Imperial College London

ProfessorDeborahAshby

Faculty of MedicineSchool of Public Health

Chair in Medical Statistics and Clinical Trials
 
 
 
//

Contact

 

+44 (0)20 7594 8704deborah.ashby Website

 
 
//

Location

 

54Stadium HouseWhite City

//

Summary

 

Publications

Publication Type
Year
to

183 results found

Achana F, Petrou S, Khan K, Gaye A, Modi N, Medicines for Neonates Investigatorset al., 2017, A methodological framework for assessing agreement between cost-effectiveness outcomes estimated using alternative sources of data on treatment costs and effects for trial-based economic evaluations., Eur J Health Econ

A new methodological framework for assessing agreement between cost-effectiveness endpoints generated using alternative sources of data on treatment costs and effects for trial-based economic evaluations is proposed. The framework can be used to validate cost-effectiveness endpoints generated from routine data sources when comparable data is available directly from trial case report forms or from another source. We illustrate application of the framework using data from a recent trial-based economic evaluation of the probiotic Bifidobacterium breve strain BBG administered to babies less than 31 weeks of gestation. Cost-effectiveness endpoints are compared using two sources of information; trial case report forms and data extracted from the National Neonatal Research Database (NNRD), a clinical database created through collaborative efforts of UK neonatal services. Focusing on mean incremental net benefits at £30,000 per episode of sepsis averted, the study revealed no evidence of discrepancy between the data sources (two-sided p values >0.4), low probability estimates of miscoverage (ranging from 0.039 to 0.060) and concordance correlation coefficients greater than 0.86. We conclude that the NNRD could potentially serve as a reliable source of data for future trial-based economic evaluations of neonatal interventions. We also discuss the potential implications of increasing opportunity to utilize routinely available data for the conduct of trial-based economic evaluations.

JOURNAL ARTICLE

Bird SM, Strang J, Ashby D, Podmore J, Robertson JR, Welch S, Meade AM, Parmar MKBet al., 2017, External data required timely response by the Trial Steering-Data Monitoring Committee for the NALoxone InVEstigation (N-ALIVE) pilot trial, CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS, Vol: 5, Pages: 100-106, ISSN: 2451-8654

JOURNAL ARTICLE

Embleton A, Ashby D, Flemyng E, Langhorne P, Meurer WJ, South A, Sydes Met al., 2017, If a tree falls in a forest: abstract view statistics as a measure of research impact, Publisher: BIOMED CENTRAL LTD, ISSN: 1745-6215

CONFERENCE PAPER

Martyn M, Liu X, Wilhelm-Benartzi C, Brown R, Ashby Det al., 2017, Issues with over-fitting in predictive models produced for stratified medicine: a case study on an ovarian cancer trial, Publisher: BIOMED CENTRAL LTD, ISSN: 1745-6215

CONFERENCE PAPER

Mason A, Winston A, Ashby D, 2017, Developing a Bayesian adaptive design for a phase I clinical trial: a case study for a novel HIV treatment, Publisher: BIOMED CENTRAL LTD, ISSN: 1745-6215

CONFERENCE PAPER

Quinn K, Traboni C, Penchala SD, Bouliotis G, Doyle N, Libri V, Khoo S, Ashby D, Weber J, Nicosia A, Cortese R, Pessi A, Winston Aet al., 2017, A first-in-human study of the novel HIV-fusion inhibitor C34-PEG(4)-Chol, SCIENTIFIC REPORTS, Vol: 7, ISSN: 2045-2322

JOURNAL ARTICLE

Santhakumaran S, Mason AJ, Gordon AC, Ashby Det al., 2017, Bayesian methods for informative missingness in longitudinal intensive care data, Publisher: BIOMED CENTRAL LTD, ISSN: 1745-6215

CONFERENCE PAPER

Santhakumaran S, Statnikov Y, Gray D, Battersby C, Ashby D, Modi N, Medicines for Neonates Investigator Groupet al., 2017, Survival of very preterm infants admitted to neonatal care in England 2008-2014: time trends and regional variation., Arch Dis Child Fetal Neonatal Ed

OBJECTIVE: To analyse survival trends and regional variation for very preterm infants admitted to neonatal care. SETTING: All neonatal units in England. PATIENTS: Infants born at 22+0-31+6 weeks+daysgestational age (GA) over 2008-2014 and admitted to neonatal care; published data for admitted infants 22+0-25+6 weeks+days GA in 1995 and 2006, and for live births at 22+0-31+6 weeks+days GA in 2013. METHODS: We obtained data from the National Neonatal Research Database. We used logistic regression to model survival probability with birth weight, GA, sex, antenatal steroid exposure and multiple birth included in the risk adjustment model and calculated annualpercentage change (APC) for trends using joinpoint regression. We evaluated survival over a 20-year period for infants <26 weeks' GA using additional published data from the EPICure studies. RESULTS: We identified 50 112 eligible infants. There was an increase in survival over 2008-2014 (2008: 88.0%; 2014: 91.3%; adjusted APC 0.46% (95% CI 0.30 to 0.62) p<0.001). The greatest improvement was at 22+0-23+6 weeks (APC 6.03% (95% CI 2.47 to 3.53) p=0.002). Improvement largely occurred in London and South of England (APC: London 1.26% (95% CI 0.60 to 1.96); South of England 1.09% (95% CI 0.36 to 1.82); Midlands and East of England 0.15% (95% CI -0.56 to 0.86); and North of England 0.26% (95% CI -0.54 to 1.07)). Survival at the earliest gestations improved at a similar rate over 1995-2014 (22+0-25+6 weeks, APC 2.73% (95% CI 2.35 to 3.12), p value for change=0.25). CONCLUSIONS: Continued national improvement in the survival of very preterm admissions masks important regional variation. Timely assessment of preterm survival is feasible using electronic records.

JOURNAL ARTICLE

Saunders P, Tsipouri V, Keir GJ, Ashby D, Flather MD, Parfrey H, Babalis D, Renzoni EA, Denton CP, Wells AU, Maher TMet al., 2017, Rituximab versus cyclophosphamide for the treatment of connective tissue disease-associated interstitial lung disease (RECITAL): study protocol for a randomised controlled trial, TRIALS, Vol: 18, ISSN: 1745-6215

JOURNAL ARTICLE

Sydes MR, Ashby D, 2017, Data Authorship as an Incentive to Data Sharing, NEW ENGLAND JOURNAL OF MEDICINE, Vol: 377, Pages: 402-402, ISSN: 0028-4793

JOURNAL ARTICLE

Tsipouri V, Saunders P, Keir GJ, Ashby D, Fletcher SV, Gibbons M, Szigeti M, Parfrey H, Renzoni EA, Denton CPet al., 2017, Rituximab versus cyclophosphamide for the treatment of connective tissue disease associated interstitial lung disease (RECITAL): a randomised controlled trial, Publisher: BIOMED CENTRAL LTD, ISSN: 1745-6215

CONFERENCE PAPER

Wilhelm-Benartzi CS, Mt-Isa S, Fiorentino F, Brown R, Ashby Det al., 2017, Challenges and methodology in the incorporation of biomarkers in cancer clinical trials, CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY, Vol: 110, Pages: 49-61, ISSN: 1040-8428

JOURNAL ARTICLE

Bicknell CD, Kiru G, Falaschetti E, Powell JT, Poulter NRet al., 2016, An evaluation of the effect of an angiotensin-converting enzyme inhibitor on the growth rate of small abdominal aortic aneurysms: a randomized placebo-controlled trial (AARDVARK), EUROPEAN HEART JOURNAL, Vol: 37, Pages: 3213-3221, ISSN: 0195-668X

JOURNAL ARTICLE

Gordon AC, Mason AJ, Thirunavukkarasu N, Perkins GD, Cecconi M, Cepkova M, Pogson DG, Aya HD, Anjum A, Frazier GJ, Santhakumaran S, Ashby D, Brett SJet al., 2016, Effect of Early Vasopressin vs Norepinephrine on Kidney Failure in Patients With Septic Shock The VANISH Randomized Clinical Trial, JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, Vol: 316, Pages: 509-518, ISSN: 0098-7484

JOURNAL ARTICLE

Gordon AC, Perkins GD, Singer M, McAuley DF, Orme RML, Santhakumaran S, Mason AJ, Cross M, Al-Beidh F, Best-Lane J, Brealey D, Nutt CL, McNamee JJ, Reschreiter H, Breen A, Liu KD, Ashby Det al., 2016, Levosimendan for the Prevention of Acute Organ Dysfunction in Sepsis, NEW ENGLAND JOURNAL OF MEDICINE, Vol: 375, Pages: 1638-1648, ISSN: 0028-4793

JOURNAL ARTICLE

Hallgreen CE, Mt-Isa S, Lieftucht A, Phillips LD, Hughes D, Talbot S, Asiimwe A, Downey G, Genov G, Hermann R, Noel R, Peters R, Micaleff A, Tzoulaki I, Ashby Det al., 2016, Literature review of visual representation of the results of benefit-risk assessments of medicinal products, PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Vol: 25, Pages: 238-250, ISSN: 1053-8569

JOURNAL ARTICLE

Hughes D, Waddingham E, Mt-Isa S, Goginsky A, Chan E, Downey GF, Hallgreen CE, Hockley KS, Juhaeri J, Lieftucht A, Metcalf MA, Noel RA, Phillips LD, Ashby D, Micaleff Aet al., 2016, Recommendations for benefit-risk assessment methodologies and visual representations, PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Vol: 25, Pages: 251-262, ISSN: 1053-8569

JOURNAL ARTICLE

Johnston SL, Szigeti M, Cross M, Brightling C, Chaudhuri R, Harrison T, Mansur A, Robison L, Sattar Z, Jackson D, Mallia P, Wong E, Corrigan C, Higgins B, Ind P, Singh D, Thomson NC, Ashby D, Chauhan Aet al., 2016, Azithromycin for Acute Exacerbations of Asthma The AZALEA Randomized Clinical Trial, JAMA INTERNAL MEDICINE, Vol: 176, Pages: 1630-1637, ISSN: 2168-6106

JOURNAL ARTICLE

Johnston SL, Szigeti M, Cross M, Brightling CE, Chaudhuri R, Harrison T, Mansur AH, Robinson L, Sattar Z, Jackson DJ, Mallia P, Wong EHC, Corrigan C, Higgins B, Ind P, Singh D, Thomson NC, Ashby D, Chauhan Aet al., 2016, A Randomised, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy Of Oral Azithromycin (500 Mg Od) As A Supplement To Standard Care For Adult Patients With Acute Exacerbations Of Asthma (the Azalea Trial), International Conference of the American-Thoracic-Society (ATS), Publisher: AMER THORACIC SOC, ISSN: 1073-449X

CONFERENCE PAPER

Lane A, Metcalfe C, Young GJ, Peters TJ, Blazeby J, Avery KNL, Dedman D, Down L, Mason MD, Neal DE, Hamdy FC, Donovan JL, ProtecT Study groupet al., 2016, Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life., BJU Int, Vol: 118, Pages: 869-879

OBJECTIVES: To present the baseline patient-reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localized prostate cancer and to compare results with other populations. MATERIALS AND METHODS: A total of 1643 randomized men, aged 50-69 years and diagnosed with clinically localized disease identified by prostate-specific antigen (PSA) testing, in nine UK cities in the period 1999-2009 were included. Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific impact on quality of life (Expanded Prostate Index Composite [EPIC], 2005 onwards; International Consultation on Incontinence Questionnaire-Urinary Incontinence [ICIQ-UI], 2001 onwards; the International Continence Society short-form male survey [ICSmaleSF]; anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), generic mental and physical health (12-item short-form health survey [SF-12]; EuroQol quality-of-life survey, the EQ-5D-3L) were assessed at prostate biopsy clinics before randomization. Descriptive statistics are presented by treatment allocation and by men's age at biopsy and PSA testing time points for selected measures. RESULTS: A total of 1438 participants completed biopsy questionnaires (88%) and 77-88% of these were analysed for individual PROMs. Fewer than 1% of participants were using pads daily (5/754). Storage lower urinary tract symptoms were frequent (e.g. nocturia 22%, 312/1423). Bowel symptoms were rare, except for loose stools (16%, 118/754). One third of participants reported erectile dysfunction (241/735) and for 16% (118/731) this was a moderate or large problem. Depression was infrequent (80/1399, 6%) but 20% of participants (278/1403) reported anxiety. Sexual function and bother were markedly worse in older men (65-70 years), whilst urinary bother and physical health were somewhat w

JOURNAL ARTICLE

Mason AJ, Gonzalez-Maffe J, Quinn K, Doyle N, Legg K, Norsworthy P, Trevelion R, Winston A, Ashby Det al., 2016, Developing a Bayesian adaptive design for a phase I clinical trial: a case study for a novel HIV treatment, Statistics in Medicine, Vol: 36, Pages: 754-771, ISSN: 1097-0258

The design of phase I studies is often challenging, because of limited evidence to inform study protocols. Adaptive designs are now well established in cancer but much less so in other clinical areas. A phase I study to assess the safety, pharmacokinetic profile and antiretroviral efficacy of C34-PEG4-Chol, a novel peptide fusion inhibitor for the treatment of HIV infection, has been set up with Medical Research Council funding. During the study workup, Bayesian adaptive designs based on the continual reassessment method were compared with a more standard rule-based design, with the aim of choosing a design that would maximise the scientific information gained from the study. The process of specifying and evaluating the design options was time consuming and required the active involvement of all members of the trial's protocol development team. However, the effort was worthwhile as the originally proposed rule-based design has been replaced by a more efficient Bayesian adaptive design. While the outcome to be modelled, design details and evaluation criteria are trial specific, the principles behind their selection are general. This case study illustrates the steps required to establish a design in a novel context.

JOURNAL ARTICLE

Mason MD, Moore R, Jones G, Lewis G, Donovan JL, Neal DE, Hamdy FC, Lane JA, Staffurth JN, ProtecT Study Groupet al., 2016, Radiotherapy for Prostate Cancer: is it 'what you do' or 'the way that you do it'? A UK Perspective on Technique and Quality Assurance., Clin Oncol (R Coll Radiol), Vol: 28, Pages: e92-e100

AIMS: The treatment of prostate cancer has evolved markedly over the last 40 years, including radiotherapy, notably with escalated dose and targeting. However, the optimal treatment for localised disease has not been established in comparative randomised trials. The aim of this article is to describe the history of prostate radiotherapy trials, including their quality assurance processes, and to compare these with the ProtecT trial. MATERIALS AND METHODS: The UK ProtecT randomised trial compares external beam conformal radiotherapy, surgery and active monitoring for clinically localised prostate cancer and will report on the primary outcome (disease-specific mortality) in 2016 following recruitment between 1999 and 2009. The embedded quality assurance programme consists of on-site machine dosimetry at the nine trial centres, a retrospective review of outlining and adherence to dose constraints based on the trial protocol in 54 participants (randomly selected, around 10% of the total randomised to radiotherapy, n = 545). These quality assurance processes and results were compared with prostate radiotherapy trials of a comparable era. RESULTS: There has been an increasingly sophisticated quality assurance programme in UK prostate radiotherapy trials over the last 15 years, reflecting dose escalation and treatment complexity. In ProtecT, machine dosimetry results were comparable between trial centres and with the UK RT01 trial. The outlining review showed that most deviations were clinically acceptable, although three (1.4%) may have been of clinical significance and were related to outlining of the prostate. Seminal vesicle outlining varied, possibly due to several prostate trials running concurrently with different protocols. Adherence to dose constraints in ProtecT was considered acceptable, with 80% of randomised participants having two or less deviations and planning target volume coverage was excellent. CONCLUSION: The ProtecT trial quality assurance re

JOURNAL ARTICLE

Quinn K, Bouliotis G, Doyle N, Winston A, Ashby D, Weber J, Libri V, Amara A, Back D, Penchala SD, Khoo S, Nelson M, Jones R, Cortese R, Pessi Aet al., 2016, A first-in-human study, in HIV-positive men, of the novel HIV-fusion inhibitor C34-PEG4-Chol, Publisher: WILEY-BLACKWELL, Pages: 18-18, ISSN: 1464-2662

CONFERENCE PAPER

Uthaya S, Liu X, Babalis D, Dore CJ, Warwick J, Bell J, Thomas L, Ashby D, Durighel G, Ederies A, Yanez-Lopez M, Modi Net al., 2016, Nutritional Evaluation and Optimisation in Neonates: a randomized, double-blind controlled trial of amino acid regimen and intravenous lipid composition in preterm parenteral nutrition, AMERICAN JOURNAL OF CLINICAL NUTRITION, Vol: 103, Pages: 1443-1452, ISSN: 0002-9165

JOURNAL ARTICLE

Waddingham E, Mt-Isa S, Nixon R, Ashby Det al., 2016, A Bayesian approach to probabilistic sensitivity analysis in structured benefit-risk assessment, BIOMETRICAL JOURNAL, Vol: 58, Pages: 28-42, ISSN: 0323-3847

JOURNAL ARTICLE

Abbara A, Jayasena CN, Christopoulos G, Narayanaswamy S, Izzi-Engbeaya C, Nijher GMK, Comninos AN, Peters D, Buckley A, Ratnasabapathy R, Prague JK, Salim R, Lavery SA, Bloom SR, Szigeti M, Ashby DA, Trew GH, Dhillo WSet al., 2015, Efficacy of Kisspeptin-54 to Trigger Oocyte Maturation in Women at High Risk of Ovarian Hyperstimulation Syndrome (OHSS) During In Vitro Fertilization (IVF) Therapy, JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM, Vol: 100, Pages: 3322-3331, ISSN: 0021-972X

JOURNAL ARTICLE

Alton EWFW, Armstrong DK, Ashby D, 2015, Repeated nebulisation of non-viral CFTR gene therapy in patients with cystic fi brosis: a randomised, double-blind, placebo-controlled, phase 2b trial (vol 3, pg 684, 2015), LANCET RESPIRATORY MEDICINE, Vol: 3, Pages: E33-E33, ISSN: 2213-2600

JOURNAL ARTICLE

Alton EWFW, Armstrong DK, Ashby D, Bayfield KJ, Bilton D, Bloomfield EV, Boyd AC, Brand J, Buchan R, Calcedo R, Carvelli P, Chan M, Cheng SH, Collie DDS, Cunningham S, Davidson HE, Davies G, Davies JC, Davies LA, Dewar MH, Doherty A, Donovan J, Dwyer NS, Elgmati HI, Featherstone RF, Gavino J, Gea-Sorli S, Geddes DM, Gibson JSR, Gill DR, Greening AP, Griesenbach U, Hansell DM, Harman K, Higgins TE, Hodges SL, Hyde SC, Hyndman L, Innes JA, Jacob J, Jones N, Keogh BF, Limberis MP, Lloyd-Evans P, Maclean AW, Manvell MC, McCormick D, McGovern M, McLachlan G, Meng C, Montero MA, Milligan H, Moyce LJ, Murray GD, Nicholson AG, Osadolor T, Parra-Leiton J, Porteous DJ, Pringle IA, Punch EK, Pytel KM, Quittner AL, Rivellini G, Saunders CJ, Scheule RK, Sheard S, Simmonds NJ, Smith K, Smith SN, Soussi N, Soussi S, Spearing EJ, Stevenson BJ, Sumner-Jones SG, Turkkila M, Ureta RP, Waller MD, Wasowicz MY, Wilson JM, Wolstenholme-Hogg Pet al., 2015, Repeated nebulisation of non-viral CFTR gene therapy in patients with cystic fibrosis: a randomised, double-blind, placebo-controlled, phase 2b trial, LANCET RESPIRATORY MEDICINE, Vol: 3, Pages: 684-691, ISSN: 2213-2600

JOURNAL ARTICLE

Chambers ES, Viardot A, Psichas A, Morrison DJ, Murphy KG, Zac-Varghese SEK, MacDougall K, Preston T, Tedford C, Finlayson GS, Blundell JE, Bell JD, Thomas EL, Mt-Isa S, Ashby D, Gibson GR, Kolida S, Dhillo WS, Bloom SR, Morley W, Clegg S, Frost Get al., 2015, Effects of targeted delivery of propionate to the human colon on appetite regulation, body weight maintenance and adiposity in overweight adults, GUT, Vol: 64, Pages: 1744-1754, ISSN: 0017-5749

JOURNAL ARTICLE

Chambers ES, Viardot A, Psichas A, Morrison DJ, Murphy KG, Zac-Varghese SEK, MacDougall K, Preston T, Tedford MC, Bell JD, Thomas EL, Mt-Isa S, Ashby D, Dhillo WS, Bloom SR, Morley WG, Clegg S, Frost Get al., 2015, Effects of elevating colonic propionate on liver fat content in overweight adults with non-alcoholic fatty liver disease: a pilot study, PROCEEDINGS OF THE NUTRITION SOCIETY, Vol: 74, Pages: E30-E30, ISSN: 0029-6651

JOURNAL ARTICLE

This data is extracted from the Web of Science and reproduced under a licence from Thomson Reuters. You may not copy or re-distribute this data in whole or in part without the written consent of the Science business of Thomson Reuters.

Request URL: http://wlsprd.imperial.ac.uk:80/respub/WEB-INF/jsp/search-html.jsp Request URI: /respub/WEB-INF/jsp/search-html.jsp Query String: respub-action=search.html&id=00579842&limit=30&person=true