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1. Acceptance and Commitment Therapy plus usual care for improving quality of life in people with motor neuron disease (COMMEND): a multicentre, parallel, randomised controlled trial in the UK

Author

Andreou, Penny, Androulaki-Korakaki, Dynameni, Blakeley, Claire, Bridges, Gary, Campbell, Iain, Davenport, Brittany, Dee, Annily, Drewry, Nicola, Flood, John, Fox, Annemieke, Girling, Melissa, Glew, Ruth, Hartley, Nick, Hocking, Sian, Howell, Mark, Keetharuth, Anju, Makin, Selina, Marsh, Jessica, Mayberry, Emily, McDonald, Alexa, McPartland, Roy, Meldrum, Steven, Mobley, Amanda, Murphy, Donnchadh, O'Brien, Marie Claire, Oliver, Mark, Patel, Darshna, Phipps, Emma, Read, Jessica, Roberts, Rhys, Rooney, Natasha, Smith, Carla, Statham, Jo, Thompson, Cara, Varma, Priya, Walker, Anne Marie, Waterhouse, Simon, Gould, Rebecca L, McDermott, Christopher J, Thompson, Benjamin J, Rawlinson, Charlotte V, Bursnall, Matt, Bradburn, Mike, Kumar, Pavithra, Turton, Emily J, White, David A, Serfaty, Marc A, Graham, Christopher D, McCracken, Lance M, Goldstein, Laura H, Al-Chalabi, Ammar, Orrell, Richard W, Williams, Tim, Noad, Rupert, Baker, Idris, Faull, Christina, Lambert, Thomas, Chhetri, Suresh K, Ealing, John, Hanratty, Anthony, Radunovic, Aleksandar, Gunawardana, Nushan, Meadows, Gail, Gorrie, George H, Young, Tracey, Lawrence, Vanessa, Cooper, Cindy, Shaw, Pamela J, and Howard, Robert J

Published
2024
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2. The MAGIC trial: a pragmatic, multicentre, parallel, noninferiority, randomised trial of melatonin versus midazolam in the premedication of anxious children attending for elective surgery under general anaesthesia

Author

Albadri, Sondos, Armstrong, Laura, Atkins, Simon, Babb, Margaret, Biercamp, Claire, Biggs, Katie, Bradburn, Mike, Buckley, Jaimie, Child-Cavill, Julie, Cope, Sean, Crawley, Simon, Dimairo, Munya, Duro, Enass, Eissa, Ayman, Flight, Laura, Gath, Jacqui, Gavel, Gil, Geary, Tim, Gilchrist, Fiona, Gopal, Padma, Hall, Jamie, Hutchence, Kate, Khandelwal, Puran, Kukreja, Pranav, Leeuwenberg, Ian, Limb, James, Loban, Amanda, Mellor, Katie, Masip, Nuria, Moores, Anthony, Oshan, Vimmi, Pickles, Edward, Ray, Jaydip, Rodd, Helen, Rolfe, Sian, Sheldon, Elena, Simmonds, Richard, Smith, Rachel, Sundar, Ashok, Thomason, Anna, Waterhouse, Simon, Wilson, Graham, Yates, Julian, Young, Tracey, Bolt, Robert, Hyslop, Marie C., Herbert, Esther, Papaioannou, Diana E., Totton, Nikki, Wilson, Matthew J., Clarkson, Janet, Evans, Christopher, Ireland, Nicholas, Kettle, Jennifer, Marshman, Zoe, Norrington, Amy C., Paton, Robert H., Vernazza, Christopher, and Deery, Christopher

Published
2024
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3. Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): a multicentre, double-blind, randomised crossover trial

Author

Tesfaye, Solomon, Sloan, Gordon, Petrie, Jennifer, White, David, Bradburn, Mike, Julious, Steven, Rajbhandari, Satyan, Sharma, Sanjeev, Rayman, Gerry, Gouni, Ravikanth, Alam, Uazman, Cooper, Cindy, Loban, Amanda, Sutherland, Katie, Glover, Rachel, Waterhouse, Simon, Turton, Emily, Horspool, Michelle, Gandhi, Rajiv, Maguire, Deirdre, Jude, Edward B, Ahmed, Syed H, Vas, Prashanth, Hariman, Christian, McDougall, Claire, Devers, Marion, Tsatlidis, Vasileios, Johnson, Martin, Rice, Andrew S C, Bouhassira, Didier, Bennett, David L, and Selvarajah, Dinesh

Published
2022
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4. Acceptance and Commitment Therapy plus usual care for improving quality of life in people with motor neuron disease (COMMEND): a multicentre, parallel, randomised controlled trial in the UK

Author

Gould, Rebecca L, primary, McDermott, Christopher J, additional, Thompson, Benjamin J, additional, Rawlinson, Charlotte V, additional, Bursnall, Matt, additional, Bradburn, Mike, additional, Kumar, Pavithra, additional, Turton, Emily J, additional, White, David A, additional, Serfaty, Marc A, additional, Graham, Christopher D, additional, McCracken, Lance M, additional, Goldstein, Laura H, additional, Al-Chalabi, Ammar, additional, Orrell, Richard W, additional, Williams, Tim, additional, Noad, Rupert, additional, Baker, Idris, additional, Faull, Christina, additional, Lambert, Thomas, additional, Chhetri, Suresh K, additional, Ealing, John, additional, Hanratty, Anthony, additional, Radunovic, Aleksandar, additional, Gunawardana, Nushan, additional, Meadows, Gail, additional, Gorrie, George H, additional, Young, Tracey, additional, Lawrence, Vanessa, additional, Cooper, Cindy, additional, Shaw, Pamela J, additional, Howard, Robert J, additional, Andreou, Penny, additional, Androulaki-Korakaki, Dynameni, additional, Blakeley, Claire, additional, Bridges, Gary, additional, Campbell, Iain, additional, Davenport, Brittany, additional, Dee, Annily, additional, Drewry, Nicola, additional, Flood, John, additional, Fox, Annemieke, additional, Girling, Melissa, additional, Glew, Ruth, additional, Hartley, Nick, additional, Hocking, Sian, additional, Howell, Mark, additional, Keetharuth, Anju, additional, Makin, Selina, additional, Marsh, Jessica, additional, Mayberry, Emily, additional, McDonald, Alexa, additional, McPartland, Roy, additional, Meldrum, Steven, additional, Mobley, Amanda, additional, Murphy, Donnchadh, additional, O'Brien, Marie Claire, additional, Oliver, Mark, additional, Patel, Darshna, additional, Phipps, Emma, additional, Read, Jessica, additional, Roberts, Rhys, additional, Rooney, Natasha, additional, Smith, Carla, additional, Statham, Jo, additional, Thompson, Cara, additional, Varma, Priya, additional, Walker, Anne Marie, additional, and Waterhouse, Simon, additional

Published
2024
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5. Prehospital early warning scores for adults with suspected sepsis: the PHEWS observational cohort and decision-analytic modelling study

Author

Goodacre, Steve, primary, Sutton, Laura, additional, Ennis, Kate, additional, Thomas, Ben, additional, Hawksworth, Olivia, additional, Iftikhar, Khurram, additional, Croft, Susan J, additional, Fuller, Gordon, additional, Waterhouse, Simon, additional, Hind, Daniel, additional, Stevenson, Matt, additional, Bradburn, Mike J, additional, Smyth, Michael, additional, Perkins, Gavin D, additional, Millins, Mark, additional, Rosser, Andy, additional, Dickson, Jon, additional, and Wilson, Matthew, additional

Published
2024
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7. The MAGIC trial: a pragmatic, multicentre, parallel, noninferiority, randomised trial of melatonin versus midazolam in the premedication of anxious children attending for elective surgery under general anaesthesia

Author

Bolt, Robert, primary, Hyslop, Marie C., additional, Herbert, Esther, additional, Papaioannou, Diana E., additional, Totton, Nikki, additional, Wilson, Matthew J., additional, Clarkson, Janet, additional, Evans, Christopher, additional, Ireland, Nicholas, additional, Kettle, Jennifer, additional, Marshman, Zoe, additional, Norrington, Amy C., additional, Paton, Robert H., additional, Vernazza, Christopher, additional, Deery, Christopher, additional, Albadri, Sondos, additional, Armstrong, Laura, additional, Atkins, Simon, additional, Babb, Margaret, additional, Biercamp, Claire, additional, Biggs, Katie, additional, Bradburn, Mike, additional, Buckley, Jaimie, additional, Child-Cavill, Julie, additional, Cope, Sean, additional, Crawley, Simon, additional, Dimairo, Munya, additional, Duro, Enass, additional, Eissa, Ayman, additional, Flight, Laura, additional, Gath, Jacqui, additional, Gavel, Gil, additional, Geary, Tim, additional, Gilchrist, Fiona, additional, Gopal, Padma, additional, Hall, Jamie, additional, Hutchence, Kate, additional, Khandelwal, Puran, additional, Kukreja, Pranav, additional, Leeuwenberg, Ian, additional, Limb, James, additional, Loban, Amanda, additional, Mellor, Katie, additional, Masip, Nuria, additional, Moores, Anthony, additional, Oshan, Vimmi, additional, Pickles, Edward, additional, Ray, Jaydip, additional, Rodd, Helen, additional, Rolfe, Sian, additional, Sheldon, Elena, additional, Simmonds, Richard, additional, Smith, Rachel, additional, Sundar, Ashok, additional, Thomason, Anna, additional, Waterhouse, Simon, additional, Wilson, Graham, additional, Yates, Julian, additional, and Young, Tracey, additional

Published
2023
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8. Prehospital early warning scores for adults with suspected sepsis: retrospective diagnostic cohort study

Author

Goodacre, Steve, primary, Sutton, Laura, additional, Thomas, Ben, additional, Hawksworth, Olivia, additional, Iftikhar, Khurram, additional, Croft, Susan, additional, Fuller, Gordon, additional, Waterhouse, Simon, additional, Hind, Daniel, additional, Bradburn, Mike, additional, Smyth, Michael Anthony, additional, Perkins, Gavin D, additional, Millins, Mark, additional, Rosser, Andy, additional, Dickson, Jon M, additional, and Wilson, Matthew Joseph, additional

Published
2023
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9. Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study

Author

Hind, Daniel, Drabble, Sarah J., Arden, Madelynne A., Mandefield, Laura, Waterhouse, Simon, Maguire, Chin, Cantrill, Hannah, Robinson, Louisa, Beever, Daniel, Scott, Alexander J., Keating, Sam, Hutchings, Marlene, Bradley, Judy, Nightingale, Julia, Allenby, Mark I., Dewar, Jane, Whelan, Pauline, Ainsworth, John, Walters, Stephen J., O’Cathain, Alicia, and Wildman, Martin J.

Published
2019
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10. Optimal pharmacotherapy pathway in adults with diabetic peripheral neuropathic pain: the OPTION-DM RCT

Author

Tesfaye, Solomon, primary, Sloan, Gordon, additional, Petrie, Jennifer, additional, White, David, additional, Bradburn, Mike, additional, Young, Tracey, additional, Rajbhandari, Satyan, additional, Sharma, Sanjeev, additional, Rayman, Gerry, additional, Gouni, Ravikanth, additional, Alam, Uazman, additional, Julious, Steven A, additional, Cooper, Cindy, additional, Loban, Amanda, additional, Sutherland, Katie, additional, Glover, Rachel, additional, Waterhouse, Simon, additional, Turton, Emily, additional, Horspool, Michelle, additional, Gandhi, Rajiv, additional, Maguire, Deirdre, additional, Jude, Edward, additional, Ahmed, Syed Haris, additional, Vas, Prashanth, additional, Hariman, Christian, additional, McDougall, Claire, additional, Devers, Marion, additional, Tsatlidis, Vasileios, additional, Johnson, Martin, additional, Bouhassira, Didier, additional, Bennett, David L, additional, and Selvarajah, Dinesh, additional

Published
2022
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11. Real-World Adherence Among Adults With Cystic Fibrosis Is Low

Author

Hoo, Zhe Hui, primary, Totton, Nikki, additional, Waterhouse, Simon, additional, Lewis, Jen, additional, Girling, Carla, additional, Bradburn, Michael, additional, Arden, Madelynne A., additional, Whelan, Pauline, additional, Ainsworth, John, additional, Dawson, Sophie, additional, Millward, Sarah, additional, Barnett, Kate, additional, Dewar, Jane, additional, Barr, Helen L., additional, Saini, Gauri, additional, Shepherd, Elizabeth, additional, Carroll, Mary, additional, Allenby, Mark I., additional, Daniels, Thomas V., additional, Nightingale, Julia A., additional, Lowther, Michelle, additional, Carolan, Charlotte, additional, Clarke, Charlotte, additional, Szczepanski, Rachel, additional, Hutchings, Marlene, additional, Edenborough, Frank P., additional, Curley, Rachael, additional, and Wildman, Martin J., additional

Published
2021
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12. An intervention to support adherence to inhaled medication in adults with cystic fibrosis: the ACtiF research programme including RCT

Author

Wildman, Martin J, primary, O’Cathain, Alicia, additional, Hind, Daniel, additional, Maguire, Chin, additional, Arden, Madelynne A, additional, Hutchings, Marlene, additional, Bradley, Judy, additional, Walters, Stephen J, additional, Whelan, Pauline, additional, Ainsworth, John, additional, Tappenden, Paul, additional, Buchan, Iain, additional, Elliott, Rachel, additional, Nicholl, Jon, additional, Elborn, Stuart, additional, Michie, Susan, additional, Mandefield, Laura, additional, Sutton, Laura, additional, Hoo, Zhe Hui, additional, Drabble, Sarah J, additional, Lumley, Elizabeth, additional, Beever, Daniel, additional, Navega Biz, Aline, additional, Scott, Anne, additional, Waterhouse, Simon, additional, Robinson, Louisa, additional, Hernández Alava, Mónica, additional, and Sasso, Alessandro, additional

Published
2021
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13. Prognostic accuracy of emergency department triage tools for adults with suspected COVID-19: the PRIEST observational cohort study

Author

Thomas, Ben, primary, Goodacre, Steve, additional, Lee, Ellen, additional, Sutton, Laura, additional, Bursnall, Matthew, additional, Loban, Amanda, additional, Waterhouse, Simon, additional, Simmonds, Richard, additional, Biggs, Katie, additional, Marincowitz, Carl, additional, Schutter, José, additional, Connelly, Sarah, additional, Sheldon, Elena, additional, Hall, Jamie, additional, Young, Emma, additional, Bentley, Andrew, additional, Challen, Kirsty, additional, Fitzsimmons, Chris, additional, Harris, Tim, additional, Lecky, Fiona, additional, Lee, Andrew, additional, Maconochie, Ian, additional, and Walter, Darren, additional

Published
2021
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14. Derivation and validation of a clinical severity score for acutely ill adults with suspected COVID-19: The PRIEST observational cohort study

Author

Goodacre, Steve, primary, Thomas, Ben, additional, Sutton, Laura, additional, Burnsall, Matthew, additional, Lee, Ellen, additional, Bradburn, Mike, additional, Loban, Amanda, additional, Waterhouse, Simon, additional, Simmonds, Richard, additional, Biggs, Katie, additional, Marincowitz, Carl, additional, Schutter, Jose, additional, Connelly, Sarah, additional, Sheldon, Elena, additional, Hall, Jamie, additional, Young, Emma, additional, Bentley, Andrew, additional, Challen, Kirsty, additional, Fitzsimmons, Chris, additional, Harris, Tim, additional, Lecky, Fiona, additional, Lee, Andrew, additional, Maconochie, Ian, additional, and Walter, Darren, additional

Published
2021
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15. Post-exertion oxygen saturation as a prognostic factor for adverse outcome in patients attending the emergency department with suspected COVID-19: a substudy of the PRIEST observational cohort study

Author

Goodacre, Steve, primary, Thomas, Ben, additional, Lee, Ellen, additional, Sutton, Laura, additional, Loban, Amanda, additional, Waterhouse, Simon, additional, Simmonds, Richard, additional, Biggs, Katie, additional, Marincowitz, Carl, additional, Schutter, José, additional, Connelly, Sarah, additional, Sheldon, Elena, additional, Hall, Jamie, additional, Young, Emma, additional, Bentley, Andrew, additional, Challen, Kirsty, additional, Fitzsimmons, Chris, additional, Harris, Tim, additional, Lecky, Fiona, additional, Lee, Andrew, additional, Maconochie, Ian, additional, and Walter, Darren, additional

Published
2020
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16. Characterisation of 22445 patients attending UK emergency departments with suspected COVID-19 infection: Observational cohort study

Author

Goodacre, Steve, primary, Thomas, Ben, additional, Lee, Ellen, additional, Sutton, Laura, additional, Loban, Amanda, additional, Waterhouse, Simon, additional, Simmonds, Richard, additional, Biggs, Katie, additional, Marincowitz, Carl, additional, Schutter, Jose, additional, Connelly, Sarah, additional, Sheldon, Elena, additional, Hall, Jamie, additional, Young, Emma, additional, Bentley, Andrew, additional, Challen, Kirsty, additional, Fitzsimmons, Chris, additional, Harris, Tim, additional, Lecky, Fiona, additional, Lee, Andrew, additional, Maconochie, Ian, additional, and Walter, Darren, additional

Published
2020
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17. Derivation and validation of a clinical severity score for acutely ill adults with suspected COVID-19: The PRIEST observational cohort study

Author

Goodacre, Steve, primary, Thomas, Ben, additional, Sutton, Laura, additional, Bursnall, Matthew, additional, Lee, Ellen, additional, Bradburn, Mike, additional, Loban, Amanda, additional, Waterhouse, Simon, additional, Simmonds, Richard, additional, Biggs, Katie, additional, Marincowitz, Carl, additional, Schutter, Jose, additional, Connelly, Sarah, additional, Sheldon, Elena, additional, Hall, Jamie, additional, Young, Emma, additional, Bentley, Andrew, additional, Challen, Kirsty, additional, Fitzimmons, Chris, additional, Harris, Tim, additional, Lecky, Fiona, additional, Lee, Andrew, additional, Maconochie, Ian, additional, and Walter, Darren, additional

Published
2020
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18. Feasibility study for supporting medication adherence for adults with cystic fibrosis: mixed-methods process evaluation

Author

Hind, Daniel, primary, Drabble, Sarah J, additional, Arden, Madelynne A, additional, Mandefield, Laura, additional, Waterhouse, Simon, additional, Maguire, Chin, additional, Cantrill, Hannah, additional, Robinson, Louisa, additional, Beever, Daniel, additional, Scott, Alex, additional, Keating, Sam, additional, Hutchings, Marlene, additional, Bradley, Judy, additional, Nightingale, Julia, additional, Allenby, Mark I, additional, Dewar, Jane, additional, Whelan, Pauline, additional, Ainsworth, John, additional, Walters, Stephen J, additional, Wildman, Martin J, additional, and O'Cathain, Alicia, additional

Published
2020
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19. Prognostic accuracy of emergency department triage tools for adults with suspected COVID-19: The PRIEST observational cohort study

Author

Thomas, Ben, primary, Goodacre, Steve, additional, Lee, Ellen, additional, Sutton, Laura, additional, Loban, Amanda, additional, Waterhouse, Simon, additional, Simmonds, Richard, additional, Biggs, Katie, additional, Marincowitz, Carl, additional, Schutter, Jose, additional, Connelly, Sarah, additional, Sheldon, Elena, additional, Hall, Jamie, additional, Young, Emma, additional, Bentley, Andrew, additional, Challen, Kirsty, additional, Fitzimmons, Chris, additional, Harris, Tim, additional, Lecky, Fiona, additional, Lee, Andrew, additional, Maconochie, Ian, additional, and Walter, Darren, additional

Published
2020
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20. Additional file 3: of Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study

Author

Hind, Daniel, Drabble, Sarah, Madelynne Arden, Mandefield, Laura, Waterhouse, Simon, Maguire, Chin, Cantrill, Hannah, Robinson, Louisa, Beever, Daniel, Scott, Alexander, Keating, Sam, Hutchings, Marlene, Bradley, Judy, Nightingale, Julia, Allenby, Mark, Dewar, Jane, Whelan, Pauline, Ainsworth, John, Walters, Stephen, O’Cathain, Alicia, and Wildman, Martin

Abstract

Release notes for 59 software development cycles between June 2015 and June 2017. (DOCX 17 kb)

Published
2019
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21. Additional file 5: of Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study

Author

Hind, Daniel, Drabble, Sarah, Madelynne Arden, Mandefield, Laura, Waterhouse, Simon, Maguire, Chin, Cantrill, Hannah, Robinson, Louisa, Beever, Daniel, Scott, Alexander, Keating, Sam, Hutchings, Marlene, Bradley, Judy, Nightingale, Julia, Allenby, Mark, Dewar, Jane, Whelan, Pauline, Ainsworth, John, Walters, Stephen, O’Cathain, Alicia, and Wildman, Martin

Subjects
sense organs, skin and connective tissue diseases
Abstract

Changes to intervention and trial procedures. (DOCX 22 kb)

Published
2019
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22. Additional file 1: of Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study

Author

Hind, Daniel, Drabble, Sarah, Madelynne Arden, Mandefield, Laura, Waterhouse, Simon, Maguire, Chin, Cantrill, Hannah, Robinson, Louisa, Beever, Daniel, Scott, Alexander, Keating, Sam, Hutchings, Marlene, Bradley, Judy, Nightingale, Julia, Allenby, Mark, Dewar, Jane, Whelan, Pauline, Ainsworth, John, Walters, Stephen, O’Cathain, Alicia, and Wildman, Martin

Abstract

Study protocol and interview guides. (PDF 2311 kb)

Published
2019
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23. Additional file 2: of Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study

Author

Hind, Daniel, Drabble, Sarah, Madelynne Arden, Mandefield, Laura, Waterhouse, Simon, Maguire, Chin, Cantrill, Hannah, Robinson, Louisa, Beever, Daniel, Scott, Alexander, Keating, Sam, Hutchings, Marlene, Bradley, Judy, Nightingale, Julia, Allenby, Mark, Dewar, Jane, Whelan, Pauline, Ainsworth, John, Walters, Stephen, O’Cathain, Alicia, and Wildman, Martin

Abstract

CONSORT checklist. (DOC 226 kb)

Published
2019
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24. Additional file 4: of Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study

Author

Hind, Daniel, Drabble, Sarah, Madelynne Arden, Mandefield, Laura, Waterhouse, Simon, Maguire, Chin, Cantrill, Hannah, Robinson, Louisa, Beever, Daniel, Scott, Alexander, Keating, Sam, Hutchings, Marlene, Bradley, Judy, Nightingale, Julia, Allenby, Mark, Dewar, Jane, Whelan, Pauline, Ainsworth, John, Walters, Stephen, O’Cathain, Alicia, and Wildman, Martin

Abstract

Statistical methods, outcomes and estimation. (DOCX 272 kb)

Published
2019
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25. Post-exertion oxygen saturation as a prognostic factor for adverse outcome in patients attending the emergency department with suspected COVID-19: a substudy of the PRIEST observational cohort study.

Author

Goodacre, Steve, Thomas, Ben, Lee, Ellen, Sutton, Laura, Loban, Amanda, Waterhouse, Simon, Simmonds, Richard, Biggs, Katie, Marincowitz, Carl, Schutter, José, Connelly, Sarah, Sheldon, Elena, Hall, Jamie, Young, Emma, Bentley, Andrew, Challen, Kirsty, Fitzsimmons, Chris, Harris, Tim, Lecky, Fiona, and Lee, Andrew

Abstract

Background: Measurement of post-exertion oxygen saturation has been proposed to assess illness severity in suspected COVID-19 infection. We aimed to determine the accuracy of post-exertional oxygen saturation for predicting adverse outcome in suspected COVID-19.Methods: We undertook a substudy of an observational cohort study across 70 emergency departments during the first wave of the COVID-19 pandemic in the UK. We collected data prospectively, using a standardised assessment form, and retrospectively, using hospital records, from patients with suspected COVID-19, and reviewed hospital records at 30 days for adverse outcome (death or receiving organ support). Patients with post-exertion oxygen saturation recorded were selected for this analysis. We constructed receiver-operating characteristic curves, calculated diagnostic parameters, and developed a multivariable model for predicting adverse outcome.Results: We analysed data from 817 patients with post-exertion oxygen saturation recorded after excluding 54 in whom measurement appeared unfeasible. The c-statistic for post-exertion change in oxygen saturation was 0.589 (95% CI 0.465 to 0.713), and the positive and negative likelihood ratios of a 3% or more desaturation were, respectively, 1.78 (1.25 to 2.53) and 0.67 (0.46 to 0.98). Multivariable analysis showed that post-exertion oxygen saturation was not a significant predictor of adverse outcome when baseline clinical assessment was taken into account (p=0.368). Secondary analysis excluding patients in whom post-exertion measurement appeared inappropriate resulted in a c-statistic of 0.699 (0.581 to 0.817), likelihood ratios of 1.98 (1.26 to 3.10) and 0.61 (0.35 to 1.07), and some evidence of additional prognostic value on multivariable analysis (p=0.019).Conclusions: Post-exertion oxygen saturation provides modest prognostic information in the assessment of selected patients attending the emergency department with suspected COVID-19.Trial Registration Number: ISRCTN Registry (ISRCTN56149622) http://www.isrctn.com/ISRCTN28342533. [ABSTRACT FROM AUTHOR]

Published
2021
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27. Role of habit in treatment adherence among adults with cystic fibrosis.

Author

Zhe Hui Hoo, Gardner, Benjamin, Arden, Madelynne A., Waterhouse, Simon, Walters, Stephen J., Campbell, Michael J., Hind, Daniel, Maguire, Chin, Dewar, Jane, Wildman, Martin J., and Hoo, Zhe Hui

Subjects
CYSTIC fibrosis, ADULTS, CYSTIC fibrosis treatment, COMPARATIVE studies, HABIT, RESEARCH methodology, MEDICAL cooperation, RESEARCH, RESEARCH funding, RESPIRATORY therapy equipment, PILOT projects, EVALUATION research, PSYCHOLOGY
Abstract

Among adults with cystic fibrosis (CF), medication adherence is low and reasons for low adherence are poorly understood. Our previous exploratory study showed that stronger 'habit' (ie, automatically experiencing an urge to use a nebuliser) was associated with higher nebuliser adherence. We performed a secondary analysis of pilot trial data (n=61) to replicate the earlier study and determine whether habit-adherence association exists in other cohorts of adults with CF. In this study, high adherers also reported stronger habit compared with low adherers. Habit may be a promising target for self-management interventions. TRIAL REGISTRATION NUMBER: ACtiF pilot, ISRCTN13076797. [ABSTRACT FROM AUTHOR]

Published
2019
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28. Role of habit in treatment adherence among adults with cystic fibrosis

Author

Hoo, Zhe Hui, Gardner, Benjamin, Arden, Madelynne A, Waterhouse, Simon, Walters, Stephen J, Campbell, Michael J, Hind, Daniel, Maguire, Chin, Dewar, Jane, and Wildman, Martin J

Abstract

Among adults with cystic fibrosis (CF), medication adherence is low and reasons for low adherence are poorly understood. Our previous exploratory study showed that stronger ‘habit’ (ie, automatically experiencing an urge to use a nebuliser) was associated with higher nebuliser adherence. We performed a secondary analysis of pilot trial data (n=61) to replicate the earlier study and determine whether habit–adherence association exists in other cohorts of adults with CF. In this study, high adherers also reported stronger habit compared with low adherers. Habit may be a promising target for self-management interventions.Trial registration numberACtiF pilot, ISRCTN13076797.

Published
2019
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29. 2109 Prehospital early warning scores for adults with suspected sepsis: retrospective diagnostic cohort study

Author

Goodacre, Steve, Sutton, Laura, Hawksworth, Olivia, Iftikhar, Khurram, Croft, Susan, Fuller, Gordon, Millins, Mark, and Waterhouse, Simon

Abstract

Aims and ObjectivesAmbulance services need to identify and prioritise patients with sepsis for early hospital assessment. We aimed to determine the accuracy of early warning scores alongside paramedic diagnostic impression to identify sepsis requiring urgent treatment.Method and DesignWe undertook a retrospective diagnostic cohort study involving adult medical cases transported to hospital by emergency ambulance in 2019. We used routine ambulance service data to calculate 21 early warning scores and categorise paramedic diagnostic impressions as sepsis, infection, nonspecific presentation, or other presentation. We linked cases to hospital records and identified those meeting the sepsis-3 definition who received urgent treatment for sepsis (reference standard). Analysis determined the accuracy of strategies that combined early warning scores at varying thresholds for positivity with paramedic diagnostic impression.Results and ConclusionWe linked 12870/24955 (51.6%) cases and identified 348/12870 (2.7%) with a positive reference standard. None of the strategies provided high sensitivity (>0.80) with acceptable positive predictive value (>0.15). The National Early Warning Score, version 2 (NEWS2) provided combinations of sensitivity and specificity that were similar or superior to all other early warning scores. The area under the receiver operating characteristic curve for NEWS2 applied to patients with a diagnostic impression of sepsis or infection was 0.756 (95% confidence interval [CI] 0.729 to 0.783). NEWS2 thresholds of >4, >6 and >8 applied to patients with a diagnostic impression of sepsis or infection respectively provided sensitivities and positive predictive values (95% CI) of 0.522 (0.469 to 0.574) and 0.216 (0.189 to 0.245), 0.447 (0.395 to 0.499) and 0.274 (0.239 to 0.313), and 0.314 (0.268 to 0.365) and 0.333 (CI 0.284 to 0.386).No strategy is ideal but using NEWS2 alongside paramedic diagnostic impression of infection or sepsis could identify one third to half of sepsis cases without prioritising unmanageable numbers. No other score provided clearly superior accuracy to NEWS2.

Published
2023
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30. Bracing Adolescent Idiopathic Scoliosis (BASIS) study - night-time versus full-time bracing in adolescent idiopathic scoliosis: study protocol for a multicentre, randomized controlled trial.

Author

Swaby L, Perry DC, Walker K, Hind D, Mills A, Jayasuriya R, Totton N, Desoysa L, Chatters R, Young B, Sherratt F, Latimer N, Keetharuth A, Kenison L, Walters S, Gardner A, Ahuja S, Campbell L, Greenwood S, Cole A, Turtle C, Waterhouse S, Davidson N, Shafafy M, Marjoram T, Oxborrow N, Sedra F, Harris M, Leong J, Lucas J, Lui D, Isaacson A, Bowey A, Harding I, Davies E, Jasani V, Khan A, Thorpe P, Tsirikos T, and Sloan S

Abstract

Aims: Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of 'full-time bracing' versus 'night-time bracing' in adolescent idiopathic scoliosis (AIS)., Methods: UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination., Discussion: The primary outcome is 'treatment failure' (Cobb angle progression to 50° or more before skeletal maturity); skeletal maturity is at Risser stage 4 in females and 5 in males, or 'treatment success' (Cobb angle less than 50° at skeletal maturity). The comparison is on a non-inferiority basis (non-inferiority margin 11%). Participants are followed up every six months while in brace, and at one and two years after skeletal maturity. Secondary outcomes include the Scoliosis Research Society 22 questionnaire and measures of quality of life, psychological effects of bracing, adherence, anxiety and depression, sleep, satisfaction, and educational attainment. All data will be collected through the British Spine Registry., Competing Interests: A. A. Cole, D. C. Perry, D. Hind, N. Totton, B. Young, N. Latimer, L. Kenison, S. Walters, A. Gardner, S. Ahuja, F. Sherratt, L. Campbell, R. Jayasuriya, A. J. Mills, S. Greenwood, and R. Chatters obtained grant funding for this project. This project was funded by the UK NIHR HTA Programme (project number NIHR131081). S. Walters reports book royalties from Wiley and Blackwell, unrelated to this study. A. Gardner also reports grants from Innovate UK, ORUK, and the Freda Ashmore Memorial Fund, payment for medicolegal services from A C Gardner Ltd, and support to attend the British Scoliosis Society meeting 2022 and BritSpine 2023, all of which are unrelated to this study. A. Gardner is also an unpaid research lead for the British Scoliosis Society. L. Campbell reports payment for online meetings, unrelated to this study. D. C. Perry is funded by a National Institute for Health Research Professorship Award, was a committee member on the NIHR Commissioning Board (2016-2021), and is a member of the editorial board of The Bone & Joint Journal. A. J. Mills is shareholder and director of the SpineCorporation Limited, which designs and supplies braces to a number of BASIS sites. A. J. Mills also holds a patent for TechnoSpine, and is an unpaid SOSORT Bracing Expert Advisor. The funder has not been involved in the design of the study. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health. L. Swaby reports grants from the National Institute for Health and Care Research, unrelated to this study. D. Hind's salary was partly funded by a research grant from the NIHR HTA., (© 2023 Swaby et al.)

Published
2023
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31. An intervention to support adherence to inhaled medication in adults with cystic fibrosis: the ACtiF research programme including RCT

Author

Wildman MJ, O’Cathain A, Hind D, Maguire C, Arden MA, Hutchings M, Bradley J, Walters SJ, Whelan P, Ainsworth J, Tappenden P, Buchan I, Elliott R, Nicholl J, Elborn S, Michie S, Mandefield L, Sutton L, Hoo ZH, Drabble SJ, Lumley E, Beever D, Navega Biz A, Scott A, Waterhouse S, Robinson L, Hernández Alava M, and Sasso A

Abstract

Background: People with cystic fibrosis frequently have low levels of adherence to inhaled medications., Objectives: The objectives were to develop and evaluate an intervention for adults with cystic fibrosis to improve adherence to their inhaled medication., Design: We used agile software methods to develop an online platform. We used mixed methods to develop a behaviour change intervention for delivery by an interventionist. These were integrated to become the CFHealthHub intervention. We undertook a feasibility study consisting of a pilot randomised controlled trial and process evaluation in two cystic fibrosis centres. We evaluated the intervention using an open-label, parallel-group randomised controlled trial with usual care as the control. Participants were randomised in a 1 : 1 ratio to intervention or usual care. Usual care consisted of clinic visits every 3 months. We undertook a process evaluation alongside the randomised controlled trial, including a fidelity study, a qualitative interview study and a mediation analysis. We undertook a health economic analysis using both a within-trial and model-based analysis., Setting: The randomised controlled trial took place in 19 UK cystic fibrosis centres., Participants: Participants were people aged ≥ 16 years with cystic fibrosis, on the cystic fibrosis registry, not post lung transplant or on the active transplant list, who were able to consent and not using dry-powder inhalers., Intervention: People with cystic fibrosis used a nebuliser with electronic monitoring capabilities. This transferred data automatically to a digital platform. People with cystic fibrosis and clinicians could monitor adherence using these data, including through a mobile application (app). CFHealthHub displayed graphs of adherence data as well as educational and problem-solving information. A trained interventionist helped people with cystic fibrosis to address their adherence., Main Outcome Measures: Randomised controlled trial – adjusted incidence rate ratio of pulmonary exacerbations meeting the modified Fuchs criteria over a 12-month follow-up period (primary outcome); change in percentage adherence; and per cent predicted forced expiratory volume in 1 second (key secondary outcomes). Process evaluation – percentage fidelity to intervention delivery, and participant and interventionist perceptions of the intervention. Economic modelling – incremental cost per quality-adjusted life-year gained., Results: Randomised controlled trial – 608 participants were randomised to the intervention ( n  = 305) or usual care ( n  = 303). To our knowledge, this was the largest randomised controlled trial in cystic fibrosis undertaken in the UK. The adjusted rate of exacerbations per year (primary outcome) was 1.63 in the intervention and 1.77 in the usual-care arm (incidence rate ratio 0.96, 95% confidence interval 0.83 to 1.12; p  = 0.638) after adjustment for covariates. The adjusted difference in mean weekly normative adherence was 9.5% (95% confidence interval 8.6% to 10.4%) across 1 year, favouring the intervention. Adjusted mean difference in forced expiratory volume in 1 second (per cent) predicted at 12 months was 1.4% (95% confidence interval –0.2% to 3.0%). No adverse events were related to the intervention. Process evaluation – fidelity of intervention delivery was high, the intervention was acceptable to people with cystic fibrosis, participants engaged with the intervention [287/305 (94%) attended the first intervention visit], expected mechanisms of action were identified and contextual factors varied between randomised controlled trial sites. Qualitative interviews with 22 people with cystic fibrosis and 26 interventionists identified that people with cystic fibrosis welcomed the objective adherence data as proof of actions to self and others, and valued the relationship that they built with the interventionists. Economic modelling – the within-trial analysis suggests that the intervention generated 0.01 additional quality-adjusted life-years at an additional cost of £865.91 per patient, leading to an incremental cost-effectiveness ratio of £71,136 per quality-adjusted life-year gained. This should be interpreted with caution owing to the short time horizon. The health economic model suggests that the intervention is expected to generate 0.17 additional quality-adjusted life-years and cost savings of £1790 over a lifetime (70-year) horizon; hence, the intervention is expected to dominate usual care. Assuming a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained, the probability that the intervention generates more net benefit than usual care is 0.89. The model results are dependent on assumptions regarding the duration over which costs and effects of the intervention apply, the impact of the intervention on forced expiratory volume in 1 second (per cent) predicted and the relationship between increased adherence and drug-prescribing levels., Limitations: Number of exacerbations is a sensitive and valid measure of clinical change used in many trials. However, data collection of this outcome in this context was challenging and could have been subject to bias. It was not possible to measure baseline adherence accurately. It was not possible to quantify the impact of the intervention on the number of packs of medicines prescribed., Conclusions: We developed a feasible and acceptable intervention that was delivered to fidelity in the randomised controlled trial. We observed no statistically significant difference in the primary outcome of exacerbation rates over 12 months. We observed an increase in normative adherence levels in a disease where adherence levels are low. The magnitude of the increase in adherence may not have been large enough to affect exacerbations., Future Work: Given the non-significant difference in the primary outcome, further research is required to explore why an increase in objective normative adherence did not reduce exacerbations and to develop interventions that reduce exacerbations., Trial Registration: Work package 3.1: Current Controlled Trials ISRCTN13076797. Work packages 3.2 and 3.3: Current Controlled Trials ISRCTN55504164., Funding: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research ; Vol. 9, No. 11. See the NIHR Journals Library website for further project information., (Copyright © 2021 Wildman et al. This work was produced by Wildman et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.)

Published
2021
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32. Post-exertion oxygen saturation as a prognostic factor for adverse outcome in patients attending the emergency department with suspected COVID-19: a substudy of the PRIEST observational cohort study.

Author

Goodacre S, Thomas B, Lee E, Sutton L, Loban A, Waterhouse S, Simmonds R, Biggs K, Marincowitz C, Schutter J, Connelly S, Sheldon E, Hall J, Young E, Bentley A, Challen K, Fitzsimmons C, Harris T, Lecky F, Lee A, Maconochie I, and Walter D

Subjects
Adult, Aged, Emergency Service, Hospital, Female, Humans, Male, Middle Aged, Prognosis, Retrospective Studies, COVID-19 diagnosis, Oxygen analysis, Physical Exertion
Abstract

Background: Measurement of post-exertion oxygen saturation has been proposed to assess illness severity in suspected COVID-19 infection. We aimed to determine the accuracy of post-exertional oxygen saturation for predicting adverse outcome in suspected COVID-19., Methods: We undertook a substudy of an observational cohort study across 70 emergency departments during the first wave of the COVID-19 pandemic in the UK. We collected data prospectively, using a standardised assessment form, and retrospectively, using hospital records, from patients with suspected COVID-19, and reviewed hospital records at 30 days for adverse outcome (death or receiving organ support). Patients with post-exertion oxygen saturation recorded were selected for this analysis. We constructed receiver-operating characteristic curves, calculated diagnostic parameters, and developed a multivariable model for predicting adverse outcome., Results: We analysed data from 817 patients with post-exertion oxygen saturation recorded after excluding 54 in whom measurement appeared unfeasible. The c-statistic for post-exertion change in oxygen saturation was 0.589 (95% CI 0.465 to 0.713), and the positive and negative likelihood ratios of a 3% or more desaturation were, respectively, 1.78 (1.25 to 2.53) and 0.67 (0.46 to 0.98). Multivariable analysis showed that post-exertion oxygen saturation was not a significant predictor of adverse outcome when baseline clinical assessment was taken into account (p=0.368). Secondary analysis excluding patients in whom post-exertion measurement appeared inappropriate resulted in a c-statistic of 0.699 (0.581 to 0.817), likelihood ratios of 1.98 (1.26 to 3.10) and 0.61 (0.35 to 1.07), and some evidence of additional prognostic value on multivariable analysis (p=0.019)., Conclusions: Post-exertion oxygen saturation provides modest prognostic information in the assessment of selected patients attending the emergency department with suspected COVID-19., Trial Registration Number: ISRCTN Registry (ISRCTN56149622) http://www.isrctn.com/ISRCTN28342533., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Published
2021
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