All Outputs (21)

Gentamicin versus ceftriaxone for the treatment of gonorrhoea (G-TOG trial): study protocol for a randomised trial (2016)
Journal Article
Brittain, C., Childs, M., Duley, L., Harding, J., Hepburn, T., Meakin, G., …Ross, J. D. (2016). Gentamicin versus ceftriaxone for the treatment of gonorrhoea (G-TOG trial): study protocol for a randomised trial. Trials, 17, Article 558. https://doi.org/10.1186/s13063-016-1683-8

Background: Gonorrhoea is a common sexually transmitted infection which causes genital pain and discomfort; in women it can also lead to pelvic inflammatory disease and infertility, and in men to epididymo-orchitis. Current treatment is with ceftriax... Read More about Gentamicin versus ceftriaxone for the treatment of gonorrhoea (G-TOG trial): study protocol for a randomised trial.

Baseline characteristics of the 3,096 patients recruited into the 'Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke' (TARDIS) trial (2016)
Journal Article
Bath, P. M., Appleton, J. P., Beridze, M., Christensen, H., Dineen, R. A., Duley, L., …Sprigg, N. (2017). Baseline characteristics of the 3,096 patients recruited into the 'Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke' (TARDIS) trial. International Journal of Stroke, 12(5), 524-538. https://doi.org/10.1177/1747493016677988

Background: The risk of recurrence following ischaemic stroke (IS) or transient ischaemic attack (TIA) is highest immediately after the event. Antiplatelet agents are effective in reducing the risk of recurrence and two agents are superior to one in... Read More about Baseline characteristics of the 3,096 patients recruited into the 'Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke' (TARDIS) trial.

FourFold Asthma Study (FAST): a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations (2016)
Journal Article
Skeggs, A., McKeever, T. M., Duley, L., Mitchell, E., Bradshaw, L., Mortimer, K., …Haydock, R. (2016). FourFold Asthma Study (FAST): a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations. Trials, 17, https://doi.org/10.1186/s13063-016-1608-6

BACKGROUND: Asthma is one of the commonest chronic diseases in the UK. Acute exacerbations of asthma are unpredictable, disruptive and frightening. They cause considerable morbidity and account for a large component of the health service costs of ast... Read More about FourFold Asthma Study (FAST): a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations.

Is speed of healing a good predictor of eventual healing of pyoderma gangrenosum? (2016)
Journal Article
Wilkes, S. R., Williams, H. C., Ormerod, A. D., Craig, F. E., Greenlaw, N., Norrie, J., …Thomas, K. S. (2016). Is speed of healing a good predictor of eventual healing of pyoderma gangrenosum?. Journal of The American Academy of Dermatology, 75(6), 1216-1220.e2. https://doi.org/10.1016/j.jaad.2016.07.049

Background: Pyoderma gangrenosum is a rare inflammatory skin condition. The STOPGAP studies compared treatments for pyoderma gangrenosum using a primary outcome of healing speed at 6 weeks. Objective: Using data from both studies we assessed the pre... Read More about Is speed of healing a good predictor of eventual healing of pyoderma gangrenosum?.

The Community In-reach Rehabilitation and Care Transition (CIRACT) clinical and cost-effectiveness randomisation controlled trial in older people admitted to hospital as an acute medical emergency (2016)
Journal Article
Sahota, O., Pulikottil-Jacob, R., Marshall, F., Montgomery, A., Tan, W., Sach, T., …Waring, J. (in press). The Community In-reach Rehabilitation and Care Transition (CIRACT) clinical and cost-effectiveness randomisation controlled trial in older people admitted to hospital as an acute medical emergency. Age and Ageing, 46(1), https://doi.org/10.1093/ageing/afw149

Objective: To compare the clinical and cost-effectiveness of a Community In-reach Rehabilitation and Care Transition (CIRACT) service with the traditional hospital-based rehabilitation (THB-Rehab) service. Design: Pragmatic randomised controlled... Read More about The Community In-reach Rehabilitation and Care Transition (CIRACT) clinical and cost-effectiveness randomisation controlled trial in older people admitted to hospital as an acute medical emergency.

Experiences of patients and healthcare professionals of NHS cardiovascular health checks: a qualitative study (2016)
Journal Article
Riley, R., Coghill, N., Montgomery, A. A., Feder, G., & Horwood, J. (2016). Experiences of patients and healthcare professionals of NHS cardiovascular health checks: a qualitative study. Journal of Public Health, 38(3), https://doi.org/10.1093/pubmed/fdv121

Background NHS Health Checks are a national cardiovascular risk assessment and management programme in England and Wales. We examined the experiences of patients attending and healthcare professionals (HCPs) conducting NHS Health Checks. Methods... Read More about Experiences of patients and healthcare professionals of NHS cardiovascular health checks: a qualitative study.

Refining Ovarian Cancer Test accuracy Scores (ROCkeTS): protocol for a prospective longitudinal test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer (2016)
Journal Article
Sundar, S., Rick, C., Dowling, F., Au, P., Snell, K., Rai, N., …Deeks, J. (2016). Refining Ovarian Cancer Test accuracy Scores (ROCkeTS): protocol for a prospective longitudinal test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer. BMJ Open, 6(8), Article e010333. https://doi.org/10.1136/bmjopen-2015-010333

© 2016 Published by the BMJ Publishing Group Limited. Ovarian cancer (OC) is associated with non-specific symptoms such as bloating, making accurate diagnosis challenging: only 1 in 3 women with OC presents through primary care referral. National Ins... Read More about Refining Ovarian Cancer Test accuracy Scores (ROCkeTS): protocol for a prospective longitudinal test accuracy study to validate new risk scores in women with symptoms of suspected ovarian cancer.

Indicated school-based intervention to improve depressive symptoms among at risk Chilean adolescents: a randomized controlled trial (2016)
Journal Article
Gaete, J., Martinez, V., Fritsch, R., Rojas, G., Montgomery, A. A., & Araya, R. (2016). Indicated school-based intervention to improve depressive symptoms among at risk Chilean adolescents: a randomized controlled trial. BMC Psychiatry, 16, Article 276. https://doi.org/10.1186/s12888-016-0985-4

Background: Depression is a disabling condition affecting people of all ages, but generally starting during adolescence. Schools seem to be an excellent setting where preventive interventions may be delivered. This study aimed to test the effectivene... Read More about Indicated school-based intervention to improve depressive symptoms among at risk Chilean adolescents: a randomized controlled trial.

Cost-effectiveness of telehealth for patients with raised cardiovascular disease risk: evidence from the Healthlines randomised controlled trial (2016)
Journal Article
Dixon, P., Hollingshurst, S., Edwards, L., Thomas, C., Gaunt, D., Foster, A., …Salisbury, C. (2016). Cost-effectiveness of telehealth for patients with raised cardiovascular disease risk: evidence from the Healthlines randomised controlled trial. BMJ Open, 6, Article e01235. https://doi.org/10.1136/bmjopen-2016-012352

Objectives: To investigate the cost-effectiveness of a telehealth intervention for primary care patients with raised cardiovascular disease (CVD) risk. Design: A prospective within-trial patient-level economic evaluation conducted alongside a rando... Read More about Cost-effectiveness of telehealth for patients with raised cardiovascular disease risk: evidence from the Healthlines randomised controlled trial.

Psychoeducation with problem-solving (PEPS) therapy for adults with personality disorder: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manualised intervention to improve social functioning (2016)
Journal Article
McMurran, M., Crawford, M. J., Reilly, J., Delport, J., McCrone, P., Whitham, D., …Day, F. (2016). Psychoeducation with problem-solving (PEPS) therapy for adults with personality disorder: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manualised intervention to improve social functioning. Health Technology Assessment, 20(52), https://doi.org/10.3310/hta20520

Main outcome measures: The primary outcome was measured by the Social Functioning Questionnaire (SFQ). Secondary outcomes were service use (general practitioner records), mood (measured via the Hospital Anxiety and Depression Scale) and client-specif... Read More about Psychoeducation with problem-solving (PEPS) therapy for adults with personality disorder: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manualised intervention to improve social functioning.

Anxiety, depression and risk of cannabis use: Examining the internalising pathway to use among Chilean adolescents (2016)
Journal Article
Stapinski, L. A., Montgomery, A. A., & Araya, R. (2016). Anxiety, depression and risk of cannabis use: Examining the internalising pathway to use among Chilean adolescents. Drug and Alcohol Dependence, 166, 109-115. https://doi.org/10.1016/j.drugalcdep.2016.06.032

Background: Adolescents who experience internalising symptoms may be susceptible to the use of alcohol and other substances in an attempt to alleviate or cope with these symptoms. We examined the hypothesised internalising pathway from symptoms of d... Read More about Anxiety, depression and risk of cannabis use: Examining the internalising pathway to use among Chilean adolescents.

Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention (2016)
Journal Article
Salisbury, C., O'Cathain, A., Edwards, L., Thomas, C., Gaunt, D., Hollingshurst, S., …Montgomery, A. A. (2016). Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention. Lancet Psychiatry, 3(6), 515-525. https://doi.org/10.1016/S2215-0366%2816%2900083-3

Background Many countries are exploring the potential of telehealth interventions manage the rising number of people with chronic conditions. However, evidence of effectiveness of telehealth is equivocal. Based on an evidence-based conceptual framew... Read More about Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention.

Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial (2016)
Journal Article
Salisbury, C., O'Cathain, A., Thomas, C., Edwards, L., Gaunt, D., Dixon, P., …Montgomery, A. A. (2016). Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial. BMJ, 353, Article i2647. https://doi.org/10.1136/bmj.i2647

Objective: To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies. Design: Pragmatic, multicentre, randomised controlled trial. Setting: 42 general practices in th... Read More about Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial.

A programme of studies including assessment of diagnostic accuracy of school hearing screening tests and a cost-effectiveness model of school entry hearing screening programmes (2016)
Journal Article
Fortnum, H., Ukoumunne, O. C., Hyde, C., Taylor, R. S., Ozolins, M., Errington, S., …Roberts, S. (2016). A programme of studies including assessment of diagnostic accuracy of school hearing screening tests and a cost-effectiveness model of school entry hearing screening programmes. Health Technology Assessment, 20(36), 1-178. https://doi.org/10.3310/hta20360

Background Identification of permanent hearing impairment at the earliest possible age is crucial to maximise the development of speech and language. Universal newborn hearing screening identifies the majority of the 1 in 1000 children born with a h... Read More about A programme of studies including assessment of diagnostic accuracy of school hearing screening tests and a cost-effectiveness model of school entry hearing screening programmes.

Evaluating Acupuncture and Standard carE for pregnant women with Back pain (EASE Back): A feasibility study and pilot randomised trial (2016)
Journal Article
Foster, N. E., Bishop, A., Bartlam, B., Ogollah, R., Barlas, P., Holden, M., …Young, J. (2016). Evaluating Acupuncture and Standard carE for pregnant women with Back pain (EASE Back): A feasibility study and pilot randomised trial. Health Technology Assessment, 20(33), 1-235. https://doi.org/10.3310/hta20330

© Queen’s Printer and Controller of HMSO 2016. Background: Many pregnant women experience low back pain. Acupuncture appears to be a safe, promising intervention but evidence is needed about its clinical effectiveness and cost-effectiveness. Objectiv... Read More about Evaluating Acupuncture and Standard carE for pregnant women with Back pain (EASE Back): A feasibility study and pilot randomised trial.

Increasing follow-up questionnaire response rates in a randomized controlled trial of telehealth for depression: three embedded controlled studies (2016)
Journal Article
Edwards, L., Salisbury, C., Horspool, K., Foster, A., Garner, K., & Montgomery, A. A. (2016). Increasing follow-up questionnaire response rates in a randomized controlled trial of telehealth for depression: three embedded controlled studies. Trials, 17, Article 107. https://doi.org/10.1186/s13063-016-1234-3

Background: Attrition is problematic in trials, and may be exacerbated in longer studies, telehealth trials and participants with depression – three features of The Healthlines Study. Advance notification, including a photograph and using action-ori... Read More about Increasing follow-up questionnaire response rates in a randomized controlled trial of telehealth for depression: three embedded controlled studies.

Validation of the Vitiligo Noticeability Scale: a patient-reported outcome measure of Vitiligo treatment success (2016)
Journal Article
Batchelor, J., Tan, W., Tour, S., Yong, A., Montgomery, A. A., & Thomas, K. (2016). Validation of the Vitiligo Noticeability Scale: a patient-reported outcome measure of Vitiligo treatment success. British Journal of Dermatology, 174(2), https://doi.org/10.1111/bjd.14208

Background: Patient-reported outcome measures are rarely used in vitiligo trials. The Vitiligo Noticeability Scale (VNS) is a new patient-reported outcome measure assessing how ‘noticeable’ the vitiligo patches are after treatment. The noticeabilit... Read More about Validation of the Vitiligo Noticeability Scale: a patient-reported outcome measure of Vitiligo treatment success.

Cost‐utility analysis of deep brain stimulation surgery plus best medical therapy versus best medical therapy in patients with Parkinson's: Economic evaluation alongside the PD SURG trial (2016)
Journal Article
McIntosh, E., Gray, A., Daniels, J., Gill, S., Ives, N., Jenkinson, C., …on behalf of The PD SURG Collaborators Group. (2016). Cost‐utility analysis of deep brain stimulation surgery plus best medical therapy versus best medical therapy in patients with Parkinson's: Economic evaluation alongside the PD SURG trial. Movement Disorders, 31(8), 1173-1182. https://doi.org/10.1002/mds.26423

Introduction Williams and colleagues reported that DBS surgery for patients with advanced PD improves motor function and quality of life compared to best medical therapy alone at 1 year, but with surgery‐related side effects in a minority. This ar... Read More about Cost‐utility analysis of deep brain stimulation surgery plus best medical therapy versus best medical therapy in patients with Parkinson's: Economic evaluation alongside the PD SURG trial.

Correction: Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD-'Assessing QbTest Utility in ADHD'(AQUA): A randomised controlled trial - December 01, 2014 (2016)
Journal Article
Hall, C. L., Walker, G. M. .., Valentine, A. Z., Guo, B., Kaylor-Hughes, C., James, M., …Hollis, C. (2016). Correction: Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD-'Assessing QbTest Utility in ADHD'(AQUA): A randomised controlled trial - December 01, 2014. BMJ Open, 6(1), Article e006838corr2. https://doi.org/10.1136/bmjopen-2014-006838corr2

Guidelines for reporting embedded recruitment trials (2016)
Journal Article
Madurasinghe, V. W., Eldridge, S., & Forbes, G. (in press). Guidelines for reporting embedded recruitment trials. Trials, 17, https://doi.org/10.1186/s13063-015-1126-y

Background: Recruitment to clinical trials is difficult with many trials failing to recruit to target and within time. Embedding trials of recruitment interventions within host trials may provide a successful way to improve this. There are no guidel... Read More about Guidelines for reporting embedded recruitment trials.