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4. The WIRE study a phase II, multi-arm, multi-centre, non-randomised window-of-opportunity clinical trial platform using a Bayesian adaptive design for proof-of-mechanism of novel treatment strategies in operable renal cell cancer – a study protocol

Author

Ursprung, Stephan, Mossop, Helen, Gallagher, Ferdia A., Sala, Evis, Skells, Richard, Sipple, Jamal A. N., Mitchell, Thomas J., Chhabra, Anita, Fife, Kate, Matakidou, Athena, Young, Gemma, Walker, Amanda, Thomas, Martin G., Ortuzar, Mireia Crispin, Sullivan, Mark, Protheroe, Andrew, Oades, Grenville, Venugopal, Balaji, Warren, Anne Y., Stone, John, Eisen, Tim, Wason, James, Welsh, Sarah J., and Stewart, Grant D.

Published
2021
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5. DNA-Repair Defects and Olaparib in Metastatic Prostate Cancer

Author

Mateo, Joaquin, Carreira, Suzanne, Sandhu, Shahneen, Miranda, Susana, Mossop, Helen, Perez-Lopez, Raquel, Nava Rodrigues, Daniel, Robinson, Dan, Omlin, Aurelius, Tunariu, Nina, Boysen, Gunther, Porta, Nuria, Flohr, Penny, Gillman, Alexa, Figueiredo, Ines, Paulding, Claire, Seed, George, Jain, Suneil, Ralph, Christy, Protheroe, Andrew, Hussain, Syed, Jones, Robert, Elliott, Tony, McGovern, Ursula, Bianchini, Diletta, Goodall, Jane, Zafeiriou, Zafeiris, Williamson, Chris T, Ferraldeschi, Roberta, Riisnaes, Ruth, Ebbs, Bernardette, Fowler, Gemma, Roda, Desamparados, Yuan, Wei, Wu, Yi-Mi, Cao, Xuhong, Brough, Rachel, Pemberton, Helen, A'Hern, Roger, Swain, Amanda, Kunju, Lakshmi P, Eeles, Rosalind, Attard, Gerhardt, Lord, Christopher J, Ashworth, Alan, Rubin, Mark A, Knudsen, Karen E, Feng, Felix Y, Chinnaiyan, Arul M, Hall, Emma, and de Bono, Johann S

Subjects
Genetics, Urologic Diseases, Human Genome, Prostate Cancer, Cancer, Clinical Research, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, 4.1 Discovery and preclinical testing of markers and technologies, Detection, screening and diagnosis, Adult, Aged, Anemia, Antineoplastic Agents, Ataxia Telangiectasia Mutated Proteins, DNA Repair, Drug Resistance, Neoplasm, Enzyme Inhibitors, Fatigue, Genes, BRCA2, Genes, Tumor Suppressor, Humans, Male, Middle Aged, Mutation, Neoplasm Metastasis, Phthalazines, Piperazines, Poly(ADP-ribose) Polymerase Inhibitors, Prostatic Neoplasms, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundProstate cancer is a heterogeneous disease, but current treatments are not based on molecular stratification. We hypothesized that metastatic, castration-resistant prostate cancers with DNA-repair defects would respond to poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibition with olaparib.MethodsWe conducted a phase 2 trial in which patients with metastatic, castration-resistant prostate cancer were treated with olaparib tablets at a dose of 400 mg twice a day. The primary end point was the response rate, defined either as an objective response according to Response Evaluation Criteria in Solid Tumors, version 1.1, or as a reduction of at least 50% in the prostate-specific antigen level or a confirmed reduction in the circulating tumor-cell count from 5 or more cells per 7.5 ml of blood to less than 5 cells per 7.5 ml. Targeted next-generation sequencing, exome and transcriptome analysis, and digital polymerase-chain-reaction testing were performed on samples from mandated tumor biopsies.ResultsOverall, 50 patients were enrolled; all had received prior treatment with docetaxel, 49 (98%) had received abiraterone or enzalutamide, and 29 (58%) had received cabazitaxel. Sixteen of 49 patients who could be evaluated had a response (33%; 95% confidence interval, 20 to 48), with 12 patients receiving the study treatment for more than 6 months. Next-generation sequencing identified homozygous deletions, deleterious mutations, or both in DNA-repair genes--including BRCA1/2, ATM, Fanconi's anemia genes, and CHEK2--in 16 of 49 patients who could be evaluated (33%). Of these 16 patients, 14 (88%) had a response to olaparib, including all 7 patients with BRCA2 loss (4 with biallelic somatic loss, and 3 with germline mutations) and 4 of 5 with ATM aberrations. The specificity of the biomarker suite was 94%. Anemia (in 10 of the 50 patients [20%]) and fatigue (in 6 [12%]) were the most common grade 3 or 4 adverse events, findings that are consistent with previous studies of olaparib.ConclusionsTreatment with the PARP inhibitor olaparib in patients whose prostate cancers were no longer responding to standard treatments and who had defects in DNA-repair genes led to a high response rate. (Funded by Cancer Research UK and others; ClinicalTrials.gov number, NCT01682772; Cancer Research UK number, CRUK/11/029.).

Published
2015

7. Data from Circulating Cell-Free DNA to Guide Prostate Cancer Treatment with PARP Inhibition

Author

Goodall, Jane, primary, Mateo, Joaquin, primary, Yuan, Wei, primary, Mossop, Helen, primary, Porta, Nuria, primary, Miranda, Susana, primary, Perez-Lopez, Raquel, primary, Dolling, David, primary, Robinson, Dan R., primary, Sandhu, Shahneen, primary, Fowler, Gemma, primary, Ebbs, Berni, primary, Flohr, Penny, primary, Seed, George, primary, Rodrigues, Daniel Nava, primary, Boysen, Gunther, primary, Bertan, Claudia, primary, Atkin, Mark, primary, Clarke, Matthew, primary, Crespo, Mateus, primary, Figueiredo, Ines, primary, Riisnaes, Ruth, primary, Sumanasuriya, Semini, primary, Rescigno, Pasquale, primary, Zafeiriou, Zafeiris, primary, Sharp, Adam, primary, Tunariu, Nina, primary, Bianchini, Diletta, primary, Gillman, Alexa, primary, Lord, Christopher J., primary, Hall, Emma, primary, Chinnaiyan, Arul M., primary, Carreira, Suzanne, primary, and de Bono, Johann S., primary

Published
2023
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8. Supplementary Figure S2 from Circulating Cell-Free DNA to Guide Prostate Cancer Treatment with PARP Inhibition

Author

Goodall, Jane, primary, Mateo, Joaquin, primary, Yuan, Wei, primary, Mossop, Helen, primary, Porta, Nuria, primary, Miranda, Susana, primary, Perez-Lopez, Raquel, primary, Dolling, David, primary, Robinson, Dan R., primary, Sandhu, Shahneen, primary, Fowler, Gemma, primary, Ebbs, Berni, primary, Flohr, Penny, primary, Seed, George, primary, Rodrigues, Daniel Nava, primary, Boysen, Gunther, primary, Bertan, Claudia, primary, Atkin, Mark, primary, Clarke, Matthew, primary, Crespo, Mateus, primary, Figueiredo, Ines, primary, Riisnaes, Ruth, primary, Sumanasuriya, Semini, primary, Rescigno, Pasquale, primary, Zafeiriou, Zafeiris, primary, Sharp, Adam, primary, Tunariu, Nina, primary, Bianchini, Diletta, primary, Gillman, Alexa, primary, Lord, Christopher J., primary, Hall, Emma, primary, Chinnaiyan, Arul M., primary, Carreira, Suzanne, primary, and de Bono, Johann S., primary

Published
2023
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9. Supplemental Table S1 from Circulating Cell-Free DNA to Guide Prostate Cancer Treatment with PARP Inhibition

Author

Goodall, Jane, primary, Mateo, Joaquin, primary, Yuan, Wei, primary, Mossop, Helen, primary, Porta, Nuria, primary, Miranda, Susana, primary, Perez-Lopez, Raquel, primary, Dolling, David, primary, Robinson, Dan R., primary, Sandhu, Shahneen, primary, Fowler, Gemma, primary, Ebbs, Berni, primary, Flohr, Penny, primary, Seed, George, primary, Rodrigues, Daniel Nava, primary, Boysen, Gunther, primary, Bertan, Claudia, primary, Atkin, Mark, primary, Clarke, Matthew, primary, Crespo, Mateus, primary, Figueiredo, Ines, primary, Riisnaes, Ruth, primary, Sumanasuriya, Semini, primary, Rescigno, Pasquale, primary, Zafeiriou, Zafeiris, primary, Sharp, Adam, primary, Tunariu, Nina, primary, Bianchini, Diletta, primary, Gillman, Alexa, primary, Lord, Christopher J., primary, Hall, Emma, primary, Chinnaiyan, Arul M., primary, Carreira, Suzanne, primary, and de Bono, Johann S., primary

Published
2023
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10. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial

Author

Dearnaley, David, Syndikus, Isabel, Mossop, Helen, Khoo, Vincent, Birtle, Alison, Bloomfield, David, Graham, John, Kirkbride, Peter, Logue, John, Malik, Zafar, Money-Kyrle, Julian, O'Sullivan, Joe M, Panades, Miguel, Parker, Chris, Patterson, Helen, Scrase, Christopher, Staffurth, John, Stockdale, Andrew, Tremlett, Jean, Bidmead, Margaret, Mayles, Helen, Naismith, Olivia, South, Chris, Gao, Annie, Cruickshank, Clare, Hassan, Shama, Pugh, Julia, Griffin, Clare, and Hall, Emma

Published
2016
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11. Hypofractionated radiotherapy versus conventionally fractionated radiotherapy for patients with intermediate-risk localised prostate cancer: 2-year patient-reported outcomes of the randomised, non-inferiority, phase 3 CHHiP trial

Author

Wilkins, Anna, Mossop, Helen, Syndikus, Isabel, Khoo, Vincent, Bloomfield, David, Parker, Chris, Logue, John, Scrase, Christopher, Patterson, Helen, Birtle, Alison, Staffurth, John, Malik, Zafar, Panades, Miguel, Eswar, Chinnamani, Graham, John, Russell, Martin, Kirkbride, Peter, O'Sullivan, Joe M, Gao, Annie, Cruickshank, Clare, Griffin, Clare, Dearnaley, David, and Hall, Emma

Published
2015
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12. Methenamine hippurate compared with antibiotic prophylaxis to prevent recurrent urinary tract infections in women: the ALTAR non-inferiority RCT

Author

Harding, Chris, primary, Chadwick, Thomas, additional, Homer, Tara, additional, Lecouturier, Jan, additional, Mossop, Helen, additional, Carnell, Sonya, additional, King, Will, additional, Abouhajar, Alaa, additional, Vale, Luke, additional, Watson, Gillian, additional, Forbes, Rebecca, additional, Currer, Stephanie, additional, Pickard, Robert, additional, Eardley, Ian, additional, Pearce, Ian, additional, Thiruchelvam, Nikesh, additional, Guerrero, Karen, additional, Walton, Katherine, additional, Hussain, Zahid, additional, Lazarowicz, Henry, additional, and Ali, Ased, additional

Published
2022
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13. Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial

Author

Harding, Chris, primary, Mossop, Helen, additional, Homer, Tara, additional, Chadwick, Thomas, additional, King, William, additional, Carnell, Sonya, additional, Lecouturier, Jan, additional, Abouhajar, Alaa, additional, Vale, Luke, additional, Watson, Gillian, additional, Forbes, Rebecca, additional, Currer, Stephanie, additional, Pickard, Robert, additional, Eardley, Ian, additional, Pearce, Ian, additional, Thiruchelvam, Nikesh, additional, Guerrero, Karen, additional, Walton, Katherine, additional, Hussain, Zahid, additional, Lazarowicz, Henry, additional, and Ali, Ased, additional

Published
2022
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14. Window-of-opportunity clinical trial platform for evaluation of novel treatment strategies in renal cell cancer (WIRE).

Author

Sipple, Jamal A N, primary, Thomas, Martin G, additional, Mossop, Helen, additional, Wason, James, additional, Gallagher, Ferdia, additional, Chhabra, Anita, additional, Warren, Anne, additional, Stone, John, additional, Venugopal, Balaji, additional, Oades, Grenville, additional, Welsh, Sarah Joanne, additional, and Stewart, Grant D., additional

Published
2022
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15. Advantages of multi-arm non-randomised sequentially allocated cohort designs for Phase II oncology trials

Author

Mossop, Helen, Grayling, Michael J, Gallagher, Ferdia, Welsh, Sarah, Stewart, Grant, Wason, James MS, Grayling, Michael J [0000-0002-0680-6668], Gallagher, Ferdia [0000-0003-4784-5230], Welsh, Sarah [0000-0001-5690-2677], Stewart, Grant [0000-0003-3188-9140], Wason, James MS [0000-0002-4691-126X], and Apollo - University of Cambridge Repository

Abstract

BACKGROUND: Efficient trial designs are required to prioritise promising drugs within Phase II trials. Adaptive designs are examples of such designs, but their efficiency is reduced if there is a delay in assessing patient responses to treatment. METHODS: Motivated by the WIRE trial in renal cell carcinoma (NCT03741426), we compare three trial approaches to testing multiple treatment arms: (1) single-arm trials in sequence with interim analyses; (2) a parallel multi-arm multi-stage trial and (3) the design used in WIRE, which we call the Multi-Arm Sequential Trial with Efficient Recruitment (MASTER) design. The MASTER design recruits patients to one arm at a time, pausing recruitment to an arm when it has recruited the required number for an interim analysis. We conduct a simulation study to compare how long the three different trial designs take to evaluate a number of new treatment arms. RESULTS: The parallel multi-arm multi-stage and the MASTER design are much more efficient than separate trials. The MASTER design provides extra efficiency when there is endpoint delay, or recruitment is very quick. CONCLUSIONS: We recommend the MASTER design as an efficient way of testing multiple promising cancer treatments in non-comparative Phase II trials., Cancer Research UK Cambridge Centre [C9685/A25177]

Published
2021

17. Ondansetron and metoclopramide as second-line antiemetics in women with nausea and vomiting in pregnancy: the EMPOWER pilot factorial RCT

Author

Robson, Stephen, primary, McParlin, Catherine, additional, Mossop, Helen, additional, Lie, Mabel, additional, Fernandez-Garcia, Cristina, additional, Howel, Denise, additional, Graham, Ruth, additional, Ternent, Laura, additional, Steel, Alison, additional, Goudie, Nicola, additional, Nadeem, Afnan, additional, Phillipson, Julia, additional, Shehmar, Manjeet, additional, Simpson, Nigel, additional, Tuffnell, Derek, additional, Campbell, Ian, additional, Williams, Rew, additional, O’Hara, Margaret E, additional, McColl, Elaine, additional, and Nelson-Piercy, Catherine, additional

Published
2021
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18. Additional file 3 of The WIRE study a phase II, multi-arm, multi-centre, non-randomised window-of-opportunity clinical trial platform using a Bayesian adaptive design for proof-of-mechanism of novel treatment strategies in operable renal cell cancer ��� a study protocol

Author

Ursprung, Stephan, Mossop, Helen, Gallagher, Ferdia A., Sala, Evis, Skells, Richard, Sipple, Jamal A. N., Mitchell, Thomas J., Chhabra, Anita, Fife, Kate, Matakidou, Athena, Young, Gemma, Walker, Amanda, Thomas, Martin G., Ortuzar, Mireia Crispin, Sullivan, Mark, Protheroe, Andrew, Oades, Grenville, Venugopal, Balaji, Warren, Anne Y., Stone, John, Eisen, Tim, Wason, James, Welsh, Sarah J., and Stewart, Grant D.

Subjects
Data_FILES
Abstract

Additional file 3.

Published
2021
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19. Additional file 2 of The WIRE study a phase II, multi-arm, multi-centre, non-randomised window-of-opportunity clinical trial platform using a Bayesian adaptive design for proof-of-mechanism of novel treatment strategies in operable renal cell cancer ��� a study protocol

Author

Ursprung, Stephan, Mossop, Helen, Gallagher, Ferdia A., Sala, Evis, Skells, Richard, Sipple, Jamal A. N., Mitchell, Thomas J., Chhabra, Anita, Fife, Kate, Matakidou, Athena, Young, Gemma, Walker, Amanda, Thomas, Martin G., Ortuzar, Mireia Crispin, Sullivan, Mark, Protheroe, Andrew, Oades, Grenville, Venugopal, Balaji, Warren, Anne Y., Stone, John, Eisen, Tim, Wason, James, Welsh, Sarah J., and Stewart, Grant D.

Subjects
Data_FILES
Abstract

Additional file 2.

Published
2021
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20. Alternative to Prophylactic Antibiotics for the Treatment of Recurrent Urinary Tract Infections in Women (ALTAR): A Multi-Centre Randomised, Non-Inferiority Trial

Author

Harding, Christopher Karl, primary, Mossop, Helen, additional, Homer, Tara, additional, Chadwick, Thomas, additional, King, William, additional, Carnell, Sonya, additional, Lecouturier, Jan, additional, Abouhajar, Alaa, additional, Vale, Luke, additional, Watson, Gillian, additional, Forbes, Rebecca, additional, Currer, Stephanie, additional, Pickard, Robert, additional, Eardley, Ian, additional, Pearce, Ian, additional, Thiruchelvam, Nikesh, additional, Guerrero, Karen, additional, Walton, Katherine, additional, Hussain, Zahid, additional, Lazarowicz, Henry, additional, and Ali, Ased, additional

Published
2021
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21. Corrigendum: Brief alcohol intervention for risky drinking in young people aged 14–15 years in secondary schools: the SIPS JR-HIGH RCT

Author

Giles, Emma L, primary, McGeechan, Grant J, additional, Coulton, Simon, additional, Deluca, Paolo, additional, Drummond, Colin, additional, Howel, Denise, additional, Kaner, Eileen, additional, McColl, Elaine, additional, McGovern, Ruth, additional, Scott, Stephanie, additional, Stamp, Elaine, additional, Sumnall, Harry, additional, Todd, Liz, additional, Vale, Luke, additional, Albani, Viviana, additional, Boniface, Sadie, additional, Ferguson, Jennifer, additional, Gilvarry, Eilish, additional, Hendrie, Nadine, additional, Howe, Nicola, additional, Mossop, Helen, additional, Ramsay, Amy, additional, Stanley, Grant, additional, and Newbury-Birch, Dorothy, additional

Published
2020
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22. A randomised assessment of image guided radiotherapy within a phase 3 trial of conventional or hypofractionated high dose intensity modulated radiotherapy for prostate cancer

Author

Murray, Julia, primary, Griffin, Clare, additional, Gulliford, Sarah, additional, Syndikus, Isabel, additional, Staffurth, John, additional, Panades, Miguel, additional, Scrase, Christopher, additional, Parker, Chris, additional, Khoo, Vincent, additional, Dean, Jamie, additional, Mayles, Helen, additional, Mayles, Philip, additional, Thomas, Simon, additional, Naismith, Olivia, additional, Baker, Angela, additional, Mossop, Helen, additional, Cruickshank, Clare, additional, Hall, Emma, additional, and Dearnaley, David, additional

Published
2020
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23. Cognitive Decline in Older Patients With Non- ST Elevation Acute Coronary Syndrome

Author

Gu, Sophie Z, Beska, Benjamin, Chan, Danny, Neely, Dermot, Batty, Jonathan A, Adams-Hall, Jennifer, Mossop, Helen, Qiu, Weiliang, Kunadian, Vijay, Gu, Sophie [0000-0001-7698-0373], and Apollo - University of Cambridge Repository

Subjects
cognition, Aged, 80 and over, Male, Coronary Angiography, Prognosis, United Kingdom, Electrocardiography, Risk Factors, non‐ST‐segment–elevation acute coronary syndrome, Prevalence, Humans, Cognitive Dysfunction, Female, Prospective Studies, Acute Coronary Syndrome, coronary artery disease, cognitive impairment, Aged, Follow-Up Studies
Abstract

Background Dementia is a growing health burden of an aging population. This study aims to evaluate the prevalence of cognitive impairment and the predictors of cognitive decline at 1 year in older patients with non-ST-elevation acute coronary syndrome undergoing invasive care. Methods and Results Older patients with non-ST-elevation acute coronary syndrome were recruited into the ICON1 study. Cognition was evaluated using Montreal Cognitive Assessment. The composite major adverse cardiovascular events comprised death, myocardial infarction, unplanned revascularization, stroke, and significant bleeding at 1 year. Of 298 patients, 271 had cognitive assessment at baseline, and 211 (78%) had follow-up Montreal Cognitive Assessment at 1 year. Mean age was 80.5±4.8 years. There was a high prevalence (n=130, 48.0%) of undiagnosed cognitive impairment (Montreal Cognitive Assessment score

Published
2019

24. Additional file 1: of ALternatives To prophylactic Antibiotics for the treatment of Recurrent urinary tract infection in women (ALTAR): study protocol for a multicentre, pragmatic, patient-randomised, non-inferiority trial

Author

Forbes, Rebecca, Ased Ali, Abouhajar, Alaa, Brennand, Catherine, Brown, Heather, Carnell, Sonya, Chadwick, Thomas, Eardley, Ian, Lecouturier, Jan, Mossop, Helen, Pearce, Ian, Pickard, Robert, Nikesh Thiruchelvam, Walton, Katherine, Wilkinson, Jennifer, and Harding, Chris

Subjects
behavioral disciplines and activities
Abstract

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 119 kb)

Published
2018
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26. Brief alcohol intervention for risky drinking in young people aged 14–15 years in secondary schools: the SIPS JR-HIGH RCT

Author

Giles, Emma L, primary, McGeechan, Grant J, additional, Coulton, Simon, additional, Deluca, Paolo, additional, Drummond, Colin, additional, Howel, Denise, additional, Kaner, Eileen, additional, McColl, Elaine, additional, McGovern, Ruth, additional, Scott, Stephanie, additional, Stamp, Elaine, additional, Sumnall, Harry, additional, Todd, Liz, additional, Vale, Luke, additional, Albani, Viviana, additional, Boniface, Sadie, additional, Ferguson, Jennifer, additional, Gilvarry, Eilish, additional, Hendrie, Nadine, additional, Howe, Nicola, additional, Mossop, Helen, additional, Ramsay, Amy, additional, Stanley, Grant, additional, and Newbury-Birch, Dorothy, additional

Published
2019
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28. Randomised, double-blind, placebo-controlled pilot trial of omeprazole in idiopathic pulmonary fibrosis

Author

Dutta, Prosenjit, primary, Funston, Wendy, additional, Mossop, Helen, additional, Ryan, Vicky, additional, Jones, Rhys, additional, Forbes, Rebecca, additional, Sen, Shilpi, additional, Pearson, Jeffrey, additional, Griffin, S Michael, additional, Smith, Jaclyn A, additional, Ward, Christopher, additional, Forrest, Ian A, additional, and Simpson, A John, additional

Published
2019
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29. Circulating Free DNA to Guide Prostate Cancer Treatment with PARP Inhibition

Author

Goodall, Jane, Mateo, Joaquin, Yuan, Wei, Mossop, Helen, Porta, Nuria, Miranda, Susana, Perez-Lopez, Raquel, Dolling, David, Robinson, Dan, Sandhu, Shahneen, Fowler, Gemma, Ebbs, Berni, Flohr, Penny, Seed, George, Rodrigues, Daniel Nava, Boysen, Gunther, Bertan, Claudia, Atkin, Mark, Clarke, Matthew, Crespo, Mateus, Figueiredo, Ines, Riisnaes, Ruth, Sumanasuriya, Semini, Rescigno, Pasquale, Zafeiriou, Zafeiris, Sharp, Adam, Tunariu, Nina, Bianchini, Diletta, Gillman, Alexa, Lord, Christopher J, Hall, Emma, Chinnaiyan, Arul M., Carreira, Suzanne, and de Bono, Johann S.

Subjects
Male, Humans, Prostatic Neoplasms, DNA, Poly(ADP-ribose) Polymerase Inhibitors, Cell-Free Nucleic Acids, Article, Biomarkers
Abstract

Biomarkers for a more precise patient care are needed in metastatic prostate cancer (mPC). We have reported a Phase II trial (TOPARP-A) of the poly(ADP)-ribose polymerase (PARP) inhibitor olaparib in mPC, demonstrating antitumor activity associating with homologous recombination DNA repair defects. We now report targeted and whole exome sequencing of serial circulating-free DNA (cfDNA) samples collected during this trial. Decreases in cfDNA concentration independently associated with outcome in multivariable analyses (HR for overall survival at week 8: 0.19; 95%CI 0.06-0.56 p=0.003). All tumor tissue somatic DNA repair mutations were detectable in cfDNA; allele frequency of somatic mutations decreased selectively in responding patients (Chi-squared p

Published
2017

30. ALternatives To prophylactic Antibiotics for the treatment of Recurrent urinary tract infection in women (ALTAR): study protocol for a multicentre, pragmatic, patient-randomised, non-inferiority trial

Author

Forbes, Rebecca, primary, Ali, Ased, additional, Abouhajar, Alaa, additional, Brennand, Catherine, additional, Brown, Heather, additional, Carnell, Sonya, additional, Chadwick, Thomas, additional, Eardley, Ian, additional, Lecouturier, Jan, additional, Mossop, Helen, additional, Pearce, Ian, additional, Pickard, Robert, additional, Thiruchelvam, Nikesh, additional, Walton, Katherine, additional, Wilkinson, Jennifer, additional, and Harding, Chris, additional

Published
2018
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31. Clinical Outcome of Prostate Cancer Patients with Germline DNA Repair Mutations: Retrospective Analysis from an International Study

Author

Mateo, Joaquin, primary, Cheng, Heather H., additional, Beltran, Himisha, additional, Dolling, David, additional, Xu, Wen, additional, Pritchard, Colin C., additional, Mossop, Helen, additional, Rescigno, Pasquale, additional, Perez-Lopez, Raquel, additional, Sailer, Verena, additional, Kolinsky, Michael, additional, Balasopoulou, Ada, additional, Bertan, Claudia, additional, Nanus, David M., additional, Tagawa, Scott T., additional, Thorne, Heather, additional, Montgomery, Bruce, additional, Carreira, Suzanne, additional, Sandhu, Shahneen, additional, Rubin, Mark A., additional, Nelson, Peter S., additional, and de Bono, Johann S., additional

Published
2018
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32. Clinical outcome of patients with germline DNA repair mutations: Results from a retrospective international study.

Author

Mateo, Joaquin, primary, Cheng, Heather H., additional, Beltran, Himisha, additional, Dolling, David, additional, Xu, Wen, additional, Pritchard, Colin, additional, Mossop, Helen, additional, Rescigno, Pasquale, additional, Perez-Lopez, Raquel, additional, Sailer, Verena, additional, Kolinsky, Michael Paul, additional, Balasopoulou, Ada, additional, Bertan, Claudia, additional, Carreira, Suzanne, additional, Thorne, Heather, additional, Montgomery, Robert B., additional, Sandhu, Shahneen Kaur, additional, Rubin, Mark A., additional, Nelson, Peter, additional, and De Bono, Johann S., additional

Published
2018
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34. Circulating Cell-Free DNA to Guide Prostate Cancer Treatment with PARP Inhibition

Author

Goodall, Jane, primary, Mateo, Joaquin, additional, Yuan, Wei, additional, Mossop, Helen, additional, Porta, Nuria, additional, Miranda, Susana, additional, Perez-Lopez, Raquel, additional, Dolling, David, additional, Robinson, Dan R., additional, Sandhu, Shahneen, additional, Fowler, Gemma, additional, Ebbs, Berni, additional, Flohr, Penny, additional, Seed, George, additional, Rodrigues, Daniel Nava, additional, Boysen, Gunther, additional, Bertan, Claudia, additional, Atkin, Mark, additional, Clarke, Matthew, additional, Crespo, Mateus, additional, Figueiredo, Ines, additional, Riisnaes, Ruth, additional, Sumanasuriya, Semini, additional, Rescigno, Pasquale, additional, Zafeiriou, Zafeiris, additional, Sharp, Adam, additional, Tunariu, Nina, additional, Bianchini, Diletta, additional, Gillman, Alexa, additional, Lord, Christopher J., additional, Hall, Emma, additional, Chinnaiyan, Arul M., additional, Carreira, Suzanne, additional, and de Bono, Johann S., additional

Published
2017
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35. Diffusion-weighted Imaging as a Treatment Response Biomarker for Evaluating Bone Metastases in Prostate Cancer: A Pilot Study

Author

Perez-Lopez, Raquel, primary, Mateo, Joaquin, additional, Mossop, Helen, additional, Blackledge, Matthew D., additional, Collins, David J., additional, Rata, Mihaela, additional, Morgan, Veronica A., additional, Macdonald, Alison, additional, Sandhu, Shahneen, additional, Lorente, David, additional, Rescigno, Pasquale, additional, Zafeiriou, Zafeiris, additional, Bianchini, Diletta, additional, Porta, Nuria, additional, Hall, Emma, additional, Leach, Martin O., additional, de Bono, Johann S., additional, Koh, Dow-Mu, additional, and Tunariu, Nina, additional

Published
2017
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36. Association of changes in circulating cell-free plasma DNA (cfDNA) and circulating tumor cells (CTC) during treatment with clinical outcome from olaparib in castration-resistant prostate cancer (CRPC): Exploratory analyses from the TOPARP-A trial.

Author

Mateo, Joaquin, primary, Mossop, Helen, additional, Goodall, Jane, additional, Lorente, David, additional, Porta, Nuria, additional, Carreira, Suzanne, additional, Miranda, Susana, additional, Zafeiriou, Zafeiris, additional, Ralph, Christy, additional, Jain, Suneil, additional, Jones, Robert J., additional, Hussain, Syed A., additional, Elliott, Tony, additional, Protheroe, Andrew, additional, Ebbs, Berni, additional, Leonard, Lorna, additional, Bianchini, Diletta, additional, Flohr, Penelope, additional, Hall, Emma, additional, and De Bono, Johann S., additional

Published
2017
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38. 5-year patient-reported outcomes of bowel and urinary bother in the CHHiP trial (CRUK/06/016).

Author

Dearnaley, David P., primary, Mossop, Helen, additional, Syndikus, Isabel, additional, Khoo, Vincent, additional, Bloomfield, DJ, additional, Parker, Chris C., additional, Logue, John, additional, Scrase, Christopher D, additional, Birtle, Alison J., additional, Staffurth, John, additional, Malik, Zafar, additional, Panades, Miguel, additional, Eswar, Chinnamani, additional, Graham, John, additional, Russell, J. Martin, additional, Gao, Annie, additional, Wilkins, Anna, additional, Cruickshank, Clare, additional, Griffin, Clare, additional, and Hall, Emma, additional

Published
2017
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39. Abstract 4340: DNA repair genes aberrations in germline DNA in metastatic castration-resistant prostate cancer patients

Author

MATEO, JOAQUIN, primary, Carreira, Suzanne, additional, Mossop, Helen, additional, Rescigno, Pasquale, additional, Kolinsky, Michael, additional, Castro, Elena, additional, Balasopoulou, Ada, additional, Hunt, Jo, additional, Roda, Desamparados, additional, Bertan, Claudia, additional, Goodall, Jane, additional, Miranda, Susana, additional, Flohr, Penny, additional, Porta, Nuria, additional, Kote-Jarai, Zsofia, additional, Olmos, David, additional, Lord, Christopher J., additional, Hall, Emma, additional, Eeles, Ros, additional, and de Bono, Johann S., additional

Published
2016
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40. Abstract 3973: Diffusion-weighted imaging of bone metastases as treatment response biomarker in prostate cancer

Author

Perez-Lopez, Raquel, primary, Blackledge, Matthew D., additional, Mossop, Helen, additional, Mateo, Joaquin, additional, Collins, David, additional, Morgan, Veronica A., additional, McDonald, Alison, additional, Sandhu, Shahneen, additional, Omlin, Aurelius, additional, Bianchini, Diletta, additional, Zafeiriou, Zafeiris, additional, Rescigno, Pasquale, additional, Kolinsky, Michael, additional, Nava Rodrigues, Daniel, additional, Flohr, Penny, additional, Ebbs, Berni, additional, Fowler, Gemma, additional, Porta, Nuria, additional, Hall, Emma, additional, Leach, Martin, additional, de Bono, Johann S., additional, Koh, Dow-Mu, additional, and Tunariu, Nina, additional

Published
2016
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41. Comparison of hypofractionated high-dose intensity-modulated radiotherapy schedules for prostate cancer: Results from the phase III randomized CHHiP trial (CRUK/06/016).

Author

Dearnaley, David P., primary, Syndikus, Isabel, additional, Mossop, Helen, additional, Birtle, Alison J., additional, Bloomfield, DJ, additional, Cruickshank, Clare, additional, Graham, John, additional, Hassan, Shama, additional, Khoo, Vincent, additional, Logue, John P., additional, Mayles, Helen, additional, Money-Kyrle, Julian, additional, Naismith, Olivia Frances, additional, Panades, Miguel, additional, Patterson, Helen, additional, Scrase, Christopher D, additional, Staffurth, John, additional, Tremlett, Jean, additional, Griffin, Clare, additional, and Hall, Emma, additional

Published
2016
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42. Abstract CT322: DNA repair defects and antitumor activity with PARP inhibition: TOPARP, a phase II trial of olaparib in metastatic castration resistant prostate cancer

Author

Mateo, Joaquin, primary, Sandhu, Shahneen, additional, Miranda, Susana, additional, Carreira, Suzanne, additional, Jain, Suneil, additional, Ralph, Christy, additional, Protheroe, Andrew, additional, Hussain, Syed, additional, Jones, Robert, additional, Elliot, Tony, additional, McGovern, Ursula, additional, Gillman, Alexa, additional, Paulding, Claire, additional, Mossop, Helen, additional, Porta, Nuria, additional, Bianchini, Diletta, additional, Zafeiriou, Zafeiris, additional, Boysen, Gunther, additional, Nava Rodrigues, Daniel, additional, Flohr, Penelope, additional, Seed, George, additional, Goodall, Jane, additional, Figueiredo, Ines, additional, Perez-Lopez, Raquel, additional, Tunariu, Nina, additional, Omlin, Aurelius, additional, Ferraldeschi, Roberta, additional, Kunju, Lakshmi P., additional, Eeles, Rosalind, additional, Attard, Gerhardt, additional, Robinson, Dan, additional, Chinnaiyan, Arul, additional, Hall, Emma, additional, and de Bono, Johann S., additional

Published
2015
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43. Clinical Outcome of Prostate Cancer Patients with Germline DNA Repair Mutations: Retrospective Analysis from an International Study

Author

Mateo, Joaquin, Cheng, Heather H, Beltran, Himisha, Dolling, David, Xu, Wen, Pritchard, Colin C, Mossop, Helen, Rescigno, Pasquale, Perez-Lopez, Raquel, Sailer, Verena, Kolinsky, Michael, Balasopoulou, Ada, Bertan, Claudia, Nanus, David M, Tagawa, Scott T, Thorne, Heather, Montgomery, Bruce, Carreira, Suzanne, Sandhu, Shahneen, Rubin, Mark Andrew, Nelson, Peter S, and De Bono, Johann S

Subjects
610 Medicine & health, 3. Good health
Abstract

BACKGROUND Germline DNA damage repair gene mutation (gDDRm) is found in >10% of metastatic prostate cancer (mPC). Their prognostic and predictive impact relating to standard therapies is unclear. OBJECTIVE To determine whether gDDRm status impacts benefit from established therapies in mPC. DESIGN, SETTING, AND PARTICIPANTS This is a retrospective, international, observational study. Medical records were reviewed for 390 mPC patients with known gDDRm status. All 372 patients from Royal Marsden (UK), Weill-Cornell (NY), and University of Washington (WA) were previously included in a prevalence study (Pritchard, NEJM 2016); the remaining 18 were gBRCA1/2m carriers, from the kConFab consortium, Australia. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Response rate (RR), progression-free survival (PFS), and overall survival (OS) data were collected. To account for potential differences between cohorts, a mixed-effect model (Weibull distribution) with random intercept per cohort was used. RESULTS AND LIMITATIONS The gDDRm status was known for all 390 patients (60 carriers of gDDRm [gDDRm+], including 37 gBRCA2m, and 330 cases not found to carry gDDRm [gDDRm-]); 74% and 69% were treated with docetaxel and abiraterone/enzalutamide, respectively, and 36% received PARP inhibitors (PARPi) and/or platinum. Median OS from castration resistance was similar among groups (3.2 vs 3.0 yr, p=0.73). Median docetaxel PFS for gDDRm+ (6.8 mo) was not significantly different from that for gDDRm- (5.1 mo), and RRs were similar (gDDRm+=61%; gDDRm-=54%). There were no significant differences in median PFS and RR on first-line abiraterone/enzalutamide (gDDRm+=8.3 mo, gDDRm-=8.3 mo; gDDRm+=46%, gDDRm-=56%). Interaction test for PARPi/platinum and gDDRm+ resulted in an OS adjusted hazard ratio of 0.59 (95% confidence interval 0.28-1.25; p=0.17). Results are limited by the retrospective nature of the analysis. CONCLUSIONS mPC patients with gDDRm appeared to benefit from standard therapies similarly to the overall population; prospective studies are ongoing to investigate the impact of PARPi/platinum. PATIENT SUMMARY Patients with inherited DNA repair mutations benefit from standard therapies similarly to other metastatic prostate cancer patients.

44. Invasive Treatment Strategy for Older Patients with Myocardial Infarction.

Author

Kunadian V, Mossop H, Shields C, Bardgett M, Watts P, Teare MD, Pritchard J, Adams-Hall J, Runnett C, Ripley DP, Carter J, Quigley J, Cooke J, Austin D, Murphy J, Kelly D, McGowan J, Veerasamy M, Felmeden D, Contractor H, Mutgi S, Irving J, Lindsay S, Galasko G, Lee K, Sultan A, Dastidar AG, Hussain S, Haq IU, de Belder M, Denvir M, Flather M, Storey RF, Newby DE, Pocock SJ, and Fox KAA

Abstract

Background: Whether a conservative strategy of medical therapy alone or a strategy of medical therapy plus invasive treatment is more beneficial in older adults with non-ST-segment elevation myocardial infarction (NSTEMI) remains unclear., Methods: We conducted a prospective, multicenter, randomized trial involving patients 75 years of age or older with NSTEMI at 48 sites in the United Kingdom. The patients were assigned in a 1:1 ratio to a conservative strategy of the best available medical therapy or an invasive strategy of coronary angiography and revascularization plus the best available medical therapy. Patients who were frail or had a high burden of coexisting conditions were eligible. The primary outcome was a composite of death from cardiovascular causes (cardiovascular death) or nonfatal myocardial infarction assessed in a time-to-event analysis., Results: A total of 1518 patients underwent randomization; 753 patients were assigned to the invasive-strategy group and 765 to the conservative-strategy group. The mean age of the patients was 82 years, 45% were women, and 32% were frail. A primary-outcome event occurred in 193 patients (25.6%) in the invasive-strategy group and 201 patients (26.3%) in the conservative-strategy group (hazard ratio, 0.94; 95% confidence interval [CI], 0.77 to 1.14; P = 0.53) over a median follow-up of 4.1 years. Cardiovascular death occurred in 15.8% of the patients in the invasive-strategy group and 14.2% of the patients in the conservative-strategy group (hazard ratio, 1.11; 95% CI, 0.86 to 1.44). Nonfatal myocardial infarction occurred in 11.7% in the invasive-strategy group and 15.0% in the conservative-strategy group (hazard ratio, 0.75; 95% CI, 0.57 to 0.99). Procedural complications occurred in less than 1% of the patients., Conclusions: In older adults with NSTEMI, an invasive strategy did not result in a significantly lower risk of cardiovascular death or nonfatal myocardial infarction (the composite primary outcome) than a conservative strategy over a median follow-up of 4.1 years. (Funded by the British Heart Foundation; BHF SENIOR-RITA ISRCTN Registry number, ISRCTN11343602.)., (Copyright © 2024 Massachusetts Medical Society.)

Published
2024
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45. Cost-effectiveness of methenamine hippurate compared with antibiotic prophylaxis for the management of recurrent urinary tract infections in secondary care: a multicentre, open-label, randomised, non-inferiority trial.

Author

King W, Homer T, Harding C, Mossop H, Chadwick T, Abouhajar A, and Vale L

Subjects
Humans, Female, Middle Aged, Adult, Recurrence, United Kingdom, Anti-Bacterial Agents economics, Anti-Bacterial Agents therapeutic use, Aged, Urinary Tract Infections prevention & control, Urinary Tract Infections economics, Urinary Tract Infections drug therapy, Cost-Benefit Analysis, Hippurates, Methenamine analogs & derivatives, Methenamine therapeutic use, Methenamine economics, Quality-Adjusted Life Years, Antibiotic Prophylaxis economics, Antibiotic Prophylaxis methods
Abstract

Objectives: To estimate the cost-effectiveness of methenamine hippurate compared with antibiotic prophylaxis in the management of recurrent urinary tract infections., Design: Multicentre, open-label, randomised, non-inferiority trial., Setting: Eight centres in the UK, recruiting from June 2016 to June 2018., Participants: Women aged ≥18 years with recurrent urinary tract infections, requiring prophylactic treatment., Interventions: Women were randomised to receive once-daily antibiotic prophylaxis or twice-daily methenamine hippurate for 12 months. Treatment allocation was not masked and crossover between arms was allowed., Primary and Secondary Outcome Measures: The primary economic outcome was the incremental cost per quality-adjusted life year (QALY) gained at 18 months. All costs were collected from a UK National Health Service perspective. QALYs were estimated based on responses to the EQ-5D-5L administered at baseline, 3, 6, 9, 12 and 18 months. Incremental costs and QALYs were estimated using an adjusted analysis which controlled for observed and unobserved characteristics. Stochastic sensitivity analysis was used to illustrate uncertainty on a cost-effectiveness plane and a cost-effectiveness acceptability curve. A sensitivity analysis, not specified in the protocol, considered the costs associated with antibiotic resistance., Results: Data on 205 participants were included in the economic analysis. On average, methenamine hippurate was less costly (-£40; 95% CI: -684 to 603) and more effective (0.014 QALYs; 95% CI: -0.05 to 0.07) than antibiotic prophylaxis. Over the range of values considered for an additional QALY, the probability of methenamine hippurate being considered cost-effective ranged from 51% to 67%., Conclusions: On average, methenamine hippurate was less costly and more effective than antibiotic prophylaxis but these results are subject to uncertainty. Methenamine hippurate is more likely to be considered cost-effective when the benefits of reduced antibiotic use were included in the analysis., Trial Registration Number: ISRCTN70219762., Competing Interests: Competing interests: CH reports personal fees from Astellas Pharma (Tokyo, Japan), Medtronic plc (Dublin, Ireland), Allergan Ltd (Dublin, Ireland), GlaxoSmithKline plc (Brentford, UK), Teleflex Medical Inc (Temecula, California, USA), Viatris (Canonsburg, Pennsylvania, USA) and grants from Medtronic plc, the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme (HTA 15/40/05) and The Urology Foundation (London, UK) outside the submitted work. LV reports being the co-ordinating editor of Cochrane Incontinence (from 2016) and being a member of NIHR HTA, Clinical Evaluation and Trials Panel from 2015 to 2018. TC reports grants from the NIHR HTA programme (HTA 16/154/01, HTA 15/130/94 and HTA 11/72/01) during the conduct of the study., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2024
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46. Evaluation of erectile potency and radiation dose to the penile bulb using image guided radiotherapy in the CHHiP trial.

Author

Murray J, Gulliford S, Griffin C, Wilkins A, Syndikus I, Staffurth J, Panades M, Scrase C, Parker C, Khoo V, Dean J, Mayles H, Mayles P, Thomas S, Naismith O, Mossop H, Cruickshank C, Hall E, and Dearnaley D

Abstract

Background and Purpose: The penile bulb (PB) dose may be critical in development of post prostate radiotherapy erectile dysfunction (ED). This study aimed to generate PB dose constraints based on dose-volume histograms (DVHs) in patients treated with prostate radiotherapy, and to identify clinical and dosimetric parameters that predict the risk of ED post prostate radiotherapy., Materials and Methods: Penile bulb DVHs were generated for 276 patients treated within the randomised IGRT substudy of the multicentre randomised trial, CHHiP. Incidence of ED in relation to dose and randomised IGRT groups were evaluated using Wilcoxon rank sum, Chi-squared test and atlases of complication incidence. Youden index was used to find dose-volume constraints that discriminated for ED. Multivariate analysis (MVA) of effect of dosimetry, clinical and patient-related variables was performed., Results: Reduced treatment margins using IGRT (IGRT-R) produced significantly reduced mean PB dose compared with standard margins (IGRT-S) (median: 25 Gy (IGRT-S) versus 11 Gy (IGRT-R); p < 0.0001). Significant difference in both mean (median: 23 Gy (ED) vs. 18 Gy (no ED); p = 0.011) and maximum (median: 59 Gy (ED) vs. 52 Gy (no ED); p = 0.018) PB doses between those with and without clinician reported ED were identified. Mean PB dose cut-point for ED was derived at around 20 Gy. On MVA, PB mean dose and age predicted for impotence., Conclusion: PB dose appears predictive of post-radiotherapy ED with calculated threshold mean dose of around 20 Gy, substantially lower than published recommendations. IGRT-R enables favourable PB dosimetry and can be recommended provided prostate coverage is not compromised., (© 2020 The Authors.)

Published
2019
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47. Brief alcohol intervention for risky drinking in young people aged 14–15 years in secondary schools: the SIPS JR-HIGH RCT

Author

Giles EL, McGeechan GJ, Coulton S, Deluca P, Drummond C, Howel D, Kaner E, McColl E, McGovern R, Scott S, Stamp E, Sumnall H, Todd L, Vale L, Albani V, Boniface S, Ferguson J, Gilvarry E, Hendrie N, Howe N, Mossop H, Ramsay A, Stanley G, and Newbury-Birch D

Abstract

Background: Adverse effects from young people’s alcohol consumption manifest in a range of physical and psychosocial factors, including neurological issues, cognitive impairment and risk-taking behaviours. The SIPS JR-HIGH pilot trial showed alcohol screening and brief intervention (ASBI) to be acceptable to young people and schools in the north-east of England., Objectives: To conduct a two-arm, individually randomised controlled trial to evaluate the effectiveness and cost-effectiveness of ASBI for risky drinking in young people aged 14–15 years in the school setting, to monitor the fidelity of ASBI and to explore the barriers to, and facilitators of, implementation with staff, young people and parents., Design: A baseline survey with a 12-month follow-up. Interviews with 30 school staff, 21 learning mentors and nine teachers, and 33 young people and two parents., Setting: Thirty state schools in four areas of England: north-east, north-west, Kent and London., Participants: Year 10 school pupils who consented to the study (aged 14–15 years, recruited between November 2015 and June 2016), school-based staff and parents of the young people who took part in the study., Interventions: Young people who screened positively on a single alcohol screening question and consented were randomised to the intervention or control arm (blinded). The intervention was a 30-minute one-to-one structured brief intervention with a trained learning mentor and an alcohol leaflet. The control group received a healthy lifestyle leaflet (no alcohol information)., Main Outcome Measures: The primary outcome measure was total alcohol consumed in the last 28 days. Secondary outcomes related to risky drinking, general psychological health, sexual risk-taking, energy drink consumption, age of first smoking, quality of life, quality-adjusted life-years, service utilisation and demographic information., Results: A total of 4523 young people completed the baseline survey, with 1064 screening positively (24%) and 443 being eligible to take part in the trial. Of those 443, 233 (53%) were randomised to the control arm and 210 were randomised to the intervention arm. Of the 443, 374 (84%) were successfully followed up at 12 months (intervention, n  = 178; control, n  = 196). The results were that the intervention showed no evidence of benefit for any alcohol-related measure when compared with the control arm. At 12 months we found a reduction from 61.9% to 43.3% using the Alcohol Use Disorders Identification Test cut-off point of 8 and cut-off point of 4 (69.0% to 60.7%). These results were not significant. A cost-effectiveness analysis showed that the average net cost saving of the brief intervention was £2865 (95% confidence interval –£11,272 to £2707) per year compared with usual practice, with the intervention showing a 76% probability of being cost saving compared with usual practice. The interview findings showed that school was an acceptable setting to carry out ASBI among staff and young people., Limitations: Recruitment of parents to take part in interviews was poor. Only 18 ASBI sessions were recorded, making it difficult to assess internal validity., Conclusions: Although the intervention was ineffective in reducing risky drinking in young people aged 14–15 years, it was well received by the young people and school staff who participated., Future Work: Uniform reporting of the outcomes used for ASBI would generate more robust conclusions on the effectiveness of ASBI in the future. Pilot feasibility studies should include more than one geographical area. Future work on involving parents is needed., Trial Registration: Current Controlled Trials ISRCTN45691494., Funding: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research ; Vol. 7, No. 9. See the NIHR Journals Library website for further project information., (Copyright © Queen’s Printer and Controller of HMSO 2019. This work was produced by Giles et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.)

Published
2019
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