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 Results: In total, 29 final and 31 draft guidance documents included OIR/AWR recommendations up to January 2010.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

Barriers and solutions to participation in exercise for moderately disabled people with multiple sclerosis not currently exercising: a consensus development study using nominal group technique

Background: Multiple sclerosis (MS) is a chronic, progressive neurological condition. The aim of this study was to explore consensus on the barriers and solutions to exercise for people with MS living in Scotland. Method: Thirty-five people with MS, not regularly exercising, were recruited and took part in five Nominal Group Technique groups throughout Scotland. Background information was collected on participants prior to each group. Participants individually and silently listed their barriers and solutions to participating in exercise. Group discussion then clarified, amended and merged ideas. Participants then ranked ideas by choosing five barriers and solutions to exercise participation. Data were analyzed using descriptive statistics and by carrying out a thematic grouping. Results: Consensus was that fatigue was a barrier to exercise participation . Other identified barriers were a lack of support and advice, the impairments arising from the condition and time. No single item achieved consensus for solutions but exercising with others, receiving support, having a positive attitude, finding time and minimizing environmental barriers were all suggested as solutions to assist in exercise participation. Conclusions: People with MS should be provided with information on how to manage their fatigue alongside any exercise prescription. Information and support should be given on how to personalize exercise to suit individual needs and abilities to overcome some of the barriers suggested within this study. Implications for rehabilitation More exercise opportunities are required. Exercise should be personalized to address the individual needs of the person with MS. Any identified barriers to exercise should be addressed

Artificial neural network algorithm for online glucose prediction from continuous glucose monitoring.

Background and Aims: Continuous glucose monitoring (CGM) devices could be useful for real-time management of diabetes therapy. In particular, CGM information could be used in real time to predict future glucose levels in order to prevent hypo-/hyperglycemic events. This article proposes a new online method for predicting future glucose concentration levels from CGM data. Methods: The predictor is implemented with an artificial neural network model (NNM). The inputs of the NNM are the values provided by the CGM sensor during the preceding 20 min, while the output is the prediction of glucose concentration at the chosen prediction horizon (PH) time. The method performance is assessed using datasets from two different CGM systems (nine subjects using the Medtronic [Northridge, CA] Guardian® and six subjects using the Abbott [Abbott Park, IL] Navigator®). Three different PHs are used: 15, 30, and 45 min. The NNM accuracy has been estimated by using the root mean square error (RMSE) and prediction delay. Results: The RMSE is around 10, 18, and 27 mg/dL for 15, 30, and 45 min of PH, respectively. The prediction delay is around 4, 9, and 14 min for upward trends and 5, 15, and 26 min for downward trends, respectively. A comparison with a previously published technique, based on an autoregressive model (ARM), has been performed. The comparison shows that the proposed NNM is more accurate than the ARM, with no significant deterioration in the prediction delay

The NorthStar Ambulatory Assessment in Duchenne muscular dystrophy: considerations for the design of clinical trials.

With the emergence of experimental therapies for Duchenne muscular dystrophy (DMD), it is fundamental to understand the natural history of this disorder to properly design clinical trials. The aims of this study were to assess the effects produced on motor function by different DMD genotypes and early initiation of glucocorticoids

Longitudinal assessment of high blood pressure in children with nonalcoholic fatty liver disease.

ObjectiveNonalcoholic fatty liver disease (NAFLD) affects 9.6% of children and may put these children at elevated risk of high blood pressure and subsequent cardiovascular morbidity and mortality. Therefore, we sought to determine the prevalence of and risk factors for high blood pressure in children with NAFLD.MethodsCohort study performed by the NIDDK NASH Clinical Research Network. There were 484 children with NAFLD ages 2 to 17 at enrollment; 382 children were assessed both at enrollment and 48 weeks afterwards. The main outcomes were high blood pressure at baseline and persistent high blood pressure at both baseline and 48 weeks.ResultsPrevalence of high blood pressure at baseline was 35.8% and prevalence of persistent high blood pressure was 21.4%. Children with high blood pressure were significantly more likely to have worse steatosis than children without high blood pressure (mild 19.8% vs. 34.2%, moderate 35.0% vs. 30.7%, severe 45.2% vs. 35.1%; P = 0.003). Higher body mass index, low-density lipoprotein, and uric acid were independent risk factors for high blood pressure (Odds Ratios: 1.10 per kg/m2, 1.09 per 10 mg/dL, 1.25 per mg/dL, respectively). Compared to boys, girls with NAFLD were significantly more likely to have persistent high blood pressure (28.4% vs.18.9%; P = 0.05).ConclusionsIn conclusion, NAFLD is a common clinical problem that places children at substantial risk for high blood pressure, which may often go undiagnosed. Thus blood pressure evaluation, control, and monitoring should be an integral component of the clinical management of children with NAFLD

Parenting interventions for ADHD: a systematic literature review and meta-analysis

Objective. To evaluate the evidence base relating to the effectiveness of parent-administered behavioral interventions for ADHD

A national survey of clinical practice for the management of whiplash-associated disorders in UK emergency departments

Objective: To undertake a national survey to determine current practice for the management of whiplash injuries in UK emergency departments (ED). Methods: Postal questionnaire survey. 316 lead consultants from all UK ED with annual new attendances of over 50 000 people were asked to indicate the use of a range of treatments and the frequency with which these treatments were used. Samples of written advice were requested and content analysis was conducted and compared with survey responses. Results: The response rate was 79% (251/316). The intervention most frequently used was verbal advice to exercise, reported by 84% of respondents for most or all cases, and advice against the use of a collar (83%). Other treatments reported as being used frequently were written advice and anti-inflammatory medication. 106 consultants (42%) provided a sample of written materials. Reference to expected recovery and encouragement for early return to activities were included in less than 6%. Nearly 50% of written materials contained information on how to use a soft collar and 61% contained information on solicitors and pursuing a personal injury claim. There were important differences between reported verbal behaviours and written advice. Conclusion: Verbal advice is the primary method for managing whiplash injuries in ED and is usually supplemented by written advice. Within individual hospitals there is a lack of consistency between verbal and written advice. The promotion of personal injury claims is a common feature of written advice. Research is required to develop effective and consistent models of advice

Cost-effectiveness of asthma control: an economic appraisal of the GOAL study

<i>Background</i>: The Gaining Optimal Asthma ControL (GOAL) study has shown the superiority of a combination of salmeterol/fluticasone propionate (SFC) compared with fluticasone propionate alone (FP) in terms of improving guideline defined asthma control. <i>Methods</i>: Clinical and economic data were taken from the GOAL study, supplemented with data on health related quality of life, in order to estimate the cost per quality adjusted life year (QALY) results for each of three strata (previously corticosteroid-free, low- and moderate-dose corticosteroid users). A series of statistical models of trial outcomes was used to construct cost effectiveness estimates across the strata of the multinational GOAL study including adjustment to the UK experience. Uncertainty was handled using the non-parametric bootstrap. Cost-effectiveness was compared with other treatments for chronic conditions. <i>Result</i>: Salmeterol/fluticasone propionate improved the proportion of patients achieving totally and well-controlled weeks resulting in a similar QALY gain across the three strata of GOAL. Additional costs of treatment were greatest in stratum 1 and least in stratum 3, with some of the costs offset by reduced health care resource use. Cost-effectiveness by stratum was £7600 (95% CI: £4800–10 700) per QALY gained for stratum 3; £11 000 (£8600–14 600) per QALY gained for stratum 2; and £13 700 (£11 000–18 300) per QALY gained for stratum 1. <i>Conclusion</i>: The GOAL study previously demonstrated the improvement in total control associated with the use of SFC compared with FP alone. This study suggests that this improvement in control is associated with cost-per-QALY figures that compare favourably with other uses of scarce health care resources

Problematic clinical features of powered wheelchair users with severely disabling multiple sclerosis

This article is made available through the Brunel Open Access Publishing Fund. Copyright @ 2014 Informa UK Ltd.Purpose: The aim of this study is to describe the clinical features of powered wheelchair users with severely disabling multiple sclerosis (MS) and explore the problematic clinical features influencing prescription. Method: Retrospective review of electronic and case note records of recipients of electric-powered indoor/outdoor powered wheelchairs (EPIOCs) attending a specialist wheelchair service between June 2007 and September 2008. Records were reviewed by a consultant in rehabilitation medicine, data systematically extracted and entered into a computer database. Further data were entered from clinical records. Data were extracted under three themes; demographic, diagnostic, clinical and wheelchair factors. Results: Records of 28 men mean age 57 (range 37–78, SD 12) years and 63 women mean age 57 (range 35–81, SD 11) years with MS were reviewed a mean of 64 (range 0–131) months after receiving their wheelchair. Twenty two comorbidities, 11 features of MS and 8 features of disability were thought to influence wheelchair prescription. Fifteen users were provided with specialised seating and 46 with tilt-in-space seats. Conclusions: Our findings suggest that people with severe MS requiring an EPIOC benefit from a holistic assessment to identify problematic clinical features that influence the prescription of the EPIOC and further medical and therapeutic interventions