Dalia Dawoud

Diagnosis and management of type 1 diabetes in adults: summary of updated NICE guidance.

#### The bottom line #### How patients were involved in the creation of this article Patients were involved at every stage of creating the guideline. Patient groups and individuals contributed to the scoping of the update and at the consultation stage. Lay members were active in the Guideline Development Group, contributing to the formulation of the recommendations summarised here, and were instrumental in setting the new treatment targets. Having type 1 diabetes reduces the life expectancy of adults in the United Kingdom by as much as 13 years.1 Despite incontrovertible evidence that good care reduces the risk of complications such as blindness, renal failure, and premature cardiovascular disease and death,2 as well as complications of treatment such as severe hypoglycaemia,3 fewer than 30% of UK adults with type 1 diabetes achieve current national treatment targets for glucose control.4 The challenges of managing type 1 diabetes do not lessen after the age of 18 years. Since the publication of the 2004 National Institute for Health and Care Excellence (NICE) guideline, new technologies to achieve diabetic control have become available—for example, insulin analogues, new glucose meters, and real time …

Conducting Economic Evaluations Alongside Randomised Trials: Current Methodological Issues and Novel Approaches

Trial-based economic evaluations are an important aspect of health technology assessment. The availability of patient-level data coupled with unbiased estimates of clinical outcomes means that randomised controlled trials are effective vehicles for the generation of economic data. However there are methodological challenges to trial-based evaluations, including the collection of reliable data on resource use and cost, choice of health outcome measure, calculating minimally important differences, dealing with missing data, extrapolating outcomes and costs over time and the analysis of multinational trials. This review focuses on the state of the art of selective elements regarding the design, conduct, analysis and reporting of trial-based economic evaluations. The limitations of existing approaches are detailed and novel methods introduced. The review is internationally relevant but with a focus towards practice in the UK.

A Systematic Review of Patients’ Perspectives on the Subcutaneous Route of Medication Administration

BackgroundSubcutaneous injections allow for self-administration, but consideration of patients’ perspectives on treatment choice is important to ensure adherence. Previous systematic reviews have been limited in their scope for assessing preferences in relation to other routes of administration.ObjectiveOur objective was to examine patients’ perspectives on subcutaneously administered self-injectable medications when compared with other routes or methods of administration for the same medicines.MethodsNine electronic databases were searched for publications since 2000 using terms pertaining to methods of administration, choice behavior, and adverse effects. Eligibility for inclusion was determined through reference to specific criteria by two independent reviewers. Results were described narratively.ResultsOf the 1726 papers screened, 85 met the inclusion criteria. Studies were focused mainly on methods of insulin administration for diabetes but also included treatments for pediatric growth disorders, multiple sclerosis, HIV, and migraine. Pen devices and autoinjectors were favored over administration with needle and syringe, particularly with respect to ergonomics, convenience, and portability. Inhalation appeared to be more acceptable than subcutaneous injection (in the case of insulin), but how subcutaneous infusion, intramuscular injection, and needle-free injection devices compare with subcutaneous injections in terms of patient preference is less certain.ConclusionsThe review identified a number of studies showing the importance of the methods and routes of drug delivery on patient choice. However, studies were prone to bias, and further robust evidence based on methodologically sound approaches is required to demonstrate how patient choice might translate to improved adherence.

Evaluation of a consultant audit and feedback programme to improve the quality of antimicrobial prescribing in acute medical admissions

This study aims to evaluate the effectiveness and acceptability of a pharmacist‐led antimicrobial stewardship intervention, consisting of consultant performance audit and feedback, on antimicrobial prescribing quality.

Basal Insulin Regimens for Adults with Type 1 Diabetes Mellitus: A Systematic Review and Network Meta-Analysis

OBJECTIVE To assess the relative efficacy and safety of basal insulin regimens in adults with type 1 diabetes mellitus (T1DM). METHODS A systematic review and Bayesian network meta-analysis (NMA) of randomized controlled trials comparing two or more basal insulin regimens were conducted. The following basal insulin regimens were included: Neutral Protamine Hagedorn (iNPH) (once [od], twice [bid], and four times daily [qid]), insulin detemir (iDet) (od and bid), insulin glargine 100 IU (iGlarg) (od), and insulin degludec (iDegl) (od). We searched the following databases: MEDLINE via OVID, Embase via OVID, and the Cochrane Library (Wiley). Study quality was appraised using Cochrane risk-of-bias checklist for randomized controlled trials. Two outcomes (change in hemoglobin A1c [HbA1c] and rate of severe/major hypoglycemia [SH]) were analyzed. Network inconsistency was assessed using Bucher and chi-square tests. RESULTS Thirty studies met the eligibility criteria. Twenty-five were included in the HbA1c network and 16 in the SH network. All studies were of moderate quality. No network inconsistency was evident in the HbA1c network. Of the seven regimens of interest, iDet (bid) had the highest probability of being best (mean change in HbA1c -0.48; 95% credible interval -0.69 to -0.29). In contrast, the SH network demonstrated both considerable uncertainty and significant network inconsistency (χ2 test, P = 0.003). CONCLUSIONS Of the specified frequency regimens, iDet (bid) had the highest probability of being the best basal insulin regimen in terms of reduction in HbA1c. Ranking of the regimens in terms of the SH rate was highly uncertain and no clear conclusion could be made.

Basal Insulin Regimens for Adults with Type 1 Diabetes Mellitus: A Cost-Utility Analysis

OBJECTIVES To assess the cost-effectiveness of basal insulin regimens for adults with type 1 diabetes mellitus in England. METHODS A cost-utility analysis was conducted in accordance with the National Institute for Health and Care Excellence reference case. The UK National Health Service and personal and social services perspective was used and a 3.5% discount rate was applied for both costs and outcomes. Relative effectiveness estimates were based on a systematic review of published trials and a Bayesian network meta-analysis. The IMS CORE Diabetes Model was used, in which net monetary benefit (NMB) was calculated using a threshold of £20,000 per quality-adjusted life-year (QALY) gained. A wide range of sensitivity analyses were conducted. RESULTS Insulin detemir (twice daily) [iDet (bid)] had the highest mean QALY gain (11.09 QALYs) and NMB (£181,456) per patient over the model time horizon. Compared with the lowest cost strategy (insulin neutral protamine Hagedorn once daily), it had an incremental cost-effectiveness ratio of £7844/QALY gained. Insulin glargine (od) [iGlarg (od)] and iDet (od) were ranked as second and third, with NMBs of £180,893 and £180,423, respectively. iDet (bid) remained the most cost-effective treatment in all the sensitivity analyses performed except when high doses were assumed (>30% increment compared with other regimens), where iGlarg (od) ranked first. CONCLUSIONS iDet (bid) is the most cost-effective regimen, providing the highest QALY gain and NMB. iGlarg (od) and iDet (od) are possible options for those for whom the iDet (bid) regimen is not acceptable or does not achieve required glycemic control.

Effectiveness and cost effectiveness of pharmacist input at the ward level: A systematic review and meta-analysis

BACKGROUND Pharmacists play important role in ensuring timely care delivery at the ward level. The optimal level of pharmacist input, however, is not clearly defined. OBJECTIVE To systematically review the evidence that assessed the outcomes of ward pharmacist input for people admitted with acute or emergent illness. METHODS The protocol and search strategies were developed with input from clinicians. Medline, EMBASE, Centre for Reviews and Dissemination, The Cochrane Library, NHS Economic Evaluations, Health Technology Assessment and Health Economic Evaluations databases were searched. Inclusion criteria specified the population as adults and young people (age >16 years) who are admitted to hospital with suspected or confirmed acute or emergent illness. Only randomised controlled trials (RCTs) published in English were eligible for inclusion in the effectiveness review. Economic studies were limited to full economic evaluations and comparative cost analysis. Included studies were quality-assessed. Data were extracted, summarised. and meta-analysed, where appropriate. RESULTS Eighteen RCTs and 7 economic studies were included. The RCTs were from USA (n = 3), Sweden (n = 2), Belgium (n = 2), China (n = 2), Australia (n = 2), Denmark (n = 2), Northern Ireland, Norway, Canada, UK and Netherlands. The economic studies were from UK (n = 2), Sweden (n = 2), Belgium and Netherlands. The results showed that regular pharmacist input was most cost effective. It reduced length-of-stay (mean = -1.74 days [95% CI: 2.76, -0.72], and increased patient and/or carer satisfaction (Relative Risk (RR) = 1.49 [1.09, 2.03] at discharge). At £20,000 per quality-adjusted life-year (QALY)-gained cost-effectiveness threshold, it was either cost-saving or cost-effective (Incremental Cost Effectiveness Ratio (ICER) = £632/QALY-gained). No evidence was found for 7-day pharmacist presence. CONCLUSIONS Pharmacist inclusion in the ward multidisciplinary team improves patient safety and satisfaction and is cost-effective when regularly provided throughout the ward stay. Research is needed to determine whether the provision of 7-day service is cost-effective.

Different Methods for Modelling Severe Hypoglycaemic Events: Implications for Effectiveness, Costs and Health Utilities

BackgroundClinical trials report severe hypoglycaemic events as the number of patients with at least one event out of the total randomised or number of events for a given total exposure. Different network meta-analysis models have been used to analyse these different data types.ObjectiveThis aim of this article was to establish the impact of using the different models on effectiveness, costs and health utility estimates.MethodsWe analysed a dataset used in a recent network meta-analysis of severe hypoglycaemic events conducted to inform National Institute for Health and Care Excellence recommendations regarding basal insulin choice for patients with type 1 diabetes mellitus. We fitted a model with a binomial likelihood reporting odds ratios (using a logit link) or hazard ratios (complementary log-log link), a model with a Poisson likelihood reporting hazard ratios and a shared-parameter model combining different types of data. We compared the results in terms of relative effects and resulting cost and disutility estimates.ResultsRelative treatment effects are similar regardless of which model or scale is used. Differences were seen in the probability of having an event on the baseline treatment with the logit model giving a baseline probability of 0.07, the complementary log-log 0.17 and the Poisson 0.29. These translate into differences of up to £110 in the yearly cost of a hypoglycaemic event and 0.004 in disutility.ConclusionWhile choice of network meta-analysis model does not have a meaningful impact on relative effects for this outcome, care should be taken to ensure that the baseline probabilities used in an economic model are accurate to avoid misrepresenting costs and effects.

Economic Evaluation and Its Types

Abstract In this chapter, we provide a basic introduction to the different forms of economic evaluation, including cost-minimization analysis, cost-effectiveness analysis, cost–benefit analysis, and cost–utility analysis. In particular, we discuss the measurement of costs and outcomes in these types of economic evaluation and explain how the perspective of an evaluation affects these forms of analysis. We discuss the measurement of costs and patient outcomes and introduce the main measurement tools used by health economists. The chapter also introduces the concepts of incremental analysis, the cost-effectiveness plane, and cost-effectiveness acceptability curves. Finally, we discuss how the results of economic evaluations can be used in decision-making.

Intravenous fluids in children and young people: summary of NICE guidance

#### What you need to know Inappropriate use of intravenous fluids in children may have serious consequences. These include death or permanent neurological injury from hyponatraemia,1 hypovolaemia, and poor organ perfusion, as well as the risks of hypervolaemia, oedema, and heart failure. Children have different fluid requirements from adults, for whom specific guidance exists.2 This article summarises the most recent recommendations from the National Institute for Health and Care Excellence (NICE).3 #### What’s new in this guidance NICE recommendations are based on systematic reviews of best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations are based on the guideline development group’s experience and opinion of what constitutes good practice. Evidence levels for the recommendations are given in italic in square brackets. The guidance covers children and young people under 16, including neonates, unless otherwise specified. ### Assessment and monitoring (figs 1⇓ and 2⇓) Fig 1 Algorithm for …