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Nonproportional Hazards for Time-to-Event Outcomes in Clinical Trials: JACC Review Topic of the Week.

Gregson J, Sharples L, Stone GW, Burman CF, Öhrn F, Pocock S.

J Am Coll Cardiol. 2019 Oct 22;74(16):2102-2112. doi: 10.1016/j.jacc.2019.08.1034. Review.


Evaluation of the impact of the GRACE risk score on the management and outcome of patients hospitalised with non-ST elevation acute coronary syndrome in the UK: protocol of the UKGRIS cluster-randomised registry-based trial.

Everett CC, Fox KA, Reynolds C, Fernandez C, Sharples L, Stocken DD, Carruthers K, Hemingway H, Yan AT, Goodman SG, Brieger D, Chew DP, Gale CP.

BMJ Open. 2019 Sep 5;9(9):e032165. doi: 10.1136/bmjopen-2019-032165.


A systematic review and meta-analysis estimating the population prevalence of comorbidities in children and adolescents aged 5 to 18 years.

Sharma V, Coleman S, Nixon J, Sharples L, Hamilton-Shield J, Rutter H, Bryant M.

Obes Rev. 2019 Oct;20(10):1341-1349. doi: 10.1111/obr.12904. Epub 2019 Jul 24. Review.


Phthalimide Derivative Shows Anti-angiogenic Activity in a 3D Microfluidic Model and No Teratogenicity in Zebrafish Embryos.

Mercurio A, Sharples L, Corbo F, Franchini C, Vacca A, Catalano A, Carocci A, Kamm RD, Pavesi A, Adriani G.

Front Pharmacol. 2019 Apr 17;10:349. doi: 10.3389/fphar.2019.00349. eCollection 2019.


MesoTRAP: a feasibility study that includes a pilot clinical trial comparing video-assisted thoracoscopic partial pleurectomy decortication with indwelling pleural catheter in patients with trapped lung due to malignant pleural mesothelioma designed to address recruitment and randomisation uncertainties and sample size requirements for a phase III trial.

Matthews C, Freeman C, Sharples LD, Fox-Rushby J, Tod A, Maskell NA, Edwards JG, Coonar AS, Sivasothy P, Hughes V, Rahman NM, Waller DA, Rintoul RC.

BMJ Open Respir Res. 2019 Jan 5;6(1):e000368. doi: 10.1136/bmjresp-2018-000368. eCollection 2019.


Non-parametric frailty Cox models for hierarchical time-to-event data.

Gasperoni F, Ieva F, Paganoni AM, Jackson CH, Sharples L.

Biostatistics. 2018 Dec 26. doi: 10.1093/biostatistics/kxy071. [Epub ahead of print]


Identifying Opportunities to Improve Intimate Partner Violence Screening in a Primary Care System.

Sharples L, Nguyen C, Singh B, Lin S.

Fam Med. 2018 Oct;50(9):702-705. doi: 10.22454/FamMed.2018.311843.


Mini-Stern Trial: A randomized trial comparing mini-sternotomy to full median sternotomy for aortic valve replacement.

Nair SK, Sudarshan CD, Thorpe BS, Singh J, Pillay T, Catarino P, Valchanov K, Codispoti M, Dunning J, Abu-Omar Y, Moorjani N, Matthews C, Freeman CJ, Fox-Rushby JA, Sharples LD.

J Thorac Cardiovasc Surg. 2018 Dec;156(6):2124-2132.e31. doi: 10.1016/j.jtcvs.2018.05.057. Epub 2018 Jun 4.


High drug related mortality rates following prison release: Assessing the acceptance likelihood of a naltrexone injection and related concerns.

Murphy PN, Mohammed F, Wareing M, Cotton A, McNeill J, Irving P, Jones S, Sharples L, Monk R, Elton P.

J Subst Abuse Treat. 2018 Sep;92:91-98. doi: 10.1016/j.jsat.2018.07.002. Epub 2018 Jul 4.


Experiences of Structured Elicitation for Model-Based Cost-Effectiveness Analyses.

Soares MO, Sharples L, Morton A, Claxton K, Bojke L.

Value Health. 2018 Jun;21(6):715-723. doi: 10.1016/j.jval.2018.01.019. Epub 2018 Apr 25. Review.


Alternative tumour necrosis factor inhibitors (TNFi) or abatacept or rituximab following failure of initial TNFi in rheumatoid arthritis: the SWITCH RCT.

Brown S, Everett CC, Naraghi K, Davies C, Dawkins B, Hulme C, McCabe C, Pavitt S, Emery P, Sharples L, Buch MH.

Health Technol Assess. 2018 Jun;22(34):1-280. doi: 10.3310/hta22340.


Does the "Weekend Effect" for Postoperative Mortality Stand Up to Scrutiny? Association for Cardiothoracic Anesthesia and Critical Care Cohort Study of 110,728 Cardiac Surgical Patients.

Papachristofi O, Klein AA, Mackay J, Nashef S, Fletcher NS, Sharples LD; Association for Cardiothoracic Anaesthesia and Critical Care (ACTACC).

J Cardiothorac Vasc Anesth. 2018 Oct;32(5):2178-2186. doi: 10.1053/j.jvca.2018.04.015. Epub 2018 Apr 5.


Amaze: a double-blind, multicentre randomised controlled trial to investigate the clinical effectiveness and cost-effectiveness of adding an ablation device-based maze procedure as an adjunct to routine cardiac surgery for patients with pre-existing atrial fibrillation.

Sharples L, Everett C, Singh J, Mills C, Spyt T, Abu-Omar Y, Fynn S, Thorpe B, Stoneman V, Goddard H, Fox-Rushby J, Nashef S.

Health Technol Assess. 2018 Apr;22(19):1-132. doi: 10.3310/hta22190.


Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation.

Nashef SAM, Fynn S, Abu-Omar Y, Spyt TJ, Mills C, Everett CC, Fox-Rushby J, Singh J, Dalrymple-Hay M, Sudarshan C, Codispoti M, Braidley P, Wells FC, Sharples LD.

Eur J Cardiothorac Surg. 2018 Oct 1;54(4):729-737. doi: 10.1093/ejcts/ezy165.


Effect of rituximab on a salivary gland ultrasound score in primary Sjögren's syndrome: results of the TRACTISS randomised double-blind multicentre substudy.

Fisher BA, Everett CC, Rout J, O'Dwyer JL, Emery P, Pitzalis C, Ng WF, Carr A, Pease CT, Price EJ, Sutcliffe N, Makdissi J, Tappuni AR, Gendi NST, Hall FC, Ruddock SP, Fernandez C, Hulme CT, Davies KA, Edwards CJ, Lanyon PC, Moots RJ, Roussou E, Richards A, Sharples LD, Bombardieri M, Bowman SJ.

Ann Rheum Dis. 2018 Mar;77(3):412-416. doi: 10.1136/annrheumdis-2017-212268. Epub 2017 Dec 23.


Methods for Handling Unobserved Covariates in a Bayesian Update of a Cost-effectiveness Model.

Thorpe B, Carroll O, Sharples L.

Med Decis Making. 2018 Feb;38(2):150-162. doi: 10.1177/0272989X17736780. Epub 2017 Dec 4.


Recovery of Left Atrial Contractile Function After Maze Surgery in Persistent Longstanding Atrial Fibrillation.

Abu-Omar Y, Thorpe BS, Freeman C, Mills C, Stoneman VEA, Gopalan D, Rana B, Spyt TJ, Sharples LD, Nashef SAM.

J Am Coll Cardiol. 2017 Oct 31;70(18):2309-2311. doi: 10.1016/j.jacc.2017.08.073. No abstract available.


Effect of individual patient risk, centre, surgeon and anaesthetist on length of stay in hospital after cardiac surgery: Association of Cardiothoracic Anaesthesia and Critical Care (ACTACC) consecutive cases series study of 10 UK specialist centres.

Papachristofi O, Klein AA, Mackay J, Nashef S, Fletcher N, Sharples LD; Association of Cardiothoracic Anaesthesia and Critical Care (ACTACC).

BMJ Open. 2017 Sep 11;7(9):e016947. doi: 10.1136/bmjopen-2017-016947.


Erratum to: Using Parameter Constraints to Choose State Structures in Cost-Effectiveness Modelling.

Thom H, Jackson C, Welton N, Sharples L.

Pharmacoeconomics. 2017 Sep;35(9):963. doi: 10.1007/s40273-017-0520-6. No abstract available.


The PETRA (Perinatal Emergency Team Response Assessment) Scale: A High-Fidelity Simulation Validation Study.

Balki M, Hoppe D, Monks D, Sharples L, Cooke ME, Tsen L, Windrim R.

J Obstet Gynaecol Can. 2017 Jul;39(7):523-533.e12. doi: 10.1016/j.jogc.2016.12.036.


Multidisciplinary Delphi Development of a Scale to Evaluate Team Function in Obstetric Emergencies: The PETRA Scale.

Balki M, Hoppe D, Monks D, Cooke ME, Sharples L, Windrim R.

J Obstet Gynaecol Can. 2017 Jun;39(6):434-442.e2. doi: 10.1016/j.jogc.2017.01.030.


The INVEST project: investigating the use of evidence synthesis in the design and analysis of clinical trials.

Clayton GL, Smith IL, Higgins JPT, Mihaylova B, Thorpe B, Cicero R, Lokuge K, Forman JR, Tierney JF, White IR, Sharples LD, Jones HE.

Trials. 2017 May 15;18(1):219. doi: 10.1186/s13063-017-1955-y.


Using Parameter Constraints to Choose State Structures in Cost-Effectiveness Modelling.

Thom H, Jackson C, Welton N, Sharples L.

Pharmacoeconomics. 2017 Sep;35(9):951-962. doi: 10.1007/s40273-017-0501-9. Erratum in: Pharmacoeconomics. 2017 Jun 26;:.


Randomized Controlled Trial of Rituximab and Cost-Effectiveness Analysis in Treating Fatigue and Oral Dryness in Primary Sjögren's Syndrome.

Bowman SJ, Everett CC, O'Dwyer JL, Emery P, Pitzalis C, Ng WF, Pease CT, Price EJ, Sutcliffe N, Gendi NST, Hall FC, Ruddock SP, Fernandez C, Reynolds C, Hulme CT, Davies KA, Edwards CJ, Lanyon PC, Moots RJ, Roussou E, Giles IP, Sharples LD, Bombardieri M.

Arthritis Rheumatol. 2017 Jul;69(7):1440-1450. doi: 10.1002/art.40093. Epub 2017 Jun 5.


Evaluation of the effects of multiple providers in complex surgical interventions.

Papachristofi O, Klein A, Sharples L.

Stat Med. 2016 Dec 10;35(28):5222-5246. doi: 10.1002/sim.7057. Epub 2016 Aug 10.


Effect of Care Guided by Cardiovascular Magnetic Resonance, Myocardial Perfusion Scintigraphy, or NICE Guidelines on Subsequent Unnecessary Angiography Rates: The CE-MARC 2 Randomized Clinical Trial.

Greenwood JP, Ripley DP, Berry C, McCann GP, Plein S, Bucciarelli-Ducci C, Dall'Armellina E, Prasad A, Bijsterveld P, Foley JR, Mangion K, Sculpher M, Walker S, Everett CC, Cairns DA, Sharples LD, Brown JM; CE-MARC 2 Investigators.

JAMA. 2016 Sep 13;316(10):1051-60. doi: 10.1001/jama.2016.12680.


Assessment of learning curves in complex surgical interventions: a consecutive case-series study.

Papachristofi O, Jenkins D, Sharples LD.

Trials. 2016 Jun 1;17(1):266. doi: 10.1186/s13063-016-1383-4.


The relationship between three-dimensional knee MRI bone shape and total knee replacement-a case control study: data from the Osteoarthritis Initiative.

Barr AJ, Dube B, Hensor EM, Kingsbury SR, Peat G, Bowes MA, Sharples LD, Conaghan PG.

Rheumatology (Oxford). 2016 Sep;55(9):1585-93. doi: 10.1093/rheumatology/kew191. Epub 2016 May 15.


Sex-related differences in left ventricular remodeling in severe aortic stenosis and reverse remodeling after aortic valve replacement: A cardiovascular magnetic resonance study.

Dobson LE, Fairbairn TA, Musa TA, Uddin A, Mundie CA, Swoboda PP, Ripley DP, McDiarmid AK, Erhayiem B, Garg P, Malkin CJ, Blackman DJ, Sharples LD, Plein S, Greenwood JP.

Am Heart J. 2016 May;175:101-11. doi: 10.1016/j.ahj.2016.02.010. Epub 2016 Feb 23.


The Impact of Anesthesiologists on Coronary Artery Bypass Graft Outcomes.

Mackay JH, Nashef SA, Paprachristofi O, Sharples L.

Anesth Analg. 2016 May;122(5):1719. doi: 10.1213/ANE.0000000000000901. No abstract available.


Anaesthetist contribution to mortality after cardiac surgery - a reply.

Mackay JH, Nashef SA, Klein AA, Papachristofi O, Sharples LD, Fletcher SN; Association of Cardiothoracic Anaesthetists (ACTA).

Anaesthesia. 2016 May;71(5):599-601. doi: 10.1111/anae.13475. No abstract available.


Extrapolating Survival from Randomized Trials Using External Data: A Review of Methods.

Jackson C, Stevens J, Ren S, Latimer N, Bojke L, Manca A, Sharples L.

Med Decis Making. 2017 May;37(4):377-390. doi: 10.1177/0272989X16639900. Epub 2016 Jul 10. Review.


The contribution of the anaesthetist to risk-adjusted mortality after cardiac surgery.

Papachristofi O, Sharples LD, Mackay JH, Nashef SA, Fletcher SN, Klein AA; Association of Cardiothoracic Anaesthetists (ACTA).

Anaesthesia. 2016 Feb;71(2):138-46. doi: 10.1111/anae.13291. Epub 2015 Oct 28.


Response to comments on "Meta-analysis of randomised controlled trials of oral mandibular advancement devices and continuous positive airway pressure for obstructive sleep apnoea-hypopnoea".

Sharples LD, Quinnell TG; TOMADO investigators.

Sleep Med Rev. 2016 Jun;27:41-2. doi: 10.1016/j.smrv.2015.08.001. Epub 2015 Aug 13. No abstract available.


Interventions in randomised controlled trials in surgery: issues to consider during trial design.

Blencowe NS, Brown JM, Cook JA, Metcalfe C, Morton DG, Nicholl J, Sharples LD, Treweek S, Blazeby JM; Members of the MRC Hub for Trials Methodology Research Network Workshop.

Trials. 2015 Sep 4;16:392. doi: 10.1186/s13063-015-0918-4. Review.


Meta-analysis of randomised controlled trials of oral mandibular advancement devices and continuous positive airway pressure for obstructive sleep apnoea-hypopnoea.

Sharples LD, Clutterbuck-James AL, Glover MJ, Bennett MS, Chadwick R, Pittman MA, Quinnell TG.

Sleep Med Rev. 2016 Jun;27:108-24. doi: 10.1016/j.smrv.2015.05.003. Epub 2015 May 30. Review.


The ETTAA study protocol: a UK-wide observational study of 'Effective Treatments for Thoracic Aortic Aneurysm'.

Sastry P, Hughes V, Hayes P, Vallabhaneni S, Sharples L, Thompson M, Catarino P, Moorjani N, Vale L, Gray J, Cook A, Elefteriades JA, Large SR; ETTAA Collaborators.

BMJ Open. 2015 Jun 2;5(6):e008147. doi: 10.1136/bmjopen-2015-008147.


An exploratory cohort study comparing prothrombin complex concentrate and fresh frozen plasma for the treatment of coagulopathy after complex cardiac surgery.

Ortmann E, Besser MW, Sharples LD, Gerrard C, Berman M, Jenkins DP, Klein AA.

Anesth Analg. 2015 Jul;121(1):26-33. doi: 10.1213/ANE.0000000000000689.


Multi-state modelling of repeated hospitalisation and death in patients with heart failure: The use of large administrative databases in clinical epidemiology.

Ieva F, Jackson CH, Sharples LD.

Stat Methods Med Res. 2017 Jun;26(3):1350-1372. doi: 10.1177/0962280215578777. Epub 2015 Mar 26.


Bayesian regression discontinuity designs: incorporating clinical knowledge in the causal analysis of primary care data.

Geneletti S, O'Keeffe AG, Sharples LD, Richardson S, Baio G.

Stat Med. 2015 Jul 10;34(15):2334-52. doi: 10.1002/sim.6486. Epub 2015 Mar 24.


State selection in Markov models for panel data with application to psoriatic arthritis.

Thom HH, Jackson CH, Commenges D, Sharples LD.

Stat Med. 2015 Jul 20;34(16):2456-75. doi: 10.1002/sim.6460. Epub 2015 Mar 5.


The 'Switch' study protocol: a randomised-controlled trial of switching to an alternative tumour-necrosis factor (TNF)-inhibitor drug or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-inhibitor drug.

Navarro Coy NC, Brown S, Bosworth A, Davies CT, Emery P, Everett CC, Fernandez C, Gray JC, Hartley S, Hulme C, Keenan AM, McCabe C, Redmond A, Reynolds C, Scott D, Sharples LD, Pavitt S, Buch MH.

BMC Musculoskelet Disord. 2014 Dec 23;15:452. doi: 10.1186/1471-2474-15-452.


Contemporary roles of registries in clinical cardiology: when do we need randomized trials?

Ieva F, Gale CP, Sharples LD.

Expert Rev Cardiovasc Ther. 2014 Dec;12(12):1383-6. doi: 10.1586/14779072.2015.982096.


Survival extrapolation in the presence of cause specific hazards.

Benaglia T, Jackson CH, Sharples LD.

Stat Med. 2015 Feb 28;34(5):796-811. doi: 10.1002/sim.6375. Epub 2014 Nov 20.


Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea-hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure.

Sharples L, Glover M, Clutterbuck-James A, Bennett M, Jordan J, Chadwick R, Pittman M, East C, Cameron M, Davies M, Oscroft N, Smith I, Morrell M, Fox-Rushby J, Quinnell T.

Health Technol Assess. 2014 Oct;18(67):1-296. doi: 10.3310/hta18670.


Regression discontinuity designs: an approach to the evaluation of treatment efficacy in primary care using observational data.

O'Keeffe AG, Geneletti S, Baio G, Sharples LD, Nazareth I, Petersen I.

BMJ. 2014 Sep 8;349:g5293. doi: 10.1136/bmj.g5293. No abstract available.


A crossover randomised controlled trial of oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea (TOMADO).

Quinnell TG, Bennett M, Jordan J, Clutterbuck-James AL, Davies MG, Smith IE, Oscroft N, Pittman MA, Cameron M, Chadwick R, Morrell MJ, Glover MJ, Fox-Rushby JA, Sharples LD.

Thorax. 2014 Oct;69(10):938-45. doi: 10.1136/thoraxjnl-2014-205464. Epub 2014 Jul 17.


Right ventricular reverse remodeling after pulmonary endarterectomy: magnetic resonance imaging and clinical and right heart catheterization assessment.

Berman M, Gopalan D, Sharples L, Screaton N, Maccan C, Sheares K, Pepke-Zaba J, Dunning J, Tsui S, Jenkins DP.

Pulm Circ. 2014 Mar;4(1):36-44. doi: 10.1086/674884.


Efficacy and cost of video-assisted thoracoscopic partial pleurectomy versus talc pleurodesis in patients with malignant pleural mesothelioma (MesoVATS): an open-label, randomised, controlled trial.

Rintoul RC, Ritchie AJ, Edwards JG, Waller DA, Coonar AS, Bennett M, Lovato E, Hughes V, Fox-Rushby JA, Sharples LD; MesoVATS Collaborators.

Lancet. 2014 Sep 20;384(9948):1118-27. doi: 10.1016/S0140-6736(14)60418-9. Epub 2014 Jun 16.


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