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1. Acceptability of Four Intervention Components Supporting Medication Adherence in Women with Breast Cancer: a Process Evaluation of a Fractional Factorial Pilot Optimization Trial

Author

Green, Sophie M. C., Rousseau, Nikki, Hall, Louise H., French, David P., Graham, Christopher D., Lloyd, Kelly E., Collinson, Michelle, Ow, Pei Loo, Taylor, Christopher, Howdon, Daniel, Foy, Robbie, Walwyn, Rebecca, Clark, Jane, Parbutt, Catherine, Waller, Jo, Buxton, Jacqueline, Moore, Sally J. L., Velikova, Galina, Farrin, Amanda, and Smith, Samuel G.

Published
2024
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2. Implementing a Medicines at Transitions Intervention (MaTI) for patients with heart failure: a process evaluation of the Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT) cluster randomised controlled trial

Author

Powell, Catherine, Ismail, Hanif, Breen, Liz, Fylan, Beth, Alderson, Sarah L, Gale, Chris P, Gardner, Peter, Silcock, Jonathan, Cundill, Bonnie, Farrin, Amanda, Mason, Ellen, Moreau, Lauren, and Alldred, David P

Published
2024
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4. Early vocational rehabilitation and psychological support for trauma patients to improve return to work (the ROWTATE trial): study protocol for an individually randomised controlled multicentre pragmatic trial

Author

Kendrick, Denise, Lindley, Rebecca, Blackburn, Lauren, Roadevin, Cristina, Thompson, Ellen, Andrews, Isabel, Anwar, Fahim, Brooks, Adam, Carlton, Edd, Crouch, Robert, Day, Florence, Fallon, Steve, Farrin, Amanda, Graham, Laura, Hoffman, Karen, Howell, Rebekah, Holmes, Jain, James, Marilyn, Jones, Trevor, Kellezi, Blerina, Kettlewell, Jade, Morriss, Richard, das Nair, Roshan, Richardson, Davina, Smith, Matthew, Timmons, Stephen, Wright-Hughes, Alexandra, and Radford, Kathryn

Published
2024
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7. Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA): study protocol for a randomised controlled trial of the clinical and cost-effectiveness of the STAMINA lifestyle intervention compared with optimised usual care, including internal pilot and parallel process evaluation

Author

McNaught, Emma, Reale, Sophie, Bourke, Liam, Brown, Janet E., Collinson, Michelle, Day, Florence, Hewison, Jenny, Farrin, Amanda J., Ibeggazene, Saïd, Innes, Aidan Q., Mason, Ellen, Meads, David, Scope, Alison, Taylor, Chris, Taylor, Steph JC., Turner, Rebecca R., and Rosario, Derek J.

Published
2024
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9. Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment in primary care (ATLANTIS): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Ford, Alexander C., Wright-Hughes, Alex, Alderson, Sarah L., Ow, Pei-Loo, Ridd, Matthew J., Foy, Robbie, Barratt, Maggie, Bianco, Gina, Bishop, Felicity L., Brindle, Richard, Brown, Sarah, Chaddock, Matthew, Christodoulou, Aimee, Cook, Heather, Cooper, Deborah, Day, Florence, Dowse, Aaron, Durnell, Jill, Emmerson, Jake, Fellows, Alasdair, Fernandez, Catherine, Guthrie, Elspeth A., Hartley, Suzanne, Herbert, Amy, Hindmarch, Damien, Howdon, Daniel, Malik, Aminah, Morris, Tom, Muir, Delia P., Longo, Roberta, Lopes Goncalves Graca, Sandra, Nath, Taposhi, Newman, Sonia, Parker, Catriona, Smith, Thomas, Taylor, Christopher A., Teasdale, Emma J., Thornton, Ruth, Tubeuf, Sandy, West, Amy, Williamson, Emma-Jane, Farrin, Amanda J., Everitt, Hazel A., Ford, Alexander C, Wright-Hughes, Alexandra, Alderson, Sarah L, Ridd, Matthew J, Bishop, Felicity L, Guthrie, Elspeth A, Muir, Delia P, Taylor, Christopher A, Teasdale, Emma J, Farrin, Amanda J, and Everitt, Hazel A

Published
2023
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10. Getting our ducks in a row: The need for data utility comparisons of healthcare systems data for clinical trials

Author

Sydes, Matthew R., Murray, Macey L., Ahmed, Saiam, Apostolidou, Sophia, Bliss, Judith M., Bloomfield, Claire, Cannings-John, Rebecca, Carpenter, James, Clayton, Tim, Clout, Madeleine, Cosgriff, Rebecca, Farrin, Amanda J., Gentry-Maharaj, Aleksandra, Gilbert, Duncan C., Harper, Charlie, James, Nicholas D., Langley, Ruth E., Lessels, Sarah, Lugg-Widger, Fiona, Mackenzie, Isla S., Mafham, Marion, Menon, Usha, Mintz, Harriet, Pinches, Heather, Robling, Michael, Wright-Hughes, Alexandra, Yorke-Edwards, Victoria, and Love, Sharon B.

Published
2024
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12. A cluster randomised controlled trial, process and economic evaluation of quality improvement collaboratives aligned to a national audit to improve the care for people with diabetes (EQUIPD): study protocol

Author

Sykes, Michael, Copsey, Bethan, Finch, Tracy, Meads, David, Farrin, Amanda, McSharry, Jenny, Holman, Naomi, Young, Bob, Berry, Alex, Ellis, Kat, Moreau, Lauren, Willis, Thomas, Alderson, Sarah, Girling, Melissa, O’Halloran, Elaine, and Foy, Robbie

Published
2023
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16. Efficient and flexible simulation-based sample size determination for clinical trials with multiple design parameters

Author

Wilson, Duncan T., Walwyn, Rebecca E. A., Hooper, Richard, Brown, Julia, and Farrin, Amanda J.

Subjects
Statistics - Methodology
Abstract

Simulation offers a simple and flexible way to estimate the power of a clinical trial when analytic formulae are not available. The computational burden of using simulation has, however, restricted its application to only the simplest of sample size determination problems, minimising a single parameter (the overall sample size) subject to power being above a target level. We describe a general framework for solving simulation-based sample size determination problems with several design parameters over which to optimise and several conflicting criteria to be minimised. The method is based on an established global optimisation algorithm widely used in the design and analysis of computer experiments, using a non-parametric regression model as an approximation of the true underlying power function. The method is flexible, can be used for almost any problem for which power can be estimated using simulation, and can be implemented using existing statistical software packages. We illustrate its application to three increasingly complicated sample size determination problems involving complex clustering structures, co-primary endpoints, and small sample considerations.

Published
2019
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17. Bayesian design and analysis of external pilot trials for complex interventions

Author

Wilson, Duncan T., Wason, James M. S., Brown, Julia, Farrin, Amanda J., and Walwyn, Rebecca E. A.

Subjects
Statistics - Methodology
Abstract

External pilot trials of complex interventions are used to help determine if and how a confirmatory trial should be undertaken, providing estimates of parameters such as recruitment, retention and adherence rates. The decision to progress to the confirmatory trial is typically made by comparing these estimates to pre-specified thresholds known as progression criteria, although the statistical properties of such decision rules are rarely assessed. Such assessment is complicated by several methodological challenges, including the simultaneous evaluation of multiple endpoints, complex multi-level models, small sample sizes, and uncertainty in nuisance parameters. In response to these challenges, we describe a Bayesian approach to the design and analysis of external pilot trials. We show how progression decisions can be made by minimising the expected value of a loss function, defined over the whole parameter space to allow for preferences and trade-offs between multiple parameters to be articulated and used in the decision making process. The assessment of preferences is kept feasible by using a piecewise constant parameterisation of the loss function, the parameters of which are chosen at the design stage to lead to desirable operating characteristics. We describe a flexible, yet computationally intensive, nested Monte Carlo algorithm for estimating operating characteristics. The method is used to revisit the design of an external pilot trial of a complex intervention designed to increase the physical activity of care home residents.

Published
2019
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18. A hypothesis test of feasibility for external pilot trials assessing recruitment, follow-up and adherence rates

Author

Wilson, Duncan T., Walwyn, Rebecca E. A., Brown, Julia, and Farrin, Amanda J.

Subjects
Statistics - Methodology
Abstract

The power of a large clinical trial can be adversely affected by low recruitment, follow-up and adherence rates. External pilot trials estimate these rates and use them, via pre-specified decision rules, to determine if the definitive trial is feasible and should go ahead. There is little methodological research underpinning how these decision rules, or the sample size of the pilot, should be chosen. In this paper we propose a hypothesis test of the feasibility of a definitive trial, to be applied to the external pilot data and used to make progression decisions. We quantify feasibility by the power of the planned trial, as a function of recruitment, follow-up and adherence rates. We use this measure to define hypotheses to test in the pilot, propose a test statistic, and show how the error rates of this test can be calculated for the common scenario of a two-arm parallel group definitive trial with a single normally distributed primary endpoint. We use our method to re-design TIGA-CUB, an external pilot trial comparing a psychotherapy with treatment as usual for children with conduct disorders. We then extend our formulation to include using the pilot data to estimate the standard deviation of the primary endpoint. and incorporate this into the progression decision.

Published
2019
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20. A randomised fractional factorial screening experiment to predict effective features of audit and feedback

Author

Wright-Hughes, Alexandra, Willis, Thomas A., Wilson, Stephanie, Weller, Ana, Lorencatto, Fabiana, Althaf, Mohamed, Seymour, Valentine, Farrin, Amanda J., Francis, Jillian, Brehaut, Jamie, Ivers, Noah, Alderson, Sarah L., Brown, Benjamin C., Feltbower, Richard G., Gale, Chris P., Stanworth, Simon J., Hartley, Suzanne, Colquhoun, Heather, Presseau, Justin, Walwyn, Rebecca, and Foy, Robbie

Published
2022
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21. Amitriptyline at low-dose and titrated for irritable bowel syndrome as second-line treatment (The ATLANTIS trial): protocol for a randomised double-blind placebo-controlled trial in primary care

Author

Alderson, Sarah L., Wright-Hughes, Alexandra, Ford, Alexander C., Farrin, Amanda, Hartley, Suzanne, Fernandez, Catherine, Taylor, Christopher, Ow, Pei Loo, Teasdale, Emma, Howdon, Daniel, Guthrie, Elspeth, Foy, Robbie, Ridd, Matthew J., Bishop, Felicity L., Muir, Delia, Chaddock, Matthew, Herbert, Amy, Cooper, Deborah, Gibbins, Ruth, Newman, Sonia, Cook, Heather, Longo, Roberta, and Everitt, Hazel

Published
2022
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22. Acceptance and Commitment Therapy to support medication decision-making and quality of life in women with breast cancer: protocol for a pilot randomised controlled trial

Author

Smith, Samuel G., Ellison, Rachel, Hall, Louise, Clark, Jane, Hartley, Suzanne, Mason, Ellen, Metherell, Jamie, Olivier, Catherine, Napp, Vicky, Naik, Jay, Buckley, Sarah, Hirst, Charlotte, Hartup, Sue, Neal, Richard D., Velikova, Galina, Farrin, Amanda, Collinson, Michelle, and Graham, Christopher D.

Published
2022
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26. The RETurn to work After stroKE (RETAKE) trial: Findings from a mixed-methods process evaluation of the Early Stroke Specialist Vocational Rehabilitation (ESSVR) intervention.

Author

Clarke, David James, Powers, Katie, Trusson, Diane, Craven, Kristelle, Phillips, Julie, Holmes, Jain, McKevitt, Christopher, Bowen, Audrey, Watkins, Caroline Leigh, Farrin, Amanda J., Wright-Hughes, Alexandra, Sach, Tracey, Chambers, Rachel, and Radford, Kate

Subjects
VOCATIONAL rehabilitation, STROKE patients, RANDOMIZED controlled trials, STROKE, OCCUPATIONAL therapists
Abstract

Introduction: A key goal for working age stroke survivors is to return to work, yet only around 50% achieve this at 12 months. Currently, there is limited evidence of effectiveness of early stroke-specialist vocational rehabilitation (ESSVR) interventions from randomised controlled trials. This study examined fidelity to ESSVR and explored social and structural factors which may have influenced implementation in the RETurn to work After stroKE (RETAKE) randomised controlled trial. Methods: Mixed-methods process evaluation assessing intervention fidelity and incorporating longitudinal case-studies exploring stroke survivors' experiences of support to return to work. Normalisation Process Theory, and the Conceptual Model for Implementation Fidelity, informed data collection and analysis. Results: Sixteen sites across England and Wales participated in RETAKE. Forty-eight occupational therapists (OTs), supported by 6 mentors experienced in vocational rehabilitation (VR), delivered the intervention (duration 12 months) between February 2018 and April 2022. Twenty-six participants (15 ESSVR, 11 usual care (UC)) were included in longitudinal case-studies. An additional 18 participants (8 ESSVR and 10 UC) were interviewed once. Nineteen OTs, 6 mentors and 19 service managers were interviewed. Fidelity was measured for 39 ESSVR participants; mean fidelity score was 78.8% (SD:19.2%, range 31–100%). Comparison of the experiences of ESSVR and UC participants indicated duration and type of support to return to work were perceived to be better for ESSVR participants. They received early, co-ordinated support including employer liaison and workplace adjustments where appropriate. In contrast, UC participants reported limited or no VR or return to work support from health professionals. Typically, UC support lasted 2–8 weeks, with poor communication and co-ordination between rehabilitation providers. Mentor support for OTs appeared to increase fidelity. Service managers indicated ESSVR would enhance post-stroke services. Conclusions: ESSVR was valued by participants and was delivered with fidelity; implementation appeared to be facilitated by mentor support for OTs. [ABSTRACT FROM AUTHOR]

Published
2024
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29. Criteria and indicators for Centers of Clinical Excellence in stroke recovery and rehabilitation: A global consensus facilitated by ISRRA

Author

Stockley, Rachel, Walker, Marion, Alt Murphy, Margit, Abd Aziz, Noor Azah, Amooba, Philemon Adoliwine, Churilov, Leonid, Farrin, Amanda, Fini, Natalie, Ghaziani, Emma, Godecke, Erin, Gutiérrez-Panchana, Tania, Jia, Jie, Kandasamy, Thoshenthri, Lindsay, Patrice, Solomon, John, Thijs, Vincent, Tindall, Tierney, Tippett, Donna, Watkins, Caroline Leigh, Lynch, Elizabeth, Stockley, Rachel, Walker, Marion, Alt Murphy, Margit, Abd Aziz, Noor Azah, Amooba, Philemon Adoliwine, Churilov, Leonid, Farrin, Amanda, Fini, Natalie, Ghaziani, Emma, Godecke, Erin, Gutiérrez-Panchana, Tania, Jia, Jie, Kandasamy, Thoshenthri, Lindsay, Patrice, Solomon, John, Thijs, Vincent, Tindall, Tierney, Tippett, Donna, Watkins, Caroline Leigh, and Lynch, Elizabeth

Abstract

Background The aim of the International Stroke Recovery and Rehabilitation Alliance is to create a world where worldwide collaboration brings major breakthroughs for the millions of people living with stroke. A key pillar of this work is to define globally relevant criteria for centers that aspire to deliver excellent clinical rehabilitation and generate exceptional outcomes for patients. Objectives This paper presents consensus work conducted with an international group of expert stroke recovery and rehabilitation researchers, clinicians, and people living with stroke to identify and define criteria and measurable indicators for Centers of Clinical Excellence (CoCE) in stroke recovery and rehabilitation. These were intentionally developed to be ambitious and internationally relevant, regardless of a country’s development or income status, to drive global improvement in stroke services. Methods Criteria and specific measurable indicators for CoCE were collaboratively developed by an international panel of stroke recovery and rehabilitation experts from 10 countries and consumer groups from 5 countries. Results The criteria and associated indicators, ranked in order of importance, focused upon (i) optimal outcome, (ii) research culture, (iii) working collaboratively with people living with stroke, (iv) knowledge exchange, (v) leadership, (vi) education, and (vii) advocacy. Work is currently underway to user-test the criteria and indicators in 14 rehabilitation centers in 10 different countries. Conclusions We anticipate that use of the criteria and indicators could support individual organizations to further develop their services and, more widely, provide a mechanism by which clinical excellence can be articulated and shared to generate global improvements in stroke care.

Published
2024

30. Criteria and indicators for centers of clinical excellence in stroke recovery and rehabilitation: A global consensus facilitated by ISRRA

Author

Stockley, Rachel C., Walker, Marion F., Murphy, Margit A., Aziz, Noor A. A., Amooba, Philemon, Churliov, Leonid, Farrin, Amanda, Fini, Natalie A., Ghaziani, Emma, Godecke, Erin, Gutierrez-Panchana, Tania, Jia, Jie, Kandasamy, Thoshenthri, Lindsay, Patrice, Solomon, John, Thijs, Vincent, Tindall, Tierney, Tippett, Donna C., Watkins, Caroline, Lynch, Elizabeth, Stockley, Rachel C., Walker, Marion F., Murphy, Margit A., Aziz, Noor A. A., Amooba, Philemon, Churliov, Leonid, Farrin, Amanda, Fini, Natalie A., Ghaziani, Emma, Godecke, Erin, Gutierrez-Panchana, Tania, Jia, Jie, Kandasamy, Thoshenthri, Lindsay, Patrice, Solomon, John, Thijs, Vincent, Tindall, Tierney, Tippett, Donna C., Watkins, Caroline, and Lynch, Elizabeth

Abstract

Background: The aim of the International Stroke Recovery and Rehabilitation Alliance is to create a world where worldwide collaboration brings major breakthroughs for the millions of people living with stroke. A key pillar of this work is to define globally relevant criteria for centers that aspire to deliver excellent clinical rehabilitation and generate exceptional outcomes for patients. Objectives: This paper presents consensus work conducted with an international group of expert stroke recovery and rehabilitation researchers, clinicians, and people living with stroke to identify and define criteria and measurable indicators for Centers of Clinical Excellence (CoCE) in stroke recovery and rehabilitation. These were intentionally developed to be ambitious and internationally relevant, regardless of a country’s development or income status, to drive global improvement in stroke services. Methods: Criteria and specific measurable indicators for CoCE were collaboratively developed by an international panel of stroke recovery and rehabilitation experts from 10 countries and consumer groups from 5 countries. Results: The criteria and associated indicators, ranked in order of importance, focused upon (i) optimal outcome, (ii) research culture, (iii) working collaboratively with people living with stroke, (iv) knowledge exchange, (v) leadership, (vi) education, and (vii) advocacy. Work is currently underway to user-test the criteria and indicators in 14 rehabilitation centers in 10 different countries. Conclusions: We anticipate that use of the criteria and indicators could support individual organizations to further develop their services and, more widely, provide a mechanism by which clinical excellence can be articulated and shared to generate global improvements in stroke care.

Published
2024

31. A pilot randomised controlled trial of acceptance and commitment therapy for medication decision‐making and quality of life in women with breast cancer: The ACTION trial.

Author

Graham, Christopher D., Ellison, Rachel, Hall, Louise H., Clark, Jane, McNaught, Emma, Green, Sophie M. C., Wilkes, Hollie, Robson, Gita, Lorentz, Ian, Holmes, Lucy, Bould, Nicky, Hartley, Suzanne, Naik, Jay, Buckley, Sarah, Hirst, Charlotte, Hartup, Sue, Foy, Robbie, Neal, Richard D., Velikova, Galina, and Farrin, Amanda

Subjects
ACCEPTANCE & commitment therapy, QUALITY of life, CANCER patients, GENERALIZED anxiety disorder, CLINICAL trials
Abstract

Objective: Non‐adherence to adjuvant endocrine therapy (AET) in women with breast cancer is common and associated with medication side‐effects and distress. We co‐designed an Acceptance and Commitment Therapy intervention (ACTION) to enhance medication decision‐making and quality of life (QoL). We undertook a pilot trial of ACTION to inform the feasibility of a phase III trial, and to examine intervention acceptability. Methods: This was a multi‐site, exploratory, two‐arm, individually randomised external pilot trial. Women with early breast cancer prescribed AET were randomised (1:1) to receive usual care (UC) or UC + ACTION. The ACTION intervention comprised a remotely delivered one‐to‐one ACT session followed by three group sessions delivered by clinical psychologists, alongside a website containing ideas for the self‐management of side effects. Results: Of the 480 women screened for eligibility, 260 (54.2%) were approached and 79 (30.4%) randomised. 71 (89.9%) women provided data at 3‐month and 70 (88.6%) at 6‐month 40 women were randomised to receive UC + ACTION and 32 (80.0%) completed the intervention. Most (75.0%) accessed the website at least once. ACTION was acceptable to participants (Borkovec & Nau Scale: mean = 7.8 [SD = 2.7] out of 10). Signals of effectiveness in favour of the UC + ACTION arm were observed for medication adherence (Adherence Starts with Knowledge questionnaire‐12), QoL (work and social adjustment scale), health‐related QoL (functional assessment of cancer therapy[FACT] general and FACT‐ES‐19/23), distress (generalised anxiety disorder ‐7, patient health questionnaire‐9) and psychological flexibility (valuing questionnaire). Conclusions: The ACTION intervention was acceptable to patients. There were promising signals for effectiveness on primary and secondary outcomes. A phase III randomised controlled trial is feasible. Trial Registration: ISRCTN12027752. [ABSTRACT FROM AUTHOR]

Published
2024
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34. Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage

Author

Toader, Alice-Maria, primary, Campbell, Marion K., additional, Quint, Jennifer K., additional, Robling, Michael, additional, Sydes, Matthew R, additional, Thorn, Joanna, additional, Wright-Hughes, Alexandra, additional, Yu, Ly-Mee, additional, Abbott, Tom. E. F., additional, Bond, Simon, additional, Caskey, Fergus J., additional, Clout, Madeleine, additional, Collinson, Michelle, additional, Copsey, Bethan, additional, Davies, Gwyneth, additional, Driscoll, Timothy, additional, Gamble, Carrol, additional, Griffin, Xavier L., additional, Hamborg, Thomas, additional, Harris, Jessica, additional, Harrison, David A., additional, Harji, Deena, additional, Henderson, Emily J., additional, Logan, Pip, additional, Love, Sharon B., additional, Magee, Laura A., additional, O’Brien, Alastair, additional, Pufulete, Maria, additional, Ramnarayan, Padmanabhan, additional, Saratzis, Athanasios, additional, Smith, Jo, additional, Solis-Trapala, Ivonne, additional, Stubbs, Clive, additional, Farrin, Amanda, additional, and Williamson, Paula, additional

Published
2024
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35. Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit

Author

Cragg, William, primary, Taylor, Chris, additional, Moreau, Lauren, additional, Collier, Howard, additional, Gilberts, Rachael, additional, McKigney, Niamh, additional, Dennett, Joanna, additional, Graca, Sandra, additional, Wheeler, Ian, additional, Bishop, Liam, additional, Barrett, Adam, additional, Hartley, Suzanne, additional, Greenwood, John P, additional, Swoboda, Peter, additional, and Farrin, Amanda J, additional

Published
2023
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36. Amitriptyline at Low-dose and Titrated for Irritable Bowel Syndrome in Primary Care: ATLANTIS: Randomised Controlled Trial

Author

Everitt, Hazel, primary, Foy, Robbie, additional, Ridd, Matthew, additional, Alderson, Sarah, additional, Thornton, Ruth, additional, Newman, Sonia, additional, Teasdale, Emma, additional, Cook, Heather, additional, cooper, deborah, additional, Fernandez, Catherine, additional, Herbert, Amy, additional, Chaddock, Matthew, additional, Wright-Hughes, Alexandra, additional, Farrin, Amanda, additional, Hartley, Suzanne, additional, Ford, Alexander, additional, Bishop, Felicity, additional, and Ow, Pei Loo, additional

Published
2023
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39. Home-based Extended Rehabilitation for Older people (HERO): study protocol for an individually randomised controlled multi-centre trial to determine the clinical and cost-effectiveness of a home-based exercise intervention for older people with frailty as extended rehabilitation following acute illness or injury, including embedded process evaluation

Author

Prescott, Matthew, Lilley-Kelly, Amanda, Cundill, Bonnie, Clarke, David, Drake, Sian, Farrin, Amanda J., Forster, Anne, Goodwin, Madeline, Goodwin, Victoria A., Hall, Abi J., Hartley, Suzanne, Holland, Mike, Hulme, Claire, Nikolova, Silviya, Parker, Catriona, Wright, Phil, Ziegler, Friederike, and Clegg, Andrew

Published
2021
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41. A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial

Author

Bryant, Maria, Burton, Wendy, Collinson, Michelle, Farrin, Amanda, Nixon, Jane, Stevens, June, Roberts, Kim, Foy, Robbie, Rutter, Harry, Copsey, Bethan, Hartley, Suzanne, Tubeuf, Sandy, and Brown, Julia

Published
2021
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43. Using healthcare systems data for outcomes in clinical trials: Issues to consider at the design stage

Author

Toader, Alice-Maria, primary, Campbell, Marion K, additional, Quint, Jennifer K, additional, Robling, Michael, additional, Sydes, Matthew R, additional, Thorn, Joanna, additional, Wright-Hughes, Alexandra, additional, Yu, Ly-Mee, additional, Abbott, Tom E.F., additional, Bond, Simon, additional, Caskey, Fergus J, additional, Clout, Madeleine, additional, Collinson, Michelle, additional, Copsey, Bethan, additional, Davies, Gwyneth, additional, Driscoll, Timothy, additional, Gamble, Carrol, additional, Griffin, Xavier L, additional, Hamborg, Thomas, additional, Harris, Jessica, additional, Harrison, David A, additional, Harji, Deena, additional, Henderson, Emily J, additional, Logan, Pip, additional, Love, Sharon B, additional, Magee, Laura A, additional, O'Brien, Alastair, additional, Pufulete, Maria, additional, Ramnarayan, Padmanabhan, additional, Saratzis, Athanasios, additional, Smith, Jo, additional, Solis-Trapala, Ivonne, additional, Stubbs, Clive, additional, Farrin, Amanda, additional, and Williamson, Paula, additional

Published
2023
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44. CONTACT: A Non-Randomised Feasibility Study of Bluetooth Enabled Wearables for Contact Tracing in UK Care Homes During the COVID-19 Pandemic.

Author

Thompson, Carl, primary, Willis, Tom, additional, Farrin, Amanda, additional, Gordon, Adam, additional, Dafu-O'Reilly, Amrit, additional, Noakes, Catherine, additional, Khaliq, Kishwer, additional, Kemp, Andrew, additional, Hall, Tom, additional, Bojke, Chris, additional, and Spilsbury, Karen, additional

Published
2023
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45. Ondansetron for irritable bowel syndrome with diarrhoea: randomised controlled trial

Author

Gunn, David, primary, Topan, Rabia, additional, Fried, Ron, additional, Holloway, Ivana, additional, Brindle, Richard, additional, Hartley, Suzanne, additional, Barnard, Lorna, additional, Corsetti, Maura, additional, Scott, S Mark, additional, Farmer, Adam, additional, Akbar, Ayesha, additional, Eugenicos, Maria, additional, Trudgill, Nigel, additional, Kapur, Kapil, additional, McLaughlin, John, additional, Sanders, David S, additional, Ramadas, Arvind, additional, Whorwell, Peter, additional, Houghton, Lesley, additional, Dinning, Phil G, additional, Aziz, Qasim, additional, Ford, Alexander C, additional, Farrin, Amanda, additional, and Spiller, Robin, additional

Published
2023
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46. Intervention to reduce sedentary behaviour and improve outcomes after stroke (Get Set Go): a study protocol for the process evaluation of a pilot cluster randomised controlled trial (RECREATE)

Author

Johansson, Jessica Faye, primary, Shannon, Rosie, additional, Mossabir, Rahena, additional, Airlie, Jennifer, additional, Ozer, Seline, additional, Moreau, Lauren A, additional, Farrin, Amanda, additional, Mead, Gillian, additional, English, Coralie, additional, Fitzsimons, Claire F, additional, Clarke, David J, additional, and Forster, Anne, additional

Published
2023
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47. “Smart” BLE Wearables for Digital Contact Tracing in Care Homes During the COVID-19 Pandemic – a Process Evaluation of the CONTACT Feasibility Study.

Author

Thompson, Carl A, primary, Dafu-O'Reilly, Amrit, additional, Willis, Thomas, additional, Gordon, Adam, additional, Noakes, Catherine, additional, Khaliq, Kishwer, additional, Farrin, Amanda, additional, Kemp, Andrew, additional, Hall, Tom, additional, Bojke, Chris, additional, and Spilsbury, Karen, additional

Published
2023
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48. Effectiveness of systemic family therapy versus treatment as usual for young people after self-harm: a pragmatic, phase 3, multicentre, randomised controlled trial

Author

Cottrell, David J, Wright-Hughes, Alexandra, Collinson, Michelle, Boston, Paula, Eisler, Ivan, Fortune, Sarah, Graham, Elizabeth H, Green, Jonathon, House, Allan O, Kerfoot, Michael, Owens, David W, Saloniki, Eirini-Christina, Simic, Mima, Lambert, Fiona, Rothwell, Justine, Tubeuf, Sandy, and Farrin, Amanda J

Published
2018
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49. An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Author

Radford, Kathryn A., Craven, Kristelle, McLellan, Vicki, Sach, Tracey H., Brindle, Richard, Holloway, Ivana, Hartley, Suzanne, Bowen, Audrey, O’Connor, Rory, Stevens, Judith, Philips, Julie, Walker, Marion, Holmes, Jain, McKevitt, Christopher, Murray, John, Watkins, Caroline, Powers, Katie, Shone, Angela, and Farrin, Amanda

Published
2020
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50. RECREATE: a study protocol for a multicentre pilot cluster randomised controlled trial (cRCT) in UK stroke services evaluating an intervention to reduce sedentary behaviour in stroke survivors (Get Set Go) with embedded process and economic evaluations

Author

Airlie, Jennifer, primary, Burton, Louisa-Jane, additional, Copsey, Bethan, additional, English, Coralie, additional, Farrin, Amanda, additional, Fitzsimons, Claire F, additional, Holloway, Ivana, additional, Horrocks, Judith, additional, Johansson, Jessica Faye, additional, Mead, Gillian, additional, Moreau, Lauren A, additional, Ozer, Seline, additional, Patel, Anita, additional, Yaziji, Nahel, additional, and Forster, Anne, additional

Published
2023
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