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Outputs (43)

Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK (2024)
Journal Article
Khan, K., Hall, C. L., Babbage, C., Dodzo, S., Greenhalgh, C., Lucassen, M., …Hollis, C. (2024). Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK. Pilot and Feasibility Studies, 10(1), Article 53. https://doi.org/10.1186/s40814-024-01475-7

Background : A serious game called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), originally developed in New Zealand and incorporating cognitive behavioural therapy (CBT) principles, has been shown to help reduce symptoms of depressi... Read More about Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK.

Choosing and evaluating randomisation methods in clinical trials: a qualitative study (2024)
Journal Article
Bruce, C. L., Iflaifel, M., Montgomery, A., Ogollah, R., Sprange, K., & Partlett, C. (2024). Choosing and evaluating randomisation methods in clinical trials: a qualitative study. Trials, 25(1), Article 199. https://doi.org/10.1186/s13063-024-08005-z

Background: There exist many different methods of allocating participants to treatment groups during a randomised controlled trial. Although there is research that explores trial characteristics that are associated with the choice of method, there is... Read More about Choosing and evaluating randomisation methods in clinical trials: a qualitative study.

Recording harms in randomised controlled trials of behaviour change interventions: a scoping review and map of the evidence (2024)
Journal Article
Papaioannou, D., Hamer-Kiwacz, S., Mooney, C., Cooper, C., O'Cathain, A., Sprange, K., & Moody, G. (2024). Recording harms in randomised controlled trials of behaviour change interventions: a scoping review and map of the evidence. Journal of Clinical Epidemiology, 169, Article 111275. https://doi.org/10.1016/j.jclinepi.2024.111275

Randomised controlled trials evaluate diverse interventions. This can include medical interventions such as drugs or surgical procedures, or behaviour change interventions that aim to change a habit, belief, or attitude to improve health e.g., health... Read More about Recording harms in randomised controlled trials of behaviour change interventions: a scoping review and map of the evidence.

Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs) (2023)
Journal Article
Madurasinghe, V. W., Knapp, P., Eldridge, S., Collier, D., Treweek, S., Rick, J., …Bower, P. (2023). Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs). BMC Medicine, 21(1), Article 425. https://doi.org/10.1186/s12916-023-03081-5

Background: People need high-quality information to make decisions about research participation. Providing information in written format alone is conventional but may not be the most effective and acceptable approach. We developed a structure for the... Read More about Can we achieve better trial recruitment by presenting patient information through multimedia? Meta-analysis of ‘studies within a trial’ (SWATs).

Transient elastography and video recovery narrative access to support recovery from alcohol misuse: development of a novel intervention for use in community alcohol treatment services (2023)
Journal Article
Rennick-Egglestone, S., Subhani, M., Knight, H., Jones, K. A., Hutton, C., Jackson, T., …Ryder, S. (2023). Transient elastography and video recovery narrative access to support recovery from alcohol misuse: development of a novel intervention for use in community alcohol treatment services. JMIR Formative Research, 7, Article e47109. https://doi.org/10.2196/47109

Background: Mortality from alcohol-related liver disease has risen significantly for three decades. Transient elastography (TE) is a non-invasive test providing a numerical marker of liver disease. Preliminary evidence suggests that receiving TE can... Read More about Transient elastography and video recovery narrative access to support recovery from alcohol misuse: development of a novel intervention for use in community alcohol treatment services.

Widening participation – recruitment methods in mental health randomised controlled trials: a qualitative study (2023)
Journal Article
Iflaifel, M., Hall, C. L., Green, H. R., Willis, A., Rennick-Egglestone, S., Juszczak, E., …Sprange, K. (2023). Widening participation – recruitment methods in mental health randomised controlled trials: a qualitative study. BMC Medical Research Methodology, 23(1), Article 211. https://doi.org/10.1186/s12874-023-02032-1

Background: Barriers to mental health research participation are well documented including distrust of services and research; and stigma surrounding mental health. They can contribute to a lack of diversity amongst participants in mental health resea... Read More about Widening participation – recruitment methods in mental health randomised controlled trials: a qualitative study.

Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD): an open-label pragmatic feasibility randomised controlled trial (2023)
Journal Article
Subhani, M., Enki, D. G., Knight, H., Jones, K. A., Sprange, K., Rennick-Egglestone, S., …Ryder, S. D. (2023). Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD): an open-label pragmatic feasibility randomised controlled trial. eClinicalMedicine, 61, Article 102069. https://doi.org/10.1016/j.eclinm.2023.102069

Background: Early identification followed by effective behaviour interventions is pivotal to changing the natural history of alcohol-related liver disease. We examined the feasibility of using transient elastography based advice and alcohol recovery... Read More about Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD): an open-label pragmatic feasibility randomised controlled trial.

Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study (2023)
Journal Article
Iflaifel, M., Sprange, K., Bell, J., Cook, A., Gamble, C., Julious, S. A., …Partlett, C. (2023). Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study. Trials, 24, Article 71. https://doi.org/10.1186/s13063-022-06992-5

Background: Existing guidelines recommend statisticians remain blinded to treatment allocation prior to the final analysis and that any interim analyses should be conducted by a separate team from the one undertaking the final analysis. However, ther... Read More about Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study.

Mental health in clinically referred children and young people before and during the Covid-19 pandemic (2022)
Journal Article
Sayal, K., Partlett, C., Bhardwaj, A., Dubicka, B., Marshall, T., Gledhill, J., …Montgomery, A. (2023). Mental health in clinically referred children and young people before and during the Covid-19 pandemic. European Child and Adolescent Psychiatry, 32(12), 2657–2666. https://doi.org/10.1007/s00787-022-02115-2

The Covid-19 pandemic and mitigation approaches, including lockdowns and school closures, are thought to have negatively impacted children and young people’s (CYP) mental health. However, the impact for clinically referred CYP is less clear. We inves... Read More about Mental health in clinically referred children and young people before and during the Covid-19 pandemic.

Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units (2022)
Journal Article
Iflaifel, M., Partlett, C., Bell, J., Cook, A., Gamble, C., Julious, S., …Sprange, K. (2022). Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units. Trials, 23(1), Article 535. https://doi.org/10.1186/s13063-022-06481-9

Background: Blinding is an established approach in clinical trials which aims to minimise the risk of performance and detection bias. There is little empirical evidence to guide UK clinical trials units (CTUs) about the practice of blinding statistic... Read More about Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units.

Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing? (2022)
Journal Article
Mitchell, E. J., Sprange, K., Treweek, S., & Nixon, E. (2022). Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing?. Trials, 23, Article 457. https://doi.org/10.1186/s13063-022-06417-3

Marketing is a core business function in commercial companies but is also frequently used by not-for-profit organisations. Marketing focuses on understanding what people value to make choices about engaging with a product or service: a concept also k... Read More about Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing?.

STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial (2022)
Journal Article
Day, F., Wyatt, L., Bhardwaj, A., Dubicka, B., Ewart, C., Gledhill, J., …Sayal, K. (2022). STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial. BMJ Open, 12(5), Article e053043. https://doi.org/10.1136/bmjopen-2021-053043

INTRODUCTION: Emotional disorders (such as anxiety and depression) are associated with considerable distress and impairment in day-to-day function for affected children and young people and for their families. Effective evidence-based interventions a... Read More about STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial.

The Journeying through Dementia psychosocial intervention versus usual care study: a two-arm, phase 3, superiority randomised controlled trial (2022)
Journal Article
Mountain, G., Cooper, C., Wright, J., Walters, S., Lee, E., Craig, C., …Young, E. (2022). The Journeying through Dementia psychosocial intervention versus usual care study: a two-arm, phase 3, superiority randomised controlled trial. Lancet Healthy Longevity, 3(4), e276-e285. https://doi.org/10.1016/S2666-7568%2822%2900059-9

Background There is an urgent clinical need for evidence based psychosocial interventions for people with mild dementia. We aimed to determine clinical and cost-effectiveness of Journeying through Dementia (JtD), an intervention designed to promote w... Read More about The Journeying through Dementia psychosocial intervention versus usual care study: a two-arm, phase 3, superiority randomised controlled trial.

The implementation of Journeying through Dementia: Strategies to run a successful pragmatic multicenter trial of a complex intervention (2021)
Journal Article
Berry, K., Wright, J., Sprange, K., Cooper, C., Courtney-Walker, R., & Mountain, G. (2021). The implementation of Journeying through Dementia: Strategies to run a successful pragmatic multicenter trial of a complex intervention. Brain and Behavior, 11(12), Article e2436. https://doi.org/10.1002/brb3.2436

Objective: A key challenge in delivering pragmatic trials of complex interventions is effective implementation within the study period and beyond. We describe a trial of an intervention to improve quality of life in mild dementia (Journeying through... Read More about The implementation of Journeying through Dementia: Strategies to run a successful pragmatic multicenter trial of a complex intervention.

Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD)? protocol for a feasibility randomised controlled trial (2021)
Journal Article
Subhani, M., Jones, K. A., Sprange, K., Rennick-Egglestone, S., Knight, H., Morling, J. R., …Ryder, S. D. (2021). Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD)? protocol for a feasibility randomised controlled trial. BMJ Open, 11(11), Article e054954. https://doi.org/10.1136/bmjopen-2021-054954

Introduction Heavy drinkers in contact with alcohol services do not routinely have access to testing to establish the severity of potential liver disease. Transient elastography by FibroScan can provide this information. A recent systematic review su... Read More about Does knowledge of liver fibrosis affect high-risk drinking behaviour (KLIFAD)? protocol for a feasibility randomised controlled trial.

Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: A randomised controlled trial (2021)
Journal Article
Sprange, K., Mountain, G., & Craig, C. (2021). Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: A randomised controlled trial. BMJ Open, 11(4), Article e043478. https://doi.org/10.1136/bmjopen-2020-043478

Objectives: Robust research of complex interventions designed to promote mental well-being in later life is required to inform service development. An essential component is ensuring that such interventions are delivered as intended. We present a det... Read More about Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: A randomised controlled trial.

Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial (2021)
Journal Article
Sprange, K., Mountain, G., & Craig, C. (2021). Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial. BMJ Open, 11(4), Article e043478. https://doi.org/10.1136/bmjopen-2020-043478

Objectives: Robust research of complex interventions designed to promote mental wellbeing in later life is required to inform service development. An essential component is ensuring that such interventions are delivered as intended. We present a deta... Read More about Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial.

Promoting independence in Dementia (Pride): A feasibility randomized controlled trial (2021)
Journal Article
Csipke, E., Shafayat, A., Sprange, K., Bradshaw, L., Montgomery, A. A., Ogollah, R., …Orrell, M. (2021). Promoting independence in Dementia (Pride): A feasibility randomized controlled trial. Clinical Interventions in Aging, 16, 363-378. https://doi.org/10.2147/CIA.S281139

© 2021 Csipke et al. Background: There is a need for interventions to foster and maintain independence for people with dementia to support community living, improve morale, and reduce stigma. We investigated a social intervention to promote living we... Read More about Promoting independence in Dementia (Pride): A feasibility randomized controlled trial.

Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial (2021)
Journal Article
Sprange, K., Beresford-Dent, J., Mountain, G., Craig, C., Mason, C., Berry, K., …Cooper, C. (2021). Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial. BMC Geriatrics, 21, Article 119. https://doi.org/10.1186/s12877-021-02070-8

Background Understanding intervention delivery as intended, particularly in complex interventions, should be underpinned by good quality fidelity assessment. We present the findings from a fidelity assessment embedded as part of a trial of a complex... Read More about Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial.

Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial (2021)
Journal Article
Sprange, K., Beresford-Dent, J., Mountain, G., Craig, C., Mason, C., Berry, K., …Cooper, C. L. (2021). Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial. BMC Geriatrics, 21(1), Article 119. https://doi.org/10.1186/s12877-021-02070-8

© 2021, The Author(s). Background: Understanding intervention delivery as intended, particularly in complex interventions, should be underpinned by good quality fidelity assessment. We present the findings from a fidelity assessment embedded as part... Read More about Assessing fidelity of a community based psychosocial intervention for people with mild dementia within a large randomised controlled trial.

Journeying through Dementia Randomised Controlled Trial of a Psychosocial Intervention for People Living with Early Dementia: Embedded Qualitative Study with Participants, Carers and Interventionists (2021)
Journal Article
Sprange, K., Beresford-Dent, J., Mountain, G., Thomas, B., Wright, J., Mason, C., & Cooper, C. L. (2021). Journeying through Dementia Randomised Controlled Trial of a Psychosocial Intervention for People Living with Early Dementia: Embedded Qualitative Study with Participants, Carers and Interventionists. Clinical Interventions in Aging, 16, 231-244. https://doi.org/10.2147/cia.s293921

Objectives: To identify the barriers and facilitators to the implementation of a complex psychosocial intervention though a study exploring the experiences of participants, carers and interventionists during a trial Methods: Individual semi-struct... Read More about Journeying through Dementia Randomised Controlled Trial of a Psychosocial Intervention for People Living with Early Dementia: Embedded Qualitative Study with Participants, Carers and Interventionists.

Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI) (2020)
Journal Article
Husbands, S., Elliott, D., Davis, T. R., Blazeby, J. M., Harrison, E. F., Montgomery, A. A., …Mills, N. (2020). Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI). Pilot and Feasibility Studies, 6(1), https://doi.org/10.1186/s40814-020-00710-1

© 2020, The Author(s). Background: Recruitment to randomised controlled trials (RCTs) can be challenging, with most trials not reaching recruitment targets. Randomised feasibility studies can be set up prior to a main trial to identify and overcome r... Read More about Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI).

Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials (2020)
Journal Article
Mitchell, E. J., GODOLPHIN, P., Meakin, G., & Sprange, K. (2020). Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials. Trials, 21, https://doi.org/10.1186/s13063-020-04465-1

© 2020 The Author(s). Background: Poor recruitment in clinical trials is well-documented. In large, multi-centre trials, communication between the coordinating centre and trial sites is essential. A commonly used communication tool is the hosting of... Read More about Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials.

Lifestyle matters randomized controlled trial of a preventive health intervention for older people: Qualitative sub study with participants and intervention facilitators (2020)
Journal Article
Mountain, G., Sprange, K., & Chatters, R. (2020). Lifestyle matters randomized controlled trial of a preventive health intervention for older people: Qualitative sub study with participants and intervention facilitators. Clinical Interventions in Aging, 15, 239-253. https://doi.org/10.2147/CIA.S232108

© 2020 Mountain et al. Objective: This qualitative study embedded within a randomized controlled trial was conducted to explore the acceptability, experiences of, and short-term impact of a preventive health intervention (Lifestyle Matters) from the... Read More about Lifestyle matters randomized controlled trial of a preventive health intervention for older people: Qualitative sub study with participants and intervention facilitators.

A randomised feasibility trial comparing needle fasciotomy with limited fasciectomy treatment for Dupuytren’s contractures (2020)
Journal Article
the HAND-1 Study group, Davis, T. R. C., Tan, W., Harrison, E. F., Hollingworth, W., Karantana, A., …Montgomery, A. A. (2020). A randomised feasibility trial comparing needle fasciotomy with limited fasciectomy treatment for Dupuytren’s contractures. Pilot and Feasibility Studies, 6(1), https://doi.org/10.1186/s40814-019-0546-y

© 2020 The Author(s). Purpose: The purpose of this study is to assess the feasibility of conducting a large, multicentre randomised controlled trial (RCT) comparing needle fasciotomy with limited fasciectomy for treatment of Dupuytren's contractures.... Read More about A randomised feasibility trial comparing needle fasciotomy with limited fasciectomy treatment for Dupuytren’s contractures.

Challenges in the design, planning and implementation of trials evaluating group interventions (2020)
Journal Article
Biggs, K., Hind, D., Gossage-Worrall, R., Sprange, K., White, D., Wright, J., …Cooper, C. (2020). Challenges in the design, planning and implementation of trials evaluating group interventions. Trials, 21(1), Article 116. https://doi.org/10.1186/s13063-019-3807-4

BACKGROUND: Group interventions are interventions delivered to groups of people rather than to individuals and are used in healthcare for mental health recovery, behaviour change, peer support, self-management and/or health education. Evaluating grou... Read More about Challenges in the design, planning and implementation of trials evaluating group interventions.

Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial (2019)
Journal Article
Shafayat, A., Csipke, E., Bradshaw, L., Charlesworth, G., Day, F., Leung, P., …Orrell, M. (2019). Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial. Trials, 20(1), Article 709. https://doi.org/10.1186/s13063-019-3838-x

Background: Memory services often see people with early stage dementia who are largely independent and able to participate in community activities but who run the risk of reducing activities and social networks. PRIDE is a self-management interventio... Read More about Promoting Independence in Dementia (PRIDE): Protocol for a Feasibility Randomised Controlled Trial.

Gentamicin, azithromycin and ceftriaxone in the treatment of gonorrhoea; the relationship between antibiotic minimum inhibitory concentration and clinical outcome (2019)
Journal Article
Cole, M., Tan, W., Fifer, H., Brittain, C., Duley, L., Hepburn, T., …Ross, J. (2020). Gentamicin, azithromycin and ceftriaxone in the treatment of gonorrhoea; the relationship between antibiotic minimum inhibitory concentration and clinical outcome. Journal of Antimicrobial Chemotherapy, 75(2), 449–457. https://doi.org/10.1093/jac/dkz436

© Crown copyright 2019. OBJECTIVES: To investigate the relationship between MIC and clinical outcome in a randomized controlled trial that compared gentamicin 240 mg plus azithromycin 1 g with ceftriaxone 500 mg plus azithromycin 1 g. MIC analysis wa... Read More about Gentamicin, azithromycin and ceftriaxone in the treatment of gonorrhoea; the relationship between antibiotic minimum inhibitory concentration and clinical outcome.

Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care (2019)
Journal Article
Wright, J., Foster, A., Cooper, C., SPRANGE, K., Walters, S., Berry, K., …Mountain, G. (2019). Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care. BMJ Open, 9(9), Article e029207. https://doi.org/10.1136/bmjopen-2019-029207

Introduction: Services are being encouraged to provide postdiagnostic treatment to those with dementia but the availability of evidence-based interventions following diagnosis has not kept pace with increase in demand. To address this need, the Journ... Read More about Study protocol for a randomised controlled trial assessing the clinical and cost-effectiveness of the Journeying through Dementia (JtD) intervention compared to usual care.

Eicosapentaenoic acid and/or aspirin for preventing colorectal adenomas during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme: the seAFOod RCT (2019)
Journal Article
Hull, M. A., Sprange, K., Hepburn, T., Tan, W., Shafayat, A., Rees, C. J., …Montgomery, A. A. (2019). Eicosapentaenoic acid and/or aspirin for preventing colorectal adenomas during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme: the seAFOod RCT. Efficacy and Mechanism Evaluation, 6(4), 1-154. https://doi.org/10.3310/eme06040

Gentamicin compared with ceftriaxone for the treatment of gonorrhoea (G-ToG): a randomised non-inferiority trial (2019)
Journal Article
Ross, J., Brittain, C., Cole, M., Dewsnap, C., Harding, J., Hepburn, T., …Duley, L. (2019). Gentamicin compared with ceftriaxone for the treatment of gonorrhoea (G-ToG): a randomised non-inferiority trial. Lancet, 393(10190), 2511-2520. https://doi.org/10.1016/S0140-6736%2818%2932817-4

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Background: Gonorrhoea is a common sexually transmitted infection for which ceftriaxone is the current first-line treatment, but antimi... Read More about Gentamicin compared with ceftriaxone for the treatment of gonorrhoea (G-ToG): a randomised non-inferiority trial.

Gentamicin as an alternative to ceftriaxone in the treatment of gonorrhoea: the G-TOG non-inferiority RCT (2019)
Journal Article
Ross, J. D., Harding, J., Duley, L., Montgomery, A. A., Hepburn, T., Tan, W., …Lawrence, T. (2019). Gentamicin as an alternative to ceftriaxone in the treatment of gonorrhoea: the G-TOG non-inferiority RCT. Health Technology Assessment, 23(20), 1-104. https://doi.org/10.3310/hta23200

Background: Gonorrhoea is a common sexually transmitted infection that can cause pain and discomfort, affect fertility in women and lead to epididymo-orchitis in men. Current treatment is with ceftriaxone, but there is increasing evidence of antimicr... Read More about Gentamicin as an alternative to ceftriaxone in the treatment of gonorrhoea: the G-TOG non-inferiority RCT.

Eicosapentaenoic acid and aspirin, alone and in combination, for the prevention of colorectal adenomas (seAFOod Polyp Prevention trial): a multicentre, randomised, double-blind, placebo-controlled, 2 × 2 factorial trial (2018)
Journal Article
Hull, M. A., Sprange, K., Hepburn, T., Tan, W., Shafayat, A., Rees, C. J., …seAFOod Collaborative Group. (2018). Eicosapentaenoic acid and aspirin, alone and in combination, for the prevention of colorectal adenomas (seAFOod Polyp Prevention trial): a multicentre, randomised, double-blind, placebo-controlled, 2 × 2 factorial trial. Lancet, 392(10164), 2583-2594. https://doi.org/10.1016/S0140-6736%2818%2931775-6

© 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background The omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA) and aspirin both have proof of concept for colorectal cancer... Read More about Eicosapentaenoic acid and aspirin, alone and in combination, for the prevention of colorectal adenomas (seAFOod Polyp Prevention trial): a multicentre, randomised, double-blind, placebo-controlled, 2 × 2 factorial trial.

The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation (2018)
Journal Article
L, R., LJ, S., JM, B., CA, R., KM, T., S, H., …Wheatley, T. (2019). The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation. Journal of Clinical Epidemiology, 106, 108-120. https://doi.org/10.1016/j.jclinepi.2018.10.004

Objective To evaluate the impact of the Quintet Recruitment Intervention (QRI) on recruitment in challenging randomized controlled trials (RCTs) that have applied the intervention. The QRI aims to understand recruitment difficulties, and then implem... Read More about The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation.

Follow-on RifAximin for the prevention of recurrence following standard treatment of infection with Clostridium difficile (RAPID): a randomised placebo controlled trial (2018)
Journal Article
Major, G., Bradshaw, L., Boota, N., Sprange, K., Diggle, M., Montgomery, A., …Spiller, R. (2018). Follow-on RifAximin for the prevention of recurrence following standard treatment of infection with Clostridium difficile (RAPID): a randomised placebo controlled trial. Gut, https://doi.org/10.1136/gutjnl-2018-316794

Background Clostridium difficile infection (CDI) recurs after initial treatment in approximately one in four patients. A single-centre pilot study suggested that this could be reduced using ‘follow-on’ rifaximin treatment. We aimed to assess the effi... Read More about Follow-on RifAximin for the prevention of recurrence following standard treatment of infection with Clostridium difficile (RAPID): a randomised placebo controlled trial.

Recruitment of older adults to three preventative lifestyle improvement studies (2018)
Journal Article
Chatters, R., Newbold, L., Sprange, K., Hind, D., Mountain, G., Shortland, K., …Woods, B. (2018). Recruitment of older adults to three preventative lifestyle improvement studies. Trials, 19, Article 121. https://doi.org/10.1186/s13063-018-2482-1

Background: Recruiting isolated older adults to clinical trials is complex, time-consuming and difficult. Previous studies have suggested querying existing databases to identify appropriate potential participants. We aim to compare recruitment tech... Read More about Recruitment of older adults to three preventative lifestyle improvement studies.

The long-term (24-month) effect on health and well-being of the Lifestyle Matters community-based intervention in people aged 65 years and over: a qualitative study (2017)
Journal Article
Chatters, R., Roberts, J., Mountain, G., Cook, S., Windle, G., Craig, C., & Sprange, K. (2017). The long-term (24-month) effect on health and well-being of the Lifestyle Matters community-based intervention in people aged 65 years and over: a qualitative study. BMJ Open, 7(9), Article e016711. https://doi.org/10.1136/bmjopen-2017-016711

Objectives To assess the long-term effect on health and well-being of the Lifestyle Matters programme. Design Qualitative study of a subset of intervention arm participants who participated in the Lifestyle Matters randomised controlled... Read More about The long-term (24-month) effect on health and well-being of the Lifestyle Matters community-based intervention in people aged 65 years and over: a qualitative study.

A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (HAND-1): Study protocol for a randomised controlled trial (2017)
Journal Article
Harrison, E., Tan, W., Mills, N., Karantana, A., Sprange, K., Duley, L., …Davis, T. (2017). A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (HAND-1): Study protocol for a randomised controlled trial. Trials, 18(1), Article 392. https://doi.org/10.1186/s13063-017-2127-9

© 2017 The Author(s). Background: Dupuytren's contractures are fibrous cords under the skin of the palm of the hand. The contractures are painless but cause one or more fingers to curl into the palm, resulting in loss of function. Standard treatment... Read More about A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (HAND-1): Study protocol for a randomised controlled trial.

A preventative lifestyle intervention for older adults (lifestyle matters): a randomised controlled trial (2017)
Journal Article
Mountain, G., Windle, G., Hind, D., Walters, S., Keertharuth, A., Chatters, R., …Roberts, J. (2017). A preventative lifestyle intervention for older adults (lifestyle matters): a randomised controlled trial. Age and Ageing, 46(4), https://doi.org/10.1093/ageing/afx021

Objectives to test whether an occupation-based lifestyle intervention can sustain and improve the mental well-being of adults aged 65 years or over compared to usual care, using an individually randomised controlled trial. Participants 288 i... Read More about A preventative lifestyle intervention for older adults (lifestyle matters): a randomised controlled trial.

Journeying through Dementia, a community-based self-management intervention for people aged 65 years and over: a feasibility study to inform a future trial (2015)
Journal Article
Sprange, K., Mountain, G., Shortland, K., Craig, C., Blackburn, D. J., Bowie, P., …Spencer, M. (2015). Journeying through Dementia, a community-based self-management intervention for people aged 65 years and over: a feasibility study to inform a future trial. Pilot and Feasibility Studies, 1, Article 42. https://doi.org/10.1186/s40814-015-0039-6

Background A study to determine the feasibility of conducting a future population-based trial into a self-management intervention for community-living adults with early stage dementia included evaluation of intervention content and modes of deli... Read More about Journeying through Dementia, a community-based self-management intervention for people aged 65 years and over: a feasibility study to inform a future trial.

SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis (2014)
Journal Article
Everard, M. L., Hind, D., Ugonna, K., Freeman, J., Bradburn, M., Cooper, C. L., …Sprange, K. (2014). SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis. Thorax, 69(12), https://doi.org/10.1136/thoraxjnl-2014-205953

Aim: Acute bronchiolitis is the commonest cause for hospitalisation in infancy. Supportive care remains the cornerstone of current management and no other therapy has been shown to influence the course of the disease. It has been suggested that addin... Read More about SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis.

Lifestyle matters for maintenance of health and wellbeing in people aged 65 years and over: study protocol for a randomised controlled trial (2013)
Journal Article
Sprange, K., Mountain, G. A., Brazier, J., Cook, S. P., Craig, C., Hind, D., …Horner, K. (2013). Lifestyle matters for maintenance of health and wellbeing in people aged 65 years and over: study protocol for a randomised controlled trial. Trials, 14, Article 302. https://doi.org/10.1186/1745-6215-14-302

Background Healthy, active ageing is strongly associated with good mental wellbeing which in turn helps to prevent mental illness. However, more investment has been made into research into interventions to prevent mental illness than into those desi... Read More about Lifestyle matters for maintenance of health and wellbeing in people aged 65 years and over: study protocol for a randomised controlled trial.