferner, Marion, Ferreira, Daniel, Ferrie, Rosemary, Filipescu, Daniela, Flassikova, Zora, Fleischer, Andreas, Font, A., Galkova, Katarina, Garcia, Irene, Garner, Matt, Gasenkampf, Andrey, Gelmanas, Arunas, Gherghina, Viorel, Gilsanz, Fernando, Giokas, George, Goebel, Ulrich, Gomes, Piedade, Gonçalves Aguiar, José Manuel, Gonzalez Monzon, Veronica, Gottschalk, André, Gouraud, Jean-Pierre, Gramigni, Elena, Grintescu, Ioana, Grynyuk, Andriy, Grytsan, Alexey, Guasch, Emilia, Gustin, Denis, Hans, Grégory, Harazim, Hana, Hervig, Tore, Hidalgo, Francisco, Higham, Charley, Hirschauer, Nicola, Hoeft, Andreas, Innerhofer, Petra, Innerhofer-Pompernigg, Nicole, Jacobs, Stefan, Jakobs, Nicolas, Jamaer, Luc, James, Sarah, Jawad, Monir, Jesus, Joana, Jhanji, Shaman, Jipa Lavina, Nicoleta, Jokinen, Johanna, Jovanovic, Gordana, Jubera, Maria Pilar, Kahn, David, Karjagin, Juri, Kasnik, Darja, Katsanoulas, Konstantinos, Kelle, Hened, Kelleher, Mortimer, Kessler, Florian, Kirigin, Borana, Kiskira, Olga, Kivik, Peeter, Klimi, Pelagia, Klučka, Jozef, Koers, Lena, Kontrimaviciut, Egle, Koopman-van Gemert, A.W.M.M., Korfiotis, Demetrios, Kosinová, Martina, Koursoumi, Eygenia, Kozek Langenecker, Sibylle, Kranke, Peter, Kresic, Marina, Krobot, Renatas, Kropman, Lucienne, Kulikov, Alexander, Kvolik, Slavica, Kvrgic, Ivana, Kyttari, Aikaterini, Lagarto, Filipa, Lance, Marcus D., Laufenberg, Rita, Lauwick, Severine, Lecoq, Jean-Pierre, Leech, Leech, lidzborski, Lionel, Liliana, Henao, Linda, Filipe, Llau Pitarch, Juan Vicente, Lopes, Ana, Lopez, Luis, Lopez Alvarez, Alexo, Lorenzi, Irene, Lorre, Gilbert, Lucian, Horhota, Lupis, Tamara, Lupu, Mary Nicoleta, Macas, Andrius, Macedo, Ana, Maggi, Genaro, Mallett, Susan, Mallor, Thomas, Manoleli, Alexandra, Manolescu, Rely, Manrique, Susana, Maquoi, Isabelle, Marios-Konstantinos, Tasoulis, Markovic Bozic, Jasmina, Markus W., Hollmann, Marques, Margarida, Martinez, Raul, Martinez, Ever, Martínez, Esther, Martinho, Helder, Martins, Diogo, Martires, Emilia, Martus, Peter, Matias, Francisco, Matot, Idit, Mauff, Susanne, Meale, Paula, Meier, Jens, Merz, Hannah, Meybohm, Patrick, Militello, Maria Grazia, Mincu, Natalia, Miranda, Maria Lina, Mirea, Liliana, Moghildea, Victoria, Moise, Alida, Molano Diaz, Pablo, Moltó, Luís, Monedero, Pablo, Moral, Victoria, Moreira, Zélia, Moret, Enrique, Mulders, Freya, Munteanu, Anna Maria, Nadia Diana, Kinast, Nair, Ashok, Neskovic, Vojislava, Ninane, Vincent, Nitu, Denisa, Oberhofer, Dagmar, Odeberg-Wernerman, Suzanne, Oganjan, Juri, Omur, Dilek, Orallo Moran, Marian Angeles, Ozkardesler, Sevda, Pacasová, Rita, Paklar, Nataša, Pandazi, Ageliki, Papaspyros, Fotios, Paraskeuopoulos, Tilemachos, Parente, Suzana, Paunescu, Marilena Alina, Pavičić Šarić, Jadranka, Pereira, Filipa, Pereira, Elizabete, Pereira, Luciane, Perry, Chris, Petri, Attila, Petrovic, Uros, Pica, Silvia, Pinheiro, Filipe, Pinto, José, Pinto, Fernando, Piwowarczyk, Paweł, Platteau, Sofie, Poeira, Rita, Popescu, Ravzan, Popica, Georgian, Poredos, Peter, Prasser, Christopher, Preckel, Benedikt, Prospiech, Audrey, Pujol, Roger, Raimundo, Ana, Raineri, Santi Maurizio, Rakic, Dragana, Ramadan, Mohammed, Ramazanoğlu, Atilla, Rantis, Athanasios, Raquel, Ferrandis, Rätsep, Indrek, Real, Catia, Reikvam, Tore, Reis, Ligia, Rigal, Jean-Christophe, Rohner, Anne, Rokk, Alar, Roman Fernandez, Adriana, Rosenberger, Peter, Rossaint, Rolf, Rozec, Bertrand, Rudolph, Till, Saeed, Yousif, Safonov, Sergej, Saka, Esra, Samama, Charles Marc, Sánchez López, Óscar, Sanchez Perez, David, Sanchez Sanchez, Yvan Enrique, Sandeep, Varma, Sandu, Madalina Nina, Sanl, Suat, Saraiva, Alexandra, Scarlatescu, Ecaterina, Schiraldi, Renato, Schittek, Gregor, Schnitter, Bettina, Schuster, Michael, Seco, Carlos, Selvi, Onur, Senard, Marc, Serra, Sofia, Serrano, Helena, Shmigelsky, Alexander, Silva, Luisa, Simeson, Karen, Singh, Rita, Sipylaite, Jurate, Skitek, Kornel, Skok, Ira, Smékalová, Olga, Smirnova, Nadezda, Sofia, Machado, Soler Pedrola:, Maria, Söndergaard, Sören, Sõrmus, Alar, Sørvoll, Ingvild Hausberg, Soumelidis, Christos, Spindler Yesel, Alenka, Stefan, Mihai, Stevanovic, Ana, Stevikova, Jordana, Stivan, Sabina, Štourač, Petr, Striteska, Jana, Strys, Lydia, Suljevic, Ismet, Tania, Moreno, Tareco, Gloria, Tena, Beatriz, Theodoraki, Kassiani, Tifrea, Marius, Tikuisis, Renatas, Tolós, Raquel, Tomasi, Roland, Tomescu, Dana, Tomkute, Gabija, Tormos, Pilar, Trepenaitis, Darius, Troyan, Galina, Unic-Stojanovic, Dragana, Unterrainer, Axel, Uranjek, Jasna, Valsamidis, Dimitrios, van Dasselaar, Nick, Van Limmen, Jurgen, van Noord, Peter, van Poorten, J.F., Vanderlaenen, Margot, Varela Garcia, Olalla, Velasco, Ana, Veljovic, Milic, Vera Bella, Jorge, Vercauteren, Marcel, Verdouw, Bas, Verenkin, Vladimir, Veselovsky, Tomas, Vieira, Helena, Villar, Tania, Visnja, Ikic, Voje, Minca, von Dossow-Hanfstingl, Vera, Von Langen, Daniel, Vorotyntsev, Sergiy, Vujanovič, Vojislav, Vukovic, Rade, Watt, Philip, Werner, Eva, Wernerman, Jan, Wittmann, Maria, Wright, Margaret, Wunder, Christian, Wyffels, Piet, Yakymenko, Yevgen, Yldrm, Çiğdem, Ylmaz, Hakan, Zacharowski, Kai, Záhorec, Roman, Zarif, Maged, Zielinska-Skitek, Ewa, and Zsisku, Lajos

Published
2016
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18. The prediction of suicide in severe mental illness: development and validation of a clinical prediction rule (OxMIS)

Author

Fazel, S, Wolf, A, Larsson, H, Mallett, S, and Fanshawe, T

Subjects
Adult, Male, Sweden, Bipolar Disorder, Adolescent, Middle Aged, Prognosis, Risk Assessment, Sensitivity and Specificity, Article, lcsh:RC321-571, Cohort Studies, Suicide, Young Adult, Logistic Models, ROC Curve, Risk Factors, Clinical Decision Rules, Multivariate Analysis, Schizophrenia, Humans, Female, Registries, lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry, Aged
Abstract

Assessment of suicide risk in individuals with severe mental illness is currently inconsistent, and based on clinical decision-making with or without tools developed for other purposes. We aimed to develop and validate a predictive model for suicide using data from linked population-based registers in individuals with severe mental illness. A national cohort of 75,158 Swedish individuals aged 15–65 with a diagnosis of severe mental illness (schizophrenia-spectrum disorders, and bipolar disorder) with 574,018 clinical patient episodes between 2001 and 2008, split into development (58,771 patients, 494 suicides) and external validation (16,387 patients, 139 suicides) samples. A multivariable derivation model was developed to determine the strength of pre-specified routinely collected socio-demographic and clinical risk factors, and then tested in external validation. We measured discrimination and calibration for prediction of suicide at 1 year using specified risk cut-offs. A 17-item clinical risk prediction model for suicide was developed and showed moderately good measures of discrimination (c-index 0.71) and calibration. For risk of suicide at 1 year, using a pre-specified 1% cut-off, sensitivity was 55% (95% confidence interval [CI] 47–63%) and specificity was 75% (95% CI 74–75%). Positive and negative predictive values were 2% and 99%, respectively. The model was used to generate a simple freely available web-based probability-based risk calculator (Oxford Mental Illness and Suicide tool or OxMIS) without categorical cut-offs. A scalable prediction score for suicide in individuals with severe mental illness is feasible. If validated in other samples and linked to effective interventions, using a probability score may assist clinical decision-making.

Published
2019

25. Reporting guideline for interventional trials of primary and incisional ventral hernia repair

Author

Parker, S G, primary, Halligan, S, additional, Berrevoet, F, additional, de Beaux, A C, additional, East, B, additional, Eker, H H, additional, Jensen, K K, additional, Jorgensen, L N, additional, Montgomery, A, additional, Morales-Conde, S, additional, Miserez, M, additional, Renard, Y, additional, Sanders, D L, additional, Simons, M, additional, Slade, D, additional, Torkington, J, additional, Blackwell, S, additional, Dames, N, additional, Windsor, A C J, additional, and Mallett, S, additional

Published
2021
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26. NeuroSAFE PROOF. Update on a multi-centre, pragmatic, RCT for men undergoing robot-assisted radical prostatectomy: Trial in progress

Author

Dinneen, E., primary, Grierson, J., additional, Haider, A., additional, Allen, C., additional, Heffernan-Ho, D., additional, Clow, R., additional, Freeman, A., additional, Briggs, T., additional, Nathan, S., additional, Brew-Graves, C., additional, Mallett, S., additional, Williams, N., additional, Persad, R., additional, Aning, J., additional, Oxley, J., additional, Oakley, N., additional, Morgan, S., additional, Tahir, F., additional, Ahmad, I., additional, Dutto, L., additional, Salmond, J., additional, Marzena, R., additional, Ben-Salha, I., additional, Kelly, J., additional, and Shaw, G., additional

Published
2021
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28. Structured risk assessment in psychiatry

Author

Fazel, S, Wolf, A, Larsson, H, Fanshawe, T, and Mallett, S

Abstract

Background: Current approaches to stratify psychiatric patients into groups based on violence risk are limited by inconsistency, variable accuracy, and unscalability. Methods: Based on a national cohort of 75 158 Swedish individuals aged 15–65 with a diagnosis of severe mental illness (schizophrenic-spectrum and bipolar disorders) with 574 018 patient episodes, we developed predictive models for violent offending through linkage of population-based registers. First, a derivation model was developed to determine strength of pre-specified criminal history, socio-demographic, and clinical risk factors, and tested it in external validation. We measured discrimination and calibration for prediction of violent offending at 1 year using specified risk cut-offs. Results: A 16 item model was developed from criminal history, socio-demographic and clinical risk factors, which are mostly routinely collected. In external validation, the model showed good measures of discrimination (c-index 0.89) and calibration. For risk of violent offending at 1 year, using a 5% cut off, sensitivity was 64% and specificity was 94%. Positive and negative predictive values were 11% and 99%, respectively. The model was used to generate a simple web-based risk calculator (OxMIV). Discussion: We have developed a prediction score in a national cohort of patients with psychosis that can be used as an adjunct to decision making in clinical practice by identifying those who are at low risk of violent offending.

Published
2021

29. Reporting guideline for interventional trials of primary and incisional ventral hernia repair

Author

Parker, S. G., Halligan, S., Berrevoet, F., de Beaux, A. C., East, B., Eker, H. H., Jensen, K. K., Jorgensen, L. N., Montgomery, A., Morales-Conde, S., Miserez, M., Renard, Y., Sanders, D. L., Simons, M., Slade, D., Torkington, J., Blackwell, S., Dames, N., Windsor, A. C.J., Mallett, S., Parker, S. G., Halligan, S., Berrevoet, F., de Beaux, A. C., East, B., Eker, H. H., Jensen, K. K., Jorgensen, L. N., Montgomery, A., Morales-Conde, S., Miserez, M., Renard, Y., Sanders, D. L., Simons, M., Slade, D., Torkington, J., Blackwell, S., Dames, N., Windsor, A. C.J., and Mallett, S.

Abstract

BACKGROUND: Primary and incisional ventral hernia trials collect unstandardized inconsistent data, limiting data interpretation and comparison. This study aimed to create two minimum data sets for primary and incisional ventral hernia interventional trials to standardize data collection and improve trial comparison. To support these data sets, standardized patient-reported outcome measures and trial methodology criteria were created. METHODS: To construct these data sets, nominal group technique methodology was employed, involving 15 internationally recognized abdominal wall surgeons and two patient representatives. Initially a maximum data set was created from previous systematic and panellist reviews. Thereafter, three stages of voting took place: stage 1, selection of the number of variables for data set inclusion; stage 2, selection of variables to be included; and stage 3, selection of variable definitions and detection methods. A steering committee interpreted and analysed the data. RESULTS: The maximum data set contained 245 variables. The three stages of voting commenced in October 2019 and had been completed by July 2020. The final primary ventral hernia data set included 32 variables, the incisional ventral hernia data set included 40 variables, the patient-reported outcome measures tool contained 25 questions, and 40 methodological criteria were chosen. The best known variable definitions were selected for accurate variable description. CT was selected as the optimal preoperative descriptor of hernia morphology. Standardized follow-up at 30 days, 1 year, and 5 years was selected. CONCLUSION: These minimum data sets, patient-reported outcome measures, and methodological criteria have allowed creation of a manual for investigators aiming to undertake primary ventral hernia or incisional ventral hernia interventional trials. Adopting these data sets will improve trial methods and comparisons.

Published
2021

32. Identify : the investigation and detection of urological neoplasia in patients referred with suspected urinary tract cancer : a multicentre cohort study

Author

Khadhouri, S., Gallagher, K.M., MacKenzie, K., Shah, T.T., Gao, C., Moore, S., Zimmermann, E., Edison, E., Jefferies, M., Nambiar, A., MacLennan, G., McGrath, J.S., Kasivisvanathan, V., Ahmed, H., Deeks, J., Emberton, M., Kumaradeevan, J., Mallett, S., Takwoingi, Y., Morris, S., Knight, A., Blick, C., Catto, J., Cohen, D., Green, J., Kelly, J., and Mostafid, H.

Published
2020

33. Everyone counts: uncovering patterns of Newstart Allowance

Author

Bowman, D, Banks, M, Whiteford, P, de Silva, A, Anantharama, N, Csereklyei, Z, Mallett, S, Bowman, D, Banks, M, Whiteford, P, de Silva, A, Anantharama, N, Csereklyei, Z, and Mallett, S

Abstract

Our analysis of administrative social security data aimed to gain a clearer understanding of income volatility in Australia. The focus is on unemployed and underemployed Australians who received Newstart Allowance (NSA1)—a group of individuals highly exposed to the risks of financial insecurity. Our findings highlight some significant misunderstandings about the scale, scope and conditionality of Newstart Allowance receipt. While longer-term reliance on NSA is an important policy issue, short-term reliance is underestimated. An increasing share of recipients—especially women—are facing irregular payments due to suspensions. Our analysis raises questions about the extent to which the Australian social security system is fulfilling its mission to improve the lifetime wellbeing of individuals and families. The study drew on DOMINO (Data Over Multiple Individual Occurrences), a Department of Social Services database that records all interactions with Centrelink since 2001. This daily, event-based data provides an important opportunity to track individual patterns of NSA receipt over a 16-year period (2001–2016). This baseline study is part of a larger research program investigating the relationship between income volatility and social security payments. The program involves researchers from the Australian National University, the Brotherhood of St. Laurence and RMIT University.

Published
2020

40. Patient deprivation and perceived scan burden negatively impact the quality of whole-body MRI

Author

Evans, R.E.C., primary, Taylor, S.A., additional, Kalasthry, J., additional, Sakai, N.S., additional, Miles, A., additional, Aboagye, A., additional, Agoramoorthy, L., additional, Ahmed, S., additional, Amadi, A., additional, Anand, G., additional, Atkin, G., additional, Austria, A., additional, Ball, S., additional, Bazari, F., additional, Beable, R., additional, Beare, S., additional, Beedham, H., additional, Beeston, T., additional, Bharwani, N., additional, Bhatnagar, G., additional, Bhowmik, A., additional, Blakeway, L., additional, Blunt, D., additional, Boavida, P., additional, Boisfer, D., additional, Breen, D., additional, Bridgewater, J., additional, Burke, S., additional, Butawan, R., additional, Campbell, Y., additional, Chang, E., additional, Chao, D., additional, Chukundah, S., additional, Clarke, C.S., additional, Collins, B., additional, Collins, C., additional, Conteh, V., additional, Couture, J., additional, Crosbie, J., additional, Curtis, H., additional, Daniel, A., additional, Davis, L., additional, Desai, K., additional, Duggan, M., additional, Ellis, S., additional, Elton, C., additional, Engledow, A., additional, Everitt, C., additional, Ferdous, S., additional, Frow, A., additional, Furneaux, M., additional, Gibbons, N., additional, Glynne-Jones, R., additional, Gogbashian, A., additional, Goh, V., additional, Gourtsoyianni, S., additional, Green, A., additional, Green, Laura, additional, Green, Liz, additional, Groves, A., additional, Guthrie, A., additional, Hadley, E., additional, Halligan, S., additional, Hameeduddin, A., additional, Hanid, G., additional, Hans, S., additional, Hans, B., additional, Higginson, A., additional, Honeyfield, L., additional, Hughes, H., additional, Hughes, J., additional, Hurl, L., additional, Isaac, E., additional, Jackson, M., additional, Jalloh, A., additional, Janes, S., additional, Jannapureddy, R., additional, Jayme, A., additional, Johnson, A., additional, Johnson, E., additional, Julka, P., additional, Karapanagiotou, E., additional, Karp, S., additional, Kay, C., additional, Kellaway, J., additional, Khan, S., additional, Koh, D., additional, Light, T., additional, Limbu, P., additional, Lock, S., additional, Locke, I., additional, Loke, T., additional, Lowe, A., additional, Lucas, N., additional, Maheswaran, S., additional, Mallett, S., additional, Marwood, E., additional, McGowan, J., additional, Mckirdy, F., additional, Mills-Baldock, T., additional, Moon, T., additional, Morgan, V., additional, Morris, S., additional, Morton, A., additional, Nasseri, S., additional, Navani, N., additional, Nichols, P., additional, Norman, C., additional, Ntala, E., additional, Nunes, A., additional, Obichere, A., additional, O'Donohue, J., additional, Olaleye, I., additional, Oliver, A., additional, Onajobi, A., additional, O'Shaughnessy, T., additional, Padhani, A., additional, Pardoe, H., additional, Partridge, W., additional, Patel, U., additional, Perry, K., additional, Piga, W., additional, Prezzi, D., additional, Prior, K., additional, Punwani, S., additional, Pyers, J., additional, Rafiee, H., additional, Rahman, F., additional, Rajanpandian, I., additional, Ramesh, S., additional, Raouf, S., additional, Reczko, K., additional, Reinhardt, A., additional, Robinson, D., additional, Rockall, A., additional, Russell, P., additional, Sargus, K., additional, Scurr, E., additional, Shahabuddin, K., additional, Sharp, A., additional, Shepherd, B., additional, Shiu, K., additional, Sidhu, H., additional, Simcock, I., additional, Simeon, C., additional, Smith, A., additional, Smith, D., additional, Snell, D., additional, Spence, J., additional, Srirajaskanthan, R., additional, Stachini, V., additional, Stegner, S., additional, Stirling, J., additional, Strickland, N., additional, Tarver, K., additional, Teague, J., additional, Thaha, M., additional, Train, M., additional, Tulmuntaha, S., additional, Tunariu, N., additional, van Ree, K., additional, Verjee, A., additional, Wanstall, C., additional, Weir, S., additional, Wijeyekoon, S., additional, Wilson, J., additional, Wilson, S., additional, Win, T., additional, Woodrow, L., additional, and Yu, D., additional

Published
2020
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42. MEPOLIZUMAB FOR THE TREATMENT OF PATIENTS WITH EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS: A PHASE III RANDOMISED, PLACEBO-CONTROLLED TRIAL

Author

Wechsler, ME, Akuthota, P, Jayne, D, Khoury, P, Klion, A, Langford, C, Merkel, PA, Moosig, F, Specks, U, Cid, MC, Luqmani, R, Brown, J, Mallett, S, Philipson, R, Yancey, SW, Steinfeld, J, Weller, PF, and Gleich, G

Subjects
Clinical Research, 6.1 Pharmaceuticals, Clinical Trials and Supportive Activities, 32 Biomedical and Clinical Sciences, 3202 Clinical Sciences, 6 Evaluation of treatments and therapeutic interventions
Abstract

MEPOLIZUMAB FOR THE TREATMENT OF PATIENTS WITH EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS: A PHASE III RANDOMISED, PLACEBO-CONTROLLED TRIAL

Published
2019
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43. Mepolizumab For The Treatment Of Patients With Eosinophilic Granulomatosis With Polyangiitis: A Phase Iii Randomized, Placebo-Controlled Trial

Author

Wechsler, M, Akuthota, P, Jayne, D, Khoury, P, Klion, A, Langford, C, Merkel, P, Moosig, F, Specks, U, Cid, M, Luqmani, R, Brown, J, Mallett, S, Philipson, R, Yancey, S, Steinfeld, J, Weller, P, and Gleich, G

Abstract

Mepolizumab For The Treatment Of Patients With Eosinophilic Granulomatosis With Polyangiitis: A Phase Iii Randomized, Placebo-Controlled Trial

Published
2019

44. Patient preferences for whole-body MRI or conventional staging pathways in lung and colorectal cancer: a discrete choice experiment

Author

Miles, A, Taylor, SA, Evans, REC, Halligan, S, Beare, S, Bridgewater, J, Goh, V, Janes, S, Navani, N, Oliver, A, Morton, A, Rockall, A, Clarke, CS, Morris, S, Aboagye, A, Agoramoorthy, L, Ahmed, S, Amadi, A, Anand, G, Atkin, G, Austria, A, Ball, S, Bazari, F, Beable, R, Beedham, H, Beeston, T, Bharwani, N, Bhatnagar, G, Bhowmik, A, Blakeway, L, Blunt, D, Boavida, P, Boisfer, D, Breen, D, Burke, S, Butawan, R, Campbell, Y, Chang, E, Chao, D, Chukundah, S, Collins, B, Collins, C, Conteh, V, Couture, J, Crosbie, J, Curtis, H, Daniel, A, Davis, L, Desai, K, Duggan, M, Ellis, S, Elton, C, Engledow, A, Everitt, C, Ferdous, S, Frow, A, Furneaux, M, Gibbons, N, Glynne-Jones, R, Gogbashian, A, Gourtsoyianni, S, Green, A, Green, L, Groves, A, Guthrie, A, Hadley, E, Hameeduddin, A, Hanid, G, Hans, S, Hans, B, Higginson, A, Honeyfield, L, Hughes, H, Hughes, J, Hurl, L, Isaac, E, Jackson, M, Jalloh, A, Jannapureddy, R, Jayme, A, Johnson, A, Johnson, E, Julka, P, Kalasthry, J, Karapanagiotou, E, Karp, S, Kay, C, Kellaway, J, Khan, S, Koh, D-M, Light, T, Limbu, P, Lock, S, Locke, I, Loke, T, Lowe, A, Lucas, N, Maheswaran, S, Mallett, S, Marwood, E, McGowan, J, Mckirdy, F, Mills-Baldock, T, Moon, T, Morgan, V, Nasseri, S, Nichols, P, Norman, C, Ntala, E, Nunes, A, Obichere, A, O'Donohue, J, Olaleye, I, Onajobi, A, O'Shaughnessy, T, Padhani, A, Pardoe, H, Partridge, W, Patel, U, Perry, K, Piga, W, Prezzi, D, Prior, K, Punwani, S, Pyers, J, Rafiee, H, Rahman, F, Rajanpandian, I, Ramesh, S, Raouf, S, Reczko, K, Reinhardt, A, Robinson, D, Russell, P, Sargus, K, Scurr, E, Shahabuddin, K, Sharp, A, Shepherd, B, Shiu, K, Sidhu, H, Simcock, I, Simeon, C, Smith, A, Smith, D, Snell, D, Spence, J, Srirajaskanthan, R, Stachini, V, Stegner, S, Stirling, J, Strickland, N, Tarver, K, Teague, J, Thaha, M, Train, M, Tulmuntaha, S, Tunariu, N, Van Ree, K, Verjee, A, Wanstall, C, Weir, S, Wijeyekoon, S, Wilson, J, Wilson, S, Win, T, Woodrow, L, Yu, D, Imperial College Healthcare NHS Trust- BRC Funding, and Department of Health

Subjects
Adult, Male, Positron emission tomography, Lung Neoplasms, Social Sciences, X-ray computed, Magnetic resonance imaging, Psychology, Multidisciplinary, Positron Emission Tomography Computed Tomography, Surveys and Questionnaires, Psychology, Humans, Whole Body Imaging, Patient preference, Prospective Studies, Tomography, Cancer, Aged, Neoplasm Staging, Science & Technology, Radiology, Nuclear Medicine & Medical Imaging, Tomography, X-ray computed, 1103 Clinical Sciences, CARE, Middle Aged, NEGATIVE AFFECT, Biomedical Social Sciences, Social Sciences, Biomedical, Nuclear Medicine & Medical Imaging, PANAS, Oncology, Positron-Emission Tomography, Regression Analysis, CLAUSTROPHOBIA, Female, STREAMLINE investigators, Colorectal Neoplasms, Life Sciences & Biomedicine
Abstract

Objectives To determine the importance placed by patients on attributes associated with whole-body MRI (WB-MRI) and standard cancer staging pathways and ascertain drivers of preference. Methods Patients recruited to two multi-centre diagnostic accuracy trials comparing WB-MRI with standard staging pathways in lung and colorectal cancer were invited to complete a discrete choice experiment (DCE), choosing between a series of alternate pathways in which 6 attributes (accuracy, time to diagnosis, scan duration, whole-body enclosure, radiation exposure, total scan number) were varied systematically. Data were analysed using a conditional logit regression model and marginal rates of substitution computed. The relative importance of each attribute and probabilities of choosing WB-MRI-based pathways were estimated. Results A total of 138 patients (mean age 65, 61% male, lung n = 72, colorectal n = 66) participated (May 2015 to September 2016). Lung cancer patients valued time to diagnosis most highly, followed by accuracy, radiation exposure, number of scans, and time in the scanner. Colorectal cancer patients valued accuracy most highly, followed by time to diagnosis, radiation exposure, and number of scans. Patients were willing to wait 0.29 (lung) and 0.45 (colorectal) weeks for a 1% increase in pathway accuracy. Patients preferred WB-MRI-based pathways (probability 0.64 [lung], 0.66 [colorectal]) if they were equivalent in accuracy, total scan number, and time to diagnosis compared with a standard staging pathway. Conclusions Staging pathways based on first-line WB-MRI are preferred by the majority of patients if they at least match standard pathways for diagnostic accuracy, time to diagnosis, and total scan number.

Published
2019

50. Improving the health of older aged care workers

Author

Hart, A, Bowman, D, Mallett, S, Hart, A, Bowman, D, and Mallett, S

Abstract

As part of the Working Well, Working Wisely study, researchers from the Brotherhood of St Laurence and the University of Melbourne investigated the health concerns of older workers in the aged care sector. We focused on ‘pink-collar’ workers, that is, care-related roles requiring less than a bachelor’s degree qualification.

Published
2019

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