Cognitive skills and the LOGSE reform in Spain: evidence from PIAAC

We use data from the Spanish sample of the Programme for the International Assessment of Adult Competencies to analyze the effect of the LOGSE (Spanish acronym for General Law of the Education System) reform passed in 1990 on numeracy and literacy proficiency of the adult population. The LOGSE effect is identified by exploiting the variability of the rate of implementation among cohorts and regions. The results change depending on the specification of the econometric model and mainly on the type of birth year trend assumed. Nonetheless, overall results suggest that the LOGSE reform did not help to increase cognitive skills of the population despite an extension of compulsory years of education and postponement of the age of initial tracking into vocational and academic studies

Health economic evaluation of lung cancer screening using a 2 diagnostic blood test : the Early detection of Cancer of the Lung 3 Scotland (ECLS)

Funding: Funding for the ECLS study was received from Oncimmune Ltd and the Scottish Government Health & Social Care Directorate of the Chief Scientist Office (CSO).Background: Diagnostic blood tests have the potential to identify lung cancer in people at high risk. We assessed the cost-effectiveness of a lung cancer screening intervention, using the EarlyCDT®-Lung Test (ECLS) with subsequent X-ray and low-dose chest CT scans (LDCT) for patients with a positive test result, compared to both usual care and LDCT screening for the target population. Methods: We conducted a model-based lifetime analysis from a UK NHS and personal social services perspective. We estimated incremental net monetary benefit (NMB) for the ECLS intervention compared to no screening and to LDCT screening. Results: The incremental NMB of ECLS intervention compared to no screening was GBP 33,179 (95% CI: −GBP 81,396, GBP 147,180) and GBP 140,609 (95% CI: -GBP 36,255, GBP 316,612), respectively, for a cost-effectiveness threshold of GBP 20,000 and GBP 30,000 per quality-adjusted life year. The same figures compared with LDCT screening were GBP 162,095 (95% CI: GBP 52,698, GBP 271,735) and GBP 52,185 (95% CI: −GBP 113,152, GBP 220,711). Conclusions: The ECLS intervention is the most cost-effective screening alternative, with the highest probability of being cost-effective, when compared to no screening or LDCT screening. This result may change with modifications of the parameters, suggesting that the three alternatives considered in the main analysis are potentially cost-effective.Peer reviewe

Health economic evaluation of lung cancer screening using a diagnostic blood test: the Early detection of Cancer of the Lung Scotland (ECLS)

Background: Diagnostic blood tests have the potential to identify lung cancer in people at high risk. We assessed the cost-effectiveness of a lung cancer screening intervention, using the Early CDT®-Lung Test (ECLS) with subsequent X-ray and low-dose chest CT scans (LDCT) for patients with a positive test result, compared to both usual care and LDCT screening for the target population. Methods: We conducted a model-based lifetime analysis from a UK NHS and personal social services perspective. We estimated incremental net monetary benefit (NMB) for the ECLS intervention compared to no screening and to LDCT screening. Results: The incremental NMB of ECLS intervention compared to no screening was GBP 33,179 (95% CI: −GBP 81,396, GBP 147,180) and GBP 140,609 (95% CI: -GBP 36,255, GBP 316,612), respectively, for a cost-effectiveness threshold of GBP 20,000 and GBP 30,000 per quality-adjusted life year. The same figures compared with LDCT screening were GBP 162,095 (95% CI: GBP 52,698, GBP 271,735) and GBP 52,185 (95% CI: −GBP 113,152, GBP 220,711). Conclusions: The ECLS intervention is the most cost-effective screening alternative, with the highest probability of being cost-effective, when compared to no screening or LDCT screening. This result may change with modifications of the parameters, suggesting that the three alternatives considered in the main analysis are potentially cost-effective

Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum

Objective: To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. Methods: Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. Interventions: Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. Results: Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was −0.02 (95% CI −0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. Conclusions: There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. Trial registration: Current Controlled Trials ISRCTN25260464

Economic evaluation of culprit lesion only PCI vs. immediate multivessel PCI in acute myocardial infarction complicated by cardiogenic shock: the CULPRIT-SHOCK trial.

BACKGROUND: The CULPRIT-SHOCK trial compared two treatment strategies for patients with acute myocardial infarction and multivessel coronary artery disease complicated by cardiogenic shock: (a) culprit vessel only percutaneous coronary intervention (CO-PCI), with additional staged revascularisation if indicated, and (b) immediate multivessel PCI (MV-PCI). METHODS: A German societal and national health service perspective was considered for three different analyses. The cost utility analysis (CUA) estimated costs and quality adjusted life years (QALYs) based on a pre-trial decision analytic model taking a lifelong time horizon. In addition, a within trial CUA estimated QALYs and costs for 1 year. Finally, the cost effectiveness analysis (CEA) used the composite primary outcome, mortality and renal failure at 30-day follow-up, and the within trial costs. Econometric and survival analysis on the trial data was used for the estimation of the model parameters. Subgroup analysis was performed following an economic protocol. RESULTS: The lifelong CUA showed an incremental cost effectiveness ratio (ICER), CO-PCI vs. MV-PCI, of €7010 per QALY and a probability of CO-PCI being the most cost-effective strategy > 64% at a €30,000 threshold. The ICER for the within trial CUA was €14,600 and the incremental cost per case of death/renal failure avoided at 30-day follow-up was €9010. Cost-effectiveness improved with patient age and for those without diabetes. CONCLUSIONS: The estimates of cost-effectiveness for CO-PCI vs. MV-PCI have been shown to change depending on the time horizon and type of economic evaluation performed. The results favoured a long-term horizon analysis for avoiding underestimation of QALY gains from the CO-PCI arm

Three versus six months of adjuvant doublet chemotherapy for patients with colorectal cancer: a multi-country cost-effectiveness and budget impact analysis

Introduction: The Short Course Oncology Treatment (SCOT) trial demonstrated non-inferiority, less toxicity and cost-effectiveness from a UK perspective of 3 versus 6 months of oxaliplatin-based chemotherapy for patients with colorectal cancer. This study assessed the cost-effectiveness of shorter treatment, and the budget impact of implementing trial findings from the perspective of all countries that recruited to SCOT: Australia, Denmark, New Zealand, Spain, Sweden and the UK. Methods: Individual cost-utility analyses (CUAs) were performed from the perspective of each country. Resource, quality of life and survival estimates from the SCOT trial (n=6,065) were used. Probabilistic sensitivity analysis and sub-group analyses were undertaken. Using undiscounted costs from these CUAs, the impact on the country specific healthcare budgets of implementing the SCOT trial findings was calculated over a 5-year period. United States dollars were the currency used, with 2019 as base year. One-way and scenario sensitivity analysis addressed uncertainty within the budget impact analysis. Results: Three months of treatment was cost-saving and cost-effective compared to 6 months from the perspective of all countries. The incremental net monetary benefit per patient ranged from $8,972 (Spain) to$13,884 (Denmark). The healthcare budget impact over 5 years for the base case scenario ranged from $3.6 million (New Zealand) to$61.4 million (UK) and totalled over $150 million across all countries. Discussion: This study has widened the transferability of results from the SCOT trial, showing shorter treatment is cost-effective from a multi-country perspective. The vast savings from implementation could fully justify the investment in conducting the SCOT trial

3-month versus 6-month adjuvant chemotherapy for patients with high-risk stage II and III colorectal cancer: 3-year follow-up of the SCOT non-inferiority RCT.

BACKGROUND: Oxaliplatin and fluoropyrimidine chemotherapy administered over 6 months is the standard adjuvant regimen for patients with high-risk stage II or III colorectal cancer. However, the regimen is associated with cumulative toxicity, characterised by chronic and often irreversible neuropathy. OBJECTIVES: To assess the efficacy of 3-month versus 6-month adjuvant chemotherapy for colorectal cancer and to compare the toxicity, health-related quality of life and cost-effectiveness of the durations. DESIGN: An international, randomised, open-label, non-inferiority, Phase III, parallel-group trial. SETTING: A total of 244 oncology clinics from six countries: UK (England, Scotland, Wales and Northern Ireland), Denmark, Spain, Sweden, Australia and New Zealand. PARTICIPANTS: Adults aged ≥ 18 years who had undergone curative resection for high-risk stage II or III adenocarcinoma of the colon or rectum. INTERVENTIONS: The adjuvant treatment regimen was either oxaliplatin and 5-fluorouracil or oxaliplatin and capecitabine, randomised to be administered over 3 or 6 months. MAIN OUTCOME MEASURES: The primary outcome was disease-free survival. Overall survival, adverse events, neuropathy and health-related quality of life were also assessed. The main cost categories were chemotherapy treatment and hospitalisation. Cost-effectiveness was assessed through incremental cost comparisons and quality-adjusted life-year gains between the options and was reported as net monetary benefit using a willingness-to-pay threshold of £30,000 per quality-adjusted life-year per patient. RESULTS: Recruitment is closed. In total, 6088 patients were randomised (3044 per group) between 27 March 2008 and 29 November 2013, with 6065 included in the intention-to-treat analyses (3-month analysis, n = 3035; 6-month analysis, n = 3030). Follow-up for the primary analysis is complete. The 3-year disease-free survival rate in the 3-month treatment group was 76.7% (standard error 0.8%) and in the 6-month treatment group was 77.1% (standard error 0.8%), equating to a hazard ratio of 1.006 (95% confidence interval 0.909 to 1.114; p-value for non-inferiority = 0.012), confirming non-inferiority for 3-month adjuvant chemotherapy. Frequent adverse events (alopecia, anaemia, anorexia, diarrhoea, fatigue, hand-foot syndrome, mucositis, sensory neuropathy, neutropenia, pain, rash, altered taste, thrombocytopenia and watery eye) showed a significant increase in grade with 6-month duration; the greatest difference was for sensory neuropathy (grade ≥ 3 was 4% for 3-month vs.16% for 6-month duration), for which a higher rate of neuropathy was seen for the 6-month treatment group from month 4 to ≥ 5 years (p < 0.001). Quality-of-life scores were better in the 3-month treatment group over months 4-6. A cost-effectiveness analysis showed 3-month treatment to cost £4881 less over the 8-year analysis period, with an incremental net monetary benefit of £7246 per patient. CONCLUSIONS: The study achieved its primary end point, showing that 3-month oxaliplatin-containing adjuvant chemotherapy is non-inferior to 6 months of the same regimen; 3-month treatment showed a better safety profile and cost less. For future work, further follow-up will refine long-term estimates of the duration effect on disease-free survival and overall survival. The health economic analysis will be updated to include long-term extrapolation for subgroups. We expect these analyses to be available in 2019-20. The Short Course Oncology Therapy (SCOT) study translational samples may allow the identification of patients who would benefit from longer treatment based on the molecular characteristics of their disease. TRIAL REGISTRATION: Current Controlled Trials ISRCTN59757862 and EudraCT 2007-003957-10. FUNDING: 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. 23, No. 64. See the NIHR Journals Library website for further project information. This research was supported by the Medical Research Council (transferred to NIHR Evaluation, Trials and Studies Coordinating Centre - Efficacy and Mechanism Evaluation; grant reference G0601705), the Swedish Cancer Society and Cancer Research UK Core Clinical Trials Unit Funding (funding reference C6716/A9894)

Earlier diagnosis of lung cancer in a randomised trial of an autoantibody blood test followed by imaging

The EarlyCDT-Lung test is a high specificity blood-based autoantibody biomarker that could contribute to predicting lung cancer risk. Here we report on the results of a phase IV biomarker evaluation of whether using the EarlyCDT-Lung test and any subsequent CT scanning to identify those at high risk of lung cancer reduces the incidence of patients with stage III/IV/Unspecified lung cancer at diagnosis, compared with the standard clinical practice at the time the study began.ECLS was a randomised controlled trial of 12,208 participants at risk of developing lung cancer in Scotland. The intervention arm received the EarlyCDT-Lung test and, if test positive, low-dose CT scanning six-monthly for up to two years. EarlyCDT-Lung test negative and control arm participants received standard clinical care. Outcomes wereassessed at two years post-randomisation using validated data on cancer occurrence, cancer staging, mortality and comorbidities. At two years, 127 lung cancers were detected in the study population (1.0%). In the intervention arm, 33/56 (58.9%) lung cancers were diagnosed at stage III/IV compared to 52/71 (73.2%) in the control arm. The hazard ratio for stage III/IV presentation was 0.64 (95% confidence interval 0.41, 0.99). There were non-significant differences in lung cancer and all-cause mortality after two years.ECLS compared EarlyCDT-Lung plus CT screening to standard clinical care (symptomatic presentation), and was not designed to assess the incremental contribution of the EarlyCDT-Lung test. The observation of a stage-shift towards earlier-stage lung cancer diagnosis merits further investigations to evaluate whether the EarlyCDT-Lung test adds anything to the emerging standard of LDCT.Registration: ClinicalTrials.Gov registration number NCT01925625

Reducing the basic reproduction number of COVID-19: a model simulation focused on QALYs, hospitalisation, productivity costs and optimal (soft) lockdown

Even if public health interventions are successful at reducing the spread of COVID-19, there is no guarantee that they will bring net benefits to the society because of the dynamic nature of the pandemic, e.g., the risk of a second outbreak if those interventions are stopped too early, and the costs of a continued lockdown. In this analysis, a discrete-time dynamic model is used to simulate the effect of reducing the effective reproduction number, driven by lockdowns ordered in March 2020 in four European countries (UK, France, Italy and Spain), on QALYs and hospitalisation costs. These benefits are valued in monetary terms (€30,000 per QALY assumed) and compared to productivity costs due to reduced economic activity during the lockdown. An analysis of the optimal duration of lockdown is performed where a net benefit is maximised. The switch to a soft lockdown is analysed and compared to a continued lockdown or no intervention. Results vary for two assumptions about hospital capacity of the health system: (a) under unlimited capacity, average benefit ranges from 8.21 to 14.21% of annual GDP, for UK and Spain, respectively; (b) under limited capacity, average benefits are higher than 30.32% of annual GDP in all countries. The simulation results imply that the benefits of lockdown are not substantial unless continued until vaccination of high-risk groups is complete. It is illustrated that lockdown may not bring net benefits under some scenarios and a soft lockdown will be a more efficient alternative from mid-June 2020 only if the basic reproduction number is maintained low (not necessarily below 1) and productivity costs are sufficiently reduced