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Pragmatic Clinical Trials Unit

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Our Publications

Many academic staff within the unit publish widely and their full publication list can be accessed via their own webpage. Here we list published reports, protocols and statistical analysis plans for the studies the PCTU has formally collaborated in.  Methodological publications can be found on our methodological publications pages. 

  • Anokye N, Fox-Rushby J, Sanghera S, Cook DG, Limb E, Furness C, Kerry SM, Victor CR, Iliffe S, Ussher M, Whincup PH, Ekelund U, deWilde S, Harris T. Short-term and long-term cost-effectiveness of a pedometer-based exercise intervention in primary care: a within-trial analysis and beyond-trial modelling. BMJ Open 2018;8:e021978. https://doi.org/10.1136/bmjopen-2018-021978 
  • Flanagan S, Kunkel J, Appleby V, Eldridge SE, Ismail S, Moreea S, Griffiths C, Walton R, Pitt M, Salmon A, Madurasinghe V, Barnes E, Simms E, Agarwal K, Foster GR. Case finding and therapy for chronic viral hepatitis in primary care (HepFREE): a cluster-randomised controlled trial. Lancet Gastroenterol Hepatol 2018; https://doi.org/10.1016/S2468-1253(18)30318-2  
  • Barbosa EC, Verhoef TI, Morris S, Solmi F, Johnson M, Sohal A, El-Shogri F, Dowrick S, Ronalds C, Griffiths C, Eldridge S, Lewis NV, Devine A, Spencer A, Feder G. Cost-effectiveness of a domestic violence and abuse training and support programme in primary care in the real world: updated modelling based on an MRC phase IV observational pragmatic implementation study. BMJ Open 2018;8:e021256. https://doi.org/10.1136/bmjopen-2017-021256 
  • Furness C, Howard E, Limb E, Cook DG, Kerry S, Wahlich C, Victor C, Ekelund U, Iliffe S, Ussher M, Whincup P, Fox-Rushby J, Ibison J, DeWilde S, Harris T. Relating process evaluation measures to complex intervention outcomes: findings from the PACE-UP primary care pedometer-based walking trial. Trials 2018;19:58. https://doi.org/10.1186/s13063-017-2428-z
  • Harris T, Kerry SM, Limb ES, Furness C, Wahlich C, Victor CR, Iliffe S, Whincup PH, Ussher M, Ekelund U, Fox-Rushby J, Ibison J, DeWilde S, McKay C, Cook DG. Physical activity levels in adults and older adults 3-4 years after pedometer-based walking interventions: Long-term follow-up of participants from two randomised controlled trials in UK primary care. PLoS Med 2018;15:e1002526. https://doi.org/10.1371/journal.pmed.1002526
  • Kerry SM, Morgan KE, Limb E, Cook DG, Furness C, Carey I, DeWilde S, Victor CR, Iliffe S, Whincup P, Ussher M, Ekelund U, Fox-Rushby J, Ibison J, Harris T. Interpreting population reach of a large, successful physical activity trial delivered through primary care. BMC Public Health 2018;18:170. https://doi.org/10.1186/s12889-018-5034-4
  • Khan KS, Moore P, Wilson M, Hooper R, Allard S, Wrench I, Roberts T, McLoughlin C, Beresford L, Geoghegan J, Daniels J, Catling S, Clark VA, Ayuk P, Robson S, Gao-Smith F, Hogg M, Jackson L, Lanz D, Dodds J. A randomised controlled trial and economic evaluation of intraoperative cell salvage during caesarean section in women at risk of haemorrhage: the SALVO (cell SALVage in Obstetrics) trial. Health Technol Assess 2018;22:1-88. https://doi.org/10.3310/hta22020
  • McAlees E, Vollebregt PF, Stevens N, Dudding TC, Emmanuel AV, Furlong PL, Hamdy S, Hooper RL, Jones JFX, Norton C, O'Connell PR, Scott SM, Knowles CH. Efficacy and mechanism of sub-sensory sacral (optimised) neuromodulation in adults with faecal incontinence: study protocol for a randomised controlled trial. Trials 2018;19:336. https://doi.org/10.1186/s13063-018-2689-1
  • Sawtell M, Sweeney L, Wiggins M, Salisbury C, Eldridge S, Greenberg L, Hunter R, Kaur I, McCourt C, Hatherall B, Findlay G, Morris J, Reading S, Renton A, Adekoya R, Green B, Harvey B, Latham S, Patel K, Vanlessen L, Harden A. Evaluation of community-level interventions to increase early initiation of antenatal care in pregnancy: protocol for the Community REACH study, a cluster randomised controlled trial with integrated process and economic evaluations. Trials 2018;19:163. https://doi.org/10.1186/s13063-018-2526-6
  • Sohal AH, Feder G, Barbosa E, Beresford L, Dowrick A, El-Shogri F, Howell A, Lewis N, Johnson M, Nightingale C, Boomla K, Morris S, Eldridge S, Griffiths C. Improving the healthcare response to domestic violence and abuse in primary care: protocol for a mixed method evaluation of the implementation of a complex intervention. BMC Public Health 2018;18:971. https://doi.org/10.1186/s12889-018-5865-z
  • Thangaratinam S, Marlin N, Newton S, Weckesser A, Bagary M, Greenhill L, Rikunenko R, D'Amico M, Rogozinska E, Kelso A, Hard K, Coleman J, Moss N, Roberts T, Middleton L, Dodds J, Pullen A, Eldridge S, Pirie A, Denny E, McCorry D, Khan KS. AntiEpileptic drug Monitoring in PREgnancy (EMPiRE): a double-blind randomised trial on effectiveness and acceptability of monitoring strategies. Health Technol Assess 2018;22:1-152. https://doi.org/10.3310/hta22230
  • Allotey J, Snell KIE, Chan C, Hooper R, Dodd J, Rogozinska E, Khan KS, Poston L, Kenny L, Myers J, Thilaganathan B, Chapell L, Mol BW, Von Dadelszen P, Ahmed A, Green M, Poon L, Khalil A, Moons KGM, Riley RD, Thangaratinam S. External validation, update and development of prediction models for preeclampsia using an Individual Participant Data (IPD) meta-analysis: the International Prediction of Pregnancy Complication Network (IPPIC pre-eclampsia) protocol. Diagn Progn Res 2017;1:16.
  • Bell L, Hooper R, Bunce C, Pasu S, Bainbridge J. Positioning In Macular hole Surgery (PIMS): statistical analysis plan for a randomised controlled trial. Trials 2017;18:274. https://doi.org/10.1186/s13063-017-2020-6
  • Duncan M, Deane J, White PD, Ridge D, Roylance R, Korszun A, Chalder T, Bhui KS, Thaha MA, Bourke L. A survey to determine usual care after cancer treatment within the United Kingdom national health service. BMC Cancer 2017;17:186. https://doi.org/10.1186/s12885-017-3172-1
  • Emmett C, Close H, Mason J, Taheri S, Stevens N, Eldridge S, Norton C, Knowles C, Yiannakou Y. Low-volume versus high-volume initiated trans-anal irrigation therapy in adults with chronic constipation: study protocol for a randomised controlled trial. Trials 2017;18:151. https://doi.org/10.1186/s13063-017-1882-y
  • Harris T, Kerry SM, Limb ES, Victor CR, Iliffe S, Ussher M, Whincup PH, Ekelund U, Fox-Rushby J, Furness C, Anokye N, Ibison J, DeWilde S, David L, Howard E, Dale R, Smith J, Cook DG. Effect of a Primary Care Walking Intervention with and without Nurse Support on Physical Activity Levels in 45- to 75-Year-Olds: The Pedometer And Consultation Evaluation (PACE-UP) Cluster Randomised Clinical Trial. PLoS Med 2017;14:e1002210. https://doi.org/10.1371/journal.pmed.1002210
  • Jolliffe DA, Greenberg L, Hooper RL, Griffiths CJ, Camargo CA, Jr., Kerley CP, Jensen ME, Mauger D, Stelmach I, Urashima M, Martineau AR. Vitamin D supplementation to prevent asthma exacerbations: a systematic review and meta-analysis of individual participant data. Lancet Respir Med 2017;5:881-890. https://doi.org/10.1016/S2213-2600(17)30306-5
  • Khan KS, Moore PAS, Wilson MJ, Hooper R, Allard S, Wrench I, Beresford L, Roberts TE, McLoughlin C, Geoghegan J, Daniels JP, Catling S, Clark VA, Ayuk P, Robson S, Gao-Smith F, Hogg M, Lanz D, Dodds J, group Ss. Cell salvage and donor blood transfusion during cesarean section: A pragmatic, multicentre randomised controlled trial (SALVO). PLoS Med 2017;14:e1002471. https://doi.org/10.1371/journal.pmed.1002471
  • Madurasinghe VW, Sohanpal R, James W, Steed L, Eldridge S, Taylor S, Griffiths C, Walton R. Smoking treatment optimisation in pharmacies (STOP): a cluster randomised pilot trial of a training intervention. Pilot Feasibility Stud 2017;3:1. https://doi.org/10.1186/s40814-016-0120-9
  • Martineau AR, Jolliffe DA, Hooper RL, Greenberg L, Aloia JF, Bergman P, Dubnov-Raz G, Esposito S, Ganmaa D, Ginde AA, Goodall EC, Grant CC, Griffiths CJ, Janssens W, Laaksi I, Manaseki-Holland S, Mauger D, Murdoch DR, Neale R, Rees JR, Simpson S, Jr., Stelmach I, Kumar GT, Urashima M, Camargo CA, Jr. Vitamin D supplementation to prevent acute respiratory tract infections: systematic review and meta-analysis of individual participant data. BMJ 2017;356:i6583. https://doi.org/10.1136/bmj.i6583
  • Norton C, Emmanuel A, Stevens N, Scott SM, Grossi U, Bannister S, Eldridge S, Mason JM, Knowles CH. Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: study protocol for a randomised controlled trial. Trials 2017;18:139. https://doi.org/10.1186/s13063-017-1880-0
  • Priebe S, Golden E, Kingdon D, Omer S, Walsh S, Katevas K, McCrone P, Eldridge S, McCabe R. Effective patient-clinician interaction to improve treatment outcomes for patients with psychosis: a mixed-methods design. Programme Grants for Applied Research 2017;5:6. https://doi.org/10.3310/pgfar05060
  • Rivas C, Sohanpal R, MacNeill V, Steed L, Edwards E, Antao L, Griffiths C, Eldridge S, Taylor S, Walton R. Determining counselling communication strategies associated with successful quits in the National Health Service community pharmacy Stop Smoking programme in East London: a focused ethnography using recorded consultations. BMJ Open 2017;7:e015664. https://doi.org/10.1136/bmjopen-2016-015664
  • Robson J, Dostal I, Madurasinghe V, Sheikh A, Hull S, Boomla K, Griffiths C, Eldridge S. NHS Health Check comorbidity and management: an observational matched study in primary care. Br J Gen Pract 2017;67:e86-e93. https://doi.org/10.3399/bjgp16X688837
  • Rogozinska E, Marlin N, Betran AP, Astrup A, Bogaerts A, Cecatti JG, Devlieger R, Dodd JM, El Beltagy N, Facchinetti F, Geiker NRW, Guelfi KJ, Haakstad LAH, Harrison CL, Hauner H, Jensen DM, Kinnunen TI, Khoury J, Luoto R, McAuliffe F, Motahari N, Morkved S, Owens J, Perales M, Petrella E, Phelan S, Poston L, Rauh K, Renault KM, Sagedal LR, Salvesen KA, Shen GX, Shub A, Scudeller T, Surita FG, Stafne SN, Teede H, Tonstad S, van Poppel MNM, Vinter CA, Vistad I, Yeo S, Dodds J, Kerry S, Jackson L, Barton P, Molyneaux E, Martin AA, Rayanagoudar G, Ruifrok AE, Roberts T, de Groot CJM, Coomarasamy A, Mol BWJ, Zamora J, Khan KS, Riley RD, Thangaratinam S. Effect of diet and physical activity based interventions in pregnancy on gestational weight gain and pregnancy outcomes: meta-analysis of individual participant data from randomised trials The International Weight Management in Pregnancy (i-WIP) Collaborative Group. BMJ 2017;358: https://doi.org/10.1136/bmj.j3119
  • Rogozinska E, Marlin N, Jackson L, Rayanagoudar G, Ruifrok AE, Dodds J, Molyneaux E, van Poppel MN, Poston L, Vinter CA, McAuliffe F, Dodd JM, Owens J, Barakat R, Perales M, Cecatti JG, Surita F, Yeo S, Bogaerts A, Devlieger R, Teede H, Harrison C, Haakstad L, Shen GX, Shub A, Beltagy NE, Motahari N, Khoury J, Tonstad S, Luoto R, Kinnunen TI, Guelfi K, Facchinetti F, Petrella E, Phelan S, Scudeller TT, Rauh K, Hauner H, Renault K, de Groot CJ, Sagedal LR, Vistad I, Stafne SN, Morkved S, Salvesen KA, Jensen DM, Vitolo M, Astrup A, Geiker NR, Kerry S, Barton P, Roberts T, Riley RD, Coomarasamy A, Mol BW, Khan KS, Thangaratinam S. Effects of antenatal diet and physical activity on maternal and fetal outcomes: individual patient data meta-analysis and health economic evaluation. Health Technol Assess 2017;21:1-158. https://doi.org/10.3310/hta21410
  • Steed L, Sohanpal R, James WY, Rivas C, Jumbe S, Chater A, Todd A, Edwards E, Macneil V, Macfarlane F, Greenhalgh T, Griffiths C, Eldridge S, Taylor S, Walton R. Equipping community pharmacy workers as agents for health behaviour change: developing and testing a theory-based smoking cessation intervention. BMJ Open 2017;7:e015637. https://doi.org/10.1136/bmjopen-2016-015637
  • Thangaratinam S, Allotey J, Marlin N, Dodds J, Cheong-See F, von Dadelszen P, Ganzevoort W, Akkermans J, Kerry S, Mol BW, Moons KG, Riley RD, Khan KS. Prediction of complications in early-onset pre-eclampsia (PREP): development and external multinational validation of prognostic models. BMC Med 2017;15:68. https://doi.org/10.1186/s12916-017-0827-3
  • Thangaratinam S, Allotey J, Marlin N, Mol BW, Von Dadelszen P, Ganzevoort W, Akkermans J, Ahmed A, Daniels J, Deeks J, Ismail K, Barnard AM, Dodds J, Kerry S, Moons C, Riley RD, Khan KS. Development and validation of Prediction models for Risks of complications in Early-onset Pre-eclampsia (PREP): a prospective cohort study. Health Technol Assess 2017;21:1-100. https://doi.org/10.3310/hta21180
  • Waugh J, Hooper R, Lamb E, Robson S, Shennan A, Milne F, Price C, Thangaratinam S, Berdunov V, Bingham J. Spot protein-creatinine ratio and spot albumin-creatinine ratio in the assessment of pre-eclampsia: a diagnostic accuracy study with decision-analytic model-based economic evaluation and acceptability analysis. Health Technol Assess 2017;21:1-90. https://doi.org/10.3310/hta21610
  • Gregory A, Ramsay J, Agnew-Davies R, Baird K, Devine A, Dunne D, Eldridge S, Howell A, Johnson M, Rutterford C, Sharp D, Feder G. Primary care identification and referral to improve safety of women experiencing domestic violence (IRIS): protocol for a pragmatic cluster randomised controlled trial. BMC Public Health 2010;10:54. https://doi.org/10.1186/1471-2458-10-54
  • Martineau AR, Nanzer AM, Satkunam KR, Packe GE, Rainbow SJ, Maunsell ZJ, Timms PM, Venton TR, Eldridge SM, Davidson RN, Wilkinson RJ, Griffiths CJ. Influence of a single oral dose of vitamin D(2) on serum 25-hydroxyvitamin D concentrations in tuberculosis patients. Int J Tuberc Lung Dis 2009;13:119-25.

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