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OBJECTIVE: The objective was to model clinical and economic outcomes of self-monitoring blood glucose (SMBG) devices with varying error ranges and strip prices for type 1 and insulin-treated type 2 diabetes patients in England.
METHODS: We programmed a simulation model that included separate risk and complication estimates by type of diabetes and evidence from in silico modeling validated by the Food and Drug Administration. Changes in SMBG error were associated with changes in hemoglobin A1c (HbA1c) and separately, changes in hypoglycemia. Markov cohort simulation estimated clinical and economic outcomes. A SMBG device with 8.4% error and strip price of £0.30 (exceeding accuracy requirements by International Organization for Standardization [ISO] 15197:2013/EN ISO 15197:2015) was compared to a device with 15% error (accuracy meeting ISO 15197:2013/EN ISO 15197:2015) and price of £0.20. Outcomes were lifetime costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs).
RESULTS: With SMBG errors associated with changes in HbA1c only, the ICER was £3064 per QALY in type 1 diabetes and £264 668 per QALY in insulin-treated type 2 diabetes for an SMBG device with 8.4% versus 15% error. With SMBG errors associated with hypoglycemic events only, the device exceeding accuracy requirements was cost-saving and more effective in insulin-treated type 1 and type 2 diabetes.
CONCLUSIONS: Investment in devices with higher strip prices but improved accuracy (less error) appears to be an efficient strategy for insulin-treated diabetes patients at high risk of severe hypoglycemia.
Memokath-051 is a thermo-expandable, nickel-titanium alloy spiral stent used to treat ureteric obstruction resulting from malignant or benign strictures. The National Institute for Health and Care Excellence (NICE) selected Memokath-051 for evaluation. The company, PNN Medical, claimed Memokath-051 has clinical superiority and cost savings compared with double-J stents. It identified five studies reporting clinical evidence on Memokath-051 and constructed a de novo cost model comparing Memokath-051 to double-J stents. Results indicated that Memokath-051 generated cost savings of £4156 per patient over 2.5 years. The External Assessment Centre (EAC) critiqued the company's submission and completed substantial additional work. Sixteen studies were identified assessing Memokath-051 and all listed comparators in the scope (double-J stents, reconstructive surgery and metallic and alloy stents) except nephrostomy. Similar success rates were reported for Memokath-051 compared with double-J and Resonance stents and worse outcomes compared with other options with evidence available. The EAC updated the company's cost model structure and modified several inputs. The EAC's model estimated that Memokath-051 generated savings of at least £1619 per patient over 5 years compared with double-J stents, was cost neutral compared with other metallic stents and was cost saving compared with surgery up to month 55. Overall, Memokath-051 is likely to be cost saving in patients not indicated for reconstructive surgery and those expected to require a ureteral stent for at least 30 months. The Medical Technologies Advisory Committee (MTAC) reviewed the evidence and supported the case for adoption, issuing partially supportive recommendations published after public consultation as Medical Technologies Guidance 35.
Evidence-based environmental management is being hindered by difficulties in locating, interpreting and synthesizing relevant information among vast scientific outputs. But software developments that allow enhanced collation and sharing of data will help.
BACKGROUND: Economic evaluations are important tools for decision makers to determine the best allocation of resources in a healthcare system. This study explored the use of economic evaluation in oral health promotion.
METHODS: A literature review identified oral health promotion programmes that measured both the health impact and costs of oral health interventions. A decision analysis model was constructed to examine the cost utility of preventing dental caries in 5 and 12-year-old children via tooth brushing schemes and fluoride varnish programmes. The costs per child that would be justified according to the National Institute for Health and Care Excellence's threshold of £20,000 per QALY were calculated.
RESULTS: The analysis showed that NICE would consider that the expenditure of £55 per child on supervised tooth brushing, or £100 per child on fluoride varnish application would give sufficient health benefits to be justified according to their threshold.
CONCLUSIONS: Greater attention needs to be paid to the collection of robust data on costs for oral health promotion. Dental researchers also urgently need to collect outcome data in a form that can be translated into a Quality of Life measure, so that the true cost effectiveness and value for money achieved through the prevention of dental disease can be recognised and compared to other allocations of resource.
No abstract available.
Clinical trial data are essential for assessments of the effectiveness of health care interventions. Information about ongoing or completed, but not yet formally published, trials has been more difficult to identify until the development of clinical trials registers and portals. This paper summarises research evidence on identifying sources of trial data, how and when to search those sources, and which future developments may enhance access to and retrieval of unpublished trial evidence.
We conducted a literature search for relevant studies and provide a narrative review of the evidence from these studies. Clinical trial data can be found in resources including clinical trials registers, regulatory agency sources, health technology assessment websites and manufacturers' websites, and submissions for regulatory approval. The challenges of searching these resources are described. Trials registers are relatively unsophisticated in terms of their search interfaces, and searchers need to adapt to each individual register. There is overlap across registers, but little research on the degree and nature of overlap and how best to search. Despite these challenges, trials registers and other resources can be rich sources of additional unique trial data, which may not be available from journal reports. New initiatives, such as OpenTrials, aim to consolidate and link all structured data and documentation related to clinical trials.
No single resource gives access to all trials, and multiple registers should be searched as sensitively as possible. Searching is challenging and should be adequately resourced. Information specialists should monitor new developments which may reduce the challenges over the coming years.
This chapter focuses on evidence synthesis and, in particular, systematic reviews, including meta-analysis. Narrative literature reviews, critical reviews, expert elicitation, systematic reviews and meta-analyses, combined or separate, are examples of evidence-synthesis approaches. A well-executed systematic review is a rigorous and replicable approach to identifying, evaluating and summarizing scientific evidence relevant to a specific clinical or policy question. Systematic review questions can be classified as questions about interventions, causes, disease burden and detection. An extensive literature search is a cornerstone of the systematic review. One of the key features of systematic reviews is the emphasis on extraction and reporting of the magnitude of outcomes and precision of estimates. The essential elements of a meta-analysis are planning, conduct and interpretation. Planning requires deciding which comparisons to make, what summary effect measure to use, which statistical model to use, and which sources of heterogeneity to assess.
