Decision-analytic models play a key role in informing healthcare resource allocation decisions. However, there are ongoing concerns with the credibility of models. Modelling methods guidance can ...encourage good practice within model development, but its value is dependent on its ability to address the areas that modellers find most challenging. Further, it is important that modelling methods and related guidance are continually updated in light of any new approaches that could potentially enhance model credibility. The objective of this article was to highlight the ways in which qualitative methods have been used and recommended to inform decision-analytic model development and enhance modelling practices. With reference to the literature, the article discusses two key ways in which qualitative methods can be, and have been, applied. The first approach involves using qualitative methods to understand and inform general and future processes of model development, and the second, using qualitative techniques to directly inform the development of individual models. The literature suggests that qualitative methods can improve the validity and credibility of modelling processes by providing a means to understand existing modelling approaches that identifies where problems are occurring and further guidance is needed. It can also be applied within model development to facilitate the input of experts to structural development. We recommend that current and future model development would benefit from the greater integration of qualitative methods, specifically by studying ‘real’ modelling processes, and by developing recommendations around how qualitative methods can be adopted within everyday modelling practice.
Background and Aims
Previous economic evaluations of smoking cessation interventions for pregnant women are limited to single components, which do not in isolation offer sufficient potential impact ...to address smoking cessation targets. To inform the development of more appropriate complex interventions, we (1) describe the development of the Economics of Smoking in Pregnancy: Household (ESIP.H) model for estimating the life‐time cost‐effectiveness of smoking cessation interventions aimed at pregnant women and (2) use a hypothetical case study to demonstrate how ESIP.H can be used to identify the characteristics of optimum smoking cessation interventions.
Methods
The hypothetical intervention was based on current evidence relating to component elements, including financial incentives, partner smoking, intensive behaviour change support, cigarettes consumption and duration of support to 12 months post‐partum. ESIP.H was developed to assess the life‐time health and cost impacts of multi‐component interventions compared with standard National Health Service (NHS) care in England. ESIP.H considers cigarette consumption, partner smoking and some health conditions (e.g. obesity) that were not included in previous models. The Markov model's parameters were estimated based on published literature, expert judgement and evidence‐based assumptions. The hypothetical intervention was evaluated from an NHS perspective.
Results
The hypothetical intervention was associated with an incremental gain in quitters (mother and partner) at 12 months postpartum of 249 95% confidence interval (CI) = 195–304 per 1000 pregnant smokers. Over the long‐term, it had an incremental negative cost of £193 (CI = –£779 to 344) and it improved health, with a 0.50 (CI = 0.36–0.69) increase in quality‐adjusted life years (QALYs) for mothers, partners and offspring, with a 100% probability of being cost‐effective.
Conclusions
The Economics of Smoking in Pregnancy: Household model for estimating cost‐effectiveness of smoking cessation interventions aimed at pregnant women found that a hypothetical smoking cessation intervention would greatly extend reach, reduce smoking and be cost‐effective.
Introduction
Decision-analytic models play an essential role in informing healthcare resource allocation decisions; however, their value to decision makers will depend on model structures being ...clinically valid to determine cost-effectiveness recommendations. Clinician involvement can help modellers to develop clinically valid but straightforward structures; however, there is little guidance available on methods for clinician input to model structure. This study aims to provide an in-depth exploration of clinician involvement in structural development, highlighting key issues and generating recommendations to optimise practices.
Methods
A qualitative study was undertaken with a range of modellers and clinicians working in different modelling contexts. In-depth interviews and case studies using observations were carried out to understand how clinicians are involved in model structural development and to identify problems and optimal approaches from informants’ perspectives.
Results
Twenty-four interviews and two case studies were undertaken with modellers and modelling teams. Key issues included the number and diversity of clinicians contributing to structural development, potentially impacting the generalisability of structures, and problems with clinician understanding of important information to contribute to model pathways. Modellers and clinicians suggested that clinician training in modelling could enhance structural processes.
Conclusions
Recommendations to optimise current practices include recruiting clinicians from a variety of backgrounds and using discussions between experts to develop valid and generalisable structures. Future research should focus on developing training materials for clinicians and finding ways to help modellers recruit clinicians from different settings.
Abstract
Objective. To investigate the potential cost-effectiveness of alternative 'test-and-treat' strategies in the prevention of spontaneous pre-term birth before 34 and 37 weeks' gestation. ...Design. Model-based economic evaluation. Setting. Clinics, general practices, health centers or any setting delivering antenatal care. Population. Asymptomatic women in early pregnancy and symptomatic women with threatened pre-term labor in later pregnancy. Methods. Data from systematic reviews of effectiveness and accuracy were combined into strategies and analyzed using a decision-tree model. Full deterministic and probabilistic sensitivity analyses were carried out. Main outcome measures. Spontaneous pre-term labor avoided for asymptomatic women and spontaneous pre-term birth avoided for symptomatic women. Results. The systematic reviews identified evidence on the accuracy of 22 types of tests and on the effectiveness of 40 possible interventions. Cost data were based on secondary evidence, supplemented with primary data from local sources. Testing prior to intervention was not shown to be the most cost-effective strategy in the main analyses for 34 and 37 weeks. Prophylactic fish oil in asymptomatic women, without prior testing, was highlighted as potentially cost-effective in preventing threatened pre-term labor before 34 weeks. In symptomatic women with a viable pregnancy, indomethacin without prior testing was a potentially cost-effective strategy to prevent pre-term birth occurring before 37 weeks. Conclusion. An effective, affordable and safe intervention applied to all mothers without prior testing is likely to be the most cost-effective strategy in the prevention of spontaneous pre-term labor and birth. The results reported in this paper are important for prioritizing future research, world-wide.
Objective To determine the effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking.Design Systematic review of randomised controlled trials.Data sources Cochrane ...Library, Medline, Embase, CINAHL, PsychINFO, Science Citation Index, registries of ongoing trials, reference lists, the drug company that sponsored most of the trials, and clinical experts.Review methods Eligible studies were published or unpublished randomised controlled trials that enrolled smokers who declared no intention to quit smoking in the short term, and compared nicotine replacement therapy (with or without motivational support) with placebo, no treatment, other pharmacological therapy, or motivational support, and reported quit rates. Two reviewers independently applied eligibility criteria. One reviewer assessed study quality and extracted data and these processes were checked by a second reviewer. The primary outcome, six months sustained abstinence from smoking beginning during treatment, was assessed by individual patient data analysis. Other outcomes were cessation and reduction at end of follow-up, and adverse events.Data synthesis Seven placebo controlled randomised controlled trials were included (four used nicotine replacement therapy gum, two nicotine replacement therapy inhaler, and one free choice of therapy). They were reduction studies that reported smoking cessation as a secondary outcome. The trials enrolled a total of 2767 smokers, gave nicotine replacement therapy for 6-18 months, and lasted 12-26 months. 6.75% of smokers receiving nicotine replacement therapy attained sustained abstinence for six months, twice the rate of those receiving placebo (relative risk (fixed effects) 2.06, 95% confidence interval 1.34 to 3.15; (random effects) 1.99, 1.01 to 3.91; five trials). The number needed to treat was 29. All other cessation and reduction outcomes were significantly more likely in smokers given nicotine replacement therapy than those given placebo. There were no statistically significant differences in adverse events (death, odds ratio 1.00, 95% confidence interval 0.25 to 4.02; serious adverse events, 1.16, 0.79 to 1.50; and discontinuation because of adverse events, 1.25, 0.64 to 2.51) except nausea, which was more common with nicotine replacement therapy (8.7% v 5.3%; odds ratio 1.69, 95% confidence interval 1.21 to 2.36).Conclusions Available trials indicate that nicotine replacement therapy is an effective intervention in achieving sustained smoking abstinence for smokers who have no intention or are unable to attempt an abrupt quit. Most of the evidence, however, comes from trials with regular behavioural support and monitoring and it is unclear whether using nicotine replacement therapy without regular contact would be as effective.
Validity and responsiveness study using a randomized clinical trial and prospective cohort study of patients with low back pain (LBP).
To provide evidence for construct validity and responsiveness to ...change of a single-item presenteeism question (SIPQ) in patients with LBP.
The SIPQ is a simple, easy to administer tool that has been used to measure the impact of back pain on reduced productivity at work (presenteeism) as a standalone measure. Evidence supporting the validity and responsiveness of the SIPQ among patients with back pain is however lacking.
The SIPQ was administered to patients consulting for back pain in a randomized controlled trial (N = 851) and a cohort intervention study (N = 922). Construct validity was assessed using convergent, divergent, and known-group validity. The validity investigation included assessing associations between the SIPQ and pain, disability, psychological, health status, and quality of life measures. Responsiveness was assessed using external indicators of change as comparators, evaluating correlation of clinical change scores and effect size statistics.
Moderate to strong correlations were found between presenteeism and pain (r: 0.44-0.77), disability (r: 0.53-0.70), and 12-Item Short Form Health Survey physical dimensions (r: -0.66 to -0.55). Presenteeism was strongly associated with disease-specific pain and disability scales. The SIPQ was responsive to changes in productivity-presenteeism change scores indicated strong correlation with change scores, and high responsiveness in distribution- and anchor-based testing.
The SIPQ is a potentially valid and responsive tool for assessing the impact of back pain on presenteeism. This SIPQ could, with relative ease, facilitate further research on the estimation of presenteeism within economic evaluation studies of musculoskeletal conditions, thus providing policymakers with estimates of economic impact of musculoskeletal disease. Further evidence is, however, merited to assess its relationship with standardized presenteeism questionnaires.
2.
Influenza causes substantial mortality in high-risk groups despite targeted vaccination programmes. This paper considers whether it is worth vaccinating healthcare workers (HCWs) against influenza to ...protect high-risk patients in a series of systematic reviews and an economic evaluation. Eighteen studies are included. Vaccination was highly effective in HCWs, with minimal adverse effects. Two trials assessed patient mortality after vaccinating HCWs, both of which showed a reduction. Despite recommendations, less than 25% of HCW in Europe and the UK are vaccinated. Five studies looked at programmes to increase uptake; these produced increases of 5%-45%. Published economic evaluations did not include patient benefit; therefore, an economic evaluation using UK data was undertaken. In the base case, vaccination was cost saving (pounds 12/vaccinee). In the most pessimistic scenario it cost pounds 405/life-year gained. Effective implementation should be a priority.
Objectives: To provide an overview of alternative approaches to modelling in economic evaluation, and to highlight situations where each of the alternative modelling techniques should be employed. ...Methods: A review of the available approaches to modelling in the economic evaluation of health care interventions with a leading discussion of examples of published studies leading to guidance in the selection of an appropriate approach in different circumstances. Results: The main approaches to modelling used in economic evaluations in health care are decision trees, Markov models and individual sampling models. These methods assume independence of individuals within the model. Where interaction between individuals is important, other methods such as discrete-event simulation or system dynamics are preferable. Conclusions: The paper highlights the crucial question to be answered when selecting the approach to modelling: can the individuals being simulated in the model be regarded as independent? This issue is very commonly not recognised by analysts but is fundamental to the appropriate application of modelling in economic evaluation.
The prevalence of smoking is higher among Pakistani and Bangladeshi males than among the general population. Smokers who receive behavioural support and medication quadruple their chances of stopping ...smoking, but evidence suggests that these populations do not use National Health Service run stop smoking clinics as frequently as would be expected given their high prevalence of smoking. This study aims to tackle some of the main barriers to use of stop smoking services and adherence to treatment programmes by redesigning service delivery to be more acceptable to these adult male populations. The study compares the effectiveness of trained Pakistani and Bangladeshi smoking cessation workers operating in an outreach capacity ('clinic + outreach') with standard care ('clinic only') to improve access to and success of National Health Service smoking cessation services.
This is a pilot cluster randomised controlled trial based in Birmingham, UK. Super output areas of Birmingham will be identified in which more than 10% of the population are of Pakistani and/or Bangladeshi origin. From these areas, 'natural geographical communities' will be identified. Sixteen aggregated agglomerations of super output areas will be identified, separating areas from each other using buffer regions in order to reduce potential contamination. These natural communities will be randomised to 'clinic + outreach' (intervention) or 'clinic only' (control) arms. The use of stop smoking services and the numbers of people quitting smoking (defined as prolonged self-reported abstinence at four weeks, three months and six months) will be assessed in each area. In addition, we will assess the impact of the intervention on adherence to smoking cessation treatments and patient satisfaction.
Objective To generate evidence on the longer term cost effectiveness of disease modifying treatments in patients with relapsing-remitting multiple sclerosis.Design Prospective cohort study with ...historical comparator.Setting Specialist multiple sclerosis clinics in 70 centres in the United Kingdom.Participants Patients with relapsing-remitting multiple sclerosis who started treatment from May 2002 to April 2005 under the UK risk sharing scheme.Interventions Treatment with interferon beta or glatiramer acetate in accordance with guidelines of the UK Association of British Neurologists.Main outcome measures Observed utility weighted progression in disability at two years’ follow-up assessed on the expanded disability status scale (EDSS) compared with that expected by applying the progression rates in a comparator dataset, modified for patients receiving treatment by multiplying by the hazard ratio derived separately for each disease modifying treatment from the randomised trials.Results In the primary per protocol analysis, progression in disability was worse than that predicted and worse than that in the untreated comparator dataset (“deviation score” of 113%; excess in mean disability status scale 0.28). In sensitivity analyses, however, the deviation score varied from −72% (using raw baseline disability status scale scores, rather than applying a “no improvement” algorithm) to 156% (imputing missing data for year two from progression rates for year one).Conclusions It is too early to reach any conclusion about the cost effectiveness of disease modifying treatments from this first interim analysis. Important methodological issues, including the need for additional comparator datasets, the potential bias from missing data, and the impact of the “no improvement” rule, will need to be addressed and long term follow-up of all patients is essential to secure meaningful results. Future analyses of the cohort are likely to be more informative, not least because they will be less sensitive to short term fluctuations in disability.
PDF
