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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 (2015)
Journal Article
Hall, C. L., Walker, G. M., Valentine, A. Z., Guo, B., Kaylor-Hughes, C., James, M., …Hollis, C. (2015). 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, 5(5), Article e006838corr1. https://doi.org/10.1136/bmjopen-2014-006838corr1

A pilot randomized controlled trial of a stepped care intervention package for depression in primary care in Nigeria (2015)
Journal Article
Oladeji, A., Kola, L., Abiona, T., & Montgomery, A. A. (in press). A pilot randomized controlled trial of a stepped care intervention package for depression in primary care in Nigeria. BMC Psychiatry, 15(96), https://doi.org/10.1186/s12888-015-0483-0

Background Depression is common in primary care and is often unrecognized and untreated. Studies are needed to demonstrate the feasibility of implementing evidence-based depression care provided by primary health care workers (PHCWs) in sub-Saharan... Read More about A pilot randomized controlled trial of a stepped care intervention package for depression in primary care in Nigeria.

A mechanistic multi-centre, parallel group, randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea (IBS-D) (2015)
Journal Article
Lam, C., Tan, W., Leighton, M., Hastings, M., Lingaya, M., Falcone, Y., …Spiller, R. C. (2015). A mechanistic multi-centre, parallel group, randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea (IBS-D). Gut, 65(1), https://doi.org/10.1136/gutjnl-2015-309122

Introduction: Immune activation has been reported in the mucosa of irritable bowel syndrome patients with diarrhoea (IBS-D) and some small studies have suggested that Mesalazine may reduce symptoms. We performed a double blind, randomised placebo con... Read More about A mechanistic multi-centre, parallel group, randomised placebo controlled trial of Mesalazine for treatment of irritable bowel syndrome with diarrhoea (IBS-D).

Blinded randomised controlled trial of low-dose Adjuvant Steroids in Adults admitted to hospital with Pandemic influenza (ASAP): a trial 'in hibernation', ready for rapid activation (2015)
Journal Article
Lim, W. S., Brittain, C., Duley, L., Edwards, S., Gordon, S., Montgomery, A., …Wootton, D. (2015). Blinded randomised controlled trial of low-dose Adjuvant Steroids in Adults admitted to hospital with Pandemic influenza (ASAP): a trial 'in hibernation', ready for rapid activation. Health Technology Assessment, 19(16), https://doi.org/10.3310/hta19160

Background: There are no completed randomised trials of the use of corticosteroids in patients with severe influenza infection. Corticosteroid use in influenza is widespread, non-systematic and marked by controversy. A recent meta-analysis of observa... Read More about Blinded randomised controlled trial of low-dose Adjuvant Steroids in Adults admitted to hospital with Pandemic influenza (ASAP): a trial 'in hibernation', ready for rapid activation.

Increasing children’s physical activity through a teaching-assistant led extracurricular intervention: process evaluation of the action 3:30 randomised feasibility trial (2015)
Journal Article
Jago, R., Sebire, S., Davies, B., Wood, L., Banfield, K., Edwards, M. J., …Fox, K. (2015). Increasing children’s physical activity through a teaching-assistant led extracurricular intervention: process evaluation of the action 3:30 randomised feasibility trial. BMC Public Health, 15(156), https://doi.org/10.1186/s12889-015-1501-3

Background Many children do not engage in recommended levels of physical activity (PA), highlighting the need to find ways to increase children’s PA. Process evaluations play an important role in improving the science of randomised controlled trials... Read More about Increasing children’s physical activity through a teaching-assistant led extracurricular intervention: process evaluation of the action 3:30 randomised feasibility trial.

The Community In-Reach and Care Transition (CIRACT) clinical and cost-effectiveness study: study protocol for a randomised controlled trial (2015)
Journal Article
Watson, A., Charlesworth, L., Jacob, R., Kendrick, D., Logan, P., Marshall, F., …Sahota, O. (2015). The Community In-Reach and Care Transition (CIRACT) clinical and cost-effectiveness study: study protocol for a randomised controlled trial. Trials, 16(41), https://doi.org/10.1186/s13063-015-0551-2

Background Older people represent a significant proportion of patients admitted to hospital. Their care compared to younger patients is more challenging, length of stay is longer, risk of hospital-acquired problems higher and the risk of being re-... Read More about The Community In-Reach and Care Transition (CIRACT) clinical and cost-effectiveness study: study protocol for a randomised controlled trial.

TElehealth in CHronic disease: mixed-methods study to develop the TECH conceptual model for intervention design and evaluation (2015)
Journal Article
Salisbury, C., Thomas, C., O'Cathain, A., Rogers, A. E., Pope, C., Yardley, L., …Montgomery, A. A. (in press). TElehealth in CHronic disease: mixed-methods study to develop the TECH conceptual model for intervention design and evaluation. BMJ Open, 5(2), Article e006448. https://doi.org/10.1136/bmjopen-2014-006448

Objective To develop a conceptual model for effective use of telehealth in the management of chronic health conditions, and to use this to develop and evaluate an intervention for people with two exemplar conditions: raised cardiovascular disease r... Read More about TElehealth in CHronic disease: mixed-methods study to develop the TECH conceptual model for intervention design and evaluation.

Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial (2015)
Journal Article
Cooper, S., Foster, K., Naughton, F., Leonardi-Bee, J., Sutton, S., Ussher, M., …Coleman, T. (2015). Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial. Trials, 16, Article 29. https://doi.org/10.1186/S13063-014-0546-4

Background Smoking in pregnancy is a public health problem. Self-help smoking cessation support can help pregnant women to stop smoking, but the effects of delivering this kind of support via SMS text message are not known. A previous randomised... Read More about Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial.

A cluster randomised feasibility trial evaluating six-month nutritional interventions in the treatment of malnutrition in care home-dwelling adults: recruitment, data collection and protocol (2015)
Journal Article
Stow, R., Rushton, A., Ives, N., Smith, C., & Rick, C. (2015). A cluster randomised feasibility trial evaluating six-month nutritional interventions in the treatment of malnutrition in care home-dwelling adults: recruitment, data collection and protocol. Pilot and Feasibility Studies, 1(3), https://doi.org/10.1186/2055-5784-1-3

Randomised trial of the fascia iliaca block versus the ‘3-in-1’ block for femoral neck fractures in the emergency department (2014)
Journal Article
Reavley, P., Montgomery, A. A., Smith, J. E., Binks, S., Elder, G., Benger, J., & Edwards, J. (in press). Randomised trial of the fascia iliaca block versus the ‘3-in-1’ block for femoral neck fractures in the emergency department. Emergency Medicine Journal, 32(9), https://doi.org/10.1136/emermed-2013-203407

Introduction: Femoral neck fractures are a common and painful injury. Femoral nerve blocks, and a variant of this technique termed the ‘3-in-1’ block, are often used in this patient group, but their effect is variable. The fascia iliaca compartment b... Read More about Randomised trial of the fascia iliaca block versus the ‘3-in-1’ block for femoral neck fractures in the emergency department.

Peer victimization during adolescence: concurrent and prospective impact on symptoms of depression and anxiety (2014)
Journal Article
Stapinski, L. A., Araya, R., Heron, J., Montgomery, A. A., & Stallard, P. (2014). Peer victimization during adolescence: concurrent and prospective impact on symptoms of depression and anxiety. Anxiety, Stress and Coping, 28(1), 105-120. https://doi.org/10.1080/10615806.2014.962023

© 2014 Taylor & Francis. Background: Peer victimization is ubiquitous across schools and cultures, and has the potential for long-lasting effects on the well-being of victims. To date, research has focused on the consequences of peer victimization... Read More about Peer victimization during adolescence: concurrent and prospective impact on symptoms of depression and anxiety.

A systematic review finds variable use of the intention-to-treat principle in musculoskeletal randomized controlled trials with missing data (2014)
Journal Article
Joseph, R., Ogollah, R., Sim, J., & Lewis, M. (2015). A systematic review finds variable use of the intention-to-treat principle in musculoskeletal randomized controlled trials with missing data. Journal of Clinical Epidemiology, 68(1), 15-24. https://doi.org/10.1016/j.jclinepi.2014.09.002

Objectives: In randomized trials, the primary analysis should be consistent with the intention-to-treat (ITT) principle and should address missing data appropriately to draw valid inferences. This review focuses on current practices relating to the... Read More about A systematic review finds variable use of the intention-to-treat principle in musculoskeletal randomized controlled trials with missing data.

Randomised feasibility trial of a teaching assistant led extracurricular physical activity intervention for 9 to 11 year olds: Action 3:30 (2014)
Journal Article
Jago, R., Sebire, S., Davies, B., Wood, L., Edwards, M. J., Banfield, K., …Montgomery, A. A. (2014). Randomised feasibility trial of a teaching assistant led extracurricular physical activity intervention for 9 to 11 year olds: Action 3:30. International Journal of Behavioral Nutrition and Physical Activity, 11, Article 114. https://doi.org/10.1186/s12966-014-0114-z

Background: Extracurricular programmes could provide a mechanism to increase the physical activity (PA) of primary-school-aged children. The aim of this feasibility study was to examine whether the Action 3:30 intervention, which is delivered by... Read More about Randomised feasibility trial of a teaching assistant led extracurricular physical activity intervention for 9 to 11 year olds: Action 3:30.

The SNAP trial: A randomised placebo-controlled trial of nicotine replacement therapy in pregnancy - Clinical effectiveness and safety until 2 years after delivery, with economic evaluation (2014)
Journal Article
Cooper, S., Lewis, S., Thornton, J., Marlow, N., Watts, K., Britton, J., …Coleman, T. (2014). The SNAP trial: A randomised placebo-controlled trial of nicotine replacement therapy in pregnancy - Clinical effectiveness and safety until 2 years after delivery, with economic evaluation. Health Technology Assessment, 18(54), 1-128. https://doi.org/10.3310/hta18540

Background: Smoking during pregnancy causes many adverse pregnancy and birth outcomes. Nicotine replacement therapy (NRT) is effective for cessation outside pregnancy but efficacy and safety in pregnancy are unknown. We hypothesised that NRT would in... Read More about The SNAP trial: A randomised placebo-controlled trial of nicotine replacement therapy in pregnancy - Clinical effectiveness and safety until 2 years after delivery, with economic evaluation.

Effects of Hypothermia for Perinatal Asphyxia on Childhood Outcomes (2014)
Journal Article
Azzopardi, D., Strohm, B., Marlow, N., Brocklehurst, P., Deierl, A., Eddama, O., …Edwards, A. D. (2014). Effects of Hypothermia for Perinatal Asphyxia on Childhood Outcomes. New England Journal of Medicine, 371(2), 140-149. https://doi.org/10.1056/nejmoa1315788

BACKGROUND: In the Total Body Hypothermia for Neonatal Encephalopathy Trial (TOBY), newborns with asphyxial encephalopathy who received hypothermic therapy had improved neurologic outcomes at 18 months of age, but it is uncertain whether such therapy... Read More about Effects of Hypothermia for Perinatal Asphyxia on Childhood Outcomes.

Changing eating behaviours to treat childhood obesity in the community using Mandolean: the Community Mandolean randomised controlled trial (ComMando) – a pilot study (2014)
Journal Article
Hamilton-Shield, J., Goodred, J., Powell, L., Thorn, J., Banks, J., Hollinghurst, S., …Turner, K. (2014). Changing eating behaviours to treat childhood obesity in the community using Mandolean: the Community Mandolean randomised controlled trial (ComMando) – a pilot study. Health Technology Assessment, 18(47), https://doi.org/10.3310/hta18470

Background Around one in five children in England is obese when they leave primary school. Thus far, it has not been demonstrated that primary care interventions to manage childhood obesity can achieve significant weight reduction. Training obese... Read More about Changing eating behaviours to treat childhood obesity in the community using Mandolean: the Community Mandolean randomised controlled trial (ComMando) – a pilot study.

Relationship between Expectation Management and Client Retention in Online Cognitive Behavioural Therapy (2014)
Journal Article
Ekberg, S., Barnes, R. K., Kessler, D. S., Mirza, S., Montgomery, A. A., Malpass, A., & Shaw, A. R. (2015). Relationship between Expectation Management and Client Retention in Online Cognitive Behavioural Therapy. Behavioural and Cognitive Psychotherapy, 43(6), 732-743. https://doi.org/10.1017/S1352465814000241

Background: Engaging clients from the outset of psychotherapy is important for therapeutic success. However, there is little research evaluating therapists’ initial attempts to engage clients in the therapeutic process. This article reports retrospec... Read More about Relationship between Expectation Management and Client Retention in Online Cognitive Behavioural Therapy.

Long-term effectiveness of dopamine agonists and monoamine oxidase B inhibitors compared with levodopa as initial treatment for Parkinson's disease (PD MED): a large, open-label, pragmatic randomised trial (2014)
Journal Article
Daniels, J., Gray, R., Ives, N., Rick, C., Patel, S., Gray, A., …Clarke, C. (2014). Long-term effectiveness of dopamine agonists and monoamine oxidase B inhibitors compared with levodopa as initial treatment for Parkinson's disease (PD MED): a large, open-label, pragmatic randomised trial. Lancet, 384(9949), 1196-1205. https://doi.org/10.1016/S0140-6736%2814%2960683-8

Background Whether initial treatment for Parkinson's disease should consist of levodopa, dopamine agonists, or monoamine oxidase type B inhibitors (MAOBI) is uncertain. We aimed to establish which of these three classes of drug, as initial treatment... Read More about Long-term effectiveness of dopamine agonists and monoamine oxidase B inhibitors compared with levodopa as initial treatment for Parkinson's disease (PD MED): a large, open-label, pragmatic randomised trial.

Lee Silverman voice treatment versus standard NHS speech and language therapy versus control in Parkinson's disease (PD COMM pilot): study protocol for a randomized controlled trial (2014)
Journal Article
Sackley, C. M., Smith, C. H., Rick, C., Brady, M. C., Ives, N., Patel, R., …Clarke, C. (2014). Lee Silverman voice treatment versus standard NHS speech and language therapy versus control in Parkinson's disease (PD COMM pilot): study protocol for a randomized controlled trial. Trials, 15, Article 213. https://doi.org/10.1186/1745-6215-15-213

Background: Parkinson’s disease is a common movement disorder affecting approximately 127,000 people in the UK, with an estimated two thirds having speech-related problems. Currently there is no preferred approach to speech and language therapy withi... Read More about Lee Silverman voice treatment versus standard NHS speech and language therapy versus control in Parkinson's disease (PD COMM pilot): study protocol for a randomized controlled trial.