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9. Theory-based predictors of multiple clinician behaviors in the management of diabetes

Author

Presseau, Justin, Johnston, Marie, Francis, Jill J., Hrisos, Susan, Stamp, Elaine, Steen, Nick, Hawthorne, Gillian, Grimshaw, Jeremy M., Elovainio, Marko, Hunter, Margaret, and Eccles, Martin P.

Subjects
Self-efficacy (Psychology) -- Analysis, Psychology and mental health
Abstract

Behavioral theory is often tested on one behavior in isolation from other behaviors and theories. We aimed to test the predictive validity of constructs from motivation and action theories of behavior across six diabetes-related clinician behaviors, within the same sample of primary care clinicians. Physicians and nurses (n = 427 from 99 practices in the United Kingdom) completed questionnaires at baseline and 12 months. Primary outcomes: six self-reported clinician behaviors related to advising, prescribing and examining measured at 12 months; secondary outcomes: baseline intention and patient-scenario-based simulated behavior. Across six behaviors, each theory accounted for a medium amount of variance for 12-month behavior (median [R.sup.2.sub.adj] = 0.15), large and medium amount of variance for two intention measures (median [R.sup.2.sub.adj] = 0.66; 0.34), and small amount of variance for simulated behavior (median [R.sup.2.sub.adj] = 0.05). Intention/proximal goals, self-efficacy, and habit predicted all behaviors. Constructs from social cognitive theory (self-efficacy), learning theory (habit) and action and coping planning consistently predicted multiple clinician behaviors and should be targeted by quality improvement interventions. Keywords Clinician behavior * Intention * Habit * Multiple behaviors * Planning * Self-efficacy, Introduction There is enduring clinical and policy interest in promoting evidence-based health care. However, the production and dissemination of evidence of clinical best practice does not automatically lead to implementation. [...]

Published
2014
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11. Matching-adjusted indirect treatment comparison of [177Lu]Lu-DOTA-TATE, everolimus and sunitinib in advanced, unresectable gastroenteropancreatic neuroendocrine tumours:Relative effectiveness of [177Lu]Lu-DOTA-TATE in gastroenteropancreatic neuroendocrine tumours

Author

Khan, Mohid S., Stamp, Elaine, Sammon, Cormac, Brabander, Tessa, de Herder, Wouter W., Pavel, Marianne E., Khan, Mohid S., Stamp, Elaine, Sammon, Cormac, Brabander, Tessa, de Herder, Wouter W., and Pavel, Marianne E.

Abstract

Head-to-head comparisons of the efficacy of treatments for gastroenteropancreatic neuroendocrine tumours (GEP-NETs) have not yet been reported. This study used a series of matching-adjusted indirect comparisons to indirectly compare the effectiveness of [177Lu]Lu-DOTA-TATE to everolimus, sunitinib and best supportive care (BSC) for extending progression-free survival and overall survival in patients with advanced, unresectable gastrointestinal (GI)-NETs and P-NETs. The results of the main analysis suggest that after accounting for differences in key prognostic variables, the hazard of progression was 62% (hazard ratio [HR], 0.38; confidence interval [CI]95 0.25–0.58) and 65% (HR 0.35 CI95 0.21–0.59) lower in patients with GI-NETs treated with [177Lu]Lu-DOTA-TATE than in those treated with everolimus and BSC, respectively. Similarly, the hazard of progression was 64% (HR 0.36 CI95 0.18–0.70), 54% (HR 0.46 CI95 0.30–0.71) and 79–87% (HR 0.21 CI95 0.13–0.32; HR 0.13 CI95 0.08–0.22) lower in patients with P-NET treated with [177Lu]Lu-DOTA-TATE than in those treated with sunitinib, everolimus and BSC, respectively. The hazard of death was 58% (HR 0.42 CI95 0.25–0.72), 47% (HR 0.53 CI95 0.33–0.87) and 44–64% (HR 0.56 CI95 0.36–0.90; HR 0.34 CI95 0.20–0.57) lower in P-patients with NET treated with [177Lu]Lu-DOTA-TATE than in those treated with sunitinib, everolimus and BSC, respectively. While our results must be interpreted with caution given the non-randomised nature of the comparisons and the potential for residual confounding, the magnitude of the effect sizes we observe and their consistency across comparators suggest that [177Lu]Lu-DOTA-TATE may be a more effective treatment option than everolimus, sunitinib and BSC in advanced, unresectable GEP-NETs.

Published
2021

12. Corrigendum: Brief alcohol intervention for risky drinking in young people aged 14–15 years in secondary schools: the SIPS JR-HIGH RCT

Author

Giles, Emma L, primary, McGeechan, Grant J, additional, Coulton, Simon, additional, Deluca, Paolo, additional, Drummond, Colin, additional, Howel, Denise, additional, Kaner, Eileen, additional, McColl, Elaine, additional, McGovern, Ruth, additional, Scott, Stephanie, additional, Stamp, Elaine, additional, Sumnall, Harry, additional, Todd, Liz, additional, Vale, Luke, additional, Albani, Viviana, additional, Boniface, Sadie, additional, Ferguson, Jennifer, additional, Gilvarry, Eilish, additional, Hendrie, Nadine, additional, Howe, Nicola, additional, Mossop, Helen, additional, Ramsay, Amy, additional, Stanley, Grant, additional, and Newbury-Birch, Dorothy, additional

Published
2020
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15. An extended stroke rehabilitation service for people who have had a stroke: the EXTRAS RCT

Author

Shaw, Lisa, primary, Bhattarai, Nawaraj, additional, Cant, Robin, additional, Drummond, Avril, additional, Ford, Gary A, additional, Forster, Anne, additional, Francis, Richard, additional, Hills, Katie, additional, Howel, Denise, additional, Laverty, Anne Marie, additional, McKevitt, Christopher, additional, McMeekin, Peter, additional, Price, Christopher, additional, Stamp, Elaine, additional, Stevens, Eleanor, additional, Vale, Luke, additional, and Rodgers, Helen, additional

Published
2020
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17. The foodscape: classification and field validation of secondary data sources across urban/rural and socio-economic classifications in England

Author

Lake Amelia A, Burgoine Thomas, Stamp Elaine, and Grieve Rachael

Subjects
Foodscape, Food environment, Secondary data, Urban, Rural, Socio-economic status, Ground-truthing, Validation, Nutritional diseases. Deficiency diseases, RC620-627, Public aspects of medicine, RA1-1270
Abstract

Abstract Background In recent years, alongside the exponential increase in the prevalence of overweight and obesity, there has been a change in the food environment (foodscape). This research focuses on methods used to measure and classify the foodscape. This paper describes the foodscape across urban/rural and socio-economic divides. It examines the validity of a database of food outlets obtained from Local Authority sources (secondary level & desk based), across urban/rural and socio-economic divides by conducting fieldwork (ground-truthing). Additionally this paper tests the efficacy of using a desk based classification system to describe food outlets, compared with ground-truthing. Methods Six geographically defined study areas were purposively selected within North East England consisting of two Lower Super Output Areas (LSOAs; a small administrative geography) each. Lists of food outlets were obtained from relevant Local Authorities (secondary level & desk based) and fieldwork (ground-truthing) was conducted. Food outlets were classified using an existing tool. Positive predictive values (PPVs) and sensitivity analysis was conducted to explore validation of secondary data sources. Agreement between 'desk' and 'field' based classifications of food outlets were assessed. Results There were 438 food outlets within all study areas; the urban low socio-economic status (SES) area had the highest number of total outlets (n = 210) and the rural high SES area had the least (n = 19). Differences in the types of outlets across areas were observed. Comparing the Local Authority list to fieldwork across the geographical areas resulted in a range of PPV values obtained; with the highest in urban low SES areas (87%) and the lowest in Rural mixed SES (79%). While sensitivity ranged from 95% in the rural mixed SES area to 60% in the rural low SES area. There were no significant associations between field/desk percentage agreements across any of the divides. Conclusion Despite the relatively small number of areas, this work furthers our understanding of the validity of using secondary data sources to identify and classify the foodscape in a variety of geographical settings. While classification of the foodscape using secondary Local Authority food outlet data with information obtained from the internet, is not without its difficulties, desk based classification would be an acceptable alternative to fieldwork, although it should be used with caution.

Published
2012
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22. Brief alcohol intervention for risky drinking in young people aged 14–15 years in secondary schools: the SIPS JR-HIGH RCT

Author

Giles, Emma L, primary, McGeechan, Grant J, additional, Coulton, Simon, additional, Deluca, Paolo, additional, Drummond, Colin, additional, Howel, Denise, additional, Kaner, Eileen, additional, McColl, Elaine, additional, McGovern, Ruth, additional, Scott, Stephanie, additional, Stamp, Elaine, additional, Sumnall, Harry, additional, Todd, Liz, additional, Vale, Luke, additional, Albani, Viviana, additional, Boniface, Sadie, additional, Ferguson, Jennifer, additional, Gilvarry, Eilish, additional, Hendrie, Nadine, additional, Howe, Nicola, additional, Mossop, Helen, additional, Ramsay, Amy, additional, Stanley, Grant, additional, and Newbury-Birch, Dorothy, additional

Published
2019
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24. Instrument development, data collection, and characteristics of practices, staff, and measures in the Improving Quality of Care in Diabetes (iQuaD) Study

Author

Elovainio Marko, Grimshaw Jeremy M, Steen Nick, Hawthorne Gillian, Johnston Marie, Stamp Elaine, Francis Jill J, Hrisos Susan, Eccles Martin P, Presseau Justin, and Hunter Margaret

Subjects
Medicine (General), R5-920
Abstract

Abstract Background Type 2 diabetes is an increasingly prevalent chronic illness and an important cause of avoidable mortality. Patients are managed by the integrated activities of clinical and non-clinical members of primary care teams. This study aimed to: investigate theoretically-based organisational, team, and individual factors determining the multiple behaviours needed to manage diabetes; and identify multilevel determinants of different diabetes management behaviours and potential interventions to improve them. This paper describes the instrument development, study recruitment, characteristics of the study participating practices and their constituent healthcare professionals and administrative staff and reports descriptive analyses of the data collected. Methods The study was a predictive study over a 12-month period. Practices (N = 99) were recruited from within the UK Medical Research Council General Practice Research Framework. We identified six behaviours chosen to cover a range of clinical activities (prescribing, non-prescribing), reflect decisions that were not necessarily straightforward (controlling blood pressure that was above target despite other drug treatment), and reflect recommended best practice as described by national guidelines. Practice attributes and a wide range of individually reported measures were assessed at baseline; measures of clinical outcome were collected over the ensuing 12 months, and a number of proxy measures of behaviour were collected at baseline and at 12 months. Data were collected by telephone interview, postal questionnaire (organisational and clinical) to practice staff, postal questionnaire to patients, and by computer data extraction query. Results All 99 practices completed a telephone interview and responded to baseline questionnaires. The organisational questionnaire was completed by 931/1236 (75.3%) administrative staff, 423/529 (80.0%) primary care doctors, and 255/314 (81.2%) nurses. Clinical questionnaires were completed by 326/361 (90.3%) primary care doctors and 163/186 (87.6%) nurses. At a practice level, we achieved response rates of 100% from clinicians in 40 practices and > 80% from clinicians in 67 practices. All measures had satisfactory internal consistency (alpha coefficient range from 0.61 to 0.97; Pearson correlation coefficient (two item measures) 0.32 to 0.81); scores were generally consistent with good practice. Measures of behaviour showed relatively high rates of performance of the six behaviours, but with considerable variability within and across the behaviours and measures. Discussion We have assembled an unparalleled data set from clinicians reporting on their cognitions in relation to the performance of six clinical behaviours involved in the management of people with one chronic disease (diabetes mellitus), using a range of organisational and individual level measures as well as information on the structure of the practice teams and across a large number of UK primary care practices. We would welcome approaches from other researchers to collaborate on the analysis of this data.

Published
2011
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25. Tropomyosin Receptor Antagonism in Cylindromatosis (TRAC), an early phase trial of a topical tropomyosin kinase inhibitor as a treatment for inherited CYLD defective skin tumours: study protocol for a randomised controlled trial

Author

Cranston, Amy, Stocken, Deborah D., Stamp, Elaine, Roblin, David, Hamlin, Julia, Langtry, James, Plummer, Ruth, Ashworth, Alan, Burn, John, and Rajan, Neil

Subjects
Skin Neoplasms, Time Factors, CYLD, DNA Mutational Analysis, Medicine (miscellaneous), Antineoplastic Agents, Administration, Cutaneous, Heterocyclic Compounds, 4 or More Rings, Drug Administration Schedule, Tropomyosin receptor kinase (TRK) inhibitor, Study Protocol, Clinical Protocols, Neoplastic Syndromes, Hereditary, Biomarkers, Tumor, Humans, Pharmacology (medical), Genetic Predisposition to Disease, Protein Kinase Inhibitors, Germ-Line Mutation, Skin, TRK inhibition, Receptor Protein-Tyrosine Kinases, Deubiquitinating Enzyme CYLD, Phenotype, Treatment Outcome, England, Chemotherapy, Adjuvant, Research Design, Cylindromatosis, CYLD defective tumours, Pegcantratinib
Abstract

Background Patients with germline mutations in a tumour suppressor gene called CYLD develop multiple, disfiguring, hair follicle tumours on the head and neck. The prognosis is poor, with up to one in four mutation carriers requiring complete surgical removal of the scalp. There are no effective medical alternatives to treat this condition. Whole genome molecular profiling experiments led to the discovery of an attractive molecular target in these skin tumour cells, named tropomyosin receptor kinase (TRK), upon which these cells demonstrate an oncogenic dependency in preclinical studies. Recently, the development of an ointment containing a TRK inhibitor (pegcantratinib — previously CT327 — from Creabilis SA) allowed for the assessment of TRK inhibition in tumours from patients with inherited CYLD mutations. Methods/design Tropomysin Receptor Antagonism in Cylindromatosis (TRAC) is a two-part, exploratory, early phase, single-centre trial. Cohort 1 is a phase 1b open-labelled trial, and cohort 2 is a phase 2a randomised double-blinded exploratory placebo-controlled trial. Cohort 1 will determine the safety and acceptability of applying pegcantratinib for 4 weeks to a single tumour on a CYLD mutation carrier that is scheduled for a routine lesion excision (n = 8 patients). Cohort 2 will investigate if CYLD defective tumours respond following 12 weeks of treatment with pegcantratinib. As patients have multiple tumours, we intend to treat 10 tumours in each patient, 5 with active treatment and 5 with placebo. Patients will be allocated both active and placebo treatments to be applied randomly to tumours on the left or right side. The target is to treat 150 tumours in a maximum of 20 patients. Tumour volume will be measured at baseline and at 4 and 12 weeks. The primary outcome measure is the proportion of tumours responding to treatment by 12 weeks, based on change in tumour volume, with secondary measures based on adverse event profile, treatment compliance and acceptability, changes in tumour volume and surface area, patient quality of life and pain. Discussion Interventions for rare genetic skin diseases are often difficult to assess in an unbiased way due to small patient numbers and the challenges of incorporating adequate controls into trial design. Here we present a single-centre, randomised, placebo-controlled trial design that leverages the multiplicity of tumours seen in an inherited skin tumour syndrome that may inform the design of other studies in similar genetic diseases. Trial registration International Standard Randomised Controlled Trial Number Registry, ISRCTN75715723. Registered on 22 October 2014. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1812-z) contains supplementary material, which is available to authorized users.

Published
2017

26. Additional file 1: of Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial

Author

Rodgers, Helen, Shaw, Lisa, Bosomworth, Helen, Aird, Lydia, Alvarado, Natasha, Sreeman Andole, Cohen, David, Dawson, Jesse, Eyre, Janet, Finch, Tracy, Ford, Gary, Hislop, Jennifer, Hogg, Steven, Howel, Denise, Hughes, Niall, Hermano Krebs, Price, Christopher, Rochester, Lynn, Stamp, Elaine, Ternent, Laura, Turner, Duncan, Vale, Luke, Warburton, Elizabeth, Wijck, Frederike Van, and Wilkes, Scott

Abstract

SPIRIT Checklist for RATULS protocol paper. (DOC 120 kb)

Published
2017
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27. Additional file 4: of Tropomyosin Receptor Antagonism in Cylindromatosis (TRAC), an early phase trial of a topical tropomyosin kinase inhibitor as a treatment for inherited CYLD defective skin tumours: study protocol for a randomised controlled trial

Author

Cranston, Amy, Stocken, Deborah, Stamp, Elaine, Roblin, David, Hamlin, Julia, Langtry, James, Plummer, Ruth, Ashworth, Alan, Burn, John, and Rajan, Neil

Abstract

Pictorial overview of phase 2a design. (PDF 152 kb)

Published
2017
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28. Additional file 5: of Tropomyosin Receptor Antagonism in Cylindromatosis (TRAC), an early phase trial of a topical tropomyosin kinase inhibitor as a treatment for inherited CYLD defective skin tumours: study protocol for a randomised controlled trial

Author

Cranston, Amy, Stocken, Deborah, Stamp, Elaine, Roblin, David, Hamlin, Julia, Langtry, James, Plummer, Ruth, Ashworth, Alan, Burn, John, and Rajan, Neil

Subjects
body regions, nervous system, fungi, food and beverages, humanities
Abstract

SPIRIT figure showing schedule of events in cohort 1 of the trial. (PDF 140 kb)

Published
2017
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29. Additional file 3: of Tropomyosin Receptor Antagonism in Cylindromatosis (TRAC), an early phase trial of a topical tropomyosin kinase inhibitor as a treatment for inherited CYLD defective skin tumours: study protocol for a randomised controlled trial

Author

Cranston, Amy, Stocken, Deborah, Stamp, Elaine, Roblin, David, Hamlin, Julia, Langtry, James, Plummer, Ruth, Ashworth, Alan, Burn, John, and Rajan, Neil

Abstract

CONSORT diagram for cohort 2: phase 2a of the trial. (PDF 166 kb)

Published
2017
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30. Additional file 2: of Tropomyosin Receptor Antagonism in Cylindromatosis (TRAC), an early phase trial of a topical tropomyosin kinase inhibitor as a treatment for inherited CYLD defective skin tumours: study protocol for a randomised controlled trial

Author

Cranston, Amy, Stocken, Deborah, Stamp, Elaine, Roblin, David, Hamlin, Julia, Langtry, James, Plummer, Ruth, Ashworth, Alan, Burn, John, and Rajan, Neil

Abstract

CONSORT diagram for cohort 1: phase 1b of the trial. (PDF 82 kb)

Published
2017
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31. Additional file 7: of Tropomyosin Receptor Antagonism in Cylindromatosis (TRAC), an early phase trial of a topical tropomyosin kinase inhibitor as a treatment for inherited CYLD defective skin tumours: study protocol for a randomised controlled trial

Author

Cranston, Amy, Stocken, Deborah, Stamp, Elaine, Roblin, David, Hamlin, Julia, Langtry, James, Plummer, Ruth, Ashworth, Alan, Burn, John, and Rajan, Neil

Abstract

SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 254 kb)

Published
2017
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32. Multicentre individual randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people aged 14-15 in a high school setting (SIPS JR-HIGH):Study protocol

Author

Giles, Emma L., Coulton, Simon, Deluca, Paolo, Drummond, Colin, Howel, Denise, Kaner, Eileen, McColl, Elaine, McGovern, Ruth, Scott, Stephanie, Stamp, Elaine, Sumnall, Harry, Tate, Les, Todd, Liz, Vale, Luke, Albani, Viviana, Boniface, Sadie, Ferguson, Jennifer, Frankham, Jo, Gilvarry, Eilish, Hendrie, Nadine, Howe, Nicola, McGeechan, Grant J, Stanley, Grant, and Newbury-Birch, Dorothy

Subjects
Counseling, Male, Adolescent, Alcohol Drinking, School Setting, education, Health Promotion, Brief Intervention, Risk-Taking, RA0421, Surveys and Questionnaires, London, Protocol, Humans, Mass Screening, Students, School Health Services, Schools, Mentors, Alcoholism, England, Adolescent Behavior, Research Design, Female, Public Health, HV5001, Alcohol, Alcoholic Intoxication, Randomised Controlled Trial
Abstract

INTRODUCTION: Drinking has adverse impacts on health, well-being, education and social outcomes for adolescents. Adolescents in England are among the heaviest drinkers in Europe. Recently, the proportion of adolescents who drink alcohol has fallen, although consumption among those who do drink has actually increased. This trial seeks to investigate how effective and efficient an alcohol brief intervention is with 11-15 years olds to encourage lower alcohol consumption. METHODS AND ANALYSIS: This is an individually randomised two-armed trial incorporating a control arm of usual school-based practice and a leaflet on a healthy lifestyle (excl. alcohol), and an intervention arm that combines usual practice with a 30 min brief intervention delivered by school learning mentors and a leaflet on alcohol. At least 30 schools will be recruited from four regions in England (North East, North West, London, Kent and Medway) to follow-up 235 per arm. The primary outcome is total alcohol consumed in the last 28 days, using the 28 day Timeline Follow Back questionnaire measured at the 12-month follow-up. The analysis of the intervention will consider effectiveness and cost-effectiveness. A qualitative study will explore, via 1:1 in-depth interviews with (n=80) parents, young people and school staff, intervention experience, intervention fidelity and acceptability issues, using thematic narrative synthesis to report qualitative data. ETHICS AND DISSEMINATION: Ethical approval was granted by Teesside University. Dissemination plans include academic publications, conference presentations, disseminating to local and national education departments and the wider public health community, including via Fuse, and engaging with school staff and young people to comment on whether and how the project can be improved. TRIAL REGISTRATION TRIAL: ISRCTN45691494; Pre-results.

Published
2016

33. Targeting Tropomyosin Receptor Kinase in Cutaneous CYLD Defective Tumors With Pegcantratinib

Author

Danilenko, Marina, primary, Stamp, Elaine, additional, Stocken, Deborah D., additional, Husain, Akhtar, additional, Zangarini, Monique, additional, Cranston, Amy, additional, Stones, Robert, additional, Sinclair, Naomi, additional, Hodgson, Kirsty, additional, Bowett, Susan A., additional, Roblin, David, additional, Traversa, Silvio, additional, Plummer, Ruth, additional, Veal, Gareth, additional, Langtry, James A. A., additional, Ashworth, Alan, additional, Burn, John, additional, and Rajan, Neil, additional

Published
2018
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34. Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial

Author

Massachusetts Institute of Technology. Department of Mechanical Engineering, Krebs, Hermano I, Rodgers, Helen, Shaw, Lisa, Bosomworth, Helen, Aird, Lydia, Alvarado, Natasha, Andole, Sreeman, Cohen, David L, Dawson, Jesse, Eyre, Janet, Finch, Tracy, Ford, Gary A, Hislop, Jennifer, Hogg, Steven, Howel, Denise, Hughes, Niall, Price, Christopher, Rochester, Lynn, Stamp, Elaine, Ternent, Laura, Turner, Duncan, Vale, Luke, Warburton, Elizabeth, van Wijck, Frederike, Wilkes, Scott, Cohen, David L., Ford, Gary A., Krebs, Hermano Igo, Massachusetts Institute of Technology. Department of Mechanical Engineering, Krebs, Hermano I, Rodgers, Helen, Shaw, Lisa, Bosomworth, Helen, Aird, Lydia, Alvarado, Natasha, Andole, Sreeman, Cohen, David L, Dawson, Jesse, Eyre, Janet, Finch, Tracy, Ford, Gary A, Hislop, Jennifer, Hogg, Steven, Howel, Denise, Hughes, Niall, Price, Christopher, Rochester, Lynn, Stamp, Elaine, Ternent, Laura, Turner, Duncan, Vale, Luke, Warburton, Elizabeth, van Wijck, Frederike, Wilkes, Scott, Cohen, David L., Ford, Gary A., and Krebs, Hermano Igo

Abstract

Background Loss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke. Methods/design Study design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation. Setting: NHS stroke services. Participants: adults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation. Randomisation groups: 1. Robot-assisted training using the InMotion robotic gym system for 45 min, three times/week for 12 weeks 2. Enhanced upper limb therapy for 45 min, three times/week for 12 weeks 3. Usual NHS care in accordance with local clinical practice Randomisation: individual participant randomisation stratified by centre, time since stroke, and severity of upper limb impairment. Primary outcome: upper limb function measured by the Action Research Arm Test (ARAT) at 3 months post randomisation. Secondary outcomes: upper limb impairment (Fugl-Meyer Test), activities of daily living (Barthel ADL Index), quality of life (Stroke Impact Scale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverse events, at 3 and 6 months. Blinding: outcomes are undertaken by blinded assessors. Economic analysis: micro-costing and economic evaluation of interventions compared to usual NHS care. A within-trial analysis, with an economic model will be used to extrapolate longer-term costs and outcomes. Process evaluation: semi-structured interviews with participants and professionals to seek their views and experiences of the rehabilitation that they have received or provided, and factors affecting the implementation of the trial. Sample size: allowing for 10% attrition, 720 participants provide 80% power to detect a 15% difference in successful outcome between each of the treatment pairs. Suc

Published
2017

35. An assessment of smear taker training in the Northern & Yorkshire Cervical Screening Programme

Author

Faulkner, Keith, Greenwood, Lesley, and Stamp, Elaine

Subjects
Medical personnel -- Training -- Research, Pap test -- Research -- Training, Health, Social sciences, Research, Training
Abstract

Objective: To assess the impact of a regional smear taker training scheme within the Northern and Yorkshire Cervical Screening Programme. Design: An analysis of cervical screening KC activity returns to [...]

Published
2003

36. Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial

Author

Rodgers, Helen, Shaw, Lisa, Bosomworth, Helen, Aird, Lydia, Alvarado, Natasha, Andole, Sreeman, Cohen, David L, Dawson, Jesse, Eyre, Janet, Finch, Tracy, Ford, Gary A, Hislop, Jennifer, Hogg, Steven, Howel, Denise, Hughes, Niall, Price, Christopher, Rochester, Lynn, Stamp, Elaine, Ternent, Laura, Turner, Duncan, Vale, Luke, Warburton, Elizabeth, van Wijck, Frederike, Wilkes, Scott, Cohen, David L., Ford, Gary A., Krebs, Hermano Igo, Krebs, Hermano I, Massachusetts Institute of Technology. Department of Mechanical Engineering, Krebs, Hermano I, and Apollo - University of Cambridge Repository

Subjects
Gerontology, Activities of daily living, Time Factors, medicine.medical_treatment, Cost-Benefit Analysis, L500, Medicine (miscellaneous), State Medicine, law.invention, Disability Evaluation, Study Protocol, 0302 clinical medicine, Randomized controlled trial, Quality of life, Clinical Protocols, law, Pharmacology (medical), 030212 general & internal medicine, Parallel process evaluation, Stroke, lcsh:R5-920, Rehabilitation, Stroke Rehabilitation, Cost-effectiveness analysis, Health Care Costs, Robotics, Biomechanical Phenomena, Exercise Therapy, medicine.anatomical_structure, Models, Economic, Treatment Outcome, Research Design, Arm, Upper limb, Quality-Adjusted Life Years, lcsh:Medicine (General), RCT, medicine.medical_specialty, Blinding, Upper Extremity, 03 medical and health sciences, medicine, Humans, business.industry, Recovery of Function, medicine.disease, United Kingdom, B900, Physical therapy, Quality of Life, business, 030217 neurology & neurosurgery
Abstract

Background Loss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke. Methods/design Study design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation. Setting: NHS stroke services. Participants: adults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation. Randomisation groups: 1. Robot-assisted training using the InMotion robotic gym system for 45 min, three times/week for 12 weeks 2. Enhanced upper limb therapy for 45 min, three times/week for 12 weeks 3. Usual NHS care in accordance with local clinical practice Randomisation: individual participant randomisation stratified by centre, time since stroke, and severity of upper limb impairment. Primary outcome: upper limb function measured by the Action Research Arm Test (ARAT) at 3 months post randomisation. Secondary outcomes: upper limb impairment (Fugl-Meyer Test), activities of daily living (Barthel ADL Index), quality of life (Stroke Impact Scale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverse events, at 3 and 6 months. Blinding: outcomes are undertaken by blinded assessors. Economic analysis: micro-costing and economic evaluation of interventions compared to usual NHS care. A within-trial analysis, with an economic model will be used to extrapolate longer-term costs and outcomes. Process evaluation: semi-structured interviews with participants and professionals to seek their views and experiences of the rehabilitation that they have received or provided, and factors affecting the implementation of the trial. Sample size: allowing for 10% attrition, 720 participants provide 80% power to detect a 15% difference in successful outcome between each of the treatment pairs. Successful outcome definition: baseline ARAT 0–7 must improve by 3 or more points; baseline ARAT 8–13 improve by 4 or more points; baseline ARAT 14–19 improve by 5 or more points; baseline ARAT 20–39 improve by 6 or more points. Discussion The results from this trial will determine whether robot-assisted training improves upper limb function post stroke. Trial registration ISRCTN, identifier: ISRCTN69371850. Registered 4 October 2013. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-2083-4) contains supplementary material, which is available to authorized users.

Published
2016

37. Proceedings of the 14th annual conference of INEBRIA

Author

Holloway, Aisha S., primary, Ferguson, Jennifer, additional, Landale, Sarah, additional, Cariola, Laura, additional, Newbury-Birch, Dorothy, additional, Flynn, Amy, additional, Knight, John R., additional, Sherritt, Lon, additional, Harris, Sion K., additional, O’Donnell, Amy J., additional, Kaner, Eileen, additional, Hanratty, Barbara, additional, Loree, Amy M., additional, Yonkers, Kimberly A., additional, Ondersma, Steven J., additional, Gilstead-Hayden, Kate, additional, Martino, Steve, additional, Adam, Angeline, additional, Schwartz, Robert P., additional, Wu, Li-Tzy, additional, Subramaniam, Geetha, additional, Sharma, Gaurav, additional, McNeely, Jennifer, additional, Berman, Anne H., additional, Kolaas, Karoline, additional, Petersén, Elisabeth, additional, Bendtsen, Preben, additional, Hedman, Erik, additional, Linderoth, Catharina, additional, Müssener, Ulrika, additional, Sinadinovic, Kristina, additional, Spak, Fredrik, additional, Gremyr, Ida, additional, Thurang, Anna, additional, Mitchell, Ann M., additional, Finnell, Deborah, additional, Savage, Christine L., additional, Mahmoud, Khadejah F., additional, Riordan, Benjamin C., additional, Conner, Tamlin S., additional, Flett, Jayde A. M., additional, Scarf, Damian, additional, McRee, Bonnie, additional, Vendetti, Janice, additional, Gallucci, Karen Steinberg, additional, Robaina, Kate, additional, Clark, Brendan J., additional, Jones, Jacqueline, additional, Reed, Kathryne D., additional, Hodapp, Rachel M., additional, Douglas, Ivor, additional, Burnham, Ellen L., additional, Aagaard, Laura, additional, Cook, Paul F., additional, Harris, Brett R., additional, Yu, Jiang, additional, Wolff, Margaret, additional, Rogers, Meighan, additional, Barbosa, Carolina, additional, Wedehase, Brendan J., additional, Dunlap, Laura J., additional, Mitchell, Shannon G., additional, Dusek, Kristi A., additional, Gryczynski, Jan, additional, Kirk, Arethusa S., additional, Oros, Marla T., additional, Hosler, Colleen, additional, O’Grady, Kevin E., additional, Brown, Barry S., additional, Angus, Colin, additional, Sherborne, Sidney, additional, Gillespie, Duncan, additional, Meier, Petra, additional, Brennan, Alan, additional, de Vargas, Divane, additional, Soares, Janaina, additional, Castelblanco, Donna, additional, Doran, Kelly M., additional, Wittman, Ian, additional, Shelley, Donna, additional, Rotrosen, John, additional, Gelberg, Lillian, additional, Edelman, E. Jennifer, additional, Maisto, Stephen A., additional, Hansen, Nathan B., additional, Cutter, Christopher J., additional, Deng, Yanhong, additional, Dziura, James, additional, Fiellin, Lynn E., additional, O’Connor, Patrick G., additional, Bedimo, Roger, additional, Gibert, Cynthia, additional, Marconi, Vincent C., additional, Rimland, David, additional, Rodriguez-Barradas, Maria C., additional, Simberkoff, Michael S., additional, Justice, Amy C., additional, Bryant, Kendall J., additional, Fiellin, David A., additional, Giles, Emma L., additional, Coulton, Simon, additional, Deluca, Paolo, additional, Drummond, Colin, additional, Howel, Denise, additional, McColl, Elaine, additional, McGovern, Ruth, additional, Scott, Stephanie, additional, Stamp, Elaine, additional, Sumnall, Harry, additional, Vale, Luke, additional, Alabani, Viviana, additional, Atkinson, Amanda, additional, Boniface, Sadie, additional, Frankham, Jo, additional, Gilvarry, Eilish, additional, Hendrie, Nadine, additional, Howe, Nicola, additional, McGeechan, Grant J., additional, Ramsey, Amy, additional, Stanley, Grant, additional, Clephane, Justine, additional, Gardiner, David, additional, Holmes, John, additional, Martin, Neil, additional, Shevills, Colin, additional, Soutar, Melanie, additional, Chi, Felicia W., additional, Weisner, Constance, additional, Ross, Thekla B., additional, Mertens, Jennifer, additional, Sterling, Stacy A., additional, Shorter, Gillian W., additional, Heather, Nick, additional, Bray, Jeremy, additional, Cohen, Hildie A., additional, McPherson, Tracy L., additional, Adam, Cyrille, additional, López-Pelayo, Hugo, additional, Gual, Antoni, additional, Segura-Garcia, Lidia, additional, Colom, Joan, additional, Ornelas, India J., additional, Doyle, Suzanne, additional, Donovan, Dennis, additional, Duran, Bonnie, additional, Torres, Vanessa, additional, Gaume, Jacques, additional, Grazioli, Véronique, additional, Fortini, Cristiana, additional, Paroz, Sophie, additional, Bertholet, Nicolas, additional, Daeppen, Jean-Bernard, additional, Satterfield, Jason M., additional, Gregorich, Steven, additional, Alvarado, Nicholas J., additional, Muñoz, Ricardo, additional, Kulieva, Gozel, additional, Vijayaraghavan, Maya, additional, Adam, Angéline, additional, Cunningham, John A., additional, Díaz, Estela, additional, Palacio-Vieira, Jorge, additional, Godinho, Alexandra, additional, Kushir, Vladyslav, additional, O’Brien, Kimberly H. M., additional, Aguinaldo, Laika D., additional, Sellers, Christina M., additional, Spirito, Anthony, additional, Chang, Grace, additional, Blake-Lamb, Tiffany, additional, LaFave, Lea R. Ayers, additional, Thies, Kathleen M., additional, Pepin, Amy L., additional, Sprangers, Kara E., additional, Bradley, Martha, additional, Jorgensen, Shasta, additional, Catano, Nico A., additional, Murray, Adelaide R., additional, Schachter, Deborah, additional, Andersen, Ronald M., additional, Rey, Guillermina Natera, additional, Vahidi, Mani, additional, Rico, Melvin W., additional, Baumeister, Sebastian E., additional, Johansson, Magnus, additional, Sinadinovic, Christina, additional, Hermansson, Ulric, additional, Andreasson, Sven, additional, O’Grady, Megan A., additional, Kapoor, Sandeep, additional, Akkari, Cherine, additional, Bernal, Camila, additional, Pappacena, Kristen, additional, Morley, Jeanne, additional, Auerbach, Mark, additional, Neighbors, Charles J., additional, Kwon, Nancy, additional, Conigliaro, Joseph, additional, Morgenstern, Jon, additional, Magill, Molly, additional, Apodaca, Timothy R., additional, Borsari, Brian, additional, Hoadley, Ariel, additional, Scott Tonigan, J., additional, Moyers, Theresa, additional, Fitzgerald, Niamh M., additional, Schölin, Lisa, additional, Barticevic, Nicolas, additional, Zuzulich, Soledad, additional, Poblete, Fernando, additional, Norambuena, Pablo, additional, Sacco, Paul, additional, Ting, Laura, additional, Beaulieu, Michele, additional, Wallace, Paul George, additional, Andrews, Matthew, additional, Daley, Kate, additional, Shenker, Don, additional, Gallagher, Louise, additional, Watson, Rod, additional, Weaver, Tim, additional, Bruguera, Pol, additional, Oliveras, Clara, additional, Gavotti, Carolina, additional, Barrio, Pablo, additional, Braddick, Fleur, additional, Miquel, Laia, additional, Suárez, Montse, additional, Bruguera, Carla, additional, Brown, Richard L., additional, Capell, Julie Whelan, additional, Paul Moberg, D., additional, Maslowsky, Julie, additional, Saunders, Laura A., additional, McCormack, Ryan P., additional, Scheidell, Joy, additional, Gonzalez, Mirelis, additional, Bauroth, Sabrina, additional, Liu, Weiwei, additional, Lindsay, Dawn L., additional, Lincoln, Piper, additional, Hagle, Holly, additional, Wallhed Finn, Sara, additional, Hammarberg, Anders, additional, Andréasson, Sven, additional, King, Sarah E., additional, Vargo, Rachael, additional, Kameg, Brayden N., additional, Acquavita, Shauna P., additional, Van Loon, Ruth Anne, additional, Smith, Rachel, additional, Brehm, Bonnie J., additional, Diers, Tiffiny, additional, Kim, Karissa, additional, Barker, Andrea, additional, Jones, Ashley L., additional, Skinner, Asheley C., additional, Hinman, Agatha, additional, Svikis, Dace S., additional, Thacker, Casey L., additional, Resnicow, Ken, additional, Beatty, Jessica R., additional, Janisse, James, additional, Puder, Karoline, additional, Bakshi, Ann-Sofie, additional, Milward, Joanna M., additional, Kimergard, Andreas, additional, Garnett, Claire V., additional, Crane, David, additional, Brown, Jamie, additional, West, Robert, additional, Michie, Susan, additional, Rosendahl, Ingvar, additional, Andersson, Claes, additional, Gajecki, Mikael, additional, Blankers, Matthijs, additional, Donoghue, Kim, additional, Lynch, Ellen, additional, Maconochie, Ian, additional, Phillips, Ceri, additional, Pockett, Rhys, additional, Phillips, Tom, additional, Patton, R., additional, Russell, Ian, additional, Strang, John, additional, Stewart, Maureen T., additional, Quinn, Amity E., additional, Brolin, Mary, additional, Evans, Brooke, additional, Horgan, Constance M., additional, Liu, Junqing, additional, McCree, Fern, additional, Kanovsky, Doug, additional, Oberlander, Tyler, additional, Zhang, Huan, additional, Hamlin, Ben, additional, Saunders, Robert, additional, Barton, Mary B., additional, Scholle, Sarah H., additional, Santora, Patricia, additional, Bhatt, Chirag, additional, Ahmed, Kazi, additional, Hodgkin, Dominic, additional, Gao, Wenwu, additional, Merrick, Elizabeth L., additional, Drebing, Charles E., additional, Larson, Mary Jo, additional, Sharma, Monica, additional, Petry, Nancy M., additional, Saitz, Richard, additional, Weisner, Constance M., additional, Young-Wolff, Kelly C., additional, Lu, Wendy Y., additional, Blosnich, John R., additional, Lehavot, Keren, additional, Glass, Joseph E., additional, Williams, Emily C., additional, Bensley, Kara M., additional, Chan, Gary, additional, Dombrowski, Julie, additional, Fortney, John, additional, Rubinsky, Anna D., additional, Lapham, Gwen T., additional, Forray, Ariadna, additional, Olmstead, Todd A., additional, Gilstad-Hayden, Kathryn, additional, Kershaw, Trace, additional, Dillon, Pamela, additional, Weaver, Michael F., additional, Grekin, Emily R., additional, Ellis, Jennifer D., additional, and McGoron, Lucy, additional

Published
2017
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38. Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial

Author

Rodgers, Helen, primary, Shaw, Lisa, additional, Bosomworth, Helen, additional, Aird, Lydia, additional, Alvarado, Natasha, additional, Andole, Sreeman, additional, Cohen, David L., additional, Dawson, Jesse, additional, Eyre, Janet, additional, Finch, Tracy, additional, Ford, Gary A., additional, Hislop, Jennifer, additional, Hogg, Steven, additional, Howel, Denise, additional, Hughes, Niall, additional, Krebs, Hermano Igo, additional, Price, Christopher, additional, Rochester, Lynn, additional, Stamp, Elaine, additional, Ternent, Laura, additional, Turner, Duncan, additional, Vale, Luke, additional, Warburton, Elizabeth, additional, van Wijck, Frederike, additional, and Wilkes, Scott, additional

Published
2017
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40. Multicentre individual randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people aged 14–15 in a high school setting (SIPS JR-HIGH): study protocol

Author

Giles, Emma L, primary, Coulton, Simon, additional, Deluca, Paolo, additional, Drummond, Colin, additional, Howel, Denise, additional, Kaner, Eileen, additional, McColl, Elaine, additional, McGovern, Ruth, additional, Scott, Stephanie, additional, Stamp, Elaine, additional, Sumnall, Harry, additional, Tate, Les, additional, Todd, Liz, additional, Vale, Luke, additional, Albani, Viviana, additional, Boniface, Sadie, additional, Ferguson, Jennifer, additional, Frankham, Jo, additional, Gilvarry, Eilish, additional, Hendrie, Nadine, additional, Howe, Nicola, additional, McGeechan, Grant J, additional, Stanley, Grant, additional, and Newbury-Birch, Dorothy, additional

Published
2016
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41. Anticipated survival and health behaviours in older English adults: cross sectional and longitudinal analysis of the English Longitudinal Study of Ageing

Author

Adams, Jean, Stamp, Elaine, Nettle, Daniel, Milne, Eugene M. G., Jagger, Carol, Adams, Jean [0000-0002-5733-7830], and Apollo - University of Cambridge Repository

Subjects
Aged, 80 and over, Male, Aging, Alcohol Drinking, Science, Health Behavior, Smoking, Middle Aged, Survival Analysis, Cohort Studies, England, Humans, Medicine, Female, Longitudinal Studies, Exercise, Research Article, Aged
Abstract

BackgroundIndividuals may make a rational decision not to engage in healthy behaviours based on their assessment of the benefits of such behaviours to them, compared to other uncontrollable threats to their health. Anticipated survival is one marker of perceived uncontrollable threats to health. We hypothesised that greater anticipated survival: a) is cross-sectionally associated with healthier patterns of behaviours; b) increases the probability that behaviours will be healthier at follow up than at baseline; and c) decreases the probability that behaviours will be 'less healthy' at follow than at baseline.MethodsData from waves 1 and 5 of the English Longitudinal Survey of Ageing provided 8 years of follow up. Perceptions of uncontrollable threats to health at baseline were measured using anticipated survival. Health behaviours considered were self-reported cigarette smoking, physical activity level, and frequency of alcohol consumption. A wide range of socio-economic, demographic, and health variables were adjusted for.ResultsGreater anticipated survival was cross-sectionally associated with lower likelihood of smoking, and higher physical activity levels, but was not associated with alcohol consumption. Lower anticipated survival was associated with decreased probability of adopting healthier patterns of physical activity, and increased probability of becoming a smoker at follow up. There were no associations between anticipated survival and change in alcohol consumption.ConclusionsOur hypotheses were partially confirmed, though associations were inconsistent across behaviours and absent for alcohol consumption. Individual assessments of uncontrollable threats to health may be an important determinant of smoking and physical activity.

Published
2015

43. Development of a multicentre randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people in a high-school setting (SIPS JR-HIGH).

Author

Giles, Emma Louise, Scott, Stephanie, Coulton, Simon, Deluca, Paolo, Drummond, Colin, Graybill, Erin, Howel, Denise, Kaner, Eileen, McColl, Elaine, McGovern, Ruth, Stamp, Elaine, Sumnall, Harry, Tate, Les, Todd, Liz, Newbury-Birch, Dorothy, Giles, Emma Louise, Scott, Stephanie, Coulton, Simon, Deluca, Paolo, Drummond, Colin, Graybill, Erin, Howel, Denise, Kaner, Eileen, McColl, Elaine, McGovern, Ruth, Stamp, Elaine, Sumnall, Harry, Tate, Les, Todd, Liz, and Newbury-Birch, Dorothy

Abstract

Background: Young people are vulnerable to the effects of alcohol consumption. Adverse effects from alcohol manifest in a range of short-term and long-term physical and psychosocial factors, including neurological issues, cognitive impairment, and risk-taking behaviours. The aim of the SIPS JR-HIGH, a multicentre randomised controlled trial (RCT), is to assess the effectiveness and cost-effectiveness of alcohol screening and brief intervention to reduce risky drinking in young people aged 14–15 years in the English high-school setting. Methods: Building on a mixed-method cluster-randomised controlled pilot feasibility trial (Current Controlled Trials, ISRCTN07073105), the proposed sample for the definitive trial, to be conducted from September, 2015, to December, 2017, has been calculated to have 90% power and will follow up 257 young people in each arm at 12-month follow-up (ISRCTN45691494). 20 schools will be recruited (in September, 2015), five of which will be from North East England, North West England, London, and Kent. The RCT will incorporate a control arm of usual school-based practice on alcohol issues and an intervention arm that combines usual care with a 30 min brief intervention delivered by school learning mentors. Individual pupils will be randomised to one of the two arms. The primary outcome will be total alcohol consumed in the past 28 days judged by the 28 day Time Line Follow Back method. Descriptive statistical analysis will be used to report the pupil-level baseline data, with multiple linear regressions being used to compare the primary outcomes between the two arms at 12 months. Findings: The pilot trial guided the development of the manualised intervention, which includes process information and a 30 min personalised interactive worksheet-based session delivered by learning mentors. The pilot suggested that this intervention was acceptable, but an intervention with parental involvement was not found to be feasible, with parents not engaging

Published
2015

45. Development of a multicentre randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people in a high-school setting (SIPS JR-HIGH)

Author

Giles, Emma Louise, primary, Scott, Stephanie, additional, Coulton, Simon, additional, Deluca, Paolo, additional, Drummond, Colin, additional, Graybill, Erin, additional, Howel, Denise, additional, Kaner, Eileen, additional, McColl, Elaine, additional, McGovern, Ruth, additional, Stamp, Elaine, additional, Sumnall, Harry, additional, Tate, Les, additional, Todd, Liz, additional, and Newbury-Birch, Dorothy, additional

Published
2015
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46. A pilot feasibility cluster randomised controlled trial of screening and brief alcohol intervention to prevent hazardous drinking in young people aged 14-15 years in a high school setting (SIPS JR-HIGH)

Author

Newbury-Birch, Dorothy, Scott, Stephanie, O’Donnell, Amy, Coulton, Simon, Howel, Denise, McColl, Elaine, Stamp, Elaine, Graybill, Erin, Gilvarry, Eilish, Laing, Kirsty, McGovern, Ruth, Deluca, Paolo, Drummond, Colin, Harle, Christine, McArdle, Paul, Tate, Les, Kaner, Eileen, Newbury-Birch, Dorothy, Scott, Stephanie, O’Donnell, Amy, Coulton, Simon, Howel, Denise, McColl, Elaine, Stamp, Elaine, Graybill, Erin, Gilvarry, Eilish, Laing, Kirsty, McGovern, Ruth, Deluca, Paolo, Drummond, Colin, Harle, Christine, McArdle, Paul, Tate, Les, and Kaner, Eileen

Abstract

Background: Approximately 33% of 15- to 16-year-olds in England report alcohol intoxication in the past month. This present work builds on the evidence base by focusing on Alcohol Screening and Brief Intervention (ASBI) to reduce hazardous drinking in younger adolescents. Objectives: To explore the feasibility and acceptability of a future definitive cluster randomised controlled trial (cRCT) of ASBI in a school setting to staff, young people and parents; to explore the fidelity of the interventions as delivered by school learning mentors; to estimate the parameters for the design of a definitive cRCT of brief alcohol intervention, including rates of eligibility, consent, participation and retention at 12 months; and to pilot the collection of cost and resource-use data to inform the cost-effectiveness/utility analysis in a definitive trial. Setting: Seven schools across one geographical area in North East England. Methods: Feasibility of trial processes, recruitment and retention and a qualitative evaluation examined facilitators and barriers to the use of ASBI approaches in the school setting in this age group. A three-arm pilot cRCT (with randomisation at the school level) with qualitative evaluation to assess the feasibility of a future definitive cRCT of the effectiveness and cost-effectiveness of ASBI in a school setting, with an integrated qualitative component. The trial ran in parallel with a repeated cross-sectional survey, which facilitated screening for the trial. Participants: Year 10 school pupils (aged 14–15 years). Interventions: Young people who screened positive on a single alcohol screening question, and consented to take part, were randomised to one of three groups: (1) feedback that their drinking habits may be risky and provision of an advice leaflet (control condition, n?=?two schools); (2) feedback as for the control condition plus a 30-minute brief interactive session, which combined structured advice and motivational interviewing techniques

Published
2014

48. A pilot feasibility cluster randomised controlled trial of screening and brief alcohol intervention to prevent hazardous drinking in young people aged 14–15 years in a high school setting (SIPS JR-HIGH)

Author

Newbury-Birch, Dorothy, primary, Scott, Stephanie, additional, O’Donnell, Amy, additional, Coulton, Simon, additional, Howel, Denise, additional, McColl, Elaine, additional, Stamp, Elaine, additional, Graybill, Erin, additional, Gilvarry, Eilish, additional, Laing, Kirsty, additional, McGovern, Ruth, additional, Deluca, Paolo, additional, Drummond, Colin, additional, Harle, Christine, additional, McArdle, Paul, additional, Tate, Les, additional, and Kaner, Eileen, additional

Published
2014
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49. Brief intervention to prevent hazardous drinking in young people aged 14–15 in a high school setting (SIPS JR-HIGH): study protocol for a randomized controlled trial

Author

O'Neill, Stephanie, Coulton, Simon, Deluca, Paolo, Deverill, Mark, Drummond, Colin, Gilvarry, Eilish, Graybill, Erin, Harle, Christine, Howel, Denise, Kaner, Eileen, McArdle, Paul, McColl, Elaine, McGovern, Ruth, Speed, Chris, Stamp, Elaine, Tate, Les, Newbury-Birch, Dorothy, O'Neill, Stephanie, Coulton, Simon, Deluca, Paolo, Deverill, Mark, Drummond, Colin, Gilvarry, Eilish, Graybill, Erin, Harle, Christine, Howel, Denise, Kaner, Eileen, McArdle, Paul, McColl, Elaine, McGovern, Ruth, Speed, Chris, Stamp, Elaine, Tate, Les, and Newbury-Birch, Dorothy

Abstract

Background: Whilst the overall proportion of young people drinking alcohol in the United Kingdom has decreased in recent years, those who do drink appear to drink a larger amount, and more frequently. Early and heavy drinking by younger adolescents is a significant public health problem linked to intellectual impairment, increased risk of injuries, mental health issues, unprotected or regretted sexual experience, violence, and sometimes accidental death, which leads to high social and economic costs. This feasibility pilot trial aims to explore the feasibility of delivering brief alcohol intervention in a school setting with adolescents aged 14 and 15 and to examine the acceptability of study measures to school staff, young people and parents. Methods and design: Seven schools across one geographical area in the North East of England will be recruited. Schools will be randomly allocated to one of three conditions: provision of an advice leaflet (control condition, n= 2 schools); a 30-minute brief interactive session, which combines structured advice and motivational interviewing techniques delivered by the school learning mentor (level 1 condition, n= 2 schools); and a 60-minute session involving family members delivered by the school learning mentor (level 2 condition, n= 3 schools). Participants will be year 10 school pupils (aged 14 and 15) who screen positively on a single alcohol screening question and who consent to take part in the trial. Year 10 pupils in all seven schools will be followed up at 6 and 12 months. Secondary outcome measures include the ten-question Alcohol-Use Disorders Identification Test. The EQ-5D-Y and a modified short service use questionnaire will inform the health and social resource costs for any future economic evaluation. Young people recruited into the trial will also complete a 28-day timeline follow back questionnaire at 12-month follow-up. A qualitative evaluation (with young people, school staff, learning mentors, and parents) w

Published
2012

50. The foodscape:classification and field validation of secondary data sources

Author

Lake, Amelia A., Burgoine, Thomas, Greenhalgh, Fiona, Stamp, Elaine, Tyrrell, Rachel, Lake, Amelia A., Burgoine, Thomas, Greenhalgh, Fiona, Stamp, Elaine, and Tyrrell, Rachel

Abstract

The aims were to; develop a food environment classification tool and to test the acceptability and validity of three secondary sources of food environment data within a defined urban area of Newcastle-Upon-Tyne, using a field validation method. A 21 point (with 77 sub-categories) classification tool was developed. The fieldwork recorded 617 establishments selling food and/or food products. The sensitivity analysis of the secondary sources against fieldwork for the Newcastle City Council data was good (83.6%), while Yell.com and the Yellow Pages were low (51.2% and 50.9%, respectively). To improve the quality of secondary data, multiple sources should be used in order to achieve a realistic picture of the foodscape. (C) 2010 Elsevier Ltd. All rights reserved.

Published
2010

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