Publications
217 results found
Phillips R, Cornelius V, 2017, Lessons to learn from the reporting of adverse events (AEs) in randomised controlled trials published in high impact journals, The 4th International Clinical Trials Methodology Conference, Publisher: BioMed Central, ISSN: 1745-6215
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
Tao C, Yu D, Cornelius V, et 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
O'Hagan M, Cornelius V, Young AH, et 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
There has only been limited research into the predictors of readmission in bipolar disorder. We carried out a 1-year follow-up of patients discharged from a single mental health unit following admission for treatment of an acute bipolar episode. Of 519 patients followed up for 1 year, 167 (32.2%) were readmitted. There was no association between readmission and any drug regimen. Prescription of antidepressants at discharge was not associated with increased risk of readmission [odds ratio (OR): 0.99, 95% confidence interval (CI): 0.98–1.01]. Among demographic factors, only smoking (OR: 1.75, 95% CI: 1.14–2.75) and age range of 42–53 years (OR: 1.99, 95% CI: 1.15–3.43) conferred an increased risk of readmission. Individually optimized drug treatment regimens are equally effective in practice. It is not clear why smoking is associated with readmission.
Harris J, Cornelius V, Ream E, et al., 2017, Anxiety after treatment for non-metastatic breast cancer: a systematic review to identify risk factors and evaluate multivariate model development, Supportive Care in Cancer, Vol: 25, Pages: 2321-2333, ISSN: 0941-4355
PurposeThe purpose of this review was to identify potential candidate predictors of anxiety in women with early-stage breast cancer (BC) after adjuvant treatments and evaluate methodological development of existing multivariable models to inform the future development of a predictive risk stratification model (PRSM).MethodsDatabases (MEDLINE, Web of Science, CINAHL, CENTRAL and PsycINFO) were searched from inception to November 2015. Eligible studies were prospective, recruited women with stage 0–3 BC, used a validated anxiety outcome ≥3 months post-treatment completion and used multivariable prediction models. Internationally accepted quality standards were used to assess predictive risk of bias and strength of evidence.ResultsSeven studies were identified: five were observational cohorts and two secondary analyses of RCTs. Variability of measurement and selective reporting precluded meta-analysis. Twenty-one candidate predictors were identified in total. Younger age and previous mental health problems were identified as risk factors in ≥3 studies. Clinical variables (e.g. treatment, tumour grade) were not identified as predictors in any studies. No studies adhered to all quality standards.ConclusionsPre-existing vulnerability to mental health problems and younger age increased the risk of anxiety after completion of treatment for BC survivors, but there was no evidence that chemotherapy was a predictor. Multiple predictors were identified but many lacked reproducibility or were not measured across studies, and inadequate reporting did not allow full evaluation of the multivariable models. The use of quality standards in the development of PRSM within supportive cancer care would improve model quality and performance, thereby allowing professionals to better target support for patients.
Harris J, Cornelius V, Ream E, et 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
PurposeThe purpose of this review was to identify potential candidate predictors of anxiety in women with early-stage breast cancer (BC) after adjuvant treatments and evaluate methodological development of existing multivariable models to inform the future development of a predictive risk stratification model (PRSM).MethodsDatabases (MEDLINE, Web of Science, CINAHL, CENTRAL and PsycINFO) were searched from inception to November 2015. Eligible studies were prospective, recruited women with stage 0–3 BC, used a validated anxiety outcome ≥3 months post-treatment completion and used multivariable prediction models. Internationally accepted quality standards were used to assess predictive risk of bias and strength of evidence.ResultsSeven studies were identified: five were observational cohorts and two secondary analyses of RCTs. Variability of measurement and selective reporting precluded meta-analysis. Twenty-one candidate predictors were identified in total. Younger age and previous mental health problems were identified as risk factors in ≥3 studies. Clinical variables (e.g. treatment, tumour grade) were not identified as predictors in any studies. No studies adhered to all quality standards.ConclusionsPre-existing vulnerability to mental health problems and younger age increased the risk of anxiety after completion of treatment for BC survivors, but there was no evidence that chemotherapy was a predictor. Multiple predictors were identified but many lacked reproducibility or were not measured across studies, and inadequate reporting did not allow full evaluation of the multivariable models. The use of quality standards in the development of PRSM within supportive cancer care would improve model quality and performance, thereby allowing professionals to better target support for patients.
Chan S, Cornelius V, Chen T, et 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
Background:The evidence for systemic treatments for severe childhood eczema is limited and largely based on extrapolation of data from adult studies. Current therapies are often immunosuppressant and may be associated with both short- and long-term side effects. There is increasing in vitro and murine-model evidence for the role of IgE in the immunopathogenesis of atopic eczema. The aim of the study is to assess whether anti-IgE treatment (omalizumab) improves eczema, compared to placebo.Methods/design:The Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT) is a randomised, double-blind, placebo-controlled study assessing the role of anti-IgE in the management of severe paediatric eczema. Children with severe atopic eczema, with an objective SCORing Atopic Dermatitis (SCORAD) score of over 40 will be recruited. These children are candidates for systemic therapy, have failed systemic therapy or have experienced side effects from systemic therapy. Sixty-two patients aged between 4 and 19 years will receive anti-IgE for 6 months. The primary outcome measure will be the validated eczema score, the objective SCORAD at 24 weeks. This study has 90% power to detect a 33% relative reduction in SCORAD between active and placebo groups, with 5% significance.Discussion:IgE may have a role to play in eczema, particularly in childhood. This forms the basis for the hypothesis that anti-IgE may be an effective treatment in this patient population.This will be the largest study to evaluate the efficacy of anti-IgE (omalizumab) versus placebo in children with severe eczema. The findings will help to clarify the role of anti-IgE as a potential treatment option in patients with severe childhood eczema.
Forster AS, Cornelius VR, Rockliffe L, et al., 2017, A protocol for a cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination among girls, Pilot and Feasibility Studies, Vol: 3, ISSN: 2055-5784
BackgroundUptake 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.MethodsAt 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 up
Wilkinson T, Bourne S, DeVos R, et al., 2017, Online Versus Face To Face Pulmonary Rehabilitation For Patients With COPD: A Randomised Controlled Trial, International Conference of the American-Thoracic-Society (ATS), Publisher: AMER THORACIC SOC, ISSN: 1073-449X
McDermott L, Wright AJ, Cornelius V, et al., 2016, Enhanced invitation methods and uptake of health checks in primary care: randomised controlled trial and cohort study using electronic health records., Health Technol Assess, Vol: 20, Pages: 1-92, ISSN: 2046-4924
BACKGROUND: A national programme of health checks to identify risk of cardiovascular disease (CVD) is being rolled out but is encountering difficulties because of low uptake. OBJECTIVE: To evaluate the effectiveness of an enhanced invitation method using the question-behaviour effect (QBE), with or without the offer of a financial incentive to return the QBE questionnaire, at increasing the uptake of health checks. The research went on to evaluate the reasons for the low uptake of invitations and compare the case mix for invited and opportunistic health checks. DESIGN: Three-arm randomised trial and cohort study. PARTICIPANTS: All participants invited for a health check from 18 general practices. Individual participants were randomised. INTERVENTIONS: (1) Standard health check invitation only; (2) QBE questionnaire followed by a standard invitation; and (3) QBE questionnaire with offer of a financial incentive to return the questionnaire, followed by a standard invitation. MAIN OUTCOME MEASURES: The primary outcome was completion of the health check within 6 months of invitation. A p-value of 0.0167 was used for significance. In the cohort study of all health checks completed during the study period, the case mix was compared for participants responding to invitations and those receiving 'opportunistic' health checks. Participants were not aware that several types of invitation were in use. The research team were blind to trial arm allocation at outcome data extraction. RESULTS: In total, 12,459 participants were included in the trial and health check uptake was evaluated for 12,052 participants for whom outcome data were collected. Health check uptake was as follows: standard invitation, 590 out of 4095 (14.41%); QBE questionnaire, 630 out of 3988 (15.80%); QBE questionnaire and financial incentive, 629 out of 3969 (15.85%). The increase in uptake associated with the QBE questionnaire was 1.43% [95% confidence interval (CI) -0.12% to 2.97%; p = 0.070]
Wright AJ, McDermott L, Cornelius VR, et al., 2016, Can the question-behaviour effect enhance uptake of cardiovascular health checks in primary care?, European Health Psychologist
Lo JW, Bunce C, Charteris D, et al., 2016, A phase III, multi-centre, double-masked randomised controlled trial of adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): statistical analysis plan., Trials, Vol: 17, ISSN: 1745-6215
BACKGROUND: Open globe ocular trauma complicated by intraocular scarring (proliferative vitreoretinopathy) is a relatively rare, blinding, but potentially treatable condition for which, at present, surgery is often unsatisfactory and visual results frequently poor. To date, no pharmacological adjuncts to surgery have been proven to be effective. The aim of the Adjunctive Steroid Combination in Ocular Trauma (ASCOT) randomised controlled trial is to determine whether adjunctive steroid (triamcinolone acetonide), given at the time of surgery, can improve the outcome of vitreoretinal surgery in patients with open globe ocular trauma. This article presents the statistical analysis plan for the main publication as approved and signed off by the Trial Steering Committee prior to the first data extraction for the Data Monitoring Committee meeting report. METHODS/DESIGN: ASCOT is a pragmatic, multi-centre, parallel-group, double-masked randomised controlled trial. The aim of the study is to recruit from 20-25 centres in the United Kingdom and randomise 300 eyes (from 300 patients) into two treatment arms. Both groups will receive standard surgical treatment and care; the intervention arm will additionally receive a pre-operative steroid combination (triamcinolone acetonide) into the vitreous cavity consisting of 4 mg/0.1 ml and 40 mg/1 ml sub-Tenon's. Participants will be followed for 6 months post-surgery. The primary outcome is the proportion of patients achieving a clinically meaning improvement in visual acuity in the study eye at 6 months after initial surgery, defined as a 10 letter score improvement in the ETDRS (the standard scale to test visual acuity). TRIAL REGISTRATION: ISRCTN30012492 . Registered on 5 September 2014. EudraCT2014-002193-37 . Registered on 5 September 2014.
Banerjee PJ, Cornelius VR, Phillips R, et al., 2016, Adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): study protocol for a phase III, multi-centre, double-masked randomised controlled trial, Trials, Vol: 17, ISSN: 1745-6215
BACKGROUND: Eyes sustaining open globe trauma are at high risk of severe visual impairment. Ocular injuries which result in visual loss invariably affect the posterior segment of the eye, and prevention of visual loss involves posterior segment (vitreoretinal) surgery. Despite improvements in vitreoretinal surgical techniques, outcomes in these patients remain unsatisfactory, and development of the intraocular scarring response proliferative vitreoretinopathy is the leading cause. Proliferative vitreoretinopathy is the most common cause of recurrent retinal detachment in these eyes; it is reported to occur in up to 45 % of cases. METHODS/DESIGN: The Adjunctive Steroid Combination in Ocular Trauma (ASCOT) trial is a multi-centre, double-masked, parallel-arm randomised controlled trial with an internal pilot designed to investigate the effectiveness and cost-effectiveness of using intravitreal and sub-Tenon's triamcinolone acetonide peri-operatively in patients undergoing vitrectomy following open globe trauma. In total, 300 eyes of 300 patients will be recruited and randomly allocated to one of two treatment groups. Both groups will receive standard surgical treatment and routine pre-operative and post-operative treatment and care. The treatment group will receive an adjunctive peri-operative steroid combination (triamcinolone acetonide) consisting of 4 mg/0.1 ml into the vitreous cavity and 40 mg/1 ml into the sub-Tenon's space. The trial incorporates a two-stage internal pilot to examine projected recruitment and retention rates. Progression criteria from the internal pilot study will enable us to determine whether to undertake the main trial. Patients and primary outcome assessors will be masked to treatment allocation. The primary outcome will be an improvement from baseline to 6 months of at least 10 on the corrected visual acuity as measured by ETDRS letter score. Secondary outcomes will be development of scarring, retinal detachme
Cornelius VR, Liu K, Peacock J, et al., 2016, Variation in adverse drug reactions listed in product information for antidepressants and anticonvulsants, between the USA and Europe: a comparison review of paired regulatory documents, BMJ Open, Vol: 6, ISSN: 2044-6055
OBJECTIVE: To compare consistency of adverse drug reaction (ADR) data in publicly available product information documents for brand drugs, between the USA and Europe. To assess the usefulness of information for prescribers and patients. DESIGN: A comparison review of product information documents for antidepressants and anticonvulsants concurrently marketed by the same pharmaceutical company in the USA and Europe. SETTING: For each drug, data were extracted from the US Product Inserts and the European Summary of Product Characteristics documents between 09/2013 and 01/2015. PARTICIPANTS: Individuals contributing ADR information to product information documents. MAIN OUTCOMES MEASURES: All ADRs reported in product information sections 5 and 6 (USA), and 4·4 and 4·8 (Europe). RESULTS: Twelve brand drugs-24 paired documents-were included. On average, there were 77 more ADRs reported in the USA compared with in the European product information document, with a median number of 201 ADRs (range: 65-425) and 114 (range: 56-265), respectively. More product information documents in the USA reported information on the source of evidence (10 vs 5) and risk (9 vs 5) for greater than 80% of ADRs included in the document. There was negligible information included regarding duration, severity, reversibility or recurrence of ADRs. On average, only 29% of ADR terms were reported in both paired documents. CONCLUSIONS: Product information documents contained a large number of ADRs, but lacked contextual data and information important to patients and prescribers, such as duration, severity and reversibility. The ADR profile was found to be inconsistently reported between the USA and Europe, for the same drug. Identifying, selecting, summarising and presenting multidimensional harm data should be underpinned by practical evidence-based guidelines. In order for prescribers to provide considered risk-benefit advice across competing drug therapies to patients, they need acces
Hallward G, Balani N, McCorkell S, et al., 2016, The Relationship Between Preoperative Hemoglobin Concentration, Use of Hospital Resources, and Outcomes in Cardiac Surgery, Journal of Cardiothoracic and Vascular Anesthesia, Vol: 30, Pages: 901-908, ISSN: 1532-8422
ObjectivesPreoperative 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.DesignA retrospective, observational cohort study.SettingA single-center tertiary referral hospital.ParticipantsThe study comprised 1,972 adult patients undergoing elective and nonelective cardiac surgery.InterventionsThe 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 ResultsThe 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).ConclusionsA 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.
Carvajal A, Arias LHM, Sáinz M, et al., 2016, Carpal tunnel syndrome associated with oral bisphosphonates. A population-based cohort study, PLOS One, Vol: 11, ISSN: 1932-6203
Mace S, Dzahini O, Cornelius V, et al., 2015, Antipsychotic use and unexpected death: A hospital-based case-control study, Acta Psychiatrica Scandinavica, Vol: 132, Pages: 479-488, ISSN: 0001-690X
Objective: To examine the risk of unexpected death in patients prescribed an antipsychotic. Unexpected death was defined as death occurring within 7 days of the onset of acute symptoms. Method: A case-control study conducted on events occurring between July 2009 and January 2011 in a UK mental health trust providing in-patient and out-patient services. Results: The study included 100 cases (deaths) and 436 unmatched controls. Current users of antipsychotics had a lower risk of unexpected death than non-users - adjusted odds ratio (OR) 0.48 (95% CI 0.24-0.94, P = 0.033). A significant reduction in risk was seen for second-generation [adjusted OR 0.42 (95% CI 0.21-0.86, P = 0.018)], but not first-generation agents [adjusted OR 0.83 (95% CI 0.31-2.20, P = 0.706)]. Treatment with antipsychotics for any duration was associated with reduced risk. Dose and route of administration did not affect risk. In a planned secondary analysis not adjusting for cardiovascular disease, prescription of an antipsychotic was not associated with increased risk of unexpected death [adjusted OR 0.56 (95% CI 0.28-1.08, P = 0.084)]. Conclusion: Our findings do not support an association between current antipsychotic use and increased risk of unexpected death.
Connolly A, Taylor D, Sparshatt A, et al., 2015, Antipsychotic prescribing in Black and White hospitalised patients (vol 25, pg 704, 2010), JOURNAL OF PSYCHOPHARMACOLOGY, Vol: 29, Pages: NP2-NP2, ISSN: 0269-8811
Dasan S, Gohil P, Cornelius V, et al., 2015, Prevalence, causes and consequences of compassion satisfaction and compassion fatigue in emergency care: a mixed-methods study of UK NHS Consultants, EMERGENCY MEDICINE JOURNAL, Vol: 32, Pages: 588-594, ISSN: 1472-0205
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- Citations: 70
Zolkipli Z, Roberts G, Cornelius V, et al., 2015, Randomized controlled trial of primary prevention of atopy using house dust mite allergen oral immunotherapy in early childhood, Journal of Allergy and Clinical Immunology, Vol: 136, Pages: 1541-1547e11, ISSN: 0091-6749
Background Children born to atopic parents are at increased risk of sensitization to environmental allergens. Objective We sought to demonstrate proof of concept for oral immunotherapy to high-dose house dust mite (HDM) allergen in infancy in the prevention of allergen sensitization and allergic diseases. Methods This was a prospective, randomized, double-blind, placebo-controlled, proof-of-concept study involving 111 infants less than 1 year of age at high risk of atopy (≥2 first-degree relatives with allergic disease) but with negative skin prick test responses to common allergens at randomization. HDM extract (active) and appropriate placebo solution were administered orally twice daily for 12 months, and children were assessed every 3 months. Coprimary outcomes were cumulative sensitization to HDM and sensitization to any common allergen during treatment, whereas development of eczema, wheeze, and food allergy were secondary outcomes. All adverse events were recorded. Results There was a significant (P =.03) reduction in sensitization to any common allergen (16.0%; 95% CI, 1.7% to 30.4%) in the active (5 [9.4%]) compared with placebo (13 [25.5%]) treatment groups. There was no treatment effect on the coprimary outcome of HDM sensitization and the secondary outcomes of eczema, wheeze, and food allergy. The intervention was well tolerated, with no differences between active and placebo treatments in numbers or nature of adverse events. Conclusion Prophylactic HDM oral immunotherapy is well tolerated in children at high heredity risk. The results met the trial's prespecified criteria for proof of concept in reducing sensitization to any allergen; however, no significant preventive effect was observed on HDM sensitization or allergy-related symptoms.
Sharma M, Cornelius VR, Patel JP, et al., 2015, Efficacy and harms of direct Oral anticoagulants in the elderly for stroke prevention in atrial fibrillation and secondary prevention of venous thromboembolism: systematic review and meta-analysis., Circulation, Vol: 132, Pages: 194-204, ISSN: 0009-7322
BACKGROUND: Evidence regarding the use of direct oral anticoagulants (DOACs) in the elderly, particularly bleeding risks, is unclear despite the presence of greater comorbidities, polypharmacy, and altered pharmacokinetics in this age group. METHODS AND RESULTS: We performed a systematic review and meta-analysis of randomized trials of DOACs (dabigatran, apixaban, rivaroxaban, and edoxaban) for efficacy and bleeding outcomes in comparison with vitamin K antagonists (VKA) in elderly participants (aged ≥75 years) treated for acute venous thromboembolism or stroke prevention in atrial fibrillation. Nineteen studies were eligible for inclusion, but only 11 reported data specifically for elderly participants. The efficacy in managing thrombotic risks for each DOAC was similar or superior to VKA in elderly patients. A nonsignificantly higher risk of major bleeding than with VKA was observed with dabigatran 150 mg (odds ratio, 1.18; 95% confidence interval, 0.97-1.44) but not with the 110-mg dose. Significantly higher gastrointestinal bleeding risks with dabigatran 150 mg (1.78, 1.35-2.35) and dabigatran 110 mg (1.40, 1.04-1.90) and lower intracranial bleeding risks than VKA for dabigatran 150 mg (0.43, 0.26-0.72) and dabigatran 110 mg (0.36, 0.22-0.61) were also observed. A significantly lower major bleeding risk in comparison with VKA was observed for apixaban (0.63, 0.51-0.77), edoxaban 60 mg (0.81, 0.67-0.98), and 30 mg (0.46, 0.38-0.57), whereas rivaroxaban showed similar risks. CONCLUSIONS: DOACs demonstrated at least equal efficacy to VKA in managing thrombotic risks in the elderly, but bleeding patterns were distinct. In particular, dabigatran was associated with a higher risk of gastrointestinal bleeding than VKA. Insufficient published data for apixaban, edoxaban, and rivaroxaban indicate that further work is needed to clarify the bleeding risks of these DOACs in the elderly. SYSTEMATIC REVIEW REGISTRATION: http://www.crd.york.ac.uk/PROSPERO. Unique identifier
Masca NGD, Hensor EMA, Cornelius VR, et al., 2015, RIPOSTE: a framework for improving the design and analysis of laboratory-based research, eLife, Vol: 4, ISSN: 2050-084X
Lack of reproducibility is an ongoing problem in some areas of the biomedical sciences. Poor experimental design and a failure to engage with experienced statisticians at key stages in the design and analysis of experiments are two factors that contribute to this problem. The RIPOSTE (Reducing IrreProducibility in labOratory STudiEs) framework has been developed to support early and regular discussions between scientists and statisticians in order to improve the design, conduct and analysis of laboratory studies and, therefore, to reduce irreproducibility. This framework is intended for use during the early stages of a research project, when specific questions or hypotheses are proposed. The essential points within the framework are explained and illustrated using three examples (a medical equipment test, a macrophage study and a gene expression study). Sound study design minimises the possibility of bias being introduced into experiments and leads to higher quality research with more reproducible results.
Taylor DM, Cornelius V, Smith L, et al., 2014, Comparative efficacy and acceptability of drug treatments for bipolar depression: a multiple-treatments meta-analysis, ACTA PSYCHIATRICA SCANDINAVICA, Vol: 130, Pages: 452-469, ISSN: 0001-690X
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- Citations: 81
Zolkipli Z, Roberts G, Cornelius V, et al., 2014, Randomised controlled trial of primary prevention of atopy using house dust mite allergen oral immunotherapy in early childhood, European-Academy-of-Allergy-and-Clinical-Immunology Congress, Publisher: WILEY-BLACKWELL, Pages: 105-105, ISSN: 0105-4538
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- Citations: 2
Forster AS, Burgess C, McDermott L, et al., 2014, Enhanced invitation methods to increase uptake of NHS health checks: study protocol for a randomized controlled trial, Trials, Vol: 15, ISSN: 1745-6215
Background:NHS Health Checks is a new program for primary prevention of heart disease, stroke, diabetes, chronic kidney disease, and vascular dementia in adults aged 40 to 74 years in England. Individuals without existing cardiovascular disease or diabetes are invited for a Health Check every 5 years. Uptake among those invited is lower than anticipated.Method:The project is a three-arm randomized controlled trial to test the hypothesis that enhanced invitation methods, using the Question-Behaviour Effect (QBE), will increase uptake of NHS Health Checks compared with a standard invitation. Participants comprise individuals eligible for an NHS Health Check registered in two London boroughs. Participants are randomized into one of three arms. Group A receives the standard NHS Health Check invitation letter, information sheet, and reminder letter at 12 weeks for nonattenders. Group B receives a QBE questionnaire 1 week before receiving the standard invitation, information sheet, and reminder letter where appropriate. Group C is the same as Group B, but participants are offered a £5 retail voucher if they return the questionnaire. Participants are randomized in equal proportions, stratified by general practice. The primary outcome is uptake of NHS Health Checks 6 months after invitation from electronic health records. We will estimate the incremental health service cost per additional completed Health Check for trial groups B and C versus trial arm A, as well as evaluating the impact of the QBE questionnaire, and questionnaire plus voucher, on the socioeconomic inequality in uptake of Health Checks.The trial includes a nested comparison of two methods for implementing allocation, one implemented manually at general practices and the other implemented automatically through the information systems used to generate invitations for the Health Check.Discussion:The research will provide evidence on whether asking individuals to complete a preliminary questionnaire, by u
Attard A, Olofinjana O, Cornelius V, et al., 2014, Paliperidone palmitate long-acting injection - prospective year-long follow-up of use in clinical practice, ACTA PSYCHIATRICA SCANDINAVICA, Vol: 130, Pages: 46-51, ISSN: 0001-690X
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- Citations: 45
Adura PT, Reed E, Macintyre J, et al., 2014, Experimental rhinovirus 16 infection in moderate asthmatics on inhaled corticosteroids, EUROPEAN RESPIRATORY JOURNAL, Vol: 43, Pages: 1186-1189, ISSN: 0903-1936
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- Citations: 15
Cathie K, Howlin R, Barraud N, et al., 2014, Low Dose Nitric Oxide As Adjunctive Therapy To Reduce Antimicrobial Tolerance Of Pseudomonas AerugINOSa biofilms In The Treatment Of Patients With Cystic Fibrosis: Report Of A Proof Of Concept Clinical Trial, Publisher: AMER THORACIC SOC, ISSN: 1073-449X
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- Citations: 2
Mehta S, Rolph R, Cornelius V, et al., 2013, Local heat preconditioning in skin sparing mastectomy: A pilot study, JOURNAL OF PLASTIC RECONSTRUCTIVE AND AESTHETIC SURGERY, Vol: 66, Pages: 1676-1682, ISSN: 1748-6815
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- Citations: 18
Sauzet O, Carvajal A, Escudero A, et al., 2013, Illustration of the Weibull Shape Parameter Signal Detection Tool Using Electronic Healthcare Record Data, DRUG SAFETY, Vol: 36, Pages: 995-1006, ISSN: 0114-5916
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- Citations: 63
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