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BACKGROUND: The increasing prevalence of type 2 diabetes in the UK creates an additional, potentially preventable burden on health care and service providers. The Healthier You: NHS Diabetes Prevention Programme aims to reduce the incidence of type 2 diabetes through the identification of people at risk and the provision of intensive lifestyle change support. The provision of this care can be monitored through quality measurement at both the general practice and specialist service level.
AIM: To develop quality measures through piloting to assess the validity, credibility, acceptability, reliability, and feasibility of any proposed measures.
DESIGN AND SETTING: The non-experimental mixed design piloting study consists of consensus testing and exploratory research with GPs, commissioners, and patients from Herefordshire, England.
METHOD: A mixed-method approach will be used to develop and validate measures for diabetes prevention care and evaluate their performance over a 6-month pilot period consisting of consensus testing using a modified RAND approach with GPs and commissioners; four focus groups with 8-10 participants discussing experiences of non-diabetic hyperglycaemia (NDH), perceived ability to access care and prevent diabetes, and views on potential quality measures; and piloting final measures with at least five general practices for baseline and 6-month data.
RESULTS: The findings will inform the implementation of the diabetes prevention quality measures on a national scale while addressing any issue with validity, credibility, feasibility, and cost-effectiveness.
CONCLUSION: Healthcare professionals and patients have the opportunity to evaluate the reliability, acceptability, and validity of measures.
BACKGROUND: Effective study identification is essential for conducting health research, developing clinical guidance and health policy and supporting health-care decision-making. Methodological search filters (combinations of search terms to capture a specific study design) can assist in searching to achieve this.
OBJECTIVES: This project investigated the methods used to assess the performance of methodological search filters, the information that searchers require when choosing search filters and how that information could be better provided.
METHODS: Five literature reviews were undertaken in 2010/11: search filter development and testing; comparison of search filters; decision-making in choosing search filters; diagnostic test accuracy (DTA) study methods; and decision-making in choosing diagnostic tests. We conducted interviews and a questionnaire with experienced searchers to learn what information assists in the choice of search filters and how filters are used. These investigations informed the development of various approaches to gathering and reporting search filter performance data. We acknowledge that there has been a regrettable delay between carrying out the project, including the searches, and the publication of this report, because of serious illness of the principal investigator.
RESULTS: The development of filters most frequently involved using a reference standard derived from hand-searching journals. Most filters were validated internally only. Reporting of methods was generally poor. Sensitivity, precision and specificity were the most commonly reported performance measures and were presented in tables. Aspects of DTA study methods are applicable to search filters, particularly in the development of the reference standard. There is limited evidence on how clinicians choose between diagnostic tests. No published literature was found on how searchers select filters. Interviewing and questioning searchers via a questionnaire found that filters were not appropriate for all tasks but were predominantly used to reduce large numbers of retrieved records and to introduce focus. The Inter Technology Appraisal Support Collaboration (InterTASC) Information Specialists' Sub-Group (ISSG) Search Filters Resource was most frequently mentioned by both groups as the resource consulted to select a filter. Randomised controlled trial (RCT) and systematic review filters, in particular the Cochrane RCT and the McMaster Hedges filters, were most frequently mentioned. The majority indicated that they used different filters depending on the requirement for sensitivity or precision. Over half of the respondents used the filters available in databases. Interviewees used various approaches when using and adapting search filters. Respondents suggested that the main factors that would make choosing a filter easier were the availability of critical appraisals and more detailed performance information. Provenance and having the filter available in a central storage location were also important.
LIMITATIONS: The questionnaire could have been shorter and could have included more multiple choice questions, and the reviews of filter performance focused on only four study designs.
CONCLUSIONS: Search filter studies should use a representative reference standard and explicitly report methods and results. Performance measures should be presented systematically and clearly. Searchers find filters useful in certain circumstances but expressed a need for more user-friendly performance information to aid filter choice. We suggest approaches to use, adapt and report search filter performance. Future work could include research around search filters and performance measures for study designs not addressed here, exploration of alternative methods of displaying performance results and numerical synthesis of performance comparison results.
OBJECTIVES: To compare the efficacy of onabotulinumtoxinA, mirabegron, and anticholinergics in adults with idiopathic overactive bladder (OAB) using network meta-analysis (NMA).
PATIENTS AND METHODS: Information sources were searched for blinded randomised controlled trials (RCTs), of =2 weeks duration, comparing any dose of onabotulinumtoxinA, eligible oral/transdermal anticholinergics, or mirabegron, with each other or placebo, in adults with OAB. Bayesian random-effects models were used to synthesise the results at week 12: NMA for responder analyses and network meta-regression (NMR) for change from baseline analyses. The NMR was used to adjust for differences in baseline severity between studies. Sensitivity analysis, excluding studies considered to be at a high risk of methodological bias, was conducted.
RESULTS: In all, 56 RCTs were included in the networks. For each outcome, results are reported for all licensed treatment doses. For each NMR, results are based on patients with an average number of episodes of the outcome at baseline. After 12 weeks, all treatments were more efficacious than placebo. Patients who received onabotulinumtoxinA (100 U) had, on average, the greatest reductions in urinary incontinence episodes (UIE), urgency episodes, and micturition frequency, and the highest odds of achieving decreases of 100% and =50% from baseline in UIE/day. When comparing onabotulinumtoxinA with other pharmacotherapies, mean differences favoured onabotulinumtoxinA 100 U over all comparators for UIE and urgency episodes (credible intervals excluded zero) and all but two of the comparators for micturition frequency. OnabotulinumtoxinA 100 U was also associated with higher odds of achieving a 100% and =50% decrease in UIE/day than most other licensed treatments in the network. The exclusion of studies with a high risk of bias had little impact on the conclusions.
CONCLUSION: The results indicate that, after 12 weeks, onabotulinumtoxinA 100 U provides greater relief of OAB symptoms compared with most other licensed doses of other pharmacotherapies in the network.
BACKGROUND: In the UK and internationally there is widespread acceptance of the value of economic evaluations to inform decisions about health care interventions. The general methods of economic evaluation of health care interventions are now well established. By contrast, approaches to social care economic evaluation are substantially less well developed. There is considerable uncertainty and disagreement about which methods to apply, and diversity in methodological practices. This makes it hard for decision makers to interpret the findings of different studies and make comparisons of value for money between different interventions evaluated using different methods. Despite previous attempts to co-ordinate methods in this area by providing guidelines (NICE, 2013, NICE, 2014), there remains considerable methodological uncertainty. NICE commissioned this scoping review to support developing a long-term strategy for how to consider social care economics in guidelines.
AIMS: The project aims to inform NICE on the methods available and the methods in development for use in undertaking economic evaluation of social care interventions. A further aim of the scoping review is to assess how well these methods address current methodological priorities for NICE in
social care economic evaluation, and to identify gaps that the work will not address. On this basis, another aim is to provide recommendations to NICE on work required to address identified gaps in the future.
METHODS: A systematic review of the published literature and a survey of experts were undertaken to identify key methods used to undertake recent economic evaluations of social care interventions. Each study was assessed in terms of the key requirements for economic evaluation. Data were
extracted on: the perspective of the analysis, the interventions compared, the evidence used on costs and effects, opportunity cost, uncertainty, and equity. Expert advisors commented on the findings of the review and this informed the results that were drawn from the studies. Recommendations were made to improve the conduct and reporting of studies, and areas of further research were identified.
RESULTS: Thirty social care economic evaluations were identified for review. Findings were reported on key requirements for economic evaluation comprising: the perspective of relevance to the decision maker, an evaluation comparing all relevant alternative interventions, use of all available evidence on costs and effects of relevance to the decision, analysis of whether the benefits of an intervention were greater than the forgone benefits of displaced interventions, assessment of the uncertainty associated with the decision, and exploration of the equity implications of the decision.
CONCLUSIONS: Methods guidance for the economic evaluation of social care interventions needs to reflect what is feasible given the available evidence and what is appropriate for social care. A more developed evidence base is required in order to undertake economic evaluation of social care interventions. This should include undertaking primary studies where the evidence is not sufficient. Studies based on decision models and secondary evidence should be used where there is sufficient evidence available to do so. Investment in applied economic evaluations of social care interventions will support more informed recommendations and also develop research capacity in social care. Further methodological research is required to improve the way economic evaluations are undertaken in this field.
OBJECTIVES: To estimate the cost of functional gastrointestinal disorders (FGIDs) and related signs and symptoms in infants to the third party payer and to parents.
STUDY DESIGN: To estimate the cost of illness (COI) of infant FGIDs, a two-stage process was applied: a systematic literature review and a COI calculation. As no pertinent papers were found in the systematic literature review, a 'de novo' analysis was performed. For the latter, the potential costs for the third party payer (the National Health Service (NHS) in England) and for parents/carers for the treatment of FGIDs in infants were calculated,
by using publicly available data. In constructing the calculation, estimates and assumptions (where necessary) were chosen to provide a lower bound (minimum) of the potential overall cost. In doing so, the interpretation of the calculation is that the true COI can be no lower than that estimated.
RESULTS: Our calculation estimated that the total costs of treating FGIDs in infants in England were at least £72.3million per year in 2014/2015 of which £49.1million was NHS expenditure on prescriptions, community care and hospital treatment. Parents incurred £23.2million in costs through purchase of over the counter remedies. Conclusions The total cost presented here is likely to be a significant underestimate as only lower bound estimates were used where applicable, and for example, costs of alternative therapies, inpatient treatments or diagnostic tests, and time off work by parents could not be adequately estimated and were omitted from the calculation. The number and kind of prescribed products and products sold over the counter to treat FGIDs suggest that there are gaps between treatment guidelines, which emphasise parental reassurance and nutritional advice, and their implementation.
OBJECTIVES: The key economic evaluation (EE) databases, NHS EED and HEED, have closed. Which databases do we now need to search to identify economic evaluations for models and systematic reviews (SRs)? We assess which databases are now the best sources of EEs and whether typical search strategies are effective.
METHODS: A quasi-gold standard (QGS) set of economic evaluations was formed from studies included in SRs of EEs undertaken to inform HTA. 9 databases were searched for each QGS reference. Yield for each database, and combination of databases, was calculated. MEDLINE search strategies reported in source SRs were re-run to assess their performance in finding EEs.
RESULTS: We built a QGS of 351 records from 46 reviews. Embase had the highest yield (0.89), followed by Scopus (0.84) and MEDLINE and PubMed (both 0.81). The HTA database identified the highest number of unique records (13/351), despite a low overall yield (0.1). All 9 databases combined retrieved 337/351 records. The most efficient combination of databases which could be searched to find records for all 337 references was Embase, Scopus, HTA Database and (MEDLINE or PubMed). 10/29 (34.5%) of re-run strategies missed at least 1 of the included records available in MEDLINE (25 records missed in total). Only 1 of the missed records was due to failings of search terms used for the economics concept.
CONCLUSIONS: For most SRs Embase, HTA Database and either PubMed or MEDLINE are likely to be sufficient to identify EEs included in bibliographic databases. Additionally searching a multidisciplinary database may be useful, particularly in non-clinical topics. Beyond this, supplementary search techniques may be more efficient than extensive database searching. Weaknesses in reported MEDLINE search strategies were identified which impacted retrieval; these weaknesses appear to be associated with population and intervention concepts, rather than the economics concept.
INTRODUCTION: The estimation of utility values for the economic evaluation of therapies for wet age-related macular degeneration (AMD) is a particular challenge. Previous economic models in wet AMD have been criticized for failing to capture the bilateral nature of wet AMD by modelling visual acuity (VA) and utility values associated with the better-seeing eye only.
METHODS: Here we present a de novo regression analysis using generalized estimating equations (GEE) applied to a previous dataset of time trade-off (TTO)-derived utility values from a sample of the UK population that wore contact lenses to simulate visual deterioration in wet AMD. This analysis allows utility values to be estimated as a function of VA in both the better-seeing eye (BSE) and worse-seeing eye (WSE).
RESULTS: VAs in both the BSE and WSE were found to be statistically significant (p < 0.05) when regressed separately. When included without an interaction term, only the coefficient for VA in the BSE was significant (p = 0.04), but when an interaction term between VA in the BSE and WSE was included, only the constant term (mean TTO utility value) was significant, potentially a result of the collinearity between the VA of the two eyes. The lack of both formal model fit statistics from the GEE approach and theoretical knowledge to support the superiority of one model over another make it difficult to select the best model. CONCLUSION: Limitations of this analysis arise from the potential influence of collinearity between the VA of both eyes, and the use of contact lenses to reflect VA states to obtain the original dataset. Whilst further research is required to elicit more accurate utility values for wet AMD, this novel regression analysis provides a possible source of utility values to allow future economic models to capture the quality of life impact of changes in VA in both eyes.
