To determine the cost-effectiveness of prenatal chromosomal microarray (CMA) when performed for structural anomalies on fetal ultrasound scan over conventional techniques.
A decision tree was ...populated using data from a prospective cohort of women undergoing testing when a fetal ultrasound scan showed a structural abnormality. Nine strategies of testing were modeled including combinations of the tests: QFPCR, G-band karyotyping, CMA and FISH for DiGeorge (22q) microdeletion.
When CMA costs GBP 405 and using a 1-Mb BAC array it would cost GBP 24,600 for every additional case detected by CMA over a combination of QFPCR, followed by G-band karyotype, followed lastly by FISH (for DiGeorge syndrome). If CMA is performed instead of conventional karyotyping alone it costs GBP 33,000 for every additional case detected. However, if the cost of CMA is reduced to GBP 360 than when CMA is performed instead of conventional karyotyping alone it would cost GBP 9,768 for every additional case detected.
The use of a prenatal BAC CMA is not currently cost-effective when compared to other testing strategies. However, as CMA costs decrease and resolution (and detection rates) increase it is likely to become the cost-effective option of the future.
Background: Results of previous research have identified the need for further investigation into the compliance with good practice guidelines for current decision-analytic modeling (DAM). Objective: ...To identify the extent to which recent model-based economic evaluations of interventions focused on lowering the blood pressure (BP) of patients with hypertension conform to published guidelines for DAM in health care using a five-dimension framework developed to assess compliance to DAM guidelines. Methods: A systematic review of English language articles was undertaken to identify published model-based economic evaluations that examined interventions aimed at lowering BP. The review covered the period January 2000 to March 2015 and included the following electronic bibliographic databases: EMBASE and Medline via Ovid interface and the Centre for Reviews and Dissemination’s (CRD) NHS-EED. Data were extracted based on different components of good practice across five dimensions utilizing a framework to assess compliance to DAM guidelines. Results: Thirteen articles were included in this review. The review found limited compliance to good practice DAM guidelines, which was most frequently justified by the lack of data. Conclusions: The assessment of structural uncertainty cannot yet be considered common practice in primary prevention and management of hypertension, and researchers seem to face difficulties with identifying sources of structural uncertainty and then handling them correctly. Additional guidelines are needed to aid researchers in identifying and managing sources of potential structural uncertainty. Adherence to guidelines is not always possible and it does pose challenges, in particular when there are limitations due to data availability that restrict, for example, a validation process.
Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many ...women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date.
The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome.
This trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy.
ISRCTN48600346.
Abstract Objective To evaluate the effectiveness of a practice nurse led strategy to improve the notification and treatment of partners of people with chlamydia infection. Design Randomised ...controlled trial. Setting 27 general practices in the Bristol and Birmingham areas. Participants 140 men and women with chlamydia (index cases) diagnosed by screening of a home collected urine sample or vulval swab specimen. Interventions Partner notification at the general practice immediately after diagnosis by trained practice nurses, with telephone follow up by a health adviser; or referral to a specialist health adviser at a genitourinary medicine clinic. Main outcome measures Primary outcome was the proportion of index cases with at least one treated sexual partner. Specified secondary outcomes included the number of sexual contacts elicited during a sexual history, positive test result for chlamydia six weeks after treatment, and the cost of each strategy in 2003 sterling prices. Results 65.3% (47/72) of participants receiving practice nurse led partner notification had at least one partner treated compared with 52.9% (39/68) of those referred to a genitourinary medicine clinic (risk difference 12.4%, 95% confidence interval −1.8% to 26.5%). Of 68 participants referred to the clinic, 21 (31%) did not attend. The costs per index case were £32.55 for the practice nurse led strategy and £32.62 for the specialist referral strategy. Conclusion Practice based partner notification by trained nurses with telephone follow up by health advisers is at least as effective as referral to a specialist health adviser at a genitourinary medicine clinic, and costs the same. Trial registration Clinical trials: NCT00112255.
Background
Heart failure is a treatable condition but making a diagnosis can be challenging.
Objective
To evaluate the performance of a clinical decision rule (CDR) with or without a natriuretic ...peptide assay for identifying heart failure in symptomatic patients presenting to primary care.
Design
Prospective, observational, diagnostic validation study and economic evaluation.
Setting
Twenty-eight general practices in central England, UK.
Participants
Primary care patients aged ≥ 55 years presenting with recent new-onset shortness of breath, lethargy or peripheral ankle oedema of > 48 hours’ duration.
Instrument
The CDR included a clinical element (male, history of myocardial infarction, crepitations at the lung bases and oedema) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) blood test. The reference standard was an expert consensus panel of three cardiology specialists.
Main outcome measure
The main outcome measure was test performance of the CDR and the natriuretic peptide test alone, and in combination, in estimating sensitivity and specificity, positive predictive value (PPV) and negative predictive value (NPV) for a diagnosis of heart failure. Economic evaluation of a decision tree with a NHS/Personal Social Services perspective determined the cost per quality-adjusted life-year (QALY) gained.
Results
In total, 304 participants were recruited to the validation cohort. The mean age was 73.9 years (standard deviation 8.8 years) and 124 (40.8%) participants were male. In total, 104 34.2%, 95% confidence interval (CI) 28.9% to 39.8% had a confirmed diagnosis of heart failure. The CDR had a sensitivity of 90% (95% CI 83% to 95%), specificity of 46% (95% CI 39% to 53%), PPV of 46% (95% CI 39% to 53%) and NPV of 90% (95% CI 83% to 95%). NT-proBNP level alone with a cut-off point of < 400 pg/ml had a sensitivity of 77% (95% CI 68% to 85%) and specificity of 92% (95% CI 87% to 95%). At the lower cut-off point of 125 pg/ml, sensitivity was 94% (95% CI 88% to 98%) and specificity was 49% (95% CI 42% to 56%). The economic model results suggest that referring a patient for a confirmatory diagnosis if they have had a previous myocardial infarction or have a NT-proBNP level that is greater than a 400 pg/ml threshold (current practice in England) is the most cost-effective option, with a cost of £4400 per QALY gained compared with a do nothing strategy. The base-case results were robust to deterministic and probabilistic sensitivity analyses.
Conclusions
Natriuretic peptide testing alone performed as well as the validated CDR in determining which patients presenting with symptoms went on to have a diagnosis of heart failure. The current NT-proBNP cut-off point of 400 pg/ml used in the UK is too high and means that one in five patients with heart failure may not be appropriately referred for further investigation and diagnosis, but this threshold was cost-effective in the REFer for EchocaRdiogram (REFER) trial. The study found only three patients with heart failure with reduced ejection fraction (HFREF), which might limit the benefits of early detection. The other diagnostic strategies with lower NT-proBNP referral levels become more cost-effective as the proportion of HFREF patients increases. International consensus on the optimal cut-off point for natriuretic peptide testing in patients with symptoms suggestive of heart failure should be sought.
Trial registration
Current Controlled Trials ISRCTN17635379.
Funding
This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and NIHR partnership.
Smoking prevalence is high among Pakistani and Bangladeshi men in the UK, but there are few tailored smoking cessation programmes for Pakistani and Bangladeshi communities. The aim of this study was ...to pilot a cluster randomised controlled trial comparing the effectiveness of Pakistani and Bangladeshi smoking cessation outreach workers with standard care to improve access to and the success of English smoking cessation services.
A pilot cluster randomised controlled trial was conducted in Birmingham, UK. Geographical lower layer super output areas were used to identify natural communities where more than 10% of the population were of Pakistani and Bangladeshi origin. 16 agglomerations of super output areas were randomised to normal care controls vs. outreach intervention. The number of people setting quit dates using NHS services, validated abstinence from smoking at four weeks, and stated abstinence at three and six months were assessed. The impact of the intervention on choice and adherence to treatments, attendance at clinic appointments and patient satisfaction were also assessed.
We were able to randomise geographical areas and deliver the outreach worker-based services. More Pakistani and Bangladeshi men made quit attempts with NHS services in intervention areas compared with control areas, rate ratio (RR) 1.32 (95%CI: 1.03-1.69). There was a small increase in the number of 4-week abstinent smokers in intervention areas (RR 1.30, 95%CI: 0.82-2.06). The proportion of service users attending weekly appointments was lower in intervention areas than control areas. No difference was found between intervention and control areas in choice and adherence to treatments or patient satisfaction with the service. The total cost of the intervention was £124,000; an estimated cost per quality-adjusted life year (QALY) gained of £8,500.
The intervention proved feasible and acceptable. Outreach workers expanded reach of smoking cessation services in diverse locations of relevance to Pakistani and Bangladeshi communities. The outreach worker model has the potential to increase community cessation rates and could prove cost-effective, but needs evaluating definitively in a larger, appropriately powered, randomised controlled trial. These future trials of outreach interventions need to be of sufficient duration to allow embedding of new models of service delivery.
Current Controlled Trials ISRCTN82127540.
Background. The ``gold-standard'' evidence of effectiveness for a clinical practice guideline is the randomized controlled trial (RCT), although RCTs have a limited ability to explore potential ...management strategies for a chronic disease where these interact over time. Modeling can be used to fill this gap, and models have become increasingly complex, with both dynamic sampling and representation of second-order uncertainty to provide more precise estimates. However, both simulation modeling and probabilistic sensitivity analysis are rarely used together. The objective of this study was to explore uncertainty in controversial areas of the 2005 American Gastroenterology Association position statement on the management of dyspepsia. Methods. Individual sampling model, incorporating a second-order probabilistic sensitivity analysis. Population. US adult patients presenting in primary care with dyspepsia. Interventions compared: empirical acid suppression, test and treat for Helicobacter pylori, initial endoscopy, acid suppression then endoscopy, test and treat then proton pump inhibitor (PPI) then endoscopy. Outcomes. Cost-effectiveness, quality-adjusted life years, and costs in US dollars from a societal perspective, measured over a 5-year period. Data sources: mainly Cochrane meta-analyses. Results. Endoscopy was dominated at all ages by other strategies. PPI therapy was the most cost-effective strategy in 30-year-olds with a low prevalence of H. pylori. In 60-year-olds, H. pylori test and treat was the most cost-effective option. Conclusions. Acid suppression alone was more cost-effective than either endoscopy or H. pylori test and treat in younger dyspepsia patients with a low prevalence of infection.
Objective To estimate the potential cost effectiveness of a population-wide risk factor reduction programme aimed at preventing cardiovascular disease.Design Economic modelling analysis.Setting ...England and Wales.Population Entire population.Model Spreadsheet model to quantify the reduction in cardiovascular disease over a decade, assuming the benefits apply consistently for men and women across age and risk groups.Main outcome measures Cardiovascular events avoided, quality adjusted life years gained, and savings in healthcare costs for a given effectiveness; estimates of how much it would be worth spending to achieve a specific outcome.Results A programme across the entire population of England and Wales (about 50 million people) that reduced cardiovascular events by just 1% would result in savings to the health service worth at least £30m (€34m; $48m) a year compared with no additional intervention. Reducing mean cholesterol concentrations or blood pressure levels in the population by 5% (as already achieved by similar interventions in some other countries) would result in annual savings worth at least £80m to £100m. Legislation or other measures to reduce dietary salt intake by 3 g/day (current mean intake approximately 8.5 g/day) would prevent approximately 30 000 cardiovascular events, with savings worth at least £40m a year. Legislation to reduce intake of industrial trans fatty acid by approximately 0.5% of total energy content might gain around 570 000 life years and generate NHS savings worth at least £230m a year.Conclusions Any intervention that achieved even a modest population-wide reduction in any major cardiovascular risk factor would produce a net cost saving to the NHS, as well as improving health. Given the conservative assumptions used in this model, the true benefits would probably be greater.
The Birmingham Rheumatoid Arthritis Model (BRAM) has been developed over a number of years to inform several appraisals of biologic drugs by the Technology Appraisals Committee of the UK National ...Institute for Health and Clinical Excellence. This article describes the processes used in the construction of the different versions of the BRAM.
PDF
