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4. Effectiveness of septoplasty compared to medical management in adults with obstruction associated with a deviated nasal septum: the NAIROS RCT

Author

Carrie, Sean, primary, Fouweather, Tony, additional, Homer, Tara, additional, O’Hara, James, additional, Rousseau, Nikki, additional, Rooshenas, Leila, additional, Bray, Alison, additional, Stocken, Deborah D, additional, Ternent, Laura, additional, Rennie, Katherine, additional, Clark, Emma, additional, Waugh, Nichola, additional, Steel, Alison J, additional, Dooley, Jemima, additional, Drinnan, Michael, additional, Hamilton, David, additional, Lloyd, Kelly, additional, Oluboyede, Yemi, additional, Wilson, Caroline, additional, Gardiner, Quentin, additional, Kara, Naveed, additional, Khwaja, Sadie, additional, Leong, Samuel Chee, additional, Maini, Sangeeta, additional, Morrison, Jillian, additional, Nix, Paul, additional, Wilson, Janet A, additional, and Teare, M Dawn, additional

Published
2024
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7. Clinical effectiveness of septoplasty versus medical management for nasal airways obstruction: multicentre, open label, randomised controlled trial

Author

Carrie, Sean, primary, O’Hara, James, additional, Fouweather, Tony, additional, Homer, Tara, additional, Rousseau, Nikki, additional, Rooshenas, Leila, additional, Bray, Alison, additional, Stocken, Deborah D, additional, Ternent, Laura, additional, Rennie, Katherine, additional, Clark, Emma, additional, Waugh, Nichola, additional, Steel, Alison J, additional, Dooley, Jemima, additional, Drinnan, Michael, additional, Hamilton, David, additional, Lloyd, Kelly, additional, Oluboyede, Yemi, additional, Wilson, Caroline, additional, Gardiner, Quentin, additional, Kara, Naveed, additional, Khwaja, Sadie, additional, Leong, Samuel C, additional, Maini, Sangeeta, additional, Morrison, Jillian, additional, Nix, Paul, additional, Wilson, Janet A, additional, and Teare, M Dawn, additional

Published
2023
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8. Continuous low-dose antibiotic prophylaxis for adults with repeated urinary tract infections (AnTIC): a randomised, open-label trial

Author

Fisher, Holly, Oluboyede, Yemi, Chadwick, Thomas, Abdel-Fattah, Mohamed, Brennand, Catherine, Fader, Mandy, Harrison, Simon, Hilton, Paul, Larcombe, James, Little, Paul, McClurg, Doreen, McColl, Elaine, N'Dow, James, Ternent, Laura, Thiruchelvam, Nikesh, Timoney, Anthony, Vale, Luke, Walton, Katherine, von Wilamowitz-Moellendorff, Alexander, Wilkinson, Jennifer, Wood, Ruth, and Pickard, Robert

Published
2018
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9. Testing methods to value health outcomes in low income countries using contingent valuation and discrete choice experiment methods

Author

Ternent, Laura

Subjects
330.0151, Contingent valuation, Developing countries
Abstract

This thesis is concerned with examining issues of theoretical validity and bias in contingent valuation (CV) and discrete choice experiment (DCE) methods in low income countries. This thesis contributes to the small body of literature on the application of CV and DCEs in low income countries and in populations which have little or no formal education. Theoretical validity is examined by testing whether willingness to pay corresponds to theoretical expectations focusing on gender and willingness to pay, sensitivity to scope, starting point bias, and strategic bias in CV. The theoretical validity of the DCE method in populations with no formal education is also explored. It is found that whilst iterative methods to elicit willingness to pay often mimic local market conditions in low income countries they are prone to starting point bias and strategic bias. An association between gender and willingness to pay was also found. Issues of gender, starting point bias and strategic behaviour can be tested for and controlled for in the estimation of willingness to pay and do not present an insurmountable problem. Willingness to pay was also found to be insensitive to the size of the benefit in CV. Using the DCE method, it was found that with the use of visual aids, DCEs can be used among respondents with no formal education. It is concluded that CV and DCEs are feasible and valid in populations with low levels of education when surveys are conducted using trained enumerators and administered using face-to-face interviews. This suggests that both techniques are capable of being used in wide variety of settings. The exception to this is a lack of evidence on sensitivity to scope. Further research is therefore required into sensitivity to scope. Further research is also required to examine the association between gender and willingness to pay.

Published
2012

10. Dual bronchodilators in Bronchiectasis study (DIBS): protocol for a pragmatic, multicentre, placebo-controlled, three-arm, double-blinded, randomised controlled trial studying bronchodilators in preventing exacerbations of bronchiectasis

Author

Morton, Miranda, primary, Wilson, Nina, additional, Homer, Tara Marie, additional, Simms, Laura, additional, Steel, Alison, additional, Maier, Rebecca, additional, Wason, James, additional, Ternent, Laura, additional, Abouhajar, Alaa, additional, Allen, Maria, additional, Joyce, Richard, additional, Hildreth, Victoria, additional, Lakey, Rachel, additional, Cherlin, Svetlana, additional, Walker, Adam, additional, Devereux, Graham, additional, Chalmers, James D, additional, Hill, Adam T, additional, Haworth, Charles, additional, Hurst, John R, additional, and De Soyza, Anthony, additional

Published
2023
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11. Photobiomodulation in the management of oral mucositis for adult head and neck cancer patients receiving irradiation: the LiTEFORM RCT

Author

Nugent, Michael, primary, Bryant, Valerie, additional, Butcher, Chrissie, additional, Fisher, Holly, additional, Gill, Sean, additional, Goranova, Rebecca, additional, Hiu, Shaun, additional, Lindley, Lyndsay, additional, O’Hara, James, additional, Oluboyede, Yemi, additional, Patterson, Joanne, additional, Rapley, Tim, additional, Robinson, Tomos, additional, Rousseau, Nikki, additional, Ryan, Vicky, additional, Shanmugasundaram, Ramkumar, additional, Sharp, Linda, additional, Smith Whelan, Ruby, additional, Stocken, Deborah D, additional, Ternent, Laura, additional, Wilson, Janet, additional, and Walker, Jenn, additional

Published
2022
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13. Public acceptability of government policies and interventions designed to improve population health in diet and active travel: A protocol for a systematic scoping review

Author

Anderson, Sophie, Robinson, Tomos, Vasiljevic, Milica, and Ternent, Laura

Subjects
Public Acceptability, Population Health, Health, Health Policy, Behaviour Change, Public Policy, Population Level Behaviour Change, Public Affairs, Public Policy and Public Administration, Social and Behavioral Sciences
Abstract

The Department of Health and Social Care in England report that around two-thirds of adults and one-third of children leaving the primary education phase are living over a healthy weight. Government policies and interventions established to change unhealthy behaviours in the population can vary in their effectiveness, acceptability and level of support when rolled out to the public. This rapid scoping review will explore existing literature to understand public acceptability and support for a variety of dietary and active travel policy interventions. The acceptability of public policy is important to ensure the design, evaluation and implementation of government interventions are effective. The objective of this scoping review is to examine which factors determine and moderate the acceptability of dietary and active travel policies.

Published
2022
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15. 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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17. Economic evaluation of robot-assisted training versus an enhanced upper limb therapy programme or usual care for patients with moderate or severe upper limb functional limitation due to stroke: results from the RATULS randomised controlled trial

Author

Fernandez-Garcia, Cristina, primary, Ternent, Laura, additional, Homer, Tara Marie, additional, Rodgers, Helen, additional, Bosomworth, Helen, additional, Shaw, Lisa, additional, Aird, Lydia, additional, Andole, Sreeman, additional, Cohen, David, additional, Dawson, Jesse, additional, Finch, Tracy, additional, Ford, Gary, additional, Francis, Richard, additional, Hogg, Steven, additional, Hughes, Niall, additional, Krebs, H I, additional, Price, Christopher, additional, Turner, Duncan, additional, Van Wijck, Frederike, additional, Wilkes, Scott, additional, Wilson, Nina, additional, and Vale, Luke, additional

Published
2021
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18. Additional file 2 of Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction

Author

Rennie, Katherine, O’Hara, James, Rousseau, Nikki, Stocken, Deborah, Howel, Denise, Ternent, Laura, Drinnan, Mike, Bray, Alison, Rooshenas, Leila, Hamilton, David, Steel, Alison, Fouweather, Tony, Ann-Marie Hynes, Eva-Maria Holstein, Yemi Oluboyede, Abouhajar, Alaa, Wilson, Janet, and Carrie, Sean

Subjects
health services administration, respiratory system
Abstract

Additional file 2. Nasal Airway Obstruction Study (NAIROS) Main Informed Consent Form, V3.0 dated 16 Jan 2019.

Published
2020
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19. EULT_manuals_070220 – Supplemental material for Evaluation of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after Stroke trial: descriptive analysis of intervention fidelity, goal selection and goal achievement

Author

Bosomworth, Helen, Rodgers, Helen, Shaw, Lisa, Smith, Leanne, Aird, Lydia, Howel, Denise, Wilson, Nina, Alvarado, Natasha, Sreeman Andole, Cohen, David L, Dawson, Jesse, Fernandez-Garcia, Cristina, Finch, Tracy, Ford, Gary A, Francis, Richard, Hogg, Steven, Hughes, Niall, Price, Christopher I, Ternent, Laura, Turner, Duncan L, Vale, Luke, Wilkes, Scott, Hermano I Krebs, and Wijck, Frederike Van

Subjects
FOS: Clinical medicine, 110604 Sports Medicine, FOS: Health sciences, 110904 Neurology and Neuromuscular Diseases, 110314 Orthopaedics
Abstract

Supplemental material, EULT_manuals_070220 for Evaluation of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after Stroke trial: descriptive analysis of intervention fidelity, goal selection and goal achievement by Helen Bosomworth, Helen Rodgers, Lisa Shaw, Leanne Smith, Lydia Aird, Denise Howel, Nina Wilson, Natasha Alvarado, Sreeman Andole, David L Cohen, Jesse Dawson, Cristina Fernandez-Garcia, Tracy Finch, Gary A Ford, Richard Francis, Steven Hogg, Niall Hughes, Christopher I Price, Laura Ternent, Duncan L Turner, Luke Vale, Scott Wilkes, Hermano I Krebs and Frederike van Wijck in Clinical Rehabilitation

Published
2020
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20. Additional file 1 of Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction

Author

Rennie, Katherine, O’Hara, James, Rousseau, Nikki, Stocken, Deborah, Howel, Denise, Ternent, Laura, Drinnan, Mike, Bray, Alison, Rooshenas, Leila, Hamilton, David, Steel, Alison, Fouweather, Tony, Ann-Marie Hynes, Eva-Maria Holstein, Yemi Oluboyede, Abouhajar, Alaa, Wilson, Janet, and Carrie, Sean

Abstract

Additional file 1. Patient Information Sheet, V5.1 dated 27 March 2019.

Published
2020
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21. Additional file 3 of Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction

Author

Rennie, Katherine, O’Hara, James, Rousseau, Nikki, Stocken, Deborah, Howel, Denise, Ternent, Laura, Drinnan, Mike, Bray, Alison, Rooshenas, Leila, Hamilton, David, Steel, Alison, Fouweather, Tony, Ann-Marie Hynes, Eva-Maria Holstein, Yemi Oluboyede, Abouhajar, Alaa, Wilson, Janet, and Carrie, Sean

Abstract

Additional file 3. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.

Published
2020
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23. Robot-assisted training compared with an enhanced upper limb therapy programme and with usual care for upper limb functional limitation after stroke: the RATULS three-group RCT

Author

Rodgers, Helen, primary, Bosomworth, Helen, additional, Krebs, Hermano I, additional, van Wijck, Frederike, additional, Howel, Denise, additional, Wilson, Nina, additional, Finch, Tracy, additional, Alvarado, Natasha, additional, Ternent, Laura, additional, Fernandez-Garcia, Cristina, additional, Aird, Lydia, additional, Andole, Sreeman, additional, Cohen, David L, additional, Dawson, Jesse, additional, Ford, Gary A, additional, Francis, Richard, additional, Hogg, Steven, additional, Hughes, Niall, additional, Price, Christopher I, additional, Turner, Duncan L, additional, Vale, Luke, additional, Wilkes, Scott, additional, and Shaw, Lisa, additional

Published
2020
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24. Evaluation of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after Stroke trial: descriptive analysis of intervention fidelity, goal selection and goal achievement

Author

Bosomworth, Helen, primary, Rodgers, Helen, additional, Shaw, Lisa, additional, Smith, Leanne, additional, Aird, Lydia, additional, Howel, Denise, additional, Wilson, Nina, additional, Alvarado, Natasha, additional, Andole, Sreeman, additional, Cohen, David L, additional, Dawson, Jesse, additional, Fernandez-Garcia, Cristina, additional, Finch, Tracy, additional, Ford, Gary A, additional, Francis, Richard, additional, Hogg, Steven, additional, Hughes, Niall, additional, Price, Christopher I, additional, Ternent, Laura, additional, Turner, Duncan L, additional, Vale, Luke, additional, Wilkes, Scott, additional, Krebs, Hermano I, additional, and van Wijck, Frederike, additional

Published
2020
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26. Economic evaluation of surgical treatments for women with stress urinary incontinence: a cost-utility and value of information analysis

Author

Javanbakht, Mehdi, primary, Moloney, Eoin, additional, Brazzelli, Miriam, additional, Wallace, Sheila, additional, Ternent, Laura, additional, Omar, Muhammad Imran, additional, Monga, Ash, additional, Saraswat, Lucky, additional, Mackie, Phil, additional, Becker, Frauke, additional, Imamura, Mari, additional, Hudson, Jemma, additional, Shimonovich, Michal, additional, MacLennan, Graeme, additional, Vale, Luke, additional, and Craig, Dawn, additional

Published
2020
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32. Using shared goal setting to improve access and equity: a mixed methods study of the Good Goals intervention in children’s occupational therapy

Author

Kolehmainen Niina, MacLennan Graeme, Ternent Laura, Duncan Edward AS, Duncan Eilidh M, Ryan Stephen B, McKee Lorna, and Francis Jill J

Subjects
Medicine (General), R5-920
Abstract

Abstract Background Access and equity in children’s therapy services may be improved by directing clinicians’ use of resources toward specific goals that are important to patients. A practice-change intervention (titled ‘Good Goals’) was designed to achieve this. This study investigated uptake, adoption, and possible effects of that intervention in children’s occupational therapy services. Methods Mixed methods case studies (n = 3 services, including 46 therapists and 558 children) were conducted. The intervention was delivered over 25 weeks through face-to-face training, team workbooks, and ‘tools for change’. Data were collected before, during, and after the intervention on a range of factors using interviews, a focus group, case note analysis, routine data, document analysis, and researchers’ observations. Results Factors related to uptake and adoptions were: mode of intervention delivery, competing demands on therapists’ time, and leadership by service manager. Service managers and therapists reported that the intervention: helped therapists establish a shared rationale for clinical decisions; increased clarity in service provision; and improved interactions with families and schools. During the study period, therapists’ behaviours changed: identifying goals, odds ratio 2.4 (95% CI 1.5 to 3.8); agreeing goals, 3.5 (2.4 to 5.1); evaluating progress, 2.0 (1.1 to 3.5). Children’s LoT decreased by two months [95% CI −8 to +4 months] across the services. Cost per therapist trained ranged from £1,003 to £1,277, depending upon service size and therapists’ salary bands. Conclusions Good Goals is a promising quality improvement intervention that can be delivered and adopted in practice and may have benefits. Further research is required to evaluate its: (i) impact on patient outcomes, effectiveness, cost-effectiveness, and (ii) transferability to other clinical contexts.

Published
2012
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33. Additional file 4: of A novel design process for selection of attributes for inclusion in discrete choice experiments: case study exploring variation in clinical decision-making about thrombolysis in the treatment of acute ischaemic stroke

Author

BrĂşn, Aoife De, Flynn, Darren, Ternent, Laura, Price, Christopher, Rodgers, Helen, Ford, Gary, Rudd, Matthew, Lancsar, Emily, Simpson, Stephen, Teah, John, and Thomson, Richard

Abstract

Operational definitions for variable attribute levels in the DCE. Table presenting definitions used for attribute levels in the DCE. (DOCX 13Â kb)

Published
2018
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34. Additional file 2: of A novel design process for selection of attributes for inclusion in discrete choice experiments: case study exploring variation in clinical decision-making about thrombolysis in the treatment of acute ischaemic stroke

Author

BrĂşn, Aoife De, Flynn, Darren, Ternent, Laura, Price, Christopher, Rodgers, Helen, Ford, Gary, Rudd, Matthew, Lancsar, Emily, Simpson, Stephen, Teah, John, and Thomson, Richard

Abstract

DCE pilot testing protocol. Interview schedule for cognitive interviewing and pilot testing of DCE. (DOCX 18Â kb)

Published
2018
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35. Additional file 1: of A novel design process for selection of attributes for inclusion in discrete choice experiments: case study exploring variation in clinical decision-making about thrombolysis in the treatment of acute ischaemic stroke

Author

BrĂşn, Aoife De, Flynn, Darren, Ternent, Laura, Price, Christopher, Rodgers, Helen, Ford, Gary, Rudd, Matthew, Lancsar, Emily, Simpson, Stephen, Teah, John, and Thomson, Richard

Abstract

On-line structured prioritisation exercise (SPE). Full survey used to collect data. (DOCX 42Â kb)

Published
2018
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36. Additional file 3: of A novel design process for selection of attributes for inclusion in discrete choice experiments: case study exploring variation in clinical decision-making about thrombolysis in the treatment of acute ischaemic stroke

Author

BrĂşn, Aoife De, Flynn, Darren, Ternent, Laura, Price, Christopher, Rodgers, Helen, Ford, Gary, Rudd, Matthew, Lancsar, Emily, Simpson, Stephen, Teah, John, and Thomson, Richard

Abstract

Stage 3 (Phase 1): Results of on-line survey (SPE). Table presenting results of SPE online survey. (DOCX 22Â kb)

Published
2018
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37. Robot assisted training for the upper limb after stroke (RATULS): a multicentre randomised controlled trial

Author

Rodgers, Helen, primary, Bosomworth, Helen, additional, Krebs, Hermano I, additional, van Wijck, Frederike, additional, Howel, Denise, additional, Wilson, Nina, additional, Aird, Lydia, additional, Alvarado, Natasha, additional, Andole, Sreeman, additional, Cohen, David L, additional, Dawson, Jesse, additional, Fernandez-Garcia, Cristina, additional, Finch, Tracy, additional, Ford, Gary A, additional, Francis, Richard, additional, Hogg, Steven, additional, Hughes, Niall, additional, Price, Christopher I, additional, Ternent, Laura, additional, Turner, Duncan L, additional, Vale, Luke, additional, Wilkes, Scott, additional, and Shaw, Lisa, additional

Published
2019
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38. Surgical interventions for women with stress urinary incontinence: systematic review and network meta-analysis of randomised controlled trials

Author

Imamura, Mari, primary, Hudson, Jemma, additional, Wallace, Sheila A, additional, MacLennan, Graeme, additional, Shimonovich, Michal, additional, Omar, Muhammad Imran, additional, Javanbakht, Mehdi, additional, Moloney, Eoin, additional, Becker, Frauke, additional, Ternent, Laura, additional, Montgomery, Isobel, additional, Mackie, Phil, additional, Saraswat, Lucky, additional, Monga, Ash, additional, Vale, Luke, additional, Craig, Dawn, additional, and Brazzelli, Miriam, additional

Published
2019
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41. Surgical treatments for women with stress urinary incontinence: the ESTER systematic review and economic evaluation

Author

Brazzelli, Miriam, primary, Javanbakht, Mehdi, additional, Imamura, Mari, additional, Hudson, Jemma, additional, Moloney, Eoin, additional, Becker, Frauke, additional, Wallace, Sheila, additional, Omar, Muhammad Imran, additional, Shimonovich, Michael, additional, MacLennan, Graeme, additional, Ternent, Laura, additional, Vale, Luke, additional, Montgomery, Isobel, additional, Mackie, Phil, additional, Saraswat, Lucky, additional, Monga, Ash, additional, and Craig, Dawn, additional

Published
2019
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42. Evaluation of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after Stroke trial: descriptive analysis of intervention fidelity, goal selection and goal achievement.

Author

Bosomworth, Helen, Rodgers, Helen, Shaw, Lisa, Smith, Leanne, Aird, Lydia, Howel, Denise, Wilson, Nina, Alvarado, Natasha, Andole, Sreeman, Cohen, David L, Dawson, Jesse, Fernandez-Garcia, Cristina, Finch, Tracy, Ford, Gary A, Francis, Richard, Hogg, Steven, Hughes, Niall, Price, Christopher I, Ternent, Laura, and Turner, Duncan L

Subjects
ARM physiology, EXERCISE physiology, EXERCISE therapy, GOAL (Psychology), LABOR productivity, LEISURE, LIFE skills, NATIONAL health services, REHABILITATION centers, RESEARCH funding, ROBOTICS, STATISTICAL sampling, HEALTH self-care, TASK performance, RANDOMIZED controlled trials, TREATMENT effectiveness, EVALUATION of human services programs, STROKE rehabilitation, STROKE patients, DESCRIPTIVE statistics, EVALUATION
Abstract

Objective: To report the fidelity of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after stroke (RATULS) randomized controlled trial, the types of goals selected and the proportion of goals achieved. Design: Descriptive analysis of data on fidelity, goal selection and achievement from an intervention group within a randomized controlled trial. Setting: Out-patient stroke rehabilitation within four UK NHS centres. Subjects: 259 participants with moderate-severe upper limb activity limitation (Action Research Arm Test 0–39) between one week and five years post first stroke. Intervention: The enhanced upper limb therapy programme aimed to provide 36 one-hour sessions, including 45 minutes of face-to-face therapy focusing on personal goals, over 12 weeks. Results: 7877/9324 (84%) sessions were attended; a median of 34 [IQR 29–36] per participant. A median of 127 [IQR 70–190] repetitions were achieved per participant per session attended. Based upon the Canadian Occupational Performance Measure, goal categories were: self-care 1449/2664 (54%); productivity 374/2664 (14%); leisure 180/2664 (7%) and 'other' 661/2664 (25%). For the 2051/2664 goals for which data were available, 1287 (51%) were achieved, ranging between 27% by participants more than 12 months post stroke with baseline Action Research Arm Test scores 0–7, and 88% by those less than three months after stroke with scores 8–19. Conclusions: Intervention fidelity was high. Goals relating to self-care were most commonly selected. The proportion of goals achieved varied, depending on time post stroke and baseline arm activity limitation. [ABSTRACT FROM AUTHOR]

Published
2021
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43. Additional file 1: of Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial

Author

Rodgers, Helen, Shaw, Lisa, Bosomworth, Helen, Aird, Lydia, Alvarado, Natasha, Sreeman Andole, Cohen, David, Dawson, Jesse, Eyre, Janet, Finch, Tracy, Ford, Gary, Hislop, Jennifer, Hogg, Steven, Howel, Denise, Hughes, Niall, Hermano Krebs, Price, Christopher, Rochester, Lynn, Stamp, Elaine, Ternent, Laura, Turner, Duncan, Vale, Luke, Warburton, Elizabeth, Wijck, Frederike Van, and Wilkes, Scott

Abstract

SPIRIT Checklist for RATULS protocol paper. (DOC 120 kb)

Published
2017
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44. Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction.

Author

Rennie, Katherine J., O'Hara, James, Rousseau, Nikki, Stocken, Deborah, Howel, Denise, Ternent, Laura, Drinnan, Mike, Bray, Alison, Rooshenas, Leila, Hamilton, David W., Steel, Alison, Fouweather, Tony, Hynes, Ann-Marie, Holstein, Eva-Maria, Oluboyede, Yemi, Abouhajar, Alaa, Wilson, Janet A., Carrie, Sean, for the NAIROS Study Group, and Gardiner, Quentin

Subjects
TURBINATE bones, NASAL septum, INTRANASAL medication, NOSE, SURGICAL clinics
Abstract

Background: Septoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasties aim to improve diurnal and nocturnal nasal obstruction. The evidence base for septoplasty clinical effectiveness is hitherto very limited.Aims: To establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated with a deviated septum.Methods/design: A multicentre, mixed-methods, open label, randomised controlled trial of septoplasty versus medical management for adults with a deviated septum and a reduced nasal airway. Eligible patients will have septal deflection visible at nasendoscopy and a nasal symptom score ≥ 30 on the NOSE questionnaire. Surgical treatment comprises septoplasty with or without reduction of the inferior nasal turbinate on the anatomically wider side of the nose. Medical management comprises a nasal saline spray followed by a fluorinated steroid spray daily for six months. The recruitment target is 378 patients, recruited from up to 17 sites across Scotland, England and Wales. Randomisation will be on a 1:1 basis, stratified by gender and severity (NOSE score). Participants will be followed up for 12 months post randomisation. The primary outcome measure is the total SNOT-22 score at 6 months. Clinical and economic outcomes will be modelled against baseline severity (NOSE scale) to inform clinical decision-making. The study includes a recruitment enhancement process, and an economic evaluation.Discussion: The NAIROS trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. Identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit.Trial Registration: EudraCT: 2017-000893-12, ISRCTN: 16168569. Registered on 24 March 2017. [ABSTRACT FROM AUTHOR]

Published
2020
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45. Continuous low-dose antibiotic prophylaxis to prevent urinary tract infection in adults who perform clean intermittent self-catheterisation: the AnTIC RCT

Author

Pickard, Robert, primary, Chadwick, Thomas, additional, Oluboyede, Yemi, additional, Brennand, Catherine, additional, von Wilamowitz-Moellendorff, Alexander, additional, McClurg, Doreen, additional, Wilkinson, Jennifer, additional, Ternent, Laura, additional, Fisher, Holly, additional, Walton, Katherine, additional, McColl, Elaine, additional, Vale, Luke, additional, Wood, Ruth, additional, Abdel-Fattah, Mohamed, additional, Hilton, Paul, additional, Fader, Mandy, additional, Harrison, Simon, additional, Larcombe, James, additional, Little, Paul, additional, Timoney, Anthony, additional, N’Dow, James, additional, Armstrong, Heather, additional, Morris, Nicola, additional, Walker, Kerry, additional, and Thiruchelvam, Nikesh, additional

Published
2018
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46. Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial

Author

Massachusetts Institute of Technology. Department of Mechanical Engineering, Krebs, Hermano I, Rodgers, Helen, Shaw, Lisa, Bosomworth, Helen, Aird, Lydia, Alvarado, Natasha, Andole, Sreeman, Cohen, David L, Dawson, Jesse, Eyre, Janet, Finch, Tracy, Ford, Gary A, Hislop, Jennifer, Hogg, Steven, Howel, Denise, Hughes, Niall, Price, Christopher, Rochester, Lynn, Stamp, Elaine, Ternent, Laura, Turner, Duncan, Vale, Luke, Warburton, Elizabeth, van Wijck, Frederike, Wilkes, Scott, Cohen, David L., Ford, Gary A., Krebs, Hermano Igo, Massachusetts Institute of Technology. Department of Mechanical Engineering, Krebs, Hermano I, Rodgers, Helen, Shaw, Lisa, Bosomworth, Helen, Aird, Lydia, Alvarado, Natasha, Andole, Sreeman, Cohen, David L, Dawson, Jesse, Eyre, Janet, Finch, Tracy, Ford, Gary A, Hislop, Jennifer, Hogg, Steven, Howel, Denise, Hughes, Niall, Price, Christopher, Rochester, Lynn, Stamp, Elaine, Ternent, Laura, Turner, Duncan, Vale, Luke, Warburton, Elizabeth, van Wijck, Frederike, Wilkes, Scott, Cohen, David L., Ford, Gary A., and Krebs, Hermano Igo

Abstract

Background Loss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke. Methods/design Study design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation. Setting: NHS stroke services. Participants: adults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation. Randomisation groups: 1. Robot-assisted training using the InMotion robotic gym system for 45 min, three times/week for 12 weeks 2. Enhanced upper limb therapy for 45 min, three times/week for 12 weeks 3. Usual NHS care in accordance with local clinical practice Randomisation: individual participant randomisation stratified by centre, time since stroke, and severity of upper limb impairment. Primary outcome: upper limb function measured by the Action Research Arm Test (ARAT) at 3 months post randomisation. Secondary outcomes: upper limb impairment (Fugl-Meyer Test), activities of daily living (Barthel ADL Index), quality of life (Stroke Impact Scale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverse events, at 3 and 6 months. Blinding: outcomes are undertaken by blinded assessors. Economic analysis: micro-costing and economic evaluation of interventions compared to usual NHS care. A within-trial analysis, with an economic model will be used to extrapolate longer-term costs and outcomes. Process evaluation: semi-structured interviews with participants and professionals to seek their views and experiences of the rehabilitation that they have received or provided, and factors affecting the implementation of the trial. Sample size: allowing for 10% attrition, 720 participants provide 80% power to detect a 15% difference in successful outcome between each of the treatment pairs. Suc

Published
2017

47. Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial

Author

Rodgers, Helen, Shaw, Lisa, Bosomworth, Helen, Aird, Lydia, Alvarado, Natasha, Andole, Sreeman, Cohen, David L, Dawson, Jesse, Eyre, Janet, Finch, Tracy, Ford, Gary A, Hislop, Jennifer, Hogg, Steven, Howel, Denise, Hughes, Niall, Price, Christopher, Rochester, Lynn, Stamp, Elaine, Ternent, Laura, Turner, Duncan, Vale, Luke, Warburton, Elizabeth, van Wijck, Frederike, Wilkes, Scott, Cohen, David L., Ford, Gary A., Krebs, Hermano Igo, Krebs, Hermano I, Massachusetts Institute of Technology. Department of Mechanical Engineering, Krebs, Hermano I, and Apollo - University of Cambridge Repository

Subjects
Gerontology, Activities of daily living, Time Factors, medicine.medical_treatment, Cost-Benefit Analysis, L500, Medicine (miscellaneous), State Medicine, law.invention, Disability Evaluation, Study Protocol, 0302 clinical medicine, Randomized controlled trial, Quality of life, Clinical Protocols, law, Pharmacology (medical), 030212 general & internal medicine, Parallel process evaluation, Stroke, lcsh:R5-920, Rehabilitation, Stroke Rehabilitation, Cost-effectiveness analysis, Health Care Costs, Robotics, Biomechanical Phenomena, Exercise Therapy, medicine.anatomical_structure, Models, Economic, Treatment Outcome, Research Design, Arm, Upper limb, Quality-Adjusted Life Years, lcsh:Medicine (General), RCT, medicine.medical_specialty, Blinding, Upper Extremity, 03 medical and health sciences, medicine, Humans, business.industry, Recovery of Function, medicine.disease, United Kingdom, B900, Physical therapy, Quality of Life, business, 030217 neurology & neurosurgery
Abstract

Background Loss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke. Methods/design Study design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation. Setting: NHS stroke services. Participants: adults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation. Randomisation groups: 1. Robot-assisted training using the InMotion robotic gym system for 45 min, three times/week for 12 weeks 2. Enhanced upper limb therapy for 45 min, three times/week for 12 weeks 3. Usual NHS care in accordance with local clinical practice Randomisation: individual participant randomisation stratified by centre, time since stroke, and severity of upper limb impairment. Primary outcome: upper limb function measured by the Action Research Arm Test (ARAT) at 3 months post randomisation. Secondary outcomes: upper limb impairment (Fugl-Meyer Test), activities of daily living (Barthel ADL Index), quality of life (Stroke Impact Scale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverse events, at 3 and 6 months. Blinding: outcomes are undertaken by blinded assessors. Economic analysis: micro-costing and economic evaluation of interventions compared to usual NHS care. A within-trial analysis, with an economic model will be used to extrapolate longer-term costs and outcomes. Process evaluation: semi-structured interviews with participants and professionals to seek their views and experiences of the rehabilitation that they have received or provided, and factors affecting the implementation of the trial. Sample size: allowing for 10% attrition, 720 participants provide 80% power to detect a 15% difference in successful outcome between each of the treatment pairs. Successful outcome definition: baseline ARAT 0–7 must improve by 3 or more points; baseline ARAT 8–13 improve by 4 or more points; baseline ARAT 14–19 improve by 5 or more points; baseline ARAT 20–39 improve by 6 or more points. Discussion The results from this trial will determine whether robot-assisted training improves upper limb function post stroke. Trial registration ISRCTN, identifier: ISRCTN69371850. Registered 4 October 2013. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2083-4) contains supplementary material, which is available to authorized users.

Published
2016

48. Acceptability of Parental Financial Incentives and Quasi-Mandatory Interventions for Preschool Vaccinations: Triangulation of Findings from Three Linked Studies

Author

Bauch, Chris T., Adams, Jean, McNaughton, Rebekah J., Wigham, Sarah, Flynn, Darren, Ternent, Laura, and Shucksmith, Janet

Subjects
B700
Abstract

Background: Childhood vaccinations are a core component of public health programmes globally. Recent measles outbreaks in the UK and USA have prompted debates about new ways to increase uptake of childhood vaccinations. Parental financial incentives and quasi-mandatory interventions (e.g. restricting entry to educational settings to fully vaccinated children) have been successfully used to increase uptake of childhood vaccinations in developing countries, but there is limited evidence of effectiveness in developed countries. Even if confirmed to be effective, widespread implementation of these interventions is dependent on acceptability to parents, professionals and other stakeholders. Methods: We conducted a systematic review (n = 11 studies included), a qualitative study with parents (n = 91) and relevant professionals (n = 24), and an on-line survey with embedded discrete choice experiment with parents (n = 521) exploring acceptability of parental financial incentives and quasi-mandatory interventions for preschool vaccinations. Here we use Triangulation Protocol to synthesise findings from the three studies. Results: There was a consistent recognition that incentives and quasi-mandatory interventions could be effective, particularly in more disadvantaged groups. Universal incentives were consistently preferred to targeted ones, but relative preferences for quasi-mandatory interventions and universal incentives varied between studies. The qualitative work revealed a consistent belief that financial incentives were not considered an appropriate motivation for vaccinating children. The costs of financial incentive interventions appeared particularly salient and there were consistent concerns in the qualitative work that incentives did not represent the best use of resources for promoting preschool vaccinations. Various suggestions for improving delivery of the current UK vaccination programme as an alternative to incentives and quasi-mandates were made. Conclusions: Parental financial incentives and quasi-mandatory interventions for increasing uptake of preschool vaccinations do not currently attract widespread enthusiastic support in the UK; but some potential benefits of these approaches are recognised.

Published
2016

49. Additional file 1: of Antibiotic treatment for intermittent bladder catheterisation with once daily prophylaxis (the AnTIC study): Study protocol for a randomised controlled trial

Author

Brennand, Catherine, Wilamowitz-Moellendorff, Alexander Von, Dunn, Sarah, Wilkinson, Jennifer, Chadwick, Thomas, Ternent, Laura, Yemi Oluboyede, Wood, Ruth, Walton, Katherine, Fader, Mandy, N’Dow, James, Abdel-Fattah, Mohamed, McClurg, Doreen, Little, Paul, Hilton, Paul, Timoney, Anthony, Morris, Nicola, Nikesh Thiruchelvam, Larcombe, James, Harrison, Simon, Armstrong, Heather, McColl, Elaine, and Pickard, Robert

Abstract

AnTIC protocol trials publication SPIRITchecklist. (DOC 119 kb)

Published
2016
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50. Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial

Author

Rodgers, Helen, primary, Shaw, Lisa, additional, Bosomworth, Helen, additional, Aird, Lydia, additional, Alvarado, Natasha, additional, Andole, Sreeman, additional, Cohen, David L., additional, Dawson, Jesse, additional, Eyre, Janet, additional, Finch, Tracy, additional, Ford, Gary A., additional, Hislop, Jennifer, additional, Hogg, Steven, additional, Howel, Denise, additional, Hughes, Niall, additional, Krebs, Hermano Igo, additional, Price, Christopher, additional, Rochester, Lynn, additional, Stamp, Elaine, additional, Ternent, Laura, additional, Turner, Duncan, additional, Vale, Luke, additional, Warburton, Elizabeth, additional, van Wijck, Frederike, additional, and Wilkes, Scott, additional

Published
2017
Full Text
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