When does NICE recommend the use of health technologies within a programme of evidence development?

This article is made available through the Brunel Open Access Publishing Fund. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.This article has been made available through the Brunel Open Access Publishing Fund.Background: There is growing interest internationally in linking reimbursement decisions with recommendations for further research. In the UK, the National Institute for Health and Clinical Excellence (NICE) can issue guidance to approve the routine use of a health intervention, reject routine use or recommend use within a research programme. These latter recommendations have restricted use to ‘only in research’ (OIR) or have recommended further research alongside routine use (‘approval with research’ or AWR). However, it is not currently clear when such recommendations are likely to be made. Objectives: This study aims to identify NICE technology appraisals where OIR or AWR recommendations were made and to examine the key considerations that led to those decisions. Methods: Draft and final guidance including OIR/AWR recommendations were identified. The documents were reviewed to establish the characteristics of the technology appraisal, the cost effectiveness of the technologies, the key considerations that led to the recommendations and the types of research required. Results: In total, 29 final and 31 draft guidance documents included OIR/AWR recommendations up to January 2010. Overall, 86 % of final guidance included OIR recommendations. Of these, the majority were for technologies considered to be cost ineffective (83 %) and the majority of final guidance (66 %) specified the need for further evidence on relative effectiveness. The use of OIR/AWR recommendations is decreasing over time and they have rarely been used in appraisals conducted through the single technology appraisal process. Conclusion: NICE has used its ability to recommend technologies within research programmes, although predominantly within the multiple technology appraisal process. OIR recommendations have been most frequently issued for technologies considered cost ineffective and the most frequently cited consideration is uncertainty related to relative effectiveness. Key considerations cited for most AWR recommendations and some OIR recommendations included a need for further evidence on long-term outcomes and adverse effects of treatment.Medical Research Counci

Acute kidney injury: an acceptable risk of treatment with renin-angiotensin system blockade in primary care?

Background: Use of renin-angiotensin system (RAS) blockade has become increasingly widespread driven by evidence-based guidance. There is concern about the role of these agents in the genesis of avoidable acute kidney injury (AKI). Objectives: To investigate the association between AKI and use of RAS blockade. Design: Multilevel hierarchical analysis of a large cohort of patients registered with UK general practitioners. Setting: Primary care practices in East and West Kent, United Kingdom. Patients: 244,715 patients from 27 practices. Measurements: Demographic, clinical, biochemical and prescription data. Methods: Analyses of data acquired between 02/3/2004 and 17/04/2012 using multilevel logistic regression to determine the relationship between AKI and use of RAS blockade; further analysed by indication for treatment with RAS blockade. Results: Sufficient serum creatinine data were available to define AKI in 63,735 patients with 208,275 blood test instances. In 95,569 instances the patient was prescribed a RAS antagonist of which 5.4% fulfilled criteria for AKI. The unadjusted odds ratio (OR) for AKI in those prescribed RAS blockade was 1.93 (1.81-2.06, 95%CI) falling to 1.11 (1.02-1.20, 95%CI) when adjusted for age, gender, co-morbidity, GFR category, proteinuria, systolic blood pressure and diuretic therapy. In patients with an evidence-based indication there was no difference in absolute risk of AKI. However, prescription of RAS blockade in the absence of indication appeared to be associated with greater risk of AKI. When analysis was repeated with AKIN2/AKIN3 as the outcome, although risk of AKI remained significant when unadjusted (OR 1.73, 95%CI 1.42-2.11, p<0.001), after full adjustment there was no increased risk (OR 0.83, 95%CI 0.63-1.09) in those taking RAS antagonists. However, when analysed by indication AKIN2/AKIN3 was significantly more likely in those prescribed RAS antagonists without indication (OR 2.04, 95%CI 1.41-2.94, p<0.001). Limitations: Observational database study. No information concerning hospitalisation. Prescribing assumptions and potential inaccurate coding. Potential survival bias; patients surviving longer will contribute more data. Conclusions: Use of RAS antagonists increased the risk of AKI, independent of common confounding variables. After correction for confounders the risk fell away and became non-significant for moderate and severe AKI. However, where there was no evidence-based indication for RAS antagonists the risk of AKI, whether mild, moderate or severe, remained greater

Categorical methods in graded ring theory

Let G be a group, R a G-graded ring and X a right G-set . We study functors between categories of modules graded by G-sets, continuing the work of [M]. As an application we obtain generalizations of Cohen-Montgomery Duality Theorems by categorical methods. Then we study when some functors introduced in [M] (which generalize some functors ocurring in [D1], [D2] and [NRV]) are separable. Finally we obtain an application to the study of the weak dimension of a group graded ring

Recommended Practices: Protecting Temporary Workers

[Excerpt] Workers employed through staffing agencies are generally called temporary or supplied workers. For the purposes of these recommended practices, “temporary workers” are those supplied to a host employer and paid by a staffing agency, whether or not the job is actually temporary. Whether temporary or permanent, all workers always have a right to a safe and healthy workplace. The staffing agency and the staffing agency’s client (the host employer) are joint employers of temporary workers and, therefore, both are responsible for providing and maintaining a safe work environment for those workers. The staffing agency and the host employer must work together to ensure that the Occupational Safety and Health Act of 1970 (the OSH Act) requirements are fully met. See 29 U.S.C. § 651. The extent of the obligations of each employer will vary depending on workplace conditions and should therefore be described in the agreement or contract between the employers. Their safety and health responsibilities will sometimes overlap. Either the staffing agency or the host employer may be better suited to ensure compliance with a particular requirement, and may assume primary responsibility for it. The joint employment structure requires effective communication and a common understanding of the division of responsibilities for safety and health. Ideally, these will be set forth in a written contract. OSHA and NIOSH recommend the following practices to staffing agencies and host employers so that they may better protect temporary workers through mutual cooperation and collaboration. Unless otherwise legally required, these recommendations are for the purpose of guidance and in some cases represent best practices

Cost-effectiveness of ocriplasmin for the treatment of vitreomacular traction and macular hole

Background: If left untreated, vitreomacular traction (VMT) will infrequently improve through spontaneous resolution of vitreomacular adhesion (VMA), and patients remain at risk of further deterioration in vision. The mainstay of treatment for VMT is vitrectomy, an invasive procedure that carries the risk of rare but serious complications and further vision loss. As such, a ‘watch and wait’ approach is often adopted before this surgical intervention is performed. Ocriplasmin (microplasmin) is a potential alternative treatment for patients with symptomatic VMA/VMT that may remove the requirement for vitrectomy. Objective: The purpose of this study was to evaluate the cost-effectiveness of ocriplasmin for the treatment of VMT in comparison to standard of care. Study design: A cohort-based computer simulation model was developed, capturing three mutually exclusive subgroups: 1) VMT without epiretinal membrane (ERM) or full thickness macular hole (FTMH), 2) VMT with ERM but no FTMH, and 3) VMT with FTMH. Transition probabilities between health states, utilities, and resource utilisation were estimated based on clinical trial results, the literature, and expert opinion. The cost per quality-adjusted life year (QALY) gained was estimated over a lifetime, using UK unit costs and utilities associated with visual acuity, adverse events, metamorphopsia, and surgical interventions. Setting: Analyses were conducted from a UK payer perspective. Population: Transition probabilities for the model were primarily estimated from patient-level data from the combined Phase 3 MIVI-TRUST trials in patients with symptomatic VMA/VMT, including when associated with a FTMH ≤400 µm. Intervention: Ocriplasmin (microplasmin) is a one-time intravitreal injection designed specifically to release the abnormal traction between the macula and the vitreous and thereby treat VMT, as well as macular hole with persistent vitreous attachment. Main outcome measure: The main outcome measure of the economic evaluation was cost per QALY. Results: In all subgroups, ocriplasmin management generated more QALYs: 1) VMT without ERM or FTMH (0.105, (0.036, 0.191)); 2) VMT with ERM but no FTMH (0.041, (0.011, 0.131)); and 3) VMT with FTMH (0.053, (−0.002, 0.113)). The initial treatment costs were partially offset by later savings and net costs were estimated at £1,901 (£1,325, £2,474), £2,491 (£1,067, £2,511), and £1,912 (£1,233, £2,506), respectively. Costs per QALY were estimated at £18,056 (£8,241, £64,874), £61,059 (£8,269, £168,664), and £36,250 (−£144,788, £290,338), respectively. Short-term efficacy parameters were found to be key drivers of results. Conclusion: Ocriplasmin is most cost-effective in VMT patients without either ERM or FTMH

Preparing young people with complex needs and their families for transition to adult services

© RCN Publishing Company Limited 2018Improving survival rates for children and young people with complex health needs requires a robust system for transition to adult services. Effective planning is essential to ensure a smooth transition process that is in the best interests of the young person and their family. This article discusses the needs and requirements for planned and purposeful transition processes to support young people with complex healthcare needs and their families. It considers the preparation of adult services, the team, the young person and their parents in line with an integrated approach and the nurse’s role. Recommendations for practice include the necessity for an integrated approach to ensure optimum outcomes and ascertaining the potential value of a nurse-led service in delivering the transition process. A carefully tailored planning strategy should be developed to prepare and support young people with complex health needs through transition

Improving the psychological evaluation of exercise referral: psychometric properties of the Exercise Referral Quality of Life Scale

There is a growing need to assess the psychological outcomes of exercise referral and the National Institute of Health and Care Excellence has called for the routine assessment of life-quality. However, a quality of life scale specific to the requirements of exercise referral is currently unavailable. Therefore, the aim of this study was to produce a quality of life measure for this purpose. The Exercise Referral Quality of Life Scale is a 22-item measure comprising three domains: mental and physical health, injury pain and illness and physical activity facilitators. Exploratory factor analysis determined the initial factor structure and was subsequently confirmed by confirmatory factor analysis. Additional scale properties were also assessed. The scale contributes to the global need for improved consistent psychological outcome assessment of exercise referral

Crossover studies can help the individualisation of care in type 2 diabetes:the MASTERMIND approach

-The MASTERMIND consortium is funded by a grant from the Medical Research Counci