All Outputs (43)

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.