ObjectiveConduct an economic evaluation based on best currently available evidence comparing alternative treatments levonorgestrel-releasing intrauterine system, depot-medroxyprogesterone acetate, ...combined oral contraceptive pill (COCP) and ‘no treatment’ to prevent recurrence of endometriosis after conservative surgery in primary care, and to inform the design of a planned trial-based economic evaluation.MethodsWe developed a state transition (Markov) model with a 36-month follow-up. The model structure was informed by a pragmatic review and clinical experts. The economic evaluation adopted a UK National Health Service perspective and was based on an outcome of incremental cost per quality-adjusted life year (QALY). As available data were limited, intentionally wide distributions were assigned around model inputs, and the average costs and outcome of the probabilistic sensitivity analyses were reported.ResultsOn average, all strategies were more expensive and generated fewer QALYs compared to no treatment. However, uncertainty attributing to the transition probabilities affected the results. Inputs relating to effectiveness, changes in treatment and the time at which the change is made were the main causes of uncertainty, illustrating areas where robust and specific data collection is required.ConclusionsThere is currently no evidence to support any treatment being recommended to prevent the recurrence of endometriosis following conservative surgery. The study highlights the importance of developing decision models at the outset of a trial to identify data requirements to conduct a robust post-trial analysis.
Urodynamics (UDS) has been considered the gold standard test for detrusor overactivity (DO) in women with an overactive bladder (OAB). Bladder ultrasonography to measure bladder wall thickness (BWT) ...is less invasive and has been proposed as an alternative test.
To estimate the reliability, reproducibility, accuracy and acceptability of BWT in women with OAB, measured by ultrasonography, in the diagnosis of DO; to explore the role of UDS and its impact on treatment outcomes; and to conduct an economic evaluation of alternative care pathways.
A cross-sectional test accuracy study.
22 UK hospitals.
687 women with OAB.
BWT was measured using transvaginal ultrasonography, and DO was assessed using UDS, which was performed blind to ultrasonographic findings. Intraobserver and interobserver reproducibility were assessed by repeated measurements from scans in 37 and 57 women, respectively, and by repeated scans in 27 women. Sensitivity and specificity were computed at pre-specified thresholds. The smallest real differences detectable of BWT were estimated using one-way analysis of variance. The pain and acceptability of both tests were evaluated by a questionnaire. Patient symptoms were measured before testing and after 6 and 12 months using the International Consultation on Incontinence modular Questionnaire Overactive Bladder (short form) (ICIQ-OAB) questionnaire and a global impression of improvement elicited at 12 months. Interventions and patient outcomes were analysed according to urodynamic diagnoses and BWT measurements. A decision-analytic model compared the cost-effectiveness of care strategies using UDS, ultrasonography or clinical history, estimating the cost per woman successfully treated and the cost per quality-adjusted life-year (QALY).
BWT showed very low sensitivity and specificity at all pre-specified cut-off points, and there was no evidence of discrimination at any threshold (p = 0.25). Extensive sensitivity and subgroup analyses did not alter the interpretation of these findings. The smallest detectable difference in BWT was estimated to be 2 mm. Pain levels following both tests appeared relatively low. The proportion of women who found the test 'totally acceptable' was significantly higher with ultrasonography than UDS (81% vs. 56%; p < 0.001). Overall, subsequent treatment was highly associated with urodynamic diagnosis (p < 0.0001). There was no evidence that BWT had any relationship with the global impression of improvement responses at 20 months (p = 0.4). Bladder ultrasonography was more costly and less effective than the other strategies. The incremental cost-effectiveness ratio (ICER) of basing treatment on the primary clinical presentation compared with UDS was £491,500 per woman successfully treated and £60,200 per QALY. Performing a UDS in those women with a clinical history of mixed urinary incontinence had an ICER of £19,500 per woman successfully treated and £12,700 per QALY compared with the provision of urodynamic to all women. For DO cases detected, UDS was the most cost-effective strategy.
There was no evidence that BWT had any relationship with DO, regardless of the cut-off point, nor any relationship to symptoms as measured by the ICIQ-OAB. Bladder ultrasonography has no diagnostic or prognostic value as a test in this condition. Furthermore, despite its greater acceptability, BWT measurement was not sufficiently reliable or reproducible.
Current Controlled Trials ISRCTN46820623.
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. 7. See the NIHR Journals Library website for further project information.
Background. There is a growing interest in the application of the capability approach in health economic analysis. The aim of the research reported here is to assess the feasibility of mapping from a ...condition-specific questionnaire (Western Ontario and McMaster Universities WOMAC Osteoarthritis Index) to a capability well-being questionnaire (ICEpop CAPability measure for Older people ICECAP-O). Methods. One hundred five osteoarthritis patients requiring joint replacement completed the 5 attributes on the ICECAP-O (attachment, security, role, enjoyment, and control) and the 3 WOMAC categories (pain, stiffness, and physical function). The prediction data set consisted of baseline scores, whereas follow-up data were used to validate the predictions. The mapping algorithms used ordinary least squares and multinomial logistic regression models to predict the relationship between WOMAC scores, categories, or items and ICECAP-O scores or the 5 ICECAP-O attributes. Results. ICECAP-O scores predicted from WOMAC category scores produced the lowest mapping error statistics (mean absolute error = 0.0832; mean squared error = 0.0142) as well as highest goodness of fit (R2 = 0.3976). Prediction of ICECAP-O attributes from WOMAC category scores was possible for the majority of capability dimensions. The “control” attribute and physical function WOMAC category exhibited the strongest relationship (R2 = 0.2143). The “attachment” attribute proved difficult to predict from any WOMAC category, which is in line with intuition given this attribute captures psychological well-being rather than pain, stiffness, or physical function. Conclusion. This is the first study to investigate the predictive ability of a condition-specific measure of health onto capability. The results presented here suggest it is feasible to map from condition-specific measures to an overall capability index, although WOMAC cannot predict individual capability in its entirety. Although the results here are encouraging for those interested in using ICECAP-O, given the small validation sample size applied, further research will be required to verify these findings.
To compare the cost-effectiveness of bladder ultrasonography, clinical history, and urodynamic testing in guiding treatment decisions in a secondary care setting for women failing first line ...conservative treatment for overactive bladder or urgency-predominant mixed urinary incontinence.
Model-based economic evaluation from a UK National Health Service (NHS) perspective using data from the Bladder Ultrasound Study (BUS) and secondary sources.
Cost-effectiveness analysis using a decision tree and a 5-year time horizon based on the outcomes of cost per woman successfully treated and cost per Quality-Adjusted Life-Year (QALY). Deterministic and probabilistic sensitivity analyses, and a value of information analysis are also undertaken.
Bladder ultrasonography is more costly and less effective test-treat strategy than clinical history and urodynamics. Treatment on the basis of clinical history alone has an incremental cost-effectiveness ratio (ICER) of £491,100 per woman successfully treated and an ICER of £60,200 per QALY compared with the treatment of all women on the basis of urodynamics. Restricting the use of urodynamics to women with a clinical history of mixed urinary incontinence only is the optimal test-treat strategy on cost-effectiveness grounds with ICERs of £19,500 per woman successfully treated and £12,700 per QALY compared with the treatment of all women based upon urodynamics. Conclusions remained robust to sensitivity analyses, but subject to large uncertainties.
Treatment based upon urodynamics can be seen as a cost-effective strategy, and particularly when targeted at women with clinical history of mixed urinary incontinence only. Further research is needed to resolve current decision uncertainty.
To undertake an economic evaluation alongside the largest randomised controlled trial comparing Levonorgestrel-releasing intrauterine device ('LNG-IUS') and usual medical treatment for women with ...menorrhagia in primary care; and compare the cost-effectiveness findings using two alternative measures of quality of life.
571 women with menorrhagia from 63 UK centres were randomised between February 2005 and July 2009. Women were randomised to having a LNG-IUS fitted, or usual medical treatment, after discussing with their general practitioner their contraceptive needs or desire to avoid hormonal treatment. The treatment was specified prior to randomisation. For the economic evaluation we developed a state transition (Markov) model with a 24 month follow-up. The model structure was informed by the trial women's pathway and clinical experts. The economic evaluation adopted a UK National Health Service perspective and was based on an outcome of incremental cost per Quality Adjusted Life Year (QALY) estimated using both EQ-5D and SF-6D.
Using EQ-5D, LNG-IUS was the most cost-effective treatment for menorrhagia. LNG-IUS costs £100 more than usual medical treatment but generated 0.07 more QALYs. The incremental cost-effectiveness ratio for LNG-IUS compared to usual medical treatment was £1600 per additional QALY. Using SF-6D, usual medical treatment was the most cost-effective treatment. Usual medical treatment was both less costly (£100) and generated 0.002 more QALYs.
Impact on quality of life is the primary indicator of treatment success in menorrhagia. However, the most cost-effective treatment differs depending on the quality of life measure used to estimate the QALY. Under UK guidelines LNG-IUS would be the recommended treatment for menorrhagia. This study demonstrates that the appropriate valuation of outcomes in menorrhagia is crucial.
Despite having high smoking rates, there have been few tailored cessation programmes for male Bangladeshi and Pakistani smokers in the UK. We report on a qualitative evaluation of a community-based, ...outreach worker delivered, intervention that aimed to increase uptake of NHS smoking cessation services and tailor services to meet the needs of Bangladeshi and Pakistani men.
This was a longitudinal, qualitative study, nested within a phase II cluster randomised controlled trial of a complex intervention. We explored the perspectives and experiences of five outreach workers, two stop smoking service managers and a specialist stop smoking advisor. Data were collected through focus group discussions, weekly diaries, observations of management meetings, shadowing of outreach workers, and one-to-one interviews with outreach workers and their managers. Analysis was undertaken using a modified Framework approach.
Outreach workers promoted cessation services by word of mouth on the streets, in health service premises, in local businesses and at a wide range of community events. They emphasised the reasons for cessation, especially health effects, financial implications, and the impact of smoking on the family. Many smokers agreed to be referred to cessation services, but few attended, this in part being explained by concerns about the relative inflexibility of existing service provision. Although outreach workers successfully expanded service reach, they faced the challenges of perceived lack of awareness of the health risks associated with smoking in older smokers and apathy in younger smokers. These were compounded by perceptions of "lip service" being given to their role by community organisations and tensions both amongst the outreach workers and with the wider management team.
Outreach workers expanded reach of the service through taking it to diverse locations of relevance to Pakistani and Bangladeshi communities. The optimum method of outreach to retain and treat Bangladeshi and Pakistani smokers effectively in cessation programmes needs further development.
To determine the cost-effectiveness of in-utero percutaneous Vesico Amniotic Shunt (VAS) in the management of fetal lower urinary tract obstruction (LUTO).
Model based economic analysis using data ...from the randomised controlled arm of the PLUTO (percutaneous vesico-amniotic shunting for lower urinary tract obstruction) trial.
Fetal medicine departments in United Kingdom, Ireland and Netherlands.
Pregnant women with a male, singleton fetus with LUTO.
Costs and outcomes were prospectively collected in the trial; three separate base case analyses were performed using the intention to treat (ITT), per protocol and uniform prior methods. Deterministic and probabilistic sensitivity analyses were performed to explore data uncertainty.
Survival at 28 days, 1 year and disease free survival at 1 year.
VAS was more expensive but appeared to result in higher rates of survival compared with conservative management in patients with LUTO. Using ITT analysis the incremental cost effectiveness ratios based on outcomes of survival at 28 days, 1 year, or 1 morbidity-free year on the VAS arm were £ 15,506, £ 15,545, and £ 43,932, respectively.
VAS is a more expensive option compared to the conservative approach in the management of individuals with LUTO. Data from the RCT suggest that VAS improves neonatal survival but does not result in significant improvements in morbidity. Our analysis concludes that VAS is not likely to be cost effective in the management of these patients given the NICE (National Institute of Health and Clinical Excellence) cost threshold of £ 20,000 per QALY.
Heart failure is a major cause of mortality and morbidity. As mortality rates are high, it is important that patients seen by general practitioners with symptoms suggestive of heart failure are ...identified quickly and treated appropriately. Identifying patients with heart failure or deciding which patients need further tests is a challenge. All patients with suspected heart failure should be diagnosed using objective tests such as echocardiography, but it is expensive, often delayed, and limited by the significant skill shortage of trained echocardiographers. Alternative approaches for diagnosing heart failure are currently limited. Clinical decision tools that combine clinical signs, symptoms or patient characteristics are designed to be used to support clinical decision-making and validated according to strict methodological procedures. The REFER Study aims to determine the accuracy and cost-effectiveness of our previously derived novel, simple clinical decision rule, a natriuretic peptide assay, or their combination, in the triage for referral for echocardiography of symptomatic adult patients who present in general practice with symptoms suggestive of heart failure.
This is a prospective, Phase II observational, diagnostic validation study of a clinical decision rule, natriuretic peptides or their combination, for diagnosing heart failure in primary care. Consecutive adult primary care patients 55 years of age or over presenting to their general practitioner with a chief complaint of recent new onset shortness of breath, lethargy or peripheral ankle oedema of over 48 hours duration, with no obvious recurrent, acute or self-limiting cause will be enrolled. Our reference standard is based upon a three step expert specialist consensus using echocardiography and clinical variables and tests.
Our clinical decision rule offers a potential solution to the diagnostic challenge of providing a timely and accurate diagnosis of heart failure in primary care. Study results will provide an evidence-base from which to develop heart failure care pathway recommendations and may be useful in standardising care. If demonstrated to be effective, the clinical decision rule will be of interest to researchers, policy makers and general practitioners worldwide.
ISRCTN17635379.
Objective To investigate the cost effectiveness of screening for Chlamydia trachomatis compared with a policy of no organised screening in the United Kingdom.Design Economic evaluation using a ...transmission dynamic mathematical model.Setting Central and southwest England.Participants Hypothetical population of 50 000 men and women, in which all those aged 16-24 years were invited to be screened each year.Main outcome measures Cost effectiveness based on major outcomes averted, defined as pelvic inflammatory disease, ectopic pregnancy, infertility, or neonatal complications.Results The incremental cost per major outcome averted for a programme of screening women only (assuming eight years of screening) was £22 300 (€33 000; $45 000) compared with no organised screening. For a programme screening both men and women, the incremental cost effectiveness ratio was approximately £28 900. Pelvic inflammatory disease leading to hospital admission was the most frequently averted major outcome. The model was highly sensitive to the incidence of major outcomes and to uptake of screening. When both were increased the cost effectiveness ratio fell to £6200 per major outcome averted for screening women only.Conclusions Proactive register based screening for chlamydia is not cost effective if the uptake of screening and incidence of complications are based on contemporary empirical studies, which show lower rates than commonly assumed. These data are relevant to discussions about the cost effectiveness of the opportunistic model of chlamydia screening being introduced in England.
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.
PDF
