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1. Safety and efficacy of tamoxifen in boys with Duchenne muscular dystrophy (TAMDMD): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Author

Ridout, Deborah, Muntoni, Francesco, Manzur, Adnan., Quinlivan, Rosaline, Baranello, Giovanni, Main, Marion, Abbott, Lianne, Burnett, Nicola, Rohwer, Anne-Marie, Milev, Evelin, Wolfe, Adrian, O'Reilly, Emer, Straub, Volker, Guglieri, Michela, Bettolo, Chiara, Muni-Lofra, Robert, James, Meredith, Sodhi, Jassi, Willis, Tracey, Wright, Elizabeth, Rylance, Claire, Birchall, Nicola, Childs, Anne-Marie, Pysden, Karen, Martos-Lozano, Cristina, Pallant, Lindsey, Wadsworth, Steph, Spinty, Stefan, Madhu, Rajesh, Karuvattil, Rajesh, Gregson, Sarah, Clark, Stuart, Wraige, Elizabeth, Jungbluth, Heinz, Gowda, Vasantha, Vanegas, Maria, Sheehan, Ennie, Wolfe, Amy, Schofield, Alex, Hughes, Imelda, McCullagh, Gary, Whitehouse, Emily, Varma, Uma., Warner, Sinead, Reading, Emily, Benson, Lucy., Moustoukas, Jenny, Strachan, Kate, Emery, Nicholas, Ong, Min, Atherton, Mark, Durso, Sarah, White, Kay, Hinde, Neil, Skone, Kate, Sanchez Marco, Silvia, Saxena, Anurag, Gibbon, Frances, TeWaterNaude, Johann, Davis, Hayley, Thompson, Laura, Majumdar, Anirban, Murugan, Archana, Lynch, Mollie, Milton, Emily, Guarino, Iolanda, Tomlinson, Richard, Jarvis, Heather, Berry, Jane, Wills, Lucy, Frimpong-Ansah, Claire, Watson, Jackie, Robertson, Gemma, Cobb, Gavin, Burslem, Julie, Horrocks, Iain, Wong, Jarod, Brunklaus, Andreas, DiMarco, Marina, Brown, Sarah, Mckenzie, Susanne, Torne, Krupa, Mohamed, Rana, Velmurugan, Vel, Prasad, Manish, Sedehizadeh, Saam, Williamson, Sarah, Fenty, Paula, Degoede, Christian, Parkes, Amy, Illingworth, Marjorie, Bhangu, Neeraj, Geary, Michelle, Palmer, Jenni, Shill, Catherine, White, Cathy, Greenfield, Kathryn, Tomos, Heledd, Gates, Sarah, Tirupathi, Sandya, Shah, Ayaz, O'Donoghue, Dara, McVeigh, Janine, McFetridge, Jaci, Nic Fhirleinn, Grainne, Hussain, Nahin, Baskaran, Dhinesh, Lambat, Zubeida, Ambegaonkar, Gautam, Krishnakumar, Deepa, Taylor, Jacqui, Moores, Jo, Stephen, Elma, Tewnion, Jane, Ramdas, Sithara, Sa, Mario, Servais, Laurent, Lilien, Charlotte, Ramjattan, Hayley, Taylor, Francesca, English, Hayley, Parasuraman, Deepak, Rabb, Rosanna, McMurchie, Heather, Henzi, Bettina C, Schmidt, Simone, Nagy, Sara, Rubino-Nacht, Daniela, Schaedelin, Sabine, Putananickal, Niveditha, Stimpson, Georgia, Amthor, Helge, Deconinck, Nicolas, de Groot, Imelda, Houwen-van Opstal, Saskia, Laugel, Vincent, Lopez Lobato, Mercedes, Madruga Garrido, Marcos, Nascimento Osorio, Andrés, Schara-Schmidt, Ulrike, von Moers, Arpad, Lawrence, Fiona, Hafner, Patricia, Dorchies, Olivier M, and Fischer, Dirk

Published
2023
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2. Safety and efficacy of tamoxifen in boys with Duchenne muscular dystrophy (TAMDMD): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Author

Henzi, Bettina C, primary, Schmidt, Simone, additional, Nagy, Sara, additional, Rubino-Nacht, Daniela, additional, Schaedelin, Sabine, additional, Putananickal, Niveditha, additional, Stimpson, Georgia, additional, Amthor, Helge, additional, Childs, Anne-Marie, additional, Deconinck, Nicolas, additional, de Groot, Imelda, additional, Horrocks, Iain, additional, Houwen-van Opstal, Saskia, additional, Laugel, Vincent, additional, Lopez Lobato, Mercedes, additional, Madruga Garrido, Marcos, additional, Nascimento Osorio, Andrés, additional, Schara-Schmidt, Ulrike, additional, Spinty, Stefan, additional, von Moers, Arpad, additional, Lawrence, Fiona, additional, Hafner, Patricia, additional, Dorchies, Olivier M, additional, Fischer, Dirk, additional, Ridout, Deborah, additional, Muntoni, Francesco, additional, Manzur, Adnan., additional, Quinlivan, Rosaline, additional, Baranello, Giovanni, additional, Main, Marion, additional, Abbott, Lianne, additional, Burnett, Nicola, additional, Rohwer, Anne-Marie, additional, Milev, Evelin, additional, Wolfe, Adrian, additional, .O'Reilly, Emer, additional, Straub, Volker, additional, Guglieri, Michela, additional, Bettolo, Chiara, additional, Muni-Lofra, Robert, additional, James, Meredith, additional, Sodhi, Jassi, additional, Willis, Tracey, additional, Wright, Elizabeth, additional, Rylance, Claire, additional, Birchall, Nicola, additional, Pysden, Karen, additional, Martos-Lozano, Cristina, additional, Pallant, Lindsey, additional, Wadsworth, Steph, additional, Madhu, Rajesh, additional, Karuvattil, Rajesh, additional, Gregson, Sarah, additional, Clark, Stuart, additional, Wraige, Elizabeth, additional, Jungbluth, Heinz, additional, Gowda, Vasantha, additional, Vanegas, Maria, additional, Sheehan, Ennie, additional, Wolfe, Amy, additional, Schofield, Alex, additional, Hughes, Imelda, additional, McCullagh, Gary, additional, Whitehouse, Emily, additional, Varma, Uma., additional, Warner, Sinead, additional, Reading, Emily, additional, Benson, Lucy., additional, Moustoukas, Jenny, additional, Strachan, Kate, additional, Emery, Nicholas, additional, Ong, Min, additional, Atherton, Mark, additional, Durso, Sarah, additional, White, Kay, additional, Hinde, Neil, additional, Skone, Kate, additional, Sanchez Marco, Silvia, additional, Saxena, Anurag, additional, Gibbon, Frances, additional, TeWaterNaude, Johann, additional, Davis, Hayley, additional, Thompson, Laura, additional, Majumdar, Anirban, additional, Murugan, Archana, additional, Lynch, Mollie, additional, Milton, Emily, additional, Guarino, Iolanda, additional, Tomlinson, Richard, additional, Jarvis, Heather, additional, Berry, Jane, additional, Wills, Lucy, additional, Frimpong-Ansah, Claire, additional, Watson, Jackie, additional, Robertson, Gemma, additional, Cobb, Gavin, additional, Burslem, Julie, additional, Wong, Jarod, additional, Brunklaus, Andreas, additional, DiMarco, Marina, additional, Brown, Sarah, additional, Mckenzie, Susanne, additional, Torne, Krupa, additional, Mohamed, Rana, additional, Velmurugan, Vel, additional, Prasad, Manish, additional, Sedehizadeh, Saam, additional, Williamson, Sarah, additional, Fenty, Paula, additional, Degoede, Christian, additional, Parkes, Amy, additional, Illingworth, Marjorie, additional, Bhangu, Neeraj, additional, Geary, Michelle, additional, Palmer, Jenni, additional, Shill, Catherine, additional, White, Cathy, additional, Greenfield, Kathryn, additional, Tomos, Heledd, additional, Gates, Sarah, additional, Tirupathi, Sandya, additional, Shah, Ayaz, additional, O'Donoghue, Dara, additional, McVeigh, Janine, additional, .McFetridge, Jaci, additional, Nic Fhirleinn, Grainne, additional, Hussain, Nahin, additional, Baskaran, Dhinesh, additional, Lambat, Zubeida, additional, Ambegaonkar, Gautam, additional, Krishnakumar, Deepa, additional, Taylor, Jacqui, additional, Moores, Jo, additional, Stephen, Elma, additional, Tewnion, Jane, additional, Ramdas, Sithara, additional, Sa, Mario, additional, Servais, Laurent, additional, Lilien, Charlotte, additional, Ramjattan, Hayley, additional, Taylor, Francesca, additional, English, Hayley, additional, Parasuraman, Deepak, additional, Rabb, Rosanna, additional, and McMurchie, Heather, additional

Published
2023
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3. Radiotherapy for Prostate Cancer: is it ‘what you do’ or ‘the way that you do it’? A UK Perspective on Technique and Quality Assurance

Author

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

Published
2016
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7. Ten-year mortality, disease progression, and treatment-related side effects in men with localised prostate cancer from the ProtecT randomised controlled trial according to treatment received

Author

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

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

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

Published
2020

11. Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life

Author

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

Subjects
Male, Urological Oncology, functional status, law.invention, Prostate cancer, 0302 clinical medicine, Randomized controlled trial, Quality of life, law, 030212 general & internal medicine, media_common, treatment, Middle Aged, Urology & Nephrology, prostate cancer, Treatment Outcome, Centre for Surgical Research, 030220 oncology & carcinogenesis, Functional status, BRTC, Sexuality, medicine.medical_specialty, Urology, Urinary system, media_common.quotation_subject, Urination, Social class, BTC (Bristol Trials Centre), 03 medical and health sciences, ProtecT trial, Digestive System Physiological Phenomena, Internal medicine, medicine, Humans, Patient Reported Outcome Measures, Aged, business.industry, Prostatic Neoplasms, 1103 Clinical Sciences, protect trial, medicine.disease, Treatment, ISRCTN 20141297, Physical therapy, Quality of Life, Sexual function, business
Abstract

Objectives To present the baseline patient-reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localized prostate cancer and to compare results with other populations. Materials and Methods A total of 1643 randomized men, aged 50–69 years and diagnosed with clinically localized disease identified by prostate-specific antigen (PSA) testing, in nine UK cities in the period 1999–2009 were included. Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific impact on quality of life (Expanded Prostate Index Composite [EPIC], 2005 onwards; International Consultation on Incontinence Questionnaire- Urinary Incontinence [ICIQ-UI], 2001 onwards; the International Continence Society short-form male survey [ICSmaleSF]; anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), generic mental and physical health (12-item short-form health survey [SF-12]; EuroQol quality-of-life survey, the EQ-5D-3L) were assessed at prostate biopsy clinics before randomization. Descriptive statistics are presented by treatment allocation and by men’s age at biopsy and PSA testing time points for selected measures. Results A total of 1438 participants completed biopsy questionnaires (88%) and 77–88% of these were analysed for individual PROMs. Fewer than 1% of participants were using pads daily (5/ 754). Storage lower urinary tract symptoms were frequent (e.g. nocturia 22%, 312/1423). Bowel symptoms were rare, except for loose stools (16%, 118/754). One third of participants reported erectile dysfunction (241/735) and for 16% (118/731) this was a moderate or large problem. Depression was infrequent (80/1399, 6%) but 20% of participants (278/1403) reported anxiety. Sexual function and bother were markedly worse in older men (65– 70 years), whilst urinary bother and physical health were somewhat worse than in younger men (49–54 years, all P < 0.001). Bowel health, urinary function and depression were unaltered by age, whilst mental health and anxiety were better in older men (P < 0.001). Only minor differences existed in mental or physical health, anxiety and depression between PSA testing and biopsy assessments. Conclusion The ProtecT trial baseline PROMs response rates were high. Symptom frequencies and generic quality of life were similar to those observed in populations screened for prostate cancer and control subjects without cancer.

Published
2016

17. Radiotherapy for Prostate Cancer: is it ‘what you do’ or ‘the way that you do it’? A UK Perspective on Technique and Quality Assurance

Author

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

Published
2016
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18. Quality assurance of the SCOPE 1 trial in oesophageal radiotherapy.

Author

Wills, Lucy, Maggs, Rhydian, Lewis, Geraint, Jones, Gareth, Nixon, Lisette, Staffurth, John, Crosby, Tom, and SCOPE 1 trial management group and collaborators

Subjects
*ESOPHAGEAL abnormalities, *RADIOTHERAPY, *ELECTROTHERAPEUTICS, *ESOPHAGUS diseases, *HOSPITAL radiological services
Abstract

Background: SCOPE 1 was the first UK based multi-centre trial involving radiotherapy of the oesophagus. A comprehensive radiotherapy trials quality assurance programme was launched with two main aims: 1. To assist centres, where needed, to adapt their radiotherapy techniques in order to achieve protocol compliance and thereby enable their participation in the trial. 2. To support the trial's clinical outcomes by ensuring the consistent planning and delivery of radiotherapy across all participating centres.Methods: A detailed information package was provided and centres were required to complete a benchmark case in which the delineated target volumes and organs at risk, dose distribution and completion of a plan assessment form were assessed prior to recruiting patients into the trial. Upon recruiting, the quality assurance (QA) programme continued to monitor the outlining and planning of radiotherapy treatments. Completion of a questionnaire was requested in order to gather information about each centre's equipment and techniques relating to their trial participation and to assess the impact of the trial nationally on standard practice for radiotherapy of the oesophagus. During the trial, advice was available for individual planning issues, and was circulated amongst the SCOPE 1 community in response to common areas of concern using bulletins.Results: 36 centres were supported through QA processes to enable their participation in SCOPE1. We discuss the issues which have arisen throughout this process and present details of the benchmark case solutions, centre questionnaires and on-trial protocol compliance. The range of submitted benchmark case GTV volumes was 29.8-67.8cm3; and PTV volumes 221.9-513.3 cm3. For the dose distributions associated with these volumes, the percentage volume of the lungs receiving 20Gy (V20Gy) ranged from 20.4 to 33.5%. Similarly, heart V40Gy ranged from 16.1 to 33.0%. Incidence of incorrect outlining of OAR volumes increased from 50% of centres at benchmark case, to 64% on trial. Sixty-five percent of centres, who returned the trial questionnaire, stated that their standard practice had changed as a result of their participation in the SCOPE1 trial.Conclusions: The SCOPE 1 QA programme outcomes lend support to the trial's clinical conclusions. The range of patient planning outcomes for the benchmark case indicated, at the outset of the trial, the significant degree of variation present in UK oesophageal radiotherapy planning outcomes, despite the presence of a protocol. This supports the case for increasingly detailed definition of practice by means of consensus protocols, training and peer review. The incidence of minor inconsistencies of technique highlights the potential for improved QA systems and the need for sufficient resource for this to be addressed within future trials. As indicated in questionnaire responses, the QA exercise as a whole has contributed to greater consistency of oesophageal radiotherapy in the UK via the adoption into standard practice of elements of the protocol.Trial Registration: The SCOPE1 trial is an International Standard Randomized Controlled Trial, ISRCTN47718479 . [ABSTRACT FROM AUTHOR]

Published
2017
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20. The Lancet

Author

WILLS, LUCY, primary, CLUTTERBUCK, P.W., additional, and EVANS, B.D.F., additional

Published
2009
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43. MEMORIAL TO DR. IRIS FOX.

Author

Barrett, FlorenceE., primary, Henry Dible, J., additional, Fox, Hilda, additional, Halliday, HildaM., additional, Shattock, ClementE., additional, Winifred Sturge, H., additional, and Wills, Lucy, additional

Published
1928
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