ORCID Profile
0000-0002-2361-3040
Current Organisation
University of Oxford
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Publisher: National Institute for Health and Care Research
Date: 05-2023
DOI: 10.3310/MNJY9014
Abstract: Bleeding among populations undergoing percutaneous coronary intervention or coronary artery bypass grafting and among conservatively managed patients with acute coronary syndrome exposed to different dual antiplatelet therapy and triple therapy (i.e. dual antiplatelet therapy plus an anticoagulant) has not been previously quantified. The objectives were to estimate hazard ratios for bleeding for different antiplatelet and triple therapy regimens, estimate resources and the associated costs of treating bleeding events, and to extend existing economic models of the cost-effectiveness of dual antiplatelet therapy. The study was designed as three retrospective population-based cohort studies emulating target randomised controlled trials. The study was set in primary and secondary care in England from 2010 to 2017. Participants were patients aged ≥ 18 years undergoing coronary artery bypass grafting or emergency percutaneous coronary intervention (for acute coronary syndrome), or conservatively managed patients with acute coronary syndrome. Data were sourced from linked Clinical Practice Research Datalink and Hospital Episode Statistics. Coronary artery bypass grafting and conservatively managed acute coronary syndrome: aspirin (reference) compared with aspirin and clopidogrel. Percutaneous coronary intervention: aspirin and clopidogrel (reference) compared with aspirin and prasugrel (ST elevation myocardial infarction only) or aspirin and ticagrelor. Primary outcome: any bleeding events up to 12 months after the index event. Secondary outcomes: major or minor bleeding, all-cause and cardiovascular mortality, mortality from bleeding, myocardial infarction, stroke, additional coronary intervention and major adverse cardiovascular events. The incidence of any bleeding was 5% among coronary artery bypass graft patients, 10% among conservatively managed acute coronary syndrome patients and 9% among emergency percutaneous coronary intervention patients, compared with 18% among patients prescribed triple therapy. Among coronary artery bypass grafting and conservatively managed acute coronary syndrome patients, dual antiplatelet therapy, compared with aspirin, increased the hazards of any bleeding (coronary artery bypass grafting: hazard ratio 1.43, 95% confidence interval 1.21 to 1.69 conservatively-managed acute coronary syndrome: hazard ratio 1.72, 95% confidence interval 1.15 to 2.57) and major adverse cardiovascular events (coronary artery bypass grafting: hazard ratio 2.06, 95% confidence interval 1.23 to 3.46 conservatively-managed acute coronary syndrome: hazard ratio 1.57, 95% confidence interval 1.38 to 1.78). Among emergency percutaneous coronary intervention patients, dual antiplatelet therapy with ticagrelor, compared with dual antiplatelet therapy with clopidogrel, increased the hazard of any bleeding (hazard ratio 1.47, 95% confidence interval 1.19 to 1.82), but did not reduce the incidence of major adverse cardiovascular events (hazard ratio 1.06, 95% confidence interval 0.89 to 1.27). Among ST elevation myocardial infarction percutaneous coronary intervention patients, dual antiplatelet therapy with prasugrel, compared with dual antiplatelet therapy with clopidogrel, increased the hazard of any bleeding (hazard ratio 1.48, 95% confidence interval 1.02 to 2.12), but did not reduce the incidence of major adverse cardiovascular events (hazard ratio 1.10, 95% confidence interval 0.80 to 1.51). Health-care costs in the first year did not differ between dual antiplatelet therapy with clopidogrel and aspirin monotherapy among either coronary artery bypass grafting patients (mean difference £94, 95% confidence interval –£155 to £763) or conservatively managed acute coronary syndrome patients (mean difference £610, 95% confidence interval –£626 to £1516), but among emergency percutaneous coronary intervention patients were higher for those receiving dual antiplatelet therapy with ticagrelor than for those receiving dual antiplatelet therapy with clopidogrel, although for only patients on concurrent proton pump inhibitors (mean difference £1145, 95% confidence interval £269 to £2195). This study suggests that more potent dual antiplatelet therapy may increase the risk of bleeding without reducing the incidence of major adverse cardiovascular events. These results should be carefully considered by clinicians and decision-makers alongside randomised controlled trial evidence when making recommendations about dual antiplatelet therapy. The estimates for bleeding and major adverse cardiovascular events may be biased from unmeasured confounding and the exclusion of an eligible subgroup of patients who could not be assigned an intervention. Because of these limitations, a formal cost-effectiveness analysis could not be conducted. Future work should explore the feasibility of using other UK data sets of routinely collected data, less susceptible to bias, to estimate the benefit and harm of antiplatelet interventions. This trial is registered as ISRCTN76607611. This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 27, No. 8. See the NIHR Journals Library website for further project information.
Publisher: BMJ
Date: 07-2019
DOI: 10.1136/BMJOPEN-2018-025700
Abstract: To identify the key drivers of cost-effectiveness for cardiovascular magnetic resonance (CMR) when patients activate the primary percutaneous coronary intervention (PPCI) pathway. Economic decision models for two patient subgroups populated from secondary sources, each with a 1 year time horizon from the perspective of the National Health Service (NHS) and personal social services in the UK. Usual care (with or without CMR) in the NHS. Patients who activated the PPCI pathway, and for Model 1: underwent an emergency coronary angiogram and PPCI, and were found to have multivessel coronary artery disease. For Model 2: underwent an emergency coronary angiogram and were found to have unobstructed coronary arteries. Model 1 (multivessel disease) compared two different ischaemia testing methods, CMR or fractional flow reserve (FFR), versus stress echocardiography. Model 2 (unobstructed arteries) compared CMR with standard echocardiography versus standard echocardiography alone. Key drivers of cost-effectiveness for CMR, incremental costs and quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios. In both models, the incremental costs and QALYs between CMR (or FFR, Model 1) versus no CMR (stress echocardiography, Model 1 and standard echocardiography, Model 2) were small (CMR: −£64 (95% CI −£232 to £187)/FFR: £360 (95% CI −£116 to £844) and CMR/FFR: 0.0012 QALYs (95% CI −0.0076 to 0.0093)) and (£98 (95% CI −£199 to £488) and 0.0005 QALYs (95% CI −0.0050 to 0.0077)), respectively. The diagnostic accuracy of the tests was the key driver of cost-effectiveness for both patient groups. If CMR were introduced for all subgroups of patients who activate the PPCI pathway, it is likely that diagnostic accuracy would be a key determinant of its cost-effectiveness. Further research is needed to definitively answer whether revascularisation guided by CMR or FFR leads to different clinical outcomes in acute coronary syndrome patients with multivessel disease.
Publisher: National Institute for Health and Care Research
Date: 10-2016
DOI: 10.3310/HTA20800
Abstract: Patients with neovascular age-related macular degeneration (nAMD) usually attend regular reviews, even when the disease is quiescent. Reviews are burdensome to health services, patients and carers. To compare the proportion of correct lesion classifications made by community-based optometrists and ophthalmologists from vignettes of patients to estimate the cost-effectiveness of community follow-up by optometrists compared with follow-up by ophthalmologists in the Hospital Eye Service (HES) to ascertain views of patients, their representatives, optometrists, ophthalmologists and clinical commissioners on the proposed shared care model. Community-based optometrists and ophthalmologists in the HES classified lesions from vignettes comprising clinical information, colour fundus photographs and optical coherence tomography images. Participants’ classifications were validated against experts’ classifications (reference standard). Internet-based application. Ophthalmologists had to have ≥ 3 years post-registration experience in ophthalmology, have passed part 1 of the Royal College of Ophthalmologists, Diploma in Ophthalmology or equivalent examination, and have experience in the age-related macular degeneration service. Optometrists had to be fully qualified, be registered with the General Optical Council for ≥ 3 years and not be participating in nAMD shared care. The trial sought to emulate a conventional trial in comparing optometrists’ and ophthalmologists’ decision-making, but vignettes, not patients, were assessed therefore, there were no interventions. Participants received training prior to assessing vignettes. Primary outcome – correct classification of the activity status of a lesion based on a vignette, compared with a reference standard. Secondary outcomes – frequencies of potentially sight-threatening errors, participants’ judgements about specific lesion components, participant-rated confidence in their decisions and cost-effectiveness of follow-up by community-based optometrists compared with HES ophthalmologists. In total, 155 participants registered for the trial 96 (48 in each professional group) completed training and main assessments and formed the analysis population. Optometrists and ophthalmologists achieved 1702 out of 2016 (84.4%) and 1722 out of 2016 (85.4%) correct classifications, respectively [odds ratio (OR) 0.91, 95% confidence interval (CI) 0.66 to 1.25 p = 0.543]. Optometrists’ decision-making was non-inferior to ophthalmologists’ with respect to the pre-specified limit of 10% absolute difference (0.298 on the odds scale). Frequencies of sight-threatening errors were similar for optometrists and ophthalmologists [57/994 (5.7%) vs. 62/994 (6.2%), OR 0.93, 95% CI 0.55 to 1.57 p = 0.789]. Ophthalmologists assessed lesion components as present less often than optometrists and were more confident about their lesion classifications than optometrists. The mean care-pathway cost for assessment was very similar by group, namely £397.33 for ophthalmologists and £410.78 for optometrists. The optometrist-led monitoring reviews were slightly more costly and less effective than ophthalmologist-led reviews, although the differences were extremely small. There was consensus that optometrist-led monitoring has the potential to reduce clinical workload and be more patient-centred. However, potential barriers are ophthalmologists’ perceptions of optometrists’ competence, the need for clinical training, the ability of the professions to work collaboratively and the financial feasibility of shared care for Clinical Commissioning Groups. The ability of optometrists to make nAMD retreatment decisions from vignettes is non-inferior to that of ophthalmologists. Various barriers to implementing shared cared for nAMD were identified. The Effectiveness, cost-effectiveness and acceptability of Community versus Hospital Eye Service follow-up for patients with neovascular age-related macular degeneration with quiescent disease (ECHoES) study web application was robust and could be used for future training or research. The benefit of reducing HES workload was not considered in the economic evaluation. A framework of programme budgeting and marginal analysis could explicitly explore the resource implications of shifting resources within a given health service area, as the benefit of reducing HES workload was not considered in the economic evaluation. Future qualitative research could investigate professional differences of opinion that were identified in multidisciplinary focus groups. Current Controlled Trials ISRCTN07479761. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 20, No. 80. See the NIHR Journals Library website for further project information.
Publisher: National Institute for Health and Care Research
Date: 10-2015
DOI: 10.3310/HTA19780
Abstract: Bevacizumab (Avastin ® , Roche), which is used in cancer therapy, is the ‘parent’ molecule from which ranibizumab (Lucentis ® , Novartis) was derived for the treatment of neovascular age-related macular degeneration (nAMD). There were reports in the literature on the effectiveness of bevacizumab in treating nAMD, but no trials. The cost per dose of bevacizumab is about 5–10% that of ranibizumab. This trial was a head-to-head comparison of these two drugs. To compare the clinical effectiveness and cost-effectiveness of ranibizumab and bevacizumab, and two treatment regimens, for nAMD. Multicentre, factorial randomised controlled trial with within-trial cost–utility and cost-minimisation analyses from the perspective of the UK NHS. Participants, health professionals and researchers were masked to allocation of drug but not regimen. Computer-generated random allocations to combinations of ranibizumab or bevacizumab, and continuous or discontinuous regimen, were stratified by centre, blocked and concealed. Twenty-three ophthalmology departments in NHS hospitals. Patients ≥ 50 years old with active nAMD in the study eye with best corrected distance visual acuity (BCVA) ≥ 25 letters measured on a Early Treatment of Diabetic Retinopathy Study (ETDRS) chart. Previous treatment for nAMD, long-standing disease, lesion diameter 6000 µm, thick blood at the fovea and any other confounding ocular disease were exclusion criteria. One eye per participant was studied the fellow eye was treated according to usual care, if required. Ranibizumab and bevacizumab were procured commercially. Doses were ranibizumab 0.5 mg or bevacizumab 1.25 mg. The repackaged bevacizumab was quality assured. All participants were treated at visits 0, 1 and 2. Participants randomised to the continuous regimen were treated monthly thereafter. Participants randomised to the discontinuous regimen were not retreated after visit 2 unless pre-specified criteria for active disease were met. If retreatment was needed, monthly injections over 3 months were mandated. The primary outcome was BCVA. The non-inferiority margin was 3.5 letters. Secondary outcomes were contrast sensitivity near visual acuity reading index neovascular lesion morphology generic and disease-specific patient-reported outcomes, including macular disease-specific quality of life survival free from treatment failure resource use quality-adjusted life-years (QALYs) and development of new geographic atrophy (GA) (outcome added during the trial). Results are reported for the study eye, except for patient-reported outcomes. Between 27 March 2008 and 15 October 2010, 610 participants were allocated and treated (314 ranibizumab, 296 bevacizumab at 3 months, 305 continuous, 300 discontinuous). After 2 years, bevacizumab was neither non-inferior nor inferior to ranibizumab [–1.37 letters, 95% confidence interval (CI) –3.75 to +1.01 letters] and discontinuous treatment was neither non-inferior nor inferior to continuous treatment (–1.63 letters, 95% CI –4.01 to +0.75 letters). Lesion thickness at the fovea was similar by drug [geometric mean ratio (GMR) 0.96, 95% CI 0.90 to 1.03 p = 0.24] but 9% less with continuous treatment (GMR 0.91, 95% CI 0.85 to 0.97 p = 0.004). Odds of developing new GA during the trial were similar by drug [odds ratio (OR) 0.87, 95% CI 0.61 to 1.25 p = 0.46] but significantly higher with continuous treatment (OR 1.47, 95% CI 1.03 to 2.11 p = 0.033). Safety outcomes did not differ by drug but mortality was lower with continuous treatment (OR 0.47, 95% CI 0.22 to 1.03 p = 0.05). Continuous ranibizumab cost £3.5M per QALY compared with continuous bevacizumab continuous bevacizumab cost £30,220 per QALY compared with discontinuous bevacizumab. These results were robust in sensitivity analyses. Ranibizumab and bevacizumab have similar efficacy. Discontinuing treatment and restarting when required results in slightly worse efficacy. Safety was worse with discontinuous treatment, although new GA developed more often with continuous treatment. Ranibizumab is not cost-effective, although it remains uncertain whether or not continuous bevacizumab is cost-effective compared with discontinuous bevacizumab at £20,000 per QALY threshold. Future studies should focus on the ocular safety of the two drugs, further optimisation of treatment regimens and criteria for stopping treatment. Current Controlled Trials ISRCTN92166560. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 19, No. 78. See the NIHR Journals Library website for further project information.
Publisher: Oxford University Press (OUP)
Date: 06-2002
Abstract: There are several alternatives for providing ultrasound scanning, besides traditional hospital-based services. One such alternative is for general practitioners (GPs) to perform scanning in the community. The aim of this study was to evaluate the impact of GP ultrasound scanning on the use of National Health Service (NHS) resources in the United Kingdom (UK), and elicit patients' preferences for having an ultrasound scan. A cost analysis and an assessment of quality of GP scans, based on a clinical audit and a postal survey of patients' preferences, were carried out. The setting was a rural general practice and urban teaching hospital in the Gr ian region of Scotland. The analysis of costs and assessment of the quality of GP scans were based on 131 patients scanned at the practice in a 6 month clinical audit period. The survey of patients' preferences was undertaken on a random s le of 500 patients from the GPs' list and 250 consecutive patients scanned at the practice. The assessment of the management of patients during audit revealed that the scanner at the practice reduced the number of hospital scans, number of out-patient and in-patient visits, and emergency admissions. The unit cost of a scan was higher in the practice than at the hospital. However, when all the costs for a scanning episode were considered, the total and average costs were lower in the practice because of the avoidance of hospital visits. The results showed that the quality of GP scanning, subject to further training, was considered to be sufficient to continue scanning at the practice. Patients preferred to be scanned at the practice, and were prepared to wait up to an extra 5 days, and accept a reduction in the accuracy of scanning of up to 3.5 per cent for their choice. Who carried out the scan was not important to patients. Although the results of the study provide some evidence to support GP scanning in this setting, further research on diagnostic accuracy and alternative models of care need to be conducted.
Publisher: Springer Science and Business Media LLC
Date: 26-05-2017
Publisher: BMJ
Date: 06-2019
DOI: 10.1136/BMJOPEN-2019-029388
Abstract: ‘Real world’ bleeding in patients exposed to different regimens of dual antiplatelet therapy (DAPT) and triple therapy (TT, DAPT plus an anticoagulant) have a clinical and economic impact but have not been previously quantified. We will use linked Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) data to assemble populations eligible for three ‘target trials’ in patient groups: percutaneous coronary intervention (PCI) coronary artery bypass grafting (CABG) conservatively managed (medication only) acute coronary syndrome (ACS). Patients ≥18 years old will be eligible if, in CPRD records, they have: ≥1 year of data before the index event no prescription for DAPT or anticoagulants in the preceding 3 months a prescription for aspirin or DAPT within 2 months after discharge from the index event. The primary outcome will be any bleeding event (CPRD or HES) up to 12 months after the index event. We will estimate adjusted HR for time to first bleeding event comparing: aspirin and clopidogrel (reference) versus aspirin and prasugrel or aspirin and ticagrelor after PCI and aspirin (reference) versus aspirin and clopidogrel after CABG and ACS. We will describe rates of bleeding in patients prescribed TT (DAPT plus an anticoagulant). Potential confounders will be identified systematically using literature review, semistructured interviews with clinicians and a short survey of clinicians. We will conduct sensitivity analyses addressing the robustness of results to the study’s main limitation—that we will not be able to identify the intervention group for patients whose bleeding event occurs before a DAPT prescription in CPRD. This protocol was approved by the Independent Scientific Advisory Committee for the UK Medicines and Healthcare Products Regulatory Agency Database Research (protocol 16_126R) and the South West Cornwall and Plymouth Research Ethics Committee (17/SW/0092). The findings will be presented in peer-reviewed journals, lay summaries and briefing papers to commissioners/other stakeholders. 76607611 Pre-results.
Publisher: Springer Science and Business Media LLC
Date: 27-10-2018
DOI: 10.1007/S11695-018-3553-9
Abstract: There is a growing interest in comparing the effectiveness and costs of alternative forms of bariatric surgery. We aimed to examine the per-patient, procedural costs of Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG) and adjustable gastric banding (AGB) in the United Kingdom. Multi-centre (two National Health Service NHS and one private hospital) micro-costing, using a time-and-motion study. Prospective collection of surgery times, staff quantities, equipment, instruments and consumables for 12 patients (four RYGB, five SG, three AGB) from patients' first surgeon interaction on the day of surgery to departure from the theatre recovery area. Costs were attached to quantities and mean costs compared. Sensitivity and scenario analyses assessed the impact of varying surgery inputs and consideration of additional plausible factors respectively on total costs. Mean procedural costs were £5002 for RYGB, £4306 for SG and £2527 for AGB. Varying staff seniority or altering procedure times had small impacts on costs (± 4-6%). Reducing prices of consumables by 20% reduced costs by 10-13%. Accounting for differences in surgical technique by altering the number of staple reloads used impacted costs by ± 7-10%. Adjusted total costs from scenario analyses were similar to NHS tariffs for RYGB and SG (difference of £51 and -£119 respectively) but were much lower for AGB (difference of £1982). These detailed costs will allow for more precise reimbursement of bariatric surgery and support comprehensive assessments of cost-effectiveness. Additional work to investigate costs of post-surgical care, re-operations and life-long support received by patients following surgery is required.
Publisher: American Association for the Advancement of Science (AAAS)
Date: 05-04-2019
Abstract: As antibiotic consumption grows, bacteria are becoming increasingly resistant to treatment. Antibiotic resistance undermines much of modern health care, which relies on access to effective antibiotics to prevent and treat infections associated with routine medical procedures. The resulting challenges have much in common with those posed by climate change, which economists have responded to with research that has informed and shaped public policy. Drawing on economic concepts such as externalities and the principal-agent relationship, we suggest how economics can help to solve the challenges arising from increasing resistance to antibiotics. We discuss solutions to the key economic issues, from incentivizing the development of effective new antibiotics to improving antibiotic stewardship through financial mechanisms and regulation.
Publisher: Springer Science and Business Media LLC
Date: 20-09-2018
Publisher: Elsevier BV
Date: 09-2022
DOI: 10.1016/J.SEMCANCER.2021.06.018
Abstract: Precision diagnostics is one of the two pillars of precision medicine. Sequencing efforts in the past decade have firmly established cancer as a primarily genetically driven disease. This concept is supported by therapeutic successes aimed at particular pathways that are perturbed by specific driver mutations in protein-coding domains and reflected in three recent FDA tissue agnostic cancer drug approvals. In addition, there is increasing evidence from studies that interrogate the entire genome by whole-genome sequencing that acquired global and complex genomic aberrations including those in non-coding regions of the genome might also reflect clinical outcome. After addressing technical, logistical, financial and ethical challenges, national initiatives now aim to introduce clinical whole-genome sequencing into real-world diagnostics as a rational and potentially cost-effective tool for response prediction in cancer and to identify patients who would benefit most from 'expensive' targeted therapies and recruitment into clinical trials. However, so far, this has not been accompanied by a systematic and prospective evaluation of the clinical utility of whole-genome sequencing within clinical trials of uniformly treated patients of defined clinical outcome. This approach would also greatly facilitate novel predictive biomarker discovery and validation, ultimately reducing size and duration of clinical trials and cost of drug development. This manuscript is the third in a series of three to review and critically appraise the potential and challenges of clinical whole-genome sequencing in solid tumors and hematological malignancies.
Publisher: Elsevier BV
Date: 05-2020
Publisher: BMJ
Date: 07-2016
Publisher: Elsevier BV
Date: 08-2019
DOI: 10.1016/J.CANEP.2019.05.002
Abstract: Exposure to ultraviolet radiation from sunlight is directly associated with melanoma skin cancer, however reducing sun-exposure can be difficult to achieve at a population level. Using a genomic risk information behaviour change trial for melanoma prevention, we classified participants as risk-seeking, risk-neutral or risk-averse for domain-specific risk taking (DOSPERT). One-way ANOVA determined the association between socio-demographic characteristics and risk-taking score, and multivariable linear regression ascertained impact of an in idual's underlying risk propensity on an objective measure of sun-exposure, standard erythemal dose (SED), at 3-months follow-up. Of 119 participants, mean age 53 years 50% males, 87% had a personal/family history of cancer 19% were classified risk-seeking, 57% risk-neutral. The mean risk-taking score was significantly higher in younger participants (≤50 years: 13.86 vs. >50 years: 11.11, p = 0.003) and lower in those with a personal/family history of skin cancer versus without (10.55 vs 13.33, p = 0.009). Risk averse in iduals had lower weekly mean SEDs at 3-months than risk neutral and risk seeking in iduals (2.56, 5.81, 4.81 respectively, p = 0.01). Risk seekers showed fewer sun protective habits (p < 0.001) and higher intentional tanning, (p = 0.01). At 3-months, risk seekers attained 16%-54% lower SEDs in the genomic information group compared with controls, however this was not significantly different across risk groups (interaction p = 0.13). An in idual's underlying risk attitude is likely associated with sun-exposure behaviours, and may modify the effect of a genomic risk information behaviour change intervention. Young people and risk seekers may benefit most from being given information on their genetic risk of melanoma.
Publisher: Elsevier BV
Date: 09-2018
DOI: 10.1016/J.JVAL.2018.06.016
Abstract: Next-generation sequencing (NGS) is considered to be a prominent ex le of "big data" because of the quantity and complexity of data it produces and because it presents an opportunity to use powerful information sources that could reduce clinical and health economic uncertainty at a patient level. One obstacle to translating NGS into routine health care has been a lack of clinical trials evaluating NGS technologies, which could be used to populate cost-effectiveness analyses (CEAs). A key question is whether big data can be used to partially support CEAs of NGS. This question has been brought into sharp focus with the creation of large national sequencing initiatives. In this article we summarize the main methodological and practical challenges of using big data as an input into CEAs of NGS. Our focus is on the challenges of using large observational datasets and cohort studies and linking these data to the genomic information obtained from NGS, as is being pursued in the conduct of large genomic sequencing initiatives. We propose potential solutions to these key challenges. We conclude that the use of genomic big data to support and inform CEAs of NGS technologies holds great promise. Nevertheless, health economists face substantial challenges when using these data and must be cognizant of them before big data can be confidently used to produce evidence on the cost-effectiveness of NGS.
Publisher: Springer Science and Business Media LLC
Date: 30-06-2020
DOI: 10.1186/S13063-020-04351-W
Abstract: The Melanoma Genomics Managing Your Risk Study is a randomised controlled trial that aims to evaluate the efficacy of providing information on personal genomic risk of melanoma in reducing ultraviolet radiation (UV) exposure, stratified by traditional risk group (low or high phenotypic risk) in the general population. The primary outcome is objectively measured total daily Standard Erythemal Doses at 12 months. Secondary outcomes include UV exposure at specific time periods, self-reported sun protection and skin-examination behaviours, psychosocial outcomes, and ethical considerations surrounding offering genomic testing at a population level. A within-trial and modelled economic evaluation will be undertaken from an Australian health system perspective to assess the cost-effectiveness of the intervention. To publish the pre-determined statistical analysis plan (SAP) before database lock and the start of analysis. This SAP describes the data synthesis, analysis principles and statistical procedures for analysing the outcomes from this trial. The SAP was approved after closure of recruitment and before completion of patient follow-up. It outlines the planned primary analyses and a range of subgroup and sensitivity analyses. Health economic outcomes are not included in this plan but will be analysed separately. The SAP will be adhered to for the final data analysis of this trial to avoid potential analysis bias that may arise from knowledge of the outcome data. This SAP is consistent with best practice and should enable transparent reporting. This SAP has been developed for the Melanoma Genomics Managing Your Risk Study and will be followed to ensure high-quality standards of internal validity and to minimise analysis bias. Prospectively registered with the Australian New Zealand Clinical Trials Registry, ID: ACTR N12617000691347 . Registered on 15 May 2017.
Publisher: Elsevier BV
Date: 02-2019
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Sarah Wordsworth.