Imperial College London

DrVictoriaCornelius

Faculty of MedicineSchool of Public Health

Senior Lecturer in Clinical Trial Statistics
 
 
 
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Contact

 

+44 (0)20 7594 1218v.cornelius

 
 
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Location

 

111Stadium HouseWhite City Campus

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Summary

 

Publications

Publication Type
Year
to

82 results found

Cornelius VR, McDermott L, Forster AS, Ashworth M, Wright AJ, Gulliford MCet al., 2018, Automated recruitment and randomisation for an efficient randomised controlled trial in primary care., Trials, Vol: 19

BACKGROUND/AIMS: Use of electronic health records and information technology to deliver more efficient clinical trials is attracting the attention of research funders and researchers. We report on methodological issues and data quality for a comparison of 'automated' and manual (or 'in-practice') methods for recruitment and randomisation in a large randomised controlled trial, with individual patient allocation in primary care. METHODS: We conducted a three-arm randomised controlled trial in primary care to evaluate interventions to improve the uptake of invited NHS health checks for cardiovascular risk assessment. Eligible participants were identified using a borough-wide health check management information system. An in-practice recruitment and randomisation method used at 12 general practices required the research team to complete monthly visits to each general practice. For the fully automated method, employed for six general practices, randomisation of eligible participants was performed automatically and remotely using a bespoke algorithm embedded in the health check management information system. RESULTS: There were 8588 and 4093 participants recruited for the manual and automated methods, respectively. The in-practice method was ready for implementation 3 months sooner than the automated method and the in-practice method allowed for full control and documentation of the randomisation procedure. However the in-practice approach was labour intensive and the requirement for participant records to be stored locally resulted in the loss of data for 10 practice months. No records for participants allocated using the automated method were lost. A fixed-effects meta-analysis showed that effect estimates for the primary outcome were consistent for the two allocation methods. CONCLUSIONS: This trial demonstrated the feasibility of automated recruitment and randomisation methods into a randomised controlled trial performed in primary care. Future research should explor

JOURNAL ARTICLE

Cro S, Mehta S, Farhadi J, Coomber B, Cornelius Vet al., 2018, Measuring skin necrosis in a randomised controlled feasibility trial of heat preconditioning on wound healing after reconstructive breast surgery: study protocol and statistical analysis plan for the PREHEAT trial., Pilot Feasibility Stud, Vol: 4, ISSN: 2055-5784

Background: Essential strategies are needed to help reduce the number of post-operative complications and associated costs for breast cancer patients undergoing reconstructive breast surgery. Evidence suggests that local heat preconditioning could help improve the provision of this procedure by reducing skin necrosis. Before testing the effectiveness of heat preconditioning in a definitive randomised controlled trial (RCT), we must first establish the best way to measure skin necrosis and estimate the event rate using this definition. Methods: PREHEAT is a single-blind randomised controlled feasibility trial comparing local heat preconditioning, using a hot water bottle, against standard care on skin necrosis among breast cancer patients undergoing reconstructive breast surgery. The primary objective of this study is to determine the best way to measure skin necrosis and to estimate the event rate using this definition in each trial arm. Secondary feasibility objectives include estimating recruitment and 30 day follow-up retention rates, levels of compliance with the heating protocol, length of stay in hospital and the rates of surgical versus conservative management of skin necrosis. The information from these objectives will inform the design of a larger definitive effectiveness and cost-effectiveness RCT. Discussion: This article describes the PREHEAT trial protocol and detailed statistical analysis plan, which includes the pre-specified criteria and process for establishing the best way to measure necrosis. This study will provide the evidence needed to establish the best way to measure skin necrosis, to use as the primary outcome in a future RCT to definitively test the effectiveness of local heat preconditioning. The pre-specified statistical analysis plan, developed prior to unblinded data extraction, sets out the analysis strategy and a comparative framework to support a committee evaluation of skin necrosis measurements. It will increase the transparen

JOURNAL ARTICLE

Harris J, Armes J, Ream E, Purssell E, Cornelius Vet al., 2018, Lesson learnt in developing predictive risk models in psychosocial-oncology: from evidence to implementation, Publisher: WILEY, Pages: 14-14, ISSN: 1057-9249

CONFERENCE PAPER

Harris J, Cornelius V, Purssell E, Ream E, Armes Jet al., 2018, A systematic review to identify risk factors for anxiety after treatment for non-metastatic breast cancer and evaluate multivariate model development, Publisher: WILEY, Pages: 13-13, ISSN: 1057-9249

CONFERENCE PAPER

McDermott L, Cornelius V, Wright AJ, Burgess C, Forster AS, Ashworth M, Khoshaba B, Clery P, Fuller F, Miller J, Dodhia H, Rudisill C, Conner MT, Gulliford MCet al., 2018, Enhanced Invitations Using the Question-Behavior Effect and Financial Incentives to Promote Health Check Uptake in Primary Care., Ann Behav Med, Vol: 52, Pages: 594-605

Background: Uptake of health checks for cardiovascular risk assessment in primary care in England is lower than anticipated. The question-behavior effect (QBE) may offer a simple, scalable intervention to increase health check uptake. Purpose: The present study aimed to evaluate the effectiveness of enhanced invitation methods employing the QBE, with or without a financial incentive to return the questionnaire, at increasing uptake of health checks. Methods: We conducted a three-arm randomized trial including all patients at 18 general practices in two London boroughs, who were invited for health checks from July 2013 to December 2014. Participants were randomized to three trial arms: (i) Standard health check invitation letter only; (ii) QBE questionnaire followed by standard invitation letter; or (iii) QBE questionnaire with offer of a financial incentive to return the questionnaire, followed by standard invitation letter. In intention to treat analysis, the primary outcome of completion of health check within 6 months of invitation, was evaluated using a p value of .0167 for significance. Results: 12,459 participants were randomized. Health check uptake was evaluated for 12,052 (97%) with outcome data collected. Health check uptake within 6 months of invitation was: standard invitation, 590 / 4,095 (14.41%); QBE questionnaire, 630 / 3,988 (15.80%); QBE questionnaire and financial incentive, 629 / 3,969 (15.85%). Difference following QBE questionnaire, 1.43% (95% confidence interval -0.12 to 2.97%, p = .070); following QBE questionnaire and financial incentive, 1.52% (-0.03 to 3.07%, p = .054). Conclusions: Uptake of health checks following a standard invitation was low and not significantly increased through enhanced invitation methods using the QBE.

JOURNAL ARTICLE

Sayar Z, Abrams ST, Alsabani M, Czuprynska J, Benjamin R, Patel JP, Roberts LN, Patel RK, Cornelius V, Arya R, Toh CHet al., 2018, Neutrophil Extracellular Traps (NETs) formation in Patients newly diagnosed with Myeloma: Findings from the Thromboprophylaxis in Multiple Myeloma (TiMM) Study, 58th Annual Scientific Meeting of the British-Society-for-Haematology, Publisher: WILEY, Pages: 140-141, ISSN: 0007-1048

CONFERENCE PAPER

Sayar Z, Czuprynska J, Patel JP, Benjamin R, Roberts LN, Patel RK, Cornelius V, Arya Ret al., 2018, Patient Perspectives of Thromboprophylaxis in Multiple Myeloma: Results from the Thromboprophylaxis in Multiple Myeloma (TiMM) study, 9th International Conference on Thrombosis and Hemostasis Issues in Cancer (ICTHIC), Publisher: PERGAMON-ELSEVIER SCIENCE LTD, Pages: S189-S190, ISSN: 0049-3848

CONFERENCE PAPER

Selby A, Munro A, Grimshaw KE, Cornelius V, Keil T, Grabenhenrich L, Clausen M, Dubakiene R, Fiocchi A, Kowalski ML, Papadopoulos NG, Reche M, Sigurdardottir ST, Sprikkelman AB, Xepapadaki P, Mills ENC, Beyer K, Roberts Get al., 2018, Prevalence estimates and risk factors for early childhood wheeze across Europe: the EuroPrevall birth cohort., Thorax

BACKGROUND: Preschool wheeze is an important problem worldwide. No comparative population-based studies covering different countries have previously been undertaken. OBJECTIVE: To assess the prevalence of early childhood wheeze across Europe and evaluate risk factors focusing on food allergy, breast feeding and smoke exposure. METHODS: Infants from nine countries were recruited into the EuroPrevall birth cohort. At 12 and 24 months, data on wheeze, allergic signs/symptoms, feeding, smoke exposure, infections and day care attendance were collected using questionnaires. Poisson regression was used to assess risk factors for wheeze. RESULTS: 12 049 infants were recruited. Data from the second year of life were available in 8805 (73.1%). The prevalence of wheeze in the second year of life ranged from <2% in Lodz (Poland) and Vilnius (Lithuania) to 13.1% (95% CI 10.7% to 15.5%) in Southampton (UK) and 17.2% (95% CI 15.0% 19.5%) in Reykjavik (Iceland). In multivariable analysis, frequent lower respiratory tract infections in the first and second years of life (incidence rate ratio (IRR) 1.9 (95% CI 1.3 to 2.6) and 2.5 (95% CI 1.9 to3.4), respectively), postnatal maternal smoking (IRR 1.6, 95% CI 1.1 to 2.4), day care attendance (IRR 1.6, 95% CI 1.1 to 2.5) and male gender (IRR 1.3, 95% CI 1.0 to 1.7) were associated with wheeze. The strength of their association with wheeze differed between countries. Food allergy and breast feeding were not independently associated with wheeze. CONCLUSION: The prevalence of early childhood wheeze varied considerably across Europe. Lower respiratory tract infections, day care attendance, postnatal smoke exposure and male gender are important risk factors. Further research is needed to identify additional modifiable risk factors that may differ between countries.

JOURNAL ARTICLE

Sin J, Henderson C, Spain D, Cornelius V, Chen T, Gillard Set al., 2018, eHealth interventions for family carers of people with long term illness: A promising approach?, CLINICAL PSYCHOLOGY REVIEW, Vol: 60, Pages: 109-125, ISSN: 0272-7358

JOURNAL ARTICLE

Bourne S, DeVos R, North M, Chauhan A, Ben G, Brown T, Cornelius V, Wilkinson Tet al., 2017, Online versus face-to-face pulmonary rehabilitation for patients with chronic obstructive pulmonary disease: randomised controlled trial, BMJ OPEN, Vol: 7, ISSN: 2044-6055

JOURNAL ARTICLE

Chan S, Cornelius V, Chen T, Radulovic S, Wan M, Jahan R, Lack Get al., 2017, Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT): the role of anti-IgE in severe paediatric eczema: study protocol for a randomised controlled trial, TRIALS, Vol: 18, ISSN: 1745-6215

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Chen T, Qin R, Wang D, Cornelius Vet al., 2017, Influence of primary outcome change on treatment effect estimates in clinical trials: meta-epidemiological study, Publisher: BIOMED CENTRAL LTD, ISSN: 1745-6215

CONFERENCE PAPER

Craythorne E, Damato E, Pavel M, Cornelius V, Coleman A, Meys R, Mallipeddi Ret al., 2017, Prospective study comparing the use of ex vivo fluorescence confocal microscopy and traditional frozen-section pathology in Mohs micrographic surgery of basal cell carcinoma, 97th Annual Meeting of the British-Association-of-Dermatologists, Publisher: WILEY, Pages: 109-109, ISSN: 0007-0963

CONFERENCE PAPER

Forster AS, Cornelius V, Rockliffe L, Marlow LAV, Bedford H, Waller Jet al., 2017, A protocol for a cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination among girls., Pilot Feasibility Stud, Vol: 3, ISSN: 2055-5784

BACKGROUND: Uptake of the human papillomavirus (HPV) vaccine in the UK is good, but there are pockets of the community who remain unprotected. Immunisation teams usually require written parental consent for a girl to receive the vaccine. Evidence suggests that uptake of the vaccine might be improved by promoting consent form return (if returned, forms are likely to grant consent). Incentivising girls to return consent forms is a promising approach to promoting consent form return. Before testing the efficacy of an incentive intervention in a randomised controlled trial (RCT), we must first establish whether the RCT is feasible. In this randomised feasibility study, we aim to establish the feasibility of conducting a cluster RCT of an adolescent incentive intervention to increase uptake of HPV vaccination. METHODS: At least six schools will be randomised to either an incentive intervention arm or a standard invitation arm. Girls in standard invitation arm schools will receive the usual HPV vaccine programme invitation materials. Girls attending schools in the incentive intervention arm will receive the standard invitation and will also be told that they will receive an incentive if they return their consent form (regardless of whether consent is granted or denied). The incentive is being entered into a prize draw to win a retail voucher. Feasibility objectives include estimating the schools' and parents' willingness to participate in the study and be randomised; response rates to questionnaires; the extent of missing data; the girls' and parents' attitudes towards the incentive offered; school staff experiences of participating, fidelity to the trial procedures, data on any unintended consequences and the possible mechanisms of action, and proof-of-concept evidence of the effect of the intervention on consent form return rates and uptake of the vaccine. Analysis of feasibility outcomes will primarily be descriptive. Consent form return rates and uptake of the vaccine

JOURNAL ARTICLE

Forster AS, Cornelius V, Rockliffe L, Marlow LAV, Bedford H, Waller Jet al., 2017, A cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination, BRITISH JOURNAL OF CANCER, Vol: 117, Pages: 1121-1127, ISSN: 0007-0920

JOURNAL ARTICLE

Harris J, Cornelius V, Ream E, Cheevers K, Armes Jet al., 2017, Anxiety after completion of treatment for early-stage breast cancer: a systematic review to identify candidate predictors and evaluate multivariable model development, SUPPORTIVE CARE IN CANCER, Vol: 25, Pages: 2321-2333, ISSN: 0941-4355

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Howlin RP, Cathie K, Hall-Stoodley L, Cornelius V, Duignan C, Allan RN, Fernandez BO, Barraud N, Bruce KD, Jefferies J, Kelso M, Kjelleberg S, Rice SA, Rogers GB, Pink S, Smith C, Sukhtankar PS, Salib R, Legg J, Carroll M, Daniels T, Feelisch M, Stoodley P, Clarke SC, Connett G, Faust SN, Webb JSet al., 2017, Low-Dose Nitric Oxide as Targeted Anti-biofilm Adjunctive Therapy to Treat Chronic Pseudomonas aeruginosa Infection in Cystic Fibrosis, MOLECULAR THERAPY, Vol: 25, Pages: 2104-2116, ISSN: 1525-0016

JOURNAL ARTICLE

Liu X, Cornelius VR, 2017, Bayesian predictive probability design in single-arm cancer phase II trials: is it superior to frequentist design?, Publisher: BIOMED CENTRAL LTD, ISSN: 1745-6215

CONFERENCE PAPER

Love SB, Brown S, Weir CJ, Harbron C, Yap C, Gaschler-Markefski B, Matcham J, Caffrey L, McKevitt C, Clive S, Craddock C, Spicer J, Cornelius Vet al., 2017, Embracing model-based designs for dose-finding trials, BRITISH JOURNAL OF CANCER, Vol: 117, Pages: 332-339, ISSN: 0007-0920

JOURNAL ARTICLE

O'Hagan M, Cornelius V, Young AH, Taylor Det al., 2017, Predictors of rehospitalization in a naturalistic cohort of patients with bipolar affective disorder, INTERNATIONAL CLINICAL PSYCHOPHARMACOLOGY, Vol: 32, Pages: 115-120, ISSN: 0268-1315

JOURNAL ARTICLE

Phillips R, Cornelius V, 2017, Lessons to learn from the reporting of adverse events (AEs) in randomised controlled trials published in high impact journals, Publisher: BIOMED CENTRAL LTD, ISSN: 1745-6215

CONFERENCE PAPER

Phillips R, Cornelius V, 2017, Overview of statistical methods to monitor harms during the conduct of a randomised controlled trial, Publisher: BIOMED CENTRAL LTD, ISSN: 1745-6215

CONFERENCE PAPER

Sin J, Gillard S, Spain D, Cornelius V, Chen T, Henderson Cet al., 2017, Effectiveness of psychoeducational interventions for family carers of people with psychosis: A systematic review and meta-analysis, CLINICAL PSYCHOLOGY REVIEW, Vol: 56, Pages: 13-24, ISSN: 0272-7358

JOURNAL ARTICLE

Tao C, Yu D, Cornelius V, Rui Q, Cai Y, Jiang Z, Zhao Zet al., 2017, Potential health impact and cost-effectiveness of drug therapy for prehypertension, INTERNATIONAL JOURNAL OF CARDIOLOGY, Vol: 240, Pages: 403-408, ISSN: 0167-5273

JOURNAL ARTICLE

Wilkinson T, Bourne S, DeVos R, North M, Chauhan A, Green B, Brown T, Cornelius Vet al., 2017, Online Versus Face To Face Pulmonary Rehabilitation For Patients With COPD: A Randomised Controlled Trial, AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, Vol: 195, ISSN: 1073-449X

JOURNAL ARTICLE

Carvajal A, Martin Arias LH, Sainz M, Escudero A, Fierro I, Sauzet O, Cornelius VR, Molokhia Met al., 2016, Carpal Tunnel Syndrome Associated with Oral Bisphosphonates. A Population-Based Cohort Study, PLOS ONE, Vol: 11, ISSN: 1932-6203

JOURNAL ARTICLE

Hallward G, Balani N, McCorkell S, Roxburgh J, Cornelius Vet al., 2016, The Relationship Between Preoperative Hemoglobin Concentration, Use of Hospital Resources, and Outcomes in Cardiac Surgery., J Cardiothorac Vasc Anesth, Vol: 30, Pages: 901-908

OBJECTIVES: Preoperative anemia is an established risk factor associated with adverse perioperative outcomes after cardiac surgery. However, limited information exists regarding the relationship between preoperative hemoglobin concentration and outcomes. The aim of this study was to investigate how outcomes are affected by preoperative hemoglobin concentration in a cohort of patients undergoing cardiac surgery. DESIGN: A retrospective, observational cohort study. SETTING: A single-center tertiary referral hospital. PARTICIPANTS: The study comprised 1,972 adult patients undergoing elective and nonelective cardiac surgery. INTERVENTIONS: The independent relationship of preoperative hemoglobin concentration was explored on blood transfusion rates, return to the operating room for bleeding and/or cardiac tamponade, postoperative intensive care unit (ICU) and in-hospital length of stay, and mortality. MEASUREMENTS AND MAIN RESULTS: The overall prevalence of anemia was 32% (629/1,972 patients). For every 1-unit increase in hemoglobin (g/dL), blood transfusion requirements were reduced by 11%, 8%, and 3% for red blood cell units, platelet pools, and fresh frozen plasma units, respectively (adjusted incident rate ratio 0.89 [95% CI 0.87-0.91], 0.92 [0.88-0.97], and 0.97 [0.96-0.99]). For each 1-unit increase in hemoglobin (g/dL), the probability (over time) of discharge from the ICU and hospital increased (adjusted hazard ratio estimates 1.04 [1.00-1.08] and 1.12 [1.12-1.16], respectively). CONCLUSIONS: A lower preoperative hemoglobin concentration resulted in increased use of hospital resources after cardiac surgery. Each g/dL unit fall in preoperative hemoglobin concentration resulted in increased blood transfusion requirements and increased postoperative ICU and hospital length of stay.

JOURNAL ARTICLE

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