Are current UK National Institute for Health and Clinical Excellence (NICE) obesity risk guidelines useful? Cross-sectional associations with cardiovascular disease risk factors in a large, representative English population.

PubMed

Tabassum, Faiza; Batty, G David

2013-01-01

The National Institute for Health and Clinical Excellence (NICE) has recently released obesity guidelines for health risk. For the first time in the UK, we estimate the utility of these guidelines by relating them to the established cardiovascular disease (CVD) risk factors. Health Survey for England (HSE) 2006, a population-based cross-sectional study in England was used with a sample size of 7225 men and women aged ≥35 years (age range: 35-97 years). The following CVD risk factor outcomes were used: hypertension, diabetes, total and high density lipoprotein cholesterol, glycated haemoglobin, fibrinogen, C-reactive protein and Framingham risk score. Four NICE categories of obesity were created based on body mass index (BMI) and waist circumference (WC): no risk (up to normal BMI and low/high WC); increased risk (normal BMI & very high WC, or obese & low WC); high risk (overweight & very high WC, or obese & high WC); and very high risk (obese I & very high WC or obese II/III with any levels of WC. Men and women in the very high risk category had the highest odds ratios (OR) of having unfavourable CVD risk factors compared to those in the no risk category. For example, the OR of having hypertension for those in the very high risk category of the NICE obesity groupings was 2.57 (95% confidence interval 2.06 to 3.21) in men, and 2.15 (1.75 to 2.64) in women. Moreover, a dose-response association between the adiposity groups and most of the CVD risk factors was observed except total cholesterol in men and low HDL in women. Similar results were apparent when the Framingham risk score was the outcome of interest. In conclusion, the current NICE definitions of obesity show utility for a range of CVD risk factors and CVD risk in both men and women.

Are Current UK National Institute for Health and Clinical Excellence (NICE) Obesity Risk Guidelines Useful? Cross-Sectional Associations with Cardiovascular Disease Risk Factors in a Large, Representative English Population

PubMed Central

Tabassum, Faiza; Batty, G. David

2013-01-01

The National Institute for Health and Clinical Excellence (NICE) has recently released obesity guidelines for health risk. For the first time in the UK, we estimate the utility of these guidelines by relating them to the established cardiovascular disease (CVD) risk factors. Health Survey for England (HSE) 2006, a population-based cross-sectional study in England was used with a sample size of 7225 men and women aged ≥35 years (age range: 35–97 years). The following CVD risk factor outcomes were used: hypertension, diabetes, total and high density lipoprotein cholesterol, glycated haemoglobin, fibrinogen, C-reactive protein and Framingham risk score. Four NICE categories of obesity were created based on body mass index (BMI) and waist circumference (WC): no risk (up to normal BMI and low/high WC); increased risk (normal BMI & very high WC, or obese & low WC); high risk (overweight & very high WC, or obese & high WC); and very high risk (obese I & very high WC or obese II/III with any levels of WC. Men and women in the very high risk category had the highest odds ratios (OR) of having unfavourable CVD risk factors compared to those in the no risk category. For example, the OR of having hypertension for those in the very high risk category of the NICE obesity groupings was 2.57 (95% confidence interval 2.06 to 3.21) in men, and 2.15 (1.75 to 2.64) in women. Moreover, a dose-response association between the adiposity groups and most of the CVD risk factors was observed except total cholesterol in men and low HDL in women. Similar results were apparent when the Framingham risk score was the outcome of interest. In conclusion, the current NICE definitions of obesity show utility for a range of CVD risk factors and CVD risk in both men and women. PMID:23844088

Reshaping policy to deliver holistic care for adolescents with Crohn's disease.

PubMed

Smith, Claudia; Gettings, Sheryl

2016-12-08

The number of adolescents with Crohn's disease (CD) is rising, with one third of cases diagnosed before turning 21 years old. Evidence shows that long-term medical intervention, school absence and the physical toll of CD on the growing adolescent also have a psychological effect on patients. In addition, poorly defined transition pathways are extending these problems into adulthood. The National Institute for Health and Care Excellence (NICE) guidelines are important in shaping service delivery and distribution. However, analysis of the full 2012 NICE CD management guidelines indicates they fall short of providing adequate recommendations for holistic management of the disease in young populations. An update in 2016 added a new clinical recommendation to the guidelines, but no further exploration of the psychosocial aspects of the impact of the disease. The authors of this article used a critical review of literature and concluded that service provision for adolescents with CD could be made better by improving CD support networks, involving young people in the development of policy centred on their care, as well as incorporating other (non-NICE) well-researched CD guidelines in national policy. These changes would improve quality of life for this vulnerable population.

Retrospective examination of lipid-lowering treatment patterns in a real-world high-risk cohort in the UK in 2014: comparison with the National Institute for Health and Care Excellence (NICE) 2014 lipid modification guidelines.

PubMed

Steen, Dylan L; Khan, Irfan; Ansell, David; Sanchez, Robert J; Ray, Kausik K

2017-02-17

In 2014, guidelines from the National Institute for Health and Care Excellence (NICE) provided updated recommendations on lipid-modifying therapy (LMT). We assessed clinical practice contemporaneous to release of these guidelines in a UK general practice setting for secondary and high-risk primary-prevention populations, and extrapolated the findings to UK nation level. Patients from The Health Improvement Network database with the following criteria were included: lipid profile in 2014 (index date); ≥20 years of age; ≥2 years representation in database prior to index; ≥1 statin indication either for atherosclerotic cardiovascular disease (ASCVD) or the non-ASCVD conditions high-risk diabetes mellitus and/or chronic kidney disease. Overall, 183 565 patients met the inclusion criteria (n=91 479 for ASCVD, 92 086 for non-ASCVD). In those with ASCVD, 79% received statin treatment and 31% received high-intensity statin. In the non-ASCVD group, 62% were on a statin and 57% received medium-intensity or high-intensity statin. In the ASCVD and non-ASCVD cohorts, 6% and 15%, respectively, were already treated according to dosing recommendations as per updated NICE guidelines. Extrapolation to the 2014 UK population indicated that, of the 3.3 million individuals with ASCVD, 2.4 million would require statin uptitration and 680 000 would require statin initiation (31% de novo initiation, 60% reinitiation, 9% addition to non-statin LMT) to achieve full concordance with updated guidelines. Of the 3.5 million high-risk non-ASCVD individuals, 1.6 million would require statin uptitration and 1.4 million would require statin initiation (59% de novo initiation, 36% reinitiation, 5% addition to non-statin LMT). A large proportion of UK individuals with ASCVD and high-risk non-ASCVD received statin treatment (79% and 62%, respectively) during the year of NICE 2014 guidelines release. Up to 94% of patients with ASCVD and 85% of high-risk non-ASCVD individuals, representing ∼3 million individuals in each group, would require statin uptitration or initiation to achieve full concordance with updated guidelines. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Will the implementation of the 2007 National Institute for Health and Clinical Excellence (NICE) guidelines on childhood urinary tract infection (UTI) in the UK miss significant urinary tract pathology?

PubMed

Deader, Rafia; Tiboni, Sonia G; Malone, Padraig S J; Fairhurst, Joanna

2012-08-01

• To investigate whether the implementation of the August 2007 National Institute for Health and Clinical Excellence (NICE) guidelines would miss significant urinary tract pathology in children with urinary tract infection (UTI). • All ultrasound (US) performed in children aged >6 months, during the year 1 August 2006 to 31 July 2007 for UTI, were retrospectively studied. • Each US scan in the study population of 346 was categorised dependent on whether it was appropriate or inappropriate to have been performed under the new guidelines and whether the US scan was normal or abnormal. • The records of each patient with an inappropriate abnormal US scan were re-analysed to see if patient management was affected by the US scan. • In 2011 patients with an original inappropriate abnormal US scan were re-evaluated to identify if any had presented with further urinary pathology. • In accordance with the NICE guidelines patients were divided by age. • Children aged 0.5-3 years: 78/95 (82%) US scans were inappropriate of which 12 (15%) were abnormal and four of these had a further documented UTI. After careful assessment of the US abnormalities it was judged that only one would have benefited from the initial US scan. • Children aged >3 years: 146/251 (58%) US scans were inappropriate of which 21(14%) were abnormal and six of these (29%) had a further documented UTI. After careful assessment of the US abnormalities it was judged that only three of 21 (14%) would have benefited from the initial US scan. • The vast majority of anomalies detected on the inappropriate US scans were of little clinical significance. • It is difficult to identify any patient who would have been truly disadvantaged if the US scan had not been performed after the initial UTI. • The NICE guidelines are safe to follow. © 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL.

Compliance with NICE guidance on the use of anti-TNFalpha agents in ankylosing spondylitis: an east and west Midlands regional audit.

PubMed

Rees, Frances; Peffers, Gillian; Bell, Carolyn; Obrenovic, Karen; Sandhu, Ravinder; Packham, Jonathan; Erb, Nicola

2012-08-01

Here we report on an audit performed to examine compliance with National Institute for Health and Clinical Excellence (NICE) guidelines for the use of anti-tumour necrosis factor alpha (anti-TNFalpha) in treating patients with ankylosing spondylitis (AS). Data from 17 rheumatology centres across the Midlands were collected prospectively from patients with AS attending outpatient clinics and retrospectively in patients receiving anti-TNFalpha but not attending outpatient clinics during the audit. In total, 80% of the 416 patients for whom data were collected were male. Of the 238 patients recruited prospectively, 41% were receiving anti-TNFalpha. Reviewing all patients on anti-TNFalpha (N=275), pre-treatment assessments 12 weeks apart were documented in 55% of patients. After anti-TNFalpha treatment had started, regular 12-weekly assessments occurred in 46% of patients. Therefore, compliance with NICE guidance was found to vary among centres. Based on our audit, clinical capacity, and clinical or patient choice might be influencing the suboptimal adherence seen in assessment timing suggested by NICE guidelines relating to the use of anti-TNFalpha in treating patients with AS.

The effects of NICE guidelines on the management of third molar teeth.

PubMed

McArdle, L W; Renton, T

2012-09-01

Third molar surgery (TMS) is probably one of the most commonly performed surgical procedures undertaken in the NHS. In 2000, the National Institute of Clinical Excellence (NICE) introduced guidelines relating to TMS. These recommended against the prophylactic removal of third molars and listed specific clinical indications for surgery. The impact of these guidelines has not been fully evaluated and this research hopes to focus the effect of these guidelines over the last ten years. Using data obtained from a variety of NHS databases such as HES (Eng & Wales), the NHSBSA and data from NHS Scotland, we looked at the age range of patients requiring third molar removal and the number of patients having third molars removed in both primary and secondary care environments from 1989 to 2009. In addition we looked at the clinical indications for TMS activity in secondary care. The mean age of patients increased from 25 years in 2000 to 32 years in 2010, with the modal (most common) age increasing from 26 to 29 years. After the introduction of clinical guidelines the number of patients requiring third molar removal in secondary care dropped by over 30%, however, since 2003 the number of patients has risen by 97%. There is also a significant increase in caries as an indication for third molar removal. More patients are requiring third molar removal with an increasing number of patients having caries related to their third molars. Patients are, on average, older confirming that the removal of third molars is shifting from a young adult population group to an older adult population group. NICE guidelines did appear to have contributed to a fall in the volume of third molars removed within the NHS post 2000. However, concluding that this reduction demonstrates the success of NICE's guidance would be a premature assumption. The number of patients now requiring third molar removal is comparable to that of the mid 1990s. NICE has influenced the management of patients with third molars but this has not resulted in any reduction in the number of patients requiring third molar removal. Coding and data collection for third molars is not uniform, leading to potential misrepresentation of data. This perhaps raises the issue that an improved universal coding system is required for the NHS and that the NICE guidelines need review.

Developing the revised NICE appraisal technical guidance to manufacturers and sponsors: opportunity or threat?

PubMed

Taylor, Rod S; Hutton, John; Culyer, Anthony J

2002-01-01

One of the principal roles of the National Institute for Clinical Excellence (NICE) is to appraise selected existing and emerging healthcare technologies and, as a result, produce guidance for the National Health Service (NHS) in England and Wales. A central part of this appraisal is the potential for manufacturers and sponsors to make a data submission. This paper describes the process of development of the second edition of technical guidance to manufacturers and sponsors for submission to NICE. The revision process took place during the period May 2000 and January 2001 and involved a number of key steps -- establishment of a guidance steering committee, review of current international guidelines of clinical and cost effectiveness, drafting of the guidance, detailed consultation with stakeholders, revision of the guidance and, finally, publication. The lessons learnt from revision of the NICE guidance for manufacturers and sponsors and some main issues for its future development are discussed.

Age-related references in national public health, technology appraisal and clinical guidelines and guidance: documentary analysis.

PubMed

Forrest, Lynne F; Adams, Jean; Ben-Shlomo, Yoav; Buckner, Stefanie; Payne, Nick; Rimmer, Melanie; Salway, Sarah; Sowden, Sarah; Walters, Kate; White, Martin

2017-05-01

older people may be less likely to receive interventions than younger people. Age bias in national guidance may influence entire public health and health care systems. We examined how English National Institute for Health & Care Excellence (NICE) guidance and guidelines consider age. we undertook a documentary analysis of NICE public health (n = 33) and clinical (n = 114) guidelines and technology appraisals (n = 212). We systematically searched for age-related terms, and conducted thematic analysis of the paragraphs in which these occurred ('age-extracts'). Quantitative analysis explored frequency of age-extracts between and within document types. Illustrative quotes were used to elaborate and explain quantitative findings. 2,314 age-extracts were identified within three themes: age documented as an a-priori consideration at scope-setting (518 age-extracts, 22.4%); documentation of differential effectiveness, cost-effectiveness or other outcomes by age (937 age-extracts, 40.5%); and documentation of age-specific recommendations (859 age-extracts, 37.1%). Public health guidelines considered age most comprehensively. There were clear examples of older-age being considered in both evidence searching and in making recommendations, suggesting that this can be achieved within current processes. we found inconsistencies in how age is considered in NICE guidance and guidelines. More effort may be required to ensure age is consistently considered. Future NICE committees should search for and document evidence of age-related differences in receipt of interventions. Where evidence relating to effectiveness and cost-effectiveness in older populations is available, more explicit age-related recommendations should be made. Where there is a lack of evidence, it should be stated what new research is needed. © The Author 2016. Published by Oxford University Press on behalf of the British Geriatrics Society.

Drug-disease and drug-drug interactions: systematic examination of recommendations in 12 UK national clinical guidelines.

PubMed

Dumbreck, Siobhan; Flynn, Angela; Nairn, Moray; Wilson, Martin; Treweek, Shaun; Mercer, Stewart W; Alderson, Phil; Thompson, Alex; Payne, Katherine; Guthrie, Bruce

2015-03-11

To identify the number of drug-disease and drug-drug interactions for exemplar index conditions within National Institute of Health and Care Excellence (NICE) clinical guidelines. Systematic identification, quantification, and classification of potentially serious drug-disease and drug-drug interactions for drugs recommended by NICE clinical guidelines for type 2 diabetes, heart failure, and depression in relation to 11 other common conditions and drugs recommended by NICE guidelines for those conditions. NICE clinical guidelines for type 2 diabetes, heart failure, and depression Potentially serious drug-disease and drug-drug interactions. Following recommendations for prescription in 12 national clinical guidelines would result in several potentially serious drug interactions. There were 32 potentially serious drug-disease interactions between drugs recommended in the guideline for type 2 diabetes and the 11 other conditions compared with six for drugs recommended in the guideline for depression and 10 for drugs recommended in the guideline for heart failure. Of these drug-disease interactions, 27 (84%) in the type 2 diabetes guideline and all of those in the two other guidelines were between the recommended drug and chronic kidney disease. More potentially serious drug-drug interactions were identified between drugs recommended by guidelines for each of the three index conditions and drugs recommended by the guidelines for the 11 other conditions: 133 drug-drug interactions for drugs recommended in the type 2 diabetes guideline, 89 for depression, and 111 for heart failure. Few of these drug-disease or drug-drug interactions were highlighted in the guidelines for the three index conditions. Drug-disease interactions were relatively uncommon with the exception of interactions when a patient also has chronic kidney disease. Guideline developers could consider a more systematic approach regarding the potential for drug-disease interactions, based on epidemiological knowledge of the comorbidities of people with the disease the guideline is focused on, and should particularly consider whether chronic kidney disease is common in the target population. In contrast, potentially serious drug-drug interactions between recommended drugs for different conditions were common. The extensive number of potentially serious interactions requires innovative interactive approaches to the production and dissemination of guidelines to allow clinicians and patients with multimorbidity to make informed decisions about drug selection. © Dumbreck et al 2015.

Searching CINAHL did not add value to clinical questions posed in NICE guidelines.

PubMed

Beckles, Zosia; Glover, Sarah; Ashe, Joanna; Stockton, Sarah; Boynton, Janette; Lai, Rosalind; Alderson, Philip

2013-09-01

This study aims to quantify the unique useful yield from the Cumulative Index to Nursing and Allied Health Literature (CINAHL) database to National Institute for Health and Clinical Excellence (NICE) clinical guidelines. A secondary objective is to investigate the relationship between this yield and different clinical question types. It is hypothesized that the unique useful yield from CINAHL is low, and this database can therefore be relegated to selective rather than routine searching. A retrospective sample of 15 NICE guidelines published between 2005 and 2009 was taken. Information on clinical review question type, number of references, and reference source was extracted. Only 0.33% (95% confidence interval: 0.01-0.64%) of references per guideline were unique to CINAHL. Nursing- or allied health (AH)-related questions were nearly three times as likely to have references unique to CINAHL as non-nursing- or AH-related questions (14.89% vs. 5.11%), and this relationship was found to be significant (P<0.05). No significant relationship was found between question type and unique CINAHL yield for drug-related questions. The very low proportion of references unique to CINAHL strongly suggests that this database can be safely relegated to selective rather than routine searching. Nursing- and AH-related questions would benefit from selective searching of CINAHL. Copyright © 2013 Elsevier Inc. All rights reserved.

[Introduction of British guidelines in perinatal mental healthcare--towards enhancing the function of perinatal mental healthcare in Japan].

PubMed

Suzuki, Toshihito

2014-01-01

Professionals in many different occupations, from psychiatrists, obstetricians, and pediatricians to nurses, midwives, pharmacists, clinical psychologists, public health nurses, and psychiatric social workers, are involved in perinatal mental healthcare. In order to enhance the function of such healthcare, it is necessary both to provide specialized training in each occupation and form a system and to smoothly conduct medical collaboration between different occupations. A deficiency in the medical function of perinatal mental healthcare greatly influences the mother and child's health, mental hygiene, and social life later in life. Therefore, a demand is seen for specialized staff and system formation capable of the following: 1) responding with appropriate perinatal management of female patients taking psychotropic drugs; 2) providing support and pregnancy consultation to female patients who wish to have children; and 3) properly handling postpartum mental disorder management, possibility of breastfeeding, and various issues that arise in mother-child relationships during upbringing. In the UK, the clinical guideline (NICE Clinical Guideline 45) for perinatal mental healthcare, which was created by the National Institute for Clinical Excellence (NICE), provides important guidelines on how to handle perinatal mental health. Aside from the NICE guideline, the Maudsley Prescribing Guidelines in Psychiatry indicates basic guidelines on prescribing perinatal drug therapy. In Japan, however, the current situation of perinatal mental healthcare is such that it has yet to be systemically developed. In this paper, we introduce the basic content in these British guidelines that should be noted. In addition, we consider the current status and future disposition of Japan's perinatal mental healthcare, with consideration for the differences in healthcare circumstances between Japan and the UK.

The U.K. NICE 2014 Guidelines for Osteoarthritis of the Knee: Lessons Learned in a Narrative Review Addressing Inadvertent Limitations and Bias.

PubMed

Birch, Stephen; Lee, Myeong Soo; Robinson, Nicola; Alraek, Terje

2017-04-01

Several systematic reviews suggest that acupuncture is effective for knee osteoarthritis (OA), and furthermore a safe and cost-effective treatment for this condition. A recent clinical practice guideline (CPG) from the National Institute for Health and Care Excellence (NICE), in the United Kingdom, recommended against the use of acupuncture on the grounds that the effect size (ES) in comparison with sham acupuncture is too small. Safety data were not considered in the review, in addition the levels of evidence for acupuncture against other recommended therapies were not compared. Consequently, it is argued that this NICE guideline has limitations that lead to several potential biases in its evaluation of acupuncture, which were not addressed correctly: (1) NICE's prior scoping process limited its review. (2) NICE introduced the method of developing recommendations based on the consideration of which interventions make "minimal important differences" of an ES of 0.5 or greater, rather than the statistical significance of the effect of an intervention when compared with an appropriate comparison. (3) Evidence that sham acupuncture is not physiologically inert and has some level of beneficial effect, hence artificially reducing the magnitude of the ES in comparison with sham. (4) The low adverse effects profile of acupuncture. (5) Evidence from trials comparing acupuncture with usual or standard care was not considered, nor was cost-effectiveness data. (6) Lack of the usual CPG "head-to-head" comparisons between interventions. If the same criteria and methods that have been applied to acupuncture were applied to other NICE-recommended therapies for knee OA, including patient centeredness, patient education, self-management and weight loss, nonsteroidal anti-inflammatory drug (NSAIDs), and cyclooxygenase-2 inhibitor (COX-2 inhibitors), these too would no longer be recommended and opiates would become the first line of drug prescription. Given the problems with sham acupuncture, perhaps now is the time to embrace pragmatic studies and employ comparative effectiveness studies instead.

A prospective audit of the impact of additional staff on the care of diabetic patients in a community podiatry service

PubMed Central

Ryan, Alexandra; Uppal, Meenakshi; Cunning, Imelda; Buckley, Claire M.

2015-01-01

Objective The purpose of this study was to evaluate the impact of the employment of additional podiatry staff on patients with diabetes attending a community-based podiatry service. Methods An audit was conducted to evaluate the intervention of two additional podiatry staff. All patients with diabetes referred to and attending community podiatry services in a specified area in the Republic of Ireland between June 2011 and June 2012 were included. The service was benchmarked against the UK gold standard outlined in the ‘Guidelines on prevention & management of foot problems in Type 2 Diabetes’ by the National Institute of Clinical Excellence (NICE). Process of care measures addressed were the number of patients with diabetes receiving treatment and the waiting times of patients with diabetes from referral to initial review. Results An increase in the number of patients with diabetes receiving treatment was seen in all risk categories (ranging from low risk to the emergency foot). Waiting times for patients with diabetes decreased post-intervention but did not reach the targets outlined in the NICE guidelines. The average time from referral to initial review of patients with an emergency diabetic foot was 37 weeks post-intervention. NICE guidelines recommend that these patients are seen within 24 hours. Discussion During the life cycle of this audit, increased numbers of patients were treated and waiting times for patients with diabetes were reduced. An internal re-organisation of the services coincided with the commencement of the additional staff. The improvements observed were due to the effects of a combination of additional staff and service re-organisation. Efficient organisation of services is key to optimal performance. Continued efforts to improve services are required to reach the standards outlined in the NICE guidelines. PMID:26048860

A prospective audit of the impact of additional staff on the care of diabetic patients in a community podiatry service.

PubMed

Ryan, Alexandra; Uppal, Meenakshi; Cunning, Imelda; Buckley, Claire M

2015-01-01

The purpose of this study was to evaluate the impact of the employment of additional podiatry staff on patients with diabetes attending a community-based podiatry service. An audit was conducted to evaluate the intervention of two additional podiatry staff. All patients with diabetes referred to and attending community podiatry services in a specified area in the Republic of Ireland between June 2011 and June 2012 were included. The service was benchmarked against the UK gold standard outlined in the 'Guidelines on prevention & management of foot problems in Type 2 Diabetes' by the National Institute of Clinical Excellence (NICE). Process of care measures addressed were the number of patients with diabetes receiving treatment and the waiting times of patients with diabetes from referral to initial review. An increase in the number of patients with diabetes receiving treatment was seen in all risk categories (ranging from low risk to the emergency foot). Waiting times for patients with diabetes decreased post-intervention but did not reach the targets outlined in the NICE guidelines. The average time from referral to initial review of patients with an emergency diabetic foot was 37 weeks post-intervention. NICE guidelines recommend that these patients are seen within 24 hours. During the life cycle of this audit, increased numbers of patients were treated and waiting times for patients with diabetes were reduced. An internal re-organisation of the services coincided with the commencement of the additional staff. The improvements observed were due to the effects of a combination of additional staff and service re-organisation. Efficient organisation of services is key to optimal performance. Continued efforts to improve services are required to reach the standards outlined in the NICE guidelines.

Quality Measurement Recommendations Relevant to Clinical Guidelines in Germany and the United Kingdom: (What) Can We Learn From Each Other?

PubMed Central

Petzold, Thomas; Deckert, Stefanie; Williamson, Paula R.; Schmitt, Jochen

2018-01-01

We conducted a systematic review of clinical guidelines (CGs) to examine the methodological approaches of quality indicator derivation in CGs, the frequency of quality indicators to check CG recommendations in routine care, and clinimetric properties of quality indicators. We analyzed the publicly available CG databases of the Association of the Scientific Medical Societies in Germany (AWMF) and National Institute for Health and Care Excellence (NICE). Data on the methodology of subsequent quality indicator derivation, the content and definition of recommended quality indicators, and clinimetric properties of measurement instruments were extracted. In Germany, no explicit methodological guidance exists, but 3 different approaches are used. For NICE, a general approach is used for the derivation of quality indicators out of quality standards. Quality indicators were defined in 34 out of 87 CGs (39%) in Germany and for 58 out of 133 (43%) NICE CGs. Statements regarding measurement properties of instruments for quality indicator assessment were missing in German and NICE documents. Thirteen pairs of CGs (32%) have associated quality indicators. Thirty-four quality indicators refer to the same aspect of the quality of care, which corresponds to 27% of the German and 7% of NICE quality indicators. The development of a standardized and internationally accepted methodology for the derivation of quality indicators relevant to CGs is needed to measure and compare quality of care in health care systems. PMID:29591538

Nutritional rehabilitation after ICU - does it happen: a qualitative interview and observational study.

PubMed

Merriweather, Judith; Smith, Pam; Walsh, Timothy

2014-03-01

To compare and contrast current nutritional rehabilitation practices against recommendations from National Institute for Health and Excellence guideline Rehabilitation after critical illness (NICE) (2009, http://www.nice.org.uk/cg83). Recovery from critical illness has gained increasing prominence over the last decade but there is remarkably little research relating to nutritional rehabilitation. The study is a qualitative study based on patient interviews and observations of ward practice. Seventeen patients were recruited into the study at discharge from the intensive care unit (ICU) of a large teaching hospital in central Scotland in 2011. Semi-structured interviews were conducted on transfer to the ward and weekly thereafter. Fourteen of these patients were followed up at three months post-ICU discharge, and a semi-structured interview was carried out. Observations of ward practice were carried out twice weekly for the duration of the ward stay. Current nutritional practice for post-intensive care patients did not reflect the recommendations from the NICE guideline. A number of organisational issues were identified as influencing nutritional care. These issues were categorised as ward culture, service-centred delivery of care and disjointed discharge planning. Their influence on nutritional care was compounded by the complex problems associated with critical illness. The NICE guideline provides few nutrition-specific recommendations for rehabilitation; however, current practice does not reflect the nutritional recommendations that are detailed in the rehabilitation care pathway. Nutritional care of post-ICU patients is problematic and strategies to overcome these issues need to be addressed in order to improve nutritional intake. © 2013 John Wiley & Sons Ltd.

Assessing the appropriateness of information on childhood fever in thermometer package leaflets: a systematic audit of thermometers available in the UK.

PubMed

Hernandez, Jose; Nicholson, Brian D; Thompson, Matthew

2015-06-01

Thermometers are found in most parents' homes, but little is known about the quality and accuracy of the information they provide, nor its consistency with current guidelines for managing fever. To compare information included with commonly available thermometers with National Institute for Health and Care Excellence (NICE) guidance for management of feverish illness in children. Systematic thermometer sampling from UK retailers between February 2013 and May 2013. Information was extracted from device packaging and leaflets on details and type of thermometer, instructions for use, normal ranges, and fever thresholds cited. This was compared with key parental recommendations from the 2013 NICE guidance on feverish illness in children. Associations were explored between cost of device and level of information. There were 123 thermometers identified (ranging from £0.99 to £69.99), none of which made explicit reference to NICE guidance. Most (n = 81, 65.9%) recommended use at a body site consistent with NICE guidance, but only 17 (13.8%) defined fever using the correct threshold (≥38.0°C), and few (n = 12, 9.8%) included advice on fever management, of which four suggested actions not advised by NICE. There was no association between thermometer cost and provision of information consistent with NICE guidance. Parents and caregivers have access to a large number of thermometers, yet they lack evidence-based information about fever detection and management, and in some cases contain misleading information. This represents a missed opportunity to disseminate best practices from guidelines for management of fever in children, and thermometer manufacturers are urged to include information consistent with current guidance. © British Journal of General Practice 2015.

What is the current NHS service provision for patients severely affected by chronic fatigue syndrome/myalgic encephalomyelitis? A national scoping exercise

PubMed Central

McDermott, Clare; Al Haddabi, Atheer; Akagi, Hiroko; Selby, Michelle; Cox, Diane; Lewith, George

2014-01-01

Background Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), in its most severe clinical presentation, can result in patients becoming housebound and bedbound so unable to access most available specialist services. This presents particular clinical risks and treatment needs for which the National Institute for Health and Care Excellence (NICE) advises specialist medical care and monitoring. The extent of National Health Service (NHS) specialist provision in England for severe CFS/ME is currently unknown. Objectives To establish the current NHS provision for patients with severe CFS/ME in England. Setting and participants All 49 English NHS specialist CFS/ME adult services in England, in 2013. Method Cross-sectional survey by email questionnaire. Primary outcome measures Adherence to NICE guidelines for severe CFS/ME. Results All 49 services replied (100%). 33% (16/49) of specialist CFS/ME services provided no service for housebound patients. 55% (27/49) services did treat patients with severe CFS/ME and their interventions followed the NICE guidelines. The remaining services (12%, 6/49) offered occasional or minimal support where funding allowed. There was one NHS unit providing specialist inpatient CFS/ME provision in England. Conclusions Study findings highlight substantial variation in access to specialist care for patients with severe presentation of CFS/ME. Where treatment was provided, this appeared to comply with NICE recommendations for this patient group. PMID:24984956

Ambiguities in the Guidelines for the Management of Arterial Hypertension: Indian Perspective with a Call for Global Harmonization.

PubMed

Rehan, Harmeet Singh; Grover, Abhinav; Hungin, A P S

2017-02-01

Many medical professional societies have formulated guidelines to treat hypertension, but there existed differences with respect to diagnosis, blood pressure (BP) targets, pharmacotherapy of hypertension, and grades of evidence. A MEDLINE search for hypertension guidelines was performed to compare Indian guidelines for hypertension (IGH) with these guidelines. A majority of the guidelines had consensus on the cutoff value (140/90 mmHg, recorded twice) to diagnose hypertension. The Joint National Committee 8 (JNC 8), IGH, Japanese Society of hypertension (JSH), Canadian Hypertension Education Program (CHEP), and American Society of Hypertension/International Society of Hypertension (ASH/ISH) guidelines provide a higher BP target for the elderly hypertensive populations, while the National Institute for Health and Care Excellence (NICE) and European Society of Hypertension (ESH) guidelines provided a lower BP target for the elderly patients. However, a meta-analysis showed benefits of having a systolic BP target of <130 mmHg for all patients. Treatment of hypertension according to JNC 8, NICE, and ASH/ISH guidelines varies among the black and the non-black population which recommended thiazide or calcium channel blockers for the black population. There is no special mention of pharmacotherapy or BP targets for the South Asian population in various guidelines including IGH despite evidence of higher risk of hypertension-associated complications in this population. It is suggested that all the available guidelines should be harmonized with highest level of evidence available to minimize ambiguities associated with management of hypertension.

A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D.

PubMed

Eswaran, Shanti L; Chey, William D; Han-Markey, Theresa; Ball, Sarah; Jackson, Kenya

2016-12-01

There has been an increasing interest in the role of fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) in irritable bowel syndrome (IBS). We report results from the first randomized controlled trial of the low FODMAP diet in US adults with IBS and diarrhea (IBS-D). The objectives were to compare the efficacy of the low FODMAP diet vs. a diet based upon modified National Institute for Health and Care Excellence guidelines (mNICE) on overall and individual symptoms in IBS-D patients. This was a single-center, randomized-controlled trial of adult patients with IBS-D (Rome III) which compared 2 diet interventions. After a 2-week screening period, eligible patients were randomized to a low FODMAP or mNICE diet for 4 weeks. The primary end point was the proportion of patients reporting adequate relief of IBS-D symptoms ≥50% of intervention weeks 3-4. Secondary outcomes included a composite end point which required response in both abdominal pain (≥30% reduction in mean daily pain score compared with baseline) and stool consistency (decrease in mean daily Bristol Stool Form of ≥1 compared with baseline), abdominal pain and stool consistency responders, and other key individual IBS symptoms assessed using daily questionnaires. After screening, 92 subjects (65 women, median age 42.6 years) were randomized. Eighty-four patients completed the study (45 low FODMAP, 39 mNICE). Baseline demographics, symptom severity, and nutrient intake were similar between groups. Fifty-two percent of the low FODMAP vs. 41% of the mNICE group reported adequate relief of their IBS-D symptoms (P=0.31). Though there was no significant difference in the proportion of composite end point responders (P=0.13), the low FODMAP diet resulted in a higher proportion of abdominal pain responders compared with the mNICE group (51% vs. 23%, P=0.008). Compared with baseline scores, the low FODMAP diet led to greater reductions in average daily scores of abdominal pain, bloating, consistency, frequency, and urgency than the mNICE diet. In this US trial, 40-50% of patients reported adequate relief of their IBS-D symptoms with the low FODMAP diet or a diet based on modified NICE guidelines. The low FODMAP diet led to significantly greater improvement in individual IBS symptoms, particularly pain and bloating, compared with the mNICE diet.

Economic modelling of diagnostic and treatment pathways in National Institute for Health and Care Excellence clinical guidelines: the Modelling Algorithm Pathways in Guidelines (MAPGuide) project.

PubMed

Lord, J; Willis, S; Eatock, J; Tappenden, P; Trapero-Bertran, M; Miners, A; Crossan, C; Westby, M; Anagnostou, A; Taylor, S; Mavranezouli, I; Wonderling, D; Alderson, P; Ruiz, F

2013-12-01

National Institute for Health and Care Excellence (NICE) clinical guidelines (CGs) make recommendations across large, complex care pathways for broad groups of patients. They rely on cost-effectiveness evidence from the literature and from new analyses for selected high-priority topics. An alternative approach would be to build a model of the full care pathway and to use this as a platform to evaluate the cost-effectiveness of multiple topics across the guideline recommendations. In this project we aimed to test the feasibility of building full guideline models for NICE guidelines and to assess if, and how, such models can be used as a basis for cost-effectiveness analysis (CEA). A 'best evidence' approach was used to inform the model parameters. Data were drawn from the guideline documentation, advice from clinical experts and rapid literature reviews on selected topics. Where possible we relied on good-quality, recent UK systematic reviews and meta-analyses. Two published NICE guidelines were used as case studies: prostate cancer and atrial fibrillation (AF). Discrete event simulation (DES) was used to model the recommended care pathways and to estimate consequent costs and outcomes. For each guideline, researchers not involved in model development collated a shortlist of topics suggested for updating. The modelling teams then attempted to evaluate options related to these topics. Cost-effectiveness results were compared with opinions about the importance of the topics elicited in a survey of stakeholders. The modelling teams developed simulations of the guideline pathways and disease processes. Development took longer and required more analytical time than anticipated. Estimates of cost-effectiveness were produced for six of the nine prostate cancer topics considered, and for five of eight AF topics. The other topics were not evaluated owing to lack of data or time constraints. The modelled results suggested 'economic priorities' for an update that differed from priorities expressed in the stakeholder survey. We did not conduct systematic reviews to inform the model parameters, and so the results might not reflect all current evidence. Data limitations and time constraints restricted the number of analyses that we could conduct. We were also unable to obtain feedback from guideline stakeholders about the usefulness of the models within project time scales. Discrete event simulation can be used to model full guideline pathways for CEA, although this requires a substantial investment of clinical and analytic time and expertise. For some topics lack of data may limit the potential for modelling. There are also uncertainties over the accessibility and adaptability of full guideline models. However, full guideline modelling offers the potential to strengthen and extend the analytical basis of NICE's CGs. Further work is needed to extend the analysis of our case study models to estimate population-level budget and health impacts. The practical usefulness of our models to guideline developers and users should also be investigated, as should the feasibility and usefulness of whole guideline modelling alongside development of a new CG. This project was funded by the Medical Research Council and the National Institute for Health Research through the Methodology Research Programme [grant number G0901504] and will be published in full in Health Technology Assessment; Vol. 17, No. 58. See the NIHR Journals Library website for further project information.

Applicability and accuracy of pretest probability calculations implemented in the NICE clinical guideline for decision making about imaging in patients with chest pain of recent onset.

PubMed

Roehle, Robert; Wieske, Viktoria; Schuetz, Georg M; Gueret, Pascal; Andreini, Daniele; Meijboom, Willem Bob; Pontone, Gianluca; Garcia, Mario; Alkadhi, Hatem; Honoris, Lily; Hausleiter, Jörg; Bettencourt, Nuno; Zimmermann, Elke; Leschka, Sebastian; Gerber, Bernhard; Rochitte, Carlos; Schoepf, U Joseph; Shabestari, Abbas Arjmand; Nørgaard, Bjarne; Sato, Akira; Knuuti, Juhani; Meijs, Matthijs F L; Brodoefel, Harald; Jenkins, Shona M M; Øvrehus, Kristian Altern; Diederichsen, Axel Cosmus Pyndt; Hamdan, Ashraf; Halvorsen, Bjørn Arild; Mendoza Rodriguez, Vladimir; Wan, Yung Liang; Rixe, Johannes; Sheikh, Mehraj; Langer, Christoph; Ghostine, Said; Martuscelli, Eugenio; Niinuma, Hiroyuki; Scholte, Arthur; Nikolaou, Konstantin; Ulimoen, Geir; Zhang, Zhaoqi; Mickley, Hans; Nieman, Koen; Kaufmann, Philipp A; Buechel, Ronny Ralf; Herzog, Bernhard A; Clouse, Melvin; Halon, David A; Leipsic, Jonathan; Bush, David; Jakamy, Reda; Sun, Kai; Yang, Lin; Johnson, Thorsten; Laissy, Jean-Pierre; Marcus, Roy; Muraglia, Simone; Tardif, Jean-Claude; Chow, Benjamin; Paul, Narinder; Maintz, David; Hoe, John; de Roos, Albert; Haase, Robert; Laule, Michael; Schlattmann, Peter; Dewey, Marc

2018-03-19

To analyse the implementation, applicability and accuracy of the pretest probability calculation provided by NICE clinical guideline 95 for decision making about imaging in patients with chest pain of recent onset. The definitions for pretest probability calculation in the original Duke clinical score and the NICE guideline were compared. We also calculated the agreement and disagreement in pretest probability and the resulting imaging and management groups based on individual patient data from the Collaborative Meta-Analysis of Cardiac CT (CoMe-CCT). 4,673 individual patient data from the CoMe-CCT Consortium were analysed. Major differences in definitions in the Duke clinical score and NICE guideline were found for the predictors age and number of risk factors. Pretest probability calculation using guideline criteria was only possible for 30.8 % (1,439/4,673) of patients despite availability of all required data due to ambiguity in guideline definitions for risk factors and age groups. Agreement regarding patient management groups was found in only 70 % (366/523) of patients in whom pretest probability calculation was possible according to both models. Our results suggest that pretest probability calculation for clinical decision making about cardiac imaging as implemented in the NICE clinical guideline for patients has relevant limitations. • Duke clinical score is not implemented correctly in NICE guideline 95. • Pretest probability assessment in NICE guideline 95 is impossible for most patients. • Improved clinical decision making requires accurate pretest probability calculation. • These refinements are essential for appropriate use of cardiac CT.

National Survey of Neurosurgeons and Stroke Physicians on Decompressive Hemicraniectomy for Malignant Middle Cerebral Artery Infarction.

PubMed

Basu, Pallavi; Jenkins, Harri; Tsang, Kevin; Vakharia, Vejay N

2017-06-01

Several studies have evaluated the use of decompressive hemicraniectomy (DHC) in malignant middle cerebral artery infarction (MMCAI). In the United Kingdom, the National Institute for Health and Care Excellence (NICE) has set criteria for selection of patients for DHC in MMCAI. We set out to survey the attitudes and practice of neurosurgeons and stroke physicians within the United Kingdom towards DHC in MMCAI. An electronic survey of questions on management of MMCAI in various clinical scenarios was submitted to the academic committees of the Society of British Neurological Surgeons and the British Association of Stroke Physicians for approval before dissemination through the consultant members. Responses were collected over 2 months. A total of 78 responses, from 51 neurosurgeons and 27 stroke physicians, were included in final analysis. A total of 54% and 24% of all respondents would recommend DHC in patients aged 60-70 and 70-80 years, respectively; 60% would advocate surgery between 48 and 72 hours and 27% beyond 72 hours. A total of 36% indicated DHC with preoperative Glasgow Coma Scale 15/15. These findings do not conform to current NICE guidelines. Stroke physicians were statistically more likely to recommend DHC in patients older than 60 years (P = 0.032) and in those with dominant multiterritorial infarcts (P = 0.042) and accept a greater postoperative modified Rankin Scale (P = 0.034) compared with neurosurgeons. In view of evidence from recent trials and differences in NICE guidelines and current clinical practice within the United Kingdom, based on our survey results, it is important to reevaluate NICE guidelines. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Utah obstetricians' opinions of planned home birth and conflicting NICE/ACOG guidelines: A qualitative study.

PubMed

Rainey, Emily; Simonsen, Sara; Stanford, Joseph; Shoaf, Kimberley; Baayd, Jami

2017-06-01

The United Kingdom's National Institute for Health and Care Excellence (NICE) recently published recommendations that support planned home birth for low-risk women. The American College of Obstetricians and Gynecologists (ACOG) remains wary of planned home birth, asserting that hospitals and birthing centers are the safest birth settings. Our objective was to examine opinions of obstetricians in Salt Lake City, Utah about home birth in the context of rising home birth rates and conflicting guidelines. Participants were recruited through online searches of Salt Lake City obstetricians and through snowball sampling. We conducted individual interviews exploring experiences with and attitudes toward planned home birth and the ACOG/NICE guidelines. Fifteen obstetricians who varied according to years of experience, location of medical training, sex, and subspecialty (resident, OB/GYN, maternal-fetal medicine specialist) were interviewed. Participants did not recommend home birth but supported a woman's right to choose her birth setting. Obstetrician opinions about planned home birth were shaped by misconceptions of home birth benefits, confusion surrounding the scope of care at home and among home birth providers, and negative transfer experiences. Participants were unfamiliar with the literature on planned home birth and/or viewed the evidence as unreliable. Support for ACOG guidelines was high, particularly in the context of the United States health care setting. Physician objectivity may be limited by biases against home birth, which stem from limited familiarity with published evidence, negative experiences with home-to-hospital transfers, and distrust of home birth providers in a health care system not designed to support home birth. © 2017 Wiley Periodicals, Inc.

To what extent are national guidelines for the management of urinary incontinence in women adhered? Data from a national audit.

PubMed

Wagg, A; Duckett, J; McClurg, D; Harari, D; Lowe, D

2011-12-01

OBJECTIVE  To assess the degree of adherence to the current National Institute for Health and Clinical Excellence (NICE) guidelines on the management of urinary incontinence (UI) in women. Retrospective survey of consecutive female inpatients and outpatients with UI as part of a national audit. NHS hospital and primary care (PC) trusts. Twenty-five women <65 years old and 25 women ≥ 65 years old from each participating site. All NHS trusts in England, Wales and Northern Ireland were eligible to participate. A web-based data collection form aligned to the NICE guidelines was constructed for the study. All data submitted to the audit were anonymous and access to the web-tool was password-protected for confidentiality. Data were returned by 128 acute and 75 PC trusts on 7846 women. No diagnosis was documented in 6.8% (153/2254) of younger and 28% (571/2011) of older women in hospitals (P < 0.001), and by 8.6% (123/1435) of younger and 21% (380/1786) of older women in PC trusts. In hospitals, 26% (396/1524) of younger women and 15% (182/1231) of older women (P < 0.001) and in PC trusts 8.2% (77/934) of younger and 4.7% (46/975) of older women underwent multichannel cystometry before conservative therapy. Documentation of discussion of causes and treatment of UI occurred in 76% (1717/2254) of younger and 44% (884/2011) of older women in hospitals (P < 0.001) and in 75% (1080/1435) of younger and 53% (948/1786) of older women in PC trusts (P < 0.001). CONCLUSION Older women are less likely to receive NICE compliant management. Adherence varies according to recommendation. There needs to be concentration on evidence-based community provision of care by competent and interested clinicians before the aims of the NICE guidelines are met. © 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.

They're NICE and Neat, but Are They Useful? A Grounded Theory of Clinical Psychologists' Beliefs About and Use of NICE Guidelines.

PubMed

Court, Alex John; Cooke, Anne; Scrivener, Amanda

2017-07-01

Guidelines are ubiquitous but inconsistently used in UK mental health services. Clinical psychologists are often influential in guideline development and implementation, but opinion within the profession is divided. This study utilized grounded theory methodology to examine clinical psychologists' beliefs about and use of NICE guidelines. Eleven clinical psychologists working in the NHS were interviewed. The overall emerging theme was; NICE guidelines are considered to have benefits but to be fraught with dangers. Participants were concerned that guidelines can create an unhelpful illusion of neatness. They managed the tension between the helpful and unhelpful aspects of guidelines by relating to them in a flexible manner. The participants reported drawing on specialist skills such as idiosyncratic formulation and integration. However, due to the pressures and dominant discourses within services they tended to practice in ways that prevent these skills from being recognized. This led to fears that their professional identity was threatened, which impacted upon perceptions of the guidelines. To our knowledge, the theoretical framework presented in this paper is the first that attempts to explain why NICE guidelines are not consistently utilized in UK mental health services. The current need for services to demonstrate 'NICE compliance' may be leading to a perverse incentive for clinical psychologists in particular to do one thing but say another and for specialist skills to be obscured. If borne out by future studies, this represents a threat to continued quality improvement and also to the profession. Copyright © 2016 John Wiley & Sons, Ltd. Guidelines have many benefits, but the current pressure for services to be 'NICE compliant' may be having unintended negative as well as positive effects. Lack of implementation may be partly the result of active choice by clinicians concerned to use the full range of professional skills and to offer flexibility and choice to service users. The current context is creating a perverse incentive for clinicians to say one thing but do another. This is problematic for services and a potential threat to the profession of clinical psychology. Copyright © 2016 John Wiley & Sons, Ltd.

An Increase in the Incidence of Infective Endocarditis in England since 2008: A secular trend interrupted time series analysis

PubMed Central

Dayer, Mark J; Jones, Simon; Prendergast, Bernard; Baddour, Larry M.; Lockhart, Peter B; Thornhill, Martin H

2017-01-01

Background Antibiotic prophylaxis (AP) administered prior to invasive procedures in patients at risk of developing infective endocarditis (IE) has historically been the focus of IE prevention. Recent changes in AP guidelines in the US and Europe have substantially reduced the numbers for whom AP is recommended. In the UK, the National Institute for Health and Care Excellence (NICE) guidelines recommended complete cessation of AP in March 2008. We report the impact of these guidelines on AP prescribing; in addition, IE incidence was examined following the introduction of the guidelines. Methods We analyzed English AP prescribing data from January 2004 to March 2013 and hospital discharge episode statistics for patients with a primary diagnosis of IE from January 2000 to March 2013. Findings AP prescribing rates fell dramatically after introduction of the NICE guidance (10,935 prescriptions/month vs. 2,236 prescriptions/month, p<0·0001). Commencing in March 2008, there was also a significant increase in the number of IE cases/month (0·11 cases/10million/month, CI 0·05–0·16, p<0·0001) above the projected historical trend. By March 2013, there were an additional 35 cases/month than would have been expected if the previous trend had continued. This increase in IE incidence was significant for both ‘high-risk’ and ‘lower-risk’ individuals. Interpretation Although our data do not establish a causal relationship, there has been a substantial reduction in AP prescribing and a significant increase in IE incidence in England since introduction of the NICE guidelines in 2008. Funding Different aspects of this study were supported by Heart Research UK and Simplyhealth [Grant Ref: RG2632/13/14] and NIDCR R03 grant [Ref: 1R03DE023092-01] from the National Institutes for Health. PMID:25467569

Incidence of infective endocarditis in England, 2000-13: a secular trend, interrupted time-series analysis.

PubMed

Dayer, Mark J; Jones, Simon; Prendergast, Bernard; Baddour, Larry M; Lockhart, Peter B; Thornhill, Martin H

2015-03-28

Antibiotic prophylaxis given before invasive dental procedures in patients at risk of developing infective endocarditis has historically been the focus of infective endocarditis prevention. Recent changes in antibiotic prophylaxis guidelines in the USA and Europe have substantially reduced the number of patients for whom antibiotic prophylaxis is recommended. In the UK, guidelines from the National Institute for Health and Clinical Excellence (NICE) recommended complete cessation of antibiotic prophylaxis for prevention of infective endocarditis in March, 2008. We aimed to investigate changes in the prescribing of antibiotic prophylaxis and the incidence of infective endocarditis since the introduction of these guidelines. We did a retrospective secular trend study, analysed as an interrupted time series, to investigate the effect of antibiotic prophylaxis versus no prophylaxis on the incidence of infective endocarditis in England. We analysed data for the prescription of antibiotic prophylaxis from Jan 1, 2004, to March 31, 2013, and hospital discharge episode statistics for patients with a primary diagnosis of infective endocarditis from Jan 1, 2000, to March 31, 2013. We compared the incidence of infective endocarditis before and after the introduction of the NICE guidelines using segmented regression analysis of the interrupted time series. Prescriptions of antibiotic prophylaxis for the prevention of infective endocarditis fell substantially after introduction of the NICE guidance (mean 10,900 prescriptions per month [Jan 1, 2004, to March 31, 2008] vs 2236 prescriptions per month [April 1, 2008, to March 31, 2013], p<0·0001). Starting in March, 2008, the number of cases of infective endocarditis increased significantly above the projected historical trend, by 0·11 cases per 10 million people per month (95% CI 0·05-0·16, p<0·0001). By March, 2013, 35 more cases per month were reported than would have been expected had the previous trend continued. This increase in the incidence of infective endocarditis was significant for both individuals at high risk of infective endocarditis and those at lower risk. Although our data do not establish a causal association, prescriptions of antibiotic prophylaxis have fallen substantially and the incidence of infective endocarditis has increased significantly in England since introduction of the 2008 NICE guidelines. Heart Research UK, Simplyhealth, and US National Institutes of Health. Copyright © 2015 Elsevier Ltd. All rights reserved.

Achieving high-quality care: a view from NICE.

PubMed

Leng, Gillian; Partridge, Gemma

2018-01-01

The National Institute for Health and Care Excellence (NICE) was established in 1999 to provide evidence-based guidance. The task of producing guidance by reviewing primary research data and using an advisory committee to develop evidence-based recommendations, is not straightforward. Guidance production is, however, less challenging than the task of putting evidence-based recommendations into practice.NICE is very sensitive to this challenge as, since 1999, over 1500 pieces of NICE guidance have been published. A number of pieces of guidance relate to heart disease, including pharmaceutical agents, new medical technologies and clinical guidelines. Examples include guidelines on acute heart failure and atrial fibrillation, and advice on technologies including edoxaban and implantable cardioverter defibrillators.The research evidence is clear that a change in practice rarely comes about as a result of simply disseminating guidance on best practice. Simple dissemination is particularly ineffective if the guidance has not been produced by a well-respected, credible organisation. It is also clear from the literature that implementation is more successful when more than one approach is taken, and when there is alignment between efforts at organisational, local and national levels.At an organisational level, there should be support from the Board for quality improvement, with ongoing measurement of progress. Resources should be provided for targeted change programmes, particularly where new guidance suggests improvements are required. A systematic process for putting change in place should include identifying barriers to change, agreeing interventions to overcome the barriers and drive forward improvement and planning for implementation and evaluation. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A Review of NICE Methods and Processes Across Health Technology Assessment Programmes: Why the Differences and What is the Impact?

PubMed

Cowles, Emma; Marsden, Grace; Cole, Amanda; Devlin, Nancy

2017-08-01

Decisions made by the National Institute for Health and Care Excellence (NICE) exert an influence on the allocation of resources within 'fixed' National Health Service budgets. Yet guidance for different types of health interventions is handled via different 'programmes' within NICE, which follow different methods and processes. The objective of this research was to identify differences in the processes and methods of NICE health technology assessment programmes and to explore how these could impact on allocative efficiency within the National Health Service. Data were extracted from the NICE technology appraisal programme, medical technologies guidance, diagnostic assessment programme, highly specialised technologies programme, and clinical guidelines process and methods manuals to undertake a systematic comparison. Five qualitative interviews were carried out with NICE members of staff and committee members to explore the reasons for the differences found. The main differences identified were in the required evidence review period, or lack thereof, mandatory funding status, the provision of a reference case for economic evaluation, the requirement for and the type of economic analysis undertaken, and the decision making criteria used for appraisal. Many of the differences found can be justified on grounds of practicality and relevance to the health technologies under assessment. Nevertheless, from a strict utilitarian view, there are several potential areas of inefficiency that could lead to the misallocation of resources within the National Health Service, although some of these might be eliminated or reduced if an egalitarian view is taken. The challenge is determining where society is willing to trade health gains between different people.

Summary of the consultation on a strategy for services for chronic obstructive pulmonary disease (COPD) in England.

PubMed

Jones, Rupert; Gruffydd-Jones, Kevin; Pinnock, Hilary; Peffers, Sarah-Jane; Lawrence, Judith; Scullion, Jane; White, Patrick; Holmes, Steve

2010-12-01

The Consultation on a Strategy for Services for COPD in England is the culmination of five years' work by respiratory specialists from all disciplines, as well as representatives from the voluntary sector, patients, carers and planners. It has been led by the Department of Health in England and the joint National Directors for the programme, Professor Sue Hill and Dr Robert Winter. The Strategy outlines service standards for providers of COPD care and is complementary to the UK National Institute for Health and Clinical Excellence (NICE) guidelines on the management of COPD. Its key elements are: • preventing the development and progression of COPD • diagnosing COPD accurately and at an early stage • developing structured care based on national guidance • promoting self-management education • reducing the number of people admitted to hospital • improving access to end-of-life care • promoting good asthma services. In essence this is an aspirational strategy which aims to change the way that the NHS in England delivers care for people with COPD by identifying them earlier and managing them optimally in order to reduce the likelihood of progression to the more severe stages of the disease. An economic impact assessment shows that implementing the Strategy will save approximately £1billion over 10 years as well as sparing many people from a debilitating illness. This supplement is based on the Strategy Consultation document as well as the NICE guidelines for COPD management. It aims to elucidate practical implementation of the COPD Strategy, and includes verbatim the Strategy recommendations as well as highly relevant clinical information from the NICE guidelines. Implementation of the Strategy recommendations should lead to optimum care for patients with COPD.

Selecting children for head CT following head injury

PubMed Central

Kemp, A; Nickerson, E; Trefan, L; Houston, R; Hyde, P; Pearson, G; Edwards, R; Parslow, RC; Maconochie, I

2016-01-01

Objective Indicators for head CT scan defined by the 2007 National Institute for Health and Care Excellence (NICE) guidelines were analysed to identify CT uptake, influential variables and yield. Design Cross-sectional study. Setting Hospital inpatient units: England, Wales, Northern Ireland and the Channel Islands. Patients Children (<15 years) admitted to hospital for more than 4 h following a head injury (September 2009 to February 2010). Interventions CT scan. Main outcome measures Number of children who had CT, extent to which NICE guidelines were followed and diagnostic yield. Results Data on 5700 children were returned by 90% of eligible hospitals, 84% of whom were admitted to a general hospital. CT scans were performed on 30.4% of children (1734), with a higher diagnostic yield in infants (56.5% (144/255)) than children aged 1 to 14 years (26.5% (391/1476)). Overall, only 40.4% (984 of 2437 children) fulfilling at least one of the four NICE criteria for CT actually underwent one. These children were much less likely to receive CT if admitted to a general hospital than to a specialist centre (OR 0.52 (95% CI 0.45 to 0.59)); there was considerable variation between healthcare regions. When indicated, children >3 years were much more likely to have CT than those <3 years (OR 2.35 (95% CI 2.08 to 2.65)). Conclusion Compliance with guidelines and diagnostic yield was variable across age groups, the type of hospital and region where children were admitted. With this pattern of clinical practice the risks of both missing intracranial injury and overuse of CT are considerable. PMID:27449674

Selecting children for head CT following head injury.

PubMed

Kemp, A; Nickerson, E; Trefan, L; Houston, R; Hyde, P; Pearson, G; Edwards, R; Parslow, R C; Maconochie, I

2016-10-01

Indicators for head CT scan defined by the 2007 National Institute for Health and Care Excellence (NICE) guidelines were analysed to identify CT uptake, influential variables and yield. Cross-sectional study. Hospital inpatient units: England, Wales, Northern Ireland and the Channel Islands. Children (<15 years) admitted to hospital for more than 4 h following a head injury (September 2009 to February 2010). CT scan. Number of children who had CT, extent to which NICE guidelines were followed and diagnostic yield. Data on 5700 children were returned by 90% of eligible hospitals, 84% of whom were admitted to a general hospital. CT scans were performed on 30.4% of children (1734), with a higher diagnostic yield in infants (56.5% (144/255)) than children aged 1 to 14 years (26.5% (391/1476)). Overall, only 40.4% (984 of 2437 children) fulfilling at least one of the four NICE criteria for CT actually underwent one. These children were much less likely to receive CT if admitted to a general hospital than to a specialist centre (OR 0.52 (95% CI 0.45 to 0.59)); there was considerable variation between healthcare regions. When indicated, children >3 years were much more likely to have CT than those <3 years (OR 2.35 (95% CI 2.08 to 2.65)). Compliance with guidelines and diagnostic yield was variable across age groups, the type of hospital and region where children were admitted. With this pattern of clinical practice the risks of both missing intracranial injury and overuse of CT are considerable. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

A feasibility study examining the effect on lung cancer diagnosis of offering a chest X-ray to higher-risk patients with chest symptoms: protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background In order to improve lung cancer survival in the UK, a greater proportion of resectable cancers must be diagnosed. It is likely that resectability rates would be increased by more timely diagnosis. Aside from screening, the only way of achieving this is to reduce the time to diagnosis in symptomatic cancers. Currently, lung cancers are mainly diagnosed by general practitioners (GPs) using the National Institute for Health and Clinical Excellence (NICE) guidelines for urgent referral for chest X-ray, which recommend urgent imaging or referral for patients who have one of a number of chest symptoms for more than 3 weeks. We are proposing to expand this recommendation to include one of a number of chest symptoms of any duration in higher-risk patients. Methods/Design We intend to conduct a trial of imaging in these higher-risk patients and compare it with NICE guidelines to see if imaging improves stage at diagnosis and resection rates. This trial would have to be large (and consequently resource-intensive) because most of these patients will not have lung cancer, making optimal design crucial. We are therefore conducting a pilot trial that will ascertain the feasibility of running a full trial and provide key information that will be required in order to design the full trial. Discussion This trial will assess the feasibility and inform the design of a large, UK-wide, clinical trial of a change to the NICE guidelines for urgent referral for chest X-ray for suspected lung cancer. It utilizes a combination of workshop, health economic, quality of life, qualitative, and quantitative methods in order to fully assess feasibility. Trial registration Clinicaltrials.gov NCT01344005 PMID:24279296

Prescribing tamoxifen in primary care for the prevention of breast cancer: a national online survey of GPs' attitudes.

PubMed

Smith, Samuel G; Foy, Robbie; McGowan, Jennifer A; Kobayashi, Lindsay C; DeCensi, Andrea; Brown, Karen; Side, Lucy; Cuzick, Jack

2017-06-01

The cancer strategy for England (2015-2020) recommends GPs prescribe tamoxifen for breast cancer primary prevention among women at increased risk. To investigate GPs' attitudes towards prescribing tamoxifen. In an online survey, GPs in England, Northern Ireland, and Wales ( n = 928) were randomised using a 2 × 2 between-subjects design to read one of four vignettes describing a healthy patient seeking a tamoxifen prescription. In the vignette, the hypothetical patient's breast cancer risk (moderate versus high) and the clinician initiating the prescription (GP prescriber versus secondary care clinician [SCC] prescriber) were manipulated in a 1:1:1:1 ratio. Outcomes were willingness to prescribe, comfort discussing harms and benefits, comfort managing the patient, factors affecting the prescribing decision, and awareness of tamoxifen and the National Institute for Health and Care Excellence (NICE) guideline CG164. Half (51.7%) of the GPs knew tamoxifen can reduce breast cancer risk, and one-quarter (24.1%) were aware of NICE guideline CG164. Responders asked to initiate prescribing (GP prescriber) were less willing to prescribe tamoxifen than those continuing a prescription initiated in secondary care (SCC prescriber) (68.9% versus 84.6%, P <0.001). The GP prescribers reported less comfort discussing tamoxifen (53.4% versus 62.5%, P = 0.01). GPs willing to prescribe were more likely to be aware of the NICE guideline ( P = 0.039) and to have acknowledged the benefits of tamoxifen ( P <0.001), and were less likely to have considered its off-licence status ( P <0.001). Initiating tamoxifen prescriptions for preventive therapy in secondary care before asking GPs to continue the patient's care may overcome some prescribing barriers. © British Journal of General Practice 2017.

Impact of Clinical Guidelines on Voiding Cystourethrogram Use and Vesicoureteral Reflux Incidence.

PubMed

Lee, Ted; Ellimoottil, Chandy; Marchetti, Kathryn A; Banerjee, Tanima; Ivančić, Vesna; Kraft, Kate H; Bloom, David A; Park, John M; Wan, Julian

2017-09-01

To prevent over diagnosis and overtreatment of vesicoureteral reflux the 2007 NICE (National Institute for Health and Care Excellence) and 2011 AAP (American Academy of Pediatrics) guidelines recommended against routine voiding cystourethrograms in children presenting with first febrile urinary tract infections. The impact of these guidelines on clinical practice is unknown. Using an administrative claims database (Clinformatics™ Data Mart) children who underwent voiding cystourethrogram studies or had a diagnosis of vesicoureteral reflux between 2001 and 2015 were identified. The cohort was divided into children age 0 to 2 and 3 to 10 years. Single and multiple group interrupted time series analyses (difference-in-difference) were performed with the guidelines as intervention points. The incidence of vesicoureteral reflux was compared across each period. Of the 51,649 children who underwent voiding cystourethrograms 19,422 (38%) were diagnosed with vesicoureteral reflux. In children 0 to 2 years old voiding cystourethrogram use did not decrease after the 2007 NICE guidelines were announced (-0.37, 95% CI -1.50 to 0.77, p = 0.52) but did decrease significantly after the 2011 AAP guidelines were announced (-2.00, 95% CI -3.35 to -0.65, p = 0.004). Among children 3 to 10 years old voiding cystourethrogram use decreased during the entire study period. There was a decrease in the incidence of vesicoureteral reflux in both groups that mirrored patterns of voiding cystourethrogram use. The 2011 AAP guidelines led to a concurrent decrease in voiding cystourethrogram use and incidence of vesicoureteral reflux among children 0 to 2 years old. Further studies are needed to assess the risks and benefits of reducing the diagnosis of vesicoureteral reflux in young children. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Trends in procedures for infertility and caesarean sections: was NICE disinvestment guidance implemented? NICE recommendation reminders.

PubMed

Chamberlain, Charlotte A; Martin, Richard M; Busby, John; Gilbert, Rebecca; Cahill, David J; Hollingworth, William

2013-02-06

National Institute for Health and Clinical Excellence (NICE) clinical guidelines and subsequent NICE issued 'recommendation reminders' advocate discontinuing two fertility procedures and caesarean sections in women with hepatitis. We assess whether NICE guidance in 2004 and recommendation reminders were associated with a change in the rate of clinical procedures performed. Routine inpatient Hospital Episode Statistics (HES) data were extracted from the HES database for 1st April 1998 to 31st March 2010 using OPCS procedure codes for varicocele operations in infertile men, endometrial biopsies in infertile women and caesarean sections in women with hepatitis B or C. We used Joinpoint regression to identify points in time when the trend in procedure rates changed markedly, to identify any influence of the release of NICE guidance. Between 1998-2010, planned caesarean sections in women with and without hepatitis B or C increased yearly (annual percentage change (APC) 4.9%, 95% CI 2.1% to 7.7%) in women with hepatitis, compared with women without (APC 4.0% [95% CI 2.7% to 5.3%] up to 2001, APC -0.6% [95% CI -2.8% to 1.8%] up to 2004 and 1.3% [95% CI 0.8% to 1.8%] up to 2010). In infertile women under 40 years of age, endometrial biopsies for investigation of infertility increased, APC 6.0% (95% CI 3.6% to 8.4%) up to 2003, APC 1.5% (95% CI -4.3% to 7.7%) to 2007 followed by APC 12.8% (95% CI 1.0% to 26.0%) to 2010. Varicocele procedures remained relatively static between 1998 and 2010 (APC -0.5%, 95% CI -2.3% to 1.3%). There was no decline in use of the three studied procedures, contrary to NICE guidance, and no change in uptake associated with the timing of NICE guidance or recommendation reminders. 'Do not do' recommendation reminders may be ineffective at improving clinical practice or achieving disinvestment.

Implementing the NICE osteoarthritis guidelines: a mixed methods study and cluster randomised trial of a model osteoarthritis consultation in primary care--the Management of OsteoArthritis In Consultations (MOSAICS) study protocol.

PubMed

Dziedzic, Krysia S; Healey, Emma L; Porcheret, Mark; Ong, Bie Nio; Main, Chris J; Jordan, Kelvin P; Lewis, Martyn; Edwards, John J; Jinks, Clare; Morden, Andrew; McHugh, Gretl A; Ryan, Sarah; Finney, Andrew; Jowett, Sue; Oppong, Raymond; Afolabi, Ebenezer; Pushpa-Rajah, Angela; Handy, June; Clarkson, Kris; Mason, Elizabeth; Whitehurst, Tracy; Hughes, Rhian W; Croft, Peter R; Hay, Elaine M

2014-08-27

There is as yet no evidence on the feasibility of implementing recommendations from the National Institute of Health and Care Excellence (NICE) osteoarthritis (OA) guidelines in primary care, or of the effect these recommendations have on the condition. The primary aim of this study is to determine the clinical and cost effectiveness of a model OA consultation (MOAC), implementing the core recommendations from the NICE OA guidelines in primary care. Secondary aims are to investigate the impact, feasibility and acceptability of the MOAC intervention; to develop and evaluate a training package for management of OA by general practitioners (GPs) and practice nurses; test the feasibility of deriving 'quality markers' of OA management using a new consultation template and medical record review; and describe the uptake of core NICE OA recommendations in participants aged 45 years and over with joint pain. A mixed methods study with a nested cluster randomised controlled trial. This study was developed according to a defined theoretical framework (the Whole System Informing Self-management Engagement). An overarching model (the Normalisation Process Theory) will be employed to undertake a comprehensive 'whole-system' evaluation of the processes and outcomes of implementing the MOAC intervention. The primary outcome is general physical health (Short Form-12 Physical component score [PCS]) (Ware 1996). The impact, acceptability and feasibility of the MOAC intervention at practice level will be assessed by comparing intervention and control practices using a Quality Indicators template and medical record review. Impact and acceptability of the intervention for patients will be assessed via self-completed outcome measures and semi-structured interviews. The impact, acceptability and feasibility of the MOAC intervention and training for GPs and practice nurses will be evaluated using a variety of methods including questionnaires, semi-structured interviews, and observations. The main output from the study will be to determine whether the MOAC intervention is clinically and cost effective. Additional outputs will be the development of the MOAC for patients consulting with joint pain in primary care, training and educational materials, and resources for patients and professionals regarding supported self-management and uptake of NICE guidance. ISRCTN number: ISRCTN06984617.

[How to assess clinical practice guidelines with AGREE II: The example of neonatal jaundice].

PubMed

Renesme, L; Bedu, A; Tourneux, P; Truffert, P

2016-03-01

Neonatal jaundice is a very frequent condition that occurs in approximately 50-70% of term or near-term (>35 GA) babies in the 1st week of life. In some cases, a high bilirubin blood level can lead to kernicterus. There is no consensus for the management of neonatal jaundice and few countries have published national clinical practice guidelines for the management of neonatal jaundice. The aim of this study was to assess the quality of these guidelines. We conducted a systematic review of the literature for national clinical practice guidelines for the management of neonatal jaundice in term or near-term babies. Four independent reviewers assessed the quality of each guideline using the AGREE II evaluation. For each of the clinical practice guidelines, the management modalities were analyzed (screening, treatment, follow-up, etc.). Seven national clinical practice guidelines were found (South Africa, USA AAP, UK NICE, Canada, Norway, Switzerland, and Israel). The AGREE II score showed widespread variation regarding the quality of these national guidelines. There was no major difference between the guidelines concerning the clinical management of these babies. The NICE guideline is the most valuable guideline regarding the AGREE II score. NICE showed that, despite a strong and rigorous methodology, there is no evidenced-based recommended code of practice (RCP). Comparing RCPs, we found no major differences. The NICE guideline showed the best quality. The AGREE II instrument should be used as a framework when developing clinical practice guidelines to improve the quality of the future guideline. In France, a national guideline is needed for a more standardized management of neonatal jaundice. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Dietetic practice in refeeding syndrome.

PubMed

Wagstaff, G

2011-10-01

The physiology and consequences of refeeding syndrome have long been recognised, although its management continues to be debated, despite the recommendations made by The National Institute for Health and Clinical Excellence (NICE) in their guideline 'Nutrition Support in Adults' (2006). The present study aims to assess current dietetic opinion and practice in this area, as well as whether the NICE recommendations have been adopted. An anonymous, self-completed Internet survey was designed investigating current practice and opinions on the NICE (2006) guidance on this subject. A link to the questionnaire was distributed with a covering letter via e-mail to the heads of department of National Health Service Trusts in the London region, UK, requesting that it be disseminated to all dietitians working with adults. After the closing date, all responses were collated and analysed. The survey elicited a 30.8% response rate. Some 89.8% of respondents have read the NICE guidance on Nutrition Support in Adults (2006) and 66.9% have changed their practice regarding refeeding syndrome management as a result. Sixty-two percent do not wait for biochemistry to normalise before commencing nutrition. Ninety-two percent of respondents completed the mini case studies indicating that current practice is inconsistent among dietitians. Neither NICE criteria for recognising patients at risk of refeeding, nor the recommended starting rates are universally followed. Seventy-five percent continue to supplement electrolytes reactively. Although limited by a small sample size, the findings of the present study suggest that dietetic practice regarding refeeding syndrome management remains inconsistent with the recommendations made by NICE, although some aspects have been adopted. © 2011 The Author. Journal of Human Nutrition and Dietetics © 2011 The British Dietetic Association Ltd.

Do NICE and CHI have no interest in safety? Opinion of the book NICE, CHI and the NHS reforms. Enabling excellence or imposing control?

PubMed

Fletcher, P

2000-08-01

Seventeen eminent and experienced people have contributed to this most valuable review of NICE and CHI and their potential impact on clinical practice in the UK. There is essentially 100% agreement that the basic concept is a good one; we all want to have the highest possible quality of clinical practice and improvements in health care. This is all motherhood and apple-pie stuff which goes without question but the problem is how it is put into effect. The contributors are also in agreement and fear that central desire for control will outweigh the benefits. The most recent NICE action, which was leaked to the media as a 'preliminary opinion', concerned the use of beta-interferon for the treatment of multiple sclerosis (MS). The opinion seems to be that beta-interferon is very expensive, that, yes, it does help some sufferers but, no, it does not help others and because it costs more than the NHS can afford no one can have it. This seems to me to be a most unsatisfactory outcome. Surely what clinical excellence demands is the refinement of diagnostic capabilities so that those who will benefit may be distinguished from those who will not. In the meantime we do the best we can even if it does mean that the NHS has to pay for some patients who do not respond. This is the inevitable consequence of the belief that a 'free' and comprehensive health service can be provided out of general taxation. Beta-interferon for the treatment of MS is an example of the observable fact that medical science is advancing at a rate considerably in excess of possible increases in funding. Possibly the most important problem identified in this book is the absence of a relevant, high quality data source for the preparation of the numerous guidelines that NICE is expected to produce each year. In a fully grown science a starting point for a quantitative procedure is the establishment of a baseline and, having done that, the scientist's next step is to produce a standard curve for use in the measurement of further investigations. I have said previously that medicine is not a fully grown science (which is one of the problems) but that does not mean that basic scientific method can be abandoned. What is the baseline for the evaluation of clinical practice? The best would be records of the progression of a disease-state in untreated patients. That, for obvious reasons, is clearly not possible so a compromise is unavoidable. Unfortunately we do not even have that compromise baseline so how do we know what is better and what is worse? In simple, single disease states and within the limits of RCTs that is sometimes possible but in a population composed of many elderly people with multiple pathology it is greatly more difficult. If NICE is to produce authoritative guidelines then its first task is to define a (compromise) baseline. For the readers of this journal the absence of safety as one of the measures of clinical excellence must be a matter of concern. All clinical interventions may be casually related to adverse reactions which may, on occasion, be serious or even fatal. Perhaps excluding safety was a conscious decision by those who created NICE. At the time of market approval information on safety is almost always limited to events occurring more frequently than 1 in 1000 exposures which is far below the desirable level of precision. If NICE is to provide advice at the time of market authorization or shortly after then it will never be in a position to include an acceptable evaluation of safety. So why give a hostage to fortune by mentioning it in NICE's remit? Time alone will tell whether NICE and CHI achieve health improvement or whether they prove to be no more than a political gesture.

Implementing NICE Guidelines on Recall Intervals into General Practice.

PubMed

Akram, Sarah; D’Cruz, Len

2010-09-01

The NICE guidelines require practitioners to ensure that each patient has a specific recall interval based on an oral health needs assessment. There appears to be a hesitancy in the profession to move away from the ‘six-month recall’. In England and Wales, Primary Care Organizations (PCOs) monitor activity using quantitative data. One particular metric measures how many patients are seen by the practice within 3 months and also between 3 and 9 months from their last course of treatment. The purpose of this paper is to introduce a quick reference chart based on the NICE guidelines which, when used in combination with clinical judgement, can aid the clinician in selecting a tailored recall interval. This paper discusses the purpose and benefits for using the guidelines in relation to NHS contractual obligations.

[Guideline-conform psychiatric psychotherapeutic treatment for patients with schizophrenia : A normative evaluation of necessary personnel requirements].

PubMed

Mehl, S; Falkai, P; Berger, M; Löhr, M; Rujescu, D; Wolff, J; Kircher, T

2016-03-01

Although national treatment guidelines and current publications of the German Federal Joint Committee (Gemeinsamer Bundesausschuss) recommend cognitive behavior therapy for all patients with schizophrenia, the implementation of these recommendations in current inpatient and outpatient treatment is only rudimentary. The aim of this study was to systematically search randomized controlled studies (RCTs), meta-analyses and the guidelines of the German Association for Psychiatry and Psychotherapy, Psychosomatics and Neurology (DGPPN) and the British National Institute for Health and Clinical Excellence (NICE) in order to assess the number of personnel necessary for psychiatric and therapeutic inpatient treatment in line with present guidelines. Moreover, the number of staff required was compared with the personnel resources designated by the German psychiatry personnel regulations (Psych-PV). The German and NICE guidelines, RCTs and meta-analyses were analyzed and an adequate weekly treatment plan for an inpatient unit was developed. Moreover, the number of personnel necessary to realize the treatment plan was calculated. In order to realize adequate inpatient treatment approximately 107 min extra for medical psychotherapeutic personnel per patient and week (of which 72 min for psychotherapy) and another 60 min for nursing staff per patient and week are required in addition to the current Psych-PV regulations. Thus, implementation in an open ward with 20 inpatients would require 3.62 positions for physicians, 0.7 positions in psychology and 12.85 positions for nursing staff (including management positions and night shifts). These evidence-based recommendations for precise specifications of inpatient treatment should lead to improved inpatient treatment in line with present guidelines. Moreover, outpatients and day patients could be included in this treatment model. The results should be considered in the construction of the future prospective payment system for inpatient psychiatric healthcare in Germany.

Crohn's disease: management in adults, children and young people - concise guidance .

PubMed

Tun, Gloria Sz; Cripps, Sarah; Lobo, Alan J

2018-06-01

Crohn's disease (CD) is a chronic inflammatory condition of the gastrointestinal tract. Individuals with CD present with acute inflammatory exacerbations as well as acute and chronic complications. Management requires specialist input from gastroenterologists, colorectal surgeons, nurse specialists and pharmacists as well as general and primary care physicians to allow appropriate selection of treatment options including surgery and rapid assessment and treatment of those with acute exacerbations. Monitoring of the individual and their medication is crucial in preventing and recognising complications including those associated with treatment. This concise guideline focuses on recommendations from National Institute for Health and Care Excellence (NICE) -Clinical -Guideline 152 (CG152) considered of key importance for implementation. © Royal College of Physicians 2018. All rights reserved.

Micturating cystourethrogram as a tool for investigating UTI in children - An institutional audit.

PubMed

Hua, L; Linke, R J; Boucaut, H A P; Khurana, S

2016-10-01

Micturating cystourethrograms (MCUG) are the gold standard for evaluating vesicoureteric reflux (VUR). There is a growing consensus for increasing the threshold for performing MCUGs following urinary tract infections (UTI) in children. There are several varying guidelines. It is important to detect high-grade reflux in the setting of an UTI because of potential long-term complications. This audit aimed to retrospectively: (1) identify the conformance rate of local guidelines at the Women's and Children's Hospital (WCH); (2) assess predictors for an abnormal MCUG; and (3) compare local guidelines against the Royal Children's Hospital, Melbourne (RCH), National Institute for Healthcare and Excellence (NICE), and American Academy of Pediatrics (AAP) guidelines for selectively detecting high-grade reflux. The number of MCUGs performed from 2008 to 2012 at the WCH radiology department was collected. Patients undergoing MCUG during the 2012 calendar year were identified. Only children having an initial MCUG as part of an UTI investigation with prerequisite imaging as per guidelines were included. Each child's age, sex, referral source, reason, renal ultrasound (RUS) prior to the MCUG, MCUG result and VUR grade were recorded. The WCH guidelines were applied to determine conformance, to evaluate predictors for an abnormal MCUG, and compared against other retrospectively applied guidelines (RCH, NICE, AAP). There was complete data for 168 children who underwent MCUG as part of an UTI investigation (median age 0.79 years, range 0.12-8.74, male:female 67:101). There were 67/168 abnormal MCUGs (62 children with VUR, five bladder diverticulum), and 97 refluxing renal units (43 high-grade VUR units). No posterior urethral valves (PUV) were identified as part of the UTI investigation. A total of 143/168 patients had prior RUS (normal:abnormal 67:76). The WCH guidelines had 82% conformance. There was no statistically significant association between an abnormal MCUG and age, sex, referral source, reason, or prior RUS result. The WCH guidelines may have missed five children with high-grade VUR (four children had surgery), compared with RCH, APP and NICE, with 8, 15, and 17 children, respectively, having high-grade VUR (two, five, and five children had surgery, respectively) show in the Summary Table. The retrospective study had limitations and possible selection bias (children with UTI without a MCUG). There were no standard treatment approaches for VUR; hence establishing a MCUG guideline is difficult. An alternative is the top-down approach. Current institutional guidelines for considering MCUG following UTI in children vary considerably. The MCUG guidelines at any institution must take into account the local management guidelines for high-grade VUR. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

The effectiveness of national guidance in changing analgesic prescribing in primary care from 2002 to 2009: An observational database study

PubMed Central

Bedson, J; Belcher, J; Martino, OI; Ndlovu, M; Rathod, T; Walters, K; Dunn, KM; Jordan, KP

2013-01-01

Background Numerous national guidelines have been issued to assist general practitioners’ safe analgesic prescribing. Their effectiveness is unclear. The objective of this study was to examine trends in general practitioners’ prescribing behaviour in relation to national guidelines. Methods This was a retrospective observational database study of registered adult patients prescribed an analgesic (2002–2009) from the Consultations in Primary Care Archive – 12 North Staffordshire general practices. Prescribing guidance from the UK Medicines Regulatory Health Authority (MHRA) regarding non-steroidal anti-inflammatory drugs (NSAIDs) and co-proxamol, and the National Institute for Health and Clinical Excellence (NICE) osteoarthritis (OA) management guidelines were considered. Analgesic prescribing rates were examined, arranged according to a classification of six equipotent medication groups: (1) basic analgesics; (2)–(5) increasingly potent opioids and (6) NSAIDs. In each quarter from 2002 to 2009, the number of patients per 10,000 registered population receiving a prescription for the first time from each group was determined. Quarters associated with significant changes in the underlying prescribing trend were determined using joinpoint regression. Results A significant decrease in incident co-proxamol and Cox-2 prescribing occurred around the time of the first MHRA advice to stop using them and were rarely prescribed thereafter. The new prescribing of weak analgesics (e.g., co-codamol 8/500) increased at this same time. Initiating topical NSAIDs significantly increased around the time of the NICE OA guidelines. Conclusions Significant prescribing changes occurred when national advice and guidelines were issued. The effectiveness of this advice may vary depending upon the content and method of dissemination. Further evaluation of the optimal methods for delivering prescribing guidance is required. PMID:22865816

Trends in procedures for infertility and caesarean sections: was NICE disinvestment guidance implemented? NICE recommendation reminders

PubMed Central

2013-01-01

Background National Institute for Health and Clinical Excellence (NICE) clinical guidelines and subsequent NICE issued ‘recommendation reminders’ advocate discontinuing two fertility procedures and caesarean sections in women with hepatitis. We assess whether NICE guidance in 2004 and recommendation reminders were associated with a change in the rate of clinical procedures performed. Methods Routine inpatient Hospital Episode Statistics (HES) data were extracted from the HES database for 1st April 1998 to 31st March 2010 using OPCS procedure codes for varicocele operations in infertile men, endometrial biopsies in infertile women and caesarean sections in women with hepatitis B or C. We used Joinpoint regression to identify points in time when the trend in procedure rates changed markedly, to identify any influence of the release of NICE guidance. Results Between 1998-2010, planned caesarean sections in women with and without hepatitis B or C increased yearly (annual percentage change (APC) 4.9%, 95% CI 2.1% to 7.7%) in women with hepatitis, compared with women without (APC 4.0% [95% CI 2.7% to 5.3%] up to 2001, APC -0.6% [95% CI -2.8% to 1.8%] up to 2004 and 1.3% [95% CI 0.8% to 1.8%] up to 2010). In infertile women under 40 years of age, endometrial biopsies for investigation of infertility increased, APC 6.0% (95% CI 3.6% to 8.4%) up to 2003, APC 1.5% (95% CI -4.3% to 7.7%) to 2007 followed by APC 12.8% (95% CI 1.0% to 26.0%) to 2010. Varicocele procedures remained relatively static between 1998 and 2010 (APC -0.5%, 95% CI -2.3% to 1.3%). Conclusions There was no decline in use of the three studied procedures, contrary to NICE guidance, and no change in uptake associated with the timing of NICE guidance or recommendation reminders. ‘Do not do’ recommendation reminders may be ineffective at improving clinical practice or achieving disinvestment. PMID:23388377

Antibiotic prophylaxis in dentistry: part II. A qualitative study of patient perspectives and understanding of the NICE guideline.

PubMed

Soheilipour, S; Scambler, S; Dickinson, C; Dunne, S M; Burke, M; Jabbarifar, S E; Newton, J T

2011-07-08

The National Institute for Health and Clinical Excellence (NICE) recommendations in 2008 for antibiotic prophylaxis before dental treatment contradict previous practice. There is a potential difficulty in explaining the new guidance to patients who have long believed that they must receive antibiotics before their dental treatment. This study investigated the patient-related barriers and facilitating factors in implementation of the NICE guidance. In-depth interviews were conducted with nine patients concerning their views about barriers and factors that could influence the implementation of the NICE guidance on antibiotic prophylaxis before dental treatment. Data were analysed using framework analysis. For patients the rationale for the NICE guidance was unclear. They understood that at the population level the risk of infective endocarditis was less than the risk of adverse reaction to antibiotics. However, on an individual level they felt that the latter risk was negligible given their previous experience of antibiotics. They were aware that standards of care change over time but were concerned that this may be an example where a mistake had been made. Patients felt that the characteristics of the person advising them about the new guidance were important in whether or not they would accept them - they wished to be advised by a clinician that they knew and trusted, and who was perceived as having appropriate expertise. Patients generally felt that they would be most reassured by information provided by a clinician who they felt they could trust and who was qualified to comment on the issue by respecting their autonomy. The implications of the findings for the development of patient information are discussed.

Implementing core NICE guidelines for osteoarthritis in primary care with a model consultation (MOSAICS): a cluster randomised controlled trial.

PubMed

Dziedzic, K S; Healey, E L; Porcheret, M; Afolabi, E K; Lewis, M; Morden, A; Jinks, C; McHugh, G A; Ryan, S; Finney, A; Main, C; Edwards, J J; Paskins, Z; Pushpa-Rajah, A; Hay, E M

2018-01-01

To determine the effectiveness of a model osteoarthritis consultation, compared with usual care, on physical function and uptake of National Institute for Health and Care Excellence (NICE) osteoarthritis recommendations, in adults ≥45 years consulting with peripheral joint pain in UK general practice. Two-arm cluster-randomised controlled trial with baseline health survey. Eight general practices in England. 525 adults ≥45 years consulting for peripheral joint pain, amongst 28,443 population survey recipients. Four intervention practices delivered the model osteoarthritis consultation to patients consulting with peripheral joint pain; four control practices continued usual care. The primary clinical outcome of the trial was the SF-12 physical component score (PCS) at 6 months; the main secondary outcome was uptake of NICE core recommendations by 6 months, measured by osteoarthritis quality indicators. A Linear Mixed Model was used to analyse clinical outcome data (SF-12 PCS). Differences in quality indicator outcomes were assessed using logistic regression. 525 eligible participants were enrolled (mean age 67.3 years, SD 10.5; 59.6% female): 288 from intervention and 237 from control practices. There were no statistically significant differences in SF-12 PCS: mean difference at the 6-month primary endpoint was -0.37 (95% CI -2.32, 1.57). Uptake of core NICE recommendations by 6 months was statistically significantly higher in the intervention arm compared with control: e.g., increased written exercise information, 20.5% (7.9, 28.3). Whilst uptake of core NICE recommendations was increased, there was no evidence of benefit of this intervention, as delivered in this pragmatic randomised trial, on the primary outcome of physical functioning at 6 months. ISRCTN06984617. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

[Clinical Practice Guidelines for Management of Schizophrenia: Evaluation Using AGREE II].

PubMed

de la Hoz Bradford, Ana María; Ávila, Mauricio J; Bohórquez Peñaranda, Adriana Patricia; García Valencia, Jenny; Arenas Borrero, Álvaro Enrique; Vélez Traslaviña, Ángela; Jaramillo González, Luis Eduardo; Gómez-Restrepo, Carlos

2014-01-01

Colombia is developing multiple national practice guidelines from a range of diseases. Clinical practice guidelines represent a very useful tool to be able to take decision over a patient care that is widely available for the clinician. In psychiatry there are a good number of international clinical guidelines for the treatment of schizophrenia nevertheless there is no article that evaluate them scientifically In the settings of developing a Colombian schizophrenia practice guideline, a systematic search was performed in multiple databases and the results were then evaluated by two trained persons. We present the results globally and by domains. We found 164 matches for possible guidelines. After screening 7 guidelines were evaluated with the AGREE II instrument. Globally and by the different domains, the National Institute for Health and Care Excellence (NICE) was the guideline that got the best score. From the guidelines that were reviewed, 4 were from Europe and only 2 were from Latin America. None of the guidelines used GRADE methodology for the recommendations. The diversity of the schizophrenia treatment guidelines does not allow an easy adoption of the recommendation by a psychiatrist in Colombia. Copyright © 2014 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

Renal tract abnormalities missed in a historical cohort of young children with UTI if the NICE and AAP imaging guidelines were applied.

PubMed

Narchi, Hassib; Marah, Muhaned; Khan, Asad Aziz; Al-Amri, Abdulla; Al-Shibli, Amar

2015-10-01

In a historical cohort of children with a urinary tract infection (UTI) who had already undergone all the imaging procedures, the aim was to determine renal tract abnormalities which would have been missed had we implemented the new guidelines from the National Institute for Health and Care Excellence in the United Kingdom (NICE) or the American Academy of Pediatrics (AAP). After a UTI episode, forty-three children (28 females, 65%) aged between 2 months and 2 years presenting at two general hospitals with a febrile UTI before 2008 underwent all the recommended imaging studies predating the new guidelines. Hydronephrosis was defined and graded according to the Society for Fetal Urology (SFU) classification. Hydronephrosis grade II (mild pelvicalyceal dilatation), grade III (moderate dilatation), and grade IV (gross dilatation with thinning of the renal cortex), duplication, vesicoureteral reflux (VUR) grade II and above, renal scarring and reduced renal uptake (<45%) on technetium-99m-labeled dimercaptosuccinic acid (DMSA) scintigraphy were considered significant abnormalities. We calculated the proportion of abnormalities which would have been missed had the new guidelines been used instead. The median of age was 7.6 months (mean 8.7, range 2-24 months), with the majority (n = 37, 86%) being under 1 year of age. Ultrasound (US) showed hydronephrosis in 14 (32%), all grade II. A voiding cystourethrogram (VCUG) was performed in all and showed VUR ≥ grade II in 16 (37%), including eight children (19%) where it was bilateral. DMSA scan showed scarring in 25 children (58%) of whom 11 (26%) had bilateral scars. Reduced differential renal uptake was present in 10 children (23%). Of the 29 children with normal US, 18 (62%) had renal scarring and nine (31%) had VUR ≥ grade II. The NICE guidelines would have missed 63% of the children with VUR ≥ grade II, including a high proportion of grades IV and V VUR, 44% of the children with renal scarring, and 20% of the children with decreased renal uptake, including some children with bilateral renal scarring and with decreased renal uptake. The AAP guidelines would have missed 56% of the children with VUR ≥ grade II, including a high proportion of grades IV and V VUR, and all children with renal scarring as well as those with decreased renal uptake. The prevalence of renal tract abnormalities missed by the new guidelines is high. They should be used with full awareness of their limitations. Copyright © 2015 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

Barriers to implementing the NICE guidelines for early-onset neonatal infection: cross-sectional survey of neonatal blood culture reporting by laboratories in the UK.

PubMed

Paul, S P; Caplan, E M; Morgan, H A; Turner, P C

2018-04-01

The National Institute for Health and Care Excellence published guidelines for managing early-onset neonatal infections in 2012. It recommended provision for reporting blood cultures (BCs) with growth detected or not detected at 36 h. To determine if this was followed, a telephone survey was conducted amongst lead biomedical scientists based at microbiology laboratories (N = 209) in the UK. Overall, 202/209 responded and 139/202 had on-site facilities for BCs. BC results with growth detected or not detected at 36 h were available out-of-hours in 36/139 (26.6%) and 66/139 (47.5%) neonatal units, respectively. Early discontinuation of antibiotics should lead to improved antibiotic stewardship. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

A comparison of HAS & NICE guidelines for the economic evaluation of health technologies in the context of their respective national health care systems and cultural environments

PubMed Central

Massetti, Marc; Aballéa, Samuel; Videau, Yann; Rémuzat, Cécile; Roïz, Julie; Toumi, Mondher

2015-01-01

Background Health technology assessment (HTA) has been reinforced in France, notably with the introduction of economic evaluation in the pricing process for the most innovative and expensive treatments. Similarly to the National Institute for Clinical Excellence (NICE) in England, the National Authority for Health (HAS), which is responsible for economic evaluation of new health technologies in France, has published recommendations on the methods of economic evaluation. Since economic assessment represents a major element of HTA in England, exploring the differences between these methodological guidelines might help to comprehend both the shape and the role economic assessment is intended to have in the French health care system. Methods Methodological guidelines for economic evaluation in France and England have been compared topic-by-topic in order to bring out key differences in the recommended methods for economic evaluation. Results The analysis of both guidelines has revealed multiple similarities between France and England, although a number of differences were also noted regarding the elected methodology of analysis, the comparison of studies’ outcomes with cost-effectiveness thresholds, the study population to consider, the quality of life valuation methods, the perspective on costs, the types of resources considered and their valuation, the discount rates to apply in order to reflect the present value of interventions, etc. To account for these differences, modifications will be required in order to adapt economic models from one country to the other. Conclusions Changes in HTA assessment methods occur in response to different challenges determined by the different philosophical and cultural considerations surrounding health and welfare as well as the political considerations regarding the role of public policies and the importance of their evaluation. PMID:27123190

Opening the black box: a study of the process of NICE guidelines implementation.

PubMed

Spyridonidis, Dimitrios; Calnan, Michael

2011-10-01

This study informs 'evidence-based' implementation by using an innovative methodology to provide further understanding of the implementation process in the English NHS using two distinctly different NICE clinical guidelines as exemplars. The implementation process was tracked retrospectively and prospectively using a comparative case-study and longitudinal design. 74 unstructured interviews were carried out with 48 key informants (managers and clinicians) between 2007 and 2009. This study has shown that the NICE guidelines implementation process has both planned and emergent components, which was well illustrated by the use of the prospective longitudinal design in this study. The implementation process might be characterised as strategic and planned to begin with but became uncontrolled and subject to negotiation as it moved from the planning phase to adoption in everyday practice. The variations in the implementation process could be best accounted for in terms of differences in the structure and nature of the local organisational context. The latter pointed to the importance of managers as well as clinicians in decision-making about implementation. While national priorities determine the context for implementation the shape of the process is influenced by the interactions between doctors and managers, which influence the way they respond to external policy initiatives such as NICE guidelines. NICE and other national health policy-makers need to recognise that the introduction of planned change 'initiatives' in clinical practice are subject to social and political influences at the micro level as well as the macro level. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

What is the quality of economic evaluations of non-drug therapies? A systematic review and critical appraisal of economic evaluations of radiotherapy for cancer.

PubMed

Barbieri, M; Weatherly, H L A; Ara, R; Basarir, H; Sculpher, M; Adams, R; Ahmed, H; Coles, C; Guerrero-Urbano, T; Nutting, C; Powell, M

2014-10-01

Breast, cervical and colorectal cancers are the three most frequent cancers in women, while lung, prostate and colorectal cancers are the most frequent in men. Much attention has been given to the economic evaluation of pharmaceuticals for treatment of cancer by the National Institute for Health and Care Excellence (NICE) in the UK and similar authorities internationally, while economic analysis developed for other types of anti-cancer interventions, including radiotherapy and surgery, are less common. Our objective was to review methods used in published cost-effectiveness studies evaluating radiotherapy for breast, cervical, colorectal, head and neck and prostate cancer, and to compare the economic evaluation methods applied with those defined in the guidelines used by the NICE technology appraisal programme. A systematic search of seven databases (MEDLINE, EMBASE, CDSR, NHSEED, HTA, DARE, EconLit) as well as research registers, the NICE website and conference proceedings was conducted in July 2012. Only economic evaluations of radiotherapy interventions in individuals diagnosed with cancer that included quality-adjusted life-years (QALYs) or life-years (LYs) were included. Included studies were appraised on the basis of satisfying essential, preferred and UK-specific methods requirements, building on the NICE Reference Case for economic evaluations and on other methods guidelines. A total of 29 studies satisfied the inclusion criteria (breast 14, colorectal 2, prostate 10, cervical 0, head and neck 3). Only two studies were conducted in the UK (13 in the USA). Among essential methods criteria, the main issue was that only three (10%) of the studies used clinical-effectiveness estimates identified through systematic review of the literature. Similarly, only eight (28%) studies sourced health-related quality-of-life data directly from patients with the condition of interest. Other essential criteria (e.g. clear description of comparators, patient group indication and appropriate time horizon) were generally fulfilled, while most of the UK-specific requirements were not met. Based on this review there is a dearth of up-to-date, robust evidence on the cost effectiveness of radiotherapy in cancer suitable to support decision making in the UK. Studies selected did not fully satisfy essential method standards currently recommended by NICE.

Evidence-based diuretics: focus on chlorthalidone and indapamide.

PubMed

DiNicolantonio, James J; Bhutani, Jaikrit; Lavie, Carl J; O'Keefe, James H

2015-03-01

Thiazide and thiazide-like diuretics are cornerstone treatments for hypertension. However, unlike chlorthalidone (CTD) and indapamide (IDP), hydrochlorothiazide (HCTZ) lacks evidence for reducing morbidity and mortality as monotherapy compared with placebo or control. Despite this fact, HCTZ is prescribed much more frequently than CTD or IDP. We believe that all hypertension guidelines should follow the National Institute for Health and Excellence (NICE) and make IDP and CTD first choice 'thiazide-like diuretics.' This article will focus on the available evidence pertaining to HCTZ versus CTD and IDP. We will review the pharmacological differences between these three diuretics, as well as the clinical trial data and important side effects.

Towards an Integrated Approach to Sexual Health Services: The Contribution of NICE Guidance on One-to-One Interventions to Prevent STIs and under 18 Conceptions

ERIC Educational Resources Information Center

Killoran, Amanda; McCormick, Geraldine

2010-01-01

Objective: To describe the development of the National Institute for Health and Clinical Excellence (NICE) evidence-based guidance on one-to-one interventions for prevention of STIs and under 18 conceptions, as a focus for an integrated approach to sexual health services. Method: Documentation of the process for developing NICE guidance that is…

Physical Health and Drug Safety in Individuals with Schizophrenia

PubMed Central

Kelly, Martina; Urness, Doug; Teehan, Michael; Ismail, Zahinoor; Gardner, David

2017-01-01

Background: While antipsychotic medications are the mainstay of therapy for individuals with schizophrenia and psychotic disorders, their use is associated with adverse effects on physical health that require the attention and care of prescribers. Methods: We used the ADAPTE process to adapt existing guideline recommendations from the National Institute for Health and Care Excellence (NICE) and Scottish Intercollegiate Guidelines Network (SIGN) guidelines on the dosing of antipsychotics and antipsychotic polypharmacy, screening for adverse effects of antipsychotics, and management of metabolic and extrapyramidal side effects to the Canadian context. Results: Prescribers are encouraged to use the lowest effective dose and to avoid the routine use of multiple antipsychotics. Scheduled monitoring of body mass index, waist circumference, blood pressure, glucose, lipids, prolactin, electrocardiograms, and extrapyramidal symptoms is recommended. Lifestyle interventions are recommended to mitigate antipsychotic-induced weight gain. Prescribers should follow Canadian guidelines on the treatment of obesity, dyslipidemia, and diabetes. Recommendations on antipsychotic drug choice are made for users particularly concerned about extrapyramidal symptoms. Conclusion: Careful monitoring and attention by prescribers may mitigate adverse effects associated with antipsychotic medications. PMID:28718324

A Cost-effectiveness Analysis of Surgery, Endothermal Ablation, Ultrasound-guided Foam Sclerotherapy and Compression Stockings for Symptomatic Varicose Veins.

PubMed

Marsden, G; Perry, M; Bradbury, A; Hickey, N; Kelley, K; Trender, H; Wonderling, D; Davies, A H

2015-12-01

The aim was to investigate the cost-effectiveness of interventional treatment for varicose veins (VV) in the UK NHS, and to inform the national clinical guideline on VV, published by the National Institute of Health and Care Excellence. An economic analysis was constructed to compare the cost-effectiveness of surgery, endothermal ablation (ETA), ultrasound-guided foam sclerotherapy (UGFS), and compression stockings (CS). The analysis was based on a Markov decision model, which was developed in consultation with members of the NICE guideline development group (GDG). The model had a 5-year time horizon, and took the perspective of the UK National Health Service. Clinical inputs were based on a network meta-analysis (NMA), informed by a systematic review of the clinical literature. Outcomes were expressed as costs and quality-adjusted life years (QALYs). All interventional treatments were found to be cost-effective compared with CS at a cost-effectiveness threshold of £20,000 per QALY gained. ETA was found to be the most cost-effective strategy overall, with an incremental cost-effectiveness ratio of £3,161 per QALY gained compared with UGFS. Surgery and CS were dominated by ETA. Interventional treatment for VV is cost-effective in the UK NHS. Specifically, based on current data, ETA is the most cost-effective treatment in people for whom it is suitable. The results of this research were used to inform recommendations within the NICE guideline on VV. Copyright © 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Current UK dental sedation practice and the 'National Institute for Health and Care Excellence' (NICE) guideline 112: sedation in children and young people.

PubMed

Coulthard, P; Craig, D; Holden, C; Robb, N D; Sury, M; Chopra, S; Holroyd, I

2015-04-24

Describe current dental sedation practice for under 19-year-olds in the UK and compare it with the recommendations of NICE guidance 112. Members of the Society for the Advancement of Anaesthesia in Dentistry and members of the Dental Sedation Teachers Group were invited to participate in an online survey. Two hundred and sixty-six dentists and doctors completed the survey. Eighty-two percent were operator and sedationist (operator-sedationist). Ninety-five percent provided written information and 94% obtained written consent. Eighty-four percent kept a written or electronic sedation record. Eighty-six percent complied with life support training expectations. Eighty-six percent had immediate access to resuscitation equipment. Sixty-seven percent of sedationists reported that treatment could not be completed under sedation for <10% of cases during the previous year. When sedation was unsuccessful, 61% said they would schedule general anaesthesia and 54.5% would schedule advanced sedation care. Forty-nine percent believed that a dentist was an appropriate person to provide advanced sedation for 12-18 years. Only 24% thought a dentist should provide advanced sedation for children<12 years, with 75% preferring an anaesthetist. The appropriate setting for advanced sedation was thought to be primary care by 33% and secondary care by 68%. We found good agreement between the current practice of sedation and the recommendations of the NICE guidance 112.

Towards a more transparent HTA process in Poland: new Polish HTA methodological guidelines

PubMed Central

Lach, Krzysztof; Dziwisz, Michal; Rémuzat, Cécile; Toumi, Mondher

2017-01-01

ABSTRACT Introduction: Health technology assessment (HTA) in Poland supports reimbursement decisions via the Polish HTA Agency (AOTMiT), whose guidelines were updated in 2016. Methods: We identified key changes introduced by the update and, before guideline publication, analysed discrepancies between AOTMiT assessments and the submitting marketing authorisation holders (MAHs) to elucidate the context of the update. We compared the clarity and detail of the new guidelines versus those of the UK’s National Institute for Health and Care Excellence (NICE). Results: The update specified more precise requirements for items such as indirect comparison or input data for economic modelling. Agency–MAH discrepancies relating to the subjects of the HTA update were found in 14.6% of published documents. The new Polish HTA guidelines were as clear and detailed as NICE’s on topics such as assessing quality of evidence and economic modelling, but were less informative when describing (for example) pairwise meta-analysis. Conclusions: The Polish HTA guidelines update demonstrates lessons learned from internal and external experiences. The new guidelines adhere more closely to UK HTA standards, being clearer and more informative. While the update is expected to reduce Agency–MAH discrepancies, there remain areas for development, such as providing templates to aid HTA submissions. PMID:28804603

Agreement and accuracy using the FIGO, ACOG and NICE cardiotocography interpretation guidelines.

PubMed

Santo, Susana; Ayres-de-Campos, Diogo; Costa-Santos, Cristina; Schnettler, William; Ugwumadu, Austin; Da Graça, Luís M

2017-02-01

One of the limitations reported with cardiotocography is the modest interobserver agreement observed in tracing interpretation. This study compared agreement, reliability and accuracy of cardiotocography interpretation using the International Federation of Gynecology and Obstetrics, American College of Obstetrics and Gynecology and National Institute for Health and Care Excellence guidelines. A total of 151 tracings were evaluated by 27 clinicians from three centers where International Federation of Gynecology and Obstetrics, American College of Obstetrics and Gynecology and National Institute for Health and Care Excellence guidelines were routinely used. Interobserver agreement was evaluated using the proportions of agreement and reliability with the κ statistic. The accuracy of tracings classified as "pathological/category III" was assessed for prediction of newborn acidemia. For all measures, 95% confidence interval were calculated. Cardiotocography classifications were more distributed with International Federation of Gynecology and Obstetrics (9, 52, 39%) and National Institute for Health and Care Excellence (30, 33, 37%) than with American College of Obstetrics and Gynecology (13, 81, 6%). The category with the highest agreement was American College of Obstetrics and Gynecology category II (proportions of agreement = 0.73, 95% confidence interval 0.70-76), and the ones with the lowest agreement were American College of Obstetrics and Gynecology categories I and III. Reliability was significantly higher with International Federation of Gynecology and Obstetrics (κ = 0.37, 95% confidence interval 0.31-0.43), and National Institute for Health and Care Excellence (κ = 0.33, 95% confidence interval 0.28-0.39) than with American College of Obstetrics and Gynecology (κ = 0.15, 95% confidence interval 0.10-0.21); however, all represent only slight/fair reliability. International Federation of Gynecology and Obstetrics and National Institute for Health and Care Excellence showed a trend towards higher sensitivities in prediction of newborn acidemia (89 and 97%, respectively) than American College of Obstetrics and Gynecology (32%), but the latter achieved a significantly higher specificity (95%). With American College of Obstetrics and Gynecology guidelines there is high agreement in category II, low reliability, low sensitivity and high specificity in prediction of acidemia. With International Federation of Gynecology and Obstetrics and National Institute for Health and Care Excellence guidelines there is higher reliability, a trend towards higher sensitivity, and lower specificity in prediction of acidemia. © 2016 Nordic Federation of Societies of Obstetrics and Gynecology.

Impact of the National Institute for Health and Care Excellence (NICE) guidance on medical technology uptake: analysis of the uptake of spinal cord stimulation in England 2008–2012

PubMed Central

Vyawahare, Bharati; Hallas, Natalie; Brookes, Morag; Taylor, Rod S; Eldabe, Sam

2014-01-01

Background The National Institute for Health and Care Excellence (NICE) Technology Appraisal Guidance on spinal cord stimulation (SCS) was published in 2008 and updated in 2012 with no change. This guidance recommends SCS as a cost-effective treatment for patients with neuropathic pain. Objective To assess the impact of NICE guidance by comparing SCS uptake in England pre-NICE (2008–2009) and post-NICE (2009–2012) guidance. We also compared the English SCS uptake rate with that of Belgium, the Netherlands, France and Germany. Design SCS implant data for England was obtained from the Hospital Episode Statistics (HES) database and compared with other European countries where comparable data were available. Results The HES data showed small increases in SCS implantation and replacement/revision procedures, and a large increase in SCS trials between 2008 and 2012. The increase in the total number of SCS procedures per million of population in England is driven primarily by revision/replacements and increased trial activity. Marked variability in SCS uptake at both health regions and primary care trust level was observed. Conclusions Despite the positive NICE recommendation for the routine use of SCS, we found no evidence of a significant impact on SCS uptake in England. Rates of SCS implantation in England are lower than many other European countries. PMID:24398364

[The role of atherogenic dyslipidaemia in clinical practice guidelines].

PubMed

Pedro-Botet, Juan; Mantilla-Morató, Teresa; Díaz-Rodríguez, Ángel; Brea-Hernando, Ángel; González-Santos, Pedro; Hernández-Mijares, Antonio; Pintó, Xavier; Millán Núñez-Cortés, Jesús

2016-01-01

Atherogenic dyslipidaemia is underdiagnosed, undertreated, and under-controlled. The aim of the present study was to assess the positioning of clinical guidelines as regards atherogenic dyslipidaemia. The major clinical guidelines of scientific societies or official agencies issued between January 1, 2012 and March 31, 2015 were collected from the MEDLINE database. High-density lipoprotein (HDL) cholesterol, triglycerides, atherogenic dyslipidaemia, non-HDL cholesterol, and apolipoprotein (apo) B were gathered from the 10 selected guidelines, and it was assessed whether these parameters were considered a cardiovascular risk factor, a therapeutic target, or proposed a pharmacological strategy. American guidelines, except the National Lipid Association (NLA), do not consider HDL cholesterol and triglycerides in cardiovascular prevention. The NLA emphasises the relevance of atherogenic dyslipidaemia. The Canadian guidelines introduced non-HDL cholesterol and ApoB as alternative targets, and proposes non-statin treatment in the presence of low HDL cholesterol and hypertriglyceridaemia. The International Atherosclerosis Society (IAS) and National Institute for Health and Care Excellence (NICE) guidelines promote the importance of non-HDL cholesterol. European, Brazilian and Japanese guidelines highlight HDL cholesterol and triglycerides, but with the limitation that the main evidence comes from sub-analysis of clinical studies. The clinical guidelines analysed do not consider, or unconvincingly address, the importance of atherogenic dyslipidaemia. Copyright © 2016 Sociedad Española de Arteriosclerosis. Published by Elsevier España. All rights reserved.

The U.K. service level audit of insulin pump therapy in adults.

PubMed

White, H D; Goenka, N; Furlong, N J; Saunders, S; Morrison, G; Langridge, P; Paul, P; Ghatak, A; Weston, P J

2014-04-01

The National Institute for Health and Clinical Excellence (NICE) published guidelines for the use of continuous subcutaneous insulin infusion in 2008 (technology appraisal 151). The first U.K.-wide insulin pump audit took place in 2012 with the aim of determining adherence to the guidance issued in NICE technology appraisal 151. The results of the adult service level audit are reported here. All centres providing continuous subcutaneous insulin infusion services to adults with diabetes in the U.K. were invited to participate. Audit metrics were aligned to technology appraisal 151. Data entry took place online using a DiabetesE formatted data collection tool. One hundred and eighty-three centres were identified as delivering adult continuous subcutaneous insulin infusion services in the U.K., of which 178 (97.3%) participated in the audit. At the time of the audit, 13 428 adults were using insulin pump therapy, giving an estimated prevalence of use of 6%. Ninety-three per cent of centres did not report any barriers in obtaining funding for patients who fulfilled NICE criteria. The mean number of consultant programmed activities dedicated to continuous subcutaneous insulin infusion services was 0.96 (range 0-8), mean whole-time equivalent diabetes specialist nurses was 0.62 (range 0-3) and mean whole-time equivalent dietitian services was 0.3 (range 0-2), of which 39, 61 and 60%, respectively, were not formally funded. The prevalence of continuous subcutaneous insulin infusion use in the U.K. falls well below the expectation of NICE (15-20%) and that of other European countries (> 15%) and the U.S.A. (40%). This may be attributable, in part, to lack of healthcare professional time needed for identification and training of new pump therapy users. © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.

Methodological quality of guidelines in gastroenterology.

PubMed

Malheiro, Rui; de Monteiro-Soares, Matilde; Hassan, Cesare; Dinis-Ribeiro, Mário

2014-06-01

Clinical guidelines are a common feature in modern endoscopy practice and they are being produced faster than ever. However, their methodological quality is rarely assessed. This study evaluated the methodological quality of current clinical guidelines in the field of gastroenterology, with an emphasis on endoscopy. Practice guidelines published by the American College of Gastroenterology (ACG), American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE), European Society of Gastrointestinal Endoscopy (ESGE), British Society of Gastroenterology (BSG), National Institute for Health and Care Excellence (NICE), and the Scottish Intercollegiate Guidelines Network (SIGN) were searched between September and October 2012 and evaluated using the AGREE II (Appraisal of Guidelines for Research and Evaluation) instrument (23 items, scores 1 - 7 for each item; higher scores mean better quality). A total of 100 guidelines were assessed. The mean number of items scoring 6 or 7 per guideline was 9.2 (out of 23 items). Overall, 99 % of guidelines failed to include the target population in the development process, and 96 % did not report facilitators and barriers to guideline application. In addition, 86 % did not include advice or tools, and 94 % did not present monitoring or auditing criteria. The global methodological quality of clinical guidelines in the field of gastroenterology is poor, particularly regarding involvement of the target population in the development of guidelines and in the provision of clear suggestions to practitioners. © Georg Thieme Verlag KG Stuttgart · New York.

Guidelines to identify abnormalities after childhood urinary tract infections: a prospective audit.

PubMed

Coulthard, Malcolm G; Lambert, Heather J; Vernon, Susan J; Hunter, Elizabeth W; Keir, Michael J

2014-05-01

To compare the childhood urinary tract infection (UTI) guidelines from the Royal College of Physicians (RCP) in 1991 and from National Institute of Health and Care Excellence (NICE) (CG54) in 2007 by measuring their efficiency at detecting urinary tract abnormalities. Children with UTIs within the Newcastle Primary Care Trust (population 70,800 children) were referred and imaged according to the RCP guidelines during 2008, and these were compared to the activity that would have been undertaken if we had implemented the CG54 guidelines, including following them through 2011 to identify those with recurrent UTIs. The numbers of children imaged, the imaging burden and efficiency, and urinary tract abnormalities detected by each guideline. Fewer children would have been imaged by CG54 than RCP (150 vs 427), but its sensitivity was lower, at 44% for detecting scarring, 10% for identifying vesicoureteric reflux and 40% for other abnormalities. Overall, it would have only detected one-quarter of the abnormal cases (8 vs 32) and would have missed five of nine children with scarring, including three with multiple lesions and one with renal impairment. Imposing an age restriction of <8 years to the RCP guidelines would reduce its screening rate by 20% and still detect 90% of the abnormalities. The CG54 guidelines do not alter the imaging efficiency compared to the RCP guidelines, but they are considerably less sensitive.

Patterns of Warfarin Use in Subgroups of Patients with Atrial Fibrillation: A Cross-Sectional Analysis of 430 General Practices in the United Kingdom

PubMed Central

Mohammed, Mohammed A.; Marshall, Tom; Nirantharakumar, Krishnarajah; Stevens, Andrew; Fitzmaurice, David

2013-01-01

Background Despite the proven efficacy of warfarin, its use in patients with Atrial Fibrillation (AF) is reportedly low. We investigated the underuse and overuse of warfarin in the management of AF in general practices in the United Kingdom (UK) against the National Institute of Clinical Excellence (NICE, UK) guidelines whilst seeking to identify subgroups of AF patients to inform efforts to optimise warfarin use. Methodology A retrospective database analysis to determine warfarin prescribing using tree models based on 50361 patients with AF (classified as low, moderate and high risk of stroke using CHADS2) from 430 general practices in the UK. Results Over one-third (37.0%, 4573/12351) of low risk AF patients were on warfarin, compared with 47.1% (8349/17709) moderate risk AF patients and 54.9% (11142/20301) high risk AF patients. Clinical subgroups (n = 15 low risk subgroups, n = 15 medium risk subgroups, n = 22 high risk subgroups) were identified. Several factors not supported by current guidelines (age, BMI, dementia, gender) were associated with the use of warfarin. Gender and BMI were associated with warfarin use in low and medium risk AF patients but not in high risk AF patients. Conclusion Whilst NICE guidelines suggest that all high risk AF patients should be on warfarin, half of those at moderate risk should be on warfarin and none of those at low risk should be on warfarin, we found evidence of over and under use of warfarin. Interventions to optimise warfarin therapy tailored to and targeting specific subgroups of AF patients identified by the tree models are required. PMID:23658703

[An increase of infective endocarditis cases in England seen with concomitant reduction in antibiotic prophylaxis since the implementation of NICE guidelines in 2008: possible explanations].

PubMed

Tiberi, Simon; Pink, Frederick; Jayakumar, Angelina; Arioli, Francesco

2015-01-01

Dayer and colleagues recently reported in The Lancet an increased incidence of infective endocarditis in England since 2008, year of NICE guideline on the restriction of antibiotic prophylaxis. They observed a concomitant decrease in the use of antibiotic prophylaxis. The temporal link between reduction of prophylaxis prescribing and increase of infective endocarditis raises the question of whether there is a causal association. In view of this observation, should we rethink antibiotic prophylaxis to prevent infective endocarditis?

Rheumatologists' judgements about the efficacy of anti-TNF therapy in two neighbouring regions.

PubMed

Kee, F; Sheehy, N; O'Hare, L; Bane, C; Bell, A; Dempster, M; FitzGerald, O

2005-11-01

The requirement in Northern Ireland to prescribe biological agents according to National Institute for Clinical Excellence/British Society for Rheumatology (NICE/BSR) guidelines and within a fixed budget has created a waiting list for treatment that has no parallel in the Republic of Ireland. The study investigated the bearing this situation may have had on consultants' judgements in the respective areas. Seventy-eight case vignettes created from the data on real patients with RA treated with biologicals in the north and south of Ireland were appraised by nine southern and eight northern consultants, who judged the clinical benefit and significance of the patients' condition after a trial of therapy. Quantitative (clinical judgement analysis) and qualitative (focus groups) techniques were used. Northern consultants perceived a slightly greater degree of clinical benefit after a trial of therapy than southern consultants. Judgement models of northern and southern consultants were broadly comparable. The latter tended to be more uniform in their judgements than the southern group. Focus group discussions with consultants largely validated the findings of the quantitative analysis but revealed how clinical judgement analysis might be misled by gaming strategies. Despite the absence of overt rationing in the south of Ireland, as far as the judgement of therapeutic benefit from biologicals was concerned, the clinical judgement policies of practitioners were very similar to those in the north. The adoption of NICE/BSR guidelines in the north may have improved the uniformity of clinical practice in Northern Ireland.

Targeting the initial investigation and management in cases of acute pulmonary embolism.

PubMed

Moore, Nicholas; Hawkins, Peter

2013-01-01

It was noted by consultants in our hospital that the early investigation of suspected pulmonary embolism (PE) lacked structure. This was causing delays in definitive diagnosis and early management. The resulting unnecessary use of investigation was also wasting resources. In particular, the inappropriate use of serum d-dimer tests was causing concern. The National Institute of Clinical Excellence (NICE) guidelines recommend use of the 2-level Well's score to target investigation in suspected PE. A baseline audit against the NICE guideline revealed that Well's scores were rarely used (only calculated in 12% of cases) and confirmed the suspicion that early investigation was poorly targeted. This project intervened using educational talks promoting the use of Well's scores in cases of suspected PE. Well's score proformas were placed in the emergency department and emergency assessment unit for reference. Their availability was advertised. This significantly increased the use of Well's scores (46% vs 11%, p<0.001). Fewer patients underwent unnecessary d-dimer measurements in cases of likely PE (65% vs 86%). Initial investigation was more targeted in cases where a Well's score had been calculated than in cases without a Well's score. For example, significantly fewer unnecessary d-dimer tests were performed in these cases (45% vs 100%, p<0.05). The cost of unnecessary investigation in suspected PE is not only significant financially but also in the resulting delay in definitive diagnosis and management for the patient. The simple intervention used here was effective in addressing this problem.

Cost-effectiveness modeling for neuropathic pain treatments: investigating the relative importance of parameters using an open-source model.

PubMed

Hirst, Matthew; Bending, Matthew W; Baio, Gianluca; Yesufu-Udechuku, Amina; Dunlop, William C N

2018-06-08

The study objective was to develop an open-source replicate of a cost-effectiveness model developed by National Institute for Health and Care (NICE) in order to explore uncertainties in health economic modeling of novel pharmacological neuropathic pain treatments. The NICE model, consisting of a decision tree with branches for discrete levels of pain relief and adverse event (AE) severities, was replicated using R and used to compare a hypothetical neuropathic pain drug to pregabalin. Model parameters were sourced from NICE's clinical guidelines and associated with probability distributions to account for underlying uncertainty. A simulation-based scenario analysis was conducted to assess how uncertainty in efficacy and AEs affected the net monetary benefit (NMB) for the hypothetical treatment at a cost-effectiveness threshold of £20,000 per QALY. Relative to pregabalin, an increase in efficacy was associated with greater NMB than an improvement in tolerability. A greater NMB was observed when efficacy was marginally higher than that of pregabalin while maintaining the same level of AEs than when efficacy was equivalent to pregabalin but with a more substantial reduction in AEs. In the latter scenario, the NMB was only positive at a low cost-effectiveness threshold. The replicate model shares the limitations described in the NICE guidelines. There is a lack of support in scientific literature for the assumption that increased efficacy is associated with a greater reduction in tolerability. The replicate model also included a single comparator, unlike the NICE model. Pain relief is a stronger driver of NMB than tolerability at a cost-effectiveness threshold of £20,000 per QALY. Health technology assessment decisions which are influenced by NICE's model may reward efficacy gains even if they are associated with more severe AEs. This contrasts with recommendations from clinical guidelines for neuropathic pain which place more equal weighting on improvements in efficacy and tolerability as value drivers.

Urinary tract infection in children: Diagnosis, treatment, imaging - Comparison of current guidelines.

PubMed

Okarska-Napierała, M; Wasilewska, A; Kuchar, E

2017-12-01

Urinary tract infection (UTI) is a frequent disorder of childhood, yet the proper approach for a child with UTI is still a matter of controversy. The objective of this study was to critically compare current guidelines for the diagnosis and management of UTI in children, in light of new scientific data. An analysis was performed of the guidelines from: American Academy of Pediatrics (AAP), National Institute for Health and Care Excellence (NICE), Italian Society of Pediatric Nephrology, Canadian Paediatric Society (CPS), Polish Society of Pediatric Nephrology, and European Association of Urology (EAU)/European Society for Pediatric Urology (ESPU). Separate aspects of the approach for a child with UTI, including diagnosis, treatment and further imaging studies, were compared, with allowance for recent research in each field. The analyzed guidelines tried to reconcile recent reports about diagnosis, treatment, and further diagnostics in pediatric UTI with prior practices and opinions, and economic capabilities. There was still a lack of sufficient data to formulate coherent, unequivocal guidelines on UTI management in children, with imaging tests remaining the main area of controversy. As a result, the authors formulated their own proposal for UTI management in children. Copyright © 2017 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

[The acceptability of the NICE recommendations for schizophrenia in the Italian Departments of Mental Health. The SIEP-DIRECT'S Project on the discrepancy between routine practice and evidence].

PubMed

Semisa, Domenico; Lasalvia, Antonio; Miceli, Maurizio; Dall'Agnola, Rosa Bruna; Pucci, Cristina; Bissoli, Sarah; Visani, Enrico; Pismataro, Carmine Pasquale; Vanetti, Michele; Pioli, Rosaria; Ruggeri, Mirella; Lora, Antonio

2008-01-01

This paper aims at presenting the most significant results emerging from the work carried out by the focus groups of the multi-centre Project SIEP-DIRECT'S. The Project is aimed at assessing the existing discrepancies between the evidence-based NICE guidelines for schizophrenia and the usual practices of care given by Italian mental health services. Each focus group was requested to give an evaluation on: (a) appropriateness of the English NICE guidelines in the context of the Italian mental health services; (b) clarity and usefulness of the 103 indicators developed on the basis of the NICE recommendations to measure their level of application within the services. In each of the 19 mental health departments or psychiatric services participating in the Project there were organized "multidisciplinary" focus groups and "specialistic" focus groups. The former included, amongst others, professional operators of the mental health services, patients, their relatives, representatives of patient organizations and general practitioners. They examined the recommendations and indicators upon which the participants could express their opinion or judgment based on their knowledge, experience or information in their possession. The latter group, composed only of psychiatrists, examined the recommendations and indicators relative to pharmacological treatments that regarded the specific competences of their professional category. Most NICE recommendations seemed appropriate to the working context of the Italian services. However, some perplexity emerged as regards specific organizational models of the services, such as the specific services for psychotic onsets or the assertive outreach teams, which were believed not to be strictly pertinent to the traditional organization of mental health care in our Country. There were also some criticisms regarding the cognitive-behavioural treatments which the NICE Guidelines recommend as the principle psychotherapeutic option for patients with schizophrenia, since in many Italian services, when the use of psychological interventions are needed, the tendency is to prefer interventions based on psychodynamic theories. The SIEP indicators were generally held to be clear and acceptable. In the view of the focus groups, the NICE guidelines are on the whole useful and suitable for orientating the services in the choice of more efficacious practices in the treatment of patients with schizophrenia. Moreover, the results obtained legitimate the use of the set of SIEP indicators for the evaluation of good practices and the quality of care offered by Italian services. Finally, the use of focus groups delines to a different context as well as the verification of the comprehensibility and applicability of SIEP indicators.

NICE guidance: a comparative study of the introduction of the single technology appraisal process and comparison with guidance from Scottish Medicines Consortium

PubMed Central

Waugh, Norman; Sharma, Pawana; Sculpher, Mark; Walker, Andrew

2012-01-01

Objectives To compare the timelines and recommendations of the Scottish Medicines Consortium (SMC) and National Institute of Health and Clinical Excellence (NICE), in particular since the single technology assessment (STA) process was introduced in 2005. Design Comparative study of drug appraisals published by NICE and SMC. Setting NICE and SMC. Participants All drugs appraised by SMC and NICE, from establishment of each organisation until August 2010, were included. Data were gathered from published reports on the NICE website, SMC annual reports and European Medicines Agency website. Primary and secondary outcome measures Primary outcome was time from marketing authorisation until publication of first guidance. The final outcome for each drug was documented. Drug appraisals by NICE (before and after the introduction of the STA process) and SMC were compared. Results NICE and SMC appraised 140 drugs, 415 were appraised by SMC alone and 102 by NICE alone. NICE recommended, with or without restriction, 90% of drugs and SMC 80%. SMC published guidance more quickly than NICE (median 7.4 compared with 21.4 months). Overall, the STA process reduced the average time to publication compared with multiple technology assessments (median 16.1 compared with 22.8 months). However, for cancer medications, the STA process took longer than multiple technology assessment (25.2 compared with 20.0 months). Conclusions Proportions of drugs recommended for NHS use by SMC and NICE are similar. SMC publishes guidance more quickly than NICE. The STA process has improved the time to publication but not for cancer drugs. The lengthier time for NICE guidance is partly due to measures to provide transparency and the widespread consultation during the NICE process. PMID:22290398

Drug reimbursement recommendations by the National Institute for Health and Clinical Excellence: have they impacted the National Health Service budget?

PubMed

Mauskopf, Josephine; Chirila, Costel; Birt, Julie; Boye, Kristina S; Bowman, Lee

2013-04-01

Determine whether reimbursement restrictions recommended by the National Institute for Health and Clinical Excellence (NICE) have impacted the United Kingdom (UK) National Health Service (NHS) budget. Data were abstracted from NICE guidance documents and costing statements through March 2011. Estimated maximum and adjusted potential budget impact (PBI) on the NHS was derived using estimates of the UK marketing-approved population and the annual cost for the new drug. Descriptive and logistic analyses were used to estimate the correlation between the degree of restrictions on reimbursement recommended by NICE for each new drug indication and the PBI controlling for clinical effectiveness and cost-effectiveness. PBI was significantly correlated with the degree of reimbursement restrictions. In descriptive analysis, the adjusted PBI for drugs that were recommended without restrictions was £20.3 million (SD = 22.2) compared with £49.8 million (SD = 90.8) for those recommended with restrictions and £71.1 million (SE = 99.9) for those not recommended. In logistic analysis, the odds ratio for less restrictive reimbursement was 0.848 (95% CI, 0.762-0.945) for each £20 million increase in the adjusted PBI. Results were similar using the maximum PBI. After controlling for clinical effectiveness and cost-effectiveness, the degree of reimbursement restriction recommended by NICE remains significantly correlated with the PBI, despite that fact that the NICE decision process does not consider budget impact. This correlation might be due to NICE consideration of effectiveness and cost-effectiveness for subgroups of the approved population. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Do implantable cardioverter defibrillators improve survival in patients with severe left ventricular systolic dysfunction after coronary artery bypass graft surgery?

PubMed

Fazal, Iftikhar A; Bates, Matthew G D; Matthews, Iain G; Turley, Andrew J

2011-06-01

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether implantable cardioverter defibrillators (ICD) improve survival in patients with severe left ventricular systolic dysfunction (LVSD) after coronary artery bypass graft (CABG) surgery. ICDs are designed to terminate potentially fatal cardiac tachyarrhythmias. A right ventricular lead is mandatory for detection, pacing and defibrillation capabilities. Dual chamber ICDs have an additional right atrial lead and are used for patients with conventional atrioventricular pacing indications. More sophisticated, biventricular devices exist to provide cardiac resynchronisation therapy (CRT) in addition to defibrillation (CRT-D). ICDs have been extensively investigated in patients with LVSD post myocardial infarction and in patients with non-ischaemic cardiomyopathy for both secondary prevention (history of ventricular arrhythmias) and primary prevention (deemed high risk for ventricular arrhythmias). This best evidence topic aims to review the evidence and its applicability to patients post CABG. Nine hundred and sixteen papers were identified using the search method outlined. Eight randomised controlled trials, two meta-analyses, and one non-randomised trial, in addition to international guidelines presented the best evidence to answer the clinical question. The current evidence base and guidelines suggest that ICDs should be considered for all patients with LVSD [ejection fraction (EF) ≤30-40%] receiving optimal pharmacological management, who are ≥40 days post MI [four weeks for National Institute for Health and Clinical Excellence (NICE)] and in New York Heart Association (NYHA) class I-III. UK NICE guidelines require in addition; non-sustained ventricular tachycardia (NSVT) on a Holter monitor and inducible ventricular tachycardia at electrophysiological study for EF between 30 and 35%; or a QRS >120 ms if EF <30%. The North American guidelines recommend EF <30% as a threshold for those with NYHA class I symptoms. The evidence is applicable to patients post CABG, provided all the other criteria are met. European Society of Cardiology (ESC) guidelines recommend waiting at least three months (consensus opinion) after revascularisation prior to assessment for an ICD, to allow time for potential recovery of ventricular function.

Lumbar Spine X-Ray as a Standard Investigation for all Low back Pain in Ghana: Is It Evidence Based?

PubMed

Tannor, Abena Y

2017-03-01

Low back pain (LBP) has a prevalence of 84% in Africa. The commonest form of imaging is plain lumbar spine x-ray. It gives a radiation dose equivalent to 65 times a chest x-ray dose and sends one of the highest doses to the human reproductive organs. The commonest cause of LBP in Africa is degenerative disease. X-ray findings do not change mode of treatment yet most physicians still routinely request for x-rays. This is a systematic review of databases including The Cochrane, CINAHL plus, AMED, and MEDLINE. Key evidence was clinical guidelines on x-ray use for low back pain. Key search terms included low back pain, x-rays, guidelines, Ghana. Four clinical guidelines on LBP emerged from two Systematic Reviews rated excellent and four good Randomized Controlled Trials: The European guidelines for acute and sub-acute non-specific Low Back Pain, The American College of Physicians and the American Pain Society guideline for diagnostic imaging for Low Back Pain, The NICE guidelines for persistent non-specific Low Back Pain and the Ghana Standard Treatment Guidelines (GSTG). All the guidelines agree that a good history and clinical examination for all LBP patients helps in diagnosing. Only GSTG recommends routine plain spinal x-rays. There is strong evidence indicating very little benefit from routine lumbar spine x-rays for all LBP. The GSTG needs to be revised considering the increased risks of radiation exposure and the x-ray costs. None declared.

Guidelines to identify abnormalities after childhood urinary tract infections: a prospective audit

PubMed Central

Coulthard, Malcolm G; Lambert, Heather J; Vernon, Susan J; Hunter, Elizabeth W; Keir, Michael J

2014-01-01

Objective To compare the childhood urinary tract infection (UTI) guidelines from the Royal College of Physicians (RCP) in 1991 and from National Institute of Health and Care Excellence (NICE) (CG54) in 2007 by measuring their efficiency at detecting urinary tract abnormalities. Design Children with UTIs within the Newcastle Primary Care Trust (population 70 800 children) were referred and imaged according to the RCP guidelines during 2008, and these were compared to the activity that would have been undertaken if we had implemented the CG54 guidelines, including following them through 2011 to identify those with recurrent UTIs. Main outcome measures The numbers of children imaged, the imaging burden and efficiency, and urinary tract abnormalities detected by each guideline. Results Fewer children would have been imaged by CG54 than RCP (150 vs 427), but its sensitivity was lower, at 44% for detecting scarring, 10% for identifying vesicoureteric reflux and 40% for other abnormalities. Overall, it would have only detected one-quarter of the abnormal cases (8 vs 32) and would have missed five of nine children with scarring, including three with multiple lesions and one with renal impairment. Imposing an age restriction of <8 years to the RCP guidelines would reduce its screening rate by 20% and still detect 90% of the abnormalities. Interpretation The CG54 guidelines do not alter the imaging efficiency compared to the RCP guidelines, but they are considerably less sensitive. PMID:24436366

Genetic testing for BRCA1: effects of a randomised study of knowledge provision on interest in testing and long term test uptake; implications for the NICE guidelines.

PubMed

Hall, Julia; Gray, Susan; A'Hern, Roger; Shanley, Susan; Watson, Maggie; Kash, Kathryn; Croyle, Robert; Eeles, Rosalind

2009-01-01

Interest in searching for mutations in BRCA1 and BRCA2 is high. Knowledge regarding these genes and the advantages and limitations of genetic testing is limited. It is unknown whether increasing knowledge about breast cancer genetic testing alters interest in testing. Three hundred and seventy nine women (260 with a family history of breast cancer; 119 with breast cancer) from The Royal Marsden NHS Foundation Trust were randomised to receive or not receive written educational information on cancer genetics. A questionnaire was completed assessing interest in BRCA1 testing and knowledge on breast cancer genetics and screening. Actual uptake of BRCA1 testing is reported with a six year follow-up. Eighty nine percent of women at risk of breast cancer and 76% of women with breast cancer were interested in BRCA1 testing (P < 0.0001). Provision of educational information did not affect level of interest. Knowledge about breast cancer susceptibility genes was poor. According to the NICE guidelines regarding eligibility for BRCA1 and BRCA2 testing, the families of 66% of the at risk group and 13% of the women with breast cancer would be eligible for testing (probability of BRCA1 mutation >or=20%). Within six years of randomisation, genetic testing was actually undertaken on 12 women, only 10 of whom would now be eligible, on the NICE guidelines. There is strong interest in BRCA1 testing. Despite considerable ignorance of factors affecting the inheritance of breast cancer, education neither reduced nor increased interest to undergo testing. The NICE guidelines successfully triage those with a high breast cancer risk to be managed in cancer genetics clinics.

Application of the Canadian CT head rules in managing minor head injuries in a UK emergency department: implications for the implementation of the NICE guidelines

PubMed Central

Sultan, H; Boyle, A; Pereira, M; Antoun, N; Maimaris, C

2004-01-01

Objective: : In 2002 a new protocol was introduced based on the Canadian CT rules. Before this the Royal College of Surgeons "Galasko" report guidelines had been followed. This study evaluates the effects of the protocol and discusses the impact of the implementation of the NICE head injury guidelines—also based on the Canadian CT rules. Methods: A "before and after" study was undertaken, using data from accident and emergency cards and hospital notes of adult patients with head injuries presenting to the emergency department over seven months in 2001 and nine months in 2002. The two groups were compared to see how rates of computed tomography (CT), admission for observation, discharge, and skull radiography had changed after introduction of the protocol. Results: : Head CT rates in patients with minor head injuries (MHI) increased significantly from 47 of 330 (14%) to 58 of 267 (20%) (p<0.05). There were also significantly increased rates of admission for observation, from 111 (34%) to 119 (45%). Skull radiography rates fell considerably from 33% of all patients with head injuries in 2001 to 1.6% in 2002, without any adverse effect. Conclusions: This study shows that it is possible to replace the current practice in the UK of risk stratification of adult MHI based on skull radiography, with slightly modified versions of the Canadian CT rule/NICE guidelines. This will result in a large reduction in skull radiography and will be associated with modest increases in CT and admissions rates. If introduction of the NICE guideline is to be realistic, the study suggests that it will not be cost neutral. PMID:15208222

The implementation of nice guidance on venous thromboembolism risk assessment and prophylaxis: a before-after observational study to assess the impact on patient safety across four hospitals in England

PubMed Central

2013-01-01

Background Venous thromboembolism (VTE) is a major cause of morbidity and mortality in hospitalised patients. VTE prevention has been identified as a major health need internationally to improve patient safety. A National Institute for Health and Clinical Excellence (NICE) guideline was issued in February 2010. Its key priorities were to assess patients for risk of VTE on admission to hospital, assess patients for bleeding risk and evaluate the risks and benefits of prescribing VTE prophylaxis. The aim of this study was to evaluate the implementation of NICE guidance and its impact on patient safety. Methods A before-after observational design was used to investigate changes in VTE risk assessment documentation and inappropriate prescribing of prophylaxis between the year prior to (2009) and the year following (2010) the implementation of NICE guidance, using data from a 3-week period during each year. A total of 408 patients were sampled in each year across four hospitals in the NHS South region. Results Implementation strategies such as audit, education and training were used. The percentage of patients for whom a VTE risk assessment was documented increased from 51.5% (210/408) in 2009 to 79.2% (323/408) in 2010; difference 27.7% (95% CI: 21.4% to 33.9%; p < 0.001). There was little evidence of change in the percentage who were prescribed prophylaxis amongst patients without a risk assessment (71.7% (142/198) in 2009 and 68.2% (58/85) in 2010; difference −3.5% (95% CI: -15.2% to 8.2%; p =0.56) nor the percentage who were prescribed low molecular weight heparin amongst patients with a contraindication (14% (4/28) in 2009 and 15% (6/41) in 2010; RD = 0.3% (95% CI: -16.5% to 17.2%; p =0.97). Conclusions The documentation of risk assessment improved following the implementation of NICE guidance; it is questionable, however, whether this led to improved patient safety with respect to prescribing appropriate prophylaxis. PMID:23734903

Enhancing recovery rates: lessons from year one of IAPT.

PubMed

Gyani, Alex; Shafran, Roz; Layard, Richard; Clark, David M

2013-09-01

The English Improving Access to Psychological Therapies (IAPT) initiative aims to make evidence-based psychological therapies for depression and anxiety disorder more widely available in the National Health Service (NHS). 32 IAPT services based on a stepped care model were established in the first year of the programme. We report on the reliable recovery rates achieved by patients treated in the services and identify predictors of recovery at patient level, service level, and as a function of compliance with National Institute of Health and Care Excellence (NICE) Treatment Guidelines. Data from 19,395 patients who were clinical cases at intake, attended at least two sessions, had at least two outcomes scores and had completed their treatment during the period were analysed. Outcome was assessed with the patient health questionnaire depression scale (PHQ-9) and the anxiety scale (GAD-7). Data completeness was high for a routine cohort study. Over 91% of treated patients had paired (pre-post) outcome scores. Overall, 40.3% of patients were reliably recovered at post-treatment, 63.7% showed reliable improvement and 6.6% showed reliable deterioration. Most patients received treatments that were recommended by NICE. When a treatment not recommended by NICE was provided, recovery rates were reduced. Service characteristics that predicted higher reliable recovery rates were: high average number of therapy sessions; higher step-up rates among individuals who started with low intensity treatment; larger services; and a larger proportion of experienced staff. Compliance with the IAPT clinical model is associated with enhanced rates of reliable recovery. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

Implementing NICE obesity guidance for staff: an NHS trust audit.

PubMed

Dalton, M B

2015-01-01

The UK National Institute of Health and Clinical Excellence (NICE) has produced guidelines (CG43) on preventing and managing overweight and obesity, which apply to the National Health Service (NHS) as an employer. To record in an NHS trust baseline assessment and management of obesity by its occupational health (OH) service staff, with reference to the standards in CG43, enabling deficiencies to be identified and improvements to be recommended as a benchmark for future measurement. Criteria relevant to OH in CG43 were identified and data were collected from trust policies, interviews with managers, questionnaires to OH staff, examination of OH resources and case notes of staff attending OH. Results were checked for compliance with CG43 standards. Although the trust met NICE standards as an employer, significant lack of compliance was found in its OH service. Only 53% of staff attending medical examinations had weight recorded, OH resources were inadequate and 75% of its staff had received no training. Problems identified included lack of written guidance, time and care pathways. The resulting action plan included a consultant-led working party liaising with the trust's health and well-being committee, training, enhanced OH resources, an obesity protocol, a database and weight management clinics. We found not only a lack of OH policy guidance but apparent inertia in dealing with obesity. The action plan demonstrated how OH clinical practice can draw upon CG43 to combat obesity in an NHS workforce. © The Author 2015. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Predictors of fever-related admissions to a paediatric assessment unit, ward and reattendances in a South London emergency department: the CABIN 2 study.

PubMed

Bustinduy, Amaya L; Chis Ster, Irina; Shaw, Rebecca; Irwin, Adam; Thiagarajan, Jaiganesh; Beynon, Rhys; Ladhani, Shamez; Sharland, Mike

2017-01-01

To explore the risk factors for ward and paediatric assessment unit (PAU) admissions from the emergency department (ED). Prospective observational study. Febrile children attending a large tertiary care ED during the winter of 2014-2015. Ward and PAU admissions, National Institute for Health and Care Excellence (NICE) guidelines classification, reattendance to the ED within 28 days and antibiotic use. A total of 1097 children attending the children's ED with fever were analysed. Risk factors for PAU admission were tachycardia (RR=1.1, 95% CI (1 to 1.1)), ill-appearance (RR=2.2, 95% CI (1.2 to 4.2)), abnormal chest findings (RR=2.1, 95% CI (1.2 to 4.3)), categorised as NICE amber (RR 1.7 95% CI (1.2 to 2.5)). There was a 30% discordance between NICE categorisation at triage and statistical internal validation. Predictors of ward admission were a systemic (RR=6.9, 95% CI (2.4 to 19.8)) or gastrointestinal illness (RR=3.8, 95% (1.4 to 10.4)) and categorised as NICE Red (RR=5.9, 95% CI (2.2 to 15.3)). Only 51 children had probable bacterial pneumonia (4.6%), 52 children had a proven urinary tract infection (4.2%), with just 2 (0.2%) positive blood cultures out of 485 (44%) children who received an antibiotic. 15% of all children reattended by 28 days and were more likely to have been categorised as Amber and had investigations on initial visit. Risk factors for PAU and ward admissions are different in this setting with high reattendance rates and very low proportion of confirmed/probable serious bacterial infections. Future studies need to focus on reducing avoidable admissions and antibiotic treatment. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Impact of investigations in general practice on timeliness of referral for patients subsequently diagnosed with cancer: analysis of national primary care audit data.

PubMed

Rubin, G P; Saunders, C L; Abel, G A; McPhail, S; Lyratzopoulos, G; Neal, R D

2015-02-17

For patients with symptoms of possible cancer who do not fulfil the criteria for urgent referral, initial investigation in primary care has been advocated in the United Kingdom and supported by additional resources. The consequence of this strategy for the timeliness of diagnosis is unknown. We analysed data from the English National Audit of Cancer Diagnosis in Primary Care on patients with lung (1494), colorectal (2111), stomach (246), oesophagus (513), pancreas (327), and ovarian (345) cancer relating to the ordering of investigations by the General Practitioner and their nature. Presenting symptoms were categorised according to National Institute for Health and Care Excellence (NICE) guidance on referral for suspected cancer. We used linear regression to estimate the mean difference in primary-care interval by cancer, after adjustment for age, gender, and the symptomatic presentation category. Primary-care investigations were undertaken in 3198/5036 (64%) of cases. The median primary-care interval was 16 days (IQR 5-45) for patients undergoing investigation and 0 days (IQR 0-10) for those not investigated. Among patients whose symptoms mandated urgent referral to secondary care according to NICE guidelines, between 37% (oesophagus) and 75% (pancreas) were first investigated in primary care. In multivariable linear regression analyses stratified by cancer site, adjustment for age, sex, and NICE referral category explained little of the observed prolongation associated with investigation. For six specified cancers, investigation in primary care was associated with later referral for specialist assessment. This effect was independent of the nature of symptoms. Some patients for whom urgent referral is mandated by NICE guidance are nevertheless investigated before referral. Reducing the intervals between test order, test performance, and reporting can help reduce the prolongation of primary-care intervals associated with investigation use. Alternative models of assessment should be considered.

Impact of investigations in general practice on timeliness of referral for patients subsequently diagnosed with cancer: analysis of national primary care audit data

PubMed Central

Rubin, G P; Saunders, C L; Abel, G A; McPhail, S; Lyratzopoulos, G; Neal, R D

2015-01-01

Background: For patients with symptoms of possible cancer who do not fulfil the criteria for urgent referral, initial investigation in primary care has been advocated in the United Kingdom and supported by additional resources. The consequence of this strategy for the timeliness of diagnosis is unknown. Methods: We analysed data from the English National Audit of Cancer Diagnosis in Primary Care on patients with lung (1494), colorectal (2111), stomach (246), oesophagus (513), pancreas (327), and ovarian (345) cancer relating to the ordering of investigations by the General Practitioner and their nature. Presenting symptoms were categorised according to National Institute for Health and Care Excellence (NICE) guidance on referral for suspected cancer. We used linear regression to estimate the mean difference in primary-care interval by cancer, after adjustment for age, gender, and the symptomatic presentation category. Results: Primary-care investigations were undertaken in 3198/5036 (64%) of cases. The median primary-care interval was 16 days (IQR 5–45) for patients undergoing investigation and 0 days (IQR 0–10) for those not investigated. Among patients whose symptoms mandated urgent referral to secondary care according to NICE guidelines, between 37% (oesophagus) and 75% (pancreas) were first investigated in primary care. In multivariable linear regression analyses stratified by cancer site, adjustment for age, sex, and NICE referral category explained little of the observed prolongation associated with investigation. Interpretation: For six specified cancers, investigation in primary care was associated with later referral for specialist assessment. This effect was independent of the nature of symptoms. Some patients for whom urgent referral is mandated by NICE guidance are nevertheless investigated before referral. Reducing the intervals between test order, test performance, and reporting can help reduce the prolongation of primary-care intervals associated with investigation use. Alternative models of assessment should be considered. PMID:25602963

Has NICE got it right? An international perspective considering the case of Technology Appraisal No. 98 by the National Institute for Health and Clinical Excellence (NICE).

PubMed

Schlander, Michael

2008-04-01

The National Institute for Health and Clinical Excellence (NICE) has been widely recognised as setting an international standard for high-quality health technology assessments (HTAs) including economic evaluation. A previous critical analysis of NICE Technology Appraisal No. 98 (TA98), evaluating methylphenidate, dexamphetamine and atomoxetine for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children, revealed a number of issues, which must cast doubt on the robustness of the NICE approach when addressing a complex clinical decision problem. The exploration of potential underlying problems will be followed by a discussion of lessons for international healthcare policy-makers, and is intended to be an invitation to further debate and inquiry, not a presentation of definitive conclusions. Pertaining to the technology assessment report, potential problems were identified relating to an unnecessarily narrow scope, data search and selection strategy, the distinction between efficacy and effectiveness, data synthesis across studies and clinical effect measures, and limitations of the economic model. The appraisal process moderated the asserted 'clear conclusions' of the assessment but could not compensate for some of its gaps. It is suggested that key issues contributing to these problems may have included a separation of clinical and economic perspectives, a highly standardised reference case analysis that was followed schematically, the absence of an effective system for quality assurance of technology assessments, and transparency deficits of the economic evaluation. Further considerations for international policy-makers looking at NICE as a potential role model for HTAs are discussed, such as institutional context, the objectives of collectively financed healthcare and related value judgments, the reliance on QALYs as a universal and comprehensive measure of health benefits, the appropriate perspective for analysis, and process-related implications.

Differences in cancer drug assessment between Spain and the United Kingdom.

PubMed

Lozano-Blázquez, Ana; Dickson, Rumona; Fraga-Fuentes, María-Dolores; Martínez-Martínez, Fernando; Calleja-Hernández, Miguel-Ángel

2015-09-01

There is no Spanish Government agency resembling the National Institute for Health and Care Excellence (NICE) in the United Kingdom (UK) that carries out a centralised evaluation and makes decisions about funding. Therefore, we aim to assess the differences between NICE and the Spanish bodies in terms of their respective processes. We compare the decisions concerning cancer drugs in the assessments made by NICE/Single Technology Appraisal with assessments made by MADRE methodology. We included all cancer drugs assessed by NICE and all MADRE reports made using a shared reports process (GENESIS) and reports from Catalonia (CAMDHA) and Andalucía (GFTHA). We compared the number of drugs assessed, the decisions taken by NICE and Spanish organizations and timelines. Between January 2011 and December 2013 NICE appraised 24 cancer drugs. In Spain, 44 reports were produced using MADRE methodology. For the 14 drugs assessed by both NICE and Spanish bodies, NICE rejected a high proportion of the drugs (50% versus 26%). GENESIS, with a median of 8 months, made decisions more quickly than NICE (13.5 months) and GFTHA (17 months). The slowest organisation was CAMDHA (24.5 months). More drugs are assessed in Spain than by NICE because there are more organisations in Spain doing this work and their processes are simpler. NICE rejects more drugs as it uses cost-effectiveness thresholds that lead to a 'not-recommended' decision, and Spanish bodies recommend cancer drugs for subgroups of patients where better results can be obtained. Timelines are better for Spanish Committees, probably because of the greater number of steps in the appraisal process by NICE. Copyright © 2015 Elsevier Ltd. All rights reserved.

Competing risks model in screening for preeclampsia by maternal characteristics and medical history.

PubMed

Wright, David; Syngelaki, Argyro; Akolekar, Ranjit; Poon, Leona C; Nicolaides, Kypros H

2015-07-01

The purpose of this study was to develop a model for preeclampsia based on maternal demographic characteristics and medical history. This was a screening study of 120,492 singleton pregnancies at 11-13 weeks' gestation, including 2704 pregnancies (2.2%) that experienced preeclampsia. A survival-time model for the gestational age at delivery with preeclampsia was developed from variables of maternal characteristics and history. This approach assumes that, if the pregnancy was to continue indefinitely, all women would experience preeclampsia and that whether they do so or not before a specified gestational age depends on competition between delivery before or after development of preeclampsia. A 5-fold cross validation study was conducted to compare the performance of the new model with the National Institute for Health and Clinical Excellence (NICE) guidelines. In the new model, increased risk for preeclampsia, with a consequent shift in the Gaussian distribution of the gestational age at delivery with preeclampsia to the left, is provided by advancing maternal age, increasing weight, Afro-Caribbean and South Asian racial origin, medical history of chronic hypertension, diabetes mellitus and systemic lupus erythematosus or antiphospholipid syndrome, family history and personal history of preeclampsia, and conception by in vitro fertilization. The risk for preeclampsia decreases with increasing maternal height and in parous women with no previous preeclampsia; in the latter, the protective effect, which is related inversely to the interpregnancy interval, persists beyond 15 years. At a screen-positive rate of 11%, as defined by NICE, the new model predicted 40%, 48%, and 54% of cases of total preeclampsia and preeclampsia requiring delivery at <37 and <34 weeks' gestation, respectively, which were significantly higher than the respective values of 35%, 40%, and 44% achieved by application of NICE guidelines. A new model that is based on maternal characteristics and medical history has been developed for the estimation of patient-specific risks for preeclampsia. Such estimation of the a priori risk for preeclampsia is an essential first step in the use of Bayes theorem to combine maternal factors with biomarkers for the continuing development of more effective methods of screening for the disease. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinician-Reported Barriers to Implementing Breast Cancer Chemoprevention in the UK: A Qualitative Investigation.

PubMed

Smith, Samuel G; Side, Lucy; Meisel, Susanne F; Horne, Rob; Cuzick, Jack; Wardle, Jane

2016-01-01

The use of tamoxifen and raloxifene as preventive therapy for women at increased risk of breast cancer was approved by the National Institute for Health and Care Excellence (NICE) in 2013. We undertook a qualitative investigation to investigate the factors affecting the implementation of preventive therapy within the UK. We recruited general practitioners (GPs) (n = 10) and clinicians working in family history or clinical genetics settings (FHCG clinicians) (n = 15) to participate in semi-structured interviews. Data were coded thematically within the Consolidated Framework for Implementation Research. FHCG clinicians focussed on the perceived lack of benefit of preventive therapy and difficulties interpreting the NICE guidelines. FHCG clinicians felt poorly informed about preventive therapy, and this discouraged patient discussions on the topic. GPs were unfamiliar with the concept of preventive therapy, and were not aware that they may be asked to prescribe it for high-risk women. GPs were reluctant to initiate therapy because it is not licensed, but were willing to continue a prescription if it had been started in secondary or tertiary care. Barriers to implementing preventive therapy within routine clinical practice are common and could be addressed by engaging all stakeholders during the development of policy documents. © 2016 The Author(s) Published by S. Karger AG, Basel.

Impact of using a non-diabetes-specific risk calculator on eligibility for statin therapy in type 2 diabetes.

PubMed

Price, H C; Coleman, R L; Stevens, R J; Holman, R R

2009-03-01

The aim of this study was to investigate the impact of using a non-diabetes-specific cardiovascular disease (CVD) risk calculator to determine eligibility for statin therapy according to current UK National Institute for Health and Clinical Excellence (NICE) guidelines for those patients with type 2 diabetes who are at an increased risk of CVD (10 year risk >or=20%). The 10 year CVD risks were estimated using the UK Prospective Diabetes Study (UKPDS) Risk Engine and the Framingham equation for 4,025 patients enrolled in the Lipids in Diabetes Study who had established type 2 diabetes and LDL-cholesterol <4.1 mmol/l. The mean (SD) age of the patients was 60.7 (8.6) years, blood pressure 141/83 (17/10) mmHg and the total cholesterol:HDL-cholesterol ratio was 3.9 (1.0). The median (interquartile range) diabetes duration was 6 (3-11) years and the HbA(1c) level was 8.0% (7.2-9.0%). The cohort comprised 65% men, 91% whites, 4% Afro-Caribbeans, 5% Asian Indians and 15% current smokers. More patients were classified as being at high risk by the UKPDS Risk Engine (65%) than by the Framingham CVD equation (63%) (p < 0.0001). The Framingham CVD equation classified fewer men and people aged <50 years old as high risk (p < 0.0001). There was no difference between the UKPDS Risk Engine and Framingham classification of women at high risk (p = 0.834). These results suggest that the use of Framingham-derived rather than UKPDS Risk Engine-derived CVD risk estimates would deny about one in 25 patients statin therapy when applying current NICE guidelines. Thus, under these guidelines the choice of CVD risk calculator is important when assessing CVD risk in patients with type 2 diabetes, particularly for the identification of the relatively small proportion of younger people who require statin therapy.

Canadian Treatment Guidelines on Psychosocial Treatment of Schizophrenia in Children and Youth.

PubMed

Lecomte, Tania; Abidi, Sabina; Garcia-Ortega, Iliana; Mian, Irfan; Jackson, Kevin; Jackson, Kim; Norman, Ross

2017-09-01

A panel of experts, including researchers, clinicians and people with lived experience, was brought together to develop the new Canadian schizophrenia guidelines for the psychosocial treatment of children and youth with schizophrenia or psychotic disorders. The ADAPTE process, which relies on adapting existing high-quality guidelines, was used. Existing guidelines for children and youth (mostly from the National Institute for Health and Care Excellence [NICE]), as well as CPA adult guidelines, were reviewed and discussed in terms of their adaptability to the Canadian context and their level of recommendation for children and youth. New treatments were also considered when recent meta-analyses suggested their usefulness. The children and youth psychosocial guidelines include many cross-sectional recommendations in terms of clinical and interpersonal skills needed to work with this clientele, setting and collaboration issues and needed adaptations for specific subpopulations. In terms of specific treatments, the treatments most strongly recommended are family intervention and cognitive behavior therapy. Also recommended, although with different degrees of support, are supported employment/supported education programs, patient education, cognitive remediation, and social skills training. Novel and upcoming psychosocial treatments are also briefly discussed. These novel Canadian guidelines for the psychosocial treatment of children and youth with schizophrenia or psychotic disorders report evidence-based treatments as well as important considerations for providers who work with this clientele. More studies with children and youth with schizophrenia and psychotic disorders are warranted. If followed, these guidelines should facilitate the recovery of children and youth with schizophrenia or psychotic disorders as well as the recovery of their families.

Canadian Treatment Guidelines on Psychosocial Treatment of Schizophrenia in Children and Youth

PubMed Central

Abidi, Sabina; Garcia-Ortega, Iliana; Mian, Irfan; Jackson, Kevin; Jackson, Kim; Norman, Ross

2017-01-01

Objective: A panel of experts, including researchers, clinicians and people with lived experience, was brought together to develop the new Canadian schizophrenia guidelines for the psychosocial treatment of children and youth with schizophrenia or psychotic disorders. Method: The ADAPTE process, which relies on adapting existing high-quality guidelines, was used. Existing guidelines for children and youth (mostly from the National Institute for Health and Care Excellence [NICE]), as well as CPA adult guidelines, were reviewed and discussed in terms of their adaptability to the Canadian context and their level of recommendation for children and youth. New treatments were also considered when recent meta-analyses suggested their usefulness. Results: The children and youth psychosocial guidelines include many cross-sectional recommendations in terms of clinical and interpersonal skills needed to work with this clientele, setting and collaboration issues and needed adaptations for specific subpopulations. In terms of specific treatments, the treatments most strongly recommended are family intervention and cognitive behavior therapy. Also recommended, although with different degrees of support, are supported employment/supported education programs, patient education, cognitive remediation, and social skills training. Novel and upcoming psychosocial treatments are also briefly discussed. Conclusion: These novel Canadian guidelines for the psychosocial treatment of children and youth with schizophrenia or psychotic disorders report evidence-based treatments as well as important considerations for providers who work with this clientele. More studies with children and youth with schizophrenia and psychotic disorders are warranted. If followed, these guidelines should facilitate the recovery of children and youth with schizophrenia or psychotic disorders as well as the recovery of their families. PMID:28886670

Does Methodological Guidance Produce Consistency? A Review of Methodological Consistency in Breast Cancer Utility Value Measurement in NICE Single Technology Appraisals.

PubMed

Rose, Micah; Rice, Stephen; Craig, Dawn

2018-06-01

Since 2004, National Institute for Health and Care Excellence (NICE) methodological guidance for technology appraisals has emphasised a strong preference for using the validated EuroQol 5-Dimensions (EQ-5D) quality-of-life instrument, measuring patient health status from patients or carers, and using the general public's preference-based valuation of different health states when assessing health benefits in economic evaluations. The aim of this study was to review all NICE single technology appraisals (STAs) for breast cancer treatments to explore consistency in the use of utility scores in light of NICE methodological guidance. A review of all published breast cancer STAs was undertaken using all publicly available STA documents for each included assessment. Utility scores were assessed for consistency with NICE-preferred methods and original data sources. Furthermore, academic assessment group work undertaken during the STA process was examined to evaluate the emphasis of NICE-preferred quality-of-life measurement methods. Twelve breast cancer STAs were identified, and many STAs used evidence that did not follow NICE's preferred utility score measurement methods. Recent STA submissions show companies using EQ-5D and mapping. Academic assessment groups rarely emphasized NICE-preferred methods, and queries about preferred methods were rare. While there appears to be a trend in recent STA submissions towards following NICE methodological guidance, historically STA guidance in breast cancer has generally not used NICE's preferred methods. Future STAs in breast cancer and reviews of older guidance should ensure that utility measurement methods are consistent with the NICE reference case to help produce consistent, equitable decision making.

Can the NICE "end-of-life premium" be given a coherent ethical justification?

PubMed

Cookson, Richard

2013-12-01

In 2009 the UK National Institute for Health and Clinical Excellence (NICE) announced that its health technology appraisal committees would henceforth give special additional weight to health gains from life-extending end-of-life treatments. This was a response to mounting concern from NICE's stakeholders that effective new drugs for end-stage cancer often fail NICE's standard test of cost effectiveness. This change of policy may be justifiable on procedural grounds as the result of a democratic political process responding to stakeholder concerns. However, according to the "accountability for reasonableness" framework proposed by the philosopher Norman Daniels and endorsed by NICE, there also needs to be transparency about the substantive ethical grounds for public health care resource allocation decisions. In that spirit, I analyze eleven potentially relevant justifications for the NICE "end-of-life premium," drawn from the economics and philosophy literature: (1) rule of rescue, (2) fair chances, (3) ex post willingness to pay, (4) caring externality, (5) financial protection, (6) symbolic value, (7) diminishing marginal value of future life years, (8) concentration of benefits, (9) dread, (10) time to set your affairs in order, and (11) severity of illness. I conclude that none of them yields a coherent ethical justification for the NICE end-of-life premium.

A method for studying decision-making by guideline development groups.

PubMed

Gardner, Benjamin; Davidson, Rosemary; McAteer, John; Michie, Susan

2009-08-05

Multidisciplinary guideline development groups (GDGs) have considerable influence on UK healthcare policy and practice, but previous research suggests that research evidence is a variable influence on GDG recommendations. The Evidence into Recommendations (EiR) study has been set up to document social-psychological influences on GDG decision-making. In this paper we aim to evaluate the relevance of existing qualitative methodologies to the EiR study, and to develop a method best-suited to capturing influences on GDG decision-making. A research team comprised of three postdoctoral research fellows and a multidisciplinary steering group assessed the utility of extant qualitative methodologies for coding verbatim GDG meeting transcripts and semi-structured interviews with GDG members. A unique configuration of techniques was developed to permit data reduction and analysis. Our method incorporates techniques from thematic analysis, grounded theory analysis, content analysis, and framework analysis. Thematic analysis of individual interviews conducted with group members at the start and end of the GDG process defines discrete problem areas to guide data extraction from GDG meeting transcripts. Data excerpts are coded both inductively and deductively, using concepts taken from theories of decision-making, social influence and group processes. These codes inform a framework analysis to describe and explain incidents within GDG meetings. We illustrate the application of the method by discussing some preliminary findings of a study of a National Institute for Health and Clinical Excellence (NICE) acute physical health GDG. This method is currently being applied to study the meetings of three of NICE GDGs. These cover topics in acute physical health, mental health and public health, and comprise a total of 45 full-day meetings. The method offers potential for application to other health care and decision-making groups.

MICE or NICE? An economic evaluation of clinical decision rules in the diagnosis of heart failure in primary care.

PubMed

Monahan, Mark; Barton, Pelham; Taylor, Clare J; Roalfe, Andrea K; Hobbs, F D Richard; Cowie, Martin; Davis, Russell; Deeks, Jon; Mant, Jonathan; McCahon, Deborah; McDonagh, Theresa; Sutton, George; Tait, Lynda

2017-08-15

Detection and treatment of heart failure (HF) can improve quality of life and reduce premature mortality. However, symptoms such as breathlessness are common in primary care, have a variety of causes and not all patients require cardiac imaging. In systems where healthcare resources are limited, ensuring those patients who are likely to have HF undergo appropriate and timely investigation is vital. A decision tree was developed to assess the cost-effectiveness of using the MICE (Male, Infarction, Crepitations, Edema) decision rule compared to other diagnostic strategies to identify HF patients presenting to primary care. Data from REFER (REFer for EchocaRdiogram), a HF diagnostic accuracy study, was used to determine which patients received the correct diagnosis decision. The model adopted a UK National Health Service (NHS) perspective. The current recommended National Institute for Health and Care Excellence (NICE) guidelines for identifying patients with HF was the most cost-effective option with a cost of £4400 per quality adjusted life year (QALY) gained compared to a "do nothing" strategy. That is, patients presenting with symptoms suggestive of HF should be referred straight for echocardiography if they had a history of myocardial infarction or if their NT-proBNP level was ≥400pg/ml. The MICE rule was more expensive and less effective than the other comparators. Base-case results were robust to sensitivity analyses. This represents the first cost-utility analysis comparing HF diagnostic strategies for symptomatic patients. Current guidelines in England were the most cost-effective option for identifying patients for confirmatory HF diagnosis. The low number of HF with Reduced Ejection Fraction patients (12%) in the REFER patient population limited the benefits of early detection. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Missed opportunities for diabetes prevention: post-pregnancy follow-up of women with gestational diabetes mellitus in England

PubMed Central

Pierce, Mary; Modder, Jo; Mortagy, Iman; Springett, Anna; Hughes, Heather; Baldeweg, Stephanie

2011-01-01

Background Women with gestational diabetes mellitus (GDM) should be followed-up to exclude ongoing diabetes and for prevention of type 2 diabetes. The National Institute for Health and Clinical Excellence (NICE) diabetes in pregnancy guideline recommends checking fasting plasma glucose (FPG) at 6 weeks postpartum (short term), and annually thereafter (long term). Aim To examine the reported practice regarding GDM follow-up. Design and setting Nationwide postal survey in England 2008-2009. Method Questionnaires were distributed to a consultant diabetologist and obstetrician in all maternity units, and to a random sample of general practices (approximately 1 in 5). Results Response rates were: 60% (915/1532) GPs, 93% (342/368) specialists; 80% of GPs and 98% of specialists reported women with GDM had short-term follow-up. More GPs (55%) than specialists (13%) used a FPG test to exclude ongoing diabetes; 26% of GPs versus 89% of specialists thought the hospital was responsible for ordering the test. Twenty per cent of GPs had difficulty in discovering women had been diagnosed with GDM in secondary care. Seventy-three per cent of specialists recommended long-term follow-up; only 39% of GPs recalled women with GDM for this. A minority of GPs and specialists had joint follow-up protocols Conclusion Follow-up of GDM in England diverged from national guidance. Despite consensus that short-term follow-up occurred, primary and secondary care doctors disagreed about the tests and responsibility for follow-up. There was lack of long-term follow-up. Agreement about the NICE guideline, its promotion and effective implementation by primary and secondary care, and the systematic recall of women with GDM for long-term follow-up is required. PMID:22152832

Pelvic floor muscle training for urinary incontinence postpartum.

PubMed

Hall, Bethany; Woodward, Sue

The offering of pelvic floor muscle exercises to all women during their first pregnancy is recommended by National Institute for Health and Care Excellence (NICE) guidelines. Pelvic floor muscles suffer significant trauma throughout pregnancy and childbirth, which may sometimes lead to urinary incontinence postpartum. However, it is uncertain how effective pelvic floor muscle exercises are in treating this incontinence. Several trials have been analysed to try to understand this question. Issues such as when the exercises were undertaken, how often they were performed and in what circumstances they were carried out, have all been considered. While it is still uncertain whether they are effective in reducing urinary incontinence postpartum, as they are non-invasive and fairly simple to carry out, they are still the first-line management for urinary incontinence postpartum with other treatments being considered if this is ineffective.

Clinical guidelines in pediatric headache: evaluation of quality using the AGREE II instrument

PubMed Central

2014-01-01

Background The Appraisal of Guidelines for Research and Evaluation (AGREE II) tool is a validated questionnaire used to assess the methodological quality of clinical guidelines (CGs). We used the AGREE II tool to assess the development process, the methodological quality, and the quality of reporting of available pediatric CGs for the management of headache in children. We also studied the variability in responses related to the characteristics of eleven Italian neuropediatric centers, showing similarities and differences in the main recommendations reported in CGs. Methods A systematic literature search was conducted from January 2002 to June 2013 on Mediline, the Cochrane database, the National Guideline Clearinghouse website and the NHS evidence search tool, using the following terms: headache, cephalalgia, guidelines and children (MESH or text words). Six CGs providing information on the diagnosis and management of headache and specific recommendations for children were selected. Eleven neuropediatric centers assessed the overall quality and the appropriateness of all available CGs using of the AGREE II instrument. Results Six CGs meeting the inclusion and exclusion criteria were identified and assessed by 11 reviewers. Our study showed that the NICE CGs was “strongly recommended” while the French and Danish CGs were mainly “not recommended”. The comparison between the overall quality score of the French CGs and the NICE CGs was statistically significant (6.54 ± 0.69 vs 4.18 ± 1.08; p =0.001). The correlation analysis between quality domain score and guideline publication date showed a statistically significant association only for the “editorial independence” domain (r = 0.842 p = 0.035). The intra-class coefficients showed that the 11 reviewers had the highest agreement for the Lewis CGs (r = 0.857), and the lowest one for the NICE CGs (r = 0.656). Statistical analyses showed that professionals from outpatient services dedicated pediatric headache assigned a higher overall quality score to the NICE CGs as compared to professionals from non-outpatient services (6.86 ± 0.38 vs 6.0 ± 0.82; p = 0.038). Conclusions CGs resulted definitely of low-moderate quality and non “homogeneous”. Further major efforts are needed to update the existing CGs according to the principles of evidence based medicine. PMID:25178699

Improving access to psychological therapies (IAPT) and treatment outcomes: epistemological assumptions and controversies.

PubMed

Williams, C H J

2015-06-01

Cognitive behaviour therapy (CBT) is recommended as a primary treatment choice in England, for anxiety and depression, by the National Institute for Health and Care Excellence (NICE). It has been argued that CBT has enjoyed political and cultural dominance and this has arguably led to maintained government investment in England for the cognitive and behavioural treatment of mental health problems. The government programme 'Improving Access to Psychological Therapies' (IAPT) aims to improve the availability of CBT. The criticism of the NICE evidence-based guidelines supporting the IAPT programme, has been the dominance of the gold standard randomized controlled trial methodology, with a focus on numerical outcome data, rather than a focus on a recovery narrative. RCT-based research is influenced by a philosophical paradigm called positivism. The IAPT culture is arguably influenced by one research paradigm and such an influence can skew services only towards numerical outcome data as the only truth of 'recovery'. An interpretative paradigm could assist in shaping service-based cultures, alter how services are evaluated and improve the richness of CBT research. This paper explores the theory of knowledge (epistemology) that underpins the evidence-based perspective of CBT and how this influences service delivery. The paper argues that the inclusion of service user narrative (qualitative data) can assist the evaluation of CBT from the user's perspective and can understand the context in which people live and how they access services. A qualitative perspective is discussed as a research strategy, capturing the lived experience of under-represented groups, such as sexual, gender and ethnic minorities. Cognitive behaviour therapy (CBT) has enjoyed political and cultural dominance within mental healthcare, with renewed government investment in England for the'Improving Access to Psychological Therapies' (IAPT) programme. The criticism of the evidence-based guidelines, published by the National Institute for Health and Care Excellence (NICE), which supports the IAPT programme has been the dominance of the gold standard randomized controlled trial methodology. The definition of 'recovery' used by IAPT is based on a positivist position, with a focus on numerical outcome data garnered through psychometric measures. An interpretative perspective of recovery, which would include a subjective individual patient/service user narrative and would include a collaborative qualitative dialogue, is arguably absent from the IAPT programme. The challenge inherent in the IAPT programme is the high demand/high turnover culture, and psychometric measures are quick to administer; however, this culture is driven from one research paradigm. An interpretative paradigm may assist in shaping service-based cultures, alter how services are evaluated, and improve the richness of CBT research. © 2015 John Wiley & Sons Ltd.

UK service level audit of insulin pump therapy in paediatrics.

PubMed

Ghatak, A; Paul, P; Hawcutt, D B; White, H D; Furlong, N J; Saunders, S; Morrison, G; Langridge, P; Weston, P J

2015-12-01

To conduct an audit of insulin pump therapy in the UK after the issue of guidelines for the use of continuous subcutaneous insulin infusion by NICE in 2008 (Technology Appraisal 151). All centres in the UK, providing pump services to children and young people were invited to participate in an online audit. Audit metrics were aligned to NICE Technology Appraisal 151 and an electronic data collection tool was used. Of the 176 UK centres identified as providing pump services, 166 (94.3%) participated in the study. A total of 5094 children and young people were identified as using continuous subcutaneous insulin infusion (19% of all paediatric patients with Type 1 diabetes), with a median (range) of 16.9 (0.67-69.4)% per centre. Units had a median of 0.58 consultant sessions, 0.43 full-time equivalent diabetic specialist nurses, and 0.1 full-time equivalent dieticians delivering the pump service. The majority of this time was not formally funded. Families could access 24-h clinical and technical support (83% units), although the delivery varied between consultant, diabetic specialist nurse and company representatives. Only 53% of units ran, or accessed, structured education programmes for continuous subcutaneous insulin infusion use. Most units (86%) allowed continuous subcutaneous insulin infusion use for paediatric inpatients, but only 56% had written guidelines for this scenario. Nine percent of units had encountered funding refusal for a patient fulfilling NICE (Technology Appraisal 151) criteria. The number of children and young people on continuous subcutaneous insulin infusion therapy is consistent with numbers estimated by NICE. There is a worrying lack of funded healthcare professional time. The audit also identified gaps in the provision of structured education and absence of written inpatient guidelines. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

An overview of NICE guidance: acute kidney injury.

PubMed

Ellis, Peter; Jenkins, Karen

Acute Kidney Injury (AKI) as a financial, resource and human burden on both the NHS and people with AKI. Clearly if AKI is the cause of much morbidity and mortality and significant amounts of it can be prevented and/or detected earlier, this could only be a good thing. In part, the problem with AKI is that it has historically been regarded as little more than a sequal to other more pressing physical illnesses and therefore not taken as seriously as it might. The 2013 guidance from NICE-clinical guideline 169-and the accompanying pathway, seek to address this with an emphasis on assessment and prevention, identification of disease, management and subsequent chronic disease management ( NICE, 2013a ).

A naturalistic study of changes in pharmacological prescription for borderline personality disorder in clinical practice: from APA to NICE guidelines.

PubMed

Pascual, Juan C; Martín-Blanco, Ana; Soler, Joaquim; Ferrer, Alicia; Tiana, Thais; Alvarez, Enrique; Pérez, Víctor

2010-11-01

Although no psychotropic agents are specifically licensed for the management of borderline personality disorder (BPD), pharmacological treatment appears to be common. This study aimed to examine the drug prescriptions for patients with BPD in clinical practice, analyze the prescription patterns from the appearance of the American Psychiatric Association guidelines in 2001 until the National Institute for Health and Clinical Excellence guidelines in 2009, and identify the factors associated with such prescription of each type of drug. Naturalistic study on 226 consecutive BPD patients admitted to an outpatient BPD program. Socio-demographic, clinical and pharmacological treatment information was collected; factors associated with drug prescription were examined using logistic regression analyses for dichotomous outcomes measures. Changes in prescription patterns over time were also evaluated. Patients received an average of 2.7 drugs; only 6% were drug-free; 56% were taking ≥3 drugs and 30% ≥4 drugs. Over the past 8 years, prescription of antidepressants has remained stable; there has been a significant reduction in prescription of benzodiazepines and an increase in the use of mood stabilizers and atypical antipsychotics. Comorbidity with Axis I disorders was the main factor associated with drug prescription. Drug prescription and polypharmacy are common in the management of BPD in clinical practice.

The impact of glaucoma referral refinement criteria on referral to, and first-visit discharge rates from, the hospital eye service: the Health Innovation & Education Cluster (HIEC) Glaucoma Pathways project.

PubMed

Ratnarajan, Gokulan; Newsom, Wendy; French, Karen; Kean, Jane; Chang, Lydia; Parker, Mike; Garway-Heath, David F; Bourne, Rupert R A

2013-03-01

To assess the impact of referral refinement criteria on the number of patients referred to, and first-visit discharges from, the Hospital Eye Service (HES) in relation to the National Institute for Health & Clinical Excellence (NICE) Glaucoma Guidelines, Joint College Group Guidance (JCG) and the NICE commissioning guidance. All low-risk (one risk factor: suspicious optic disc, abnormal visual field (VF), raised intra-ocular pressure (IOP) (22-28 mmHg) or IOP asymmetry (>5 mmHg) and high-risk (more than one risk factor, shallow anterior chamber or IOP >28 mmHg) referrals to the HES from 2006 to 2011 were analysed. Low-risk referrals were seen by Optometrists with a specialist interest in glaucoma and high-risk referrals were referred directly to the HES. Two thousand nine hundred and twelve patient records were analysed. The highest Consultant first-visit discharge rates were for referrals based on IOP alone (45% for IOP 22-28 mmHg) and IOP asymmetry (53%), VF defect alone (46%) and for abnormal IOP and VF (54%). The lowest first-visit discharge rates were for referrals for suspicious optic disc (19%) and IOP >28 mmHg (22%). 73% of patients aged 65-80 and 60% of patients aged >80 who were referred by the OSI due to an IOP between 22-28 mmHg would have satisfied the JCG criteria for non-referral. For patients referred with an IOP >28 mmHg and an otherwise normal examination, adherence to the NICE commissioning guidance would have resulted in 6% fewer referrals. In 2010 this scheme reduced the number of patients attending the HES by 15%, which resulted in a saving of £16 258 (13%). The results support that referrals for a raised IOP alone or in combination with an abnormal VF be classified as low-risk and undergo referral refinement. Adherence to the JCG and the NICE commissioning guidance as onward referral criteria for specialist optometrists in this referral refinement scheme would result in fewer referrals. Ophthalmic & Physiological Optics © 2013 The College of Optometrists.

The management of Convulsive Refractory Status Epilepticus in adults in the UK: No consistency in practice and little access to continuous EEG monitoring.

PubMed

Patel, Mitesh; Bagary, Manny; McCorry, Dougall

2015-01-01

Convulsive Status Epilepticus (CSE) is a common neurological emergency with patients presenting with prolonged epileptic activity. Sub-optimal management is coupled with high morbidity and mortality. Continuous electroencephalogram (EEG) monitoring is considered essential by the National Institute for Health and Care Excellence (NICE) in the management of Convulsive Refractory Status Epilepticus (CRSE). The aim of this research was to determine current clinical practice in the management of CRSE amongst adults in intensive care units (ICU) in the UK and establish if the use of a standardised protocol requires re-enforcement within trusts. 75 randomly selected UK NHS Trusts were contacted and asked to complete a questionnaire in addition to providing their protocol for CRSE management in ICU. 55 (73%) trusts responded. While 31 (56% of responders) had a protocol available in ICU for early stages of CSE, just 21 (38%) trusts had specific guidelines if CRSE occurred. Only 23 (42%) trusts involved neurologists at any stage of management and just 18 (33%) have access to continuous EEG monitoring. This study identifies significant inconsistency in the management of CSE in ICU's across the UK. A minority of ICU units have a protocol for CRSE or access to continuous EEG monitoring despite it being considered fundamental for management and supported by NICE guidance. Copyright © 2014 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

The social and cultural construction of psychiatric knowledge: an analysis of NICE guidelines on depression and ADHD

PubMed Central

Moncrieff, Joanna; Timimi, Sami

2013-01-01

The current paper presents an analysis of the NICE guidelines on depression and attention deficit hyperactivity disorder (ADHD) from the perspective of the philosophy of science, guided particularly by Foucault's notion of the symbiosis of knowledge and power. It examines how data that challenged the orthodox position on the validity and drug treatment of these conditions was managed in the process of guideline development. The depression guideline briefly considered the complexity and heterogeneity of depression, and numerous methodological problems with evaluating treatments, including antidepressants. However, the guideline recommendations made no reference to these issues and ignored evidence that questioned the analysis of antidepressant trials. The guideline on ADHD reviewed validity, but did not consider evidence from the critical literature, and overlooked inconsistencies in the data. The guideline identified that drug trials have shown no long-term benefit in ADHD, but still recommended treatment with stimulant drugs for children with severe symptoms and for all adults claiming consensus for this position. Both guidelines demonstrate how contradictory data are managed so as not to jeopardise the currently predominant view that ADHD and depression are valid and un-contentious medical conditions that should be treated with drugs. The subjective nature of guideline formation that is revealed illustrates Foucault's suggestion that the authority of medicine operates to promote a technological view of the nature of certain human problems, which in turn strengthens medical hegemony over these areas. PMID:23496174

[The German program for disease management guidelines: type 2 diabetes--diabetic retinopathy/maculopathy guideline 2006. Short review].

PubMed

Ollenschläger, Günter; Kopp, Ina; Thole, Henning; Lelgemann, Monika

2007-02-15

In Germany, the first national consensus between six medical scientific associations on evidence-based recommendations for prevention and therapy of retinopathy/maculopathy in type 2 diabetes was reached in fall 2006. The recommendations' main sources are the NICE Retinopathy Guideline 2002, and existing German guidelines and reviews of recent scientific evidence. The article gives an overview on authors, sources, and key recommendations of the German National Disease Management Guideline Type 2 Diabetes-Retinopathy/Maculopathy 2006 (www.diabetes.versorgungsleitlinien.de).

Cardiovascular risk assessment in rheumatoid arthritis – controversies and the new approach

PubMed Central

Głuszko, Piotr

2016-01-01

The current methods of cardiovascular (CV) risk assessment in the course of inflammatory connective tissue diseases are a subject of considerable controversy. Comparing different methods of CV risk assessment in current rheumatoid arthritis (RA) guidelines, only a few of them recommend the use of formal risk calculators. These are the EULAR guidelines suggesting the use of SCORE and the British Society for Rheumatology guidelines performed in collaboration with NICE preferring the use of QRISK-2. Analyzing the latest American and British reports, two main concepts could be identified. The first one is to focus on risk calculators developed for the general population taking into account RA, and the calculator that might fulfill this role is the new QRISK-2 presented by NICE in 2014. The second concept is to create RA-specific risk calculators, such as the Expanded Cardiovascular Risk Prediction Score for RA. In this review we also discuss the efficiency of a new Pooled Cohort Equation and other calculators in the general and RA population. PMID:27504023

Assessment and management of alcohol dependence and withdrawal in the acute hospital: concise guidance.

PubMed

Stewart, Stephen; Swain, Sharon

2012-06-01

Alcohol dependence is common among patients attending acute hospitals. It can be the major reason for attendance or a significant cofactor. Assessment of these patients in the acute setting can be challenging owing to the multidisciplinary approach required. Doctors in acute hospitals are often inexperienced in managing dependence, a mental health problem. They might focus on the physical harms or the withdrawal, a consequence of the dependence. For this reason, assessment of dependence and prevention and management of acute alcohol withdrawal are often suboptimal. There is little existing guidance on how to manage this patient population, especially in non-specialist settings. With recently published National Institute for Health and Clinical Excellence (NICE) guidance on the management of dependence and withdrawal, now is the perfect time to produce concise guidelines in the hope that a more succinct suite of guidance can reach a larger audience.

Screening contacts of patients with extrapulmonary TB for latent TB infection.

PubMed

Humphreys, Anna; Abbara, Aula; Williams, Sion; John, Laurence; Corrah, Tumena; McGregor, Alastair; Davidson, Robert N

2018-03-01

2016 TB National Institute for Health and Care Excellence (NICE) guidelines imply that contacts of extrapulmonary TB do not require screening for latent TB infection. At our high TB prevalence site, we identified 189 active cases of TB for whom there were 698 close contacts. 29.1% of the contacts of pulmonary TB and 10.7% of the contacts of extrapulmonary TB had active or latent TB infection. This supports screening contacts of extrapulmonary TB at our site and presents a way to access high-risk individuals. We propose to continue to screen the contacts of our patients with extrapulmonary TB and recommend other TB units audit their local results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Falls screening and assessment tools used in acute mental health settings: a review of policies in England and Wales

PubMed Central

Narayanan, V.; Dickinson, A.; Victor, C.; Griffiths, C.; Humphrey, D.

2016-01-01

Objectives There is an urgent need to improve the care of older people at risk of falls or who experience falls in mental health settings. The aims of this study were to evaluate the individual falls risk assessment tools adopted by National Health Service (NHS) mental health trusts in England and healthcare boards in Wales, to evaluate the comprehensiveness of these tools and to review their predictive validity. Methods All NHS mental health trusts in England (n = 56) and healthcare boards in Wales (n = 6) were invited to supply their falls policies and other relevant documentation (e.g. local falls audits). In order to check the comprehensiveness of tools listed in policy documents, the risk variables of the tools adopted by the mental health trusts’ policies were compared with the 2004 National Institute for Health and Care Excellence (NICE) falls prevention guidelines. A comprehensive analytical literature review was undertaken to evaluate the predictive validity of the tools used in these settings. Results Falls policies were obtained from 46 mental health trusts. Thirty-five policies met the study inclusion criteria and were included in the analysis. The main falls assessment tools used were the St. Thomas’ Risk Assessment Tool in Falling Elderly Inpatients (STRATIFY), Falls Risk Assessment Scale for the Elderly, Morse Falls Scale (MFS) and Falls Risk Assessment Tool (FRAT). On detailed examination, a number of different versions of the FRAT were evident; validated tools had inconsistent predictive validity and none of them had been validated in mental health settings. Conclusions Falls risk assessment is the most commonly used component of risk prevention strategies, but most policies included unvalidated tools and even well validated tool such as the STRATIFY and the MFS that are reported to have inconsistent predictive accuracy. This raises questions about operational usefulness, as none of these tools have been tested in acute mental health settings. The falls risk assessment tools from only four mental health trusts met all the recommendations of the NICE falls guidelines on multifactorial assessment for prevention of falls. The recent NICE (2013) guidance states that tools predicting risk using numeric scales should no longer be used; however, multifactorial risk assessment and interventions tailored to patient needs is recommended. Trusts will need to update their policies in response to this guidance. PMID:26395210

Grouping diabetes checks could confuse score and reward process.

PubMed

Kleebauer, Alistair

2014-08-19

Diabetes nurses have questioned whether GP practices will have the staff capacity to carry out eight health checks on diabetes patients recommended by the National Institute for Care and Health Excellence (NICE).

Evidence based guidelines and current practice for physiotherapy management of knee osteoarthritis.

PubMed

Walsh, Nicola E; Hurley, Michael V

2009-03-01

To document physiotherapy provision for patients with knee osteoarthritis (OA) in relation to the United Kingdom (UK) recently published National Institute of health and Clinical Excellence (NICE) guidelines for osteoarthritis. Questionnaire survey of chartered physiotherapists. 300 postal questionnaires were distributed to Physiotherapy Departments requesting information regarding source of referrals, treatment aims, preferred methods of treatment and service delivery. Responses were received from 83 physiotherapists (28 %), predominantly working in the UK National Health Service. Approximately equal numbers of referrals came from primary and secondary care. Aims of physiotherapy management were to; encourage self-management; increase strength and range of movement; reduce pain; and improve function. To achieve these, exercise was utilised by 100% of practitioners, often supplemented with electrotherapeutic modalities (66%), manual therapy (64%) and acupuncture (60%). The majority of patients received individual treatment for a total contact time of 1-2 hours, whilst most group interventions lasted 5-6 hours. Approximately half (54%) of respondents reported using outcome measures to determine treatment efficacy. Although knee OA is usually managed in primary care, the similar number of referrals from primary and secondary care may suggest a deviation from evidence-based management guidelines. The guidelines' recommendations of exercise, patient education and self-management are observed by physiotherapists, but other modalities are often used despite poor or no research evidence supporting their efficacy. Whether any of these interventions are clinically beneficial is speculative as treatment outcomes were frequently under-evaluated.

Updated recommendations: an assessment of NICE clinical guidelines

PubMed Central

2014-01-01

Background Updating is important to ensure clinical guideline (CG) recommendations remain valid. However, little research has been undertaken in this field. We assessed CGs produced by the National Institute for Health and Care Excellence (NICE) to identify and describe updated recommendations and to investigate potential factors associated with updating. Also, we evaluated the reporting and presentation of recommendation changes. Methods We performed a descriptive analysis of original and updated CGs and recommendations, and an assessment of presentation formats and methods for recording information. We conducted a case-control study, defining cases as original recommendations that were updated (‘new-replaced’ recommendations), and controls as original recommendations that were considered to remain valid (‘not changed’ recommendations). We performed a comparison of main characteristics between cases and controls, and we planned a multiple regression analysis to identify potential predictive factors for updating. Results We included nine updated CGs (1,306 recommendations) and their corresponding original versions (1,106 recommendations). Updated CGs included 812 (62%) recommendations ‘not reviewed’, 368 (28.1%) ‘new’ recommendations, 104 (7.9%) ‘amended’ recommendations, and 25 (1.9%) recommendations reviewed but unchanged. The presentation formats used to indicate the changes in recommendations varied widely across CGs. Changes in ‘amended’, ‘deleted’, and ‘new-replaced’ recommendations (n = 296) were reported infrequently, mostly in appendices. These changes were recorded in 167 (56.4%) recommendations; and were explained in 81 (27.4%) recommendations. We retrieved a total of 7.1% (n = 78) case recommendations (‘new-replaced’) and 2.4% (n = 27) control recommendations (‘not changed’) in original CGs. The updates were mainly from ‘Fertility CG’, about ‘gynaecology, pregnancy and birth’ topic, and ‘treatment’ or ‘prevention’ purposes. We did not perform the multiple regression analysis as originally planned due to the small sample of recommendations retrieved. Conclusion Our study is the first to describe and assess updated CGs and recommendations from a national guideline program. Our results highlight the pressing need to standardise the reporting and presentation of updated recommendations and the research gap about the optimal way to present updates to guideline users. Furthermore, there is a need to investigate updating predictive factors. PMID:24919856

A regional audit of the use of COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) in rheumatology clinics in the West Midlands, in relation to NICE guidelines.

PubMed

Price-Forbes, A N; Callaghan, R; Allen, M E; Rowe, I F

2005-07-01

Whilst all non-steroidal anti-inflammatory drugs (NSAIDs) can cause adverse gastrointestinal events, COX-2-selective inhibitors (COX-2) may have improved gastrointestinal safety compared with non-selective NSAIDs (NSNSAIDs). In 2001, the National Institute for Clinical Excellence (NICE) published guidance on the use of the COX-2 agents celecoxib, rofecoxib, meloxicam and etodolac for rheumatoid arthritis (RA) and osteoarthritis (OA). This study aimed to audit the appropriateness of NSAID use in relation to NICE guidance in rheumatology out-patients. Questionnaires were completed for all patients attending clinics in 18 rheumatology units in the West Midlands over a 2-week period. Data collected included patient demographics, NSAID type, indications, duration of use (> or =3 months was considered prolonged), and concomitant prescription of corticosteroids, warfarin and gastroprotective agents. Data were collected on 2846 patients; 1164 (41%) were taking NSAIDs (791 NSNSAIDs, 373 COX-2). Of the 1164 NSAID users, 753 (65%) had a diagnosis of RA or OA (483 NSNSAIDs, 270 COX-2). Overall, 37% of NSAID prescriptions were appropriate. Of the NSNSAID users, 92% had at least one risk factor for adverse gastrointestinal events and were therefore inappropriately treated. Prolonged use (in 89%) and age > or =65 yr (in 23%) were the most frequent risk factors identified. Of the COX-2 users, 97% had one or more risk factors and were appropriately treated. Analysis of the RA/OA subgroup revealed similar findings. Thirty-six per cent were taking NSAIDs appropriately; 97% of NSNSAID use was inappropriate and 97% of COX-2 use was appropriate treatment. In the whole cohort, gastroprotective agents were used in 26% of NSNSAID users, 56% of gastroprotective agents being proton pump inhibitors. Ninety-two per cent of patients attending rheumatology clinics who were taking NSNSAIDs should have been prescribed a COX-2-selective agent in relation to NICE guidance. Duration of use and age > or =65 yr emerged numerically as the most important risk factors. Significant numbers of patients taking NSNSAIDs may be at risk from adverse gastrointestinal events and clinicians may wish to review their prescribing patterns. Conversely, 97% of patients taking COX-2 agents were treated appropriately. Although practice overall conformed poorly with NICE guidance, NSAID prescribing also needs to be considered in the context of recent concerns regarding the cardiovascular risks of COX-2 agents.

Implementing UK Autism Policy & National Institute for Health and Care Excellence Guidance--Assessing the Impact of Autism Training for Frontline Staff in Community Learning Disabilities Teams

ERIC Educational Resources Information Center

Clark, Alex; Browne, Sarah; Boardman, Liz; Hewitt, Lealah; Light, Sophie

2016-01-01

UK National Autism Strategy (Department of Health, 2010 and National Institute for Health and Care Excellence guidance (NICE, 2012) states that frontline staff should have a good understanding of Autism. Fifty-six clinical and administrative staff from a multidisciplinary community Learning Disability service completed an electronic questionnaire…

Examining the implementation of NICE guidance: cross-sectional survey of the use of NICE interventional procedures guidance by NHS Trusts.

PubMed

Lowson, Karin; Jenks, Michelle; Filby, Alexandra; Carr, Louise; Campbell, Bruce; Powell, John

2015-06-30

In the UK, NHS hospitals receive large amounts of evidence-based recommendations for care delivery from the National Institute for Health and Care Excellence (NICE) and other organisations. Little is known about how NHS organisations implement such guidance and best practice for doing so. This study was therefore designed to examine the dissemination, decision-making, and monitoring processes for NICE interventional procedures (IP) guidance and to investigate the barriers and enablers to the implementation of such guidance. A cross-sectional survey questionnaire was developed and distributed to individuals responsible for managing the processes around NICE guidance in all 181 acute NHS hospitals in England, Scotland, Wales and Northern Ireland. A review of acute NHS hospital policies for implementing NICE guidance was also undertaken using information available in the public domain and from organisations' websites. The response rate to the survey was 75 % with 135 completed surveys received. Additionally, policies from 25 % of acute NHS hospitals were identified and analysed. NHS acute hospitals typically had detailed processes in place to implement NICE guidance, although organisations recognised barriers to implementation including organisational process barriers, clinical engagement and poor targeting with a large number of guidance issued. Examples of enablers to, and good practice for, implementation of guidance were found, most notably the value of shared learning experiences between NHS hospitals. Implications for NICE were also identified. These included making improvements to the layout of guidance, signposting on the website and making better use of their shared learning platform. Most organisations have robust processes in place to deal with implementing guidance. However, resource limitations and the scope of guidance received by organisations create barriers relating to organisational processes, clinician engagement and financing of new procedures. Guidance implementation can be facilitated through encouragement of shared learning by organisations such as NICE and open knowledge transfer between organisations.

A cost-effectiveness analysis of celecoxib compared with diclofenac in the treatment of pain in osteoarthritis (OA) within the Swedish health system using an adaptation of the NICE OA model.

PubMed

Brereton, Nicholas; Pennington, Becky; Ekelund, Mats; Akehurst, Ronald

2014-09-01

Celecoxib for the treatment of pain resulting from osteoarthritis (OA) was reviewed by the Tandvårds- och läkemedelsförmånsverket-Dental and Pharmaceutical Benefits Board (TLV) in Sweden in late 2010. This study aimed to evaluate the incremental cost-effectiveness ratio (ICER) of celecoxib plus a proton pump inhibitor (PPI) compared to diclofenac plus a PPI in a Swedish setting. The National Institute for Health and Care Excellence (NICE) in the UK developed a health economic model as part of their 2008 assessment of treatments for OA. In this analysis, the model was reconstructed and adapted to a Swedish perspective. Drug costs were updated using the TLV database. Adverse event costs were calculated using the regional price list of Southern Sweden and the standard treatment guidelines from the county council of Stockholm. Costs for treating cardiovascular (CV) events were taken from the Swedish DRG codes and the literature. Over a patient's lifetime treatment with celecoxib plus a PPI was associated with a quality-adjusted life year (QALY) gain of 0.006 per patient when compared to diclofenac plus a PPI. There was an increase in discounted costs of 529 kr per patient, which resulted in an incremental cost-effectiveness ratio (ICER) of 82,313 kr ($12,141). Sensitivity analysis showed that treatment was more cost effective in patients with an increased risk of bleeding or gastrointestinal (GI) complications. The results suggest that celecoxib plus a PPI is a cost effective treatment for OA when compared to diclofenac plus a PPI. Treatment is shown to be more cost effective in Sweden for patients with a high risk of bleeding or GI complications. It was in this population that the TLV gave a positive recommendation. There are known limitations on efficacy in the original NICE model.

The role of GLP-1 mimetics and basal insulin analogues in type 2 diabetes mellitus: guidance from studies of liraglutide.

PubMed

Barnett, A H

2012-04-01

In people with type 2 diabetes mellitus (T2DM), the incretin effect is reduced, but the recent advent of dipeptidyl peptidase-4 inhibitors and glucagon-like peptide (GLP)-1 agonists/analogues has enabled restoration of at least some of the function of the incretin system, with accompanying improvements in glycaemic control. Two GLP-1 receptor agonists/analogues are currently approved for the treatment of T2DM-exenatide (Byetta®, Eli Lilly & Co., Indianapolis, IN, US) and liraglutide (Victoza®, Novo Nordisk, Bagsvaerd, Denmark); a once-weekly formulation of exenatide (Bydureon®, Eli Lilly & Co.) has also been approved by the European Medicines Agency. The National Institute for Health and Clinical Excellence (NICE) has recently published guidance on the use of liraglutide in T2DM, based on evidence from the Liraglutide Effect and Action in Diabetes (LEAD) Phase III trial programme, which compared liraglutide with existing glucose-lowering therapies, such as exenatide and insulin glargine. The LEAD programme reported HbA1c reductions from 0.8 to 1.5% with liraglutide (1.2 and 1.8 mg), accompanied by low rates of hypoglycaemia and some weight loss; side effects were primarily gastrointestinal in nature (e.g. nausea and diarrhoea). Based on the findings of the LEAD studies and the NICE recommendation, liraglutide now represents an important therapy widely available in the UK for certain patient groups, including those with a body mass index (BMI) ≥35.0 kg/m(2) , and patients with a BMI <35 kg/m(2) who are considered unsuitable for insulin and are failing to meet targets for glycaemic control with oral agents. NICE guidelines still suggest that most patients without considerable obesity (BMI <35 kg/m(2) ) are probably best managed using insulin therapy. Evidence also suggests a future role for GLP-1 mimetics in combination with basal insulin. © 2011 Blackwell Publishing Ltd.

The role of GLP-1 mimetics and basal insulin analogues in type 2 diabetes mellitus: guidance from studies of liraglutide

PubMed Central

Barnett, A H

2012-01-01

In people with type 2 diabetes mellitus (T2DM), the incretin effect is reduced, but the recent advent of dipeptidyl peptidase-4 inhibitors and glucagon-like peptide (GLP)-1 agonists/analogues has enabled restoration of at least some of the function of the incretin system, with accompanying improvements in glycaemic control. Two GLP-1 receptor agonists/analogues are currently approved for the treatment of T2DM—exenatide (Byetta®, Eli Lilly & Co., Indianapolis, IN, US) and liraglutide (Victoza®, Novo Nordisk, Bagsvaerd, Denmark); a once-weekly formulation of exenatide (Bydureon®, Eli Lilly & Co.) has also been approved by the European Medicines Agency. The National Institute for Health and Clinical Excellence (NICE) has recently published guidance on the use of liraglutide in T2DM, based on evidence from the Liraglutide Effect and Action in Diabetes (LEAD) Phase III trial programme, which compared liraglutide with existing glucose-lowering therapies, such as exenatide and insulin glargine. The LEAD programme reported HbA1c reductions from 0.8 to 1.5% with liraglutide (1.2 and 1.8 mg), accompanied by low rates of hypoglycaemia and some weight loss; side effects were primarily gastrointestinal in nature (e.g. nausea and diarrhoea). Based on the findings of the LEAD studies and the NICE recommendation, liraglutide now represents an important therapy widely available in the UK for certain patient groups, including those with a body mass index (BMI) ≥35.0 kg/m2, and patients with a BMI <35 kg/m2 who are considered unsuitable for insulin and are failing to meet targets for glycaemic control with oral agents. NICE guidelines still suggest that most patients without considerable obesity (BMI <35 kg/m2) are probably best managed using insulin therapy. Evidence also suggests a future role for GLP-1 mimetics in combination with basal insulin. PMID:22051096

The Management of Patients with Depression In Primary Care: an Audit Review.

PubMed

Henfrey, Helen

2015-09-01

The IAPT scheme was introduced in 2007 to implement the recommendations from NICE guidelines regarding psychological therapy for depression. This retrospective audit carried out across two General Practice Surgeries evaluates the care being given in relation to the standards of NICE guidelines. Initial audit found variable concordance, however after discussion of this at a local audit meeting and the displaying of posters and leaflets detailing the IAPT scheme this was improved on re-audit. Training should be provided to General Practitioners regarding the standards of care for patients with low mood or depression. In this training there should be an emphasis on the role of psychological therapy and details given of local resources. Posters and leaflets should be clearly displayed to allow patients to self-refer to IAPT. A close watch must be given to waiting times for the IAPT service as demands increase.

An audit of ECT in England 2011-2015: Usage, demographics, and adherence to guidelines and legislation.

PubMed

Read, John; Harrop, Christopher; Geekie, Jim; Renton, Julia

2017-10-20

Electroconvulsive therapy (ECT) continues to be used in England, but without comprehensive national auditing. Therefore, information was gathered on usage, demographics, consent, and adherence to the guidelines of the National Institute of Clinical Excellence (N.I.C.E.) and to the Mental Health Act. Freedom of Information Act requests were sent to 56 National Health Service Trusts. Thirty-two trusts provided some usable data. Only 10 were able to report how many people received psychological therapy prior to ECT in accordance with N.I.C.E. recommendations, with figures ranging from 0% to 100%. The number of people currently receiving ECT in England annually is between 2,100 and 2,700, and falling. There was a 12-fold difference between the Trusts with the highest and lowest usage rates per capita. Most recipients are still women (66%) and over 60 (56%). More than a third (39%) is given without consent, with 30% of Trusts not adhering to mental health legislation concerning second opinions. At least 44% were not using validated measures of efficacy, and at least 33% failed to do so for adverse effects. Only four provided any actual data for positive outcomes or adverse effects. None provided any data on efficacy beyond the end of treatment. National audits should be reinstated. Independent, objective monitoring of adverse effects is urgently required. An investigation into why ECT is still administered excessively to older people and women seems long overdue. Mental health staff should seek to ensure that all depressed people in their service are offered evidence-based psychological treatments before being offered E.C.T. Staff should lobby managers to ensure proper auditing of E.C.T. within their service Individuals receiving ECT should be closely monitored for adverse cognitive effects Overuse of ECT with women and older people should be avoided. © 2017 The British Psychological Society.

The role of health economics in the evaluation of surgery and operative technologies.

PubMed

Taylor, Matthew

2017-02-01

Dr Matthew Taylor is the director of York Health Economics Consortium and leads the Consortium's health technology assessment program. The work of York Health Economics Consortium involves empirical research in health economics for both the private and public sectors. Dr Taylor is the scientific lead for the National Institute for Health and Care Excellence (NICE) Economic and Methodological Unit and a former member of NICE's Public Health Advisory Committee. He is also managing director (Europe) of Minerva, an international network of health economics consultancies. Copyright © 2016 Elsevier Inc. All rights reserved.

Review of the role of NICE in promoting the adoption of innovative cardiac technologies.

PubMed

Groves, Peter H; Pomfrett, Chris; Marlow, Mirella

2018-05-17

The National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP) promotes the adoption of innovative diagnostic and therapeutic technologies into National Health Service (NHS) clinical practice through the publication of guidance and briefing documents. Since the inception of the programme in 2009, there have been 7 medical technologiesguidance, 3 diagnostics guidance and 23 medtechinnovation briefing documents published that are relevant to the heart and circulation. Medical technologies guidance is published by NICE for selected single technologies if they offer plausible additional benefits to patients and the healthcare system. Diagnostic guidance is published for diagnostic technologies if they have the potential to improve health outcomes, but if their introduction may be associated with an increase in overall cost to the NHS. Medtechinnovation briefings provide evidence-based advice to those considering the implementation of new medical devices or diagnostic technologies. This review provides reference to all of the guidance and briefing medical technology documents that NICE has published that are relevant to the heart and circulation and reflect on their diverse recommendations. The interaction of MTEP with other NICE programmes is integral to its effectiveness and the means by which consistency is ensured across the different NICE programmes is described. The importance of the input of clinical experts from the cardiovascular professional community and the engagement by NICE with cardiovascular professional societies is highlighted as being fundamental to ensuring the quality of guidance outputs as well as to promoting their implementation and adoption. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

What are specialist mental health clinician attitudes to guideline recommendations for the treatment of depression in young people?

PubMed

Hetrick, Sarah E; Simmons, Magenta; Thompson, Andrew; Parker, Alexandra G

2011-11-01

We sought to examine potential barriers to the use of evidence-based guidelines for youth depression in a tertiary specialist mental health service, as part of an initiative to implement evidence based practice within the service. This was a qualitative study adopting a social constructionist perspective using focus groups. The focus groups, conducted with all clinicians (medical and allied health), were audiotaped, transcribed and thematic analysis was undertaken. Clinicians were asked about the barriers to implementing four key recommendations from the National Institute for Health and Clinical Excellence (NICE) guidelines. Barriers existed at (i) the individual clinician level; (ii) the clinical level in terms of the presentation of young people; and (iii) the service level. The key individual clinician level barrier was a stated belief that the guidelines were not relevant to the young people presenting to the service, with little evidence to guide practice. Related, the main barrier with regard to the clinical presentation was the severity and complexity of this presentation, often making the delivery of interventions like cognitive behavioural therapy (CBT) difficult. At the service level, a lack of integration with primary and secondary level care meant sequencing interventions according to guideline recommendations was difficult. There is a clear imperative to develop the evidence base to ensure that effective treatments for young people aged up to 25 years with severe and complex disorders that include comorbid conditions, suicide risk and psychosocial difficulties are investigated and disseminated. Furthermore, this work has highlighted the need for greater investment in models of care that ensure integration between existing primary and secondary care and enhanced specialist early intervention mental health services for young people.

The right to try.

PubMed

Pearce, Lynne

2015-01-20

Many clinical commissioning groups have ignored 2013 national guidelines requiring them to make IVF available. NICE has recently issued a quality standard to tackle this postcode lottery. Nurses can help by alerting local decision makers to the human and fi nancial cost of infertility.

Platelet-rich plasma (PRP) for knee disorders

PubMed Central

Shahid, Mohammad; Kundra, Rik

2017-01-01

Platelet-rich plasma (PRP) is an autologous blood product with platelet concentrations above baseline values. The process involves the extraction of blood from the patient which is then centrifuged to obtain a concentrated suspension of platelets by plasmapheresis. It then undergoes a two-stage centrifugation process to separate the solid and liquid components of the anticoagulated blood. PRP owes its therapeutic use to the growth factors released by the platelets which are claimed to possess multiple regenerative properties. In the knee, PRP has been used in patients with articular cartilage pathology, ligamentous and meniscal injuries. There is a growing body of evidence to support its use in selected indications and this review looks at the most recent evidence. We also look at the current UK National Institute of Health & Clinical Excellence (NICE) guidelines with respect to osteoarthritis and the use of PRP in the knee. Cite this article: EFORT Open Rev 2017;2:28–34. DOI: 10.1302/2058-5241.2.160004. PMID:28607768

Looking beyond satisfaction: evaluating the value and impact of information skills training.

PubMed

Raynor, Michael; Craven, Jenny

2015-03-01

In this feature guest writers Michael Raynor and Jenny Craven from the National Institute for Health and Care Excellence (NICE) present an overview of their evaluative research study on the value and impact of the information skills training courses they provide at NICE. In particular, this small study used a combination of qualitative and quantitative data to look beyond satisfaction and confidence levels and identify whether learning had actually taken place as a result of attending the sessions, and how new skills were used by the attendees in their day-to-day work. H.S. © 2015 Health Libraries Journal.

Quality assessment of a sample of mobile app-based health behavior change interventions using a tool based on the National Institute of Health and Care Excellence behavior change guidance.

PubMed

McMillan, Brian; Hickey, Eamonn; Patel, Mahendra G; Mitchell, Caroline

2016-03-01

To quality assess a sample of health behavior change apps from the NHS Apps Library using a rating tool based on the 2014 National Institute for Health and Care Excellence behavior change guidance (NICE BCG). A qualitative analysis of the NICE BCG identified themes and questions for a quality assessment of health behavior change apps. These were refined by further discussion and piloting, and applied by two independent raters to a sample of NHS Library apps (N=49). Disagreements were resolved following discussions with a third rater. Themes identified were; purpose, planning, usability, tailoring, behavior change technique (BCT), maintenance, evaluation, data security and documentation. Overall, purpose of the apps was clear, but evidence for collaboration with users or professionals was lacking. Usability information was poor and tailoring disappointing. Most used recognized BCTs but paid less attention to behavior maintenance than initiation. Information on app evaluation and documentation was sparse. This study furthers the work of the NHS Apps Library, adapting the NICE (2014) behavior change guidance for quality assessment of behavior change apps. This study helps lay the foundations for development of a quality assurance tool for mobile health apps aimed at health behavior change. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Substructure analysis using NICE/SPAR and applications of force to linear and nonlinear structures. [spacecraft masts

NASA Technical Reports Server (NTRS)

Razzaq, Zia; Prasad, Venkatesh; Darbhamulla, Siva Prasad; Bhati, Ravinder; Lin, Cai

1987-01-01

Parallel computing studies are presented for a variety of structural analysis problems. Included are the substructure planar analysis of rectangular panels with and without a hole, the static analysis of space mast, using NICE/SPAR and FORCE, and substructure analysis of plane rigid-jointed frames using FORCE. The computations are carried out on the Flex/32 MultiComputer using one to eighteen processors. The NICE/SPAR runstream samples are documented for the panel problem. For the substructure analysis of plane frames, a computer program is developed to demonstrate the effectiveness of a substructuring technique when FORCE is enforced. Ongoing research activities for an elasto-plastic stability analysis problem using FORCE, and stability analysis of the focus problem using NICE/SPAR are briefly summarized. Speedup curves for the panel, the mast, and the frame problems provide a basic understanding of the effectiveness of parallel computing procedures utilized or developed, within the domain of the parameters considered. Although the speedup curves obtained exhibit various levels of computational efficiency, they clearly demonstrate the excellent promise which parallel computing holds for the structural analysis problem. Source code is given for the elasto-plastic stability problem and the FORCE program.

Canadian Schizophrenia Guidelines: Schizophrenia and Other Psychotic Disorders with Coexisting Substance Use Disorders.

PubMed

Crockford, David; Addington, Donald

2017-09-01

Persons with schizophrenia and other psychotic disorders frequently have coexisting substance use disorders that require modifications to treatment approaches for best outcomes. The objectives of this review were to identify evidence-based practices best practices that improve outcomes for individuals with schizophrenia and substance used disorders. We reviewed guidelines that were published in the last 5 years and that included systematic reviews or meta-analyses. Most of our recommendations came from 2 publications from the National Institute for Health and Care Excellence (NICE): the 2011 guidance titled Coexisting Severe Mental Illness (Psychosis) and Substance Misuse: Assessment and Management in Healthcare Settings and the 2014 guidance titled Psychosis and Schizophrenia in Adults: Prevention and Management. We placed these recommendations into the Canadian context to create this guideline. Evidence supports the inclusion of individuals with coexisting substance use disorders in first-episode psychosis programs. The programs should integrate psychosis and substance use treatments, emphasizing ongoing monitoring of both substance use and patterns and symptoms. The best outcomes are achieved with combined use of antipsychotic medications and addiction-based psychosocial interventions. However, limited evidence is available to recommend using one antipsychotic medication over another or one psychosocial intervention over another for persons with schizophrenia and other psychotic disorders with coexisting substance use disorders. Treating persons who have schizophrenia and other psychotic disorders with coexisting substance use disorders can present clinical challenges, but modifications in practice can help engage and retain people in treatment, where significant improvements over time can be expected.

Resource Planning in Glaucoma: A Tool to Evaluate Glaucoma Service Capacity.

PubMed

Batra, Ruchika; Sharma, Hannah E; Elaraoud, Ibrahim; Mohamed, Shabbir

2017-12-28

The National Patient Safety Agency (2009) publication advising timely follow-up of patients with established glaucoma followed several reported instances of visual loss due to postponed appointments and patients lost to follow-up. The Royal College of Ophthalmologists Quality Standards Development Group stated that all hospital appointments should occur within 15% of the intended follow-up period. To determine whether: 1. Glaucoma follow-up appointments at a teaching hospital occur within the requested time 2. Appointments are requested at appropriate intervals based on the NICE Guidelines 3. The capacity of the glaucoma service is adequate Methods: A two-part audit was undertaken of 98 and 99 consecutive patients respectively attending specialist glaucoma clinics. In the first part, the reasons for delayed appointments were recorded. In the second part the requested follow-up was compared with NICE guidelines where applicable. Based on the findings, changes were implemented and a re-audit of 100 patients was carried out. The initial audit found that although clinical decisions regarding follow-up intervals were 100% compliant with NICE guidelines where applicable, 24% of appointments were delayed beyond 15% of the requested period, due to administrative errors and inadequate capacity, leading to significant clinical deterioration in two patients. Following the introduction of an electronic appointment tracker and increased clinical capacity created by extra clinics and clinicians, the re-audit found a marked decrease in the percentage of appointments being delayed (9%). This audit is a useful tool to evaluate glaucoma service provision, assist in resource planning for the service and bring about change in a non-confrontational way. It can be widely applied and adapted for use in other medical specialities.

[The German Program for Disease Management Guidelines: COPD Guideline 2006. Short review].

PubMed

Ollenschläger, Günter; Kopp, Ina; Lelgemann, Monika

2007-01-15

In Germany, the first national consensus on evidence-based recommendations for COPD prevention and disease management was reached in spring 2006. After a development period of 9 months, the National Disease Management Guideline COPD was finalized by nominal group process under the authorship of the scientific societies for pneumology (DGP and Atemwegsliga), general internal medicine (DGIM), family medicine (DEGAM), and the Drug Commission of the German Medical Association (AKDAE). The recommendations' main sources are the NICE COPD Guideline 2004, the GOLD Recommendations as well as existing German guidelines and reviews of recent scientific evidence. The article gives an overview on authors, sources, and key recommendations of the German National Disease Management Guideline COPD 2006 (www.copd.versorgungsleitlinien.de).

A systematic review of what factors attract and retain nurses in aged and dementia care.

PubMed

Chenoweth, Lynn; Jeon, Yun-Hee; Merlyn, Teri; Brodaty, Henry

2010-01-01

To present evidence-based factors for the recruitment and retention of licensed nurses caring for older people and persons with dementia. The international nurse shortage crisis is intensified in the aged and dementia care sector. Strategies to address this crisis rely on qualitative, quasi-experimental, anecdotal and unsubstantiated literature. Systematic literature review. Search terms 'nurse''nurses''nursing''clinical supervision''staff''staffing''staff mix''staff levels''recruitment''retention''aged care''gerontology''gerontological''dementia care''residential''nursing home,' were used in all possible combinations and applied in a wide range of relevant academic databases, with secondary hand searches of selected bibliographies. Two hundred and twenty-six papers were retrieved and scanned, with 105 chosen for closer examination that were relevant to recruitment and retention strategies for dementia and aged care nursing. Twenty-five of the papers chosen for review were rated at level 2++ to 3, according to the guidelines of the National Institute for Health and Clinical Excellence (The NICE Guidelines Manual, National Institute for Health and Clinical Excellence, London). The 25 critically reviewed papers are organised as promising strategies for (1) nurse recruitment and (2) nurse retention. The intrinsic rewards of the caring role attract nurses to dementia and aged care. Essential strategies linking recruitment with retention are: careful selection of student nurse clinical placements and their ongoing supervision and education, training for skills, leadership and teamwork for new and existing nurses, increased staffing levels, pay parity across different health settings and family friendly policies. A family-friendly, learning environment that values and nurtures its nursing staff, in the same way as nurses are expected to value and care for their patients and residents, is critical in ensuring their retention in dementia and aged care.

Alcohol and sexual health in young people: the role of PSHE.

PubMed

Rowlinson, Louise

2014-12-01

This paper explores the relationship between sexual health and alcohol in young people in contemporary society, and the role of personal, social and health and economic education (PSHE). This research was prompted by the decision of the Department of Health (DH) not to publish National Institute for Health and Care Excellence (NICE) guidance on PSHE in January 2011. The guidance was requested following a Department for Education internal review into PSHE education. This paper will review qualitative and quantitative research, and data pertaining to the issue of sexual health behaviour and alcohol use among young people in the UK and the role of PSHE education. NICE guidance remains the 'gold standard' for evidence-based healthcare service provision and its implications for sexually transmitted infection and teenage pregnancy rates remains a high priority. Equally, research supports that addressing the issue of alcohol is an increasing priority in young people. This paper will argue that the NICE PSHE review findings should be updated, published and implemented.

DECISION-COMPONENTS OF NICE'S TECHNOLOGY APPRAISALS ASSESSMENT FRAMEWORK.

PubMed

de Folter, Joost; Trusheim, Mark; Jonsson, Pall; Garner, Sarah

2018-01-01

Value assessment frameworks have gained prominence recently in the context of U.S. healthcare. Such frameworks set out a series of factors that are considered in funding decisions. The UK's National Institute of Health and Care Excellence (NICE) is an established health technology assessment (HTA) agency. We present a novel application of text analysis that characterizes NICE's Technology Appraisals in the context of the newer assessment frameworks and present the results in a visual way. A total of 243 documents of NICE's medicines guidance from 2007 to 2016 were analyzed. Text analysis was used to identify a hierarchical set of decision factors considered in the assessments. The frequency of decision factors stated in the documents was determined and their association with terms related to uncertainty. The results were incorporated into visual representations of hierarchical factors. We identified 125 decision factors, and hierarchically grouped these into eight domains: Clinical Effectiveness, Cost Effectiveness, Condition, Current Practice, Clinical Need, New Treatment, Studies, and Other Factors. Textual analysis showed all domains appeared consistently in the guidance documents. Many factors were commonly associated with terms relating to uncertainty. A series of visual representations was created. This study reveals the complexity and consistency of NICE's decision-making processes and demonstrates that cost effectiveness is not the only decision-criteria. The study highlights the importance of processes and methodology that can take both quantitative and qualitative information into account. Visualizations can help effectively communicate this complex information during the decision-making process and subsequently to stakeholders.

A time-series study of percutaneous closure of patent foramen ovale: premature adoption?

PubMed Central

Lew, Kian Nian; Angelini, Gianni D; Hollingworth, William

2016-01-01

Objectives To evaluate the impact of National Institute for Health and Care Excellence (NICE) guidance in January 2005 and subsequent trial evidence on the adoption of percutaneous closure of patent foramen ovale (PCPFO). Methods A retrospective time series study was conducted using the Inpatient Hospital Episode Statistics (HES) England. A total of 3801 patients, aged ≥18 and ≤60 years, who had PCPFO from 1 April 2006 to 31 March 2012 in England. Percentage change annualised (PCA) in PCPFO procedure rates between initial NICE guidance and publication of trial results was analysed. Results Between Quarter 2, 2006 and Quarter 4, 2009, 2163 PCPFO procedures were performed, with an increasing PCA of 48.4%. The procedure rate peaked before the presentation of equivocal results from the first randomised controlled trial (RCT) in late 2010, and declined between Quarter 4, 2009 and Quarter 4, 2011 (PCA=−15.3%). Of more than 2300 patients recruited to three RCTs, only 71 were recruited in English hospitals. Conclusions PCPFO was rapidly adopted after the publication of initial NICE guidance despite the absence of RCT evidence of efficacy. Very few English patients participated in international RCTs of PCPFO, suggesting that NICE recommendations also failed to encourage the generation of RCT evidence. PMID:26835140

Transparency in practice: Evidence from 'verification analyses' issued by the Polish Agency for Health Technology Assessment in 2012-2015.

PubMed

Ozierański, Piotr; Löblová, Olga; Nicholls, Natalia; Csanádi, Marcell; Kaló, Zoltán; McKee, Martin; King, Lawrence

2018-01-08

Transparency is recognised to be a key underpinning of the work of health technology assessment (HTA) agencies, yet it has only recently become a subject of systematic inquiry. We contribute to this research field by considering the Polish Agency for Health Technology Assessment (AHTAPol). We situate the AHTAPol in a broader context by comparing it with the National Institute for Health and Care Excellence (NICE) in England. To this end, we analyse all 332 assessment reports, called verification analyses, that the AHTAPol issued from 2012 to 2015, and a stratified sample of 22 Evidence Review Group reports published by NICE in the same period. Overall, by increasingly presenting its key conclusions in assessment reports, the AHTAPol has reached the transparency standards set out by NICE in transparency of HTA outputs. The AHTAPol is more transparent than NICE in certain aspects of the HTA process, such as providing rationales for redacting assessment reports and providing summaries of expert opinions. Nevertheless, it is less transparent in other areas of the HTA process, such as including information on expert conflicts of interest. Our findings have important implications for understanding HTA in Poland and more broadly. We use them to formulate recommendations for policymakers.

NICE technology appraisals: working with multiple levels of uncertainty and the potential for bias.

PubMed

Brown, Patrick; Calnan, Michael

2013-05-01

One of the key roles of the English National Institute for Health and Clinical Excellence (NICE) is technology appraisal. This essentially involves evaluating the cost effectiveness of pharmaceutical products and other technologies for use within the National Health Service. Based on a content analysis of key documents which shed light on the nature of appraisals, this paper draws attention to the multiple layers of uncertainty and complexity which are latent within the appraisal process, and the often socially constructed mechanisms for tackling these. Epistemic assumptions, bounded rationality and more explicitly relational forms of managing knowledge are applied to this end. These findings are discussed in the context of the literature highlighting the inherently social process of regulation. A framework is developed which posits the various forms of uncertainty, and responses to these, as potential conduits of regulatory bias-in need of further research. That NICE's authority is itself regulated by other actors within the regulatory regime, particularly the pharmaceutical industry, exposes it to the threat of regulatory capture. Following Lehoux, it is concluded that a more transparent and reflexive format for technological appraisals is necessary. This would enable a more robust, defensible form of decision-making and moreover enable NICE to preserve its legitimacy in the midst of pressures which threaten this.

Seeing the NICE side of cost-effectiveness analysis: a qualitative investigation of the use of CEA in NICE technology appraisals.

PubMed

Bryan, Stirling; Williams, Iestyn; McIver, Shirley

2007-02-01

Resource scarcity is the raison d'être for the discipline of economics. Thus, the primary purpose of economic analysis is to help decision-makers when addressing problems arising due to the scarcity problem. The research reported here was concerned with how cost-effectiveness information is used by the National Institute for Health & Clinical Excellence (NICE) in national technology coverage decisions in the UK, and how its impact might be increased. The research followed a qualitative case study methodology with semi-structured interviews, supported by observation and analysis of secondary sources. Our research highlights that the technology appraisal function of NICE represents an important progression for the UK health economics community: new cost-effectiveness work is commissioned for each technology and that work directly informs national health policy. However, accountability in policy decisions necessitates that the information upon which decisions are based (including cost-effectiveness analysis, CEA) is accessible. This was found to be a serious problem and represents one of the main ongoing challenges. Other issues highlighted include perceived weaknesses in analysis methods and the poor alignment between the health maximisation objectives assumed in economic analyses and the range of other objectives facing decision-makers in reality. Copyright (c) 2006 John Wiley & Sons, Ltd.

Assessment of the 2016 National Institute for Health and Care Excellence high-sensitivity troponin rule-out strategy

PubMed Central

Greenslade, Jaimi; Cullen, Louise; Than, Martin; Kendall, Jason; Body, Richard; Parsonage, William A; Khattab, Ahmed

2018-01-01

Objective We aimed to evaluate the limit of detection of high-sensitivity troponin (hs-cTn) and Thrombolysis In Myocardial Infarction (TIMI) score combination rule-out strategy suggested within the 2016 National Institute for Health and Care Excellence (NICE) Chest Pain of Recent Onset guidelines and establish the optimal TIMI score threshold for clinical use. Methods A pooled analysis of adult patients presenting to the emergency department with chest pain and a non-ischaemic ECG, recruited into six prospective studies, from Australia, New Zealand and the UK. We evaluated the sensitivity of TIMI score thresholds from 0 to 2 alongside hs-cTnT or hs-cTnI for the primary outcome of major adverse cardiac events within 30 days. Results Data were available for 3159 patients for hs-cTnT and 4532 for hs-cTnI, of these 376 (11.9%) and 445 (9.8%) had major adverse cardiac events, respectively. Using a TIMI score of 0, the sensitivity for the primary outcome was 99.5% (95% CI 98.1% to 99.9%) alongside hs-cTnT and 98.9% (97.4% to 99.6%)%) alongside hs-cTnI, identifying 17.9% and 21.0% of patients as low risk, respectively. For a TIMI score ≤1 sensitivity was 98.9% (97.3% to 99.7%)%) alongside hs-cTnT and 98.4% (96.8% to 99.4%)%) alongside hs-cTnI, identifying 28.1% and 35.7% as low risk, respectively. For TIMI≤2, meta-sensitivity was <98% with either assay. Conclusions Our findings support the rule-out strategy suggested by NICE. The TIMI score threshold suggested for clinical use is 0. The proportion of patients identified as low risk (18%–21%) and suitable for early discharge using this threshold may be sufficient to encourage change of practice. Trial registration numbers ADAPT observational study/IMPACT intervention trial ACTRN12611001069943. ADAPT-ADP randomised controlled trial ACTRN12610000766011. EDACS-ADP randomised controlled trial ACTRN12613000745741. TRUST observational study ISRCTN no. 21109279. PMID:28864718

Investigating the prostate specific antigen, body mass index and age relationship: is an age-BMI-adjusted PSA model clinically useful?

PubMed

Harrison, Sean; Tilling, Kate; Turner, Emma L; Lane, J Athene; Simpkin, Andrew; Davis, Michael; Donovan, Jenny; Hamdy, Freddie C; Neal, David E; Martin, Richard M

2016-12-01

Previous studies indicate a possible inverse relationship between prostate-specific antigen (PSA) and body mass index (BMI), and a positive relationship between PSA and age. We investigated the associations between age, BMI, PSA, and screen-detected prostate cancer to determine whether an age-BMI-adjusted PSA model would be clinically useful for detecting prostate cancer. Cross-sectional analysis nested within the UK ProtecT trial of treatments for localized cancer. Of 18,238 men aged 50-69 years, 9,457 men without screen-detected prostate cancer (controls) and 1,836 men with prostate cancer (cases) met inclusion criteria: no history of prostate cancer or diabetes; PSA < 10 ng/ml; BMI between 15 and 50 kg/m 2 . Multivariable linear regression models were used to investigate the relationship between log-PSA, age, and BMI in all men, controlling for prostate cancer status. In the 11,293 included men, the median PSA was 1.2 ng/ml (IQR: 0.7-2.6); mean age 61.7 years (SD 4.9); and mean BMI 26.8 kg/m 2 (SD 3.7). There were a 5.1% decrease in PSA per 5 kg/m 2 increase in BMI (95% CI 3.4-6.8) and a 13.6% increase in PSA per 5-year increase in age (95% CI 12.0-15.1). Interaction tests showed no evidence for different associations between age, BMI, and PSA in men above and below 3.0 ng/ml (all p for interaction >0.2). The age-BMI-adjusted PSA model performed as well as an age-adjusted model based on National Institute for Health and Care Excellence (NICE) guidelines at detecting prostate cancer. Age and BMI were associated with small changes in PSA. An age-BMI-adjusted PSA model is no more clinically useful for detecting prostate cancer than current NICE guidelines. Future studies looking at the effect of different variables on PSA, independent of their effect on prostate cancer, may improve the discrimination of PSA for prostate cancer.

Canadian Schizophrenia Guidelines: Schizophrenia and Other Psychotic Disorders with Coexisting Substance Use Disorders

PubMed Central

Addington, Donald

2017-01-01

Objective: Persons with schizophrenia and other psychotic disorders frequently have coexisting substance use disorders that require modifications to treatment approaches for best outcomes. The objectives of this review were to identify evidence-based practices best practices that improve outcomes for individuals with schizophrenia and substance used disorders. Method: We reviewed guidelines that were published in the last 5 years and that included systematic reviews or meta-analyses. Most of our recommendations came from 2 publications from the National Institute for Health and Care Excellence (NICE): the 2011 guidance titled Coexisting Severe Mental Illness (Psychosis) and Substance Misuse: Assessment and Management in Healthcare Settings and the 2014 guidance titled Psychosis and Schizophrenia in Adults: Prevention and Management. We placed these recommendations into the Canadian context to create this guideline. Results: Evidence supports the inclusion of individuals with coexisting substance use disorders in first-episode psychosis programs. The programs should integrate psychosis and substance use treatments, emphasizing ongoing monitoring of both substance use and patterns and symptoms. The best outcomes are achieved with combined use of antipsychotic medications and addiction-based psychosocial interventions. However, limited evidence is available to recommend using one antipsychotic medication over another or one psychosocial intervention over another for persons with schizophrenia and other psychotic disorders with coexisting substance use disorders. Conclusions: Treating persons who have schizophrenia and other psychotic disorders with coexisting substance use disorders can present clinical challenges, but modifications in practice can help engage and retain people in treatment, where significant improvements over time can be expected. PMID:28886671

Type 2 diabetes mellitus in older people: a brief statement of key principles of modern day management including the assessment of frailty. A national collaborative stakeholder initiative.

PubMed

Strain, W D; Hope, S V; Green, A; Kar, P; Valabhji, J; Sinclair, A J

2018-04-07

Rates of population ageing are unprecedented and this, combined with the progressive urbanization of lifestyles, has led to a dramatic shift in the epidemiology of diabetes towards old age, particularly to those aged 60-79 years. Both ageing and diabetes are recognized as important risk factors for the development of functional decline and disability. In addition, diabetes is associated with a high economic, social and health burden. Traditional macrovascular and microvascular complications of diabetes appear to account for less than half of the diabetes-related disability observed in older people. Despite this, older adults are under-represented in clinical trials. Guidelines from organizations such as the National Institute for Health and Care Excellence (NICE), the European Association for the Study of Diabetes, and the American Diabetes Association acknowledge the need for individualized care, but the glycaemic targets that are suggested to constitute good control [HbA 1c 53-59 mmol/mol (7-7.5%)] are too tight for frail older individuals. We present a framework for the assessment of older adults and guidelines for the management of this population according to their frailty status, with the intention of reducing complications and improving quality of life for these people. © 2018 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.

Pilot of a randomised controlled trial of the selective serotonin reuptake inhibitor sertraline versus cognitive behavioural therapy for anxiety symptoms in people with generalised anxiety disorder who have failed to respond to low-intensity psychological treatments as defined by the National Institute for Health and Care Excellence guidelines.

PubMed

Buszewicz, Marta; Cape, John; Serfaty, Marc; Shafran, Roz; Kabir, Thomas; Tyrer, Peter; Clarke, Caroline S; Nazareth, Irwin

2017-08-01

Generalised anxiety disorder (GAD) is common, causing unpleasant symptoms and impaired functioning. The National Institute for Health and Care Excellence (NICE) guidelines have established good evidence for low-intensity psychological interventions, but a significant number of patients will not respond and require more intensive step 3 interventions, recommended as either high-intensity cognitive behavioural therapy (CBT) or a pharmacological treatment such as sertraline. However, there are no head-to-head comparisons evaluating which is more clinically effective and cost-effective, and current guidelines suggest that treatment choice at step 3 is based mainly on patient preference. To assess clinical effectiveness and cost-effectiveness at 12 months of treatment with the selective serotonin reuptake inhibitor (SSRI) sertraline compared with CBT for patients with persistent GAD not improved with NICE-defined low-intensity psychological interventions. Participant randomised trial comparing treatment with sertraline with high-intensity CBT for patients with GAD who had not responded to low-intensity psychological interventions. Community-based recruitment from local Improving Access to Psychological Therapies (IAPT) services. Four pilot services located in urban, suburban and semirural settings. People considered likely to have GAD and not responding to low-intensity psychological interventions identified at review by IAPT psychological well-being practitioners (PWPs). Those scoring ≥ 10 on the Generalised Anxiety Disorder-7 (GAD-7) anxiety measure were asked to consider involvement in the trial. Aged ≥ 18 years, a score of ≥ 10 on the GAD-7, a primary diagnosis of GAD diagnosed on the Mini International Neuropsychiatric Interview questionnaire and failure to respond to NICE-defined low-intensity interventions. Inability to participate because of insufficient English or cognitive impairment, current major depression, comorbid anxiety disorder(s) causing greater distress than GAD, significant dependence on alcohol or illicit drugs, comorbid psychotic disorder, received antidepressants in past 8 weeks or high-intensity psychological therapy in previous 6 months and any contraindications to treatment with sertraline. Consenting eligible participants randomised via an independent, web-based, computerised system. (1) The SSRI sertraline prescribed in therapeutic doses by the patient's general practitioner for 12 months and (2) 14 (± 2) CBT sessions delivered by high-intensity IAPT psychological therapists in accordance with a standardised manual designed for GAD. The primary outcome was the Hospital Anxiety and Depression Scale - Anxiety component at 12 months. Secondary outcomes included measures of depression, social functioning, comorbid anxiety disorders, patient satisfaction and economic evaluation, collected by postal self-completion questionnaires. Only seven internal pilot participants were recruited against a target of 40 participants at 7 months. Far fewer potential participants were identified than anticipated from IAPT services, probably because PWPs rarely considered GAD the main treatment priority. Of those identified, three-quarters declined participation; the majority (30/45) were reluctant to consider the possibility of randomisation to medication. Poor recruitment was the main limiting factor, and the trial closed prematurely. It is unclear how much of the recruitment difficulty was a result of conducting the trial within a psychological therapy service and how much was possibly a result of difficulty identifying participants with primary GAD. It may be easier to answer this important question by recruiting people from primary care rather than from those already engaged in a psychological treatment service. Current Controlled Trials ISCRTN14845583. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 21, No. 45. See the NIHR Journals Library website for further project information.

The Type and Impact of Evidence Review Group Exploratory Analyses in the NICE Single Technology Appraisal Process.

PubMed

Carroll, Christopher; Kaltenthaler, Eva; Hill-McManus, Daniel; Scope, Alison; Holmes, Michael; Rice, Stephen; Rose, Micah; Tappenden, Paul; Woolacott, Nerys

2017-06-01

As part of the UK National Institute for Health and Care Excellence (NICE) single technology appraisal process, independent evidence review groups (ERGs) critically appraise a company's submission relating to a specific technology and indication. To explore the type of additional exploratory analyses conducted by ERGs and their impact on the recommendations made by NICE. The 100 most recently completed single technology appraisals with published guidance were selected for inclusion. A content analysis of relevant documents was undertaken to identify and extract relevant data, and narrative synthesis was used to rationalize and present these data. The types of exploratory analysis conducted in relation to companies' models were fixing errors, addressing violations, addressing matters of judgment, and the provision of a new, ERG-preferred base case. Ninety-three of the 100 ERG reports contained at least one of these analyses. The most frequently reported type of analysis in these 93 ERG reports related to the category "Matters of judgment," which was reported in 83 reports (89%). At least one of the exploratory analyses conducted and reported by an ERG is mentioned in 97% of NICE appraisal consultation documents and 94% of NICE final appraisal determinations, and had a clear influence on recommendations in 72% of appraisal consultation documents and 47% of final appraisal determinations. These results suggest that the additional analyses undertaken by ERGs in the appraisal of company submissions are highly influential in the policy-making and decision-making process. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

What is the actual cost of providing the intrauterine system for contraception in a UK community sexual and reproductive health setting?

PubMed

Cook, Louise; Fleming, Charlotte

2014-01-01

The anticipated increase in uptake of intrauterine system (IUS) fittings is slower than predicted by the National Institute for Health and Clinical Excellence (NICE). There is evidence to suggest that this is because of a high perceived cost of providing this contraceptive method. Whereas studies to date have all guessed at these costs, we calculated the actual costs of providing the IUS. We tracked the notes of 283 women who had an IUS fitted in our community sexual and reproductive health service for 5 years. We recorded duration of use, measured the actual cost of all appointments and interventions over the lifespan of the device, and compared our findings with NICE predicted costs. With 70% complete follow-up, the average duration of use of the IUS was 3.44 years compared to NICE's prediction of 3.32. The average annual cost of providing an IUS for contraception in community clinics was £54.55 per woman; this compares with £70.49 modelled by NICE for provision in primary care. Most (80%) of the cost is incurred in the first year. The cost of managing problems is small. Providing the IUS for contraception was 23% cheaper in the present study than that predicted by NICE and cheaper than providing combined oral contraception in our service. Fitting IUSs in community clinics may be cheaper than in primary care. Streamlining the patient pathway will reduce costs further. Restricting access to the IUS because of initial cost is a false economy.

What's the evidence that NICE guidance has been implemented? Results from a national evaluation using time series analysis, audit of patients' notes, and interviews.

PubMed

Sheldon, Trevor A; Cullum, Nicky; Dawson, Diane; Lankshear, Annette; Lowson, Karin; Watt, Ian; West, Peter; Wright, Dianne; Wright, John

2004-10-30

To assess the extent and pattern of implementation of guidance issued by the National Institute for Clinical Excellence (NICE). Interrupted time series analysis, review of case notes, survey, and interviews. Acute and primary care trusts in England and Wales. All primary care prescribing, hospital pharmacies; a random sample of 20 acute trusts, 17 mental health trusts, and 21 primary care trusts; and senior clinicians and managers from five acute trusts. Rates of prescribing and use of procedures and medical devices relative to evidence based guidance. 6308 usable patient audit forms were returned. Implementation of NICE guidance varied by trust and by topic. Prescribing of some taxanes for cancer (P < 0.002) and orlistat for obesity (P < 0.001) significantly increased in line with guidance. Prescribing of drugs for Alzheimer's disease and prophylactic extraction of wisdom teeth showed trends consistent with, but not obviously a consequence of, the guidance. Prescribing practice often did not accord with the details of the guidance. No change was apparent in the use of hearing aids, hip prostheses, implantable cardioverter defibrillators, laparoscopic hernia repair, and laparoscopic colorectal cancer surgery after NICE guidance had been issued. Implementation of NICE guidance has been variable. Guidance seems more likely to be adopted when there is strong professional support, a stable and convincing evidence base, and no increased or unfunded costs, in organisations that have established good systems for tracking guidance implementation and where the professionals involved are not isolated. Guidance needs to be clear and reflect the clinical context.

Review and evaluation of the methodological quality of the existing guidelines and recommendations for inherited neurometabolic disorders.

PubMed

Cassis, Linda; Cortès-Saladelafont, Elisenda; Molero-Luis, Marta; Yubero, Delia; González, Maria Julieta; Ormazábal, Aida; Fons, Carme; Jou, Cristina; Sierra, Cristina; Castejon Ponce, Esperanza; Ramos, Federico; Armstrong, Judith; O'Callaghan, M Mar; Casado, Mercedes; Montero, Raquel; Meavilla-Olivas, Silvia; Artuch, Rafael; Barić, Ivo; Bartoloni, Franco; Bellettato, Cinzia Maria; Bonifazi, Fedele; Ceci, Adriana; Cvitanović-Šojat, Ljerka; Dali, Christine I; D'Avanzo, Francesca; Fumic, Ksenija; Giannuzzi, Viviana; Lampe, Christina; Scarpa, Maurizio; Garcia-Cazorla, Ángels

2015-12-30

Inherited neurometabolic disorders (iNMDs) represent a group of almost seven hundred rare diseases whose common manifestations are clinical neurologic or cognitive symptoms that can appear at any time, in the first months/years of age or even later in adulthood. Early diagnosis and timely treatments are often pivotal for the favorable course of the disease. Thus, the elaboration of new evidence-based recommendations for iNMD diagnosis and management is increasingly requested by health care professionals and patients, even though the methodological quality of existing guidelines is largely unclear. InNerMeD-I-Network is the first European network on iNMDs that was created with the aim of sharing and increasing validated information about diagnosis and management of neurometabolic disorders. One of the goals of the project was to determine the number and the methodological quality of existing guidelines and recommendations for iNMDs. We performed a systematic search on PubMed, the National Guideline Clearinghouse (NGC), the Guidelines International Network (G-I-N), the Scottish Intercollegiate Guideline Network (SIGN) and the National Institute for Health and Care Excellence (NICE) to identify all the published guidelines and recommendations for iNMDs from January 2000 to June 2015. The methodological quality of the selected documents was determined using the AGREE II instrument, an appraisal tool composed of 6 domains covering 23 key items. A total of 55 records met the inclusion criteria, 11 % were about groups of disorders, whereas the majority encompassed only one disorder. Lysosomal disorders, and in particular Fabry, Gaucher disease and mucopolysaccharidoses where the most studied. The overall methodological quality of the recommendation was acceptable and increased over time, with 25 % of the identified guidelines strongly recommended by the appraisers, 64 % recommended, and 11 % not recommended. However, heterogeneity in the obtained scores for each domain was observed among documents covering different groups of disorders and some domains like 'stakeholder involvement' and 'applicability' were generally scarcely addressed. Greater efforts should be devoted to improve the methodological quality of guidelines and recommendations for iNMDs and AGREE II instrument seems advisable for new guideline development. The elaboration of new guidelines encompassing still uncovered disorders is badly needed.

A primary care audit of familial risk in patients with a personal history of breast cancer.

PubMed

Nathan, Paul; Ahluwalia, Aneeta; Chorley, Wendy

2014-12-01

Breast cancer is the most common cancer diagnosed in women, both in the UK and worldwide. A small proportion of women are at very high risk of breast cancer, having a particularly strong family history. The National Institute for Health and Clinical Excellence (NICE) has advised that practitioners should not, in most instances, actively seek to identify women with a family history of breast cancer. An audit was undertaken at an urban primary care practice of 15,000 patients, using a paper-based, self-administered questionnaire sent to patients identified with a personal history of breast cancer. The aim of this audit was to determine whether using targeted screening of relatives of patients with breast cancer to identify familial cancer risk is worthwhile in primary care. Since these patients might already expected to have been risk assessed following their initial diagnosis, this audit acts as a quality improvement exercise. The audit used a validated family history questionnaire and risk assessment tool as a screening approach for identifying and grading familial risk in line with the NICE guidelines, to guide referral to the familial cancer screening service. The response rate to family history questionnaires was 54 % and the majority of patients responded positively to their practitioner seeking to identify familial cancer risks in their family. Of the 57 returned questionnaires, over a half (54 %) contained pedigrees with individuals eligible for referral. Patients and their relatives who are often registered with the practice welcome the discussion. An appropriate referral can therefore be made. The findings suggest a role for primary care practitioners in the identification of those at higher familial risk. However integrated systems and processes need designing to facilitate this work.

Metal-on-metal hip resurfacing in patients younger than 50 years: a retrospective analysis : 1285 cases, 12-year survivorship.

PubMed

Gaillard, Melissa D; Gross, Thomas P

2017-06-02

The Nordic registry reports patients under 50 years old with total hip replacements realize only 83% 10-year implant survivorship. These results do not meet the 95% 10-year survivorship guideline posed by the UK's National Institute for Health and Care Excellence (NICE) in 2014. The purpose of this study is threefold: First, we evaluate if metal-on-metal hip resurfacing arthroplasty meets these high standards in younger patients. Next, we compare outcomes between age groups to determine if younger patients are at higher risk for revision or complication. Lastly, we assess how outcomes between sexes changed over time. From January 2001 to August 2013, a single surgeon performed 1285 metal-on-metal hip resurfacings in patients younger than 50 years old. We compared these to an older cohort matched by sex and BMI. Kaplan-Meier implant survivorship was 96.5% at 10 years and 96.3% at 12 years; this did not differ from implant survivorship for older patients. Implant survivorship at 12 years was 98 and 93% for younger men and women, respectively; survivorship for women improved from 93 to 97% by using exclusively Biomet implants. There were four (0.3%) adverse wear-related failures, with no instances of wear or problematic ion levels since 2009. Activity scores improved from 5.4 ± 2.3 preoperatively to 7.6 ± 1.9 postoperatively (p < 0.0001), with 43% of patients reporting a UCLA activity score of 9 or 10. Hip resurfacing exceeds the stricter 2014 NICE survivorship criteria independently in men and women even when performed on patients under 50 years old.

Cost-effective public health guidance: asking questions from the decision-maker's viewpoint.

PubMed

Chalkidou, Kalipso; Culyer, Anthony; Naidoo, Bhash; Littlejohns, Peter

2008-03-01

In February 2004, in his assessment of the long-term financial viability of the NHS, Derek Wanless recommended the use of 'a consistent framework, such as the methodology developed by NICE, to evaluate the cost-effectiveness of interventions and initiatives across health care and public health'. One year later public health was added to NICE's remit and the new National Institute for Health and Clinical Excellence (NICE) was established, with amended statutory instruments to permit consideration of broader public sector costs when developing cost-effective guidance for public health. With the principle of 'a consistent framework' put forward by Wanless as the starting point, this paper provides an insight into the most challenging aspects of applying the principles of cost-effectiveness analysis in the public health context from the policymaker's perspective. It reflects on the long-term consequences of taking on responsibility for producing public health guidance on the Institute's overall approach to guidance development and describes the tension between striving for consistency and cross-evaluation comparability while ensuring that the methodological tools used are fit for the purpose of developing public health guidance.

Prioritising public health guidance topics in the National Institute for Health and Care Excellence using the Analytic Hierarchy Process.

PubMed

Reddy, B P; Kelly, M P; Thokala, P; Walters, S J; Duenas, A

2014-10-01

The Centre for Public Health (CPH), at the United Kingdom's National Institute for Health and Care Excellence (NICE) is responsible for producing national guidance relating to the promotion of good health and the prevention and treatment of disease. Given the challenges of developing guidance in this area, choosing the most appropriate topics for further study is of fundamental importance. This paper explores the current prioritisation process and describes how the Analytic Hierarchy Process (AHP), a multi criteria decision analysis (MCDA) technique, might be used to do so. A proposed approach is outlined, which was tested in a proof of concept pilot. This consisted of eight participants with experience of related NICE committees building scores for each topic together in a 'decision conference' setting. Criteria were identified and subsequently weighted to indicate the relative importance of each. Participants then collaboratively estimated the performance of each topic on each criterion. Total scores for each topic were calculated, which could be ranked and used as the basis for better informed discussion for prioritising topics to recommend to the Minister for future guidance. Sensitivity analyses of the dataset found it to be robust. Choosing the right topics for guidance at the earliest possible time is of fundamental importance to public health guidance, and judgement is likely to play an important part in doing so. MCDA techniques offer a potentially useful approach to structuring the problem in a rational and transparent way. NICE should consider carefully whether such an approach might be worth pursuing in the future.

The Role of Teachers in the Assessment of Children Suspected of Having AD/HD

ERIC Educational Resources Information Center

Salmon, Gill; Kirby, Amanda

2009-01-01

In the light of recent guidance published by The National Institute for Health and Clinical Excellence (NICE) on the diagnosis and management of attention deficit disorders in children, young persons and adults, Gill Salmon, a consultant Child and Adolescent Psychiatrist based in Swansea, South Wales, and Amanda Kirby, Professor of Developmental…

Audit of Helicobacter pylori Testing in Microbiology Laboratories in England: To Inform Compliance with NICE Guidance and the Feasibility of Routine Antimicrobial Resistance Surveillance

PubMed Central

Allison, Rosalie; Lecky, Donna M.; Bull, Megan; Turner, Kim; Godbole, Gauri

2016-01-01

Introduction. The National Institute for Health and Clinical Excellence (NICE) guidance recommends that dyspeptic patients are tested for Helicobacter pylori using a urea breath test, stool antigen test, or serology. Antibiotic resistance in H. pylori is globally increasing, but treatment in England is rarely guided by susceptibility testing or surveillance. Aims. To determine compliance of microbiology laboratories in England with NICE guidance and whether laboratories perform culture and antibiotic susceptibility testing (AST). Methods. In 2015, 170 accredited English microbiology laboratories were surveyed, by email. Results. 121/170 (71%) laboratories responded; 96% provided H. pylori testing (78% on site). 94% provided H. pylori diagnosis using stool antigen; only four provided serology as their noninvasive test; 3/4 of these encouraged urea breath tests in their acute trusts. Only 22/94 (23%) of the laboratories performed H. pylori cultures from gastric biopsies on site; 9/22 performed AST, but the vast majority processed less than one specimen/week. Conclusions. Only five laboratories in England do not comply with NICE guidance; these will need the guidance reinforced. National surveillance needs to be implemented; culture-based AST would need to be centralised. Moving forward, detection of resistance in H. pylori from stool specimens using molecular methods (PCR) needs to be explored. PMID:27829836

Probabilistic sensitivity analysis for NICE technology assessment: not an optional extra.

PubMed

Claxton, Karl; Sculpher, Mark; McCabe, Chris; Briggs, Andrew; Akehurst, Ron; Buxton, Martin; Brazier, John; O'Hagan, Tony

2005-04-01

Recently the National Institute for Clinical Excellence (NICE) updated its methods guidance for technology assessment. One aspect of the new guidance is to require the use of probabilistic sensitivity analysis with all cost-effectiveness models submitted to the Institute. The purpose of this paper is to place the NICE guidance on dealing with uncertainty into a broader context of the requirements for decision making; to explain the general approach that was taken in its development; and to address each of the issues which have been raised in the debate about the role of probabilistic sensitivity analysis in general. The most appropriate starting point for developing guidance is to establish what is required for decision making. On the basis of these requirements, the methods and framework of analysis which can best meet these needs can then be identified. It will be argued that the guidance on dealing with uncertainty and, in particular, the requirement for probabilistic sensitivity analysis, is justified by the requirements of the type of decisions that NICE is asked to make. Given this foundation, the main issues and criticisms raised during and after the consultation process are reviewed. Finally, some of the methodological challenges posed by the need fully to characterise decision uncertainty and to inform the research agenda will be identified and discussed. Copyright (c) 2005 John Wiley & Sons, Ltd.

Beyond Rules to Guidelines

ERIC Educational Resources Information Center

Gartrell, Dan

2010-01-01

Rules are not helpful in the adult-child community. They are usually stated in the negative: "No," "Don't," etc. The way they are worded, adults seem to expect children to break them. Even when they are not totally negative, like "Be nice to your friends," rules have an "or else" moral implication that adults carry around in their heads. When…

Access to aidable residual hearing in adult candidates for cochlear implantation in the UK.

PubMed

Fielden, Claire A; Hampton, Rosa; Smith, Sandra; Kitterick, Pádraig T

2016-04-01

Guidance from the National Institute for Health and Care Excellence (NICE) permits candidates to receive a cochlear implant provided they only hear sounds louder than 90 dB HL at 2 and 4 kHz. In some patients, their level of residual hearing may be sufficient to warrant the use of a hearing aid in their non-implanted ear. A survey of unilaterally implanted adults indicated that those implanted since the publication of NICE guidance were almost seven times more likely to use a hearing aid than those implanted prior to this. If contralateral hearing aid use provides additional benefits over implant use alone, it may be appropriate to consider the capacity to use residual hearing following implantation when determining candidacy.

Review of utility values for economic modeling in type 2 diabetes.

PubMed

Beaudet, Amélie; Clegg, John; Thuresson, Per-Olof; Lloyd, Adam; McEwan, Phil

2014-06-01

Economic analysis in type 2 diabetes mellitus (T2DM) requires an assessment of the effect of a wide range of complications. The objective of this article was to identify a set of utility values consistent with the National Institute for Health and Care Excellence (NICE) reference case and to critically discuss and illustrate challenges in creating such a utility set. A systematic literature review was conducted to identify studies reporting utility values for relevant complications. The methodology of each study was assessed for consistency with the NICE reference case. A suggested set of utility values applicable to modeling was derived, giving preference to studies reporting multiple complications and correcting for comorbidity. The review considered 21 relevant diabetes complications. A total of 16,574 articles were identified; after screening, 61 articles were assessed for methodological quality. Nineteen articles met NICE criteria, reporting utility values for 20 of 21 relevant complications. For renal transplant, because no articles meeting NICE criteria were identified, two articles using other methodologies were included. Index value estimates for T2DM without complication ranged from 0.711 to 0.940. Utility decrement associated with complications ranged from 0.014 (minor hypoglycemia) to 0.28 (amputation). Limitations associated with the selection of a utility value for use in economic modeling included variability in patient recruitment, heterogeneity in statistical analysis, large variability around some point estimates, and lack of recent data. A reference set of utility values for T2DM and its complications in line with NICE requirements was identified. This research illustrates the challenges associated with systematically selecting utility data for economic evaluations. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

What's the evidence that NICE guidance has been implemented? Results from a national evaluation using time series analysis, audit of patients' notes, and interviews

PubMed Central

Sheldon, Trevor A; Cullum, Nicky; Dawson, Diane; Lankshear, Annette; Lowson, Karin; Watt, Ian; West, Peter; Wright, Dianne; Wright, John

2004-01-01

Objectives To assess the extent and pattern of implementation of guidance issued by the National Institute for Clinical Excellence (NICE). Design Interrupted time series analysis, review of case notes, survey, and interviews. Setting Acute and primary care trusts in England and Wales. Participants All primary care prescribing, hospital pharmacies; a random sample of 20 acute trusts, 17 mental health trusts, and 21 primary care trusts; and senior clinicians and managers from five acute trusts. Main outcome measures Rates of prescribing and use of procedures and medical devices relative to evidence based guidance. Results 6308 usable patient audit forms were returned. Implementation of NICE guidance varied by trust and by topic. Prescribing of some taxanes for cancer (P < 0.002) and orlistat for obesity (P < 0.001) significantly increased in line with guidance. Prescribing of drugs for Alzheimer's disease and prophylactic extraction of wisdom teeth showed trends consistent with, but not obviously a consequence of, the guidance. Prescribing practice often did not accord with the details of the guidance. No change was apparent in the use of hearing aids, hip prostheses, implantable cardioverter defibrillators, laparoscopic hernia repair, and laparoscopic colorectal cancer surgery after NICE guidance had been issued. Conclusions Implementation of NICE guidance has been variable. Guidance seems more likely to be adopted when there is strong professional support, a stable and convincing evidence base, and no increased or unfunded costs, in organisations that have established good systems for tracking guidance implementation and where the professionals involved are not isolated. Guidance needs to be clear and reflect the clinical context. PMID:15514342

Health benefit assessment of pharmaceuticals: An international comparison of decisions from Germany, England, Scotland and Australia.

PubMed

Fischer, Katharina Elisabeth; Heisser, Thomas; Stargardt, Tom

2016-10-01

Little is known on the performance of the newly introduced health benefit assessment process, AMNOG, in Germany compared to other health technology assessment agencies. We analysed whether decisions of the German Federal Joint Committee (FJC) deviate from decisions of the UK National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and the Australian Pharmaceutical Benefits Advisory Committee (PBAC). We analysed decisions made for comparable patient subgroups by the four agencies between 2011 and 2014. First, decisions were compared (a) by their final outcome, i.e. whether a health benefit was identified, and (b) by the agencies' judgement on comparative effectiveness. Subsequently, we partially explored reasons for differences between HTA agencies. From the 192 FJC decisions, we identified 55 that overlapped with NICE, 166 with SMC and 119 with PBAC. FJC agreed with NICE in 40% in final outcome (Cohen's Kappa=-0.13). Similar results were obtained for FJC and SMC (47.6%, kappa=0.03) and FJC and PBAC (48.7%, kappa=0.07). Agreement increased when comparing judgements based on comparative effectiveness only. However, the FJC's final decision was positive only in 43.6%, 39.2% and 44.5% of the patient subgroups, as opposed to 74.5% (NICE), 68.7% (SMC), and 68.9% (PBAC), respectively. We show that the FJC - an agency relatively new in structurally assessing the health benefit of pharmaceuticals - deviates considerably in decisions compared to other HTA agencies. Our study also reveals that the FJC tends to appraise stricter than NICE. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline: a systematic review.

PubMed

Zeng, Xiantao; Zhang, Yonggang; Kwong, Joey S W; Zhang, Chao; Li, Sheng; Sun, Feng; Niu, Yuming; Du, Liang

2015-02-01

To systematically review the methodological assessment tools for pre-clinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline. We searched PubMed, the Cochrane Handbook for Systematic Reviews of Interventions, Joanna Briggs Institute (JBI) Reviewers Manual, Centre for Reviews and Dissemination, Critical Appraisal Skills Programme (CASP), Scottish Intercollegiate Guidelines Network (SIGN), and the National Institute for Clinical Excellence (NICE) up to May 20th, 2014. Two authors selected studies and extracted data; quantitative analysis was performed to summarize the characteristics of included tools. We included a total of 21 assessment tools for analysis. A number of tools were developed by academic organizations, and some were developed by only a small group of researchers. The JBI developed the highest number of methodological assessment tools, with CASP coming second. Tools for assessing the methodological quality of randomized controlled studies were most abundant. The Cochrane Collaboration's tool for assessing risk of bias is the best available tool for assessing RCTs. For cohort and case-control studies, we recommend the use of the Newcastle-Ottawa Scale. The Methodological Index for Non-Randomized Studies (MINORS) is an excellent tool for assessing non-randomized interventional studies, and the Agency for Healthcare Research and Quality (ARHQ) methodology checklist is applicable for cross-sectional studies. For diagnostic accuracy test studies, the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool is recommended; the SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool is available for assessing animal studies; Assessment of Multiple Systematic Reviews (AMSTAR) is a measurement tool for systematic reviews/meta-analyses; an 18-item tool has been developed for appraising case series studies, and the Appraisal of Guidelines, Research and Evaluation (AGREE)-II instrument is widely used to evaluate clinical practice guidelines. We have successfully identified a variety of methodological assessment tools for different types of study design. However, further efforts in the development of critical appraisal tools are warranted since there is currently a lack of such tools for other fields, e.g. genetic studies, and some existing tools (nested case-control studies and case reports, for example) are in need of updating to be in line with current research practice and rigor. In addition, it is very important that all critical appraisal tools remain subjective and performance bias is effectively avoided. © 2015 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd.

NACA Muroc Staff of 1949 at NACA barbecue

NASA Technical Reports Server (NTRS)

1949-01-01

On a nice day in November 1949 the NACA High-Speed Flight Station employees enjoy a break from a week of research by attending a barbecue on the Rawliegh Duntley ranch. The food was excellent and the camaraderie with friends and family members was welcome. Games were played with the winners applauded--fun for everyone before the start of another week.

Current primary care management of children aged 1-36 months with urinary tract infections in Europe: large scale survey of paediatric practice.

PubMed

Hadjipanayis, Adamos; Grossman, Zachi; Del Torso, Stefano; van Esso, Diego; Dornbusch, Hans Juergen; Mazur, Artur; Drabik, Anna; Montini, Giovanni

2015-04-01

To describe current practice among European paediatricians regarding diagnosis and management of urinary tract infections in children aged 1-36 months and to compare these practices with recently published guidelines. Web-based large scale survey evaluating knowledge of, attitudes towards and the methods for diagnosing, treating and managing urinary tract infections in children. Primary and secondary care practices in Europe. 1129 paediatricians. A diagnosis of urinary tract infection is considered by 62% of the respondents in children aged 1-36 months with unexplained fever. The preferred method of urine collection is use of a bag (53% for infants <3 months and 59% for children 4-36 months of age). 60% of paediatricians agree that oral and parenteral antibiotics have equal efficacy. Co-amoxiclav is the antibiotic of choice for 41% of participants, while 9% prescribe amoxicillin. 80% of respondents prescribe ultrasound in all children with a confirmed urinary tract infection. 63% of respondents prescribe a cystography when abnormalities are revealed during ultrasound evaluation. A quarter of respondents recommend antibiotic prophylaxis for all children with any vesicoureteral reflux. The data among European countries are very heterogeneous. The three most recent urinary tract infection guidelines (the National Institute for Health and Care Excellence (NICE), the American Academy of Paediatrics and the Italian Society of Paediatric Nephrology) are not followed properly. Management of febrile urinary tract infections remains controversial and heterogeneous in Europe. Simple, short, practical and easy-to-remember guidelines and educational strategies to ensure their implementation should be developed. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Correction to: Applicability and accuracy of pretest probability calculations implemented in the NICE clinical guideline for decision making about imaging in patients with chest pain of recent onset.

PubMed

Roehle, Robert; Wieske, Viktoria; Schuetz, Georg M; Gueret, Pascal; Andreini, Daniele; Meijboom, Willem Bob; Pontone, Gianluca; Garcia, Mario; Alkadhi, Hatem; Honoris, Lily; Hausleiter, Jörg; Bettencourt, Nuno; Zimmermann, Elke; Leschka, Sebastian; Gerber, Bernhard; Rochitte, Carlos; Schoepf, U Joseph; Shabestari, Abbas Arjmand; Nørgaard, Bjarne; Sato, Akira; Knuuti, Juhani; Meijs, Matthijs F L; Brodoefel, Harald; Jenkins, Shona M M; Øvrehus, Kristian Altern; Diederichsen, Axel Cosmus Pyndt; Hamdan, Ashraf; Halvorsen, Bjørn Arild; Rodriguez, Vladimir Mendoza; Wan, Yung Liang; Rixe, Johannes; Sheikh, Mehraj; Langer, Christoph; Ghostine, Said; Martuscelli, Eugenio; Niinuma, Hiroyuki; Scholte, Arthur; Nikolaou, Konstantin; Ulimoen, Geir; Zhang, Zhaoqi; Mickley, Hans; Nieman, Koen; Kaufmann, Philipp A; Buechel, Ronny Ralf; Herzog, Bernhard A; Clouse, Melvin; Halon, David A; Leipsic, Jonathan; Bush, David; Jakamy, Reda; Sun, Kai; Yang, Lin; Johnson, Thorsten; Laissy, Jean-Pierre; Marcus, Roy; Muraglia, Simone; Tardif, Jean-Claude; Chow, Benjamin; Paul, Narinder; Maintz, David; Hoe, John; de Roos, Albert; Haase, Robert; Laule, Michael; Schlattmann, Peter; Dewey, Marc

2018-06-01

The original version of this article, published on 19 March 2018, unfortunately contained a mistake. The following correction has therefore been made in the original: The names of the authors Philipp A. Kaufmann, Ronny Ralf Buechel and Bernhard A. Herzog were presented incorrectly.

Impact of NICE guidance on tamoxifen prescribing in England 2011-2017: an interrupted time series analysis.

PubMed

Curtis, Helen J; Walker, Alex J; Goldacre, Ben

2018-05-01

Tamoxifen was recommended by NICE in 2013 for chemoprevention of breast cancer, but a recent survey suggested only a quarter of GPs are aware of this. We set out to measure the uptake of tamoxifen, and the alternative raloxifene, in national prescribing data sets. Tamoxifen and raloxifene data were extracted from England's monthly prescribing data sets, October 2010-October 2017. We used interrupted time series analysis to reveal national and local responses to guidelines. We investigated variation between practices by calculating percentiles for prescribing rates and ratios of change. We found an increase in monthly tamoxifen prescribing following release of the guidelines, with an increase in gradient (p = 0.001) but no step change (p = 0.342). Alongside a small change in raloxifene prescribing we estimate 8450 women took up chemoprevention between 2013 and 2016. We did not find evidence that this was limited to a small group of practices. Our results suggest that the uptake of new guidance on chemoprevention has been slow and has potentially left women exposed to avoidable risk. Improving dissemination of guidance to healthcare professionals and routinely monitoring implementation could help reduce this risk.

Antimicrobial Stewardship

PubMed Central

King, Sarah; Exley, Josephine; Taylor, Jirka; Kruithof, Kristy; Larkin, Jody; Pardal, Mafalda

2016-01-01

Abstract RAND Europe undertook a systematic review of the evidence of effectiveness and cost effectiveness on changing the public's risk related behaviour pertaining to antimicrobial use to inform the development of a NICE public health guideline aimed at delaying antimicrobial resistance (AMR). The review considered educational interventions targeting individuals, communities or the general public delivered via any mode. Specifically, it aimed to address: 1. Which educational interventions are effective and cost-effective in changing the public's behaviour to ensure they only ask for antimicrobials when appropriate and use them correctly? 2. Which educational interventions are effective and cost-effective in changing the public's behaviour to prevent infection and reduce the spread of antimicrobial resistance? Overall, 60 studies met the inclusion criteria; 29 related to research question 1, and 36 related to research question 2 (five studies were applicable to both). The key findings are summarised in “Evidence Statements” in accordance with NICE guidelines. Evidence Statements provide a high level overview of the key features of the evidence including: the number of studies, the quality of evidence, and the direction of the estimated effect followed by a brief summary of each of the supporting studies. Studies are grouped into Evidence Statements by setting and intervention. PMID:28083399

[Applicability of "do not do recommendations" from the National Institute for Health and Care Excellence in a quaternary care hospital].

PubMed

Martin, S; Miñarro, R; Cano, P; Aranda, J M

2015-01-01

To qualitatively and quantitatively identify the level of agreement between the clinical staff of a quaternary care hospital and the National Institute for Health and Care Excellence (NICE) "do not do" recommendations, and to submit a strategic alternative for effective implementation. An ad hoc form was designed to evaluate level of clinical disagreement from the experience and knowledge of the clinical staff, as well as the applicability, usefulness, effectivity and efficiency of all the NICE "do not do" recommendations that had been published up to June 2012, checking their stability up to the July 2014 update. Description of the process of design and implementation of the strategic alternative to improve compliance is presented. The great majority (90%) of Clinical Unit directors agree with the NICE recommendations, with 64% finding them useful or very useful, 52% finding them applicable, and 32% and 34% thinking they are of high effectivity and efficiency, respectively. However, 20% of the efficient ones are not being applied. Moreover, knowledge discordances that might lead to clinical disagreements were detected. A strategic intervention, combining culture and incentives for good clinical practices, has been implemented. The improvement in the use of the good clinical practice recommendations is directly related to the agreement of its definition and evidence. An evaluation strategy of its application by the health professionals is essential to achieve an impact in avoidable costs. Moreover, to control for harmful effects of the economic impact on patient safety, it will be necessary to simultaneously evaluate clinical/health outcome indicators tightly linked to the applied recommendations. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

First line fertility treatment strategies regarding IUI and IVF require clinical evidence.

PubMed

Bahadur, G; Homburg, R; Muneer, A; Racich, P; Alangaden, T; Al-Habib, A; Okolo, S

2016-06-01

The advent of intracytoplasmic sperm injection (ICSI) has contributed to a significant growth in the delivery of assisted conception technique, such that IVF/ICSI procedures are now recommended over other interventions. Even the UK National Institute for Health Care Excellence (NICE) guidelines controversially recommends against intrauterine insemination (IUI) procedures in favour of IVF. We reflect on some of the clinical, economic, financial and ethical realities that have been used to selectively promote IVF over IUI, which is less intrusive and more patient friendly, obviates the need for embryo storage and has a global application. The evidence strongly favours IUI over IVF in selected couples and national funding strategies should include IUI treatment options. IUI, practised optimally as a first line treatment in up to six cycles, would also ease the pressures on public funds to allow the provision of up to three IVF cycles for couple who need it. Fertility clinics should also strive towards ISO15189 accreditation standards for basic semen diagnosis for male infertility used to triage ICSI treatment, to reduce the over-diagnosis of severe male factor infertility. Importantly, there is a need to develop global guidelines on inclusion policies for IVF/ICSI procedures. These suggestions are an ethically sound basis for constructing the provision of publicly funded fertility treatments. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Challenging current views on bile acid diarrhoea and malabsorption.

PubMed

Kurien, Matthew; Thurgar, Elizabeth; Davies, Ashley; Akehurst, Ron; Andreyev, Jervoise

2018-04-01

In 2012, the National Institute for Health and Care Excellence (NICE) assessed guidance (DG7) on the use of tauroselcholic ( 75 selenium) acid (also known as SeHCAT) for the investigation of diarrhoea due to bile acid malabsorption (BAM) in patients with IBS-D and in patients with Crohn's disease who have not had an ileal resection. NICE concluded that tauroselcholic ( 75 selenium) acid was recommended for use in research only. NICE will be reviewing the decision to update the guidance for tauroselcholic ( 75 selenium) acid, for these populations, in March 2017. Our aim is to summarise advances in BAM, also known as bile acid diarrhoea (BAD), and encourage clinicians to re-evaluate their understanding of this disorder. We review the prevalence, diagnosis and treatment of BAD/BAM. We describe the new evidence available since the original NICE review in 2012, and discuss the economic issues associated with failure to diagnose or to treat BAD/BAM accurately. There is new and compelling evidence available since DG7, which shows that tauroselcholic ( 75 selenium) acid scanning is a powerful tool in the diagnosis of BAD/BAM. We summarise published prevalence data (approximately 1% prevalence in the UK, as suggested by clinical practice diagnosis rates), and highlight that the true prevalence of BAD/BAM could be far greater than this. We present evidence that challenges current opinion about this disorder, and we commend both clinicians and health technology assessment (HTA) agencies for being open to arguments and new evidence in any future HTAs.

Blood transfusion practice in the UK and Ireland: a survey of palliative care physicians.

PubMed

Neoh, Karen; Stanworth, Simon; Bennett, Michael I

2018-03-23

Red cell (blood) transfusions are used in palliative care to manage patients with symptomatic anaemia or when patients have lost blood. We aimed to understand current blood transfusion practice among palliative medicine doctors and compare this with National Institute for Health and Care Excellence (NICE) guidance. NICE guidance advocates more restrictive transfusion practice but is based on clinical trials in non-palliative care contexts; the extent to which these findings should be applied to palliative care remains unclear. Four clinical vignettes of common clinical palliative care scenarios were developed. Members of the Association for Palliative Medicine were invited to complete the survey. Results were compared with acceptable responses based on current NICE recommendations and analysed to determine the influence of respondents' gender, experience or work setting. 27% of 1070 members responded. Overall, ideal or acceptable responses were selected by less than half of doctors to all four vignettes. Doctors were more liberal in prescribing blood transfusions than NICE guidance would advocate. Senior doctors were less likely to choose an acceptable response than junior colleagues. Palliative care practice is varied and not consistent with a restrictive blood transfusion policy. More recently trained doctors follow less liberal practices than senior colleagues. More direct evidence of benefits and harms of blood transfusion is needed in palliative care to inform practice. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Critical Imperative for the Reform of British Interpretation of Fetal Heart Rate Decelerations: Analysis of FIGO and NICE Guidelines, Post-Truth Foundations, Cognitive Fallacies, Myths and Occam's Razor.

PubMed

Sholapurkar, Shashikant L

2017-04-01

Cardiotocography (CTG) has disappointingly failed to show good predictability for fetal acidemia or neonatal outcomes in several large studies. A complete rethink of CTG interpretation will not be out of place. Fetal heart rate (FHR) decelerations are the most common deviations, benign as well as manifestation of impending fetal hypoxemia/acidemia, much more commonly than FHR baseline or variability. Their specific nomenclature is important (center-stage) because it provides the basic concepts and framework on which the complex "pattern recognition" of CTG interpretation by clinicians depends. Unfortunately, the discrimination of FHR decelerations seems to be muddled since the British obstetrics adopted the concept of vast majority of FHR decelerations being "variable" (cord-compression). With proliferation of confusing waveform criteria, "atypical variables" became the commonest cause of suspicious/pathological CTG. However, National Institute for Health and Care Excellence (NICE) (2014) had to disband the "typical" and "atypical" terminology because of flawed classifying criteria. This analytical review makes a strong case that there are major and fundamental framing and confirmation fallacies (not just biases) in interpretation of FHR decelerations by NICE (2014) and International Federation of Gynecology and Obstetrics (FIGO) (2015), probably the biggest in modern medicine. This "post-truth" approach is incompatible with scientific practice. Moreover, it amounts to setting oneself for failure. The inertia to change could be best described as "backfire effect". There is abundant evidence that head-compression (and other non-hypoxic mediators) causes rapid rather than shallow/gradual decelerations. Currently, the vast majority of decelerations are attributed to unproven cord compression underpinned by flawed disproven pathophysiological hypotheses. Their further discrimination based on abstract, random, trial and error criteria remains unresolved suggesting a false premise to begin with. This is not surprising considering that the commonest pathophysiology of intrapartum hypoxemia is contraction-induced reduction in uteroplacental perfusion (sometimes already compromised) and not cord compression at all. This distorted categorization causes confusion, false-alarm fatigue and difficulty in focusing on real pathological decelerations making CTG interpretation dysfunctional ultimately compromising patient safety. Obstetricians/midwives should demand reverting to the previous more scientific British categorization of decelerations based solely on time relationship to contractions as advocated by the pioneers like Hon and Caldeyro-Barcia, rather than accepting the current "post-truth" scenario.

Impact of NICE guidance on rates of haemorrhage after tonsillectomy: an evaluation of guidance issued during an ongoing national tonsillectomy audit.

PubMed

Audit, National Prospective Tonsillectomy

2008-08-01

The National Institute for Health and Clinical Excellence (NICE) issued guidance on surgical techniques for tonsillectomy during a national audit of surgical practice and postoperative complications. To assess the impact of the guidance on tonsillectomy practice and outcomes. An interrupted time-series analysis of routinely collected Hospital Episodes Statistics data, and an analysis of longitudinal trends in surgical technique using data from the National Prospective Tonsillectomy Audit. Patients undergoing tonsillectomy in English NHS hospitals between January 2002 and December 2004. Postoperative haemorrhage within 28 days. The rate of haemorrhage increased by 0.5% per year from 2002, reaching 6.4% when the guidance was published. After publication, the rate of haemorrhage fell immediately to 5.7% (difference 0.7%: 95% CI -1.3% to 0.0%) and the rate of increase appeared to have stopped. Data from the National Prospective Tonsillectomy Audit showed that the fall coincided with a shift in surgical techniques, which was consistent with the guidance. NICE guidance influenced surgical tonsillectomy technique and in turn produced an immediate fall in postoperative haemorrhage. The ongoing national audit and strong support from the surgical specialist association may have aided its implementation.

The diagnostic test accuracy of rectal examination for prostate cancer diagnosis in symptomatic patients: a systematic review.

PubMed

Jones, Daniel; Friend, Charlotte; Dreher, Andreas; Allgar, Victoria; Macleod, Una

2018-06-02

Prostate cancer is the most common cancer in men in the UK. NICE guidelines on recognition and referral of suspected cancer, recommend performing digital rectal examination (DRE) on patients with urinary symptoms and urgently referring if the prostate feels malignant. However, this is based on the results of one case control study, so it is not known if DRE performed in primary care is an accurate method of detecting prostate cancer. The aim of this review is to ascertain the sensitivity, specificity, positive and negative predictive value of DRE for the detection of prostate cancer in symptomatic patients in primary care. CENTRAL, MEDLINE, EMBASE and CINAHL databases were searched in august 2015 for studies in which a DRE was performed in primary care on symptomatic patients and compared against a reference diagnostic procedure. Four studies were included with a total of 3225 patients. The sensitivity and specificity for DRE as a predictor of prostate cancer in symptomatic patients was 28.6 and 90.7%, respectively. The positive and negative predictive values were 42.3 and 84.2%, respectively. This review found that DRE performed in general practice is accurate, and supports the UK NICE guidelines that patients with a malignant prostate on examination are referred urgently for suspected prostate cancer. Abnormal DRE carried a 42.3% chance of malignancy, above the 3% risk threshold which NICE guidance suggests warrants an urgent referral. However this review questions the benefit of performing a DRE in primary care in the first instance, suggesting that a patient's risk of prostate cancer based on symptoms alone would warrant urgent referral even if the DRE feels normal.

[Clinical guidelines for the management of schizophrenia:Aims and limitations (Ι)].

PubMed

Margariti, M; Hadjulis, M; Lazaridou, M; Angelidis, G F; Fotopoulos, V; Markaki, L; Koulouri, F

2017-01-01

The initiative for the development of national treatment guidelines, dates back to the '90s. In Greece, however, National Clinical Guidelines for the management of schizophrenia were first formulated in 2014 when a Working Group was set up for this purpose by the Greek Ministry of Health. The objective of this Working Group was to provide evidence-based recommendations covering the pharmacological and psychosocial treatment of schizophrenia as well as the development of appropriate treatment services. The Working Group utilized the NICE Guideline (National Institute of Clinical Excellence, 2010, 2014) for the management of Psychosis & Schizophrenia as the main guide to develop the Greek National Guidelines , and in addition the American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients with Schizophrenia (APA 2004), the Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for the treatment of schizophrenia and related disorders (Royal Australian and New Zealand College of Psychiatrists 2005) , as well as other relevant sources. The Working Group also took into consideration the available Greek bibliography as well as the external evaluations of the Greek psychiatric reform programs. A special effort was made to adapt the international experience to the current Greek landscape with the constraints resulting from the uneven dispersion of mental health services, the lack of coordination between services, the incomplete sectorization of mental health services provided as part of the National Health System, the still underdeveloped Primary Care Health Service, and last but not least the difficult economic situation in Greece. After the preparation of the draft guidelines, a thorough consultation followed with the relevant stakeholders, including mental health professionals, user associations and representatives of the Greek Ombudsman. Additionally, the Hellenic Psychiatric Association established an Expert Committee in Spring 2016, that contributed with its observations to the final exercise. This article will be followed by two further publications (incorporating the Hellenic Psychiatric Association comments) which include: (1) the summary recommendations regarding the pharmacological, psychological and psychosocial interventions in the treatment of schizophrenia, and (2) the summary recommendations regarding: (a) the role of primary health care service and the role of the family physician in the treatment of schizophrenia (b) the summary recommendations regarding continuity of care and c) the summary recommendations regarding community interventions with documented effectiveness in the treatment of schizophrenia.

Improving outcomes for people in mental health crisis: a rapid synthesis of the evidence for available models of care.

PubMed

Paton, Fiona; Wright, Kath; Ayre, Nigel; Dare, Ceri; Johnson, Sonia; Lloyd-Evans, Brynmor; Simpson, Alan; Webber, Martin; Meader, Nick

2016-01-01

Crisis Concordat was established to improve outcomes for people experiencing a mental health crisis. The Crisis Concordat sets out four stages of the crisis care pathway: (1) access to support before crisis point; (2) urgent and emergency access to crisis care; (3) quality treatment and care in crisis; and (4) promoting recovery. To evaluate the clinical effectiveness and cost-effectiveness of the models of care for improving outcomes at each stage of the care pathway. Electronic databases were searched for guidelines, reviews and, where necessary, primary studies. The searches were performed on 25 and 26 June 2014 for NHS Evidence, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, NHS Economic Evaluation Database, and the Health Technology Assessment (HTA) and PROSPERO databases, and on 11 November 2014 for MEDLINE, PsycINFO and the Criminal Justice Abstracts databases. Relevant reports and reference lists of retrieved articles were scanned to identify additional studies. When guidelines covered a topic comprehensively, further literature was not assessed; however, where there were gaps, systematic reviews and then primary studies were assessed in order of priority. Systematic reviews were critically appraised using the Risk Of Bias In Systematic reviews assessment tool, trials were assessed using the Cochrane risk-of-bias tool, studies without a control group were assessed using the National Institute for Health and Care Excellence (NICE) prognostic studies tool and qualitative studies were assessed using the Critical Appraisal Skills Programme quality assessment tool. A narrative synthesis was conducted for each stage of the care pathway structured according to the type of care model assessed. The type and range of evidence identified precluded the use of meta-analysis. One review of reviews, six systematic reviews, nine guidelines and 15 primary studies were included. There was very limited evidence for access to support before crisis point. There was evidence of benefits for liaison psychiatry teams in improving service-related outcomes in emergency departments, but this was often limited by potential confounding in most studies. There was limited evidence regarding models to improve urgent and emergency access to crisis care to guide police officers in their Mental Health Act responsibilities. There was positive evidence on clinical effectiveness and cost-effectiveness of crisis resolution teams but variability in implementation. Current work from the Crisis resolution team Optimisation and RElapse prevention study aims to improve fidelity in delivering these models. Crisis houses and acute day hospital care are also currently recommended by NICE. There was a large evidence base on promoting recovery with a range of interventions recommended by NICE likely to be important in helping people stay well. Most evidence was rated as low or very low quality, but this partly reflects the difficulty of conducting research into complex interventions for people in a mental health crisis and does not imply that all research was poorly conducted. However, there are currently important gaps in research for a number of stages of the crisis care pathway. Particular gaps in research on access to support before crisis point and urgent and emergency access to crisis care were found. In addition, more high-quality research is needed on the clinical effectiveness and cost-effectiveness of mental health crisis care, including effective components of inpatient care, post-discharge transitional care and Community Mental Health Teams/intensive case management teams. This study is registered as PROSPERO CRD42014013279. The National Institute for Health Research HTA programme.

A Diet Low in Fermentable Oligo-, Di-, and Monosaccharides and Polyols Improves Quality of Life and Reduces Activity Impairment in Patients With Irritable Bowel Syndrome and Diarrhea.

PubMed

Eswaran, Shanti; Chey, William D; Jackson, Kenya; Pillai, Sivaram; Chey, Samuel W; Han-Markey, Theresa

2017-12-01

We investigated the effects of a diet low in fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) vs traditional dietary recommendations on health-related quality of life (QOL), anxiety and depression, work productivity, and sleep quality in patients with irritable bowel syndrome and diarrhea (IBS-D). We conducted a prospective, single-center, single-blind trial of 92 adult patients with IBS-D (65 women; median age, 42.6 years) randomly assigned to groups placed on a diet low in FODMAPs or a modified diet recommended by the National Institute for Health and Care Excellence (mNICE) for 4 weeks. IBS-associated QOL (IBS-QOL), psychosocial distress (based on the Hospital Anxiety and Depression Scale), work productivity (based on the Work Productivity and Activity Impairment), and sleep quality were assessed before and after diet periods. Eighty-four patients completed the study (45 in the low-FODMAP group and 39 in the mNICE group). At 4 weeks, patients on the diet low in FODMAPs had a larger mean increase in IBS-QOL score than did patients on the mNICE diet (15.0 vs 5.0; 95% CI, -17.4 to -4.3). A significantly higher proportion of patients in the low-FODMAP diet group had a meaningful clinical response, based on IBS-QOL score, than in the mNICE group (52% vs 21%; 95% CI, -0.52 to -0.08). Anxiety scores decreased in the low-FODMAP diet group compared with the mNICE group (95% CI, 0.46-2.80). Activity impairment was significantly reduced with the low-FODMAP diet (-22.89) compared with the mNICE diet (-9.44; 95% CI, 2.72-24.20). In a randomized, controlled trial, a diet low in FODMAPs led to significantly greater improvements in health-related QOL, anxiety, and activity impairment compared with a diet based on traditional recommendations for patients with IBS-D. ClinicalTrials.gov, number NCT01624610. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

NICE recommendations for psychotherapy in depression: Of limited clinical utility.

PubMed

McQueen, D; Smith, P St John

2015-01-01

In 2009/10 NICE partially updated its guidelines on the treatment and management of depression in adults. Due to methodological shortcomings the recommendations for psychotherapy must be treated with caution. Despite recognising the heterogeneous and comorbid nature of depression, and the limitations of depression as a unitary diagnostic category, NICE treats depression as if it were a unitary entity differentiated only by severity. The guidance ignores important aetiological factors such as trauma, loss and maltreatment, personality and interpersonal difficulties. It excludes the largest naturalistic studies on clinical populations treated in the National Health Service on the grounds that they are observational studies conducted in heterogeneous groups with mixed neurotic disorders. It unquestioningly accepts that the "brand" of psychotherapy has construct validity, and ignores psychotherapy process research indicating significant commonalities, and overlap, between treatment modalities and evidence that individual practitioner effects are larger than the differences between treatment modalities. It fails to consider patient differences and preferences, which are known to influence uptake, completion and response. It takes an exclusively short-term perspective on a chronic relapsing disorder. It does not consider the evidence for longer-term treatments. It is of special concern that NICE misrepresents the findings of its own systematic review by implying that CBT and IPT are superior treatments. NICE's systematic review actually found no evidence of superiority between CBT, IPT, psychodynamic psychotherapy, or counselling. Based on the exclusion of much clinically relevant research demonstrating the effectiveness of psychodynamic psychotherapy and counselling many commentators have alleged a bias towards CBT in the guidance. With regard to service delivery NICE proposes the replacement of psychiatric assessment and individualised treatment plans, with an unproven stepped-care model. These clinical and theoretical limitations, perceived bias in the selection of studies, neglect of patient differences, preferences and values, misrepresentation of results of the systematic review, and the proposal for an unproven service delivery model together seriously undermine the validity of the guidance. The guidance, lacking validity is of questionable use, it undermines patient autonomy, professional expertise and, ultimately, patient welfare.

Introduction into the NHS of magnetic sphincter augmentation: an innovative surgical therapy for reflux - results and challenges.

PubMed

Prakash, D; Campbell, B; Wajed, S

2018-04-01

Introduction Gastro-oesophageal reflux disease (GORD) is a common, chronic debilitating condition. Surgical management traditionally involves fundoplication. Magnetic sphincter augmentation (MSA) is a new definitive treatment. We describe our experience of introducing this innovative therapy into NHS practice and report the early clinical outcomes. Methods MSA was introduced into NHS practice following successful acceptance of a cost-effective business plan and close observation of National Institute for Health and Care Excellence (NICE) recommendations for new procedures, including a carefully planned prospective data collection over a two-year follow-up period. Results Forty-seven patients underwent MSA over the 40-month period. Reflux health-related quality of life (GERD-HRQL) was significantly improved after the procedure and maintained at one- and two-year (P < 0.0001) follow-up. Drug dependency went from 100% at baseline to 2.6% and 8.7% after one and two years. High levels of patient satisfaction were reported. There were no adverse events. Conclusions MSA is highly effective in the treatment of uncomplicated GORD, with durable results and an excellent safety profile. This laparoscopic, minimally invasive procedure provides a good alternative for patients where surgical anatomy is unaltered. Our experience demonstrates that innovative technology can be incorporated into NHS practice with an acceptable business plan and compliance with NICE recommendations.

NICE-Accredited Commissioning Guidance for Weight Assessment and Management Clinics: a Model for a Specialist Multidisciplinary Team Approach for People with Severe Obesity.

PubMed

Welbourn, Richard; Dixon, John; Barth, Julian H; Finer, Nicholas; Hughes, Carly A; le Roux, Carel W; Wass, John

2016-03-01

Despite increasing prevalence of obesity, no country has successfully implemented comprehensive pathways to provide advice to all the severely obese patients that seek treatment. We aimed to formulate pathways for referral into and out of weight assessment and management clinics (WAMCs) that include internal medicine/primary care physicians as part of a multidisciplinary team that could provide specialist advice and interventions, including referral for bariatric surgery. Using a National Institute of Health and Care Excellence (NICE)-accredited process, a Guidance Development Group conducted a literature search identifying existing WAMCs. As very few examples of effective structures and clinical pathways existed, the current evidence base for optimal assessment and management of bariatric surgery patients was used to reach a consensus. The model we describe could be adopted internationally by health services to manage severely obese patients.

Peer-teaching of evidence-based medicine.

PubMed

Rees, Eliot; Sinha, Yashashwi; Chitnis, Abhishek; Archer, James; Fotheringham, Victoria; Renwick, Stephen

2014-07-01

Many medical schools teach the principles of evidence-based medicine (EBM) as part of their undergraduate curriculum. Medical students perceive that EBM is valuable to their undergraduate and postgraduate career. Students may experience barriers to applying EBM principles, especially when searching for evidence or identifying high-quality resources. The UK National Institute for Health and Care Excellence (NICE) Evidence Search is a service that enables access to authoritative clinical and non-clinical evidence and best practice through a web-based portal. Evidence-based medicine workshops were organised and delivered by fourth-year medical students, having first received training from NICE to become NICE student champions. The workshops covered the basic principles of EBM and focused on retrieving EBM resources for study through the NICE Evidence Search portal. The scheme was evaluated using a pre-workshop survey and an 8-12 week post-workshop survey. Self-reported confidence in searching for evidence-based resources increased from 29 per cent before the workshop to 87 per cent after the workshop. Only 1 per cent of students rated evidence-based resources as their first preference pre-workshop, compared with 31 per cent post-workshop. The results show that although many students were aware of evidence-based resources, they tended not to use them as their preferred resource. Despite appreciating the value of evidence-based resources, few students were confident in accessing and using such resources for pre-clinical study. A peer-taught workshop in EBM improved students' confidence with, and use of, evidence-based resources. © 2014 John Wiley & Sons Ltd.

Having your cake and eating it: office of fair trading proposal for funding new drugs to benefit patients and innovative companies.

PubMed

Godman, Brian; Haycox, Alan; Schwabe, Ulrich; Joppi, Roberta; Garattini, Silvio

2008-01-01

There are insufficient resources in the UK to fund all new technologies and new indications approved by the National Institute for Health and Clinical Excellence (NICE). Diverting funding from existing sources will have a detrimental effect on the provision of other priority services. The UK Office of Fair Trading (OFT) recently suggested a value-based pricing approach that appears workable but has generated considerable debate. Their proposal of a 25% premium for the originator product once generics are available is more generous than seen in a number of other European countries, where typically only the lowest priced product is reimbursed. The OFT proposal for a maximum 50% premium for patent-protected products, versus the prices of generics in a class or related classes, is also more generous than the proposed reforms for the pricing of proton pump inhibitors in Sweden or current reforms in Germany. In our opinion, the OFT proposals are persuasive and in accordance with the reforms seen in other European countries, and therefore should be adopted. The alternatives to fully funding new drugs or new indications as approved by NICE are either tightening the cost per QALY threshold, giving NICE an annual national budget to fund its advice alongside suggested areas for disinvestment, proactively switching patients from high-cost brand-name drugs to generics, or further delaying funding for new drugs and new indications approved by NICE. The majority of these suggestions are not in the best interests of patients or innovative pharmaceutical companies seeking to reap the rewards of their efforts.

The MAGEC system for spinal lengthening in children with scoliosis: A NICE Medical Technology Guidance.

PubMed

Jenks, Michelle; Craig, Joyce; Higgins, Joanne; Willits, Iain; Barata, Teresa; Wood, Hannah; Kimpton, Christine; Sims, Andrew

2014-12-01

Scoliosis-structural lateral curvature of the spine-affects around four children per 1,000. The MAGEC system comprises a magnetically distractible spinal rod implant and an external remote controller, which lengthens the rod; this system avoids repeated surgical lengthening. Rod implants brace the spine internally and are lengthened as the child grows, preventing worsening of scoliosis and delaying the need for spinal fusion. The Medical Technologies Advisory Committee at the National Institute for Health and Care Excellence (NICE) selected the MAGEC system for evaluation in a NICE medical technologies guidance. Six studies were identified by the sponsor (Ellipse Technologies Inc.) as being relevant to the decision problem. Meta-analysis was used to compare the clinical evidence results with those of one conventional growth rod study, and equal efficacy of the two devices was concluded. The key weakness was selection of a single comparator study. The External Assessment Centre (EAC) identified 16 conventional growth rod studies and undertook meta-analyses of relevant outcomes. Its critique highlighted limitations around study heterogeneity and variations in baseline characteristics and follow-up duration, precluding the ability to draw firm conclusions. The sponsor constructed a de novo costing model showing that MAGEC rods generated cost savings of £9,946 per patient after 6 years, compared with conventional rods. The EAC critiqued and updated the model structure and inputs, calculating robust cost savings of £12,077 per patient with MAGEC rods compared with conventional rods over 6 years. The year of valuation was 2012. NICE issued a positive recommendation as supported by the evidence (Medical Technologies Guidance 18).

Low-dose-rate brachytherapy for the treatment of localised prostate cancer in men with a high risk of disease relapse.

PubMed

Laing, Robert; Uribe, Jennifer; Uribe-Lewis, Santiago; Money-Kyrle, Julian; Perna, Carla; Chintzoglou, Stylianos; Khaksar, Sara; Langley, Stephen E M

2018-04-01

To report clinical outcomes of 125 I low-dose-rate prostate brachytherapy (LDR-PB) as monotherapy or combined with androgen-deprivation therapy (ADT) and/or external beam radiotherapy (EBRT) in high-risk localised prostate cancer. Analysis of clinical outcomes from a prospective cohort of patients treated with LDR-PB alone or combined treatment in a single institution. Men with a high risk of disease relapse were identified by the National Institute for Health and Care Excellence (NICE) criteria or by the National Comprehensive Cancer Network (NCCN) criteria. Relapse-free survival (RFS), overall survival (OS), prostate cancer-specific survival (PCSS), and metastases-free survival (MFS), were analysed together with patient-reported symptom scores and physician-reported adverse events. The NICE and NCCN criteria identified 267 and 202 high-risk patients, respectively. NICE-defined patients had significantly lower pre-treatment PSA levels, Gleason scores <7, and a greater proportion of patients who received LDR-PB monotherapy. At 9 years after implantation RFS was 89% and 87% in the NICE and NCCN groups, respectively (log-rank P = 0.637), and OS 93% and 94%, respectively (log-rank P = 0.481). All of the survival estimates were similar between LDR-PB monotherapy and combined therapies. Cox proportional hazards regression confirmed RFS was similar between the treatment types. Treatment-related toxicity was also similar between the treatment methods. LDR-PB is effective at controlling localised prostate cancer in patients with a high risk of disease relapse. As the present study was not randomised, it is not possible to define those patients who need the addition of ADT and/or EBRT. However, the NICE criteria appear suitable to define treatment options where patients could benefit from LDR-PB as monotherapy or combined treatment. This choice should be discussed with the patient taking into account comorbidities and presence of multiple high-risk factors. © 2018 The Authors BJU International © 2018 BJU International Published by John Wiley & Sons Ltd.

Diagnosis of gestational diabetes mellitus: falling through the net.

PubMed

Meek, Claire L; Lewis, Hannah B; Patient, Charlotte; Murphy, Helen R; Simmons, David

2015-09-01

Gestational diabetes mellitus (GDM) is associated with increased risks to mother and child, but globally agreed diagnostic criteria remain elusive. Identification of women with GDM is important, as treatment reduces adverse outcomes such as perinatal death, shoulder dystocia and neonatal hypoglycaemia. Recently, the UK's National Institute for Health and Care Excellence (NICE) recommended new diagnostic thresholds for GDM which are different from the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria endorsed by the WHO. The study aim was to assess neonatal and obstetric outcomes among women who would test positive for the IADPSG criteria but negative for the NICE 2015 criteria. Data from 25,543 consecutive singleton live births (2004-2008) were obtained retrospectively from hospital records. Women were screened with a random plasma glucose (RPG; 12-16 weeks) and a 50 g glucose challenge test (GCT; 26-28 weeks). If RPG >7.0 mmol/l, GCT >7.7 mmol/l or symptoms were present, a 75 g OGTT was offered (n = 3,848). In this study, GDM prevalence was 4.13% (NICE 2015) and 4.62% (IADPSG). Women who 'fell through the net', testing NICE-negative but IADPSG-positive (n = 387), had a higher risk of having a large-for-gestational-age (LGA) infant (birthweight >90th percentile for gestational age; adjusted OR [95% CI] 3.12 [2.44, 3.98]), Caesarean delivery (1.44 [1.15, 1.81]) and polyhydramnios (6.90 [3.94, 12.08]) compared with women with negative screening results and no OGTT (n = 21,695). LGA risk was highest among women with fasting plasma glucose 5.1-5.5 mmol/l (n = 167): the mean birthweight was 350 g above that of the reference population and 37.7% of infants were LGA. The IADPSG criteria identify women at substantial risk of complications who would not be identified by the NICE 2015 criteria.

Sensitivity analysis in economic evaluation: an audit of NICE current practice and a review of its use and value in decision-making.

PubMed

Andronis, L; Barton, P; Bryan, S

2009-06-01

To determine how we define good practice in sensitivity analysis in general and probabilistic sensitivity analysis (PSA) in particular, and to what extent it has been adhered to in the independent economic evaluations undertaken for the National Institute for Health and Clinical Excellence (NICE) over recent years; to establish what policy impact sensitivity analysis has in the context of NICE, and policy-makers' views on sensitivity analysis and uncertainty, and what use is made of sensitivity analysis in policy decision-making. Three major electronic databases, MEDLINE, EMBASE and the NHS Economic Evaluation Database, were searched from inception to February 2008. The meaning of 'good practice' in the broad area of sensitivity analysis was explored through a review of the literature. An audit was undertaken of the 15 most recent NICE multiple technology appraisal judgements and their related reports to assess how sensitivity analysis has been undertaken by independent academic teams for NICE. A review of the policy and guidance documents issued by NICE aimed to assess the policy impact of the sensitivity analysis and the PSA in particular. Qualitative interview data from NICE Technology Appraisal Committee members, collected as part of an earlier study, were also analysed to assess the value attached to the sensitivity analysis components of the economic analyses conducted for NICE. All forms of sensitivity analysis, notably both deterministic and probabilistic approaches, have their supporters and their detractors. Practice in relation to univariate sensitivity analysis is highly variable, with considerable lack of clarity in relation to the methods used and the basis of the ranges employed. In relation to PSA, there is a high level of variability in the form of distribution used for similar parameters, and the justification for such choices is rarely given. Virtually all analyses failed to consider correlations within the PSA, and this is an area of concern. Uncertainty is considered explicitly in the process of arriving at a decision by the NICE Technology Appraisal Committee, and a correlation between high levels of uncertainty and negative decisions was indicated. The findings suggest considerable value in deterministic sensitivity analysis. Such analyses serve to highlight which model parameters are critical to driving a decision. Strong support was expressed for PSA, principally because it provides an indication of the parameter uncertainty around the incremental cost-effectiveness ratio. The review and the policy impact assessment focused exclusively on documentary evidence, excluding other sources that might have revealed further insights on this issue. In seeking to address parameter uncertainty, both deterministic and probabilistic sensitivity analyses should be used. It is evident that some cost-effectiveness work, especially around the sensitivity analysis components, represents a challenge in making it accessible to those making decisions. This speaks to the training agenda for those sitting on such decision-making bodies, and to the importance of clear presentation of analyses by the academic community.

[CT scans in children with head/brain injury: five years after the revision of the guideline on "mild traumatic head/brain injury"].

PubMed

Hageman, G Gerard

2015-01-01

In 2010 the guideline on mild traumatic head/ brain injury for both adults and children was revised under the supervision of the Dutch Neurology Society. The revised guideline endorsed rules for decisions on whether to carry out diagnostic imaging investigations (brain CT scanning) and formulates indications for admission. Unfortunately, 5 years after its introduction, it is clear that the guideline rules result in excessive brain CT scanning, in which no more serious head injury is diagnosed. Brain injury may be present in (small) children even if symptoms are absent at first presentation. Also, clinical signs do not predict intracranial complications. This was nicely demonstrated in a study by Tilma, Bekhof and Brand of 410 children with mTBI: no clinical symptom or sign reliably predicted the risk of intracranial bleeding. They advise hospitalisation for observation instead of brain CT scanning. It may be necessary to review part of the Dutch guideline on mTBI.

Impact of stent diameter and length on in-stent restenosis after DES vs BMS implantation in patients needing large coronary stents-A clinical and health-economic evaluation.

PubMed

Zbinden, Rainer; von Felten, Stefanie; Wein, Bastian; Tueller, David; Kurz, David J; Reho, Ivano; Galatius, Soren; Alber, Hannes; Conen, David; Pfisterer, Matthias; Kaiser, Christoph; Eberli, Franz R

2017-02-01

The British National Institute of Clinical Excellence (NICE) guidelines recommend to use drug-eluting stents (DES) instead of bare-metal stents (BMS) only in lesions >15 mm in length or in vessels <3 mm in diameter. We analyzed the impact of stent length and stent diameter on in-stent restenosis (ISR) in the BASKET-PROVE study population and evaluated the cost-effectiveness of DES compared to BMS. The BASKET-PROVE trial compared DES vs BMS in large coronary arteries (≥3 mm). We calculated incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves with regard to quality-adjusted life years (QALYs) gained and target lesion revascularizations (TLRs) avoided. A total of 2278 patients were included in the analysis. A total of 74 ISR in 63 patients were observed. In-stent restenosis was significantly more frequent in segments treated with a BMS compared to segments treated with a DES (5.4% vs 0.76%; P<.001). The benefit of a DES compared to a BMS regarding ISR was consistent among the subgroups of stent length >15 mm and ≤15 mm, respectively. With the use of DES in short lesions, there was only a minimal gain of 0.005 in QALYs. At a threshold of 10 000 CHF per TLR avoided, DES had a high probability of being cost-effective. In the BASKET-PROVE study population, the strongest predictor of ISR is the use of a BMS, even in patients in need of stents ≥3.0 mm and ≤15 mm lesion length and DES were cost-effective. This should prompt the NICE to reevaluate its recommendation to use DES instead of BMS only in vessels <3.0 mm and lesions >15 mm length. © 2016 John Wiley & Sons Ltd.

Lenalidomide for the Treatment of Low- or Intermediate-1-Risk Myelodysplastic Syndromes Associated with Deletion 5q Cytogenetic Abnormality: An Evidence Review of the NICE Submission from Celgene.

PubMed

Blommestein, Hedwig M; Armstrong, Nigel; Ryder, Steve; Deshpande, Sohan; Worthy, Gill; Noake, Caro; Riemsma, Rob; Kleijnen, Jos; Severens, Johan L; Al, Maiwenn J

2016-01-01

The National Institute for Health and Care Excellence (NICE) invited the manufacturer of lenalidomide (Celgene) to submit evidence of the clinical and cost effectiveness of the drug for treating adults with myelodysplastic syndromes (MDS) associated with deletion 5q cytogenetic abnormality, as part of the Institute's single technology appraisal (STA) process. Kleijnen Systematic Reviews Ltd (KSR), in collaboration with Erasmus University Rotterdam, was commissioned to act as the Evidence Review Group (ERG). This paper describes the company's submission, the ERG review, and the NICE's subsequent decisions. The ERG reviewed the evidence for clinical and cost effectiveness of the technology, as submitted by the manufacturer to the NICE. The ERG searched for relevant additional evidence and validated the manufacturer's decision analytic model to examine the robustness of the cost-effectiveness results. Clinical effectiveness was obtained from a three-arm, European, randomized, phase III trial among red blood cell (RBC) transfusion-dependent patients with low-/intermediate-1-risk del5q31 MDS. The primary endpoint was RBC independence for ≥26 weeks, and was reached by a higher proportion of patients in the lenalidomide 10 and 5 mg groups compared with placebo (56.1 and 42.6 vs 5.9 %, respectively; both p < 0.001). The option of dose adjustments after 16 weeks due to dose-limiting toxicities or lack of response made long-term effectiveness estimates unreliable, e.g. overall survival (OS). The de novo model of the manufacturer included a Markov state-transition cost-utility model implemented in Microsoft Excel. The base-case incremental cost-effectiveness ratio (ICER) of the manufacturer was £56,965. The ERG assessment indicated that the modeling structure represented the course of the disease; however, a few errors were identified and some of the input parameters were challenged. In response to the appraisal documentation, the company revised the economic model, which increased the ICER to £68,125 per quality-adjusted life-year. The NICE Appraisal Committee (AC) did not recommend lenalidomide as a cost-effective treatment. Subsequently, the manufacturer submitted a Patient Access Scheme (PAS) that provided lenalidomide free of charge for patients who remained on treatment after 26 cycles. This PAS improved the ICER to £25,300, although the AC considered the proportion of patients who received treatment beyond 26 cycles, and hence the ICER, to be uncertain. Nevertheless, the AC accepted a commitment from the manufacturer to publish, once available, data on the proportion of patients eligible for the PAS, and believed this provided reassurance that lenalidomide was a cost-effective treatment for low- or intermediate-1-risk MDS patients.

Reducing the overuse of βhCG measurements in the emergency gynaecology clinic.

PubMed

Frost, Lucy

2016-01-01

Serial βhCG testing can be a helpful tool in deciding how to manage pregnancy of unknown location. Its use in emergency gynaecology clinics can prevent unnecessary admission and intervention. However, despite NICE Guidelines on when it is safe to opt for conservative management, it was identified that there was a problem with over-testing of βhCG when patients could be discharged with instructions to repeat a urinary pregnancy test in two weeks. Two PDSA cycles were undertaken to improve the awareness of NICE guidelines: the first involved formal and informal educational sessions and the second involved the inclusion of a guideline summary on the front of patients' notes when they were having serial βhCG tests for doctors to refer to. Case notes were reviewed for 157 women who had βhCG tests at baseline and 48 hours. Of these, 139 were suitable for serial βhCG testing, and 83 of these were suitable for discharge after 48 hours. Of the 83 patients that were eligible for discharge, there were 31 unnecessary βhCG tests done, 23 of which were prior to intervention. A significant improvement was noted, with between 4-10 unnecessary βhCG tests per fortnight prior to intervention, 0-3 following the first intervention, and 0-2 following the second. Reduction in unnecessary βhCG testing has positive implications for patients, who do not have to take unnecessary time off work, prolong an already very distressing period, and have unnecessary blood tests. There are also cost and time saving implications for the hospital.

Olaratumab in Combination with Doxorubicin for the Treatment of Advanced Soft Tissue Sarcoma: An Evidence Review Group Perspective of a National Institute for Health and Care Excellence Single Technology Appraisal.

PubMed

Tikhonova, Irina A; Jones-Hughes, Tracey; Dunham, James; Warren, Fiona C; Robinson, Sophie; Stephens, Peter; Hoyle, Martin

2018-01-01

The manufacturer of olaratumab (Lartruvo ® ), Eli Lilly & Company Limited, submitted evidence for the clinical and cost effectiveness of this drug, in combination with doxorubicin, for untreated advanced soft tissue sarcoma (STS) not amenable to surgery or radiotherapy, as part of the National Institute for Health and Care Excellence (NICE) Single Technology Appraisal process. The Peninsula Technology Assessment Group, commissioned to act as the Evidence Review Group (ERG), critically reviewed the company's submission. Clinical effectiveness evidence for the company's analysis was derived from an open-label, randomised controlled trial, JGDG. The analysis was based on a partitioned survival model with a time horizon of 25 years, and the perspective was of the UK National Health Service (NHS) and Personal Social Services. Costs and benefits were discounted at 3.5% per year. Given the available evidence, olaratumab is likely to meet NICE's end-of-life criteria. To improve the cost effectiveness of olaratumab, the company offered a discount through a Commercial Access Agreement (CAA) with the NHS England. When the discount was applied, the mean base-case and probabilistic incremental cost-effectiveness ratios (ICERs) for olaratumab plus doxorubicin versus the standard-of-care doxorubicin were £46,076 and £47,127 per quality-adjusted life-year (QALY) gained, respectively; the probability of this treatment being cost effective at the willingness-to-pay threshold of £50,000 per QALY gained, applicable to end-of-life treatments, was 0.54. The respective ICERs from the ERG's analysis were approximately £60,000/QALY gained, and the probability of the treatment being cost effective was 0.21. In August 2017, the NICE Appraisal Committee recommended olaratumab in combination with doxorubicin for this indication for use via the UK Cancer Drugs Fund under the agreed CAA until further evidence being collected in the ongoing phase III trial-ANNOUNCE-becomes available in December 2020.

Spot protein-creatinine ratio and spot albumin-creatinine ratio in the assessment of pre-eclampsia: a diagnostic accuracy study with decision-analytic model-based economic evaluation and acceptability analysis.

PubMed

Waugh, Jason; Hooper, Richard; Lamb, Edmund; Robson, Stephen; Shennan, Andrew; Milne, Fiona; Price, Christopher; Thangaratinam, Shakila; Berdunov, Vladislav; Bingham, Jenn

2017-10-01

The National Institute for Health and Care Excellence (NICE) guidelines highlighted the need for 'large, high-quality prospective studies comparing the various methods of measuring proteinuria in women with new-onset hypertensive disorders during pregnancy'. The primary objective was to evaluate quantitative assessments of spot protein-creatinine ratio (SPCR) and spot albumin-creatinine ratio (SACR) in predicting severe pre-eclampsia (PE) compared with 24-hour urine protein measurement. The secondary objectives were to investigate interlaboratory assay variation, to evaluate SPCR and SACR thresholds in predicting adverse maternal and fetal outcomes and to assess the cost-effectiveness of these models. This was a prospective diagnostic accuracy cohort study, with decision-analytic modelling and a cost-effectiveness analysis. The setting was 36 obstetric units in England, UK. Pregnant women (aged ≥ 16 years), who were at > 20 weeks' gestation with confirmed gestational hypertension and trace or more proteinuria on an automated dipstick urinalysis. Women provided a spot urine sample for protein analysis (the recruitment sample) and were asked to collect a 24-hour urine sample, which was stored for secondary analysis. A further spot sample of urine was taken immediately before delivery. Outcome data were collected from hospital records. There were four index tests on a spot sample of urine: (1) SPCR test (conducted at the local laboratory); (2) SPCR test [conducted at the central laboratory using the benzethonium chloride (BZC) assay]; (3) SPCR test [conducted at the central laboratory using the pyrogallol red (PGR) assay]; and (4) SACR test (conducted at the central laboratory using an automated chemistry analyser). The comparator tests on 24-hour urine collection were a central test using the BZC assay and a central test using the PGR assay. The primary reference standard was the NICE definition of severe PE. Secondary reference standards were a clinician diagnosis of severe PE, which is defined as treatment with magnesium sulphate or with severe PE protocol; adverse perinatal outcome; one or more of perinatal or infant mortality, bronchopulmonary dysplasia, necrotising enterocolitis or grade III/IV intraventricular haemorrhage; and economic cost and outcomes. Health service data on service use and costs followed published economic models. In total, 959 women were available for primary analysis and 417 of them had severe PE. The diagnostic accuracy of the four assays on spot urine samples against the reference standards was similar. The three SPCR tests had sensitivities in excess of 90% at prespecified thresholds, with poor specificities and negative likelihood ratios of ≥ 0.1. The SACR test had a significantly higher sensitivity of 99% (confidence interval 98% to 100%) and lower specificity. Receiver operating characteristic (ROC) curves were similar (area under ROC curve between 0.87 and 0.89); the area under the central laboratory's SACR curve was significantly higher ( p  = 0.004). The central laboratory's SACR test was the most cost-effective option, generating an additional 0.03 quality-adjusted life-years at an additional cost of £45.07 compared with the local laboratory's SPCR test. The probabilistic analysis showed it to have a 100% probability of being cost-effective at the standard willingness-to-pay threshold recommended by NICE. Implementation of NICE guidelines has led to an increased intervention rate in the study population that affected recruitment rates and led to revised sample size calculations. Evidence from this clinical study does not support the recommendation of 24-hour urine sample collection in hypertensive pregnant women. The SACR test had better diagnostic performance when predicting severe pre-eclampsia. All four tests could potentially be used as rule-out tests for the NICE definition of severe PE. Testing SACR at a threshold of 8 mg/mmol should be studied as a 'rule-out' test of proteinuria. Current Controlled Trials ISRCTN82607486. This project was funded by the National Institute Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 21, No. 61. See the NIHR Journals Library website for further project information.

Health technology adoption and the politics of governance in the UK.

PubMed

Milewa, Timothy

2006-12-01

The manner in which clinical and cost-effectiveness data are used to inform decisions about the funding and availability of drugs, therapies and medical devices is inherently politicised within collectively financed systems of health care. The National Institute for Health and Clinical Excellence (NICE) was established by the British government in 1999 to reach evidence-based decisions on whether selected health technologies should be made available by the National Health Service in England and Wales. But NICE is also required to involve a broad range of interested parties in the decision-making process, provide detailed rationales for its rulings and defend appeals from aggrieved parties. Debates about the emergence of "deliberative" forms of policy governance--based upon participation by a broad range of stakeholders rather than reliance on scientific, bureaucratic or political expertise alone--are thus particularly apposite. This article draws on a study of decision-making within NICE by focusing upon the tenor and orientation of deliberation about the adoption of health technologies. Does such deliberation take place upon a level playing field for different interests? Or do implicit parameters and understandings in the deliberative process tend to privilege some interests by structuring debate and attendant outcomes? Findings suggest that deliberative assumptions and parameters pertaining to fluid and contestable ideas of transparent reasoning and domain competence both reflect and shape relationships of influence and marginality among participants. Broader analytical implications centre on a distinction between "deliberative democracy" and "democratic deliberation". The extent to which this distinction is acknowledged and addressed in policy and practise will have marked implications for the substantive nature of attempts to broaden involvement in decision-making within public sector bodies such as NICE.

Integrating health technology assessment requirements in the clinical development of medicines: the experience from NICE scientific advice.

PubMed

Maignen, François; Osipenko, Leeza; Pinilla-Dominguez, Pilar; Crowe, Emily

2017-03-01

The primary objective of the study was to analyse the proposed clinical development and economic evaluation plans for investigational medicinal products for which pharmaceutical companies have sought health technology assessment (HTA) scientific advice (SA). We have selected and analysed all the scientific advice procedures undertaken by National Institute for Health and Care Excellence (NICE) SA between 1 January 2009 and 3 December 2015 for investigational medicinal products. We have mapped the questions asked by the companies and the areas of advice highlighted in the advice reports to the sections of the NICE methods guide to the technology appraisals (2013). An overwhelming proportion of SA procedures have addressed questions related to the clinical development and specifically the main pivotal efficacy studies. Approximately a quarter of the questions relate to the approaches to economic evaluation. Questions raised in European Medicines Agency-HTA procedures generally focus on clinical efficacy issues whereas cost-effectiveness ones tend to dominate in NICE-only procedures. Our analysis shows that the issues mostly discussed in the HTA SA are the choice of comparator, the generalisability of the clinical trial evidence to the NHS practice and the impact of the clinical trial outcomes on quality of life and survival. Less disagreement with the developers' plans was seen in the choice of clinical endpoints, population definition, position of the technology in the treatment pathway and study design. Scientific advice is designed to improve the quality of evidence and approaches to evidence generation for future regulatory approval and HTA evaluation. Our experience to date suggests that payer requirements are inconsistently integrated in the clinical development programmes. More efforts should be dedicated to demonstrating the clinical value of new medicinal products to patients and key decision-makers.

A nurse-led clinic for patients consulting with osteoarthritis in general practice: development and impact of training in a cluster randomised controlled trial.

PubMed

Healey, Emma L; Main, Chris J; Ryan, Sarah; McHugh, Gretl A; Porcheret, Mark; Finney, Andrew G; Morden, Andrew; Dziedzic, Krysia S

2016-12-21

Despite a lack of service provision for people with osteoarthritis (OA), each year 1 in 5 of the general population consults a GP about a musculoskeletal condition such as OA. Consequently this may provide an opportunity for practice nurses to take an active role in helping patients manage their condition. A nurse led clinic for supporting patients with OA was developed for the MOSAICS study investigating how to implement the NICE 2014 OA Guideline core recommendations. This paper has two main objectives, firstly to provide an overview of the nurse-led OA clinic, and secondly to describe the development, key learning objectives, content and impact of the training to support its delivery. A training programme was developed and delivered to provide practice nurses with the knowledge and skill set needed to run the nurse-led OA clinic. The impact of the training programme on knowledge, confidence and OA management was evaluated using case report forms and pre and post training questionnaires. The pre-training questionnaire identified a gap between what practice nurses feel they can do and what they should be doing in line with NICE OA guidelines. Evaluation of the training suggests that it enabled practice nurses to feel more knowledgeable and confident in supporting patients to manage their OA and this was reflected in the clinical management patients received in the nurse-led OA clinics. A significant gap between what is recommended and what practice nurses feel they can currently provide in terms of OA management was evident. The development of a nurse training programme goes some way to develop a system in primary care for delivering the core recommendations by NICE. The cluster trial linked to this training was conducted from May 2012 through February 2014 by the Arthritis Research UK Primary Care Centre, Keele University, UK (Trial registration number ISRCTN06984617 ).

Critical Imperative for the Reform of British Interpretation of Fetal Heart Rate Decelerations: Analysis of FIGO and NICE Guidelines, Post-Truth Foundations, Cognitive Fallacies, Myths and Occam’s Razor

PubMed Central

Sholapurkar, Shashikant L.

2017-01-01

Cardiotocography (CTG) has disappointingly failed to show good predictability for fetal acidemia or neonatal outcomes in several large studies. A complete rethink of CTG interpretation will not be out of place. Fetal heart rate (FHR) decelerations are the most common deviations, benign as well as manifestation of impending fetal hypoxemia/acidemia, much more commonly than FHR baseline or variability. Their specific nomenclature is important (center-stage) because it provides the basic concepts and framework on which the complex “pattern recognition” of CTG interpretation by clinicians depends. Unfortunately, the discrimination of FHR decelerations seems to be muddled since the British obstetrics adopted the concept of vast majority of FHR decelerations being “variable” (cord-compression). With proliferation of confusing waveform criteria, “atypical variables” became the commonest cause of suspicious/pathological CTG. However, National Institute for Health and Care Excellence (NICE) (2014) had to disband the “typical” and “atypical” terminology because of flawed classifying criteria. This analytical review makes a strong case that there are major and fundamental framing and confirmation fallacies (not just biases) in interpretation of FHR decelerations by NICE (2014) and International Federation of Gynecology and Obstetrics (FIGO) (2015), probably the biggest in modern medicine. This “post-truth” approach is incompatible with scientific practice. Moreover, it amounts to setting oneself for failure. The inertia to change could be best described as “backfire effect”. There is abundant evidence that head-compression (and other non-hypoxic mediators) causes rapid rather than shallow/gradual decelerations. Currently, the vast majority of decelerations are attributed to unproven cord compression underpinned by flawed disproven pathophysiological hypotheses. Their further discrimination based on abstract, random, trial and error criteria remains unresolved suggesting a false premise to begin with. This is not surprising considering that the commonest pathophysiology of intrapartum hypoxemia is contraction-induced reduction in uteroplacental perfusion (sometimes already compromised) and not cord compression at all. This distorted categorization causes confusion, false-alarm fatigue and difficulty in focusing on real pathological decelerations making CTG interpretation dysfunctional ultimately compromising patient safety. Obstetricians/midwives should demand reverting to the previous more scientific British categorization of decelerations based solely on time relationship to contractions as advocated by the pioneers like Hon and Caldeyro-Barcia, rather than accepting the current “post-truth” scenario. PMID:28270884

The impact of 2013 UK NICE guidelines on the management of varicose veins at the Heart of England NHS Foundation Trust, Birmingham, UK.

PubMed

Davies, Huw Ob; Popplewell, Matthew; Bate, Gareth; Kelly, Lisa; Darvall, Katy; Bradbury, Andrew W

2016-10-01

Although varicose veins are a common cause of morbidity, the UK National Health Service and private medical insurers have previously sought to ration their treatment in a non-evidence based manner in order to limit health-care expenditure and reimbursement. In July 2013, the UK National Institute for Health and Care Excellence published new national Clinical Guidelines (CG168) to promote evidence-based commissioning and management of varicose veins. The aim of this study was to evaluate the impact of CG168 on the referral and management of varicose veins at the Heart of England NHS Foundation Trust, Birmingham, UK. Interrogation of a prospectively gathered database, provided by the Heart of England NHS Foundation Trust Performance Unit, of patients undergoing interventions for varicose veins since 1 January 2012. Patients treated before (group 1) and after (group 2) publication of CG168 were compared. There were 253 patients, 286 legs (48% male, mean (range) age 54 (20-91) years) treated in group 1, and 417 patients, 452 legs, (46% male, mean (range) age 54 (14-90) years) treated in group 2, an increase of 65%. CG168 was associated with a significant reduction in the use of surgery (131 patients (52%) group 1 vs. 127 patients (30%) group 2, p = 0.0003, χ(2)), no change in endothermal ablation (30 patients (12%) group 1 vs. 45 patients (11%) group 2), a significant increase in ultrasound-guided foam sclerotherapy (92 patients (36%) group 1 and 245 patients (59%) group 2, p = 0.0001, χ(2)) and an increase in treatment for C2/3 disease (53% group 1 and 65.2% group 2, p = 0.0022, χ(2)). Publication of National Institute for Health and Care Excellence CG168 has been associated with a significant increase (65%) in the number of patients treated, referral at an earlier (CEAP C) stage and increased use of endovenous treatment. CG 168 has been highly effective in improving access to, and quality of care, for varicose veins at Heart of England NHS Foundation Trust. © The Author(s) 2015.

Insomnia management in prisons in England and Wales: a mixed-methods study.

PubMed

Dewa, Lindsay H; Hassan, Lamiece; Shaw, Jenny J; Senior, Jane

2017-06-01

Insomnia in prison is common; however, research is limited regarding the management strategies that prison establishments employ. To address this knowledge gap, we conducted a survey to identify how insomnia is detected, diagnosed and treated in adult prisons in England and Wales. Telephone interviews with a purposive sample of health-care managers were then conducted. The survey was sent to all establishments holding adult prisoners, covering screening and assessment methods to detect insomnia; treatment options, both pharmacological and non-pharmacological; the importance of insomnia as a treatable condition; and staff training available. Eighty-four (73%) prisons completed the survey. Few had a stepped approach to insomnia management, as recommended by National Institute for Health and Care Excellence (NICE) guidelines. The most common treatments available were sleep hygiene education and medication, offered by 94 and 88% of respondents, respectively. Analysis of telephone interviews revealed four main themes: insomnia as a normal occurrence in prison; the problem of medication in prison; the negative impact of the prison environment; and effective management of insomnia in prison. The current findings suggest that logistical, ethical and security barriers and a lack of staff knowledge and training impact negatively on the management of insomnia in prison. © 2017 European Sleep Research Society.

Societal views on NICE, cancer drugs fund and value-based pricing criteria for prioritising medicines: a cross-sectional survey of 4118 adults in Great Britain.

PubMed

Linley, Warren G; Hughes, Dyfrig A

2013-08-01

The criteria used by the National Institute for Health and Clinical Excellence (NICE) for accepting higher incremental cost-effectiveness ratios for some medicines over others, and the recent introduction of the Cancer Drugs Fund (CDF) in England, are assumed to reflect societal preferences for National Health Service resource allocation. Robust empirical evidence to this effect is lacking. To explore societal preferences for these and other criteria, including those proposed for rewarding new medicines under the future value-based pricing (VBP) system, we conducted a choice-based experiment in 4118 UK adults via web-based surveys. Preferences were determined by asking respondents to allocate fixed funds between different patient and disease types reflecting nine specific prioritisation criteria. Respondents supported the criteria proposed under the VBP system (for severe diseases, address unmet needs, are innovative--provided they offered substantial health benefits, and have wider societal benefits) but did not support the end-of-life premium or the prioritisation of children or disadvantaged populations as specified by NICE, nor the special funding status for treatments of rare diseases, nor the CDF. Policies introduced on the basis of perceived--and not actual--societal values may lead to inappropriate resource allocation decisions with the potential for significant population health and economic consequences. Copyright © 2012 John Wiley & Sons, Ltd.

Apremilast for the Treatment of Moderate to Severe Plaque Psoriasis: A Critique of the Evidence.

PubMed

Hinde, Sebastian; Wade, Ros; Palmer, Stephen; Woolacott, Nerys; Spackman, Eldon

2016-06-01

As part of the National Institute for Health and Care Excellence's (NICE) single technology appraisal (STA) process, apremilast was assessed to determine the clinical and cost effectiveness of its use in the treatment of moderate to severe plaque psoriasis in two patient populations, differentiated by the severity of the patient's Psoriasis Area Severity Index (PASI) score. The Centre for Reviews and Dissemination (CRD) and the Centre for Health Economics (CHE) Technology Appraisal Group at the University of York was commissioned to act as the evidence review group (ERG). This article provides a summary of the company's submission, the ERG report and NICE's subsequent guidance. In the company's initial submission, a sequence of treatments including apremilast was found to be both more effective and cheaper than a comparator sequence without it in both populations considered. However, this result was found to be highly sensitive to a series of assumptions made by the company, primarily reflecting the costs of best supportive care once no further treatments are available, and the source of utility estimates. A re-estimation of the cost effectiveness of apremilast by the ERG suggested that the apremilast sequence in the two populations was more effective, but due to high additional costs was not indicative of a cost-effective use of NHS resources. As such, in the final appraisal decision NICE concluded that apremilast was not cost effective in either population.

Improving quality for maternal care - a case study from Kerala, India

PubMed Central

Vlad, Ioana; Paily, VP; Sadanandan, Rajeev; Cluzeau, Françoise; Beena, M; Nair, Rajasekharan; Newbatt, Emma; Ghosh, Sujit; Sandeep, K; Chalkidou, Kalipso

2016-01-01

Background: The implementation of maternal health guidelines remains unsatisfactory, even for simple, well established interventions. In settings where most births occur in health facilities, as is the case in Kerala, India, preventing maternal mortality is linked to quality of care improvements. Context: Evidence-informed quality standards (QS), including quality statements and measurable structure and process indicators, are one innovative way of tackling the guideline implementation gap. Having adopted a zero tolerance policy to maternal deaths, the Government of Kerala worked in partnership with the Kerala Federation of Obstetricians & Gynaecologists (KFOG) and NICE International to select the clinical topic, develop and initiate implementation of the first clinical QS for reducing maternal mortality in the state. Description of practice: The NICE QS development framework was adapted to the Kerala context, with local ownership being a key principle. Locally generated evidence identified post-partum haemorrhage as the leading cause of maternal death, and as the key priority for the QS. A multidisciplinary group (including policy-makers, gynaecologists and obstetricians, nurses and administrators) was established. Multi-stakeholder workshops convened by the group ensured that the statements, derived from global and local guidelines, and their corresponding indicators were relevant and acceptable to clinicians and policy-makers in Kerala. Furthermore, it helped identify practical methods for implementing the standards and monitoring outcomes. Lessons learned: An independent evaluation of the project highlighted the equal importance of a strong evidence-base and an inclusive development process. There is no one-size-fits-all process for QS development; a principle-based approach might be a better guide for countries to adapt global evidence to their local context. PMID:27441084

A comparison of neuromuscular electrical stimulation and traditional therapy, versus traditional therapy in patients with longstanding dysphagia.

PubMed

Frost, Jo; Robinson, H Fiona; Hibberd, Judi

2018-06-01

Dysphagia in adults arises from a range of causes including acquired neurological disorders and some cancers. Previous research has suggested that treatment using neuromuscular electrical stimulation (NMES) when used in conjunction with conventional therapy is effective. This review describes the recent literature and a small prospective case series carried out in the United Kingdom. This study contributed to support National Institute of Clinical Excellence (NICE) guidance for clinicians who wish to include NMES in a rehabilitation programme for dysphagic patients, specifically with reference to safety and the impact on swallowing function of this intervention. In 2014, the UK NICE issued guidelines enabling UK therapists to trial the use of NMES, but the guidelines also sought additional evidence on the impact on swallowing function of NMES and the incidence of side effects. This small prospective case series investigated both of these aspects with a group of patients with dysphagia of neurological origin who had not achieved adequate swallowing function with traditional therapy alone. This study recruited 10 adult patients with dysphagia of neurological origin. All had previously received traditional swallowing therapy for at least 6 months but only achieved a Functional Oral Intake Scale of 4 or less (a scale for amounts and types of oral intake). The total study period was 10 weeks for each subject comprising 5 weeks of traditional therapy delivered three times a week followed by 5 weeks of NMES concurrent with traditional therapy (NMES + traditional therapy) delivered three times a week using the VitalStim stimulator (VitalStim Therapy, UK). In addition, the Quality of Life in Swallowing and Eating Assessment Tool 10 (quality of life scales) were determined to allow comparison between studies. Nine subjects achieved an improvement in swallowing function after NMES + traditional therapy was measured using the Functional Oral Intake Scale, giving a statistically significant improvement (P < 0.001) when NMES + traditional therapy was compared with traditional therapy. In addition, there was a low incidence of adverse effects with only minor adverse events occurring in 1.3% of electrode pair placements. The current preliminary study suggests that NMES + traditional therapy has a good safety record and may improve oral intake and patient reported swallowing outcomes for subjects with long-standing dysphagia of neurological cause, which has not responded to traditional therapy. Provided care is taken with skin preparation and electrode placement the risk of adverse effects from the treatment was minimal. Significantly, in 30% of the subjects, an improvement in voice quality was found.

Effects of Carbonization Temperature on Nature of Nanostructured Electrode Materials Derived from Fe-MOF for Supercapacitors

NASA Astrophysics Data System (ADS)

Sui, Yanwei; Zhang, Dongling; Han, Yongpeng; Sun, Zhi; Qi, Jiqiu; Wei, Fuxiang; He, Yezeng; Meng, Qingkun

2018-05-01

This work successfully demonstrates various temperature carbonization of iron based metal organic framework to derive electrode materials for supercapacitors. Furthermore, impacts of calcined temperatures on the nature of as-prepared products are reported, and samples obtained at 300, 400, 500, 600 and 700 °C were investigated respectively. The products reveals excellent electrochemical performance. Carbonized at 600 °C, the composite materials display the highest specific capacitance of 972 F/g at a current density of 1 A/g. Carbonized at 500 °C, the capacitance retention of materials reach up to 93%. The high specific capacitance and excellent cyclic stability of the developed materials would exhibit nice prospect for the practical utilization of electrode materials.

Bevacizumab for metastatic colorectal cancer: a NICE single technology appraisal.

PubMed

Whyte, Sophie; Pandor, Abdullah; Stevenson, Matt

2012-12-01

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of bevacizumab (Roche Products) to submit evidence for the clinical and cost effectiveness of this drug for the treatment of patients with metastatic colorectal cancer (mCRC), as part of the Institute's Single Technology Appraisal (STA) process. The School of Health and Related Research (ScHARR) at the University of Sheffield was commissioned to act as the Evidence Review Group (ERG). This paper provides a description of the company submission, the ERG review and NICE's subsequent decisions. The ERG produced a critical review of the evidence for the clinical and cost effectiveness of the technology provided within the manufacturer's submission to NICE. The ERG also independently searched for relevant evidence and modified the manufacturer's decision analytic model to examine the impact of altering some of the key assumptions. The main clinical effectiveness data were derived from a phase III, multicentre, multinational, two-arm, randomized, open-label study with the primary objective of confirming the non-inferiority of oxaliplatin plus capecitabine (XELOX) compared with oxaliplatin plus 5-fluorouracil and folinic acid (FOLFOX-4) in adult patients with histologically confirmed mCRC who had not previously been treated. The ERG considered that the NO16966 trial was of reasonable methodological quality and demonstrated a significant improvement in both progression-free and overall survival when bevacizumab is added to either XELOX or FOLFOX-4. The ERG considered that the size of the actual treatment effect of bevacizumab was uncertain due to trial design limitations, imbalance of a known prognostic factor, relatively short treatment duration compared with that allowed within the trial protocol, and interpretation of the statistical analyses. The manufacturer's submission included a de novo economic evaluation using a cost-effectiveness model built in Microsoft® Excel. The ERG believed that the modelling structure employed was appropriate but highlighted several areas of uncertainty that had the potential to have a significant impact on the resulting incremental cost-effectiveness ratios (ICERs). The areas of uncertainty identified by the ERG included whether chemotherapy would be administered continuously or intermittently, patient access scheme (PAS) costs and uptake, survival that was dependent on the statistical analyses used, and the likely duration of continued treatment with bevacizumab after cessation of oxaliplatin and the efficacy associated with continuation. The STA described here highlighted the challenges in appraising interventions with a complex PAS. Based on the analyses that include a discount to the list price of oxaliplatin, the ERG concluded that the ICERs for the addition of bevacizumab to XELOX or FOLFOX were both over £50 000. The NICE Appraisal Committee concluded that bevacizumab in combination with oxaliplatin and either 5-fluorouracil plus folinic acid or capecitabine (i.e. FOLFOX or XELOX) was not recommended for the treatment of mCRC.

Azacitidine for Treating Acute Myeloid Leukaemia with More Than 30 % Bone Marrow Blasts: An Evidence Review Group Perspective of a National Institute for Health and Care Excellence Single Technology Appraisal.

PubMed

Tikhonova, Irina A; Hoyle, Martin W; Snowsill, Tristan M; Cooper, Chris; Varley-Campbell, Joanna L; Rudin, Claudius E; Mujica Mota, Ruben E

2017-03-01

The National Institute for Health and Care Excellence (NICE) invited the manufacturer of azacitidine (Celgene) to submit evidence for the clinical and cost effectiveness of this drug for the treatment of acute myeloid leukaemia with more than 30 % bone marrow blasts in adults who are not eligible for haematopoietic stem cell transplantation, as part of the NICE's Single Technology Appraisal process. The Peninsula Technology Assessment Group was commissioned to act as the Evidence Review Group (ERG). The ERG produced a critical review of the evidence contained within the company's submission to NICE. The clinical effectiveness data used in the company's economic analysis were derived from a single randomised controlled trial, AZA-AML-001. It was an international, multicentre, controlled, phase III study with an open-label, parallel-group design conducted to determine the efficacy and safety of azacitidine against a conventional care regimen (CCR). The CCR was a composite comparator of acute myeloid leukaemia treatments currently available in the National Health Service: intensive chemotherapy followed by best supportive care (BSC) upon disease relapse or progression, non-intensive chemotherapy followed by BSC and BSC only. In AZA-AML-001, the primary endpoint was overall survival. Azacitidine appeared to be superior to the CCR, with median overall survival of 10.4 and 6.5 months, respectively. However, in the intention-to-treat analysis, the survival advantage associated with azacitidine was not statistically significant. The company submitted a de novo economic evaluation based on a partitioned survival model with four health states: "Remission", "Non-remission", "Relapse/Progressive disease" and "Death". The model time horizon was 10 years. The perspective was the National Health Service and Personal Social Services. Costs and health effects were discounted at the rate of 3.5 % per year. The base-case incremental cost-effectiveness ratio (ICER) of azacitidine compared with the CCR was £20,648 per quality-adjusted life-year (QALY) gained. In the probabilistic sensitivity analysis, the mean ICER was £17,423 per QALY. At the willingness-to-pay of £20,000, £30,000 and £50,000 per QALY, the probability of azacitidine being cost effective was 0.699, 0.908 and 0.996, respectively. The ERG identified a number of errors in Celgene's model and concluded that the results of the company's economic evaluation could not be considered robust. After amendments to Celgene's model, the base-case ICER was £273,308 per QALY gained. In the probabilistic sensitivity analysis, the mean ICER was £277,123 per QALY. At a willingness-to-pay of £100,000 per QALY, the probability of azacitidine being cost effective was less than 5 %. In all exploratory analyses conducted by the ERG, the ICER exceeded the NICE's cost-effectiveness threshold range of £20,000-30,000 per QALY. Given the evidence provided in the submission, azacitidine did not fulfil NICE's end-of-life criteria. After considering the analyses performed by the ERG and submissions from clinician and patient experts, the NICE Appraisal Committee did not recommend azacitidine for this indication.

Center of Excellence in Biotechnology (Research)

DTIC Science & Technology

1993-03-01

1990) "Canine X-linked Muscular Dystrophy : Morphologic Lesions", J. Neurol Sci, 29. 1-23. F. Walker, E. Nice, L. Fabri, F.J. Moy, J-F. Liu, R. Wu...antidepressmats, and anesthetics. In this program, the mRNAs for the muscle and neuronal types of the receptor have been expressed in yeast, and have shown to...been used in chemical kinetic measurements of receptor function in neuronal PC12 cells, muscle BC3HI cells and XenoQfs oocytes. Another principal area of

The evolving role of paramedics - a NICE problem to have?

PubMed

Eaton, Georgette; Mahtani, Kamal; Catterall, Matt

2018-07-01

This short essay supports the growing role of paramedics in the clinical and academic workforce. We present a commentary of recent draft consultations by the National Institute for Health and Care Excellence in England that set out how the role of paramedics may be evolving to assist with the changing demands on the clinical workforce. Using these consultations as a basis, we extend their recommendations and suggest that the profession should also lead the academically driven evaluation of these new roles.

[Suicide Risk Assessment in the Clinical Practice Guidelines for the Diagnosis and Management of Depression in Colombia].

PubMed

Gómez Restrepo, Carlos; Bohórquez Peñaranda, Adriana Patricia; Gil Lemus, Laura Marcela; Jaramillo, Luis Eduardo; García Valencia, Jenny; Bravo Narváez, Eliana; de la Hoz Bradford, Ana María; Palacio, Carlos

2013-01-01

Suicide is the most serious complications of depression. It has high associated health costs and causes millions of deaths worldwide per year. Given its implications, it is important to know the factors that increase the risk of its occurrence and the most useful tools for addressing it. To identify the signs and symptoms that indicate an increased risk of suicide, and factors that increase the risk in patients diagnosed with depression. To establish the tools best fitted to identify suicide risk in people with depression. Clinical practice guidelines were developed, following those of the methodmethodological guidelines of the Ministry of Social Protection, to collect evidence and to adjust recommendations. Recommendations from the NICE90 and CANMAT guidelines were adopted and updated for questions found in these guidelines, while new recommendations were developed for questions not found in them. Basic points and recommendations are presented from a chapter of the clinical practice guidelines on depressive episodes and recurrent depressive disorder related to suicide risk assessment. Their corresponding recommendation levels are included. Copyright © 2013 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

National audit of continence care: adherence to National Institute for Health and Clinical Excellence (NICE) guidance in older versus younger adults with faecal incontinence.

PubMed

Harari, Danielle; Husk, Janet; Lowe, Derek; Wagg, Adrian

2014-11-01

previous UK National Audits of Continence Care showed low rates of assessment and treatment of faecal incontinence (FI) in older people. the 2009 audit assessed adherence to the National Institute for Health and Clinical Excellence guidelines on management of FI and compared care in older versus younger patients. fifteen older (65+) and 15 younger (18-65) patients with FI were to be audited in hospital (inpatient or outpatient), primary care (PC) and care home sites. data were submitted for n = 2,930 cases from 133 hospitals, n = 1,729 from 97 PC surgeries and n = 693 from 63 care homes. Bowel history was not documented in 41% older versus 24% younger patients in hospitals and 27 versus 19% in PC (both P < 0.001). In older people, there was no documented focused examination in one-third in hospitals, one-half in PC and three-quarters in care homes. Overall, <50% had documented treatment for an identified bowel-related cause of FI. FI was frequently attributed to co-morbidity. Few patients received copies of their treatment plan. Quality-of-life impact was poorly documented particularly in hospitals. this national audit shows deficits in documented assessment, diagnosis and treatment for adults with FI despite availability of clinical guidance. Overall care is significantly poorer for older people. Clinicians, including geriatricians, need to lead on improving care in older people including comprehensive assessment where needed. Improvement in some indicators in older people with successive audits suggests that ongoing national audit with linked information resources can be useful as both monitor and agent for change. © The Author 2014. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Chapter 8 Haemoglobin, ferritin and erythropoietin amongst UK adult dialysis patients in 2010: national and centre-specific analyses.

PubMed

Webb, Lynsey; Gilg, Julie; Wilkie, Martin

2012-01-01

The UK Renal Association (RA) and National Institute for Health and Clinical Excellence (NICE) have published clinical practice guidelines which include recommendations for management of anaemia in established renal failure. To determine the extent to which the guidelines for anaemia management are met in the UK. Quarterly data were obtained regarding haemoglobin (Hb) and factors that influence Hb from renal centres in England, Wales, Northern Ireland (EWNI) and the Scottish Renal Registry for the incident and prevalent renal replacement therapy (RRT) cohorts for 2010. In the UK, in 2010 53.6% of patients commenced dialysis therapy with Hb ≥ 10.0 g/dl (median Hb 10.1 g/dl). The median Hb of haemodialysis (HD) patients was 11.5 g/dl with an interquartile range (IQR) of 10.5-12.3 g/dl. Of HD patients 84.6% had Hb ≥ 10.0 g/dl. The median Hb of peritoneal dialysis (PD) patients in the UK was 11.6 g/dl (IQR 10.6-12.5 g/dl). Of UK PD patients, 87.2% had Hb ≥ 10.0 g/dl. The median ferritin in HD patients in EWNI was 444 µg/L (IQR 299-635) and 96% of HD patients had a ferritin ≥ 100 µg/L. The median ferritin in PD patients was 264 µg/L (IQR 148-426) with 86% of PD patients having a ferritin ≥ 100 µg/L. In EWNI the mean Erythropoietin Stimulating Agent (ESA) dose was higher for HD than PD patients (9,020 vs. 6,202 IU/week). Of prevalent HD patients, 52.7% had Hb ≥ 10 and ≤ 12 g/dl. Of prevalent PD patients, 54.3% had Hb 10.5-12.5 g/dl. Copyright © 2012 S. Karger AG, Basel.

The process of developing evidence-based guidance in medicine and public health: a qualitative study of views from the inside

PubMed Central

2013-01-01

Background There has been significant investment in developing guidelines to improve clinical and public health practice. Though much is known about the processes of evidence synthesis and evidence-based guidelines implementation, we know little about how evidence presented to advisory groups is interpreted and used to form practice recommendations or what happens where evidence is lacking. This study investigates how members of advisory groups of NICE (National Institute of Health and Clinical Excellence) conceptualize evidence and experience the process. Methods Members of three advisory groups for acute physical, mental and public health were interviewed at the beginning and end of the life of the group. Seventeen were interviewed at both time points; five were interviewed just once at time one; and 17 were interviewed only once after guidance completion. Using thematic and content analysis, interview transcripts were analysed to identify the main themes. Results Three themes were identified: 1. What is the task? Different members conceptualized the task differently; some emphasized the importance of evidence at the top of the quality hierarchy while others emphasized the importance of personal experience. 2. Who gets heard? Managing the diversity of opinion and vested interests was a challenge for the groups; service users were valued and as was the importance of fostering good working relationships between group members. 3. What is the process? Group members valued debate and recognized the need to marshal discussion; most members were satisfied with the process and output. Conclusions Evidence doesn’t form recommendations on its own, but requires human judgement. Diversity of opinion within advisory groups was seen as key to making well-informed judgments relevant to forming recommendations. However, that diversity can bring tensions in the evaluation of evidence and its translation into practice recommendations. PMID:24006933

'Targeted top down' approach for the investigation of UTI: A 10-year follow-up study in a cohort of 1000 children.

PubMed

Broadis, E; Kronfli, R; Flett, M E; Cascio, S; O'Toole, S J

2016-02-01

Investigations following urinary tract infection (UTI) aim to identify children who are prone to renal scarring, which may be preventable. In 2002, in an attempt to reduce unnecessary intervention, the present institution standardised the investigation of children with a confirmed UTI. This study aimed to identify the significance of urological abnormalities on investigations following a UTI in children, prior to the introduction of the National Institute for Health and Care Excellence (NICE) guidelines. Clinical information on the first 1000 patients was retrieved from a prospective UTI hospital database. The follow-up period was 10 years. There were 180 males and 820 females (M:F = 1:4.5). The median age of presentation was 5 years (range 11 days-16 years). A renal ultrasound (US) was performed on all patients, and was normal in 93% of cases (n = 889) (see Figure). Of the 7% who had an abnormal US (n = 71), 54 were female and 17 male (M:F = 1:3). A total of 372 DMSA scans were requested and 350 attended their appointment. Of these, 278 cases (79%) were reported as normal, while 72 had an abnormality documented. Of these 72 patients with abnormalities on DMSA scan, 49 had a repeat DMSA scan: 30 demonstrated permanent scarring, while the DMSA scan became normal in 19. Sixteen of the 278 patients whose DMSA scan was initially normal had a repeat DMSA scan due to symptoms, and all scans were normal. Twelve (1.2%) patients required surgical intervention: three underwent circumcision for recurrent UTIs; three underwent endoscopic treatment of VUR; one had a PUV resection; one underwent a cystoscopy; three had a pyeloplasty for pelvi-ureteric junction obstruction; and one had a ureteric reimplantation for vesico-ureteric junction obstruction. After initial investigations and management, 936 patients were discharged from the UTI clinic: 47 of them re-presented - 40 with recurrent UTIs and seven with dysuria. Thirty-five of the 47 children who re-presented with urological symptoms underwent a DMSA scan, which showed scarring in three (6%). Only 12% of children have a significant radiological abnormality picked up on investigation following a UTI. The present investigation approach differed from the NICE guidelines, where imaging is based on patient age and characteristics of the UTI. All children had a renal US, while DMSA scans were reserved for those children <1 year of age or those with upper tract symptoms. The present protocol recommended a renal US in all children presenting with a UTI. This promptly identified those with pelvi-ureteric junction obstruction and those with PUV, who all presented >6 months of age with a single UTI and, therefore, based on the NICE guidelines would not have undergone a renal US. Of the children who re-presented with further UTIs, a significant number were found to have dysfunctional voiding. As this link is well reported, it may be appropriate to screen for this in older children at initial presentation. Only three patients, who had a US at presentation, were subsequently found to have scarring on DMSA. After 10 years of follow-up, this could represent a false negative rate of 0.3% for the screening programme. None of the girls were found to have VUR or needed any surgical intervention, which suggested that early identification of the scarring might not have altered management. Few patients required surgical intervention, all of whom were identified early. No patient who re-presented required intervention. This would suggest that the present protocol is effective at picking up abnormalities that require surgical management. This study suggested that after a childhood UTI, the liberal use of renal ultrasound and a focused 'top down' approach to investigation is likely to identify the vast majority of children who require intervention. Copyright © 2015 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

Contraindications for external cephalic version in breech position at term: a systematic review.

PubMed

Rosman, Ageeth N; Guijt, Aline; Vlemmix, Floortje; Rijnders, Marlies; Mol, Ben W J; Kok, Marjolein

2013-02-01

External cephalic version (ECV) is a safe and effective intervention that can prevent breech delivery, thus reducing the need for cesarean delivery. It is recommended in national guidelines. These guidelines also mention contraindications for ECV, and thereby restrict the application of ECV. We assessed whether the formulation of these contraindications in guidelines are based on empiric data. Systematic review. Pregnant women with a singleton breech presentation from 34 weeks. We searched the National Guideline Clearinghouse, the Cochrane Central Register of Controlled Trials, MEDLINE (1953-2009), EMBASE (1980-2009), TRIP database (until 2011), NHS (National Health Services, until 2011), Diseases database (until 2011) and NICE guidelines (until 2011) for existing guidelines on ECV and studied the reproducibility of the contraindications stated in the guidelines. Furthermore, we systematically reviewed the literature for contraindications and evidence on these contraindications. Contraindications of ECV. We found five guidelines mentioning 18 contraindications, varying from five to 13 per guideline. The contraindications were not reproducible between the guidelines with oligohydramnios as the only contraindication mentioned in all guidelines. The literature search yielded 60 studies reporting on 39 different contraindications, of which we could only assess evidence of six of them. The present study shows that there is no general consensus on the eligibility of patients for ECV. Therefore we propose to limit contraindications for ECV to clear empirical evidence or to those with a clear pathophysiological relevance. © 2012 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2012 Nordic Federation of Societies of Obstetrics and Gynecology.

Depoliticisation, Resilience and the Herceptin Post-Code Lottery Crisis: Holding Back the Tide

PubMed Central

2015-01-01

Research Highlights and Abstract This article: Covers new empirical terrain in the study of depoliticisation, with an in-depth case study of health technology regulation; Analyses depoliticisation from a novel analytical perspective, examining how depoliticised institutions are resilient to external pressure for politicisation; Posits a distinctive framework for analysing resilience, drawing on cognate literatures on policy networks and agencification; Raises interesting and distinctive questions about the nature of depoliticisation in advanced liberal democracies, arguing it is more contested than commonly acknowledged. Depoliticisation as a concept offers distinctive insights into how governments attempt to relieve political pressures in liberal democracies. Analysis has examined the effects of depoliticisation tactics on the public, but not how those tactics are sustained during moments of political tension. Drawing on policy networks and agencification literatures, this article examines how these tactics are resilient against pressure for politicisation. Using an in-depth case study of the controversial appraisal of cancer drug Herceptin in 2005/6 by the National Institute for Health and Clinical Excellence (NICE), the article examines how ‘resilient’ NICE was to external politicisation. It is argued that NICE was resilient because it was effectively ‘insulated’ by formal procedures and informal norms of deference to scientific expertise. This mechanism is termed ‘institutional double glazing’. The conclusion suggests developments to the conceptual and methodological framework of depoliticisation, and highlights theoretical insights into the nature of ‘anti-politics’ in contemporary democracies. PMID:27904418

The NHS: assessing new technologies, NICE and value for money.

PubMed

Stevens, A; Chalkidou, K; Littlejohns, P

2011-06-01

The healthcare system in the UK, essentially the NHS, is an open economic system subject to the same pressures as any other economic system. The pressures concern limited resources coupled with powerful drivers for increasing spending: invention, demography and inflation. There have only ever been three types of economic system: steady state (everything, as in a feudal system, stays as it was the year before), market capitalism (supply and demand are allowed to find their own equilibrium) and some version of central planning. In healthcare, most advanced countries favour the last of the three. This is for three reasons: distribution (not only are the poor less able to pay for sickness, but sickness exacerbates poverty), information (markets operate poorly when providers can easily outsmart customers) and externalities (it is in the interest of everyone that infectious diseases and the other knock-on consequences of ill health are ameliorated). So in the UK, the state, with a good deal of cross-party consensus, directs most of health service supply. This system has become more complex over the decades since the formation of the NHS in 1948. A notable element of the complexity is the regulation of the introduction of new technologies. A key element of the regulatory system has been the National Institute for Health and Clinical Excellence (NICE), and a key aspect of NICE's decisions has been not just value, but also value for money. This has not been without controversy.

Strategies for Sustainable Cancer Care.

PubMed

Kerr, David J; Jani, Anant; Gray, Sir Muir

2016-01-01

There is an increasing focus on the relative cost-effectiveness and sustainability of delivering high-quality cancer care, with most emphasis, debatably, given to cost control of innovative treatments. It is difficult to calculate all the direct and indirect contributors to the total cost of cancer treatment, but it is estimated that cancer drugs constitute 10% to 30% of the total cost of cancer care. A 2007 study in France showed the contribution of drug costs was less than 20%, with approximately 70% of the total expenditure on cancer accounted for by health care resource use, such as hospitalization. The U.K. government established the National Institute for Health and Care Excellence (NICE)-the dominant function of which is technology appraisal-to assess the clinical and cost-effectiveness of new pharmaceutical and biopharmaceutical products. This is to ensure that all National Health Service (NHS) patients have equitable access to the most clinically effective and cost-effective treatments that are viable. NICE has developed a transparent, public process to judge incremental cost-effectiveness using the quality-adjusted life year (QALY), which allows comparisons of cost-effectiveness across medical specialties. NICE has been both lauded and criticized-especially when it passes judgment on marginally effective but expensive anticancer drugs-but it provides a route to "rational rationing" and, therefore, may contribute to sustainable cancer care by highlighting the issue of affordable medicine. This implies a challenge to the wider oncology community as to how we might cooperate to introduce the concept of value-driven cancer care.

Oncology drug health technology assessment recommendations: Canadian versus UK experiences

PubMed Central

Chabot, Isabelle; Rocchi, Angela

2014-01-01

Background Canada has two health technology assessment (HTA) agencies responsible for oncology drug funding recommendations: the Institut National d’Excellence en Santé et Services Sociaux (INESSS) for the province of Québec and the pan-Canadian Oncology Drug Review for the rest of Canada. The objective of the research was to review and compare the recommendations of these two agencies alongside an international comparator – the National Institute for Health and Care Excellence (NICE) in the United Kingdom – with respect to their recommendations records and the influence of clinical and cost-effectiveness evidence on the recommendations. Methods Recommendations were identified from the three agencies from January 1, 2002 to June 1, 2013. Recommendations were limited to five cancer sites (lung, breast, colon, kidney, blood) and to metastatic/advanced settings. Descriptive analyses examined the frequency of positive recommendations and factors related to a positive recommendation. For each recommendation, only publicly available information posted on the agency website was used to abstract data. Results There was a wide variation in the rate of positive recommendations, ranging from 48% for NICE to 95% for Canada’s national process (among the 74% of its recommendations that were publicly posted). Interagency agreement was low, with full agreement for only six of the 14 drugs commonly reviewed by all three agencies. Evidence of a survival gain was not necessary for a positive recommendation; progression-free survival was acceptable. Different approaches were taken when addressing unacceptable cost-effectiveness. NICE was most likely to yield a negative recommendation on these grounds, whereas Canada’s national process was most likely to yield a positive recommendation with a required pricing arrangement. Conclusion In this analysis, the primary reason for the observed divergence between agency recommendations appeared to be the availability of mechanisms in each jurisdiction to address cost-effectiveness subsequent to the HTA assessment process. Furthermore, caution is needed when interpreting cross-agency comparisons between HTA agencies, as recommendations may not correspond directly to subsequent funding decisions and actual patient access. This may be a concern, given the high international profile of assessments conducted by the reviewed HTA agencies. PMID:25075196

NHS Diabetes Prevention Programme in England: formative evaluation of the programme in early phase implementation.

PubMed

Penn, Linda; Rodrigues, Angela; Haste, Anna; Marques, Marta M; Budig, Kirsten; Sainsbury, Kirby; Bell, Ruth; Araújo-Soares, Vera; White, Martin; Summerbell, Carolyn; Goyder, Elizabeth; Brennan, Alan; Adamson, Ashley J; Sniehotta, Falko F

2018-02-21

Evaluation of the demonstrator phase and first wave roll-out of the National Health Service (NHS) Diabetes Prevention Programme (DPP) in England. To examine: (1) intervention design, provision and fidelity assessment procedures; (2) risk assessment and recruitment pathways and (3) data collection for monitoring and evaluation. To provide recommendations informing decision makers on programme quality, improvements and future evaluation. We reviewed programme documents, mapping against the NHS DPP specification and National Institute for Health and Care Excellence (NICE) public health guideline: Type 2 diabetes (T2D) prevention in people at high risk (PH38), conducted qualitative research using individual interviews and focus group discussions with stakeholders and examined recruitment, fidelity and data collection procedures. Seven NHS DPP demonstrator sites and, subsequently, 27 first wave areas across England. Intensive behavioural intervention with weight loss, diet and physical activity goals. The national programme specifies at least 13 sessions over 9 months, delivered face to face to groups of 15-20 adults with non-diabetic hyperglycaemia, mainly recruited from primary care and NHS Health Checks. Participants for qualitative research were purposively sampled to provide a spread of stakeholder experience. Documents for review were provided via the NHS DPP Management Group. The NHS DPP specification reflected current evidence with a clear framework for service provision. Providers, with national capacity to deliver, supplied intervention plans compliant with this framework. Stakeholders highlighted limitations in fidelity assessment and recruitment and retention challenges, especially in reach and equity, that could adversely impact on implementation. Risk assessment for first wave eligibility differed from NICE guidance. The NHS DPP provides an evidence-based behavioural intervention for prevention of T2D in adults at high risk, with capacity to deliver nationally. Framework specification allows for balance between consistency and contextual variation in intervention delivery, with session details devolved to providers. Limitations in fidelity assurance, data collection procedures and recruitment issues could adversely impact on intervention effectiveness and restrict evaluation. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Adherence to exercise referral schemes by participants - what do providers and commissioners need to know? A systematic review of barriers and facilitators.

PubMed

Morgan, Fiona; Battersby, Alysia; Weightman, Alison L; Searchfield, Lydia; Turley, Ruth; Morgan, Helen; Jagroo, James; Ellis, Simon

2016-03-05

Physical inactivity levels are rising worldwide with major implications for the health of the population and the prevalence of non-communicable diseases. Exercise referral schemes (ERS) continue to be a popular intervention utilised by healthcare practitioners to increase physical activity. We undertook a systematic review of views studies in order to inform guidance from the UK National Institute of Health and Care Excellence (NICE) on exercise referral schemes to promote physical activity. This paper reports on the participant views identified, to inform those seeking to refine schemes to increase attendance and adherence. Fifteen databases and a wide range of websites and grey literature sources were searched systematically for publications from 1995 to June 2013. In addition, a range of supplementary methods including, a call for evidence by NICE, contacting authors, reference list checking and citation tracking were utilised to identify additional research. Studies were included where they detailed schemes for adults aged 19 years or older who were 'inactive' (i.e. they are not currently meeting UK physical activity guidelines). Study selection was conducted independently in duplicate. Quality assessment was undertaken by one reviewer and checked by a second, with 20 % of papers being considered independently in duplicate. Papers were coded in qualitative data analysis software Atlas.ti. This review was reported in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement). Evidence from 33 UK-relevant studies identified that support from providers, other attendees and family was an important facilitator of adherence and 'making exercise a habit' post programme, as was the variety and personalised nature of sessions offered. Barriers to attendance included the inconvenient timing of sessions, their cost and location. An intimidating gym atmosphere, a dislike of the music and TV and a lack of confidence in operating gym equipment were frequently reported. These findings provide valuable insights that commissioners and providers should consider. The main themes were consistent across a large number of studies and further research should concentrate on programmes that reflect these findings.

Feasibility of using administrative data for identifying medical reasons to delay hip fracture surgery: a Canadian database study.

PubMed

Guy, Pierre; Sheehan, Katie J; Morin, Suzanne N; Waddell, James; Dunbar, Michael; Harvey, Edward; Sirett, Susan; Sobolev, Boris; Kuramoto, Lisa; Tang, Michael

2017-10-05

Failure to account for medically necessary delays may lead to an underestimation of early surgery benefits. This study investigated the feasibility of using administrative data to identify the National Institute for Health and Care Excellence (NICE) 124 guideline list of conditions that appropriately delay hip fracture surgery. We assembled a list of diagnosis and procedure codes to reflect the NICE 124 conditions. The list was reviewed and updated by an advanced clinical coder. The list was refined by five clinical experts. We then screened Canadian Institute for Health Information discharge abstracts for 153 918 patients surgically treated for a non-pathological first hip fracture between 1 January 2004 and 31 December 2012 for diagnosis codes present on admission and procedure codes that antedated hip fracture surgery. We classified abstracts as having medical reasons for delaying surgery based on the presence of these codes. In total, 10 237 (6.7%; 95% CI 6.5% to 6.8%) patients had diagnostic and procedure codes indicating medical reasons for delay. The most common reasons for medical delay were exacerbation of a chronic chest condition (35.9%) and acute chest infection (23.2%). The proportion of patients with reasons for medical delays increased with time from admission to surgery: 3.9% (95% CI 3.6% to 4.1%) for same day surgery; 4.7% (95% CI 4.5% to 4.8%) for surgery 1 day after admission; 7.1% (95% CI 6.9% to 7.4%) for surgery 2 days after admission; and 15.5% (95% CI 15.1% to 16.0%) for surgery more than 2 days after admission. The trend was seen for admissions on weekday working hours, weekday after hours and on weekends. Administrative data can be considered to identify conditions that appropriately delay hip fracture surgery. Accounting for medically necessary delays can improve estimates of the effectiveness of early surgery. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

NHS Diabetes Prevention Programme in England: formative evaluation of the programme in early phase implementation

PubMed Central

Penn, Linda; Rodrigues, Angela; Haste, Anna; Marques, Marta M; Budig, Kirsten; Sainsbury, Kirby; Bell, Ruth; Araújo-Soares, Vera; White, Martin; Summerbell, Carolyn; Goyder, Elizabeth; Brennan, Alan; Adamson, Ashley J; Sniehotta, Falko F

2018-01-01

Objectives Evaluation of the demonstrator phase and first wave roll-out of the National Health Service (NHS) Diabetes Prevention Programme (DPP) in England. To examine: (1) intervention design, provision and fidelity assessment procedures; (2) risk assessment and recruitment pathways and (3) data collection for monitoring and evaluation. To provide recommendations informing decision makers on programme quality, improvements and future evaluation. Design We reviewed programme documents, mapping against the NHS DPP specification and National Institute for Health and Care Excellence (NICE) public health guideline: Type 2 diabetes (T2D) prevention in people at high risk (PH38), conducted qualitative research using individual interviews and focus group discussions with stakeholders and examined recruitment, fidelity and data collection procedures. Setting Seven NHS DPP demonstrator sites and, subsequently, 27 first wave areas across England. Interventions Intensive behavioural intervention with weight loss, diet and physical activity goals. The national programme specifies at least 13 sessions over 9 months, delivered face to face to groups of 15–20 adults with non-diabetic hyperglycaemia, mainly recruited from primary care and NHS Health Checks. Participants Participants for qualitative research were purposively sampled to provide a spread of stakeholder experience. Documents for review were provided via the NHS DPP Management Group. Findings The NHS DPP specification reflected current evidence with a clear framework for service provision. Providers, with national capacity to deliver, supplied intervention plans compliant with this framework. Stakeholders highlighted limitations in fidelity assessment and recruitment and retention challenges, especially in reach and equity, that could adversely impact on implementation. Risk assessment for first wave eligibility differed from NICE guidance. Conclusions The NHS DPP provides an evidence-based behavioural intervention for prevention of T2D in adults at high risk, with capacity to deliver nationally. Framework specification allows for balance between consistency and contextual variation in intervention delivery, with session details devolved to providers. Limitations in fidelity assurance, data collection procedures and recruitment issues could adversely impact on intervention effectiveness and restrict evaluation. PMID:29467134

Achievement of NICE quality standards for patients with new presentation of inflammatory arthritis: observations from the National Clinical Audit for Rheumatoid and Early Inflammatory Arthritis.

PubMed

Ledingham, Joanna M; Snowden, Neil; Rivett, Ali; Galloway, James; Ide, Zoe; Firth, Jill; MacPhie, Elizabeth; Kandala, Ngianga; Dennison, Elaine M; Rowe, Ian

2017-02-01

A national audit was performed assessing the early management of suspected inflammatory arthritis by English and Welsh rheumatology units. The aim of this audit was to measure the performance of rheumatology services against National Institute for Health and Care Excellence (NICE) quality standards (QSs) for the management of early inflammatory arthritis benchmarked to regional and national comparators for the first time in the UK. All individuals >16 years of age presenting to rheumatology services in England and Wales with suspected new-onset inflammatory arthritis were included in the audit. Information was collected against six NICE QSs that pertain to early inflammatory arthritis management. We present national data for the 6354 patients recruited from 1 February 2014 to 31 January 2015; 97% of trusts and health boards in England and Wales participated in this audit. Only 17% of patients were referred by their general practitioner within 3 days of first presentation. Specialist rheumatology assessment occurred within 3 weeks of referral in 38% of patients. The target of DMARD initiation within 6 weeks of referral was achieved in 53% of RA patients; 36% were treated with combination DMARDs and 82% with steroids within the first 3 months of specialist care. Fifty-nine per cent of patients received structured education on their arthritis within 1 month of diagnosis. In total, 91% of patients had a treatment target set; the agreed target was achieved within 3 months of specialist review in only 27% of patients. Access to urgent advice via a telephone helpline was reported to be available in 96% of trusts. The audit has highlighted gaps between NICE standards and delivery of care, as well as substantial geographic variability. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Comparison Among Recommendations for the Management of Arterial Hypertension Issued by Last US, Canadian, British and European Guidelines.

PubMed

Antza, Christina; Doundoulakis, Ioannis; Stabouli, Stella; Kotsis, Vasilios

2018-03-01

Guidelines for the management of hypertension have been issued by different hypertension societies or organizations. Despite many similarities one can identify major differences in the diagnosis, management and treatment of the hypertensive patients among ESH/ESC, NICE, Canadian and NJC8 guidelines. Differences that can be identified are in the definition of hypertension in the elderly population, the optimal blood pressure targets in different hypertensive populations such as patients with diabetes and chronic kidney disease patients and the choose of the initial and appropriate antihypertensive agent depending on comorbidities of the treated population. Everyday clinical praxis physicians are confused by these differences and these incongruities contribute to doctor and patient inertia to reduce blood pressure levels at an optimal level. Community physicians cannot easily distinguish what recommendations are the best to be used for their patients. The critical view of these differences can also help the guidelines committees to make appropriate changes and finally to agree to a global view of recommendations for the management and treatment of hypertension.

Comparing patient access to pharmaceuticals in the UK and US.

PubMed

Cohen, Joshua; Cairns, Catherine; Paquette, Cherie; Faden, Laura

2006-01-01

The debate on access to new drugs has focused on the time lag between applications for approval and granting of marketing authorisation. This delay was identified as the first barrier with respect to patient access to new drugs, encompassing the hurdles of safety, efficacy and quality. Additional barriers have since been identified. These pertain to reimbursement and pricing of approved drugs, the so-called fourth and fifth hurdles. We reviewed 38 National Institute for Health and Clinical Excellence (NICE) guidance appraisals carried out between April 1999 and April 2005. These appraisals included 71 recently approved drugs considered to have either high clinical or cost impact. For each drug we first determined its marketing approval date by the British Medicines Healthcare Products Agency (MHRA) or European Medicines Evaluation Agency (EMEA). Secondly, we determined if each drug was approved by the US FDA for marketing and, if so, the date when it was approved. Thirdly, we considered whether and when each drug was recommended for reimbursement and use by NICE, and whether conditions of reimbursement applied. Fourthly, for the subset of FDA-approved drugs, we examined formulary placement, cost sharing and conditions of reimbursement on three-tier formularies used by seven leading US third-party payers serving Medicare beneficiaries. Fifthly, we reviewed each NICE recommendation to determine if cost-effectiveness data were referred to either in the appraisal documentation or in the final recommendation. Sixthly, we asked a spokesperson from each US payer whether cost-effectiveness assessments or rebates played a role in determining formulary placement of drugs in our sample, and whether there was a lag between marketing approval and reimbursement for any of the covered drugs. Of the 71 drugs contained in 38 NICE guidance appraisals, the US FDA approved 64. On average, the subset of 64 drugs received marketing authorisation in the US prior to the UK. On average, US plans covered 87% of the 64 drugs, the same percentage of drugs recommended for NHS reimbursement and use. Cost sharing in the US was significantly higher than in the UK, with wider variation across plans. On average, drugs covered in the US had fewer conditions of reimbursement (15%) than the percentage of drugs given conditions by NICE (46%). US plans were quicker to decide to reimburse drugs following marketing approval than NICE. The US provides faster, more flexible access to most, but not all, of the UK-approved pharmaceuticals in our sample. However, US patients have higher cost sharing than the UK and coverage is less evenly spread across the population. From a policy perspective, our study findings confirm the need to bolster the NICE fast-track initiative to decrease the amount of time it takes to appraise certain new pharmaceuticals. Also, the study findings point to the need in the US for careful monitoring of plan compliance with regulations pertaining to the Medicare drug benefit, particularly with respect to formulary restrictions and limits on cost sharing.

Lens ray diagrams with a spreadsheet

NASA Astrophysics Data System (ADS)

González, Manuel I.

2018-05-01

Physicists create spreadsheets customarily to carry out numerical calculations and to display their results in a meaningful, nice-looking way. Spreadsheets can also be used to display a vivid geometrical model of a physical system. This statement is illustrated with an example taken from geometrical optics: images formed by a thin lens. A careful mixture of standard Excel functions allows to display a realistic automated ray diagram. The suggested spreadsheet is intended as an auxiliary didactic tool for instructors who wish to teach their students to create their own ray diagrams.

European Geophysical Society (23rd) General Assembly, Annales Geophysicae. Part 2. Hydrology, Oceans & Atmosphere, Supplement 2 to Volume 16 Held in Nice, France on 20-24 April 1998

DTIC Science & Technology

1998-01-01

sand and gravel outcrops - led to a database of hydraulic conductivities, porosities and kinetic parameters for each lithologjcal fades present in...sedimentological methods. The resulting 2D high-resolution data sets represent a veiy detailed database of excellent quality. On the basis of one example...from an outcrop in southwest Germany the process of building up the database is explained and the results of modelling of transport kinetics in such

Welfarism, extra-welfarism and capability: the spread of ideas in health economics.

PubMed

Coast, Joanna; Smith, Richard D; Lorgelly, Paula

2008-10-01

This paper explores the spread of ideas within health economics, in relation to the impact of the capability approach to date and the extent to which it might impact in the future. The paper uses UK decision making to illustrate this spread of ideas. Within health economics, Culyer used the capability approach in developing the extra-welfarist perspective (where health status directly influences which social state is preferred). It is not a direct application of capability as the evaluation's focus remains narrow; the concern is with functioning, and maximisation is retained. Culyer's work provided a theoretical basis for using quality-adjusted life-years in decision making and this perspective is accepted as the basis for evaluation by the UK National Institute of Health and Clinical Excellence (NICE). To the extent that extra-welfarism represents a capability approach, capabilities influence NICE's decision making and hence UK health care provision. This paper explores the extent to which extra-welfarism draws on the capability approach; the spread of extra-welfarist ideas; and recent interest in more direct applications of the capability approach.

Corail uncemented hemiarthroplasty with a Cathcart head for intracapsular hip fractures.

PubMed

Kendrick, B J L; Wilson, H A; Lippett, J E; McAndrew, A R; Andrade, A J M D

2013-11-01

The National Institute for Health and Clinical Excellence (NICE) guidelines from 2011 recommend the use of cemented hemi-arthroplasty for appropriate patients with an intracapsular hip fracture. In our institution all patients who were admitted with an intracapsular hip fracture and were suitable for a hemi-arthroplasty between April 2010 and July 2012 received an uncemented prosthesis according to our established departmental routine practice. A retrospective analysis of outcome was performed to establish whether the continued use of an uncemented stem was justified. Patient, surgical and outcome data were collected on the National Hip Fracture database. A total of 306 patients received a Cathcart modular head on a Corail uncemented stem as a hemi-arthroplasty. The mean age of the patients was 83.3 years (SD 7.56; 46.6 to 94) and 216 (70.6%) were women. The mortality rate at 30 days was 5.8%. A total of 46.5% of patients returned to their own home by 30 days, which increased to 73.2% by 120 days. The implant used as a hemi-arthroplasty for intracapsular hip fracture provided satisfactory results, with a good rate of return to pre-injury place of residence and an acceptable mortality rate. Surgery should be performed by those who are familiar with the design of the stem and understand what is required for successful implantation.

Do English NHS Microbiology laboratories offer adequate services for the diagnosis of UTI in children? Healthcare Quality Improvement Partnership (HQIP) Audit of Standard Operational Procedures.

PubMed

McNulty, Cliodna A M; Verlander, Neville Q; Moore, Philippa C L; Larcombe, James; Dudley, Jan; Banerjee, Jaydip; Jadresic, Lyda

2015-09-01

The National Institute of Care Excellence (NICE) 2007 guidance CG54, on urinary tract infection (UTI) in children, states that clinicians should use urgent microscopy and culture as the preferred method for diagnosing UTI in the hospital setting for severe illness in children under 3 years old and from the GP setting in children under 3 years old with intermediate risk of severe illness. NICE also recommends that all 'infants and children with atypical UTI (including non-Escherichia coli infections) should have renal imaging after a first infection'. We surveyed all microbiology laboratories in England with Clinical Pathology Accreditation to determine standard operating procedures (SOPs) for urgent microscopy, culture and reporting of children's urine and to ascertain whether the SOPs facilitate compliance with NICE guidance. We undertook a computer search in six microbiology laboratories in south-west England to determine urine submissions and urine reports in children under 3 years. Seventy-three per cent of laboratories (110/150) participated. Enterobacteriaceae that were not E. coli were reported only as coliforms (rather than non-E. coli coliforms) by 61% (67/110) of laboratories. Eighty-eight per cent of laboratories (97/110) provided urgent microscopy for hospital and 54% for general practice (GP) paediatric urines; 61% of laboratories (confidence interval 52-70%) cultured 1 μl volume of urine, which equates to one colony if the bacterial load is 106 c.f.u. l(-1). Only 22% (24/110) of laboratories reported non-E. coli coliforms and provided urgent microscopy for both hospital and GP childhood urines; only three laboratories also cultured a 5 μl volume of urine. Only one of six laboratories in our submission audit had a significant increase in urine submissions and urines reported from children less than 3 years old between the predicted pre-2007 level in the absence of guidance and the 2008 level following publication of the NICE guidance. Less than a quarter of laboratories were providing a service that would allow clinicians to fully comply with the first line recommendations in the 2007 NICE UTI in children guidance. Laboratory urine submission report figures suggest that the guidance has not led to an increase in diagnosis of UTI in children under 3 years old.

George M. Low Trophy NASA's Quality and Excellence Award, 1992. Application guidelines: Small business

NASA Technical Reports Server (NTRS)

1992-01-01

Guidelines are given for the selection of small business candidates for the George M. Low Trophy, NASA's Quality and Excellence Award, 1992. Topics covered include candidate eligibility, the selection process milestone schedule, the nomination letter, and the application report.

Medical curricula and preventing childhood obesity: pooling the resources of medical students and primary care to inform curricula.

PubMed

Wylie, Ann; Furmedge, Daniel S; Appleton, Amber; Toop, Helen; Coats, Tom

2009-03-01

The study aimed to firstly provide a small self-selecting group of medical students with the opportunity to explore current approaches and opportunities addressing the prevention of childhood obesity and, secondly, to consider what aspects could be part of the taught curriculum. Medical students in their third and fourth year were invited to self-design special study modules (SSMs) exploring interventions and processes addressing the growing concern about childhood obesity. One student looked at the role of the primary care teams, two looked at community-based opportunities to improve physical activity in urban areas where there is significant deprivation and one student explored the complex role of the media as a social determinant of dietary patterns and sedentary behaviour. Primary care health professionals questioned their role in regard to raising the topic of obesity in the consultation and had limited awareness of current NICE guidelines and local interventions for referral. Local authority physical activity programmes have an important role in preventing and tackling obesity and although the media are regulated, there is limited impact on reducing obesity. Conversely, the influence of the media is complex and enables medical students and teachers to be aware of some of the social determinants influencing health-related behaviour. About a third of UK GP practices have some role in medical undergraduate education. It will therefore be inevitable that students will encounter GPs working with prevention and management of childhood obesity, however limited, and this will increasingly be part of the teaching agenda, whether formal and planned or opportunistic. Curricula could include being familiar with the evidence that informs NICE guidelines, observing these guidelines being implemented and their limitations, awareness of local schemes for referral to prevent or treat obesity and the influence of wider determinants on diet and physical activity behaviour, including the media.

Responses to gestational weight management guidance: a thematic analysis of comments made by women in online parenting forums

PubMed Central

2014-01-01

Background The National Institute for Health and Clinical Excellence (NICE) published guidance on weight management in pregnancy in July 2010 (NICE public health guidance 27: 2010), and this received considerable press coverage across a range of media. This offered an opportunity to examine how gestational weight management guidance was received by UK women. Methods A thematic analysis was conducted of 400 posts made in UK-based parenting internet forums in the week following the publication of the NICE guidance. This allowed us to examine the naturally occurring comments from 202 women who posted about the guidance on public forums. Results Three main themes were identified and explored: i) Perceived control/responsibility ii) Risk perception iii) Confused messages. Conclusions Women differed in their perceptions of the level of control that they had over being overweight with some feeling responsible and motivated to maintain a healthy lifestyle. Others felt there were multiple factors influencing their weight issues beyond their control. There were reports of feeling guilty about the impact of weight on the growing baby and experiencing significant obesity stigma from the public and health professionals. Information about the risks of overweight and obesity in pregnancy were difficult messages for women to hear, and for health professionals to deliver. Women reported being confused by the messages that they received. Health messages need to be delivered sensitively to women, and health professionals need support and training to do this. Risk information should always be accompanied with clear advice and support to help women to manage their weight in pregnancy. PMID:24981024

Responses to gestational weight management guidance: a thematic analysis of comments made by women in online parenting forums.

PubMed

Arden, Madelynne A; Duxbury, Alexandra M S; Soltani, Hora

2014-06-30

The National Institute for Health and Clinical Excellence (NICE) published guidance on weight management in pregnancy in July 2010 (NICE public health guidance 27: 2010), and this received considerable press coverage across a range of media. This offered an opportunity to examine how gestational weight management guidance was received by UK women. A thematic analysis was conducted of 400 posts made in UK-based parenting internet forums in the week following the publication of the NICE guidance. This allowed us to examine the naturally occurring comments from 202 women who posted about the guidance on public forums. Three main themes were identified and explored: i) Perceived control/responsibility ii) Risk perception iii) Confused messages. Women differed in their perceptions of the level of control that they had over being overweight with some feeling responsible and motivated to maintain a healthy lifestyle. Others felt there were multiple factors influencing their weight issues beyond their control. There were reports of feeling guilty about the impact of weight on the growing baby and experiencing significant obesity stigma from the public and health professionals. Information about the risks of overweight and obesity in pregnancy were difficult messages for women to hear, and for health professionals to deliver. Women reported being confused by the messages that they received. Health messages need to be delivered sensitively to women, and health professionals need support and training to do this. Risk information should always be accompanied with clear advice and support to help women to manage their weight in pregnancy.

A prescription survey of antipsychotic use in England and Wales following the introduction of NICE guidance.

PubMed

MacE, Shubhra; Taylor, David

2005-01-01

Objective : In the United Kingdom (UK) the National Institute for Clinical Excellence (NICE) has recommended the use of atypical antipsychotics for the treatment of schizophrenia. As part of its guidance it discourages the concurrent use of typical and atypical antipsychotics. In previous prescribing surveys antipsychotic polypharmacy has been noted to be widespread. We sought to evaluate atypical antipsychotic prescribing after the publication of NICE guidance. Method : We invited psychiatric centres in England and Wales to participate, in March 2004, in an atypical antipsychotic prescribing survey of hospital in-patients. Results : Thirty-six in-patient units submitted data for 2012 patients. After exclusions, 1092 patients were eligible. Of these, 28.6% (312) were prescribed a typical alongside an atypical antipsychotic and 19.3% (211) were prescribed high-dose antipsychotics. Co-prescription was more prevalent in patients aged 40 years and above (32.0 vs. 25.3%; P=0.018). It was also noted that in centres employing senior pharmacists, co-prescription was more common (28.6 vs. 14.3%; P=0.03). High-dose treatment was more commonly observed in patients of a white ethnic background (20.6 vs. 13.9%; P=0.02) as well as in patients aged 40 years and above (24.4 vs. 15.0%; P<0.001). Prescription of anticholinergics was significantly more prevalent in those receiving atypical and typical combinations than atypicals alone (26.0 vs. 12.0%; P<0.001). Conclusions : Antipsychotic polypharmacy remains commonplace. Similarly the prescription of high-dose antipsychotics is also widespread.

Evaluation of the NICE mini-GRACE risk scores for acute myocardial infarction using the Myocardial Ischaemia National Audit Project (MINAP) 2003-2009: National Institute for Cardiovascular Outcomes Research (NICOR).

PubMed

Simms, Alexander D; Reynolds, Stephanie; Pieper, Karen; Baxter, Paul D; Cattle, Brian A; Batin, Phillip D; Wilson, John I; Deanfield, John E; West, Robert M; Fox, Keith A A; Hall, Alistair S; Gale, Christopher P

2013-01-01

To evaluate the performance of the National Institute for Health and Clinical Excellence (NICE) mini-Global Registry of Acute Coronary Events (GRACE) (MG) and adjusted mini-GRACE (AMG) risk scores. Retrospective observational study. 215 acute hospitals in England and Wales. 137 084 patients discharged from hospital with a diagnosis of acute myocardial infarction (AMI) between 2003 and 2009, as recorded in the Myocardial Ischaemia National Audit Project (MINAP). Model performance indices of calibration accuracy, discriminative and explanatory performance, including net reclassification index (NRI) and integrated discrimination improvement. Of 495 263 index patients hospitalised with AMI, there were 53 196 ST elevation myocardial infarction and 83 888 non-ST elevation myocardial infarction (NSTEMI) (27.7%) cases with complete data for all AMG variables. For AMI, AMG calibration was better than MG calibration (Hosmer-Lemeshow goodness of fit test: p=0.33 vs p<0.05). MG and AMG predictive accuracy and discriminative ability were good (Brier score: 0.10 vs 0.09; C statistic: 0.82 and 0.84, respectively). The NRI of AMG over MG was 8.1% (p<0.05). Model performance was reduced in patients with NSTEMI, chronic heart failure, chronic renal failure and in patients aged ≥85 years. The AMG and MG risk scores, utilised by NICE, demonstrated good performance across a range of indices using MINAP data, but performed less well in higher risk subgroups. Although indices were better for AMG, its application may be constrained by missing predictors.

Validation of two algorithms for managing children with a non-blanching rash.

PubMed

Riordan, F Andrew I; Jones, Laura; Clark, Julia

2016-08-01

Paediatricians are concerned that children who present with a non-blanching rash (NBR) may have meningococcal disease (MCD). Two algorithms have been devised to help identify which children with an NBR have MCD. To evaluate the NBR algorithms' ability to identify children with MCD. The Newcastle-Birmingham-Liverpool (NBL) algorithm was applied retrospectively to three cohorts of children who had presented with NBRs. This algorithm was also piloted in four hospitals, and then used prospectively for 12 months in one hospital. The National Institute for Health and Care Excellence (NICE) algorithm was validated retrospectively using data from all cohorts. The cohorts included 625 children, 145 (23%) of whom had confirmed or probable MCD. Paediatricians empirically treated 324 (52%) children with antibiotics. The NBL algorithm identified all children with MCD and suggested treatment for a further 86 children (sensitivity 100%, specificity 82%). One child with MCD did not receive immediate antibiotic treatment, despite this being suggested by the algorithm. The NICE algorithm suggested 382 children (61%) who should be treated with antibiotics. This included 141 of the 145 children with MCD (sensitivity 97%, specificity 50%). These algorithms may help paediatricians identify children with MCD who present with NBRs. The NBL algorithm may be more specific than the NICE algorithm as it includes fewer features suggesting MCD. The only significant delay in treatment of MCD occurred when the algorithms were not followed. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The Health Technology Assessment of companion diagnostics: experience of NICE.

PubMed

Byron, Sarah K; Crabb, Nick; George, Elisabeth; Marlow, Mirella; Newland, Adrian

2014-03-15

Companion diagnostics are used to aid clinical decision making to identify patients who are most likely to respond to treatment. They are becoming increasingly important as more new pharmaceuticals receive licensed indications that require the use of a companion diagnostic to identify the appropriate patient subgroup for treatment. These pharmaceuticals have proven benefit in the treatment of some cancers and other diseases, and also have potential to precisely tailor treatments to the individual in the future. However, the increasing use of companion diagnostics could place a substantial burden on health system resources to provide potentially high volumes of testing. This situation, in part, has led policy makers and Health Technology Assessment (HTA) bodies to review the policies and methods used to make reimbursement decisions for pharmaceuticals requiring companion diagnostics. The assessment of a pharmaceutical alongside the companion diagnostic used in the clinical trials may be relatively straightforward, although there are a number of challenges associated with assessing pharmaceuticals where a range of alternative companion diagnostics are available for use in routine clinical practice. The UK HTA body, the National Institute for Health and Care Excellence (NICE), has developed policy for considering companion diagnostics using its Technology Appraisal and Diagnostics Assessment Programs. Some HTA bodies in other countries have also adapted their policies and methods to accommodate the assessment of companion diagnostics. Here, we provide insight into the HTA of companion diagnostics for reimbursement decisions and how the associated challenges are being addressed, in particular by NICE. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." ©2014 AACR.

The impact of chronic pain on opioid addiction treatment: a systematic review protocol.

PubMed

Dennis, Brittany B; Bawor, Monica; Paul, James; Varenbut, Michael; Daiter, Jeff; Plater, Carolyn; Pare, Guillaume; Marsh, David C; Worster, Andrew; Desai, Dipika; Thabane, Lehana; Samaan, Zainab

2015-04-16

The consequences of opioid relapse among patients being treated with opioid substitution treatment (OST) are serious and can result in abnormal cardiovascular function, overdose, and mortality. Chronic pain is a major risk factor for opioid relapse within the addiction treatment setting. There exist a number of opioid maintenance therapies including methadone, buprenorphine, naltrexone, and levomethadyl acetate (LAAM), of which the mediating effects of pain on treatment attrition, substance use behavior, and social functioning may differ across therapies. We aim to 1) evaluate the impact of pain on the treatment outcomes of addiction patients being managed with OST and 2) identify the most recently published opioid maintenance treatment guidelines from the United States, Canada, and the UK to determine how the evidence is being translated into clinical practice. The authors will search Medline, EMBASE, PubMed, PsycINFO, Web of Science, Cochrane Database of Systematic Reviews, ProQuest Dissertations and theses Database, Cochrane Central Register of Controlled Trials (CENTRAL), World Health Organization International Clinical Trials Registry Platform Search Portal, and the National Institutes for Health Clinical Trials Registry. We will search www. gov and the National Institute for Care and Excellence (NICE) databases to identify the most recently published OST guidelines. All screening and data extraction will be completed in duplicate. Provided the data are suitable, we will perform a multiple treatment comparison using Bayesian meta-analytic methods to produce summary statistics estimating the effect of chronic pain on all OSTs. Our primary outcome is substance use behavior, which includes opioid and non-opioid substance use. We will also evaluate secondary endpoints such as treatment retention, general physical health, intervention adherence, personal and social functioning, as well as psychiatric symptoms. This review will capture the experience of treatment outcomes for a sub-population of opioid addiction patients and provide an opportunity to distinguish the best quality guidelines for OST. If chronic pain truly does result in negative consequences for opioid addiction patients, it is important we identify which OSTs are most appropriate for chronic pain patients as well as ensure the treatment guidelines incorporate this information. PROSPERO CRD42014014015 http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42014014015#.VS1Qw1wkKGM.

Rivaroxaban for Preventing Atherothrombotic Events in People with Acute Coronary Syndrome and Elevated Cardiac Biomarkers: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

PubMed

Pandor, Abdullah; Pollard, Daniel; Chico, Tim; Henderson, Robert; Stevenson, Matt

2016-05-01

As part of its Single Technology Appraisal process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures rivaroxaban (Xarelto, Bayer) to submit evidence of the clinical and cost effectiveness of rivaroxaban for the prevention of adverse outcomes in patients after the acute management of acute coronary syndrome (ACS). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence for the clinical and cost effectiveness of the technology, based upon the company's submission to NICE. The evidence was derived mainly from a randomised, double-blind, phase III, placebo-controlled trial of rivaroxaban (either 2.5 or 5 mg twice daily) in patients with recent ACS [unstable angina, non-ST segment elevation myocardial infarction (NSTEMI) or ST segment elevation myocardial infarction (STEMI)]. In addition, all patients received antiplatelet therapy [aspirin alone or aspirin and a thienopyridine either as clopidogrel (approximately 99 %) or ticlopidine (approximately 1 %) according to national or local guidelines]. The higher dose of rivaroxaban (5 mg twice daily) did not form part of the marketing authorisation. A post hoc subgroup analysis of the licensed patients who had ACS with elevated cardiac biomarkers (that is, patients with STEMI and NSTEMI) without prior stroke or transient ischaemic stroke showed that compared with standard care, the addition of rivaroxaban (2.5 mg twice daily) to existing antiplatelet therapy reduced the composite endpoint of cardiovascular mortality, myocardial infarction or stroke, but increased the risk of major bleeding and intracranial haemorrhage. However, there were a number of limitations in the evidence base that warrant caution in its interpretation. In particular, the evidence may be confounded because of the post hoc subgroup analysis, modified intention-to-treat analyses, high dropout rates and missing vital status data. Results from the company's economic evaluation showed that the deterministic incremental cost-effectiveness ratio (ICER) for rivaroxaban in combination with aspirin plus clopidogrel or with aspirin alone compared with aspirin plus clopidogrel or aspirin alone was £6203 per quality-adjusted life-year (QALY) gained. In contrast, the ERG's preferred base case estimate was £5622 per QALY gained. The ICER did not rise above £10,000 per QALY gained in any of the sensitivity analyses undertaken by the ERG, although the inflexibility of the company's economic model precluded the ERG from formally undertaking all desired exploratory analyses. As such, only a crude exploration of the impact of additional bleeding events could be undertaken. The NICE Appraisal Committee concluded that the ICERs presented were all within the range that could be considered cost effective and that the results of the ERG's exploratory sensitivity and scenario analyses suggested that the ICER was unlikely to increase to the extent that it would become unacceptable. The Appraisal Committee therefore concluded that rivaroxaban in combination with aspirin plus clopidogrel, or with aspirin alone, was a cost-effective use of National Health Service (NHS) resources for preventing atherothrombotic events in people with ACS and elevated cardiac biomarkers.

Reviews

NASA Astrophysics Data System (ADS)

2007-07-01

WE RECOMMEND God: The Failed Hypothesis A book that applies scientific logic to the search for a creator Go with the Flow This CD-ROM proves a great resource for teaching fluids Collins GCSE Student Book for EdExcel 360 Additional Science An attractive update that will sit well in modern classrooms The Rough Guide to Climate Change This book contains a thorough study of the must-teach subject InspireData Presentation software ideal for analysing data in the field WORTH A LOOK Uncertain Science...Uncertain World A book to persuade the public that unanswered questions are not a failure of science or scientists Fisher Space Pen An interesting teaching resource and a nice bit of stationery HANDLE WITH CARE Russian Space Pen A joke gift at best—no physics here IGCSE Physics for EdExcel Dull, old-fashioned approach to teaching the new qualification WEB WATCH How news headlines can prove a valuable tool to get pupils interested in a subject

Tackling malnutrition among older people in the community.

PubMed

Denny, Anna

2007-03-01

Undernutrition - of both macronutrients and micronutrients - is still a surprisingly common problem among older people in the UK. There is a variety of nutritional supplements that community nurses need to be aware of in managing their patients' nutritional requirements. Different supplements are taken for different disease states. This article looks at the various nutrient and energy requirements that relate directly to clients on the district nurse's caseload. Some of the negative consequences of malnutrition of the older adult are discussed, as are the NICE guidelines for nutrition. Factors affecting dietary intake in older people are considered.

The methodological quality of guidelines for hospital-acquired pneumonia and ventilator-associated pneumonia: A systematic review.

PubMed

Ambaras Khan, R; Aziz, Z

2018-05-02

Clinical practice guidelines serve as a framework for physicians to make decisions and to support best practice for optimizing patient care. However, if the guidelines do not address all the important components of optimal care sufficiently, the quality and validity of the guidelines can be reduced. The objectives of this study were to systematically review current guidelines for hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP), evaluate their methodological quality and highlight the similarities and differences in their recommendations for empirical antibiotic and antibiotic de-escalation strategies. This review is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. Electronic databases including MEDLINE, CINAHL, PubMed and EMBASE were searched up to September 2017 for relevant guidelines. Other databases such as NICE, Scottish Intercollegiate Guidelines Network (SIGN) and the websites of professional societies were also searched for relevant guidelines. The quality and reporting of included guidelines were assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE-II) instrument. Six guidelines were eligible for inclusion in our review. Among 6 domains of AGREE-II, "clarity of presentation" scored the highest (80.6%), whereas "applicability" scored the lowest (11.8%). All the guidelines supported the antibiotic de-escalation strategy, whereas the majority of the guidelines (5 of 6) recommended that empirical antibiotic therapy should be implemented in accordance with local microbiological data. All the guidelines suggested that for early-onset HAP/VAP, therapy should start with a narrow spectrum empirical antibiotic such as penicillin or cephalosporins, whereas for late-onset HAP/VAP, the guidelines recommended the use of a broader spectrum empirical antibiotic such as the penicillin extended spectrum carbapenems and glycopeptides. Expert guidelines promote the judicious use of antibiotics and prevent antibiotic overuse. The quality and validity of available HAP/VAP guidelines would be enhanced by improving their adherence to accepted best practice for the management of HAP and VAP. © 2018 John Wiley & Sons Ltd.

The Role of Noncomparative Evidence in Health Technology Assessment Decisions.

PubMed

Griffiths, Elizabeth A; Macaulay, Richard; Vadlamudi, Nirma K; Uddin, Jasim; Samuels, Ebony R

2017-12-01

Many health technology assessment (HTA) agencies express a preference for randomized controlled trial evidence when appraising health technologies; nevertheless, it is not always feasible or ethical to conduct such comparative trials. To assess the role of noncomparative evidence in HTA decision making. The Web sites of the National Institute for Health and Care Excellence (NICE) in the United Kingdom, the Canadian Agency for Drugs and Technologies in Health (CADTH) in Canada, and the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen [IQWiG]) in Germany were searched for single HTA reports (published between January 2010 and December 2015). The product, indication, outcome, and clinical evidence presented (comparative/noncomparative) were double-extracted, with any discrepancies reconciled. A noncomparative study was defined as any study not presenting results against another treatment (including placebo or best supportive care), regardless of phase or setting, including dose-ranging studies. A total of 549 appraisals were extracted. Noncomparative evidence was considered in 38% (45 of 118) of NICE submissions, 13% (34 of 262) of CADTH submissions, and 12% (20 of 169) of IQWiG submissions. Evidence submissions based exclusively on noncomparative evidence were presented in only 4% (5 of 118) of NICE appraisals, 6% (16 of 262) of CADTH appraisals, and 4% (6 of 169) of IQWiG appraisals. Most drugs appraised solely on the basis of noncomparative evidence were indicated for cancer or hepatitis C. Positive outcome rates (encompassing recommended/restricted/added-benefit decisions) for submissions presenting only noncomparative evidence were similar to overall recommendation rates for CADTH (69% vs. 68%, respectively), but were numerically lower for NICE (60% vs. 84%, respectively) and IQWiG (17% vs. 38%, respectively) (P > 0.05 for all). Noncomparative studies can be viewed as acceptable clinical evidence by HTA agencies when these study designs are justifiable and when treatment effect can be convincingly demonstrated, but their use is currently limited. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Are life-extending treatments for terminal illnesses a special case? Exploring choices and societal viewpoints.

PubMed

McHugh, Neil; van Exel, Job; Mason, Helen; Godwin, Jon; Collins, Marissa; Donaldson, Cam; Baker, Rachel

2018-02-01

Criteria used by the National Institute for Health and Care Excellence (NICE) to assess life-extending, end-of-life (EoL) treatments imply that health gains from such treatments are valued more than other health gains. Despite claims that the policy is supported by societal values, evidence from preference elicitation studies is mixed and in-depth research has shown there are different societal viewpoints. Few studies elicit preferences for policies directly or combine different approaches to understand preferences. Survey questions were designed to investigate support for NICE EoL guidance at national and regional levels. These 'Decision Rule' and 'Treatment Choice' questions were administered to an online sample of 1496 UK respondents in May 2014. The same respondents answered questions designed to elicit their agreement with three viewpoints (previously identified and described) in relation to provision of EoL treatments for terminally ill patients. We report the findings of these choice questions and examine how they relate to each other and respondents' viewpoints. The Decision Rule questions described three policies: DA - a standard 'value for money' test, applied to all health technologies; DB - giving special consideration to all treatments for terminal illnesses; and DC - giving special consideration to specific categories of treatments for terminal illnesses e.g. life extension (as in NICE EoL guidance) or those that improve quality-of-life (QoL). Three Treatment Choices were presented: TA - improving QoL for patients with a non-terminal illness; TB - extending life for EoL patients; and TC - improving QoL at the EoL. DC received most support (45%) with most respondents giving special consideration to EoL only when treatments improved QoL. The most commonly preferred treatment choices were TA (51%) and TC (43%). Overall, this study challenges claims about public support for NICE's EoL guidance and the focus on life extension at EoL and substantiates existing evidence of plurality in societal values. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Do English NHS Microbiology laboratories offer adequate services for the diagnosis of UTI in children? Healthcare Quality Improvement Partnership (HQIP) Audit of Standard Operational Procedures

PubMed Central

Verlander, Neville Q.; Moore, Philippa C. L.; Larcombe, James; Dudley, Jan; Banerjee, Jaydip; Jadresic, Lyda

2015-01-01

The National Institute of Care Excellence (NICE) 2007 guidance CG54, on urinary tract infection (UTI) in children, states that clinicians should use urgent microscopy and culture as the preferred method for diagnosing UTI in the hospital setting for severe illness in children under 3 years old and from the GP setting in children under 3 years old with intermediate risk of severe illness. NICE also recommends that all ‘infants and children with atypical UTI (including non-Escherichia coli infections) should have renal imaging after a first infection’. We surveyed all microbiology laboratories in England with Clinical Pathology Accreditation to determine standard operating procedures (SOPs) for urgent microscopy, culture and reporting of children's urine and to ascertain whether the SOPs facilitate compliance with NICE guidance. We undertook a computer search in six microbiology laboratories in south-west England to determine urine submissions and urine reports in children under 3 years. Seventy-three per cent of laboratories (110/150) participated. Enterobacteriaceae that were not E. coli were reported only as coliforms (rather than non-E. coli coliforms) by 61 % (67/110) of laboratories. Eighty-eight per cent of laboratories (97/110) provided urgent microscopy for hospital and 54 % for general practice (GP) paediatric urines; 61 % of laboratories (confidence interval 52–70 %) cultured 1 μl volume of urine, which equates to one colony if the bacterial load is 106 c.f.u. l− 1. Only 22 % (24/110) of laboratories reported non-E. coli coliforms and provided urgent microscopy for both hospital and GP childhood urines; only three laboratories also cultured a 5 μl volume of urine. Only one of six laboratories in our submission audit had a significant increase in urine submissions and urines reported from children less than 3 years old between the predicted pre-2007 level in the absence of guidance and the 2008 level following publication of the NICE guidance. Less than a quarter of laboratories were providing a service that would allow clinicians to fully comply with the first line recommendations in the 2007 NICE UTI in children guidance. Laboratory urine submission report figures suggest that the guidance has not led to an increase in diagnosis of UTI in children under 3 years old. PMID:26297550

Ledipasvir-Sofosbuvir for Treating Chronic Hepatitis C: A NICE Single Technology Appraisal-An Evidence Review Group Perspective.

PubMed

Thokala, P; Simpson, E L; Tappenden, P; Stevens, J W; Dickinson, K; Ryder, S; Harrison, P

2016-08-01

The National Institute for Health and Care Excellence (NICE) invited Gilead, the company manufacturing ledipasvir-sofosbuvir (LDV/SOF), to submit evidence for the clinical effectiveness and cost effectiveness of LDV/SOF for treating chronic hepatitis C. The School of Health and Related Research (ScHARR) Technology Assessment Group was commissioned as the Evidence Review Group (ERG). This paper describes the company's submission (CS), the ERG review and the subsequent decision of the NICE Appraisal Committee (AC). The ERG produced a critical review of the clinical effectiveness and cost-effectiveness evidence of LDV/SOF based upon the CS. The clinical effectiveness data for LDV/SOF were taken from ten trials: three phase III trials and seven phase II trials. Trials compared different durations of LDV/SOF, with and without ribavirin (RBV). There were no head-to-head trials comparing LDV/SOF with any comparator listed in the NICE scope. Data from the trials were mostly from populations with genotype 1 (GT1) disease, although some limited data were available for populations with genotypes 3 and 4. For GT1 treatment-naïve patients, sustained viral response for 12 weeks (SVR12) rates for LDV/SOF ranged from 93.1 to 99.4 % for subgroups of patients with non-cirrhotic disease, whilst SVR rates of 94.1 to 100 % were reported for subgroups of patients with compensated cirrhosis. For GT1 treatment-experienced patients, SVR12 rates ranging from 95.4 to 100 % were reported for subgroups of non-cirrhotic patients, and SVR rates ranging from 81.8 to 100 % were reported within subgroups of patients with compensated cirrhosis. Comparator data were not searched systematically as part of the submission, but were based on the company's previous NICE submission of sofosbuvir, with additional targeted searches. The ERG's critical appraisal of the company's economic evaluation highlighted a number of concerns. The ERG's base case analyses suggested that the incremental cost-effectiveness ratios (ICERs) for LDV/SOF (+RBV) are dependent on (a) treatment durations, (b) whether patients have been previously treated and (c) whether patients have liver cirrhosis or not. The AC concluded that it was appropriate to use the approach taken in the ERG's exploratory analyses, in line with the marketing authorisation, which considered people with and without cirrhosis separately, and estimated the cost effectiveness for each recommended treatment duration of LDV/SOF.

A change in the trend in dosulepin usage following the introduction of a prescribing indicator but not after two national safety warnings.

PubMed

Deslandes, P N; Jenkins, K S L; Haines, K E; Hutchings, S; Cannings-John, R; Lewis, T L; Bracchi, R C; Routledge, P A

2016-04-01

The tricyclic antidepressant dosulepin has been associated with an increased risk of toxicity in overdose compared with other antidepressants. In the UK, the MHRA and NICE have issued advice on the prescribing of dosulepin, and a National Prescribing Indicator (NPI) to monitor usage was introduced in Wales in 2011. The aim of this study was to assess whether trends in dosulepin usage in Wales and NE England changed following the two pieces of safety guidance and the introduction of the National Prescribing Indicator in Wales. Primary care dosulepin usage in the 12 months prior to and following MHRA safety advice (in 2007), NICE guideline CG90 (in 2009) and the introduction of the NPI (in 2011) was obtained. Usage was measured using defined daily doses (DDDs) per 1000 prescribing units (PUs). The trends in the 12 months prior to and following the introduction of prescribing advice and the NPI were compared using an autoregressive integrated moving average (ARIMA) model. In Wales, the trend in dosulepin usage did not change significantly prior to and following the MHRA advice: -0·18 and -0·43 DDDs/1000PUs per month, respectively (P = 0·07), or prior to and following NICE CG90: -0·30 and -0·49 DDDs/1000PUs per month, respectively (P = 0·35). In the 12 months prior to and following the introduction of the NPI, the trend was -0·45 and -0·98 DDDs/1000PUs per month, respectively (P = 0·001). In NE England, the trend did not alter significantly following the NICE advice or the introduction of the NPI in Wales. The trend in dosulepin usage in Wales altered significantly following the introduction of the NPI, but not after the other prescribing advice. This association, coupled with the absence of a significant change in NE England over the same period, provided some evidence of the effectiveness of the NPI in prompting a change in prescribing behaviour in Wales. © 2016 John Wiley & Sons Ltd.

Who does the numbers? The role of third-party technology assessment to inform health systems' decision-making about the funding of health technologies.

PubMed

Barbieri, Marco; Hawkins, Neil; Sculpher, Mark

2009-01-01

There is an increasing number of health-care systems using economic evaluations to inform decisions about the reimbursement of health technologies. There are usually two separate elements of this process: assembling relevant evidence and undertaking analyses (technology assessment), and decision-making. In most systems, technology assessment is undertaken by the manufacturer of the technology. In a few, "third-party" assessment is used. In the United Kingdom, the National Institute for Health and Clinical Excellence used a combination of third-party and manufacturer assessments between 1999 and 2005. After this point, a Single Technology Appraisal program (using manufacturer-based assessment) was instituted for some technologies. Here the role of third-party assessment is considered in this from of decision-making. The article reviews the requirements of economic evaluation to support decision-making, and considers the extent to which each type of assessment is likely to meet these requirements. It also attempts to address whether the two forms of assessment differ in their impact on decision-making using a comparison of the decisions made by National Institute for Health and Clinical Excellence (NICE) (under its multiple-technology appraisal system) and the Scottish Medicines Consortium (SMC), which relies on manufacturer assessment. The comparison is limited by the small number of technologies considered by both bodies. Nevertheless, it suggests that there are potentially important differences between the two bodies, with NICE generally placing more restrictions of the use of technologies. The article concludes that there are potential advantages to third-party assessment, but its cost and timing may preclude its use for all new technologies. A hybrid arrangement is suggested where third-party assessment is used in particular circumstances.

Evidence-based medicine meets democracy: the role of evidence-based public health guidelines in local government.

PubMed

Kelly, M P; Atkins, L; Littleford, C; Leng, G; Michie, S

2017-12-01

In 2013, many public health functions transferred from the National Health Service to local government in England. From 2006 NICE had produced public health guidelines based on the principles of evidence-based medicine. This study explores how the guidelines were received in the new environment in local government and related issues raised relating to the use of evidence in local authoritites. In depth, interviews with 31 elected members and officers, including Directors of Public Health, from four very different local government organizations ('local authorities'). Participants reported that (i) there were tensions between evidence-based, and political decision-making; (ii) there were differences in views about what constituted 'good' evidence and (iii) that organizational life is an important mediator in the way evidence is used. Democratic political decision-making does not necessarily naturally align with decision-making based on evidence from the international scientific literature, and local knowledge and local evidence are very important in the ways that public health decisions are made. © The Author 2017. Published by Oxford University Press on behalf of Faculty of Public Health.

UK Renal Registry 13th Annual Report (December 2010): Chapter 9: haemoglobin, ferritin and erythropoietin amongst UK adult dialysis patients in 2009: national and centre-specific analyses.

PubMed

Gilg, Julie; Webb, Lynsey; Feest, Terry; Fogarty, Damian

2011-01-01

The UK Renal Association (RA) and National Institute for Health and Clinical Excellence (NICE) have published Clinical Practice Guidelines which include recommendations for management of anaemia in established renal failure. To determine the extent to which the guidelines for anaemia management are met in the UK. Quarterly data were obtained regarding haemoglobin (Hb) and factors that influence Hb from renal centres in England, Wales, Northern Ireland (EWNI) and the Scottish Renal Registry for the incident and prevalent renal replacement therapy (RRT) cohorts for 2009. In the UK, in 2009 55% of patients commenced dialysis therapy with Hb x10.0 g/dl (median Hb 10.2 g/dl). The median Hb of haemodialysis (HD) patients was 11.6 g/dl with an interquartile range (IQR) of 10.6 - 12.4 g/dl. Of HD patients 85% had Hb ≥ 10.0 g/dl. The median Hb of peritoneal dialysis (PD) patients in the UK was 11.7 g/dl (IQR 10.7-12.6 g/dl). Of UK PD patients, 88% had Hb ≥ 10.0 g/dl. The median ferritin in HD patients in EWNI was 441 mg/L (IQR 289-629) and 96% of HD patients had a ferritin ≥ 100 mg/L. The median ferritin in PD patients was 249 mg/L (IQR 142-412) with 86% of PD patients having a ferritin 5100 mg/L. In EWNI the mean Erythropoietin Stimulating Agent (ESA) dose was higher for HD than PD patients (9,507 vs. 6,212 IU/week). In 2009, 56% of prevalent HD patients had a Hb ≥ 10.5 and ≤ 12.5 g/dl compared with 54% in 2008 and 53% in 2007. Fifty-four percent of prevalent PD patients had a Hb ≥10.5 and ≤12.5 g/dl compared to 55% in 2008. Copyright © 2011 S. Karger AG, Basel.

Performance of 2014 NICE defibrillator implantation guidelines in heart failure risk stratification.

PubMed

Cubbon, Richard M; Witte, Klaus K; Kearney, Lorraine C; Gierula, John; Byrom, Rowenna; Paton, Maria; Sengupta, Anshuman; Patel, Peysh A; Mn Walker, Andrew; Cairns, David A; Rajwani, Adil; Hall, Alistair S; Sapsford, Robert J; Kearney, Mark T

2016-05-15

Define the real-world performance of recently updated National Institute for Health and Care Excellence guidelines (TA314) on implantable cardioverter-defibrillator (ICD) use in people with chronic heart failure. Multicentre prospective cohort study of 1026 patients with stable chronic heart failure, associated with left ventricular ejection fraction (LVEF) ≤45% recruited in cardiology outpatient departments of four UK hospitals. We assessed the capacity of TA314 to identify patients at increased risk of sudden cardiac death (SCD) or appropriate ICD shock. The overall risk of SCD or appropriate ICD shock was 2.1 events per 100 patient-years (95% CI 1.7 to 2.6). Patients meeting TA314 ICD criteria (31.1%) were 2.5-fold (95% CI 1.6 to 3.9) more likely to suffer SCD or appropriate ICD shock; they were also 1.5-fold (95% CI 1.1 to 2.2) more likely to die from non-cardiovascular causes and 1.6-fold (95% CI 1.1 to 2.3) more likely to die from progressive heart failure. Patients with diabetes not meeting TA314 criteria experienced comparable absolute risk of SCD or appropriate ICD shock to patients without diabetes who met TA314 criteria. Patients with ischaemic cardiomyopathy not meeting TA314 criteria experienced comparable absolute risk of SCD or appropriate ICD shock to patients with non-ischaemic cardiomyopathy who met TA314 criteria. TA314 can identify patients with reduced LVEF who are at increased relative risk of sudden death. Clinicians should also consider clinical context and the absolute risk of SCD when advising patients about the potential risks and benefits of ICD therapy. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Atrial fibrillation: stroke prevention in focus.

PubMed

Ferguson, Caleb; Inglis, Sally C; Newton, Phillip J; Middleton, Sandy; Macdonald, Peter S; Davidson, Patricia M

2014-05-01

Atrial fibrillation (AF) is a common arrhythmia and a risk factor for stroke and other, adverse events. Internationally there have been recent advancements in the therapies available for, stroke prevention in AF. Nurses will care for individuals with AF across a variety of primary and acute, care settings and should be familiar with evidence based therapies. This paper provides a review of the epidemiology of AF and stroke, stroke and bleeding risk, assessment tools and evidence based treatments for the prevention of stroke in AF including the use of, novel anti-thrombin agents. A review of key databases was conducted from 2002 to 2012 using the key search terms 'atrial, fibrillation' 'anticoagulation' 'risk assessment' and 'clinical management'. The following electronic, databases were searched: CINAHL, Medline, Scopus, the Cochrane Library and Google Scholar., Reference lists were manually hand searched. Key clinical guidelines from National Institute for, Clinical Excellence (NICE, UK), American Heart Association (AHA, USA), American College of Cardiology, (ACC, USA) and the European Society of Cardiology (ESC) and key government policy documents were, also included. Articles were included in the review if they addressed nursing management with a focus, on Australia. Many treatment options exist for AF. Best practice guidelines make a variety of, recommendations which include cardioversion, ablation, pulmonary vein isolation, pharmacological, agents for rate or rhythm control approaches, and antithrombotic therapy (including anticoagulation, and antiplatelet therapy). Treatment should be patient centred and individualised based upon, persistency of the rhythm, causal nature, risk and co-morbid conditions. AF is a common and burdensome condition where treatment is complex and not without, risk. Nurses will encounter individuals with AF across a variety of primary and acute care areas, understanding the risk of AF and appropriate therapies is important across all care settings. Treatment, must be individually tailored to the needs of the patient and balanced with the best available evidence. Copyright © 2013 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.

A UK survey of rehabilitation following critical illness: implementation of NICE Clinical Guidance 83 (CG83) following hospital discharge.

PubMed

Connolly, Bronwen; Douiri, A; Steier, J; Moxham, J; Denehy, L; Hart, N

2014-05-15

To determine the implementation of National Institute for Health and Care Excellence guidance (NICE CG83) for posthospital discharge critical illness follow-up and rehabilitation programmes. Closed-question postal survey. Adult intensive care units (ICUs) across the UK, identified from national databases of organisations. Specialist-only and private ICUs were not included. Senior respiratory critical care physiotherapy clinicians. A representative sample of 182 surveys was returned from the 240 distributed (75.8% (95% CI 70.4 to 81.2)). Only 48 organisations (27.3% (95% CI 20.7 to 33.9)) offered a follow-up service 2-3 months following hospital discharge, the majority (n=39, 84.8%) in clinic format. 12 organisations reported posthospital discharge rehabilitation programmes (6.8% (95% CI 3.1 to 10.5)), albeit only 10 of these operated on a regular basis. Lack of funding was reported as the most frequent (n=149/164, 90%) and main barrier (n=99/156, 63.5%) to providing services. Insufficient resources (n=71/164, 43.3%) and lack of priority by the clinical management team (n=66/164, 40.2%) were also highly cited barriers to service delivery. NICE CG83 has been successful in profiling the importance of rehabilitation for survivors of critical illness. However, 4 years following publication of CG83 there has been limited development of this clinical service across the UK. Strategies to support delivery of such quality improvement programmes are urgently required to enhance patient care. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Vision Amniotic Leak Detector (ALD) to Eliminate Amniotic Fluid Leakage as a Cause of Vaginal Wetness in Pregnancy: A NICE Medical Technology Guidance.

PubMed

Ray, A F; Peirce, S C; Wilkes, A R; Carolan-Rees, G

2015-10-01

In prelabour rupture of membranes (PROM) or preterm PROM the amniotic membranes rupture prior to labour. Where this is not overt a speculum examination is undertaken to confirm diagnosis. The Vision Amniotic Leak Detector (ALD) is a panty liner that can diagnose amniotic fluid as a cause of vaginal wetness. It was evaluated by the UK National Institute for Health and Care Excellence (NICE) as part of the Medical Technologies Evaluation Programme. The sponsor (CommonSense Ltd) identified five studies, of which three were deemed within scope by the External Assessment Centre (EAC). Two of these three used an inappropriate comparator. The EAC recalculated the diagnostic accuracy of Vision ALD using speculum examination as the comparator: sensitivity of 97% (95% CI 93-99%), negative predictive value of 96% (95% CI 92-98%). A negative result would therefore allow patients to be discharged with confidence. In the sponsor's cost-consequence model only patients with a positive Vision ALD result would have a speculum examination, producing a cost saving of around £10 per patient. The EAC felt that some costs were unjustified and the model did not include infection outcomes or use in a community setting. The EAC revised the sponsor's model and found the results were most sensitive to clinician costs. Vision ALD was associated with savings of around £15-£25 per patient when administration in lower-cost community healthcare avoided a referral to a higher-cost secondary-care centre. NICE published guidance MTG15 in July 2013 recommending that the case for adopting Vision ALD was supported by the evidence.

Issues Related to the Frequency of Exploratory Analyses by Evidence Review Groups in the NICE Single Technology Appraisal Process.

PubMed

Kaltenthaler, Eva; Carroll, Christopher; Hill-McManus, Daniel; Scope, Alison; Holmes, Michael; Rice, Stephen; Rose, Micah; Tappenden, Paul; Woolacott, Nerys

2017-06-01

Evidence Review Groups (ERGs) critically appraise company submissions as part of the National Institute for Health and Care Excellence (NICE) Single Technology Appraisal (STA) process. As part of their critique of the evidence submitted by companies, the ERGs undertake exploratory analyses to explore uncertainties in the company's model. The aim of this study was to explore pre-defined factors that might influence or predict the extent of ERG exploratory analyses. The aim of this study was to explore predefined factors that might influence or predict the extent of ERG exploratory analyses. We undertook content analysis of over 400 documents, including ERG reports and related documentation for the 100 most recent STAs (2009-2014) for which guidance has been published. Relevant data were extracted from the documents and narrative synthesis was used to summarise the extracted data. All data were extracted and checked by two researchers. Forty different companies submitted documents as part of the NICE STA process. The most common disease area covered by the STAs was cancer (44%), and most ERG reports (n = 93) contained at least one exploratory analysis. The incidence and frequency of ERG exploratory analyses does not appear to be related to any developments in the appraisal process, the disease area covered by the STA, or the company's base-case incremental cost-effectiveness ratio (ICER). However, there does appear to be a pattern in the mean number of analyses conducted by particular ERGs, but the reasons for this are unclear and potentially complex. No clear patterns were identified regarding the presence or frequency of exploratory analyses, apart from the mean number conducted by individual ERGs. More research is needed to understand this relationship.

Evolution of the evidence on the effectiveness and cost-effectiveness of acetylcholinesterase inhibitors and memantine for Alzheimer's disease: systematic review and economic model.

PubMed

Hyde, Christopher; Peters, Jaime; Bond, Mary; Rogers, Gabriel; Hoyle, Martin; Anderson, Rob; Jeffreys, Mike; Davis, Sarah; Thokala, Praveen; Moxham, Tiffany

2013-01-01

in 2007 the National Institute of Health and Clinical Excellence (NICE) restricted the use of acetylcholinesterase inhibitors and memantine. we conducted a health technology assessment (HTA) of the effectiveness and cost-effectiveness of donepezil, galantamine, rivastigmine and memantine for the treatment of AD to re-consider and up-date the evidence base used to inform the 2007 NICE decision. The systematic review of effectiveness targeted randomised controlled trials. A comprehensive search, including MEDLINE, Embase and the Cochrane Library, was conducted from January 2004 to March 2010. All key review steps were done by two reviewers. Random effects meta-analysis was conducted. The cost-effectiveness was assessed using a cohort-based model with three health states: pre-institutionalised, institutionalised and dead. The perspective was NHS and Personal Social Services and the cost year 2009. confidence about the size and statistical significance of the estimates of effect of galantamine, rivastigmine and memantine improved on function and global impact in particular. Cost-effectiveness also changed. For donepezil, galantamine and rivastigmine, the incremental cost per quality-adjusted life year (QALY) in 2004 was above £50,000; in 2010 the same drugs 'dominated' best supportive care (improved clinical outcome at reduced cost). This was primarily because of changes in the modelled costs of introducing the drugs. For memantine, the cost-effectiveness also improved from a range of £37-53,000 per QALY gained to a base-case of £32,000. there has been a change in the evidence base between 2004 and 2010 consistent with the change in NICE guidance. Further evolution in cost-effectiveness estimates is possible particularly if there are changes in drug prices.

A NEW HEALTH TECHNOLOGY ASSESSMENT SYSTEM FOR DEVICES: THE FIRST FIVE YEARS.

PubMed

Campbell, Bruce; Dobson, Lee; Higgins, Joanne; Dillon, Bernice; Marlow, Mirella; Pomfrett, Chris

2017-01-01

The aim of this study was to review 5 years of activity from a new system devised by the National Institute for Health and Care Excellence (NICE), for assessing medical devices and diagnostics aimed at identifying and speeding adoption of technologies with clinical and cost advantages, compared with current practice in the United Kingdom healthcare system. All eligible notified technologies were classified using the Food and Drug Administration and Global Medical Device Nomenclature nomenclatures. Decisions about selecting technologies for full assessment to produce NICE recommendations were reviewed, along with the reasons given to companies for not selecting products. Between 2009 and 2014, 186 technologies were notified (46 percent therapeutic and 54 percent diagnostic). Thirty-nine were judged ineligible (no regulatory approval), and 147 were considered by an independent committee. Of these, eighty (54 percent) were not selected for full assessment, most commonly because of insufficient evidence (86 percent): there were uncertainties specifically about benefits to the health service (54 percent), to patients (39 percent), and about cost (24 percent). The remaining 67 were selected and assessed for Medical Technology guidance (52 percent) (noninferior and/or lower cost consequences than current practice), for Diagnostics guidance (43 percent) or other NICE recommendations about adoption and use. Classifying technologies by two different systems showed no selection bias for any technology type or disease area. Identifying new or under-used devices and diagnostics with potential benefits and promoting their adoption is important to health services in the United Kingdom and worldwide. This new system offers a means of fostering both uptake and further research. Lack of research data on new products is a major obstacle to evaluation.

Value based pricing, research and development, and patient access schemes. Will the United Kingdom get it right or wrong?

PubMed Central

Towse, Adrian

2010-01-01

The National Health Service (NHS) should reward innovation it values. This will enable the NHS and the United Kingdom (UK) economy to benefit and impact positively on the Research and Development (R&D) decision making of companies. The National Institute for Health and Clinical Excellence (NICE) currently seeks to do this on behalf of the NHS. Yet the Office of Fair Trading proposals for Value Based Pricing add price setting powers – initially for the Department of Health (DH) and then for NICE. This introduces an additional substantial uncertainty that will impact on R&D and, conditional on R&D proceeding, on launch (or not) in the UK. Instead of adding to uncertainty the institutional arrangements for assessing value should seek to be predictable and science based, building on NICE's current arrangements. The real challenge is to increase understanding of the underlying cost-effectiveness of the technology itself by collecting evidence alongside use. The 2009 Pharmaceutical Price Regulation Scheme sought to help do this with Flexible Pricing (FP) and Patient Access Schemes (PASs). The PASs to date have increased access to medicines, but no schemes proposed to date have yet helped to tackle outcomes uncertainty. The 2010 Innovation Pass can also be seen as a form of ‘coverage with evidence development.’ The NHS is understandably concerned about the costs of running such evidence collection schemes. Enabling the NHS to deliver on such schemes will impact favourably on R&D decisions. Increasing the uncertainty in the UK NHS market through government price setting will reduce incentives for R&D and for early UK launch. PMID:20716236

ViibraTip for Testing Vibration Perception to Detect Diabetic Peripheral Neuropathy: A NICE Medical Technology Guidance.

PubMed

Willits, Iain; Cole, Helen; Jones, Roseanne; Dimmock, Paul; Arber, Mick; Craig, Joyce; Sims, Andrew

2015-08-01

VibraTip™ was selected by the Medical Technologies Advisory Committee (MTAC) to undergo evaluation through the National Institute for Health and Care Excellence (NICE). VibraTip™ provides a vibratory stimulus for the purpose of detecting diabetic peripheral neuropathy (DPN) in patients with type 1 or 2 diabetes mellitus, and is intended to replace the current practice of using the 128 Hz tuning fork or 10 g monofilament (comparators). The sponsor (McCallan Medical) provided clinical and economic submissions which were evaluated by an External Assessment Centre (EAC). Of six diagnostic studies identified, the EAC considered that only one was directly relevant to the assessment. This study indicated VibraTip™ had a sensitivity of 0.79 (95 % CI 0.69-0.90) and specificity of 0.82 (95 % CI 0.74-0.90) for DPN using a neurothesiometer at 25 V as a reference standard. This was non-inferior to the comparators, but the sample size (n = 141) was too small to draw unequivocal conclusions and it is unclear how generalisable results were to clinical practice. The sponsor presented a de facto cost-minimisation model that in the base case showed minimal cost savings and, in sensitivity analysis which assumed diagnostic superiority of VibraTip™, showed large savings. The EAC appraised this model and concluded it was flawed as it was not evidence based and costs were likely to be unrealistic. The MTAC considered that the technology showed promise but decided the case for adoption was not proven, and therefore made a research recommendation as is reflected in NICE Medical Technology Guidance 22.

How well do vital signs identify children with serious infections in paediatric emergency care?

PubMed

Thompson, M; Coad, N; Harnden, A; Mayon-White, R; Perera, R; Mant, D

2009-11-01

To determine whether vital signs identify children with serious infections, and to compare their diagnostic value with that of the Manchester triage score (MTS) and National Institute for Health and Clinical Excellence (NICE) traffic light system of clinical risk factors. Prospective cohort of children presenting with suspected acute infection. We recorded vital signs, level of consciousness, activity level, respiratory distress, hydration and MTS category. Paediatric assessment unit at a teaching hospital in England. 700 children (median age 3 years), of whom 357 (51.0%) were referred from primary care, 198 (28.3%) self-referrals and 116 (16.6%) emergency ambulance transfers. Just over half (383 or 54.7%) were admitted. Severity of infection categorised as serious, intermediate, minor or not infection. Children with serious or intermediate infections (n = 313) were significantly more likely than those with minor or no infection (n = 387) to have a temperature >or=39 degrees C, tachycardia, saturations 2 seconds. Having one or more of temperature >or=39 degrees C, saturations

Value based pricing, research and development, and patient access schemes. Will the United Kingdom get it right or wrong?

PubMed

Towse, Adrian

2010-09-01

The National Health Service (NHS) should reward innovation it values. This will enable the NHS and the United Kingdom (UK) economy to benefit and impact positively on the Research and Development (R&D) decision making of companies. The National Institute for Health and Clinical Excellence (NICE) currently seeks to do this on behalf of the NHS. Yet the Office of Fair Trading proposals for Value Based Pricing add price setting powers--initially for the Department of Health (DH) and then for NICE. This introduces an additional substantial uncertainty that will impact on R&D and, conditional on R&D proceeding, on launch (or not) in the UK. Instead of adding to uncertainty the institutional arrangements for assessing value should seek to be predictable and science based, building on NICE's current arrangements. The real challenge is to increase understanding of the underlying cost-effectiveness of the technology itself by collecting evidence alongside use. The 2009 Pharmaceutical Price Regulation Scheme sought to help do this with Flexible Pricing (FP) and Patient Access Schemes (PASs). The PASs to date have increased access to medicines, but no schemes proposed to date have yet helped to tackle outcomes uncertainty. The 2010 Innovation Pass can also be seen as a form of 'coverage with evidence development.' The NHS is understandably concerned about the costs of running such evidence collection schemes. Enabling the NHS to deliver on such schemes will impact favourably on R&D decisions. Increasing the uncertainty in the UK NHS market through government price setting will reduce incentives for R&D and for early UK launch.

Improving the implementation of NICE public health workplace guidance: an evaluation of the effectiveness of action-planning workshops in NHS trusts in England.

PubMed

Jones, Sarah; Sloan, David; Evans, Hannah E R; Williams, Sian

2015-08-01

There is evidence that health and well-being of the National Health Service (NHS) workforce affects organizational and patient outcomes. A Cochrane review of the effectiveness of clinical audit to improve quality of care has shown great variation between studies, depending on the design and intensity of support offered. This study evaluates the effectiveness of an organizational audit methodology with (1) action-planning workshops and follow-up and (2) audit feedback alone, to support the implementation of the National Institute for Health and Care Excellence (NICE) workplace guidance. Two rounds of audit using a self-administered online questionnaire were conducted. An overall implementation score was devised for each trust. Following round 1, interviews were conducted with a cohort of trusts with high scores. The interviews used a theory-based framework to identify predictors of and barriers to successful implementation. From this, the content for action-planning workshops was devised and workshops held with lower scoring trusts. The remaining trusts received only written feedback on their audit results. Changes in the implementation score between rounds 1 and 2 were compared within and between cohorts. The median improvement in scores between rounds 1 and 2 was statistically significant except where baseline score was high. The improvement for trusts who received workshops was very much better than those who did not (P < 0.001). This difference remained after adjustment using stratification by baseline score (P = 0.001). Audit, combined with action-planning workshops and follow-up, appears to be more effective in improving implementation of NICE workplace health and well-being guidance than audit with feedback alone. © 2015 John Wiley & Sons, Ltd.

Management of obesity in patients with type 2 diabetes mellitus in primary care.

PubMed

Mohammad, Shoaib; Ahmad, Jamal

2016-01-01

Obesity and being overweight is the most powerful risk factor accounting for 80-90% of patients with type 2 diabetes mellitus (T2DM). The epidemic of obesity is driving the diabetes epidemic to alarming levels and primary care is becoming an important setting for obesity management in T2DM in India. Yet many primary care providers feel ill-equipped or inadequately supported to address obesity in patients with diabetes. This article reviews the most recent and strongest evidence-based strategies that may aid physicians in management of obesity in patients with T2DM in primary care. A systematic literature search of MEDLINE using the search terms Obesity, Obesity in T2DM, weight loss and Primary Care was conducted. The American Diabetes Association, National Institute for Health, National Institute of Health and Excellence (NICE), Scottish Intercollegiate Guidelines Network (SIGN) and World Health Organization websites were also searched. Most studies in this area are observational in design with few randomized controlled trials (RCTs). Articles and studies involving meta-analysis or RCTs were preferred over other types. Effective weight management treatment in T2DM patient can be implemented in the primary care setting. Evidence based individualized lifestyle and pharmacologic measures supported by behavioral intervention and counseling with appropriate and informed surgical referrals has the potential to improve the success of weight management within primary care. Copyright © 2016 Diabetes India. Published by Elsevier Ltd. All rights reserved.

Protocol for the prospective validation study: 'Screening programme for pre-eclampsia' (SPREE).

PubMed

Tan, M Y; Koutoulas, L; Wright, D; Nicolaides, K H; Poon, L C Y

2017-08-01

Pre-eclampsia (PE), which affects about 2% of pregnancies, is a major cause of maternal and perinatal morbidity and mortality. Early detection of PE can improve pregnancy outcome by providing timely intervention and closer monitoring. The current guideline from the UK National Institute for Health and Care Excellence (NICE) recommends that, at the booking visit, women identified with one major risk factor or more than one moderate risk factor for PE should be advised to take low-dose aspirin daily from 12 weeks until delivery. However, performance of the current method of screening is poor and identifies only about 35% of PE. Extensive studies in the last decade have established that the best performance for early prediction of PE can be achieved by using a novel Bayes' theorem-based method that combines maternal characteristics and medical history together with measurements of mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI), serum placental growth factor (PlGF) and pregnancy-associated plasma protein-A (PAPP-A) at 11-13 weeks' gestation. This forms the 'combined test', which could be simplified to the 'mini combined test' when only maternal factors, MAP and PAPP-A are taken into consideration. We present the protocol (version 3.1, 14 November 2016) for the 'Screening programme for pre-eclampsia' (SPREE) study, a prospective multicenter cohort study that will be carried out in seven National Health Service maternity hospitals in England. Eligible pregnant women attending their routine scan at 11-13 weeks' gestation will be invited to participate in this study. Maternal characteristics and history and measurements of MAP, UtA-PI, serum PAPP-A and PlGF will be recorded according to standardized protocols. The patient-specific risk for PE will be calculated and data on pregnancy outcomes collected. We hypothesize that the first-trimester mini combined test and combined test for PE screening, using the Bayes' theorem-based method, are likely to be superior to the current method recommended by NICE that is based on maternal demographics and history alone. Enrollment for the study commenced in April 2016. The study is registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

BOOK REVIEW: Solitons, Instantons, and Twistors Solitons, Instantons, and Twistors

NASA Astrophysics Data System (ADS)

Witt, Donald M.

2011-04-01

Solitons and instantons play important roles both in pure and applied mathematics as well as in theoretical physics where they are related to the topological structure of the vacuum. Twistors are a useful tool for solving nonlinear differential equations and are useful for the study of the antiself-dual Yang-Mills equations and the Einstein equations. Many books and more advanced monographs have been written on these topics. However, this new book by Maciej Dunajski is a complete first introduction to all of the topics in the title. Moreover, it covers them in a very unique way, through integrable systems. The approach taken in this book is that of mathematical physics à la field theory. The book starts by giving an introduction to integrable systems of ordinary and partial differential equations and proceeds from there. Gauge theories are not covered until chapter 6 which means the reader learning the material for the first time can build up confidence with simpler models of solitons and instantons before encountering them in gauge theories. The book also has an extremely clear introduction to twistor theory useful to both mathematicians and physicists. In particular, the twistor theory presentation may be of interest to string theorists wanting understand twistors. There are many useful connections to research into general relativity. Chapter 9 on gravitational instantons is great treatment useful to anyone doing research in classical or quantum gravity. There is also a nice discussion of Kaluza-Klein monopoles. The three appendices A-C cover the necessary background material of basic differential geometry, complex manifolds, and partial differential equations needed to fully understand the subject. The reader who has some level of expertise in any of the topics covered can jump right into that material without necessarily reading all of the earlier chapters because of the extremely clear writing style of the author. This makes the book an excellent reference on instantons, solitons and twistors. However, I found it useful to read the whole book because the author has a beautiful perspective on and presentation of the material. Maciej Dunajski developed the book out of notes from a series of lecture courses he taught on these subjects over a five year period at Cambridge University. This fact makes the book an excellent choice for a textbook on the subject with each of the 10 chapters containing nice problems and exercises. Additionally, the wealth of information contained in the book makes it a great reference book for any theoretical physicist or mathematician to own. As an introduction to an exciting area of research, this book is excellent because it is not only accessible but self contained. A wonderful feature of the book is the clear and informative explanation of the topics and the wealth of examples. The presentation style of the book means that it is accessible to readers ranging from advanced undergraduates doing research to experts. It would be an excellent textbook for a course at the advanced undergraduate level or graduate level in either mathematics or physics. This book will become a standard on the subject. The typesetting of the book is very clean, with nicely sized fonts and clean uniform notation. It includes 35 illustrations which helpfully illustrated text. It is my pleasure to highly recommend it to anyone from an advanced undergraduate to a researcher in the fields covered.

The NICE recommendation for drug-coated balloons and its global impact.

PubMed

Eccleshall, Simon; Waliszewski, M

2015-06-01

The clinical efficacy and safety of drug-coated balloon (DCB) angioplasty in patients with coronary in-stent restenosis (ISR) has been demonstrated. The objective of this article is to provide comparative cost efficacy data for DCB angioplasty in various countries based on the original methodology of the Medical Technologies Evaluation Programme (MTEP) at the National Institute for Health and Clinical Excellence (NICE) in 2010. Published and unpublished Health Technology Assessment (HTA) reports were evaluated for comparison in selected countries. Furthermore, a systematic review of economic evaluations of DCB angioplasty versus standard treatments (uncoated balloon angioplasty or drug-eluting stent implantations) was conducted. National cost efficacy data were evaluated using Markov state transition models which were adapted to fit each country's device and procedure related costs. The clinical input for adverse events was defined with two relevant trials for in-stent restenosis of bare metal stents (BMS-ISR) and of drug-eluting stents (DES-ISR). In the UK, Germany, Switzerland, South Africa, Japan and Brazil, DCB angioplasty is cost-effective when compared with drug-eluting stents to treat either BMS-ISR or DES-ISR. DCB angioplasty ought to be the preferred treatment option for patients with BMS-ISR and DES-ISR from the payers' point of view. © The Author(s), 2015.

Current strategies for monitoring men with localised prostate cancer lack a strong evidence base: observational longitudinal study.

PubMed

Metcalfe, C; Tilling, K; Davis, M; Lane, J A; Martin, R M; Kynaston, H; Powell, P; Neal, D E; Hamdy, F; Donovan, J L

2009-08-04

The UK National Institute for Health and Clinical Excellence (NICE) guidance recommends conservative management of men with 'low-risk' localised prostate cancer, monitoring the disease using prostate-specific antigen (PSA) kinetics and re-biopsy. However, there is little evidence of the changes in PSA level that should alert to the need for clinical re-assessment. This study compares the alerts resulting from PSA kinetics and a novel longitudinal reference range approach, which incorporates age-related changes, during the monitoring of 408 men with localised prostate cancer. Men were monitored by regular PSA tests over a mean of 2.9 years, recording when a man's PSA doubling time fell below 2 years, PSA velocity exceeded 2 ng ml(-1) per year, or when his upper 10% reference range was exceeded. Prostate-specific antigen doubling time and PSA velocity alerted a high proportion of men initially but became unresponsive to changes with successive tests. Calculating doubling time using recent PSA measurements reduced the decline in response. The reference range method maintained responsiveness to changes in PSA level throughout the monitoring. The increasing unresponsiveness of PSA kinetics is a consequence of the underlying regression model. Novel methods are needed for evaluation in cohorts currently being managed by monitoring. Meanwhile, the NICE guidance should be cautious.

Ruxolitinib for the treatment of myelofibrosis: a NICE single technology appraisal.

PubMed

Wade, Ros; Rose, Micah; Neilson, Aileen Rae; Stirk, Lisa; Rodriguez-Lopez, Rocio; Bowen, David; Craig, Dawn; Woolacott, Nerys

2013-10-01

The National Institute for Health and Care Excellence (NICE) invited the manufacturer of ruxolitinib (Novartis) to submit clinical and cost-effectiveness evidence for ruxolitinib within its licensed indication (the treatment of disease-related splenomegaly or symptoms in adult patients with myelofibrosis), according to the Institute's Single Technology Appraisal process. The Centre for Reviews and Dissemination and Centre for Health Economics at the University of York were commissioned to act as the independent Evidence Review Group (ERG). This article provides a description of the company submission, the ERG review and the resulting NICE guidance TA289 issued in June 2013. The ERG critically reviewed the evidence presented in the manufacturer's submission and identified areas requiring clarification, for which the manufacturer provided additional evidence. The main clinical effectiveness data were derived from two phase III, multicentre, randomised controlled trials (RCTs): Controlled myelofibrosis study with oral JAK inhibitor treatment (COMFORT)-II compared ruxolitinib with best available therapy (BAT), and COMFORT-I compared ruxolitinib with placebo. These RCTs demonstrated that ruxolitinib confers significant benefits in terms of spleen size reduction and improvement in symptom burden. In the COMFORT-II trial, a reduction in spleen volume of ≥35 % was achieved in 28 % of ruxolitinib-treated patients compared with 0 % of patients in the BAT group (p < 0.001) at 48 weeks, and there was a mean change in spleen volume of -30.1 versus +7.3 % (p < 0.001). Ruxolitinib also provided significant improvements in myelofibrosis-associated symptoms and health-related quality-of-life compared with BAT and placebo. The ERG concluded that ruxolitinib appears to reduce splenomegaly and its associated symptoms, but that there was considerable uncertainty surrounding the manufacturer's cost-effectiveness estimates due to limitations in the manufacturer's model. The manufacturer's model did not allow for disease progression, did not accurately capture symptomatic relief, had several implausible or unjustified assumptions, and there were several parameter choices that the ERG found sub-optimal. ERG sensitivity analyses found that nearly all plausible adjustments to the model reduced the cost effectiveness of ruxolitinib. It is very likely that the base-case incremental cost-effectiveness ratio of £73,980/quality-adjusted life-year presented by the manufacturer represents a best-case scenario. The NICE Appraisal Committee concluded that ruxolitinib was clinically effective, but could not be considered a cost effective use of National Health Service (NHS) resources for treating disease-related splenomegaly or symptoms in adults with myelofibrosis. Ruxolitinib is not recommended for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythaemia vera myelofibrosis and post-essential thrombocythaemia myelofibrosis in NICE TA289.

Degarelix for Treating Advanced Hormone-Dependent Prostate Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

PubMed

Uttley, Lesley; Whyte, Sophie; Gomersall, Timothy; Ren, Shijie; Wong, Ruth; Chambers, Duncan; Tappenden, Paul

2017-07-01

As part of its Single Technology Appraisal Process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of degarelix (Ferring Pharmaceuticals) to submit evidence for the clinical and cost effectiveness of degarelix for the treatment of advanced hormone-dependent prostate cancer. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence contained within the company's submission to NICE. The evidence, which included a randomised controlled trial (RCT) of degarelix versus leuprorelin, found that degarelix was non-inferior to leuprorelin for reduction of testosterone levels and that degarelix achieved a more rapid suppression of prostate-specific antigen levels and subsequently decreased incidences of testosterone flare associated with luteinising hormone releasing-hormone (LHRH) agonists. However, protection against testosterone flare for the comparators in the clinical trials was not employed in line with UK clinical practice. Further claims surrounding overall survival, cardiovascular adverse events and clinical equivalence of the comparator drugs from six RCTs of degarelix should be regarded with caution because of flaws and inconsistencies in the pooling of trial data to draw conclusions. The cost-effectiveness evidence included a de novo economic model. Based on the ERG's preferred base case, the deterministic incremental cost-effectiveness analysis (ICER) for degarelix versus 3-monthly triptorelin was £14,798 per quality-adjusted life-year (QALY) gained. Additional scenario analyses undertaken by the ERG resulted in ICERs for degarelix versus 3-monthly triptorelin ranging from £17,067 to £35,589 per QALY gained. Subgroup analyses undertaken using the Appraisal Committee's preferred assumptions suggested that degarelix was not cost effective for the subgroup with metastatic disease but could be cost effective for the subgroup with spinal metastases. The company submitted further evidence to NICE following an initial negative Appraisal Committee decision. Further analyses from the Decision Support Unit found that that, whilst some evidence indicated that degarelix could be cost effective for a small subgroup of people with spinal cord compression (SCC), data on the potential size of this subgroup and the rate of SCC were insufficient to estimate an ICER based on the evidence submitted by the company and a separately commissioned systematic review. NICE recommended degarelix as an option for treating advanced hormone-dependent prostate cancer in people with spinal metastases, only if the commissioner can achieve at least the same discounted drug cost as that available to the UK NHS in June 2016.

Crizotinib for Untreated Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

PubMed

Morgan, Philip; Woolacott, Nerys; Biswas, Mousumi; Mebrahtu, Teumzghi; Harden, Melissa; Hodgson, Robert

2017-09-01

As part of the National Institute for Health and Care Excellence (NICE) single technology appraisal process, the manufacturer of crizotinib submitted evidence on the clinical and cost effectiveness of crizotinib in untreated anaplastic lymphoma kinase-positive (ALK-positive) non-small-cell lung cancer (NSCLC). Crizotinib has previously been assessed by NICE for patients with previously treated ALK-positive NSCLC (TA 296). It was not approved in this previous appraisal, but had been made available through the cancer drugs fund. As part of this new appraisal, the company included a price discount patient access scheme (PAS). The Centre for Reviews and Dissemination and Centre for Health Economics Technology Appraisal Group at the University of York was commissioned to act as the independent Evidence Review Group (ERG). This article provides a description of the company's submission and the ERG's review and summarises the resulting NICE guidance issued in August 2016. The main clinical-effectiveness data were derived from a multicentre randomised controlled trial-PROFILE 1014-that compared crizotinib with pemetrexed chemotherapy in combination with carboplatin or cisplatin in patients with untreated non-squamous ALK-positive NSCLC. In the trial, crizotinib demonstrated improvements in progression-free survival (PFS) and overall survival (OS). The company's economic model was a three-state 'area under the curve' Markov model. The base-case incremental cost-effectiveness ratio (ICER) was estimated to be greater than £50,000 per quality-adjusted life-year (QALY) gained (excluding the PAS discount). The ERG assessment of the evidence submitted by the company raised a number of concerns. In terms of the clinical evidence, the OS benefit was highly uncertain due to the cross-over permitted in the trial and the immaturity of the data; only 26% of events had occurred by the data cut-off point. In the economic modelling, the most significant concerns related to the analysis of OS and assumptions made regarding the duration of therapy. The ERG exploratory re-analysis of the OS data relaxed the assumption of proportional hazards made in the company submission, which demonstrated significant uncertainty regarding the OS gains from crizotinib. The ERG reconfigured the economic model so that duration of therapy was based on the area under the curve analysis of the PROFILE 1014 trial, dramatically increasing the cost associated with implementing crizotinib and consequently, substantially increasing the ICER. At the first appraisal meeting, the NICE Appraisal Committee concluded that crizotinib, while clinically effective, was not sufficiently cost effective for use in the UK NHS. Following the consultation, the company offered a revised PAS and conducted extensive re-analysis, resulting in a revised base-case ICER of £47,291 per QALY gained. The NICE Appraisal Committee concluded that crizotinib was likely to be a cost-effective use of NHS resources, despite the uncertainty that persisted around a number of factors, namely the long-term survival benefit of crizotinib. Crizotinib was therefore recommended as an option for untreated ALK-positive advanced NSCLC in adults.

An Update on Improvements to NiCE Support for RELAP-7

DOE Office of Scientific and Technical Information (OSTI.GOV)

McCaskey, Alex; Wojtowicz, Anna; Deyton, Jordan H.

The Multiphysics Object-Oriented Simulation Environment (MOOSE) is a framework that facilitates the development of applications that rely on finite-element analysis to solve a coupled, nonlinear system of partial differential equations. RELAP-7 represents an update to the venerable RELAP-5 simulator that is built upon this framework and attempts to model the balance-of-plant concerns in a full nuclear plant. This report details the continued support and integration of RELAP-7 and the NEAMS Integrated Computational Environment (NiCE). RELAP-7 is fully supported by the NiCE due to on-going work to tightly integrate NiCE with the MOOSE framework, and subsequently the applications built upon it.more » NiCE development throughout the first quarter of FY15 has focused on improvements, bug fixes, and feature additions to existing MOOSE-based application support. Specifically, this report will focus on improvements to the NiCE MOOSE Model Builder, the MOOSE application job launcher, and the 3D Nuclear Plant Viewer. This report also includes a comprehensive tutorial that guides RELAP-7 users through the basic NiCE workflow: from input generation and 3D Plant modeling, to massively parallel job launch and post-simulation data visualization.« less

Quantifying bile acid malabsorption helps predict response and tailor sequestrant therapy.

PubMed

Orekoya, Oluwafikunayo; McLaughlin, John; Leitao, Eugenia; Johns, Wendy; Lal, Simon; Paine, Peter

2015-06-01

Although recognised as a cause of chronic diarrhoea for over forty years, diagnostic tests and treatments for bile acid malabsorption (BAM) remain controversial. Recent National Institute for Health and Care Excellence (NICE) guidelines highlighted the lack of evidence in the field, and called for further research. This retrospective study explores the BAM subtype and severity, the use and response to bile acid sequestrants (BAS) and the prevalence of abnormal colonic histology. 264 selenium-75-labelled homocholic acid conjugated taurine (SeHCAT)-tested patient records were reviewed and the severity and subtype of BAM, presence of colonic histopathology and response to BAS were recorded. 53% of patients tested had BAM, with type-2 BAM in 45% of patients with presumed irritable bowel syndrome. Colonic histological abnormalities were similar overall between patients with (29%) or without (23%) BAM (p = 0.46) and between BAM subtypes, with no significant presence of inflammatory changes. 63% of patients with BAM had a successful BAS response which showed a trend to decreased response with reduced severity. Colestyramine was unsuccessful in 44% (38/87) and 45% of these (17/38) were related to medication intolerance, despite a positive SeHCAT. 47% (7/15) of colestyramine failures had a successful colesevelam response. No patient reported colesevelam intolerance. Quantifying severity of BAM appears to be useful in predicting BAS response. Colesevelam was better tolerated than colestyramine and showed some efficacy in colestyramine failures. Colestyramine failure should not be used to exclude BAM. Colonic histology is of no relevance. © Royal College of Physicians 2015. All rights reserved.

Left Gastric Artery Embolisation for the Treatment of Obesity: a Systematic Review.

PubMed

Kordzadeh, Ali; Lorenzi, Bruno; Hanif, Muhammad A; Charalabopoulos, Alexandros

2018-04-03

Endovascular left gastric artery (LGA) embolisation has gained significant attention in the treatment of obesity/morbid obesity and reduction of ghrelin. The objective of this systematic review is to evaluate the recent literature, strengths, limitations and practical aspects of this new procedure in combination with its physiological and anatomical paradigm. A systematic electronic search of literature from 1966 to June 2017 in Medline, CINHAL, Embase, Scopus and Cochrane library in English language and adult subjects was conducted. This search was conducted in accordance with Preferred Reporting in Systematic Review and Meta-Analysis (PRISMA) guidelines. Quality assessment of the articles was performed, using Oxford critical appraisal skills programme (CASP), and their recommendation for practice was examined through National Institute for health Care Excellence (NICE). Inter-related reliability (Cronbach's Alpha) was assessed between the two independent reviewers. A total of n = 62 individuals were subjected to LGA embolisation. At 1-3 months, 7-11% and, at 12 months, 2% weight reduction was associated with ghrelin concentration reduction of 36% at 6 months. There was Haemoglobin A1c reduction (7.4 to 6.3%) and improved quality of life (SF-36 questionnaire) at 6 months (9.5 points) (range, 3.2-17.2). Despite immediate epigastric pain and mucosal ulceration, no long-term adverse outcome was identified. The overall length of stay was 2-3 days. The outcome of this review (level of evidence 3) suggests LGA embolisation is feasible and effective and perhaps a safe procedure in the treatment of obesity and reduction of ghrelin. However, further trials are highly advocated.

Neutron Star Interior Composition Explorer (NICE)

NASA Technical Reports Server (NTRS)

Gendreau, Keith C.; Arzoumanian, Zaven

2008-01-01

This viewgraph presentation contains an overview of the mission of the Neutron Star Interior Composition Explorer (NICE), a proposed International Space Station (ISS) payload dedicated ot the study of neutron stars. There are also reviews of the Science Objectives of the payload,the science measurements, the design and the expected performance for the instruments for NICE,

(Non-adiabatic) string creation on nice slices in Schwarzschild black holes

NASA Astrophysics Data System (ADS)

Puhm, Andrea; Rojas, Francisco; Ugajin, Tomonori

2017-04-01

Nice slices have played a pivotal role in the discussion of the black hole information paradox as they avoid regions of strong spacetime curvature and yet smoothly cut through the infalling matter and the outgoing Hawking radiation, thus, justifying the use of low energy field theory. To avoid information loss it has been argued recently, however, that local effective field theory has to break down at the horizon. To assess the extent of this breakdown in a UV complete framework we study string-theoretic effects on nice slices in Schwarzschild black holes. Our purpose is two-fold. First, we use nice slices to address various open questions and caveats of [1] where it was argued that boost-enhanced non-adiabatic string-theoretic effects at the horizon could provide a dynamical mechanism for the firewall. Second, we identify two non-adiabatic effects on nice slices in Schwarzschild black holes: pair production of open strings near the horizon enhanced by the presence of the infinite tower of highly excited string states and a late-time non-adiabatic effect intrinsic to nice slices.

Are food and drink retailers within NHS venues adhering to NICE Quality standard 94 guidance on childhood obesity? A cross-sectional study of two large secondary care NHS hospitals in England

PubMed Central

James, Alice; Birch, Laura; Fletcher, Peter; Pearson, Sally; Boyce, Catherine; Ness, Andy R; Hamilton-Shield, Julian P; Lithander, Fiona E

2017-01-01

Objective To assess whether the food and drink retail outlets in two major National Health Service (NHS) district general hospitals in England adhere to quality statements 1–3 of the UK National Institute for Health and Care Excellence (NICE) quality standard 94. Design Cross-sectional, descriptive study to assess the food and drink options available in vending machines, restaurants, cafes and shops in two secondary care hospitals. Main outcome measures Adherence to quality statement 1 whereby the food and drink items available in the vending machines were classified as either healthy or less healthy using the Nutrient Profiling Model (NPM). Compliance with quality statements 2 and 3 was assessed through the measurement of how clearly the shops, cafes and restaurants displayed nutrition information on menus, and the availability and prominent display of healthy food and drink options in retail outlets, respectively. Results Adherence to quality statement 1 was poor. Of the 18 vending machines assessed, only 7 (39%) served both a healthy food and a healthy drink option. Neither hospital was compliant with quality statement 2 wherein nutritional information was not available on menus of food providers in either hospital. There was inconsistent compliance with quality standard 3 whereby healthy food and drink options were prominently displayed in the two main hospital restaurants, but all shops and cafes prioritised the display of unhealthy items. Conclusions Neither hospital was consistently compliant with quality statements 1–3 of the NICE quality standard 94. Improving the availability of healthy foods and drinks while reducing the display and accessibility to less healthy options in NHS venues may improve family awareness of healthy alternatives. Making it easier for parents to direct their children to healthier choices is an ostensibly central component of our healthcare system. PMID:29150472

Evolocumab for Treating Primary Hypercholesterolaemia and Mixed Dyslipidaemia: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

PubMed

Carroll, Christopher; Tappenden, Paul; Rafia, Rachid; Hamilton, Jean; Chambers, Duncan; Clowes, Mark; Durrington, Paul; Qureshi, Nadeem; Wierzbicki, Anthony S

2016-11-16

As part of its Single Technology Appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of evolocumab (Amgen) to submit evidence on the clinical and cost effectiveness of evolocumab. The appraisal assessed evolocumab as monotherapy or in combination with a statin (HMG-CoA reductase inhibitor) with or without ezetimibe, or in combination with ezetimibe (without statin therapy), in adult patients with primary hypercholesterolaemia (which includes mixed dyslipidaemia), for whom statins do not provide optimal control of their low-density lipoprotein cholesterol (LDL-C) levels and/or for whom statins are contraindicated or not tolerated. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence for the clinical and cost effectiveness of the technology, based on the company's submission to NICE. The evidence was derived mainly from four randomised controlled trials comparing evolocumab either with ezetimibe or placebo in adults with primary familial or non-familial hypercholesterolaemia, who were either able to take statins or who were statin-intolerant. The clinical effectiveness review found that evolocumab is efficacious at lowering LDL-C but that there was uncertainty regarding its impact on cardiovascular disease outcomes. In response to the ERG's critique of the submitted health economic model, the company submitted an amended model, which also included a Patient Access Scheme (PAS). Based on this, the deterministic incremental cost-effectiveness ratios (ICERs) for evolocumab against ezetimibe were above £74,000 and £45,000 per quality-adjusted life-year (QALY) gained within the non-familial primary and secondary prevention population, respectively, whilst the ICERs within the heterozygous familial hypercholesterolaemia population were approximately £23,000 per QALY gained. The final determination was that evolocumab would be a clinically and cost effective use of UK National Health Service resources in certain patient subgroups.

Parafricta Bootees and Undergarments to Reduce Skin Breakdown in People with or at Risk of Pressure Ulcers: A NICE Medical Technologies Guidance.

PubMed

Meads, Catherine; Glover, Matthew; Dimmock, Paul; Pokhrel, Subhash

2016-12-01

As part of the development of the National Institute for Health and Care Excellence (NICE) Medical Technologies Guidance on Parafricta Bootees and Undergarments to reduce skin breakdown in people with, or at risk of, pressure ulcers, the manufacturer (APA Parafricta Ltd) submitted clinical and economic evidence, which was critically appraised by an External Assessment Centre (EAC) and subsequently used by the Medical Technologies Advisory Committee (MTAC) to develop recommendations for further research. The University of Birmingham and Brunel University, acting as a consortium, were commissioned to act as the EAC, independently appraising the submission. This article is an overview of the original evidence submitted, the EAC's findings and the final NICE guidance. Very little comparative evidence was submitted to demonstrate the effectiveness of Parafricta Bootees or Undergarments. The sponsor submitted a simple cost analysis to estimate the costs of using Parafricta in addition to current practice-in comparison with current practice alone-in hospital and community settings separately. The analysis took a National Health Service (NHS) perspective. The basis of the analysis was a previously published comparative study, which showed no statistical difference in average lengths of stay between patients who wore Parafricta Undergarments and Bootees, and those who did not. The economic model incorporated the costs of Parafricta but assumed shorter lengths of stay with Parafricta. The sponsor concluded that Parafricta was cost saving relative to the comparators. The EAC made amendments to the sponsor's analysis to correct for errors and to reflect alternative assumptions. Parafricta remained cost saving in most analyses, and the savings per prevalent case ranged from £757 in the hospital model to £3455 in the community model. All analyses were severely limited by the available data on effectiveness-in particular, a lack of good-quality comparative studies.

The Urolift System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A NICE Medical Technology Guidance.

PubMed

Ray, Alistair; Morgan, Helen; Wilkes, Antony; Carter, Kimberley; Carolan-Rees, Grace

2016-10-01

As part of its Medical Technologies Evaluation Programme (MTEP), the National Institute for Health and Care Excellence (NICE) invited Neotract (manufacturer) to submit clinical and economic evidence for their prostatic urethral lift device, Urolift, for the relief of lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS BPH). The Urolift System uses implants to retract the prostatic lobe away from the urethral lumen. The clinical evidence used in the manufacturer's submission shows that Urolift is effective for the treatment of BPH. Urolift delivers a weighted mean International Prostate Symptom Score (IPSS) improvement of between 9.22 and 11.82 points. These Urolift improvements are greater than a published 'marked improvement' in IPSS score of 8.80. Comparison with randomised controlled trials (RCTs) of TURP (Transurethral Resection of Prostate) and HoLEP (Holmium Laser Enucleation of Prostate) show that Urolift does not yield better clinical outcomes from baseline compared to TURP and HoLEP in terms of IPSS, QoL (Quality of Life) and Qmax (maximum urinary flow). However, Urolift appears to have the advantage in terms of minimal and mild complications, and this may be of interest to patients and urologists. The economic case for Urolift was made using a very detailed and thorough de novo cost model. The base case posed by the manufacturer placed Urolift at almost cost-neutral (£3 cost incurring, based on 2014 prices) compared to TURP, and £418 cost incurring compared to HoLEP. In an additional scenario comparing day-case Urolift with in-patient TURP, the estimated per-patient savings with Urolift were £286 compared with monopolar TURP (mTURP) and £159 compared with bipolar TURP (BiTURP). NICE guidance MTG26 recommends that the case for adoption of Urolift was supported by the evidence, when implemented in a day-case setting.

A simple clinical coding strategy to improve recording of child maltreatment concerns: an audit study.

PubMed

McGovern, Andrew Peter; Woodman, Jenny; Allister, Janice; van Vlymen, Jeremy; Liyanage, Harshana; Jones, Simon; Rafi, Imran; de Lusignan, Simon; Gilbert, Ruth

2015-01-14

Recording concerns about child maltreatment, including minor concerns, is recommended by the General Medical Council (GMC) and National Institute for Health and Clinical Excellence (NICE) but there is evidence of substantial under-recording. To determine whether a simple coding strategy improved recording of maltreatment-related concerns in electronic primary care records. Clinical audit of rates of maltreatment-related coding before January 2010-December 2011 and after January-December 2012 implementation of a simple coding strategy in 11 English family practices. The strategy included encouraging general practitioners to use, always and as a minimum, the Read code 'Child is cause for concern'. A total of 25,106 children aged 0-18 years were registered with these practices. We also undertook a qualitative service evaluation to investigate barriers to recording. Outcomes were recording of 1) any maltreatment-related codes, 2) child protection proceedings and 3) child was a cause for concern. We found increased recording of any maltreatment-related code (rate ratio 1.4; 95% CI 1.1-1.6), child protection procedures (RR 1.4; 95% CI 1.1-1.6) and cause for concern (RR 2.5; 95% CI 1.8-3.4) after implementation of the coding strategy. Clinicians cited the simplicity of the coding strategy as the most important factor assisting implementation. This simple coding strategy improved clinician's recording of maltreatment-related concerns in a small sample of practices with some 'buy-in'. Further research should investigate how recording can best support the doctor-patient relationship. HOW THIS FITS IN: Recording concerns about child maltreatment, including minor concerns, is recommended by the General Medical Council (GMC) and National Institute for Health and Clinical Excellence (NICE), but there is evidence of substantial under-recording. We describe a simple clinical coding strategy that helped general practitioners to improve recording of maltreatment-related concerns. These improvements could improve case finding of children at risk and information sharing.

Developing resources to support the diagnosis and management of Chronic Fatigue Syndrome/Myalgic Encephalitis (CFS/ME) in primary care: a qualitative study.

PubMed

Hannon, Kerin; Peters, Sarah; Fisher, Louise; Riste, Lisa; Wearden, Alison; Lovell, Karina; Turner, Pam; Leech, Yvonne; Chew-Graham, Carolyn

2012-09-21

NICE guidelines emphasise the need for a confident, early diagnosis of Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME) in Primary Care with management tailored to the needs of the patient. Research suggests that GPs are reluctant to make the diagnosis and resources for management are currently inadequate. This study aimed to develop resources for practitioners and patients to support the diagnosis and management of CFS/ME in primary care. Semi structured interviews were conducted with patients, carers, GPs, practice nurses and CFS/ME specialists in North West England. All interviews were audio recorded, transcribed and analysed qualitatively using open explorative thematic coding. Two patient involvement groups were consulted at each stage of the development of resources to ensure that the resources reflect everyday issues faced by people living with CFS/ME. Patients and carers stressed the importance of recognising CFS/ME as a legitimate condition, and the need to be believed by health care professionals. GPs and practice nurses stated that they do not always have the knowledge or skills to diagnose and manage the condition. They expressed a preference for an online training package. For patients, information on getting the most out of a consultation and the role of carers was thought to be important. Patients did not want to be overloaded with information at diagnosis, and suggested information should be given in steps. A DVD was suggested, to enable information sharing with carers and family, and also for those whose symptoms act as a barrier to reading. Rather than use a top-down approach to the development of training for health care practitioners and information for patients and carers, we have used data from key stakeholders to develop a patient DVD, patient leaflets to guide symptom management and a modular e-learning resource which should equip GPs to diagnose and manage CFS/ME effectively, meet NICE guidelines and give patients acceptable, evidence-based information.

Provision of smoking cessation support for pregnant women in England: results from an online survey of NHS stop smoking services for pregnant women

PubMed Central

2014-01-01

Background Smoking during pregnancy is a major public health concern and an NHS priority. In 2010, 26% of UK women smoked immediately before or during their pregnancy and 12% smoked continuously. Smoking cessation support is provided through free at the point of use Stop Smoking Services for Pregnant women (SSSP). However, to date, little is known of how these services provide support across England. The aim of this study was to describe the key elements of support provided through English SSSP. Methods SSSP managers were invited to participate in this survey by email. Data were then collected via an online questionnaire; one survey was completed for each SSSP. Up to four reminder emails were sent over a two month period. Results 86% (121 of 141) of services completed the survey. Responding services were, on average, larger than non-responding services in terms of the number of pregnant women setting quit dates and successfully quitting (p < 0.01). In line with the 2010 NICE guidelines, Stop Smoking in Pregnancy and following Childbirth, one in five SSSP identified pregnant smokers using carbon monoxide (CO) testing and refer via an opt-out pathway. All services offered nicotine replacement therapy (NRT) to pregnant women and 87% of services also offered dual therapy NRT, i.e. combination of a patch and short acting NRT product.. The 2010 NICE guidelines note that services should be flexible and client-centred. Consistent with this, SSSP offer pregnant women a range of support types (median 4) including couple/family, group (open or closed) or one-to-one. These are available in a number of locations (median 5), including in community venues, clinics and women’s homes. Conclusions English Stop Smoking Services offer behavioural support and pharmacotherapy to pregnant women motivated to quit smoking. Interventions provided are generally evidence-based and delivered in a variety of both social and health care settings. PMID:24593130

Introduction to the computational structural mechanics testbed

NASA Technical Reports Server (NTRS)

Lotts, C. G.; Greene, W. H.; Mccleary, S. L.; Knight, N. F., Jr.; Paulson, S. S.; Gillian, R. E.

1987-01-01

The Computational Structural Mechanics (CSM) testbed software system based on the SPAR finite element code and the NICE system is described. This software is denoted NICE/SPAR. NICE was developed at Lockheed Palo Alto Research Laboratory and contains data management utilities, a command language interpreter, and a command language definition for integrating engineering computational modules. SPAR is a system of programs used for finite element structural analysis developed for NASA by Lockheed and Engineering Information Systems, Inc. It includes many complementary structural analysis, thermal analysis, utility functions which communicate through a common database. The work on NICE/SPAR was motivated by requirements for a highly modular and flexible structural analysis system to use as a tool in carrying out research in computational methods and exploring computer hardware. Analysis examples are presented which demonstrate the benefits gained from a combination of the NICE command language with a SPAR computational modules.

A Review of Ruxolitinib for the Treatment of Myelofibrosis: A Critique of the Evidence.

PubMed

Wade, Ros; Hodgson, Robert; Biswas, Mousumi; Harden, Melissa; Woolacott, Nerys

2017-02-01

As part of the National Institute for Health and Care Excellence's (NICE) Single Technology Appraisal (STA) process, ruxolitinib was assessed to determine the clinical and cost effectiveness of its use in the treatment of disease-related splenomegaly or symptoms in adults with myelofibrosis. Ruxolitinib had previously been assessed as part of the STA process and was not recommended in NICE guidance issued in June 2013 (TA289). A review of TA289 was commissioned following the availability of new longer-term survival data; a price discount patient access scheme (PAS) was also introduced. The Centre for Reviews and Dissemination (CRD) and Centre for Health Economics (CHE) Technology Appraisal Group at the University of York was commissioned to act as the independent Evidence Review Group (ERG). This article provides a summary of the manufacturer or sponsor of the technology's (referred to as the company) submission, the ERG review and the resulting NICE guidance issued in March 2016. The main clinical effectiveness data were derived from two good-quality multicentre randomised controlled trials (RCTs): COMFORT-II compared ruxolitinib with best available therapy (BAT) and COMFORT-I compared ruxolitinib with placebo. Both RCTs demonstrated a statistically significant reduction in splenomegaly and its associated symptoms in intermediate-2 and high-risk myelofibrosis patients. Overall survival was statistically significantly improved with ruxolitinib compared with BAT at 3.5 years of follow-up in the COMFORT-II trial (hazard ratio 0.58, 95 % CI 0.36-0.93). Grade 3-4 adverse events were more frequent in the ruxolitinib group than in the BAT group; 42 % compared with 25 %. Evidence relating to patients with lower-risk disease or low platelet counts (50-100 × 10 9 /L) was less robust. The company's economic model was well-presented and had an appropriate model structure. The base-case incremental cost-effectiveness ratio (ICER) was estimated to be around £45,000 per quality-adjusted life-year (QALY) gained (including the PAS discount). Extensive sensitivity and scenario analyses were presented, demonstrating that the estimated ICER was robust to a range of input values and assumptions made in the model. Alternative scenarios presented by the ERG showed only modest increases in the estimated ICER, primarily as a result of including an element of drug wastage within the model. Alternative scenarios resulted in estimated ICERs ranging from around £45,000 to £49,000 per QALY gained (including the PAS discount). At the first appraisal meeting, the NICE Appraisal Committee concluded that ruxolitinib was clinically effective and was a cost effective use of National Health Service (NHS) resources for patients with high-risk myelofibrosis who meet NICE's end-of-life criteria. Following the consultation, the company offered a revised PAS, resulting in a revised base-case ICER of £31,229 per QALY gained. The company also presented new evidence on the cost effectiveness of ruxolitinib in intermediate-2 and high-risk subgroups and a revised version of the model. The NICE Appraisal Committee considered the new evidence and recommended ruxolitinib for the treatment of patients with intermediate-2-risk disease as well as patients with high-risk disease, based on International Prognostic Scoring System (IPSS) prognostic factors.

Cetuximab for recurrent and/or metastatic squamous cell carcinoma of the head and neck: a NICE single technology appraisal.

PubMed

Bagust, Adrian; Greenhalgh, Janette; Boland, Angela; Fleeman, Nigel; McLeod, Claire; Dickson, Rumona; Dundar, Yenal; Proudlove, Christine; Shaw, Richard

2010-01-01

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of cetuximab (Merck Serono) to submit evidence for the clinical and cost effectiveness of cetuximab in combination with platinum-based chemotherapy (CTX) for the treatment of patients with recurrent and/or metastatic squamous cell cancer of the head and neck (SCCHN) according to the Institute's Single Technology Appraisal (STA) process. The Liverpool Reviews and Implementation Group at the University of Liverpool was commissioned to act as the Evidence Review Group (ERG). This article summarizes the ERG's review of the evidence submitted by the manufacturer. A summary of the Appraisal Committee (AC) decision is provided. The ERG reviewed the clinical evidence in accordance with the decision problem defined by NICE. The analysis of the submitted model assessed the appropriateness of the manufacturer's approach to modelling the decision problem, the reliability of model implementation and the extent of conformity to published standards and prevailing norms of practice within the health economics modelling community. Particular attention was paid to issues likely to impact substantially on the base-case cost-effectiveness results. Clinical-effectiveness evidence was derived from a single randomized controlled trial (RCT). Results presented for clinical outcomes were strongly supportive of benefits resulting from the use of cetuximab. Cetuximab + platinum-based CTX with 5 fluorouracil (5-FU) extended median overall survival (OS) from 7.4 months in the CTX group to 10.1 months in the cetuximab + CTX group. Median progression-free survival rose from 3.3 months to 5.6 months, best overall response to therapy increased from 19.5% to 35.6%, disease control rate rose from 60% to 81.1% and median time to treatment failure was 4.8 months compared with 3.0 months. Exploratory subgroup analyses indicated significant OS benefits in 11 of 16 pre-planned analyses. The ERG identified a number of issues relating to the clinical-effectiveness results: consideration was limited to first-line use of cetuximab; patients in the trial were younger and fitter than those presenting in UK clinical practice; there was no evidence of survival advantage for patients with metastatic disease; there was no evidence of effectiveness in patients not cetuximab-naive; and the quality-of-life data were poor. The submitted incremental cost-effectiveness ratio was considerably above the NICE threshold. The ERG questioned the submitted economic model on a number of grounds: the rationale for creating an economic model rather than direct analysis of trial data; the use of Weibull functions for survival models; inaccurate CTX costs; selection of health state utilities; inaccurate unit costs; and lack of mid-cycle correction. After amending the model, the ERG considered the use of cetuximab to be not cost effective for NICE at any price. The AC concluded that cetuximab in combination with platinum-based CTX should not be recommended for the treatment of patients with recurrent and/or metastatic SCCHN. Patients already receiving this treatment for this indication should have the option to continue treatment until they and their clinician consider it appropriate to stop. This was the first appraisal to consider the end-of-life medicines criteria introduced by NICE in January 2009.

Deep brain stimulation: a return journey from psychiatry to neurology.

PubMed

Ashkan, Keyoumars; Shotbolt, Paul; David, Anthony S; Samuel, Michael

2013-06-01

Deep brain stimulation (DBS) has emerged as an effective neurosurgical tool to treat a range of conditions. Its use in movement disorders such as Parkinson's disease, tremor and dystonia is now well established and has been approved by the National Institute of Clinical Excellence (NICE). The NICE does, however, emphasise the need for a multidisciplinary team to manage these patients. Such a team is traditionally composed of neurologists, neurosurgeons and neuropsychologists. Neuropsychiatrists, however, are increasingly recognised as essential members given many psychiatric considerations that may arise in patients undergoing DBS. Patient selection, assessment of competence to consent and treatment of postoperative psychiatric disease are just a few areas where neuropsychiatric input is invaluable. Partly driven by this close team working and partly based on the early history of DBS for psychiatric disorders, there is increasing interest in re-exploring the potential of neurosurgery to treat patients with psychiatric disease, such as depression and obsessive-compulsive disorder. Although the clinical experience and evidence with DBS in this group of patients are steadily increasing, many questions remain unanswered. Yet, the characteristics of optimal surgical candidates, the best choice of DBS target, the most effective stimulating parameters and the extent of postoperative improvement are not clear for most psychiatric conditions. Further research is therefore required to define how DBS can be best utilised to improve the quality of life of patients with psychiatric disease.

Weak evidence on nalmefene creates dilemmas for clinicians and poses questions for regulators and researchers

PubMed Central

Angus, Kathryn; Elders, Andrew; de Andrade, Marisa; Raistrick, Duncan; Heather, Nick; McCambridge, Jim

2016-01-01

Abstract Background and aims Nalmefene has been approved in Europe for the treatment of alcohol dependence and subsequently recommended by the UK National Institute for Health and Care Excellence (NICE). This study examines critically the evidence base underpinning both decisions and the issues arising. Methods Published studies of nalmefene were identified through a systematic search, with documents from the European Medicines Agency, the NICE appraisal and public clinical trial registries also examined to identify methodological issues. Results Efficacy data used to support the licensing of nalmefene suffer from risk of bias due to lack of specification of a priori outcome measures and sensitivity analyses, use of post‐hoc sample refinement and the use of inappropriate comparators. Despite this, evidence for the efficacy of nalmefene in reducing alcohol consumption in those with alcohol dependence is, at best, modest, and of uncertain significance to individual patients. The relevance of existing trial data to routine primary care practice is doubtful. Conclusions Problems with the registration, design, analysis and reporting of clinical trials of nalmefene did not prevent it being licensed and recommended for treating alcohol dependence. This creates dilemmas for primary care clinicians and commissioning organisations where nalmefene has been heavily promoted, and poses wider questions about the effectiveness of the medicines regulation system and how to develop the alcohol treatment evidence base. PMID:27262594

Nitrogen Cycle Evaluation (NiCE) Chip for the Simultaneous Analysis of Multiple N-Cycle Associated Genes.

PubMed

Oshiki, Mamoru; Segawa, Takahiro; Ishii, Satoshi

2018-02-02

Various microorganisms play key roles in the Nitrogen (N) cycle. Quantitative PCR (qPCR) and PCR-amplicon sequencing of the N cycle functional genes allow us to analyze the abundance and diversity of microbes responsible in the N transforming reactions in various environmental samples. However, analysis of multiple target genes can be cumbersome and expensive. PCR-independent analysis, such as metagenomics and metatranscriptomics, is useful but expensive especially when we analyze multiple samples and try to detect N cycle functional genes present at relatively low abundance. Here, we present the application of microfluidic qPCR chip technology to simultaneously quantify and prepare amplicon sequence libraries for multiple N cycle functional genes as well as taxon-specific 16S rRNA gene markers for many samples. This approach, named as N cycle evaluation (NiCE) chip, was evaluated by using DNA from pure and artificially mixed bacterial cultures and by comparing the results with those obtained by conventional qPCR and amplicon sequencing methods. Quantitative results obtained by the NiCE chip were comparable to those obtained by conventional qPCR. In addition, the NiCE chip was successfully applied to examine abundance and diversity of N cycle functional genes in wastewater samples. Although non-specific amplification was detected on the NiCE chip, this could be overcome by optimizing the primer sequences in the future. As the NiCE chip can provide high-throughput format to quantify and prepare sequence libraries for multiple N cycle functional genes, this tool should advance our ability to explore N cycling in various samples. Importance. We report a novel approach, namely Nitrogen Cycle Evaluation (NiCE) chip by using microfluidic qPCR chip technology. By sequencing the amplicons recovered from the NiCE chip, we can assess diversities of the N cycle functional genes. The NiCE chip technology is applicable to analyze the temporal dynamics of the N cycle gene transcriptions in wastewater treatment bioreactors. The NiCE chip can provide high-throughput format to quantify and prepare sequence libraries for multiple N cycle functional genes. While there is a room for future improvement, this tool should significantly advance our ability to explore the N cycle in various environmental samples. Copyright © 2018 American Society for Microbiology.

Accessibility and implementation in UK services of an effective depression relapse prevention programme – mindfulness-based cognitive therapy (MBCT): ASPIRE study protocol

PubMed Central

2014-01-01

Background Mindfulness-based cognitive therapy (MBCT) is a cost-effective psychosocial prevention programme that helps people with recurrent depression stay well in the long term. It was singled out in the 2009 National Institute for Health and Clinical Excellence (NICE) Depression Guideline as a key priority for implementation. Despite good evidence and guideline recommendations, its roll-out and accessibility across the UK appears to be limited and inequitably distributed. The study aims to describe the current state of MBCT accessibility and implementation across the UK, develop an explanatory framework of what is hindering and facilitating its progress in different areas, and develop an Implementation Plan and related resources to promote better and more equitable availability and use of MBCT within the UK National Health Service. Methods/Design This project is a two-phase qualitative, exploratory and explanatory research study, using an interview survey and in-depth case studies theoretically underpinned by the Promoting Action on Implementation in Health Services (PARIHS) framework. Interviews will be conducted with stakeholders involved in commissioning, managing and implementing MBCT services in each of the four UK countries, and will include areas where MBCT services are being implemented successfully and where implementation is not working well. In-depth case studies will be undertaken on a range of MBCT services to develop a detailed understanding of the barriers and facilitators to implementation. Guided by the study’s conceptual framework, data will be synthesized across Phase 1 and Phase 2 to develop a fit for purpose implementation plan. Discussion Promoting the uptake of evidence-based treatments into routine practice and understanding what influences these processes has the potential to support the adoption and spread of nationally recommended interventions like MBCT. This study could inform a larger scale implementation trial and feed into future implementation of MBCT with other long-term conditions and associated co-morbidities. It could also inform the implementation of interventions that are acceptable and effective, but are not widely accessible or implemented. PMID:24884603

UK Renal Registry 15th annual report: Chapter 6 haemoglobin, ferritin and erythropoietin amongst UK adult dialysis patients in 2011: national and centre-specific analyses.

PubMed

Rao, Anirudh; Gilg, Julie; Williams, Andrew

2013-01-01

The UK Renal Association (RA) and National Institute for Health and Care Excellence (NICE) have published Clinical Practice Guidelines which include recommendations for management of anaemia in established renal failure. To determine the extent to which the guidelines for anaemia management are met in the UK. Quarterly data were obtained for haemoglobin (Hb) and factors that influence Hb from renal centres in England, Wales, Northern Ireland (E, W, NI) and the Scottish Renal Registry for the incident and prevalent renal replacement therapy (RRT) cohorts for 2011. In the UK, in 2011 51% of patients commenced dialysis therapy with Hb ≥10.0 g/dl (median Hb 10 g/dl). Of patients in the early presentation group, 55% started dialysis with Hb ≥10.0 g/dl whilst 37% of patients presenting late started dialysis with Hb ≥10.0 g/dl. The UK median Hb of haemodialysis (HD) patients was 11.2 g/dl with an inter-quartile range (IQR) of 10.3-12.1 g/dl. Of UK HD patients, 82% had Hb ≥10.0 g/dl. The median Hb of peritoneal dialysis (PD) patients in the UK was 11.4 g/dl (IQR 10.5-12.3 g/dl). Of UK PD patients, 85% had Hb ≥10.0 g/dl. The median ferritin in HD patients in the UK was 436 mg/L (IQR 292-625) and 96% of HD patients had a ferritin ≥100 mg/ L. In EW&NI the median ferritin in PD patients was 273 mg/ L (IQR 153-446) with 86% of PD patients having a ferritin ≥100 mg/L. In EW&NI the mean erythropoietin stimulating agent (ESA) dose was higher for HD than PD patients (8,740 vs. 6,624 IU/week). Prevalent HD and PD patients had 56% and 53% respectively within the Hb ≥10 and ≤12 g/dl target. Copyright © 2013 S. Karger AG, Basel.

Does the cancer drugs fund lead to faster uptake of cost-effective drugs? A time-trend analysis comparing England and Wales.

PubMed

Chamberlain, C; Collin, S M; Stephens, P; Donovan, J; Bahl, A; Hollingworth, W

2014-10-28

The Cancer Drugs Fund (CDF) provides £200 million annually in England for 'anti-cancer' drugs. We used a controlled pre-/post-intervention design to compare IMS Health dispensing data for 15 cancer drugs (2007-2012) in England vs Wales, stratified by pre-CDF NICE drug approval status (rejected, mixed recommendations, recommended, not appraised). The CDF was associated with increased prescribing in England for three of five drugs rejected or with mixed NICE recommendations. The prescribing volume ratios (PVR) ranged from 1.29 (95% CI 1.00, 1.67) for sorafenib to 3.28 (2.59, 4.14) for bevacizumab (NICE rejected) and 0.93 (0.81, 1.06) and 1.35 (1.21, 1.49) for sunitinib and imatinib respectively (mixed recommendations). Post CDF prescribing in England increased for both drugs awaiting NICE appraisal pre-CDF (lapatinib PVR=7.44 (5.81, 9.54), panitumumab PVR=5.40 (1.20, 24.42)) and subsequently rejected. The CDF was not associated with increased prescribing in England of NICE-recommended drugs. The three most recently launched, subsequently recommended drugs were adopted faster in Wales (from pazopanib PVR=0.51 (0.28, 0.96) to abiraterone PVR=0.78 (0.61-0.99)). These data indicate that the CDF is used to access drugs deemed not cost-effective by NICE. The CDF did not expedite access to new cost-effective cancer agents prior to NICE approval.

Elucidating the Complex Lineshapes Resulting from the Highly Sensitive, Ion Selective, Technique Nice-Ohvms

NASA Astrophysics Data System (ADS)

Hodges, James N.; Siller, Brian; McCall, Benjamin J.

2015-06-01

The technique Noise Immune Cavity Enhanced Optical Heterodyne Velocity Modulation Spectroscopy, or NICE-OHVMS, has been used to great effect to precisely and accurately measure a variety of molecular ion transitions from species such as H_3^+, CH_5^+, HeH^+, and HCO^+, achieving MHz or in some cases sub-MHz uncertainty. It is a powerful technique, but a complete theoretical understanding of the complex NICE-OHVMS lineshape is needed to fully unlock its potential. NICE-OHVMS is the direct result of the combination of the highly sensitive spectroscopic technique Noise Immune Cavity Enhanced Optical Heterodyne Molecular Spectroscopy(NICE-OHMS) with Velocity Modulation Spectroscopy(VMS), applying the most sensitive optical detection method with ion species selectivity. The theoretical underpinnings of NICE-OHMS lineshapes are well established, as are those of VMS. This presentation is the logical extension of those two preceding bodies of work. Simulations of NICE-OHVMS lineshapes under a variety of conditions and fits of experimental data to the model are presented. The significance and accuracy of the various inferred parameters, along with the prospect of using them to extract additional information from observed transitions, are discussed. J.~N. Hodges, et al. J. Chem. Phys. (2013), 139, 164201. A.~J. Perry, et al. J. Chem. Phys. (2014), 141, 101101. K.~N. Crabtree, et al. Chem. Phys. Lett. (2012), 551, 1-6. F.~M. Schmidt, et al. J. Opt. Soc. Amer. A (2008), 24, 1392--1405. J.~W. Farley, J. Chem. Phys. (1991), 95, 5590--5602.

Glue, steam and Clarivein--Best practice techniques and evidence.

PubMed

Whiteley, Mark S

2015-11-01

In July 2013, the National Institute of Health and Clinical Excellence (NICE) recommended "endothermal" ablation (meaning endovenous thermal ablation) is the first line treatment for truncal venous reflux in varicose veins. The initial endovenous thermoablation devices were radiofrequency ablation and endovenous laser ablation. More recently, Glue (cyanoacrylate), endovenous steam and Clarivein (mechanochemical ablation or MOCA) have entered the market as new endovenous techniques for the treatment of varicose veins. Glue and Clarivein do not require tumescent anaesthesia and do not use heat and therefore termed non-tumescent non-thermal (NTNT). Steam both requires tumescence and is also a thermal technique (TT). This article reviews the current position of these 3 new technologies in the treatment of varicose veins. © The Author(s) 2015.

Critical Appraisal of International Clinical Practice Guidelines in Kidney Transplantation Using the Appraisal of Guidelines for Research and Education (AGREE) II Tool: A Systematic Review.

PubMed

OʼDonoghue, Katriona Jane Marie; Reed, Rhiannon D; Knight, Simon R; O'Callaghan, John M; Ayaz-Shah, Anam A; Hassan, Sevda; Weissenbacher, Annemarie; Morris, Peter J; Pengel, Liset H M

2018-05-22

Whilst Clinical Practice Guidelines (CPGs) are used for the development of local protocols in kidney transplantation (Ktx), the quality of their methodology is variable. This systematic review aimed to critically appraise international CPGs in all aspects of Ktx using the Appraisal of Guidelines for Research and Evaluation (AGREE) II tool. CPGs in Ktx and donation published between 2010 and 2017 were identified from MEDLINE, Embase, National Guideline Clearinghouse, NHS and NICE Evidence Searches, and the websites of transplant societies. Using AGREE II, 3 appraisers assessed the quality of CPGs. Interrater reliability was measured using the intraclass correlation coefficient (ICC). Searches identified 3,168 records and 115 CPGs were included. The highest scoring AGREE II domain was 'Scope and Purpose' (80%; Range 30-100%), followed by 'Clarity of Presentation' (77%; Range 43-98%), 'Editorial independence' (52%; Range 0-94%), 'Rigour of Development' (47%; Range 6-97%) and 'Stakeholder Involvement' (41%; Range 11-85%). The poorest scoring domain was 'Applicability' (31%; Range 3-74%). Most CPGs were recommended for future use either with (63%) or without modifications (18%). A small number were not recommended for future use (14%) or reviewers did not agree on recommending the CPG (5%). The overall mean CPG quality score was 4 out of 7 (Range 2-7). The mean ICC of 0.74 indicated substantial agreement between reviewers. The quality of international CPGs in Ktx was variable, and most CPGs lacked key aspects of methodological robustness and transparency. Improvements in methodology, patient involvement and strategies for implementation are required.

Renal function monitoring in heart failure – what is the optimal frequency? A narrative review

PubMed Central

Wright, David; Devonald, Mark Alexander John; Pirmohamed, Munir

2017-01-01

The second most common cause of hospitalization due to adverse drug reactions in the UK is renal dysfunction due to diuretics, particularly in patients with heart failure, where diuretic therapy is a mainstay of treatment regimens. Therefore, the optimal frequency for monitoring renal function in these patients is an important consideration for preventing renal failure and hospitalization. This review looks at the current evidence for optimal monitoring practices of renal function in patients with heart failure according to national and international guidelines on the management of heart failure (AHA/NICE/ESC/SIGN). Current guidance of renal function monitoring is in large part based on expert opinion, with a lack of clinical studies that have specifically evaluated the optimal frequency of renal function monitoring in patients with heart failure. Furthermore, there is variability between guidelines, and recommendations are typically nonspecific. Safer prescribing of diuretics in combination with other antiheart failure treatments requires better evidence for frequency of renal function monitoring. We suggest developing more personalized monitoring rather than from the current medication‐based guidance. Such flexible clinical guidelines could be implemented using intelligent clinical decision support systems. Personalized renal function monitoring would be more effective in preventing renal decline, rather than reacting to it. PMID:28901643

[Ambulatory blood pressure monitoring for hypertension diagnosis?

PubMed

Gijón Conde, T; Banegas, J R

2017-01-01

The early and accurate diagnosis of hypertension is essential given its importance in the development of cardiovascular disease. The boundaries between normal blood pressure (BP) and hypertension are arbitrary and based on the benefits of treating exceeding those of not treating. Conventional BP measurement at the clinic only offers information of a particular time and presents multiple biases dependent on inherent variability of BP and measurement technique itself. Multiple studies have demonstrated the prognosis superiority in the development of cardiovascular disease of ambulatory blood pressure monitoring (ABPM), allows detection of white coat hypertension, avoiding overdiagnosis and overtreatment, and the detection of patients with masked hypertension who are at risk of underdetection and undertreatment. ABPM also assess nightime BP and circadian variability, providing additional prognostic value. ABPM is recognized in the diagnosis of hypertension in 2011 British NICE Guidelines, very argued at the 2013 European Society of Hypertension guidelines, and recommended in the US Preventive Services Task Force in 2015, 2016 Canadian Guidelines and the 2016 Spanish Program of Preventive Activities and Health Promotion (PAPPS). Its generalization is likely to be only a matter of time. Copyright © 2017 Sociedad Española de Hipertension-Liga Española para la Lucha de la Hipertensión Arterial (SEH-LELHA). Publicado por Elsevier España, S.L.U. All rights reserved.

Completing the cycle: The use of audit to develop a mental health service in times of austerity.

PubMed

Shah, Nisha; Donaldson, Lucinda; Giridhar, Ramya

2013-12-01

A published audit demonstrated that a pilot psychiatric clinic failed to capture predicted numbers of women with severe and enduring mental illness. On the basis of recommendations from this audit, along with those from the Royal College of Psychiatrists and NICE guidelines, a more comprehensive psychiatric service was developed to meet this demand and therefore manage risk more effectively. Over the course of a year, the new service attracted a higher rate of referrals of pregnant women with severe and enduring mental illness. The majority referral source continued to be midwifery-led. Audit is a useful tool for evaluating and informing service development and helped us identify further improvements needed to deliver an effective mental health service.

The TURis System for Transurethral Resection of the Prostate: A NICE Medical Technology Guidance.

PubMed

Cleves, Andrew; Dimmock, Paul; Hewitt, Neil; Carolan-Rees, Grace

2016-06-01

The transurethral resection in saline (TURis) system was notified by the company Olympus Medical to the National Institute of Health and Care Excellence's (NICE's) Medical Technologies Evaluation Programme. Following selection for medical technologies guidance, the company developed a submission of clinical and economic evidence for evaluation. TURis is a bipolar surgical system for treating men with lower urinary tract symptoms due to benign prostatic enlargement. The comparator is any monopolar transurethral resection of the prostate (mTURP) system. Cedar, a collaboration between Cardiff and Vale University Health Board, Cardiff University and Swansea University in the UK, acted as an External Assessment Centre (EAC) for NICE to independently critique the company's submission of evidence. Eight randomised trials provided evidence for TURis, demonstrating efficacy equivalent to that of mTURP for improvement of symptoms. The company presented meta-analyses of key outcome measures, and the EAC made methodological modifications in response to the heterogeneity of the trial data. The EAC analysis found that TURis substantially reduced the relative risks of transurethral resection syndrome (relative risk 0.18 [95 % confidence interval 0.05-0.62]) and blood transfusion (relative risk 0.35 [95 % confidence interval 0.19-0.65]). The company provided a de novo economic model comparing TURis with mTURP. The EAC critiqued the model methodology and made modifications. This found TURis to be cost saving at £70.55 per case for existing Olympus customers and cost incurring at £19.80 per case for non-Olympus customers. When an additional scenario based on the only available data on readmission (due to any cause) from a single trial was modelled, the estimated cost saving per case was £375.02 for existing users of Olympus electrosurgery equipment and £284.66 per case when new Olympus equipment would need to be purchased. Meta-analysis of eight randomised trials showed that TURis is associated with a statistically significantly reduced risk of transurethral resection syndrome and a reduced need for blood transfusion-two factors that may drive cost saving for the National Health Service. The clinical data are equivocal as to whether TURis shortens the hospital stay. Limited data from a single study suggest that TURis may reduce the rate of readmission after surgery. The NICE guidance supports adoption of the TURis technology for performing transurethral resection of the prostate in men with lower urinary tract symptoms due to benign prostatic enlargement.

Trastuzumab Emtansine for Treating HER2-Positive, Unresectable, Locally Advanced or Metastatic Breast Cancer After Treatment with Trastuzumab and a Taxane: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

PubMed

Squires, Hazel; Stevenson, Matt; Simpson, Emma; Harvey, Rebecca; Stevens, John

2016-07-01

The National Institute for Health and Care Excellence (NICE) invited the manufacturer of trastuzumab emtansine (T-DM1) (Kadcyla(®); Roche) to submit evidence of its clinical and cost-effectiveness for treating human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced or metastatic breast cancer after treatment with trastuzumab and a taxane. The School of Health and Related Research Technology Appraisal Group (ScHARR-TAG) at the University of Sheffield were the independent Evidence Review Group (ERG) who produced a critical review of the company's submission to NICE. The ERG also independently searched for relevant evidence and modified the submitted decision analytic model to produce a revised estimate of cost-effectiveness and examine the impact of altering some of the key assumptions. The clinical effectiveness data were taken from two randomised controlled trials that reported a significant advantage in progression-free survival (PFS) for T-DM1 over lapatinib in combination with capecitabine (EMILIA trial), and over the treatment of physician's choice (TH3RESA trial). A network meta-analysis suggested T-DM1 was the best treatment in terms of both overall survival and PFS compared with lapatinib in combination with capecitabine; trastuzumab in combination with capecitabine; and capecitabine monotherapy. Adverse event (AE) data were taken from a pooled analysis of additional trials of T-DM1 as a single agent. The most common grade 3 or greater AEs for T-DM1 were thrombocytopenia and hepatotoxicity. Following the clarification process, the manufacturer reported a deterministic incremental cost-effectiveness ratio (ICER) for T-DM1 compared with lapatinib in combination with capecitabine of £167,236, the latter of which was estimated to have an ICER of £49,798 compared with capecitabine monotherapy. The ERG produced similar values of £166,429 and £50,620 respectively. All other comparators were dominated. During the appraisal, the manufacturer offered an analysis of a patient access scheme (PAS), which suggested that T-DM1 had a 0 % probability of being cost-effective at an ICER of £30,000 per QALY gained. The NICE Appraisal Committee concluded that while the clinical effectiveness of T-DM1 had been proven, it was not likely to represent a cost-effective use of National Health Service resources and therefore its use could not be recommended.

One-Step Generation of Multifunctional Polyelectrolyte Microcapsules via Nanoscale Interfacial Complexation in Emulsion (NICE)

DOE PAGES

Kim, Miju; Yeo, Seon Ju; Highley, Christopher B.; ...

2015-07-14

Polyelectrolyte microcapsules represent versatile stimuli-responsive structures that enable the encapsulation, protection, and release of active agents. Their conventional preparation methods, however, tend to be time-consuming, yield low encapsulation efficiency, and seldom allow for the dual incorporation of hydrophilic and hydrophobic materials, limiting their widespread utilization. In this work, we present a method to fabricate stimuli-responsive polyelectrolyte microcapsules in one step based on nanoscale interfacial complexation in emulsions (NICE) followed by spontaneous droplet hatching. NICE microcapsules can incorporate both hydrophilic and hydrophobic materials and also can be induced to trigger the release of encapsulated materials by changes in the solution pHmore » or ionic strength. We also show that NICE microcapsules can be functionalized with nanomaterials to exhibit useful functionality, such as response to a magnetic field and disassembly in response to light. NICE represents a potentially transformative method to prepare multifunctional nanoengineered polyelectrolyte microcapsules for various applications such as drug delivery and cell mimicry.« less

One-Step Generation of Multifunctional Polyelectrolyte Microcapsules via Nanoscale Interfacial Complexation in Emulsion (NICE).

PubMed

Kim, Miju; Yeo, Seon Ju; Highley, Christopher B; Burdick, Jason A; Yoo, Pil J; Doh, Junsang; Lee, Daeyeon

2015-08-25

Polyelectrolyte microcapsules represent versatile stimuli-responsive structures that enable the encapsulation, protection, and release of active agents. Their conventional preparation methods, however, tend to be time-consuming, yield low encapsulation efficiency, and seldom allow for the dual incorporation of hydrophilic and hydrophobic materials, limiting their widespread utilization. In this work, we present a method to fabricate stimuli-responsive polyelectrolyte microcapsules in one step based on nanoscale interfacial complexation in emulsions (NICE) followed by spontaneous droplet hatching. NICE microcapsules can incorporate both hydrophilic and hydrophobic materials and also can be induced to trigger the release of encapsulated materials by changes in the solution pH or ionic strength. We also show that NICE microcapsules can be functionalized with nanomaterials to exhibit useful functionality, such as response to a magnetic field and disassembly in response to light. NICE represents a potentially transformative method to prepare multifunctional nanoengineered polyelectrolyte microcapsules for various applications such as drug delivery and cell mimicry.

One-Step Generation of Multifunctional Polyelectrolyte Microcapsules via Nanoscale Interfacial Complexation in Emulsion (NICE)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kim, Miju; Yeo, Seon Ju; Highley, Christopher B.

Polyelectrolyte microcapsules represent versatile stimuli-responsive structures that enable the encapsulation, protection, and release of active agents. Their conventional preparation methods, however, tend to be time-consuming, yield low encapsulation efficiency, and seldom allow for the dual incorporation of hydrophilic and hydrophobic materials, limiting their widespread utilization. In this work, we present a method to fabricate stimuli-responsive polyelectrolyte microcapsules in one step based on nanoscale interfacial complexation in emulsions (NICE) followed by spontaneous droplet hatching. NICE microcapsules can incorporate both hydrophilic and hydrophobic materials and also can be induced to trigger the release of encapsulated materials by changes in the solution pHmore » or ionic strength. We also show that NICE microcapsules can be functionalized with nanomaterials to exhibit useful functionality, such as response to a magnetic field and disassembly in response to light. NICE represents a potentially transformative method to prepare multifunctional nanoengineered polyelectrolyte microcapsules for various applications such as drug delivery and cell mimicry.« less

"Patients with amyotrophic lateral sclerosis (ALS) are usually nice persons"-How physicians experienced in ALS see the personality characteristics of their patients.

PubMed

Mehl, Theresa; Jordan, Berit; Zierz, Stephan

2017-01-01

Physicians experienced in the treatment of patients with amyotrophic lateral sclerosis (ALS) occasionally describe these patients as "nice" persons. ALS experienced physicians ( n  =   36) were asked to assess the personality characteristics of ALS patients using a multidimensional personality questionnaire based on the five-factor model of personality. Control groups consisted of physicians experienced in Myasthenia gravis (MG) ( n  =   21) and lung cancer (LC) ( n  =   36). In the dimension Agreeableness ALS patients were rated significantly higher than the other groups ( p  <   .001). This was mainly due to the high scores for converse adjective pairs "stubborn-compliant" and "selfish-helpful". The dimension Agreeableness is very similar to "niceness". Results support the anecdotal description of ALS patients as "nice" persons. Personality characteristics of ALS patients differentiate them from other patient groups. It remains open whether the "nice" personality structure is linked to the susceptibility to the disease.

The use of exploratory analyses within the National Institute for Health and Care Excellence single technology appraisal process: an evaluation and qualitative analysis.

PubMed

Kaltenthaler, Eva; Carroll, Christopher; Hill-McManus, Daniel; Scope, Alison; Holmes, Michael; Rice, Stephen; Rose, Micah; Tappenden, Paul; Woolacott, Nerys

2016-04-01

As part of the National Institute for Health and Care Excellence (NICE) single technology appraisal (STA) process, independent Evidence Review Groups (ERGs) critically appraise the company submission. During the critical appraisal process the ERG may undertake analyses to explore uncertainties around the company's model and their implications for decision-making. The ERG reports are a central component of the evidence considered by the NICE Technology Appraisal Committees (ACs) in their deliberations. The aim of this research was to develop an understanding of the number and type of exploratory analyses undertaken by the ERGs within the STA process and to understand how these analyses are used by the NICE ACs in their decision-making. The 100 most recently completed STAs with published guidance were selected for inclusion in the analysis. The documents considered were ERG reports, clarification letters, the first appraisal consultation document and the final appraisal determination. Over 400 documents were assessed in this study. The categories of types of exploratory analyses included fixing errors, fixing violations, addressing matters of judgement and the ERG-preferred base case. A content analysis of documents (documentary analysis) was undertaken to identify and extract relevant data, and narrative synthesis was then used to rationalise and present these data. The level and type of detail in ERG reports and clarification letters varied considerably. The vast majority (93%) of ERG reports reported one or more exploratory analyses. The most frequently reported type of analysis in these 93 ERG reports related to the category 'matters of judgement', which was reported in 83 (89%) reports. The category 'ERG base-case/preferred analysis' was reported in 45 (48%) reports, the category 'fixing errors' was reported in 33 (35%) reports and the category 'fixing violations' was reported in 17 (18%) reports. The exploratory analyses performed were the result of issues raised by an ERG in its critique of the submitted economic evidence. These analyses had more influence on recommendations earlier in the STA process than later on in the process. The descriptions of analyses undertaken were often highly specific to a particular STA and could be inconsistent across ERG reports and thus difficult to interpret. Evidence Review Groups frequently conduct exploratory analyses to test or improve the economic evaluations submitted by companies as part of the STA process. ERG exploratory analyses often have an influence on the recommendations produced by the ACs. More in-depth analysis is needed to understand how ERGs make decisions regarding which exploratory analyses should be undertaken. More research is also needed to fully understand which types of exploratory analyses are most useful to ACs in their decision-making. The National Institute for Health Research Health Technology Assessment programme.

To What Extent do Clinical Practice Guidelines Respond to the Needs and Preferences of Patients Diagnosed with Obsessive-Compulsive Disorder?

PubMed

Villena-Jimena, Amelia; Gómez-Ocaña, Clara; Amor-Mercado, Gisela; Núñez-Vega, Amanda; Morales-Asencio, José Miguel; Hurtado, María Magdalena

The number of Clinical Practice Guidelines (CPG) to help in making clinical decisions is increasing. However, there is currently a lack of CPG for Obsessive-Compulsive Disorder that take into account the requirements and expectations of the patients. The aim of the present study was to determine whether recommendations of the NICE guideline, "Obsessive-compulsive disorder: core interventions in the treatment of obsessive-compulsive disorder and body dysmorphic disorder" agrees with the needs and preferences of patients diagnosed with OCD in the mental health service. Two focal groups were formed with a total of 12 participants. They were asked about the impact of the disorder in their lives, their experiences with the mental health services, their satisfaction with treatments, and about their psychological resources. Preferences and needs were compared with the recommendations of the guidelines, and to facilitate their analysis, they were classified into four topics: information, accessibility, treatments, and therapeutic relationship. The results showed a high agreement between recommendations and patients preferences, particularly as regards high-intensity psychological interventions. Some discrepancies included the lack of prior low-intensity psychological interventions in mental health service, and the difficulty of rapid access the professionals. There is significant concordance between recommendations and patients preferences and demands, which are only partially responded to by the health services. Copyright © 2017 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

Systematic review and meta-analysis of the role of mental training in the acquisition of technical skills in surgery.

PubMed

Rao, Ahsan; Tait, Ian; Alijani, Afshin

2015-09-01

Mental training is rehearsal of mental imagery without physically performing the task. The aim of the study was to perform systematic review and meta-analysis on all the available data to evaluate the role of mental training in the acquisition of surgical technical skills. The following search databases were used: EMBASE, MEDLINE, Web of Science, Clinicaltrials.gov.uk, SIGN guidelines, NICE guidelines, and Cochrane review register. Meta-analysis was performed using Revman 5.2 statistical software. There were a total of 9 randomized controlled trials with 474 participants, of which 189 participants received mental training. Five randomized controlled trials concluded positive impact of mental training. Mental training group did not show any significant improvement in overall performance of the task carried in each study (P = .06). Mental training can be used as an important supplementary tool in learning surgical skills when run in parallel with physical training and applied to trainees with some experience of the skill. Copyright © 2015 Elsevier Inc. All rights reserved.

Site-specific mutagenesis of the nodule-infected cell expression (NICE) element and the AT-rich element ATRE-BS2* of the Sesbania rostrata leghemoglobin glb3 promoter.

PubMed Central

Szczyglowski, K; Szabados, L; Fujimoto, S Y; Silver, D; de Bruijn, F J

1994-01-01

Sesbania rostrata leghemoglobin glb3 (Srglb3) promoter sequences responsible for expression in infected cells of transgenic Lotus corniculatus nodules were delimited to a 78-bp Dral-Hinfl fragment. This region, which is located between coordinates -194 to -116 relative to the start codon of the Srglb3 gene, was named the nodule-infected cell expression (NICE) element. Insertion of the NICE element into the truncated nopaline synthase promoter was found to confer a nodule-specific expression pattern on this normally root-enhanced promoter. Within the NICE element, three distinct motifs ([A]AAAGAT, TTGTCTCTT, and CACCC[T]) were identified; they are highly conserved in the promoter regions of a variety of plant (leg)hemoglobin genes. The NICE element and the adjacent AT-rich element (ATRE-BS2*) were subjected to site-directed mutagenesis. The expression patterns of nine selected Srglb3 promoter fragments carrying mutations in ATRE-BS2* and 19 with mutations in the NICE element were examined. Mutations in ATRE-BS2* had varying effects on Srglb3 promoter activity, ranging from a two- to threefold reduction to a slight stimulation of activity. Mutations in the highly conserved (A)AAAGAT motif of the NICE element reduced Srglb3 promoter activity two- to fourfold, whereas mutations in the TCTT portion of the TTGTCTCTT motif virtually abolished promoter activity, demonstrating the essential nature of these motifs for Srglb3 gene expression. An A-to-T substitution in the CACCC(T) motif of the NICE element also abolished Srglb3 promoter activity, while a C-to-T mutation at position 4 resulted in a threefold reduction of promoter strength. The latter phenotypes resemble the effect of similar mutations in the conserved CACCC motif located in the promoter region of mammalian beta-globin genes. The possible analogies between these two systems will be discussed. PMID:8180496

Improving the management of people with a family history of breast cancer in primary care: before and after study of audit-based education

PubMed Central

2013-01-01

Background In England, guidance from National Institute for Clinical Excellence (NICE) states women with a family history of breast cancer presenting to primary care should be reassured or referred. We reviewed the evidence for interventions that might be applied in primary care and conducted an audit of whether low risk women are correctly advised and flagged. Methods We conducted a literature review to identify modifiable risk factors. We extracted routinely collected data from the computerised medical record systems of 6 general practices (population approximately 30,000); of the variables identified in the guidance. We implemented a quality improvement (QI) intervention called audit-based education (ABE) comparing participant practices with guidelines and each other before and after; we report odds ratios (OR) of any change in data recording. Results The review revealed evidence for advising on: diet, weight control, physical exercise, and alcohol. The proportion of patients with recordings of family history of: disease, neoplasms, and breast cancer were: 39.3%, 5.1% and 1.3% respectively. There was no significant change in the recording of family history of disease or cancer; OR 1.02 (95% CI 0.98-1.06); and 1.08 (95% CI 0.99-1.17) respectively. Recording of alcohol consumption and smoking both increased significantly; OR 1.36 (95% CI 1.30-1.43); and 1.42 (95% CI 1.27-1.60) respectively. Recording lifestyle advice fell; OR 0.84 (95% CI 0.81-0.88). Conclusions The study informs about current data recording and willingness to engage in ABE. Recording of risk factors improved after the intervention. Further QI is needed to achieve adherence to current guidance. PMID:23879178

Anaesthetic and other treatments of shell shock: World War I and beyond.

PubMed

McKenzie, A G

2012-03-01

Post-traumatic stress disorder (PTSD) is an important health risk factor for military personnel deployed in modern warfare. In World War I this condition (then known as shell shock or 'neurasthenia') was such a problem that 'forward psychiatry' was begun by French doctors in 1915. Some British doctors tried general anaesthesia as a treatment (ether and chloroform), while others preferred application of electricity. Four British 'forward psychiatric units' were set up in 1917. Hospitals for shell shocked soldiers were also established in Britain, including (for officers) Craiglockhart War Hospital in Edinburgh; patients diagnosed to have more serious psychiatric conditions were transferred to the Royal Edinburgh Asylum. Towards the end of 1918 anaesthetic and electrical treatments of shell shock were gradually displaced by modified Freudian methods psychodynamic intervention. The efficacy of 'forward psychiatry' was controversial. In 1922 the War Office produced a report on shell shock with recommendations for prevention of war neurosis. However, when World War II broke out in 1939, this seemed to have been ignored. The term 'combat fatigue' was introduced as breakdown rates became alarming, and then the value of pre-selection was recognised. At the Maudsley Hospital in London in 1940 barbiturate abreaction was advocated for quick relief from severe anxiety and hysteria, using i.v. anaesthetics: Somnifaine, paraldehyde, Sodium Amytal. 'Pentothal narcosis' and 'narco-analysis' were adopted by British and American military psychiatrists. However, by 1945 medical thinking gradually settled on the same approaches that had seemed to be effective in 1918. The term PTSD was introduced in 1980. In the UK the National Institute for Health and Clinical Excellence (NICE) guidelines for management (2005) recommend trauma-focussed Cognitive Behavioural Therapy and consideration of antidepressants.

A multisite audit to assess how women with complex social factors access and engage with maternity services.

PubMed

Rayment-Jones, Hannah; Butler, Eleanor; Miller, Chelsie; Nay, Christine; O'Dowd, Jennifer

2017-09-01

to audit women with socially complex lives' documented access to and engagement with antenatal care provided by three inner city, UK maternity services in relation to birth and neonatal outcomes, and referral processes. women living socially complex lives, including young mothers, recently arrived immigrants, non-English speaking, and those experiencing domestic violence, poor mental health, drug and alcohol abuse, and poverty experience high rates of morbidity, mortality and poor birth outcomes. This is associated with late access to and poor engagement with antenatal care. data was collected from three separate NHS trusts data management systems for a total of 182 women living socially complex lives, between January and December 2015. Data was presented by individual trust and compared to standards derived from NICE guidelines, local trust policy and national statistic using Excel and SPSS Version 22. Tests of correlation were carried out to minimise risks of confounding factors in characteristic differences. non-English speaking women were much less likely to have accessed care within the recommended timeframes, with over 70% of the sample not booked for maternity care by 12 weeks gestation. On average 89% primiparous women across all samples had less than the recommended number of antenatal appointments. No sample met the audit criteria in terms of number of antenatal appointments attended. Data held on the perinatal data management systems for a number of outcomes and processes was largely incomplete and appeared unreliable. this data forms a baseline against which to assess the impact of future service developments aimed at improving access and engagement with services for women living with complex social factors. The audit identified issues with the completeness and reliability of data on the perinatal data management system. Copyright © 2017 Elsevier Ltd. All rights reserved.

Personalized reminiscence therapy M-health application for patients living with dementia: Innovating using open source code repository.

PubMed

Zhang, Melvyn W B; Ho, Roger C M

2017-01-01

Dementia is known to be an illness which brings forth marked disability amongst the elderly individuals. At times, patients living with dementia do also experience non-cognitive symptoms, and these symptoms include that of hallucinations, delusional beliefs as well as emotional liability, sexualized behaviours and aggression. According to the National Institute of Clinical Excellence (NICE) guidelines, non-pharmacological techniques are typically the first-line option prior to the consideration of adjuvant pharmacological options. Reminiscence and music therapy are thus viable options. Lazar et al. [3] previously performed a systematic review with regards to the utilization of technology to delivery reminiscence based therapy to individuals who are living with dementia and has highlighted that technology does have benefits in the delivery of reminiscence therapy. However, to date, there has been a paucity of M-health innovations in this area. In addition, most of the current innovations are not personalized for each of the person living with Dementia. Prior research has highlighted the utility for open source repository in bioinformatics study. The authors hoped to explain how they managed to tap upon and make use of open source repository in the development of a personalized M-health reminiscence therapy innovation for patients living with dementia. The availability of open source code repository has changed the way healthcare professionals and developers develop smartphone applications today. Conventionally, a long iterative process is needed in the development of native application, mainly because of the need for native programming and coding, especially so if the application needs to have interactive features or features that could be personalized. Such repository enables the rapid and cost effective development of application. Moreover, developers are also able to further innovate, as less time is spend in the iterative process.

Venous thromboembolism: patient awareness and education in the pre-operative assessment clinic.

PubMed

Haymes, Adam

2016-04-01

Each year venous thromboembolism (VTE) causes up to 60,000 deaths in the UK, many resulting from hospital-acquired thromboses following elective surgery. National Institute for Health and Clinical Excellence (NICE) guidelines state that all elective surgical patients should receive verbal and written information pre-operatively regarding the risks of developing VTE. This audit assessed elective surgical patient's prior awareness of VTE and examined how effective targeted patient education during the pre-operative assessment is in increasing this awareness. A 13 point questionnaire designed to assess a pre-operative patient's understanding of topics relating to VTE was provided to consecutive patients identified as being at risk of developing VTE at the end of their pre-operative assessment over a two-week period. A total of 68 questionnaires were completed. Provision of verbal and written information was poor (47 %, n = 32 and 47 %, n = 32 respectively). Despite this, 71 % (n = 48) of patients were aware of the consequences of developing VTE. Many patients correctly identified surgery (71 %, n = 48), immobility (71 %, n = 48) and being overweight (68 %, n = 46) as risk factors, but not dehydration (47 %, n = 32). Lack of awareness regarding personal methods to reduce the risk of developing a VTE post-operatively (24 %, n = 16) and potential side-effects of medical prophylaxis (32 %, n = 22) were also identified. Many patients already possess an awareness of VTE, however, specific knowledge regarding its risk factors and methods of prevention is lacking. Provision of targeted written and verbal educational information during the pre-operative assessment is an effective method of increasing a patient's awareness of these topics. Increased patient awareness may empower patients in their post-operative recovery and enable them to make more informed decisions regarding VTE prophylaxis options.

Trial of Optimal Personalised Care After Treatment for Gynaecological cancer (TOPCAT-G): a study protocol for a randomised feasibility trial.

PubMed

Pye, Kirstie; Totton, Nicola; Stuart, Nicholas; Whitaker, Rhiannon; Morrison, Val; Edwards, Rhiannon Tudor; Yeo, Seow Tien; Timmis, Laura J; Butterworth, Caryl; Hall, Liz; Rai, Tekendra; Hoare, Zoe; Neal, Richard D; Wilkinson, Clare; Leeson, Simon

2016-01-01

Gynaecological cancers are diagnosed in over 1000 women in Wales every year. We estimate that this is costing the National Health Service (NHS) in excess of £1 million per annum for routine follow-up appointments alone. Follow-up care is not evidence-based, and there are no definitive guidelines from The National Institute for Health and Care Excellence (NICE) for the type of follow-up that should be delivered. Standard care is to provide a regular medical review of the patient in a hospital-based outpatient clinic for a minimum of 5 years. This study is to evaluate the feasibility of a proposed alternative where the patients are delivered a specialist nurse-led telephone intervention known as Optimal Personalised Care After Treatment for Gynaecological cancer (OPCAT-G), which comprised of a protocol-based patient education, patient empowerment and structured needs assessment. The study will recruit female patients who have completed treatment for cervical, endometrial, epithelial ovarian or vulval cancer within the previous 3 months in Betsi Cadwaladr University Health Board (BCUHB) in North Wales. Following recruitment, participants will be randomised to one of two arms in the trial (standard care or OPCAT-G intervention). The primary outcomes for the trial are patient recruitment and attrition rates, and the secondary outcomes are quality of life, health status and capability, using the EORTC QLQ-C30, EQ-5D-3L and ICECAP-A measures. Additionally, a client service receipt inventory (CSRI) will be collected in order to pilot an economic evaluation. The results from this feasibility study will be used to inform a fully powered randomised controlled trial to evaluate the difference between standard care and the OPCAT-G intervention. ISRCTN45565436.

Impact of Oncotype DX breast Recurrence Score testing on adjuvant chemotherapy use in early breast cancer: Real world experience in Greater Manchester, UK.

PubMed

Loncaster, J; Armstrong, A; Howell, S; Wilson, G; Welch, R; Chittalia, A; Valentine, W J; Bundred, N J

2017-05-01

The National Institute for Health and Clinical Excellence (NICE) recommended the Oncotype DX ® Breast Recurrence Score ® (RS) assay as an option for informing adjuvant chemotherapy decisions in node-negative, oestrogen receptor (ER)+, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer assessed to be at intermediate risk of recurrence based on clinicopathological factors. We evaluated the impact of RS testing on adjuvant chemotherapy decision-making in routine clinical practice in a UK Cancer Network. RS testing was performed in 201 females with newly diagnosed, ER+, HER2-negative, invasive breast cancer who underwent breast surgery with curative intent, were calculated to have a >3% overall survival benefit at 10 years from adjuvant chemotherapy based on PREDICT, and were considered for adjuvant chemotherapy. The impact of RS testing on adjuvant treatment decisions/associated cost was assessed. In all patients, the multi-disciplinary team recommended chemotherapy but the RS result allowed 127/201 patients (63.2%) to avoid unnecessary adjuvant chemotherapy. Amongst ER+, HER2-negative, node-negative patients (eligible for Oncotype DX testing in UK guidelines), 60.3% were spared chemotherapy. In node-positive patients, the assay reduced the use of chemotherapy by 69.2%. The use of RS testing to guide treatment in these 201 patients was associated with significant cost saving (when considering the cost of RS testing for all patients plus chemotherapy and its associated cost for 74 patients). Incorporating RS testing into routine clinical practice for selected node-negative and node-positive breast cancer patients significantly reduces the use of chemotherapy (p < 0.001) with its associated morbidity and costs. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest

PubMed Central

2012-01-01

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this first paper we discuss: the target audience(s) for guidelines and their use of guidelines; identifying topics for guidelines; guideline group composition (including consumer involvement) and the processes by which guideline groups function and the important procedural issue of managing conflicts of interest in guideline development. PMID:22762776

Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest.

PubMed

Eccles, Martin P; Grimshaw, Jeremy M; Shekelle, Paul; Schünemann, Holger J; Woolf, Steven

2012-07-04

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this first paper we discuss: the target audience(s) for guidelines and their use of guidelines; identifying topics for guidelines; guideline group composition (including consumer involvement) and the processes by which guideline groups function and the important procedural issue of managing conflicts of interest in guideline development.

Of lamp posts, keys, and fabled drunkards: A perspectival tale of 4 guidelines.

PubMed

Greenhalgh, Trisha

2018-04-15

Evidence-based medicine is the application of research findings to inform individual clinical decisions. There is a tension-both philosophical and practical-between the average result from a population study and the circumstances and needs of an individual patient. This personal account of "evidence-based" trauma care illustrates and explores this tension. The author, a keen athlete, describes her experience of a high-impact cycle accident that led to limb fractures (which were diagnosed and treated according to evidence-based guidelines) and also an occult injury to the cervical spine (which was not diagnosed at the time). Some evidence-based guidelines are reviewed and applied to the case. The clinical record described the cycle accident as a "fall." Initial assessment directed the clinicians' gaze to the obvious injuries, whose treatment was straightforward. On admission, the patient (aged 55 years at the time) was offered "falls prevention" via a guideline-based checklist. Several months later, neurological sequelae indicated possible damage to the cervical spine. But the NICE Guideline recommending cervical spine imaging in cases of high-impact trauma had not been considered-perhaps because the clinical narrative had been prematurely assigned to the script of "older person with fall." Furthermore, the author, who was (appropriately) treated with neurosurgery, was surprised at the response of clinical colleagues, based on application of an irrelevant section of a guideline, that her cervical discectomy was "nonevidence based." Nonsteroidal anti-inflammatory drugs for postoperative pain were indicated in this patient even though they were not recommended for the average patient. As Sir John Grimley Evans' warned, we should avoid using evidence-based guidelines in the manner of the fabled drunkard who searched under the lamp post for his key because that was where the light was, even though he knew he had lost his key somewhere else. © 2018 The Authors Journal of Evaluation in Clinical Practice Published by John Wiley & Sons Ltd.

Urgent revision required of NICE guidance relating to prevention of spread of vCJD through neurosurgical instruments.

PubMed

George, Kuriakose

2014-04-01

In 2006, NICE brought out guidance relating to prevention of vCJD through contaminated surgical instruments. This was with the aim of protecting patients born after 1997 who did not have any risk of developing vCJD through eating beef contaminated with BSE through the food chain. Many adult neurosurgical units did not pay much attention to this until 2013 when they were suddenly faced with these children who were now 16 and being admitted to the adult neurosurgical service rather than pediatric. The NICE guidance requires that most patients born after 1997 be operated on using a separate set of neurosurgical instruments than those born before this. This is proving to be a huge financial, as well as logistical, challenge and also a clinical risk as attention is being diverted to searching for the right kit when it should be spent on saving lives. It is now clear in 2013 that the risks that NICE feared were perhaps overstated as there is nowhere near the number of deaths from vCJD that NICE had feared would happen. Worldwide there have been only five cases whereby CJD was transmitted through contaminated neurosurgical instruments and the last case was in 1976. There have been no cases of vCJD transmission attributed to use of contaminated neurosurgical instruments. NICE should revisit this guidance urgently in view of these circumstances.

(Non-adiabatic) string creation on nice slices in Schwarzschild black holes

DOE PAGES

Puhm, Andrea; Rojas, Francisco; Ugajin, Tomonori

2017-04-27

Nice slices have played a pivotal role in the discussion of the black hole information paradox as they avoid regions of strong spacetime curvature and yet smoothly cut through the infalling matter and the outgoing Hawking radiation, thus, justifying the use of low energy field theory. To avoid information loss it has been argued recently, however, that local effective field theory has to break down at the horizon. To assess the extent of this breakdown in a UV complete framework we study string-theoretic effects on nice slices in Schwarzschild black holes. Here, our purpose is two-fold. First, we use nicemore » slices to address various open questions and caveats of [1] where it was argued that boost-enhanced non-adiabatic string-theoretic effects at the horizon could provide a dynamical mechanism for the firewall. Second, we identify two non-adiabatic effects on nice slices in Schwarzschild black holes: pair production of open strings near the horizon enhanced by the presence of the infinite tower of highly excited string states and a late-time non-adiabatic effect intrinsic to nice slices.« less

(Non-adiabatic) string creation on nice slices in Schwarzschild black holes

DOE Office of Scientific and Technical Information (OSTI.GOV)

Puhm, Andrea; Rojas, Francisco; Ugajin, Tomonori

Nice slices have played a pivotal role in the discussion of the black hole information paradox as they avoid regions of strong spacetime curvature and yet smoothly cut through the infalling matter and the outgoing Hawking radiation, thus, justifying the use of low energy field theory. To avoid information loss it has been argued recently, however, that local effective field theory has to break down at the horizon. To assess the extent of this breakdown in a UV complete framework we study string-theoretic effects on nice slices in Schwarzschild black holes. Here, our purpose is two-fold. First, we use nicemore » slices to address various open questions and caveats of [1] where it was argued that boost-enhanced non-adiabatic string-theoretic effects at the horizon could provide a dynamical mechanism for the firewall. Second, we identify two non-adiabatic effects on nice slices in Schwarzschild black holes: pair production of open strings near the horizon enhanced by the presence of the infinite tower of highly excited string states and a late-time non-adiabatic effect intrinsic to nice slices.« less

Nanoengineered Ionic-Covalent Entanglement (NICE) Bioinks for 3D Bioprinting.

PubMed

Chimene, David; Peak, Charles W; Gentry, James L; Carrow, James K; Cross, Lauren M; Mondragon, Eli; Cardoso, Guinea B; Kaunas, Roland; Gaharwar, Akhilesh K

2018-03-28

We introduce an enhanced nanoengineered ionic-covalent entanglement (NICE) bioink for the fabrication of mechanically stiff and elastomeric 3D biostructures. NICE bioink formulations combine nanocomposite and ionic-covalent entanglement (ICE) strengthening mechanisms to print customizable cell-laden constructs for tissue engineering with high structural fidelity and mechanical stiffness. Nanocomposite and ICE strengthening mechanisms complement each other through synergistic interactions, improving mechanical strength, elasticity, toughness, and flow properties beyond the sum of the effects of either reinforcement technique alone. Herschel-Bulkley flow behavior shields encapsulated cells from excessive shear stresses during extrusion. The encapsulated cells readily proliferate and maintain high cell viability over 120 days within the 3D-printed structure, which is vital for long-term tissue regeneration. A unique aspect of the NICE bioink is its ability to print much taller structures, with higher aspect ratios, than can be achieved with conventional bioinks without requiring secondary supports. We envision that NICE bioinks can be used to bioprint complex, large-scale, cell-laden constructs for tissue engineering with high structural fidelity and mechanical stiffness for applications in custom bioprinted scaffolds and tissue engineered implants.

Interim Guidelines Growing Longleaf Seedlings in Containers

Treesearch

James P. Barnett; Mark J. Hainds; George A. Hernandez

2002-01-01

These interim guidelines are designed for producers and users of longleaf pine container stock. They are not meant to exclude any container product. The seedling specifications listed in the preferred category are attainable by the grower and will result in excellent field sur vival and early height growth.

Tuberculin skin testing: Spectrum of adverse reactions.

PubMed

Praveen, Ramar; Bahuguna, Amit; Dhadwal, Bhumesh Singh

2015-01-01

Tuberculin skin testing (TST) is one of the primary diagnostic modalities recommended by the World Health Organization (WHO) and the National Institute for Health and Care Excellence (NICE) study conducted in the United Kingdom (UK) for diagnosing tuberculosis (TB). Even after acceptance as a diagnostic modality and stern standardization, TST has its own flaws that include a spectrum of adverse reactions. We report a series of cases with a spectrum of adverse reactions occurring with a higher frequency than present in the available evidence. The study has some demerits such as being a retrospective one with interobserver variation and lack of histopathological confirmation. The observation is presented to accentuate the fact that adverse reactions are not a rarity and that further studies are required to establish the cause and exact incidence of the same.

A comparative review of Haute Autorité de Santé and National Institute for Health and Care Excellence health technology assessments of Ikervis® to treat severe keratitis in adult patients with dry eye disease which has not improved despite treatment with tear substitutes.

PubMed

Eroglu, Yasmina Iffet

2017-01-01

Background: In 2015, Ikervis® became the only EMA-approved cyclosporine A (CsA) eye-drop for the treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes. Since the 1980s, CsA has been used empirically for ocular conditions in veterinary medicine then in humans. However, its extremely low aqueous solubility led to its administration in vegetable oils, which is characterized by low ocular availability, poor intraocular penetration, poor tolerability and short shelf-life. Concentrations from 0.05% to 2% are compounded on an industrial scale and reimbursed throughout Europe. In France, Ikervis® has been granted an ASMR score of 5 by HAS, whereas in UK NICE endorsed its use. Objective: To review the dry eye disease environment, its challenges and available treatment options, and compare the NICE and HAS assessments to question HAS' decision to maintain full reimbursement of compounded CsA formulations in the absence of evidence, while reimbursing the EMA-approved drug at 15%. extensive search on PubMED. Results: Comparator selection, composite score assessment and use of CE model are key differentiators. Conclusion: In topical formulations, improvements to the vehicle are key innovations that can bring significant benefits. After the USA, a Compounding Act is needed in Europe.

A comparative review of Haute Autorité de Santé and National Institute for Health and Care Excellence health technology assessments of Ikervis® to treat severe keratitis in adult patients with dry eye disease which has not improved despite treatment with tear substitutes

PubMed Central

Eroglu, Yasmina Iffet

2017-01-01

ABSTRACT Background: In 2015, Ikervis® became the only EMA-approved cyclosporine A (CsA) eye-drop for the treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes. Since the 1980s, CsA has been used empirically for ocular conditions in veterinary medicine then in humans. However, its extremely low aqueous solubility led to its administration in vegetable oils, which is characterized by low ocular availability, poor intraocular penetration, poor tolerability and short shelf-life. Concentrations from 0.05% to 2% are compounded on an industrial scale and reimbursed throughout Europe. In France, Ikervis® has been granted an ASMR score of 5 by HAS, whereas in UK NICE endorsed its use. Objective: To review the dry eye disease environment, its challenges and available treatment options, and compare the NICE and HAS assessments to question HAS’ decision to maintain full reimbursement of compounded CsA formulations in the absence of evidence, while reimbursing the EMA-approved drug at 15%. Method: extensive search on PubMED. Results: Comparator selection, composite score assessment and use of CE model are key differentiators. Conclusion: In topical formulations, improvements to the vehicle are key innovations that can bring significant benefits. After the USA, a Compounding Act is needed in Europe. PMID:28839524

NASA Innovations in Climate Education Connects Audiences Coast-to-Coast for Climate Literacy via the NASA Digital Learning Network

NASA Astrophysics Data System (ADS)

Murray, B.; Barnes, M. H.; Chambers, L. H.; Pippin, M. R.; Martin, A. M.; Geyer, A. J.; Leber, M.; Joyner, E.; Small, C.; Dublin, D.

2013-12-01

The Minority University Research and Education Program (MUREP) NASA Innovations in Climate Education (NICE) project advances NASA's Office of Education's strategic initiative to improve the quality of the nation's Science, Technology, Engineering and Mathematics (STEM) education and enhance literacy about climate and other Earth systems environmental changes. NICE also strategically supports the United States' progressive initiative to enhance the science and technology enterprise for successful competition in the 21st century global community. To extend to wider networks in 2013, MUREP NICE partnered with the NASA Digital Learning Network (DLNTM) in a unique, non-traditional collaborative model to significantly increase the impact and connection with formal and informal educators, curriculum developers, science education specialists, and researchers regarding climate literacy. DLN offers an expansive distance learning capability that bridges presenters with education audiences for interactive, web-based, synchronous and asynchronous Educator Professional Development (EPD). DLN services over 10,000 educators each year. In 3rd quarter FY13 alone DLN totaled 3,361 connections with educators. The DLN allows for cost effective (no travel) engagement of multiple geographically dispersed audiences with presenters from remote locations. This facilitates interactive communication among participants through distance education, allowing them to share local experiences with one another. A comprehensive four-part EPD workshop, featuring several NICE Principal Investigators (PI) and NASA subject matter experts was developed for NICE in April 2013. Topics covered in the workshop progressed from a simple introduction of Earth's energy budget, through explanation of temperature data collection and evidence of temperature rise, impacts on phenology, and finally consequences for bugs and birds. This event was an innovative hybrid workshop, connecting onsite teachers interactively with remotely connected participants and presenters across the nation. In addition to the 19 educators who participated live, 298 watched the sessions via a webcast. A similar workshop series experienced 300% growth in 2 years indicating the potential for comparable growth of NICE events. Due to unanimous requests for more information on these and other topics, beginning Fall 2013, NICE will reach into additional educators' classrooms via the DLN to deliver continued EPD from NICE PIs and other NASA researchers. With DLN capability, hundreds of additional unique viewers have been exposed to NICE via the DLN this year. This large-scale effort allows for long term, sustained engagement of the global community. We intend to take advantage of capabilities of the DLN as we continue to scale NICE events to wider audiences. The use of distance education allows for immediate release of new information and more frequent connections, resulting in sustained engagement of participants. This presentation will explore the various successes and future opportunities for expanding the impact of climate literacy via the NASA DLN, a large-scale collaborative network.

Ramucirumab for Treating Advanced Gastric Cancer or Gastro-Oesophageal Junction Adenocarcinoma Previously Treated with Chemotherapy: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

PubMed

Büyükkaramikli, Nasuh C; Blommestein, Hedwig M; Riemsma, Rob; Armstrong, Nigel; Clay, Fiona J; Ross, Janine; Worthy, Gill; Severens, Johan; Kleijnen, Jos; Al, Maiwenn J

2017-12-01

The National Institute for Health and Care Excellence (NICE) invited the company that manufactures ramucirumab (Cyramza ® , Eli Lilly and Company) to submit evidence of the clinical and cost effectiveness of the drug administered alone (monotherapy) or with paclitaxel (combination therapy) for treating adults with advanced gastric cancer or gastro-oesophageal junction (GC/GOJ) adenocarcinoma that were previously treated with chemotherapy, as part of the Institute's single technology appraisal (STA) process. Kleijnen Systematic Reviews Ltd (KSR), in collaboration with Erasmus University Rotterdam, was commissioned to act as the Evidence Review Group (ERG). This paper describes the company's submission, the ERG review, and NICE's subsequent decisions. Clinical effectiveness evidence for ramucirumab monotherapy (RAM), compared with best supportive care (BSC), was based on data from the REGARD trial. Clinical effectiveness evidence for ramucirumab combination therapy (RAM + PAC), compared with paclitaxel monotherapy (PAC), was based on data from the RAINBOW trial. In addition, the company undertook a network meta-analysis (NMA) to compare RAM + PAC with BSC and docetaxel. Cost-effectiveness evidence of monotherapy and combination therapy relied on partitioned survival, cost-utility models. The base-case incremental cost-effectiveness ratio (ICER) of the company was £188,640 (vs BSC) per quality-adjusted life-year (QALY) gained for monotherapy and £118,209 (vs BSC) per QALY gained for combination therapy. The ERG assessment indicated that the modelling structure represented the course of the disease; however, a few errors were identified and some of the input parameters were challenged. The ERG provided a new base case, with ICERs (vs BSC) of £188,100 (monotherapy) per QALY gained and £129,400 (combination therapy) per QALY gained and conducted additional exploratory analyses. The NICE Appraisal Committee (AC), considered the company's decision problem was in line with the NICE scope, with the exception of the choice of comparators for the combination therapy model. The most plausible ICER for ramucirumab monotherapy compared with BSC was £188,100 per QALY gained. The Committee considered that the ERG's exploratory analysis in which RAM + PAC was compared with PAC by using the direct head-to-head data (including utilities) from the RAINBOW trial, provided the most plausible ICER (i.e. £408,200 per QALY gained) for ramucirumab combination therapy. The Committee concluded that end-of-life considerations cannot be applied for either case, since neither failed to offer an extension to life of at least 3 months. The company did not submit a patient access scheme (PAS). After consideration of the evidence, the Committee concluded that ramucirumab alone or with paclitaxel could not be considered a cost-effective use of National Health Service resources for treating advanced GC/GOJ patients that were previously treated with chemotherapy, and therefore its use could not be recommended. We might wonder if a complete STA process is necessary for treatments without a PAS, which are, according to the company's submission, already associated with ICERs far above the currently accepted threshold in all (base-case, sensitivity and scenario) analyses.

[How it should be enabled network cooperation on healthcare services. Towards an HispaNICE?

PubMed

Abellán Perpiñán, José María; Martínez Pérez, Jorge Eduardo

2016-11-01

Although the Spanish Network of Health Technology Assessment was founded in 2012, it is true that its actual influence on the rationalization of the National Health System's healthcare basket is scarce. The main argument of this article is that the Spanish Network of HTA should work "as if" it was an HispaNICE. That is to say, transferring the NICE's advantages to Spanish context. Copyright © 2016. Publicado por Elsevier España, S.L.U.

Exploring perceptions of "wellness" in black ethnic minority individuals at risk of developing psychosis.

PubMed

Codjoe, Louisa; Byrne, Majella; Lister, Matthew; McGuire, Philip; Valmaggia, Lucia

2013-03-01

The NICE Schizophrenia guidelines (NICE, 2009, Update) recommend that services should address cultural differences in treatment, expectations and adherence, and clients' explanatory models of illness should be better understood. Service users from Black African and Black Caribbean communities are overrepresented in psychosis services in the UK, yet there is no literature on how wellness is understood by this group. This study explored perceptions of wellness in Black African and Black Caribbean individuals with an At Risk Mental State (ARMS) for psychosis. A Q set of potential meanings of wellness was identified from a literature search and interviews with people at risk of developing psychosis. From this, 50 potential definitions were identified; twenty Black African and Black Caribbean ARMS clients ranked these definitions. Following factor analysis of completed Q sorts, six factors emerged that offered insight into perceptions of wellness in this population. These factors included: sense of social purpose explanation, the surviving God's test explanation, the internalization of spirituality explanation, understanding and attribution of symptoms to witchcraft explanation, avoidance and adversity explanation, and seeking help to cope explanation. Although preliminary, differences between the factors suggests that there may be perceptions of wellness specific to these groups that are distinct from the medical view of wellness promoted within early detection services. These differences may potentially impact upon engagement, particularly factors that clients feel may facilitate or aide their recovery. It is suggested that these differences need to be considered as part of the assessment and formulation process.

Supporting the management of type 2 diabetes with pharmacist-led reviews: an observational analysis.

PubMed

Langran, Tim; Nanda, Nithya; Bataveljic, Attia; Gonzalez-Durio, Javier

2017-03-03

Describe and assess the impact of a pharmacist-led patient review programme on the management and control of type 2 diabetes (T2D). Uncontrolled prospective cohort study with before and after intervention data collection. General practices within NHS Slough Clinical Commissioning Group (CCG). 5910 patients with T2D. Pharmacists reviewed 5910 patients and worked with general practice teams to schedule any of the 9 key care processes recommended by the National Institute for Health and Care Excellence (NICE) that the patients were lacking, to optimise medication and to make other interventions such as providing lifestyle advice. The proportion of patients receiving the NICE-recommended 9 key care processes and proportion of patients whose glycated haemoglobin (HbA1c), blood pressure (BP) or total cholesterol (TC) readings were over target before and after the intervention period. The proportion of patients receiving all of the NICE-recommended 9 key care processes increased from 46% at project outset in April 2013 to 58% on completion in April 2014 and the percentage of patients achieving HbA1c, BP and TC targets all increased (65% to 70%, 70% to 76%, 78% to 82%, respectively). Quality Outcomes Framework (QOF) data for Slough CCG showed the percentage of diabetic patients achieving target HbA1c, BP and TC readings increased from April 2013 to April 2014, but then diminished in the year after project completion. The pharmacist-led review increased the number of key care processes administered and improved diabetic control during the year of programme delivery. The improvement abated during the year after, suggesting that such programmes should be ongoing rather than fixed term. The programme combined the strategic drive and project facilitation skills of Slough CCG, the general practice teams' knowledge of their patients and the clinical and information technology skills of an experienced pharmacist team. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Simulation of 1998-Big Flood in Changjiang River Catchment, China

NASA Astrophysics Data System (ADS)

Nakayama, T.; Watanabe, M.

2006-05-01

Almost every year, China is affected by severe flooding, which causes considerable economic loss and serious damage to towns and farms. Big floods are mainly concentrated in the middle and lower reaches of the "seven big rivers", which include the Changjiang (Yangtze) River, the Yellow (Huanghe) River, and the Huaihe River. The Changjiang River is the fourth largest water resource to the oceans after the Amazon, Zaire, and Orinoco Rivers. In addition to abnormal weather, artificial effects were considered as main causes of the big flood disaster in the Changjiang River catchment by the previous researches; (i) extreme deforestation and soil erosion in the upper reaches, (ii) shrinking of lake water volumes and their reduced connection with the Changjiang River due to reclamation of lakes that retarded water in the middle reaches, and (iii) restriction of channel capacity following levee construction. Because there is an urgent need to quantify these relations on the spatial scale of the whole catchment in order to prevent flood damage as small as possible, it is very important to evaluate the complicated phenomena of water/heat dynamics in the Changjiang River catchment by using process-based models. The present research focuses on simulating the water/heat dynamics for 1998 big-flood with 60-year recurrent period in the Changjiang River catchment. We compared the flood period of 1998 with the normal period of 1987-1988. We expanded the NIES Integrated Catchment-based Eco-hydrology (NICE) model (Nakayama and Watanabe, 2004; Nakayama et al., 2006) for the application to broader catchments in order to evaluate large- scale flooding in the Changjiang River (NICE-FLD). We simulated the water/heat dynamics in the entire catchment (3,000 km wide by 1,000 km long) with a resolution of 10 km mesh by using the NICE-FLD. The model reproduced excellently the river discharge, soil moisture, evapotranspiration, groundwater level, et al. Furthermore, we evaluated the role of flood storage capacity in the lakes and farms in relation to the water/heat budgets, and simulated the change of water/heat dynamics by human activity in order to help decision-making on sustainable development in the catchment.

Simulation of irrigation effect on water cycle in Yellow River catchment, China

NASA Astrophysics Data System (ADS)

Nakayama, T.; Watanabe, M.

2006-12-01

The Yellow River is 5,464 km long with a catchment area of 794,712 km2 if the Erdos inner flow area is included. This river catchment is divided between the upper region (length: 3472 km, area: 428,235 km2) from the headwater to Lanzhou in Gansu province, the middle region (length: 1,206 km, area: 343,751 km2) from Lanzhou to Huayuankou in Henan province, and the lower region (length: 786 km, area: 22,726 km2) from Huayuankou to the estuary. This river is well known for high sand content, frequent floods, unique channel characteristics in the lower reach (the river bed is higher than the land outside the banks), and the limited water resources. Since the competition of a large-scale irrigation project in 1969, noticeable river drying has been observed in the Yellow River. This flow dry-up phenomena, i.e., zero-flow in sections of the river channel, resulting from the intense competition between water supply and water demand, has occurred more and more often during the last 30 years. It is very important for decision making to ensure sustainable water resource utilization whether human activities were the only cause of the water shortage, the climate has changed during the last several decades in this catchment, and the water shortage has anything to do with climatic warming. The present research focuses on simulating the groundwater/river irrigation-effects on the water/heat dynamics in the Yellow River catchment. We combined the NIES Integrated Catchment-based Eco-hydrology (NICE) model (Nakayama and Watanabe, 2004, 2006; Nakayama et al., 2006) with the agricultural model in order to evaluate river drying in the Yellow River (NICE-DRY). We simulated the water/heat dynamics in the entire catchment with a resolution of 10 km mesh by using the NICE-DRY. The model reproduced excellently the river discharge, soil moisture, evapotranspiration, groundwater level, crop water use, crop productivity, et al. Furthermore, we evaluated the role of irrigation on the water/heat budgets, and simulated the change of water/heat dynamics by human activity in order to help decision-making on sustainable development in the catchment.

The Clinical and Cost Effectiveness of Apremilast for Treating Active Psoriatic Arthritis: A Critique of the Evidence.

PubMed

Sideris, Eleftherios; Corbett, Mark; Palmer, Stephen; Woolacott, Nerys; Bojke, Laura

2016-11-01

As part of the National Institute for Health and Clinical Excellence (NICE) single technology appraisal (STA) process, the manufacturer of apremilast was invited to submit evidence for its clinical and cost effectiveness for the treatment of active psoriatic arthritis (PsA) for whom disease-modifying anti-rheumatic drugs (DMARDs) have been inadequately effective, not tolerated or contraindicated. The Centre for Reviews and Dissemination and Centre for Health Economics at the University of York were commissioned to act as the independent Evidence Review Group (ERG). This paper provides a description of the ERG review of the company's submission, the ERG report and submission and summarises the NICE Appraisal Committee's subsequent guidance (December 2015). In the company's initial submission, the base-case analysis resulted in an incremental cost-effectiveness ratio (ICER) of £14,683 per quality-adjusted life-year (QALY) gained for the sequence including apremilast (positioned before tumour necrosis factor [TNF]-α inhibitors) versus a comparator sequence without apremilast. However, the ERG considered that the base-case sequence proposed by the company represented a limited set of potentially relevant treatment sequences and positions for apremilast. The company's base-case results were therefore not a sufficient basis to inform the most efficient use and position of apremilast. The exploratory ERG analyses indicated that apremilast is more effective (i.e. produces higher health gains) when positioned after TNF-α inhibitor therapies. Furthermore, assumptions made regarding a potential beneficial effect of apremilast on long-term Health Assessment Questionnaire (HAQ) progression, which cannot be substantiated, have a very significant impact on results. The NICE Appraisal Committee (AC), when taking into account their preferred assumptions for HAQ progression for patients on treatment with apremilast, placebo response and monitoring costs for apremilast, concluded that the addition of apremilast resulted in cost savings but also a QALY loss. These cost savings were not high enough to compensate for the clinical effectiveness that would be lost. The AC thus decided that apremilast alone or in combination with DMARD therapy is not recommended for treating adults with active PsA that has not responded to prior DMARD therapy, or where such therapy is not tolerated.

Renal function monitoring in heart failure - what is the optimal frequency? A narrative review.

PubMed

Al-Naher, Ahmed; Wright, David; Devonald, Mark Alexander John; Pirmohamed, Munir

2018-01-01

The second most common cause of hospitalization due to adverse drug reactions in the UK is renal dysfunction due to diuretics, particularly in patients with heart failure, where diuretic therapy is a mainstay of treatment regimens. Therefore, the optimal frequency for monitoring renal function in these patients is an important consideration for preventing renal failure and hospitalization. This review looks at the current evidence for optimal monitoring practices of renal function in patients with heart failure according to national and international guidelines on the management of heart failure (AHA/NICE/ESC/SIGN). Current guidance of renal function monitoring is in large part based on expert opinion, with a lack of clinical studies that have specifically evaluated the optimal frequency of renal function monitoring in patients with heart failure. Furthermore, there is variability between guidelines, and recommendations are typically nonspecific. Safer prescribing of diuretics in combination with other antiheart failure treatments requires better evidence for frequency of renal function monitoring. We suggest developing more personalized monitoring rather than from the current medication-based guidance. Such flexible clinical guidelines could be implemented using intelligent clinical decision support systems. Personalized renal function monitoring would be more effective in preventing renal decline, rather than reacting to it. © 2017 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

[SPRINT on clinical practice: It's time to change the management of arterial hypertension in Latin America?

PubMed

Galvez-Olortegui, José Kelvin; Condor-Rojas, Yudy; Galvez-Olortegui, Tomas Vladimir; Camacho-Saavedra, Luis

This paper analyzes the feasibility of the implementation of SPRINT trial results, the need to rethink the clinical practice guidelines(CPG) for the management of arterial hypertension and associated costs with daily practice applicability. SPRINT is a clinical trial comparing systolic blood pressure control <120mmHg and <140mmHg over cardiovascular complications, generating a great worldwide impact followed by publication of several studies that addressed relevance, usefulness, applicability and controversial aspects of SPRINT from different perspectives. Achieving blood pressure goals is one of the most discussed issue in widely used hypertension CPG around the world and in Latin American. SPRINT has generated and will generate a great impact on CPG, being necessary the reassessment of blood pressure goals and inclusion in future CPG, as has been considered in 2016 Canadian guideline and will be considered in NICE guideline update scheduled for June. The SPRINT trial raises new evidence for the management of hypertension, useful in people over 50 years, from urban populations, with defined cardiovascular risk without associated comorbidities. The applicability of SPRINT in Latin America is limited by increased costs associated with hypertensive patients' integrated health care, low care coverage, and lack of integrated care programs. Copyright © 2016 Instituto Nacional de Cardiología Ignacio Chávez. Publicado por Masson Doyma México S.A. All rights reserved.

Toward Improving Quality of End-of-Life Care: Encoding Clinical Guidelines and Standing Orders Using the Omaha System.

PubMed

Slipka, Allison F; Monsen, Karen A

2018-02-01

End-of-life care (EOLC) relieves the suffering of millions of people around the globe each year. A growing body of hospice care research has led to the creation of several evidence-based clinical guidelines for EOLC. As evidence for the effectiveness of timely EOLC swells, so does the increased need for efficient information exchange between disciplines and across the care continuum. The purpose of this study was to investigate the feasibility of using the Omaha System as a framework for encoding interoperable evidence-based EOL interventions with specified temporality for use across disciplines and settings. Four evidence-based clinical guidelines and one current set of hospice standing orders were encoded using the Omaha System Problem Classification Scheme and Intervention Scheme, as well as Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT). The resulting encoded guideline was entered on a Microsoft Excel spreadsheet and made available for public use on the Omaha System Guidelines website. The resulting EOLC guideline consisted of 153 interventions that may enable patients and their surrogates, clinicians, and ancillary providers to communicate interventions in a universally comprehensible way. Evidence-based interventions from diverse disciplines involved in EOLC are described within this guideline using the Omaha System. Because the Omaha System and clinical guidelines are maintained in the public domain, encoding interventions is achievable by anyone with access to the Internet and basic Excel skills. Using the guideline as a documentation template customized for unique patient needs, clinicians can quantify and track patient care across the care continuum to ensure timely evidence-based interventions. Clinical guidelines coded in the Omaha System can support the use of multidisciplinary evidence-based interventions to improve quality of EOLC across settings and professions. © 2017 Sigma Theta Tau International.

Developing clinical practice guidelines: reviewing, reporting, and publishing guidelines; updating guidelines; and the emerging issues of enhancing guideline implementability and accounting for comorbid conditions in guideline development

PubMed Central

2012-01-01

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this third paper we discuss the issues of: reviewing, reporting, and publishing guidelines; updating guidelines; and the two emerging issues of enhancing guideline implementability and how guideline developers should approach dealing with the issue of patients who will be the subject of guidelines having co-morbid conditions. PMID:22762242

Homework Policies and Guidelines. Turning the Tide: An Agenda for Excellence in Pennsylvania Public Schools.

ERIC Educational Resources Information Center

Pennsylvania State Dept. of Education, Harrisburg.

For homework to be effective, a clear, written policy should be developed that considers local needs, sound educational theories, and current research. This handbook is intended to assist school districts, particularly in Pennsylvania, in planning, developing, and implementing homework policies and guidelines. The booklet first briefly reviews the…

Noise-Immune Cavity-Enhanced Optical Frequency Comb Spectroscopy

NASA Astrophysics Data System (ADS)

Rutkowski, Lucile; Khodabakhsh, Amir; Johanssson, Alexandra C.; Foltynowicz, Aleksandra

2015-06-01

We present noise-immune cavity-enhanced optical frequency comb spectroscopy (NICE-OFCS), a recently developed technique for sensitive, broadband, and high resolution spectroscopy. In NICE-OFCS an optical frequency comb (OFC) is locked to a high finesse cavity and phase-modulated at a frequency precisely equal to (a multiple of) the cavity free spectral range. Since each comb line and sideband is transmitted through a separate cavity mode in exactly the same way, any residual frequency noise on the OFC relative to the cavity affects each component in an identical manner. The transmitted intensity contains a beat signal at the modulation frequency that is immune to frequency-to-amplitude noise conversion by the cavity, in a way similar to continuous wave noise-immune cavity-enhanced optical heterodyne molecular spectroscopy (NICE-OHMS). The light transmitted through the cavity is detected with a fast-scanning Fourier-transform spectrometer (FTS) and the NICE-OFCS signal is obtained by fast Fourier transform of the synchronously demodulated interferogram. Our NICE-OFCS system is based on an Er:fiber femtosecond laser locked to a cavity with a finesse of ˜9000 and a fast-scanning FTS equipped with a high-bandwidth commercial detector. We measured NICE-OFCS signals from the 3νb{1}+νb{3} overtone band of CO_2 around 1.57 μm and achieved absorption sensitivity 6.4×10-11cm-1 Hz-1/2 per spectral element, corresponding to a minimum detectable CO_2 concentration of 25 ppb after 330 s integration time. We will describe the principles of the technique and its technical implementation, and discuss the spectral lineshapes of the NICE-OFCS signals. A. Khodabakhsh, C. Abd Alrahman, and A. Foltynowicz, Opt. Lett. 39, 5034-5037 (2014). J. Ye, L. S. Ma, and J. L. Hall, J. Opt. Soc. Am. B 15, 6-15 (1998). A. Khodabakhsh, A. C. Johansson, and A. Foltynowicz, Appl. Phys. B (2015) doi:10.1007/s00340-015-6010-7.

Low-lying electronic states of Li 2+ and Li 2-

NASA Astrophysics Data System (ADS)

Konowalow, Daniel D.; Fish, James L.

1984-02-01

Potential curves for the eight lowest lying electronic states of Li2+ and the two lowest-lying states of Li2- are obtained by valence configuration calculations which-utilize an effective core potential. The calculated ionization potential of the ground state of Li2 is found to b. 5.16 eV and its electron affinity is 0.429 eV. Both values are in excellent agreement with recent experimental values and with value deduced from other high quality ab initio quantum mechanical treatments. When our potential curve for the Li2+(12Σg+ state, is corrected for the core-valence correlation error we obtain spectroscopic constants which agree nicely with the experimental values of Bernheim, Gold and Tipton (BGT). For example, we findDe = 10460 ± 140 cm-1 while BGT reportDe = 10469 ± 6 cm-1.

Applying fenton process in acrylic fiber wastewater treatment and practice teaching

NASA Astrophysics Data System (ADS)

Zhang, Chunhui; Jiang, Shan

2018-02-01

Acrylic fiber manufacturing wastewater, containing a wider range of pollutants, high concentration of refractory organics, poisonous and harmful matters, was significant to treat from the effluents of wastewater treatment plants (WWTPs). In this work, a Fenton reactor was employed for advanced treatment of the WWTP effluents. An orthogonal test and a parametric study were carried out to determine the effect of the main operating conditions and the Fenton process attain excellent performance on the degradation of pollutants under an optimal condition of ferrous dosage was 6.25 mM, hydrogen peroxide was 75 mM and initial pH value was 3.0 in 90 min reaction time. The removal efficiency of COD, TOC, NH4 +-N and TN reached from 45% to 69%. Lastly, as a teaching advice, the Fenton reactor was used in practicing teaching nicely.

Reviews

NASA Astrophysics Data System (ADS)

2006-11-01

WE RECOMMEND Critical mass Philip Ball explores the idea of the physics of society. Eurekas and Euphorias A humorous yet insightful collection of scientific anecdotes. Wind turbine Low-cost wind turbine produces excellent results. Science Center Nemo Hands-on science centre has some great displays for teenagers. Crocodile Physics There’s something for everyone in this lesson software package. Wireless Dynamics Sensor System A fun way to measure and record altitude and acceleration. WORTH A LOOK Climate Change Begins at Home This well researched book tackles the issue of saving our planet. The Little Doctor Datalogger Datalogger has lots of facilities but needs some manual processing. HANDLE WITH CARE The Physics of Basketball Only of interest to budding physicists obsessed with basketball. Virtual Physics This package offers nice simulations but not a lot else. WEB WATCH An eclectic mix of nuclear- and general-physics websites.

[Promoting recovery of schizophrenic patients: discrepancy between routine practice and evidence. The SIEP-DIRECT'S Project].

PubMed

Semisa, Domenico; Casacchia, Massimo; Di Munzio, Walter; Neri, Giovanni; Buscaglia, Giacinto; Burti, Lorenzo; Pucci, Cristina; Corlito, Giuseppe; Bacigalupi, Maurizio; Parravani, Roberto; Roncone, Rita; Cristofalo, Doriana; Lora, Antonio; Ruggeri, Mirella

2008-01-01

The aim of this work is to present the main discrepancies, as evidenced by the SIEP-DIRECT'S Project, between the evidence-based NICE guidelines for schizophrenia and the usual practices of the Italian mental health services in order to promote the recovery of patients with schizophrenia. Starting from the main NICE recommendations on recovery promotion, 41 indicators were developed. These were experimented in 19 participating Italian Mental Health Departments (MHD) or Psychiatric Services through self-evaluation of the activities carried out to promote patient recovery with the aim of assessing the level of adherence to the recommendations. The data required by most of the indicators were obtained from the psychiatric informative system or from the Direction of the MHD. Moreover, specific research was carried out on the clinical records and on representative patient samples. Furthermore, for 14 indicators, there was requested an assessment by the part of "multidisciplinary" or "specialistic" focus groups who then attributed a score according to a defined "ad hoc" scale. According to the data obtained, although the mental health services seem to care about the physical condition of their patients, they do not routinely examine principle parameters such as blood pressure, glycaemia etc., and collaboration with general practitioners is often complex or not uniformly practiced. Most psychiatrists and psychologists possess the basic communication skills but not enough competences in cognitive-behavioural treatments; such treatments, and every other form of structured individual psychotherapy, are seldom carried out and seem to have become marginal activities within the Services. Also family psycho-educational interventions are under-used. The Services are very active in the care of multi-problem schizophrenia patients, who make up a large percentage (almost a quarter, on average) of the patients in their care. These patients are offered specific and integrated treatment plans with the involvement of other health services and social agencies operating in the territory. The strategies adopted by the services for the pharmacological treatment in the prevention of relapses and for patients with frequent crises or with treatment-resistant schizophrenia are all in line with the NICE recommendations. Finally, the Services promote activities of vocational training and supported employment, but the outcomes of these are often unsatisfactory. The results of the study show a picture of the Italian mental health services with bright yet also dark areas as regards recovery promotion activities. The Services seem to guarantee adequate pharmacological evidence-based treatments, an integrated assistance and good management of multi-problem patients. They have difficulty, however, with respect to the monitoring of the physical health of the patients, psychotherapeutic activities, including those for families, and the promotion of supported employment. Moreover, they still show problems regarding the structuring and formalizing of care processes. To improve this situation, they should make greater use of professional guidelines, protocols and written procedures.

Peer teaching and information retrieval: the role of the NICE Evidence search student champion scheme in enhancing students' confidence.

PubMed

Sbaffi, Laura; Hallsworth, Elaine; Weist, Anne

2018-03-01

This research reports on the NICE Evidence search (ES) student champion scheme (SCS) first five years of activity (2011-2016) in terms of its impact on health care undergraduate students' information search skills and search confidence. A review of students' evaluation of the scheme was carried out to chart the changes in attitude towards NICE Evidence search as an online health care information source and to monitor students' approach to information seeking. This study is based on the results of questionnaires distributed to students before and after attending a training session on NICE Evidence search delivered by their own peers. The exercise was implemented in health related universities in England over a period of five consecutive academic years. (i) Students' search confidence improved considerably after the training; (ii) ES was perceived as being an increasingly useful resource of evidence based information for their studies; (iii) the training helped students develop discerning search skills and use evidence based information sources more consistently and critically. The NICE SCS improves confidence in approaching information tasks amongst health care undergraduate students. Future developments could involve offering the training at the onset of a course of study and adopting online delivery formats to expand its geographical reach. © 2018 Health Libraries Group.

Modeling and performance analysis using extended fuzzy-timing Petri nets for networked virtual environments.

PubMed

Zhou, Y; Murata, T; Defanti, T A

2000-01-01

Despite their attractive properties, networked virtual environments (net-VEs) are notoriously difficult to design, implement, and test due to the concurrency, real-time and networking features in these systems. Net-VEs demand high quality-of-service (QoS) requirements on the network to maintain natural and real-time interactions among users. The current practice for net-VE design is basically trial and error, empirical, and totally lacks formal methods. This paper proposes to apply a Petri net formal modeling technique to a net-VE-NICE (narrative immersive constructionist/collaborative environment), predict the net-VE performance based on simulation, and improve the net-VE performance. NICE is essentially a network of collaborative virtual reality systems called the CAVE-(CAVE automatic virtual environment). First, we introduce extended fuzzy-timing Petri net (EFTN) modeling and analysis techniques. Then, we present EFTN models of the CAVE, NICE, and transport layer protocol used in NICE: transmission control protocol (TCP). We show the possibility analysis based on the EFTN model for the CAVE. Then, by using these models and design/CPN as the simulation tool, we conducted various simulations to study real-time behavior, network effects and performance (latencies and jitters) of NICE. Our simulation results are consistent with experimental data.

The Cost Effectiveness of Lubiprostone in Chronic Idiopathic Constipation.

PubMed

Pennington, Becky; Marriott, Emily-Ruth; Lichtlen, Peter; Akbar, Ayesha; Hatswell, Anthony J

2018-01-04

The objective of this study was to evaluate the cost effectiveness of lubiprostone, prucalopride, placebo and immediate referral to secondary care in chronic idiopathic constipation (CIC) in an economic model that was used by the UK National Institute for Health and Care Excellence (NICE) in developing guidance. We developed a cohort state-transition model to reflect the treatment pathway in CIC from the UK NHS and personal social services perspective. Time on treatment was determined by a treatment continuation rule using data from an indirect comparison and survival curves fitted to long-term data. Quality of life was defined by whether CIC was resolved or unresolved, using published values. Costs were determined by drug acquisition costs, invasive procedures and healthcare resource use (associated with resolved or unresolved CIC), using published UK sources. Deterministic and probabilistic sensitivity analyses were conducted. Over a 10-year time horizon, lubiprostone was more costly and more effective than placebo and immediate referral to secondary care, with incremental cost-effectiveness ratios (ICERs) of £58,979 and £21,152. Lubiprostone dominated prucalopride in the base case and with a time horizon of 1 year. The main sensitivity for the comparison against placebo was the assumptions around placebo cost and efficacy. The main sensitivity for the comparison against prucalopride was the endpoint used in the indirect comparison. Lubiprostone may be cost effective compared with prucalopride or immediate referral but not compared with placebo in the base case. The implementation of the guidance issued by NICE should increase quality of life for patients with CIC and provide a further treatment option.

Economic Modeling Considerations for Rare Diseases.

PubMed

Pearson, Isobel; Rothwell, Ben; Olaye, Andrew; Knight, Christopher

2018-05-01

To identify challenges that affect the feasibility and rigor of economic models in rare diseases and strategies that manufacturers have employed in health technology assessment submissions to demonstrate the value of new orphan products that have limited study data. Targeted reviews of PubMed, the National Institute for Health and Care Excellence's (NICE's) Highly Specialised Technologies (HST), and the Scottish Medicines Consortium's (SMC's) ultra-orphan submissions were performed. A total of 19 PubMed studies, 3 published NICE HSTs, and 11 ultra-orphan SMC submissions were eligible for inclusion. In rare diseases, a number of different factors may affect the model's ability to comply with good practice recommendations. Many products for the treatment of rare diseases have an incomplete efficacy and safety profile at product launch. In addition, there is often limited available natural history and epidemiology data. Information on the direct and indirect cost burden of an orphan disease also may be limited, making it difficult to estimate the potential economic benefit of treatment. These challenges can prevent accurate estimation of a new product's benefits in relation to costs. Approaches that can address such challenges include using patient and/or clinician feedback to inform model assumptions; data from disease analogues; epidemiological techniques, such as matching-adjusted indirect comparison; and long-term data collection. Modeling in rare diseases is often challenging; however, a number of approaches are available to support the development of model structures and the collation of input parameters and to manage uncertainty. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Bivalirudin for the treatment of ST-segment elevation myocardial infarction: a NICE single technology appraisal.

PubMed

Simpson, E L; Fitzgerald, P; Evans, P; Tappenden, P; Kalita, N; Reckless, J P D; Bakhai, A

2013-04-01

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer (The Medicines Company) of bivalirudin to submit evidence for its clinical and cost effectiveness within its licensed indication for the treatment of adults with ST-segment elevation myocardial infarction (STEMI) intended for primary percutaneous coronary intervention (PPCI), as part of NICE's single technology appraisal (STA) process. The School of Health and Related Research (ScHARR) at the University of Sheffield was commissioned to act as the Evidence Review Group (ERG), which produced a review of the evidence within the manufacturer's submission to NICE. This article describes the manufacturer's submission, the ERG review and NICE's subsequent decisions. The main evidence was derived from one randomized controlled trial (RCT) of STEMI patients intended for PPCI, comparing bivalirudin with unfractionated heparin plus glycoprotein IIb/IIIa inhibitors (GPIs). Bivalirudin was associated with a significant reduction in cardiac mortality at 30 days (p = 0.03) and at 1-year follow-up (p = 0.005), and a significant reduction in major bleeding at 30 days (p < 0.001) and 1 year (p < 0.0001), compared with heparin plus GPI. Stent thrombosis up to 24 hours following PPCI was significantly (p < 0.001) more common with bivalirudin. However, there was no significant treatment effect for stent thrombosis from 1 to 30 days (p = 0.28), or at 1-year follow-up (p = 0.53). There were no significant treatment group differences at 30 days and at 1 year in stroke (p = 0.68 and p = 0.99, respectively), in myocardial infarction [MI] (p = 0.90 and p = 0.22, respectively), or in the need for the revascularization of the target vessel for ischaemia (p = 0.18 and p = 0.12, respectively). There were two decision-analytic models: the base-case scenario used 1-year follow-up data from the RCT; and a sensitivity analysis used 3-year follow-up data. Resource use was primarily drawn from this RCT. Health-related quality-of-life (HR-QOL) estimates were drawn from a UK cohort study. Both models evaluated the incremental costs and outcomes of bivalirudin compared with heparin plus GPI for patients with STEMI intended for PPCI. The analysis adopted a UK NHS perspective over a lifetime horizon. Unit costs were based on year 2009-2010 prices. The model adopted a decision-tree structure to reflect initial events for the initial period (stroke, repeat MI, minor/major bleeding events, repeat revascularization and death) and a two-state Markov component to simulate longer-term survival. The economic analysis suggested that bivalirudin is expected to dominate the heparin plus GPI strategy. This finding was consistent across the probabilistic sensitivity analysis and the vast majority of deterministic sensitivity analyses undertaken. Three exceptions to this finding were observed for the following sensitivity analyses: (1) the exclusive use of eptifibatide as the GPI (incremental cost-effectiveness ratio [ICER] = £1,764); (2) the combination of 100 % eptifibatide use, 100 % radial arterial access and no differential length between strategies for initial hospital stay (ICER = £4,106); and (3) a longer length of ward stay (increase of 0.33 days) for the initial hospitalization (ICER = £415). The Appraisal Committee (AC) gave a positive recommendation for bivalirudin for the treatment of adults with STEMI undergoing PPCI.

Dabigatran for the prevention of stroke and systemic embolism in atrial fibrillation: A NICE single technology appraisal.

PubMed

Faria, Rita; Spackman, Eldon; Burch, Jane; Corbacho, Belen; Todd, Derick; Pepper, Chris; Woolacott, Nerys; Palmer, Stephen

2013-07-01

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of dabigatran etexilate (Boehringer Ingelheim Ltd, UK) to submit evidence for the clinical and cost-effectiveness of this drug for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) as part of the NICE single technology appraisal process. The Centre for Reviews and Dissemination and the Centre for Health Economics at the University of York were commissioned to act as the evidence review group (ERG). This article presents a summary of the manufacturer's submission, the ERG report and the subsequent development of NICE guidance for the use of dabigatran within the UK National Health Service. Dabigatran was granted marketing authorisation by the European Medicines Agency for a sequential dosing regimen (DBG sequential), in which patients under 80 years are treated with dabigatran 150 mg twice daily (DBG150) and patients 80 years and over are given dabigatran 110 mg twice daily (DBG110). NICE decisions are bound by the marketing authorisation; therefore, the decision problem faced by the committee was whether the DBG sequential regimen was effective and cost-effective compared with warfarin or aspirin for patients with non-valvular AF and one or more risk factors. The RE-LY trial, a large multi-centre non-inferiority randomised clinical trial, was the primary source of clinical evidence. DBG150 was shown to be non-inferior, and subsequently superior to warfarin, for the primary outcome of all stroke/systemic embolism. DBG110 was found to be non-inferior to warfarin. Results were presented for a post hoc subgroup analysis for patients under and over 80 years of age, where DBG110 showed a statistically significant reduction of haemorrhagic stroke and intracranial haemorrhage in comparison to warfarin in patients over 80 years of age. This post hoc subgroup analysis by age was the basis for the licensed DBG sequential regimen. The economic evaluation compared the costs and outcomes of DBG110, DBG150 and DBG sequential against warfarin, aspirin, and aspirin plus clopidogrel. Across the three dosing regimens, dabigatran was associated with greater costs and better health outcomes than warfarin; however, DBG150 offered the most benefits and dominated DBG110 and DBG sequential (i.e. less costly and more effective). The cost-effectiveness of DBG150 was less favourable for patients well controlled on warfarin. In the first appraisal meeting, the committee issued a 'minded no' decision until additional analyses on the licensed DBG sequential regimen were presented by the manufacturer. These additional analyses indicated that the incremental cost-effectiveness ratio (ICER) of the DBG sequential regimen compared with warfarin ranged from £8,388 to £18,987 per quality-adjusted life year (QALY) gained depending on the level of monitoring costs assumed for warfarin. Patients on warfarin would need to be within therapeutic range 83-85 % of the time for the ICER to exceed £30,000 per additional QALY. Following consideration of the additional evidence and the responses from a large number of consultees and commentators, the committee recommended dabigatran as DBG sequential as an option for the prevention of stroke and systemic embolism in people with non-valvular AF with one or more risk factors for ischaemic stroke.

Talimogene Laherparepvec for Treating Metastatic Melanoma: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

PubMed

Fleeman, Nigel; Bagust, Adrian; Boland, Angela; Beale, Sophie; Richardson, Marty; Krishan, Ashma; Stainthorpe, Angela; Abdulla, Ahmed; Kotas, Eleanor; Banks, Lindsay; Payne, Miranda

2017-10-01

The National Institute for Health and Care Excellence (NICE) invited the manufacturer (Amgen) of talimogene laherparepvec (T-VEC) to submit clinical and cost-effectiveness evidence for previously untreated advanced (unresectable or metastatic) melanoma as part of the Institute's Single Technology Appraisal process. The Liverpool Reviews and Implementation Group (LRiG) at the University of Liverpool was commissioned to act as the Evidence Review Group (ERG). This article presents a summary of the company's submission of T-VEC, the ERG review and the resulting NICE guidance (TA410), issued in September 2016. T-VEC is an oncolytic virus therapy granted a marketing authorisation by the European Commission for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. Clinical evidence for T-VEC versus granulocyte-macrophage colony-stimulating factor (GM-CSF) was derived from the multinational, open-label randomised controlled OPTiM trial [Oncovex (GM-CSF) Pivotal Trial in Melanoma]. In accordance with T-VEC's marketing authorisation, the company's submission focused primarily on 249 patients with stage IIIB to stage IV/M1a disease who constituted 57% of the overall trial population (T-VEC, n = 163 and GM-CSF, n = 86). Results from analyses of durable response rate, objective response rate, time to treatment failure and overall survival all showed marked and statistically significant improvements for patients treated with T-VEC compared with those treated with GM-CSF. However, GM-CSF is not used to treat melanoma in clinical practice. It was not possible to compare treatment with T-VEC with an appropriate comparator using conventionally accepted methods due to the absence of comparative head-to-head data or trials with sufficient common comparators. Therefore, the company compared T-VEC with ipilimumab using what it described as modified Korn and two-step Korn methods. Results from these analyses suggested that treatment with T-VEC was at least as effective as treatment with ipilimumab. Using the discounted patient access scheme (PAS) price for T-VEC and list price for ipilimumab, the company reported incremental cost-effectiveness ratios (ICERs) per quality-adjusted life-year (QALY) gained. For the comparison of treatment with T-VEC versus ipilimumab, the ICER per QALY gained was -£16,367 using the modified Korn method and -£60,271 using the two-step Korn method. The NICE Appraisal Committee (AC) agreed with the ERG that the company's methods for estimating clinical effectiveness of T-VEC versus ipilimumab were flawed and therefore produced unreliable results for modelling progression in stage IIIB to stage IVM1a melanoma. The AC concluded that the clinical and cost effectiveness of treatment with T-VEC compared with ipilimumab is unknown in patients with stage IIIB to stage IV/M1a disease. However, the AC considered that T-VEC may be a reasonable option for treating patients who are unsuitable for treatment with systemically administered immunotherapies (such as ipilimumab). T-VEC was therefore recommended by NICE as a treatment option for adults with unresectable, regionally or distantly metastatic (stage IIIB to stage IVM1a) melanoma that has not spread to bone, brain, lung or other internal organs, only if treatment with systemically administered immunotherapies is not suitable and the company provides T-VEC at the agreed discounted PAS price.

Ipilimumab for Previously Untreated Unresectable Malignant Melanoma: A Critique of the Evidence.

PubMed

Giannopoulou, Christina; Sideris, Eleftherios; Wade, Ros; Moe-Byrne, Thirimon; Eastwood, Alison; McKenna, Claire

2015-12-01

The National Institute for Health and Care Excellence (NICE) invited the manufacturer of ipilimumab (Bristol-Myers Squibb Pharmaceuticals Limited) to submit clinical and cost-effectiveness evidence for previously untreated advanced (unresectable or metastatic) melanoma as part of the Institute's Single Technology Appraisal process. The Centre for Reviews and Dissemination and Centre for Health Economics at the University of York were commissioned to act as the independent Evidence Review Group (ERG). This article presents a summary of the manufacturer's submission of ipilimumab, the ERG review and the resulting NICE guidance TA319, issued in July 2014. Ipilimumab at a recommended dose of 3 mg/kg monotherapy was previously granted marketing authorisation by the European Medicines Agency in adult patients who had received prior therapy and was recommended by NICE in guidance TA268. In October 2013, the EMA approved the extension of this indication to previously untreated advanced melanoma patients. NICE decisions are bound by the marketing authorisation; therefore, the decision problem faced by the NICE Appraisal Committee was whether ipilimumab at a recommended dose of 3 mg/kg monotherapy was effective and cost effective compared with first-line standard of care involving dacarbazine (DTIC) and vemurafenib (for BRAF V600 mutation-positive patients). The CA184-024 trial was the primary source of clinical evidence for ipilimumab. However, this was based on a dose of 10 mg/kg with concomitant DTIC. The results over a 5-year period indicated that ipilimumab 10 mg/kg plus DTIC demonstrated a significant increase in median overall survival (OS) of 2.1 months compared with DTIC plus placebo (11.2 vs. 9.1 months). The BRIM-3 trial, which was an open-label randomised controlled trial (RCT) in BRAF V600 mutation-positive patients, was the primary source of evidence for an indirect comparison with vemurafenib. The results showed that vemurafenib increased median OS by 3.6 months compared with DTIC (13.2 vs. 9.6 months). The economic evaluation compared the costs and outcomes of ipilimumab by assuming that the 3 mg/kg dosing regimen was clinically equivalent in efficacy to an ipilimumab 10 mg/kg dosing regimen plus DTIC and by using a treatment sequencing approach that incorporated second-line active therapy and third-line best supportive care (BSC). In the first appraisal meeting, the committee recommended ipilimumab only in the context of research as part of a clinical study. This was primarily based on the lack of robust evidence to support the assumption of clinical equivalence between dosages and the absence of evidence available to inform the sequential use of treatments. Following the consultation, the manufacturer submitted additional analyses and evidence to support the cost effectiveness of ipilimumab at first line. The manufacturer's response was based on concerns relating to uncertainty surrounding the relative efficacy of ipilimumab 3 mg/kg monotherapy compared with DTIC and vemurafenib, comparability of the patient populations at first and second line, and the effects of concomitant DTIC. These additional analyses indicated that the incremental cost-effectiveness ratio (ICER) was £ 47,900 per quality-adjusted life-year (QALY) gained for ipilimumab compared with DTIC and £ 28,600 per QALY gained for ipilimumab compared with vemurafenib. Following consideration of the additional evidence and the responses from a large number of consultees and commentators, the committee recommended ipilimumab as an option for adults with previously untreated advanced melanoma.

Newer agents for blood glucose control in type 2 diabetes: systematic review and economic evaluation.

PubMed

Waugh, N; Cummins, E; Royle, P; Clar, C; Marien, M; Richter, B; Philip, S

2010-07-01

In May 2008, the National Institute for Health and Clinical Excellence (NICE) issued an updated guideline [clinical guideline (CG) 66] for the management of all aspects of type 2 diabetes. This report aims to provide information on new drug developments to support a 'new drugs update' to the 2008 guideline. To review the newer agents available for blood glucose control in type 2 diabetes from four classes: the glucagon-like peptide-1 (GLP-1) analogue exenatide; dipeptidyl peptidase-4 (DPP-4) inhibitors sitagliptin and vildagliptin; the long-acting insulin analogues, glargine and detemir; and to review concerns about the safety of the thiazolidinediones. The following databases were searched: MEDLINE (1990-April 2008), EMBASE (1990-April 2008), the Cochrane Library (all sections) Issue 2, 2008, and the Science Citation Index and ISI Proceedings (2000-April 2008). The websites of the American Diabetes Association, the European Association for the Study of Diabetes, the US Food and Drug Administration, the European Medicines Evaluation Agency and the Medicines and Healthcare Products Regulatory Agency were searched, as were manufacturers' websites. Data extraction was carried out by one person, and checked by a second. Studies were assessed for quality using standard methods for reviews of trials. Meta-analyses were carried out using the Cochrane Review Manager (RevMan) software. Inclusion and exclusion criteria were based on current standard clinical practice in the UK, as outlined in NICE CG 66. The outcomes for the GLP-1 analogues, DPP-4 inhibitors and the long-acting insulin analogues were: glycaemic control, reflected by glycated haemoglobin (HbA1c) level, hypoglycaemic episodes, changes in weight, adverse events, quality of life and costs. Modelling of the cost-effectiveness of the various regimes used the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model. Exenatide improved glycaemic control by around 1%, and had the added benefit of weight loss. The gliptins were effective in improving glycaemic control, reducing HbA1c level by about 0.8%. Glargine and detemir were equivalent to Neutral Protamine Hagedorn (NPH) (and to each other) in terms of glycaemic control but had modest advantages in terms of hypoglycaemia, especially nocturnal. Detemir, used only once daily, appeared to cause slightly less weight gain than glargine. The glitazones appeared to have similar effectiveness in controlling hyperglycaemia. Both can cause heart failure and fractures, but rosiglitazone appears to slightly increase the risk of cardiovascular events whereas pioglitazone reduces it. Eight trials examined the benefits of adding pioglitazone to an insulin regimen; in our meta-analysis, the mean reduction in HbA1c level was 0.54% [95% confidence interval (CI) -0.70 to -0.38] and hypoglycaemia was marginally more frequent in the pioglitazone arms [relative risk (RR) 1.27, 95% CI 0.99 to 1.63]. In most studies, those on pioglitazone gained more weight than those who were not. In terms of annual drug acquisition costs among the non-insulin regimes for a representative patient with a body mass index of around 30 kg/m2, the gliptins were the cheapest of the new drugs, with costs of between 386 pounds and 460 pounds. The glitazone costs were similar, with total annual costs for pioglitazone and for rosiglitazone of around 437 pounds and 482 pounds, respectively. Exenatide was more expensive, with an annual cost of around 830 pounds. Regimens containing insulin fell between the gliptins and exenatide in terms of their direct costs, with a NPH-based regimen having an annual cost of around 468 pounds for the representative patient, whereas the glargine and detemir regimens were more expensive, at around 634 pounds and 716 pounds, respectively. Comparisons of sitagliptin and rosiglitazone, and of vidagliptin and pioglitazone slowed clinical equivalence in terms of quality-adjusted life-years (QALYs), but the gliptins were marginally less costly. Exenatide, when compared with glargine, appeared to be cost-effective. Comparing glargine with NPH showed an additional anticipated cost of around 1800 pounds. Within the comparison of detemir and NPH, the overall treatment costs for detemir were slightly higher, at between 2700 pounds and 2600 pounds. The UKPDS Outcomes Model does not directly address aspects of the treatments under consideration, for example the direct utility effects from weight loss or weight gain, severe hypoglycaemic events and the fear of severe hypoglycaemic events. Also, small differences in QALYs among the drugs lead to fluctuations in incremental cost-effectiveness ratios. Exenatide, the gliptins and detemir were all clinically effective. The long-acting insulin analogues glargine and detemir appeared to have only slight clinical advantages over NPH, but had much higher costs and did not appear to be cost-effective as first-line insulins for type 2 diabetes. Neither did exenatide appear to be cost-effective compared with NPH but, when used as third drug after failure of dual oral combination therapy, exenatide appeared cost-effective relative to glargine in this analysis. The gliptins are similar to the glitazones in glycaemic control and costs, and appeared to have fewer long-term side effects. Therefore, it appears, as supported by recent NICE guidelines, that NPH should be the preferred first-line insulin for the treatment of type 2 diabetes. More economic analysis is required to establish when it becomes cost-effective to switch from NPH to a long-acting analogue. Also, long-term follow-up studies of exenatide and the gliptins, and data on combined insulin and exenatide treatment, would be useful.

Here Comes the Bride... and Her Teeth Are Nice and Bright

MedlinePlus

FOR THE DENTAL PATIENT ... Here comes the bride … … and her teeth are nice and bright! P lanning a wedding? There will ... SMILE Professional cleaning. A professional cleaning in a dental office before your wedding can help remove stains ...

Vertical thermodynamic structure of the troposphere during the Norwegian young sea ICE expedition (N-ICE2015)

NASA Astrophysics Data System (ADS)

Kayser, Markus; Maturilli, Marion; Graham, Robert M.; Hudson, Stephen R.; Rinke, Annette; Cohen, Lana; Kim, Joo-Hong; Park, Sang-Jong; Moon, Woosok; Granskog, Mats A.

2017-10-01

The Norwegian young sea ICE (N-ICE2015) expedition was designed to investigate the atmosphere-snow-ice-ocean interactions in the young and thin sea ice regime north of Svalbard. Radiosondes were launched twice daily during the expedition from January to June 2015. Here we use these upper air measurements to study the multiple cyclonic events observed during N-ICE2015 with respect to changes in the vertical thermodynamic structure, moisture content, and boundary layer characteristics. We provide statistics of temperature inversion characteristics, static stability, and boundary layer extent. During winter, when radiative cooling is most effective, we find the strongest impact of synoptic cyclones. Changes to thermodynamic characteristics of the boundary layer are associated with transitions between the radiatively "clear" and "opaque" atmospheric states. In spring, radiative fluxes warm the surface leading to lifted temperature inversions and a statically unstable boundary layer. Further, we compare the N-ICE2015 static stability distributions to corresponding profiles from ERA-Interim reanalysis, from the closest land station in the Arctic North Atlantic sector, Ny-Ålesund, and to soundings from the SHEBA expedition (1997/1998). We find similar stability characteristics for N-ICE2015 and SHEBA throughout the troposphere, despite differences in location, sea ice thickness, and snow cover. For Ny-Ålesund, we observe similar characteristics above 1000 m, while the topography and ice-free fjord surrounding Ny-Ålesund generate great differences below. The long-term radiosonde record (1993-2014) from Ny-Ålesund indicates that during the N-ICE2015 spring period, temperatures were close to the climatological mean, while the lowest 3000 m were 1-3°C warmer than the climatology during winter.

A Successful Senior Seminar: Unsolved Problems in Number Theory

ERIC Educational Resources Information Center

Styer, Robert

2014-01-01

The "Unsolved Problems in Number Theory" book by Richard Guy provides nice problems suitable for a typical math major. We give examples of problems that have worked well in our senior seminar course and some nice results that senior math majors can obtain.

Secondary Science Teachers as Curriculum Makers: Mapping and Designing Scotland's New Curriculum for Excellence

ERIC Educational Resources Information Center

Wallace, Carolyn S.; Priestley, Mark R.

2017-01-01

Scotland is one of several countries to have recently implemented a new national curriculum to highlight 21st century educational priorities. Teachers have been mandated to follow the new curriculum guidelines, known as Curriculum for Excellence (CfE), since the fall of 2010. The purpose of this study was to use a phenomenological lens to…

Medical Malpractice Implications of Clinical Practice Guidelines.

PubMed

Ruhl, Douglas S; Siegal, Gil

2017-08-01

Clinical practice guidelines aim to improve medical care by clarifying and making useful recommendations to providers. Although providers should account for patients' unique characteristics when determining a treatment plan, it is generally perceived as good practice to follow guidelines when applicable. This is of interest in malpractice litigation, where it is essential to establish a standard of care to evaluate the performances of providers. Although the opinions of expert witnesses are used to determine standards of care, guidelines are expected to play a leading role. Guidelines alone should not establish a legal standard but may help inform this discussion in the courtroom. Therefore, it is incumbent that excellent, practical, and timely guidelines are continually created and updated in a transparent way. These guidelines must be very clear and underscore the various strengths of recommendation based on the quality of available evidence.

Bringing Global Climate Change Education to Alabama Middle School and High School Classrooms

NASA Astrophysics Data System (ADS)

Lee, M.; Mitra, C.; Percival, E.; Thomas, A.; Lucy, T.; Hickman, E.; Cox, J.; Chaudhury, S. R.; Rodger, C.

2013-12-01

A NASA-funded Innovations in Climate Education (NICE) Program has been launched in Alabama to improve high school and middle school education in climate change science. The overarching goal is to generate a better informed public that understands the consequences of climate change and can contribute to sound decision making on related issues. Inquiry based NICE modules have been incorporated into the existing course of study for 9-12 grade biology, chemistry, and physics classes. In addition, new modules in three major content areas (earth and space science, physical science, and biological science) have been introduced to selected 6-8 grade science teachers in the summer of 2013. The NICE modules employ five E's of the learning cycle: Engage, Explore, Explain, Extend and Evaluate. Modules learning activities include field data collection, laboratory measurements, and data visualization and interpretation. Teachers are trained in the use of these modules for their classroom through unique partnership with Alabama Science in Motion (ASIM) and the Alabama Math Science Technology Initiative (AMSTI). Certified AMSTI teachers attend summer professional development workshops taught by ASIM and AMSTI specialists to learn to use NICE modules. During the school year, the specialists in turn deliver the needed equipment to conduct NICE classroom exercises and serve as an in-classroom resource for teachers and their students. Scientists are partnered with learning and teaching specialists and lead teachers to implement and test efficacy of instructional materials, models, and NASA data used in classroom. The assessment by professional evaluators after the development of the modules and the training of teachers indicates that the modules are complete, clear, and user-friendly. The overall teacher satisfaction from the teacher training was 4.88/5.00. After completing the module teacher training, the teachers reported a strong agreement that the content developed in the NICE modules should be included in the Alabama secondary curriculum. Eventually, the NICE program has the potential to reach over 200,000 students when the modules are fully implemented in every school in the state of Alabama. The project can give these students access to expertise and equipment, thereby strengthening the connections between the universities, state education administrators, and the community.

Screen Study Guides.

ERIC Educational Resources Information Center

Duncan, Barry

1969-01-01

This study guide for Arthur Lipsett's film "Very Nice, Very Nice" is in four parts. First, it describes and evaluates the film, discusses Lipsett's unusual juxtapositions, fast cutting, and fragmented speeches as indications of his satirical intent, and suggests that the only meaningful summation of the film's content is through pattern…

Noise-immune cavity-enhanced analytical atomic spectrometry - NICE-AAS - A technique for detection of elements down to zeptogram amounts

NASA Astrophysics Data System (ADS)

Axner, Ove; Ehlers, Patrick; Hausmaninger, Thomas; Silander, Isak; Ma, Weiguang

2014-10-01

Noise-immune cavity-enhanced optical heterodyne molecular spectroscopy (NICE-OHMS) is a powerful technique for detection of molecular compounds in gas phase that is based on a combination of two important concepts: frequency modulation spectroscopy (FMS) for reduction of noise, and cavity enhancement, for prolongation of the interaction length between the light and the sample. Due to its unique properties, it has demonstrated unparalleled detection sensitivity when it comes to detection of molecular constituents in the gas phase. However, despite these, it has so far not been used for detection of atoms, i.e. for elemental analysis. The present work presents an assessment of the expected performance of Doppler-broadened (Db) NICE-OHMS for analytical atomic spectrometry, then referred to as noise-immune cavity-enhanced analytical atomic spectrometry (NICE-AAS). After a description of the basic principles of Db-NICE-OHMS, the modulation and detection conditions for optimum performance are identified. Based on a previous demonstrated detection sensitivity of Db-NICE-OHMS of 5 × 10- 12 cm- 1 Hz- 1/2 (corresponding to a single-pass absorbance of 7 × 10- 11 over 10 s), the expected limits of detection (LODs) of Hg and Na by NICE-AAS are estimated. Hg is assumed to be detected in gas phase directly while Na is considered to be atomized in a graphite furnace (GF) prior to detection. It is shown that in the absence of spectral interferences, contaminated sample compartments, and optical saturation, it should be feasible to detect Hg down to 10 zg/cm3 (10 fg/m3 or 10- 5 ng/m3), which corresponds to 25 atoms/cm3, and Na down to 0.5 zg (zg = zeptogram = 10- 21 g), representing 50 zg/mL (parts-per-sextillion, pps, 1:1021) in liquid solution (assuming a sample of 10 μL) or solely 15 atoms injected into the GF, respectively. These LODs are several orders of magnitude lower (better) than any previous laser-based absorption technique previously demonstrated under atmospheric pressure conditions. It is prophesied that NICE-AAS could provide such high detection sensitivity that the instrumentation should not, by itself, be the limiting factor of an assessment of elemental abundance; the accuracy of an assessment would then instead be limited by concomitant species, e.g. originating from the handling procedures of the sample or the environment.

Tropospheric characteristics over sea ice during N-ICE2015

NASA Astrophysics Data System (ADS)

Kayser, Markus; Maturilli, Marion; Graham, Robert; Hudson, Stephen; Cohen, Lana; Rinke, Annette; Kim, Joo-Hong; Park, Sang-Jong; Moon, Woosok; Granskog, Mats

2017-04-01

Over recent years, the Arctic Ocean region has shifted towards a younger and thinner sea-ice regime. The Norwegian young sea ICE (N-ICE2015) expedition was designed to investigate the atmosphere-snow-ice-ocean interactions in this new ice regime north of Svalbard. Here we analyze upper-air measurements made by radiosondes launched twice daily together with surface meteorology observations during N-ICE2015 from January to June 2015. We study the multiple cyclonic events observed during N-ICE2015 with respect to changes in the vertical thermodynamic structure, sudden increases in moisture content and temperature, temperature inversions and boundary layer dynamics. The influence of synoptic cyclones is strongest under polar night conditions, when radiative cooling is most effective and the moisture content is low. We find that transitions between the radiatively clear and opaque state are the largest drivers of changes to temperature inversion and stability characteristics in the boundary layer during winter. In spring radiative fluxes warm the surface leading to lifted temperature inversions and a statically unstable boundary layer. The unique N-ICE2015 dataset is used for case studies investigating changes in the vertical structure of the atmosphere under varying synoptic conditions. The goal is to deepen our understanding of synoptic interactions within the Arctic climate system, to improve model performance, as well as to identify gaps in instrumentation, which precludes further investigations.

Advanced MCT technologies at LETI for space applications

NASA Astrophysics Data System (ADS)

Durand, A.; Destefanis, G.; Gravrand, O.; Rothmann, J.

This document is a recap of an oral presentation made at Nice during the INSU Astrophysics Detector Workshop 2008. It aims at giving an overview of the achievements and ongoing developments presently carried out at CEA-LETI in the field of Infrared focal plane array. Although most of the research actually performed at LETI is not driven by space oriented application, the excellence and the cutting edge of the outcome is or can be applied to space-dedicated components. This paper focus on features and developments from which astrophysics observation would benefit in the near future on the European market. This encompassed “traditionnal” developments such as format enlargement, low dark current technology such as p/n structure but it also shade light on promising and thrilling development such as avalanche photodiode array. It eventually gives some hints of none MCT technologies processed at LETI.

Children's Sociolinguistic Evaluations of Nice Foreigners and Mean Americans

ERIC Educational Resources Information Center

Kinzler, Katherine D.; DeJesus, Jasmine M.

2013-01-01

Three experiments investigated 5- to 6-year-old monolingual English-speaking American children's sociolinguistic evaluations of others based on their accent (native, foreign) and social actions (nice, mean, neutral). In Experiment 1, children expressed social preferences for native-accented English speakers over foreign-accented speakers, and they…

Guidelines for the use of fiberglass reinforced plastic in utility FGD systems. [Flue gas desulfurization (FGD); contains glossary

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rapoza, R.J.; Vollmer, H.R.; Haberly, K.L.

1992-11-01

Fiberglass reinforced plastic (FRP) materials offer excellent corrosion-resistant properties and long-term cost advantages compared to exotic alloys or organic lining systems. This guideline document provides potential buyers of FRP FGD (flue gas desulfurization) equipment with enough knowledge of FRP materials and methods to make informed decisions when procuring FRP equipment or services. It is divided into the following chapters: application criteria, procurement strategies, FRP basics, guidelines for designing FRP equipment, quality management. A glossary and manufacturers information/recommendations are included.

Singapore Cancer Network (SCAN) Guidelines for Adjuvant Chemotherapy in Resected Non-Small Cell Lung Cancer.

PubMed

2015-10-01

The SCAN lung cancer workgroup aimed to develop Singapore Cancer Network (SCAN) clinical practice guidelines for the use of adjuvant systemic therapy for non-small cell lung cancer in Singapore. The workgroup utilised a modified ADAPTE process to calibrate high quality international evidence-based clinical practice guidelines to our local setting. Five international guidelines were evaluated- those developed by the National Comprehensive Cancer Network (2014), European Society of Medical Oncology (2014), National Institute of Clinical Excellence (2012), Scottish Intercollegiate Guidelines Network (2014), and the Cancer Care Council Australia (2012). Recommendations on the selection of patients, chemotherapy regimen, treatment for stage I disease, treatment for positive margins and treatment options for pN2 disease with negative margins were produced. These adapted guidelines form the SCAN Guidelines 2015 for adjuvant systemic therapy of non-small cell lung cancer.

The refeeding syndrome. Importance of phosphorus.

PubMed

Araujo Castro, Marta; Vázquez Martínez, Clotilde

2018-06-22

Refeeding syndrome (RS) is a complex disease that occurs when nutritional support is initiated after a period of starvation. The hallmark feature is the hypophosphataemia, however other biochemical abnormalities like hypokalaemia, hypomagnesaemia, thiamine deficiency and disorder of sodium and fluid balance are common. The incidence of RS is unknown as no universally accepted definition exists, but it is frequently underdiagnosed. RS is a potentially fatal, but preventable, disorder. The identification of patients at risk is crucial to improve their management. If RS is diagnosed, there is one guideline (NICE 2006) in place to help its treatment (but it is based on low quality of evidence). The aims of this review are: highlight the importance of this problem in malnourished patients, discuss the pathophysiology and clinical characteristics, with a final series of recommendations to reduce the risk of the syndrome and facilitate the treatment. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

Improving access to psychological therapies in voice disorders: a cognitive behavioural therapy model.

PubMed

Miller, Tracy; Deary, Vincent; Patterson, Jo

2014-06-01

The improving access to psychological therapies initiative has highlighted the importance of managing mental health problems effectively, and research has shown excellent outcomes from cognitive behavioural therapy (CBT) interventions. Patients presenting with functional dysphonia will often also describe psychological distress including anxiety, depression and reduced general well-being, and it is felt that effective voice therapy needs to include the management of psychological well-being. The evidence for the use of CBT enhanced voice therapy is limited to date. Recent research has only started to identify the benefits of this approach and questions regarding how to achieve and maintain competence are essential. Voice therapy outcomes are positive and patients receiving CBT with voice therapy have shown more improvement in their general well-being and distress. CBT is a very well evidenced therapy and recommended by The National Institute for Health and Care Excellence (NICE) as the treatment of choice for mental health difficulties and medically unexplained symptoms. Allied health professionals are increasingly being trained to use CBT skills in the management of a number of symptoms/illnesses, and this should be considered for the management of functional dysphonia. However, there is a need for more research and detailed consideration of how therapists should be trained and supervised and how cost-effective this approach may be.

Purchasing practices in a hospital environment: an ethical analysis.

PubMed

Florsheim, R; Paderon, E S

1992-05-01

The critical state of the hospital industry, as previously described, generates a difficult decision environment for the materiel manager and those in the purchasing function. The unique life- and death circumstances of hospitals impose a further onus on those who manage them. In the name of saving lives, they can find a convenient excuse to disregard all moral principles, forgetting the Socratic dictum "it is not enough that one lives, but that one lives well." Without the moral "right stuff," they can easily give in to the seductions of momentary gains and glory through ethical short-cuts. There is wisdom and consolation in the words that "nice guys may appear to finish last, but usually they're running in a different race." Studies have established a direct relationship between corporate excellence and ethical values. The reality of competition in the hospital industry dictates that the integration of ethics into the life of the organization should happen by design and not by accident. This is what is meant by strategy. If hospitals would strive for excellence to survive and grow, they should have a strategy with a mission statement that also embodies its moral values and moral agenda. Such an approach does not guarantee that an organization will become immune to moral contamination, but it does provide an antidote.

Gabapentin Superadded to a Pre-Existent Regime Containing Amytriptyline for Chronic Sciatica.

PubMed

Robertson, Kelvin L; Marshman, Laurence A G

2016-11-01

There is currently a gross lack of evidence base guiding the medical management of chronic sciatica (CS). Only scant previous studies have assessed gabapentin (GBP) in CS. Extrapolating NICE-UK guidelines, prescribing authorities often insist on trialling anti-depressants (e.g., amytriptyline, AMP) as a first line for neuropathic pain states such as CS. When super-adding second-line agents, such as GBP, NICE-UK encourages overlap with first-line agents to avoid decreased pain-control. No study has reflected this practice. Evaluate efficacy and side effects (SE) of GBP superadded to a pre-existent regime containing AMP for CS. Prospective cohort of patients with unilateral CS attending a specialist spine clinic. Eligible patients had experienced partial benefit to a pre-existent regime containing AMP: none had significant SE. No drugs other than GBP were added or discontinued (the latter was considered inequitable) for 3 months. Visual analog pain score (VAS), Oswestry disability index (ODI), and SE were recorded. Efficacy: in 56% (43/77) there were reductions in VAS (5.3 ± 3.6→2.8 ± 2.7, P < 0.0001) and ODI (42.8 ± 31.1→30.7 ± 25.2, P = 0.008). SE: Eighty-two SE (23 types) were reported in 53% (41/77). Efficacy was less in those with SE: a trend existed for a lesser reduction in VAS (2.0 ± 2.4 v 3.0 ± 2.7, P = 0.08), which proved significant for ODI (8.1 ± 11.4 v 16.7 ± 18.2, P = 0.01). Thirty-four percent (26/77) discontinued GBP all within 1 week (i.e., during titration). This is the first prospective cohort study of GBP super-added to a pre-existent regime containing AMP for CS, as per routine clinical practice and NICE-UK principles. Super-added GBP demonstrated further efficacy over the previous regime in 56%; however, SE were frequent (53%) and diverse (23 types), and 34% abruptly discarded GBP. Although SE were associated with decreased efficacy, 37% nevertheless tolerated GBP despite SE. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Wind shear over the Nice Côte d'Azur airport: case studies

NASA Astrophysics Data System (ADS)

Boilley, A.; Mahfouf, J.-F.

2013-09-01

The Nice Côte d'Azur international airport is subject to horizontal low-level wind shears. Detecting and predicting these hazards is a major concern for aircraft security. A measurement campaign took place over the Nice airport in 2009 including 4 anemometers, 1 wind lidar and 1 wind profiler. Two wind shear events were observed during this measurement campaign. Numerical simulations were carried out with Meso-NH in a configuration compatible with near-real time applications to determine the ability of the numerical model to predict these events and to study the meteorological situations generating an horizontal wind shear. A comparison between numerical simulation and the observation dataset is conducted in this paper.

Wind shear over the Nice Côte d'Azur airport: case studies

NASA Astrophysics Data System (ADS)

Boilley, A.; Mahfouf, J.-F.

2013-04-01

The Nice Côte d'Azur international airport is subject to horizontal low-level wind shears. Detecting and predicting these hazards is a major concern for aircraft security. A measurement campaign took place over the Nice airport in 2009 including 4 anemometers, 1 wind lidar and 1 wind profiler. Two wind shear events were observed during this measurement campaign. Numerical simulations were carried out with Meso-NH in a configuration compatible with near-real time applications to determine the ability of the numerical model to predict these events and to study the meteorological situations generating a horizontal wind shear. A comparison between numerical simulation and the observation dataset is conducted in this paper.

Vedolizumab for the Treatment of Adults with Moderate-to-Severe Active Ulcerative Colitis: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

PubMed

Essat, Munira; Tappenden, Paul; Ren, Shijie; Bessey, Alice; Archer, Rachel; Wong, Ruth; Lobo, Alan; Hoque, Sami

2016-03-01

As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of vedolizumab (Takeda UK) to submit evidence of the clinical effectiveness and cost effectiveness of vedolizumab for the treatment of patients with moderate-to-severe active ulcerative colitis (UC). The Evidence Review Group (ERG) produced a critical review of the evidence for the clinical effectiveness and cost effectiveness of the technology, based upon the company's submission to NICE. The evidence was derived mainly from GEMINI 1, a Phase 3, multicentre, randomised, double-blinded, placebo-controlled study of the induction and maintenance of clinical response and remission by vedolizumab (MLN0002) in patients with moderate-to-severe active UC with an inadequate response to, loss of response to or intolerance of conventional therapy or anti-tumour necrosis factor (TNF)-α. The clinical evidence showed that vedolizumab performed significantly better than placebo in both the induction and maintenance phases. In the post hoc subgroup analyses in patients with or without prior anti-TNF-α therapy, vedolizumab performed better then placebo (p value not reported). In addition, a greater improvement in health-related quality of life was observed in patients treated with vedolizumab, and the frequency and types of adverse events were similar in the vedolizumab and placebo groups, but the evidence was limited to short-term follow-up. There were a number of limitations and uncertainties in the clinical evidence base, which warrants caution in its interpretation--in particular, the post hoc subgroup analyses and high dropout rates in the maintenance phase of GEMINI 1. The company also presented a network meta-analysis of vedolizumab versus other biologic therapies indicated for moderate-to-severe UC. However, the ERG considered that the results presented may have underestimated the uncertainty in treatment effects, since fixed-effects models were used, despite clear evidence of heterogeneity among the trials included in the network. Results from the company's economic evaluation (which included price reductions to reflect the proposed patient access scheme for vedolizumab) suggested that vedolizumab is the most effective option compared with surgery and conventional therapy in the following three populations: (1) a mixed intention-to-treat population, including patients who have previously received anti-TNF-α therapy and those who are anti-TNF-α naïve; (2) patients who are anti-TNF-α naïve only; and (3) patients who have previously failed anti-TNF-α therapy only. The ERG concluded that the results of the company's economic evaluation could not be considered robust, because of errors in model implementation, omission of relevant comparators, deviations from the NICE reference case and questionable model assumptions. The ERG amended the company's model and demonstrated that vedolizumab is expected to be dominated by surgery in all three populations.

The Clinical and Cost Effectiveness of Vortioxetine for the Treatment of a Major Depressive Episode in Patients With Failed Prior Antidepressant Therapy: A Critique of the Evidence.

PubMed

Lomas, James; Llewellyn, Alexis; Soares, Marta; Simmonds, Mark; Wright, Kath; Eastwood, Alison; Palmer, Stephen

2016-09-01

The National Institute for Health and Care Excellence (NICE) invited the manufacturer of vortioxetine (Lundbeck) to submit clinical and cost-effectiveness evidence for vortioxetine for the treatment of major depressive episodes (MDEs), as part of the Institute's Single Technology Appraisal (STA) process. The Centre for Reviews and Dissemination and Centre for Health Economics at the University of York were commissioned to act as the independent Evidence Review Group (ERG). This article provides a description of the company submission, the ERG review and the resulting NICE guidance TA367 issued in November 2015. The ERG critically reviewed the evidence presented in the manufacturer's submission and identified areas requiring clarification, for which the manufacturer provided additional evidence. Two phase III randomised controlled trials for a second-line population involving vortioxetine were identified-REVIVE and TAK318. These two trials represent only 972 of over 7000 patients included in trials of vortioxetine. In REVIVE, there was a statistically significant difference in depression scores favouring vortioxetine compared with agomelatine [mean Montgomery-Åsberg Depression Rating Scale (MADRS) score difference of 2.16 points; 95 % confidence interval 0.81-3.51]. The ERG concluded that, based on all the evidence, rather than the substantially restricted subset of evidence originally considered by the manufacturer, vortioxetine is likely to be similar in efficacy to other analysed antidepressants [citalopram, sertraline, escitalopram and venlafaxine extended release (XR)], and may be more efficacious than agomelatine and inferior to duloxetine. The ERG concluded that vortioxetine may be more tolerable than other analysed antidepressants (sertraline, venlafaxine XR and bupropion), although the limited data prevent firm conclusions. The base-case incremental cost-effectiveness ratio (ICER) of vortioxetine reported by the manufacturer was £378 per quality-adjusted life-year (QALY) compared with venlafaxine. Given considerable concerns about the indirect treatment comparison undertaken by the manufacturer, the use of only a restrictive subset of the available evidence, and concerns regarding comparators and structural model assumptions, the ERG believes that this is not a valid estimate of the cost effectiveness of vortioxetine. Following corrections made to the model made by the ERG, the estimated cost effectiveness of vortioxetine was sensitive to the source of evidence used, in addition to whether certain comparators were excluded. The NICE thus asked the manufacturer to provide a revised economic model, which incorporated the broader evidence base and considered the cost effectiveness of vortioxetine as a third-line treatment. Assuming equal efficacy, vortioxetine was shown to be less costly and generate a higher QALY gain than relevant comparators at the third-line of treatment owing to its tolerability and adverse event profile. The NICE Appraisal Committee recommended vortioxetine as an option for treating MDEs in adults whose condition has responded inadequately to two antidepressants within the current episode.

Being "Nice" or Being "Normal": Girls Resisting Discourses of "Coolness"

ERIC Educational Resources Information Center

Paechter, Carrie; Clark, Sheryl

2016-01-01

In this paper we consider discourses of friendship and belonging mobilised by girls who are not part of the dominant "cool" group in one English primary school. We explore how, by investing in alternative and, at times, resistant, discourses of "being nice" and "being normal" these "non-cool" girls were able…

An Update on Improvements to NiCE Support for PROTEUS

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bennett, Andrew; McCaskey, Alexander J.; Billings, Jay Jay

2015-09-01

The Department of Energy Office of Nuclear Energy's Nuclear Energy Advanced Modeling and Simulation (NEAMS) program has supported the development of the NEAMS Integrated Computational Environment (NiCE), a modeling and simulation workflow environment that provides services and plugins to facilitate tasks such as code execution, model input construction, visualization, and data analysis. This report details the development of workflows for the reactor core neutronics application, PROTEUS. This advanced neutronics application (primarily developed at Argonne National Laboratory) aims to improve nuclear reactor design and analysis by providing an extensible and massively parallel, finite-element solver for current and advanced reactor fuel neutronicsmore » modeling. The integration of PROTEUS-specific tools into NiCE is intended to make the advanced capabilities that PROTEUS provides more accessible to the nuclear energy research and development community. This report will detail the work done to improve existing PROTEUS workflow support in NiCE. We will demonstrate and discuss these improvements, including the development of flexible IO services, an improved interface for input generation, and the addition of advanced Fortran development tools natively in the platform.« less

Quality of data collected for severity of illness scores in the Dutch National Intensive Care Evaluation (NICE) registry.

PubMed

Arts, Daniëlle; de Keizer, Nicolette; Scheffer, Gert-Jan; de Jonge, Evert

2002-05-01

To analyse the quality of data used to measure severity of illness in the Dutch National Intensive Care Evaluation (NICE) registry, after implementation of quality improving procedures. Data were re-abstracted from the paper records of patients or the Patient Data Management System and compared to the data contained in the registry. The re-abstracted data were considered to be the gold standard. ICUs of nine Dutch hospitals that had been collecting data for the NICE registry for at least 1 year. The mean percentages of inaccurate and incomplete data, per hospital, over all variables, were 6.1%+/-4.4 (SD) and 2.7%+/-4.4 (SD), respectively. The mean difference in severity of illness scores between registry data and re-abstracted data was 0.2 points for APACHE II and 0.4 points for SAPS II. The mean difference in predicted mortality according to APACHE II and SAPS II between registry data and re-abstracted data was 0.4% and 0.02%, respectively. The current data quality of the NICE registry is good and justifies evaluative research. These positive results might be explained by the implementation of several quality assurance procedures in the NICE registry, such as training and automatic data checks. Electronic supplementary material to this paper can be obtained by using the Springer LINK server located at http://dx.doi.org/10.1007/s00134-002-1272-z

In Vitro Assessment of the Antimicrobial Efficacy of Optimized Nitroglycerin-Citrate-Ethanol as a Nonantibiotic, Antimicrobial Catheter Lock Solution for Prevention of Central Line-Associated Bloodstream Infections

PubMed Central

Reitzel, Ruth A.; Hirsh-Ginsberg, Cheryl; Murray, Kimberly; Chaftari, Anne-Marie; Hachem, Ray; Raad, Issam

2016-01-01

The rapid, broad-spectrum, biofilm-eradicating activity of the combination of 0.01% nitroglycerin, 7% citrate, and 20% ethanol and its potential as a nonantibiotic, antimicrobial catheter lock solution (ACLS) were previously reported. Here, a nitroglycerin-citrate-ethanol (NiCE) ACLS optimized for clinical assessment was developed by reducing the nitroglycerin and citrate concentrations and increasing the ethanol concentration. Biofilm-eradicating activity was sustained when the ethanol concentration was increased from 20 to 22% which fully compensated for reducing the citrate concentration from 7% to 4% as well as the nitroglycerin concentration from 0.01% to 0.0015% or 0.003%. The optimized formulations demonstrated complete and rapid (2 h) eradication of methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-intermediate Staphylococcus aureus (VISA), methicillin-resistant Staphylococcus epidermidis (MRSE), vancomycin-resistant enterococci (VRE), multidrug-resistant (MDR) Pseudomonas aeruginosa, MDR Klebsiella pneumoniae, MDR Enterobacter cloacae, MDR Acinetobacter baumannii, MDR Escherichia coli, MDR Stenotrophomonas maltophilia, Candida albicans, and Candida glabrata biofilms. The optimized NiCE lock solutions demonstrated anticoagulant activities comparable to those of heparin lock solutions. NiCE lock solution was significantly more effective than taurolidine-citrate-heparin lock solution in eradicating biofilms of Staphylococcus aureus and Candida glabrata. The optimized, nonantibiotic, heparin-free NiCE lock solution demonstrates rapid broad-spectrum biofilm eradication as well as effective anticoagulant activity, making NiCE a high-quality ACLS candidate for clinical assessment. PMID:27297475

Contraception counselling of female soldiers in primary healthcare facilities.

PubMed

Crabb, Sarah L

2015-06-01

Effectiveness of barrier and oral contraceptive pills is dependent on daily adherence and consistency that cannot always be guaranteed by military lifestyle. Long-acting reversible contraceptive (LARC) methods could provide a good alternative to guarantee effective contraception in unpredictable scenarios, and recent studies have suggested they could provide wider non-contraceptive benefits. LARC has been proven to be more cost effective than the combined oral contraceptive pill. The National Institute of Health and Care Excellence (NICE) has released guidelines on contraception provision to ensure all women receive the contraception method that is most appropriate to the individual. A retrospective audit of 105 sets of primary healthcare notes of serving female soldiers was assessed to establish contraceptive choices and whether appropriate information had been provided within the last year of their last consultation. 100% had seen a healthcare provider capable of providing contraceptive advice in the last year. 69% documented as using some form of non-surgical contraception versus 58% quoted as national usage. 21% were using some form of LARC versus 8% national usage. 66% of eligible women had not had LARC discussed with them, and of these 50% did not have any contraceptive usage documented. Among other consultations, 41% had had a medical within the year period, of which over half had no documented contraceptive status. As military healthcare providers, we have more exposure to our patients than NHS equivalents and this small study suggests there is an increased demand for contraception. Contraceptive choice counselling should be a mandatory part of routine initial medicals. If the situation demands a medical for any other reason, a documented contraception status should form an important part of the risk assessment process. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A community-based group-guided self-help intervention for low mood and stress: study protocol for a randomized controlled trial.

PubMed

McClay, Carrie-Anne; Morrison, Jill; McConnachie, Alex; Williams, Christopher

2013-11-19

Depression is a mental health condition which affects millions of people each year, with worldwide rates increasing. Cognitive behavioral therapy (CBT) is recommended in the National Institute for Health and Clinical Excellence (NICE) guidelines for the treatment of depression. However, waiting lists can cause delays for face-to-face therapy. Also a proportion of people decline to present for help through the health service - the so-called treatment gap. Self-referral to CBT using community-based group interventions delivered by a voluntary sector organization may serve to resolve this problem. The aim of this randomized controlled trial (RCT) is to determine the efficacy of such a guided CBT self-help course, the 'Living Life to the Full' (LLTTF) classes delivered by the charity Action on Depression (AOD). The primary outcome is level of depression at 6 months assessed using the patient health questionnaire-9 (PHQ9) depression scale. Secondary measures include levels of anxiety and social functioning. Participants with symptoms of low mood will be recruited from the community through newspaper adverts and also via the AOD website. Participants will receive either immediate or delayed access to guided CBT self-help classes - the eight session LLTTF course. The primary endpoint will be at 6 months at which point the delayed group will be offered the intervention. Levels of depression, anxiety and social functioning will be assessed and an economic analysis will be carried out. This RCT will test whether the LLTTF intervention is effective and/or cost-effective. If the LLTTF community-based classes are found to be cost effective, they may be helpful as both an intervention for those already seeking care in the health service, as well as those seeking help outside that setting, widening access to psychological therapy. Current Controlled Trials ISRCTN86292664.

The investigation and differential diagnosis of Asperger syndrome in adults.

PubMed

Lehnhardt, Fritz-Georg; Gawronski, Astrid; Pfeiffer, Kathleen; Kockler, Hanna; Schilbach, Leonhard; Vogeley, Kai

2013-11-08

As a result of the increased public interest in autism spectrum disorders (ASD), certain core manifestations of ASD--impaired social interaction and communication, bizarre interests--are now commonly recognized as being typical of autism, not only in children, but in adults as well. More often than before, general practitioners, neurologists, and psychiatrists find themselves being asked whether a patient is suffering from previously unrecognized Asperger syndrome (AS). The prevalence of ASD is estimated at 1%, and the ratio of diagnosed to undiagnosed cases at about 3:2. Little is known about the diagnostic evaluation of AS in adulthood. We selectively searched the Medline database for pertinent literature, paying special attention to diagnostic manuals and to the guideline of the United Kingdom's National Institute for Health and Care Excellence (NICE). Centrally important aspects of the diagnosis of AS include an assessment of the patient's ability to assume the emotional perspectives of others, non-verbal modes of expression, repetitive behavior patterns, and childhood social behavioral history. The autism quotient (AQ) is now established as a simple but nonspecific screening test. Up to 70% of all affected adults have comorbid disturbances, most often depression and anxiety disorders. The differential diagnosis includes personality disorders, anxiety disorders, obsessive-compulsive disorder, and attention deficit-hyperactivity disorder. The diagnostic assessment should proceed in stepwise fashion, starting from simple screening in primary care and then moving on to evaluation of the suspected diagnosis by a mental health care specialist, followed by extensive further investigation in an outpatient clinic specifically devoted to patients with autism spectrum disorders. The diagnostic assessment of autism in adults requires knowledge of the core and accompanying manifestations of autism and of their differential diagnoses. More research is needed for the development of further screening tests and the precise determination of diagnosis rates, differential diagnoses, nd comorbidities.

Specialist perioperative allergy clinic services in the UK 2016: Results from the Royal College of Anaesthetists Sixth National Audit Project.

PubMed

Egner, W; Cook, T; Harper, N; Garcez, T; Marinho, S; Kong, K L; Nasser, S; Thomas, M; Warner, A; Hitchman, J; Floss, K

2017-10-01

Guidelines for investigation of perioperative drug allergy exist, but the quality of services is unknown. Specialist perioperative anaphylaxis services were surveyed through the Royal College of Anaesthetists 6 th National Audit Project. We compare self-declared UK practice in specialist perioperative allergy services with national recommendations. A SurveyMonkey™ questionnaire was distributed to providers of allergy services in the UK. Responses were assessed for adherence to the best practice recommendations of the British Society for Allergy and Clinical Immunology (BSACI), the Association of Anaesthetists of Great Britain and Ireland and the National Institute for Health and Care Excellence (NICE) Guidance on Drug Allergy-CG183. Over 1200 patients were evaluated in 44 centres annually. Variation in workload, waiting times, access, staffing and diagnostic approach was noted. Paediatric centres had the longest routine waiting times (most wait >13 weeks) in contrast to adult centres (most wait <12 weeks). Service leads are allergists/immunologists (91%) or anaesthetists (7%). Potentially important differences were seen in: testing repertoire [10/44 (23%) lacked BSACI compliant neuromuscular blocking agent (NMBA) panels and 17/44 (39%) lacked a NAP6-defined extended panel; many failed to screen all cases for chlorhexidine 19/44 (43%) or latex 21/44 (48%)], staffing [only 26/44 (59%) had specialist nurses and 18/44 (41%) an anaesthetist] and provision of information [18/44 (41%) gave immediate information in clinic and 5/44 (11%) sign-posted support groups]. Most centres were able to provide diagnostic challenges to antibiotics [40/44 (91%]) and local anaesthetics [41/44 (93%)]. Diagnostic testing is not harmonized, with marked variability in the NMBA panels used to identify safe alternatives. Chlorhexidine and latex are not part of routine testing in many centres. Poor access to services and patient information provision require attention. Harmonization of diagnostic approach is desirable, particularly with regard to a minimum NMBA panel for identification of safe alternatives. © 2017 John Wiley & Sons Ltd.

Delivering a quality-assured fracture liaison service in a UK teaching hospital-is it achievable?

PubMed

Shipman, K E; Stammers, J; Doyle, A; Gittoes, N

2016-10-01

To determine whether new national guidance on the specifications of a fracture liaison service are realistically deliverable, 1 year of data on the performance of such a service were audited. Audit targets were mostly met. This audit demonstrates that these standards are deliverable in a real world setting. UK service specifications for a fracture liaison service (FLS) have been produced (National Osteoporosis Society, NOS) to promote effective commissioning and delivery of the highest quality care to patients with fragility fractures. How deliverable these standards are has not as yet been methodically reported. Our FLS was modelled on the ten NOS standards; performance was audited after 1 year to determine whether these standards could be delivered and to describe the lessons learnt. Performance was audited against the NOS FLS Service Standards, with management based on the Fracture Risk Assessment Tool (FRAX®), the four-item Falls Risk Assessment Tool (FRAT), National Institute for Health and Care Excellence (NICE) and the National Osteoporosis Guideline Groups (NOGG) guidance. Data were recorded prospectively on a database. The FLS commenced in May 2014, was fully operational in August 2014 and data were captured from 1 September 2014 to 1 September 2015. The FLS detected 1773 patients and standards were largely achieved. Most, 94 %, patients were seen within 6 weeks, 533 DXA requests were generated, 804 outpatient FRAT assessments were recorded (134 required falls intervention) and 773 patients had bone treatments started. On follow-up at 3 months, between 78-79 % were still taking medication. Preliminary evaluation of a FLS implemented according to UK NOS standards demonstrates that the model is practical to apply to a large teaching hospital population. Collection and review of outcome and cost effectiveness data is required to determine the performance of this model in comparison with existing models.

Blood pressure self-monitoring in pregnancy: examining feasibility in a prospective cohort study.

PubMed

Tucker, Katherine L; Taylor, Kathryn S; Crawford, Carole; Hodgkinson, James A; Bankhead, Clare; Carver, Tricia; Ewers, Elizabeth; Glogowska, Margaret; Greenfield, Sheila M; Ingram, Lucy; Hinton, Lisa; Khan, Khalid S; Locock, Louise; Mackillop, Lucy; McCourt, Christine; Pirie, Alexander M; Stevens, Richard; McManus, Richard J

2017-12-28

Raised blood pressure (BP) affects approximately 10% of pregnancies worldwide, and a high proportion of affected women develop pre-eclampsia. This study aimed to evaluate the feasibility of self-monitoring of BP in pregnancy in women at higher risk of pre-eclampsia. This prospective cohort study of self-monitoring BP in pregnancy was carried out in two hospital trusts in Birmingham and Oxford and thirteen primary care practices in Oxfordshire. Eligible women were those defined by the UK National Institute for Health and Care Excellence (NICE) guidelines as at higher risk of pre-eclampsia. A total of 201 participants were recruited between 12 and 16 weeks of pregnancy and were asked to take two BP readings twice daily three times a week through their pregnancy. Primary outcomes were recruitment, retention and persistence of self-monitoring. Study recruitment and retention were analysed with descriptive statistics. Survival analysis was used to evaluate the persistence of self-monitoring and the performance of self-monitoring in the early detection of gestational hypertension, compared to clinic BP monitoring. Secondary outcomes were the mean clinic and self-monitored BP readings and the performance of self-monitoring in the detection of gestational hypertension and pre-eclampsia compared to clinic BP. Of 201 women recruited, 161 (80%) remained in the study at 36 weeks or to the end of their pregnancy, 162 (81%) provided any home readings suitable for analysis, 148 (74%) continued to self-monitor at 20 weeks and 107 (66%) at 36 weeks. Self-monitored readings were similar in value to contemporaneous matched clinic readings for both systolic and diastolic BP. Of the 23 who developed gestational hypertension or pre-eclampsia and self-monitored, 9 (39%) had a raised home BP prior to a raised clinic BP. Self-monitoring of BP in pregnancy is feasible and has potential to be useful in the early detection of gestational hypertensive disorders but maintaining self-monitoring throughout pregnancy requires support and probably enhanced training.

Effectiveness of interventions to reduce indoor air pollution and/or improve health in homes using solid fuel in lower and middle income countries: protocol for a systematic review.

PubMed

Quansah, Reginald; Ochieng, Caroline A; Semple, Sean; Juvekar, Sanjar; Emina, Jacques; Armah, Frederick Ato; Luginaah, Isaac

2015-03-04

Indoor air pollution (IAP) interventions are widely promoted as a means of reducing indoor air pollution/health from solid fuel use; and research addressing impact of these interventions has increased substantially in the past two decades. It is timely and important to understand more about effectiveness of these interventions. We describe the protocol of a systematic review to (i) evaluate effectiveness of IAP interventions to improve indoor air quality and/or health in homes using solid fuel for cooking and/or heating in lower- and middle-income countries, (ii) identify the most effective intervention to improve indoor air quality and/or health, and (iii) identify future research needs. This review will be conducted according to the National Institute for Health and Care Excellence (NICE) guidelines and will be reported following the PRISMA statement. Ovid MEDLINE, Ovid Embase, SCOPUS, and PubMed searches were conducted in September 2013 and updated in November 2014 (and include any further search updates in February 2015). Additional references will be located through searching the references cited by identified studies and through the World Health Organization Global database of household air pollution measurements. We will also search our own archives. Data extraction and risk of bias assessment of all included papers will be conducted independently by five reviewers. The study will provide insights into what interventions are most effective in reducing indoor air pollution and/or adverse health outcomes in homes using solid fuel for cooking or heating in lower- or middle-income countries. The findings from this review will be used to inform future IAP interventions and policy on poverty reduction and health improvement in poor communities who rely on biomass and solid fuels for cooking and heating. The review has been registered with PROSPERO (registration number CRD42014009768 ).

Cost-effectiveness of integrated collaborative care for comorbid major depression in patients with cancer☆

PubMed Central

Duarte, A.; Walker, J.; Walker, S.; Richardson, G.; Holm Hansen, C.; Martin, P.; Murray, G.; Sculpher, M.; Sharpe, M.

2015-01-01

Objectives Comorbid major depression is associated with reduced quality of life and greater use of healthcare resources. A recent randomised trial (SMaRT, Symptom Management Research Trials, Oncology-2) found that a collaborative care treatment programme (Depression Care for People with Cancer, DCPC) was highly effective in treating depression in patients with cancer. This study aims to estimate the cost-effectiveness of DCPC compared with usual care from a health service perspective. Methods Costs were estimated using UK national unit cost estimates and health outcomes measured using quality-adjusted life-years (QALYs). Incremental cost-effectiveness of DCPC compared with usual care was calculated and scenario analyses performed to test alternative assumptions on costs and missing data. Uncertainty was characterised using cost-effectiveness acceptability curves. The probability of DCPC being cost-effective was determined using the UK National Institute for Health and Care Excellence's (NICE) cost-effectiveness threshold range of £20,000 to £30,000 per QALY gained. Results DCPC cost on average £631 more than usual care per patient, and resulted in a mean gain of 0.066 QALYs, yielding an incremental cost-effectiveness ratio of £9549 per QALY. The probability of DCPC being cost-effective was 0.9 or greater at cost-effectiveness thresholds above £20,000 per QALY for the base case and scenario analyses. Conclusions Compared with usual care, DCPC is likely to be cost-effective at the current thresholds used by NICE. This study adds to the weight of evidence that collaborative care treatment models are cost-effective for depression, and provides new evidence regarding their use in specialist medical settings. PMID:26652589

Comparison of anticancer drug coverage decisions in the United States and United Kingdom: does the evidence support the rhetoric?

PubMed

Mason, Anne; Drummond, Michael; Ramsey, Scott; Campbell, Jonathan; Raisch, Dennis

2010-07-10

In contrast to the United States, several European countries have health technology assessment programs for drugs, many of which assess cost effectiveness. Coverage decisions that consider cost effectiveness may lead to restrictions in access. For a purposive sample of five decision-making bodies, we analyzed US and United Kingdom coverage decisions on all anticancer drugs approved by the US Food and Drug Administration (FDA) from 2004 to 2008. Data sources for the timing and outcome of licensing and coverage decisions included published and unpublished documentation, Web sites, and personal communication. The FDA approved 59 anticancer drugs over the study period, of which 46 were also approved by the European Medicines Agency. In the United States, 100% of drugs were covered, mostly without restriction. However, the United Kingdom bodies made positive coverage decisions for less than half of licensed drugs (National Institute for Health and Clinical Excellence [NICE]: 39%; Scottish Medicines Consortium [SMC]: 43%). Whereas the Centers for Medicare and Medicaid Services (CMS) and the Department of Veterans Affairs (VA) covered all 59 drugs from the FDA license date, delays were evident for some Regence Group decisions that were informed by cost effectiveness (median, 0 days; semi-interquartile range [SIQR], 122 days; n = 22). Relative to the European Medicines Agency license date, median time to coverage was 783 days (SIQR, 170 days) for NICE and 231 days (SIQR, 129 days) for the SMC. Anticancer drug coverage decisions that consider cost effectiveness are associated with greater restrictions and slower time to coverage. However, this approach may represent an explicit alternative to rationing achieved through the use of patient copayments.

Using Real-World Data in Health Technology Assessment (HTA) Practice: A Comparative Study of Five HTA Agencies.

PubMed

Makady, Amr; van Veelen, Ard; Jonsson, Páll; Moseley, Owen; D'Andon, Anne; de Boer, Anthonius; Hillege, Hans; Klungel, Olaf; Goettsch, Wim

2018-03-01

Reimbursement decisions are conventionally based on evidence from randomised controlled trials (RCTs), which often have high internal validity but low external validity. Real-world data (RWD) may provide complimentary evidence for relative effectiveness assessments (REAs) and cost-effectiveness assessments (CEAs). This study examines whether RWD is incorporated in health technology assessment (HTA) of melanoma drugs by European HTA agencies, as well as differences in RWD use between agencies and across time. HTA reports published between 1 January 2011 and 31 December 2016 were retrieved from websites of agencies representing five jurisdictions: England [National Institute for Health and Care Excellence (NICE)], Scotland [Scottish Medicines Consortium (SMC)], France [Haute Autorité de santé (HAS)], Germany [Institute for Quality and Efficacy in Healthcare (IQWiG)] and The Netherlands [Zorginstituut Nederland (ZIN)]. A standardized data extraction form was used to extract information on RWD inclusion for both REAs and CEAs. Overall, 52 reports were retrieved, all of which contained REAs; CEAs were present in 25 of the reports. RWD was included in 28 of the 52 REAs (54%), mainly to estimate melanoma prevalence, and in 22 of the 25 (88%) CEAs, mainly to extrapolate long-term effectiveness and/or identify drug-related costs. Differences emerged between agencies regarding RWD use in REAs; the ZIN and IQWiG cited RWD for evidence on prevalence, whereas the NICE, SMC and HAS additionally cited RWD use for drug effectiveness. No visible trend for RWD use in REAs and CEAs over time was observed. In general, RWD inclusion was higher in CEAs than REAs, and was mostly used to estimate melanoma prevalence in REAs or to predict long-term effectiveness in CEAs. Differences emerged between agencies' use of RWD; however, no visible trends for RWD use over time were observed.

Personalized prevention in high risk individuals: Managing hormones and beyond.

PubMed

Evans, D Gareth; Howell, Sacha J; Howell, Anthony

2018-06-01

Increasing numbers of women are being identified at 'high-risk' of breast cancer, defined by The National Institute of Health and Care Excellence (NICE) as a 10-year risk of ≥8%. Classically women have been so identified through family history based risk algorithms or genetic testing of high-risk genes. Recent research has shown that assessment of mammographic density and single nucleotide polymorphisms (SNPs), when combined with established risk factors, trebles the number of women reaching the high risk threshold. The options for risk reduction in such women include endocrine chemoprevention with the selective estrogen receptor modulators tamoxifen and raloxifene or the aromatase inhibitors anastrozole or exemestane. NICE recommends offering anastrozole to postmenopausal women at high-risk of breast cancer as cost effectiveness analysis showed this to be cost saving to the National Health Service. Overall uptake to chemoprevention has been disappointingly low but this may improve with the improved efficacy of aromatase inhibitors, particularly the lack of toxicity to the endometrium and thrombogenic risks. Novel approaches to chemoprevention under investigation include lower dose and topical tamoxifen, denosumab, anti-progestins and metformin. Although oophorectomy is usually only recommended to women at increased risk of ovarian cancer it has been shown in numerous studies to reduce breast cancer risks in the general population and in those with mutations in BRCA1/2. However, recent evidence from studies that have confined analysis to true prospective follow up have cast doubt on the efficacy of oophorectomy to reduce breast cancer risk in BRCA1 mutation carriers, at least in the short-term. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

A discrete event simulation to model the cost-utility of fingolimod and natalizumab in rapidly evolving severe relapsing-remitting multiple sclerosis in the UK.

PubMed

Montgomery, Stephen M; Maruszczak, Maciej J; Slater, David; Kusel, Jeanette; Nicholas, Richard; Adlard, Nicholas

2017-05-01

Two disease-modifying therapies are licensed in the EU for use in rapidly-evolving severe (RES) relapsing-remitting multiple sclerosis (RRMS), fingolimod and natalizumab. Here a discrete event simulation (DES) model to analyze the cost-effectiveness of natalizumab and fingolimod in the RES population, from the perspective of the National Health Service (NHS) in the UK, is reported. A DES model was developed to track individual RES patients, based on Expanded Disability Status Scale scores. Individual patient characteristics were taken from the RES sub-groups of the pivotal trials for fingolimod. Utility data were in line with previous models. Published costs were inflated to NHS cost year 2015. Owing to the confidential patient access scheme (PAS) discount applied to fingolimod in the UK, a range of discount levels were applied to the fingolimod list price, to capture the likelihood of natalizumab being cost-effective in a real-world setting. At the lower National Institute of Health and Care Excellence (NICE) threshold of £20,000/quality-adjusted life year (QALY), fingolimod only required a discount greater than 0.8% of list price to be cost-effective. At the upper threshold of £30,000/QALY employed by the NICE, fingolimod was cost-effective if the confidential discount is greater than 2.5%. Sensitivity analyses conducted using fingolimod list-price showed the model to be most sensitive to changes in the cost of each drug, particularly fingolimod. The DES model shows that only a modest discount to the UK fingolimod list-price is required to make fingolimod a more cost-effective option than natalizumab in RES RRMS.

Identifying and prioritizing lower value services from Dutch specialist guidelines and a comparison with the UK do-not-do list.

PubMed

Wammes, Joost Johan Godert; van den Akker-van Marle, M Elske; Verkerk, Eva W; van Dulmen, Simone A; Westert, Gert P; van Asselt, Antoinette D I; Kool, R B

2016-11-25

The term 'lower value services' concerns healthcare that is of little or no value to the patient and consequently should not be provided routinely, or not be provided at all. De-adoption of lower value care may occur through explicit recommendations in clinical guidelines. The present study aimed to generate a comprehensive list of lower value services for the Netherlands that assesses the type of care and associated medical conditions. The list was compared with the NICE do-not-do list (United Kingdom). Finally, the feasibility of prioritizing the list was studied to identify conditions where de-adoption is warranted. Dutch clinical guidelines (published from 2010 to 2015) were searched for lower value services. The lower value services identified were categorized by type of care (diagnostics, treatment with and without medication), type of lower value service (not routinely provided or not provided at all), and ICD10 codes (international classification of diseases). The list was prioritized per ICD10 code, based on the number of lower value services per ICD10 code, prevalence, and burden of disease. A total of 1366 lower value services were found in the 193 Dutch guidelines included in our study. Of the lower value services, 30% covered diagnostics, 29% related to surgical and medical treatment without drugs primarily, and 39% related to drug treatment. The majority (77%) of all lower value services was on care that should not be offered at all, whereas the other 23% recommended on care that should not be offered routinely. ICD10 chapters that included most lower value services were neoplasms and diseases of the nervous system. Dutch guidelines appear to contain more lower value services than UK guidelines. The prioritization processes revealed several conditions, including back pain, chronic obstructive pulmonary disease, and ischemic heart diseases, where lower value services most likely occur and de-adoption is warranted. In this study, a comprehensive list of lower value services for Dutch hospital care was developed. A feasible method for prioritizing lower value services was established. Identifying and prioritizing lower value services is the first of several necessary steps in reducing them.

South African Guidelines Excellence (SAGE): Adopt, adapt, or contextualise?

PubMed

Dizon, J M; Grimmer, K; Louw, Q; Kredo, T; Young, T; Machingaidze, S

2016-12-01

Clinical practice guideline (CPG) activities must be planned carefully for efficient use of available resources and evidence-based implementation. De novo development of CPGs may sometimes 'recreate the wheel' and delay implementation. Three innovative alternatives to de novo CPG development (adopt, contextualise or adapt) are outlined, which have greater potential than de novo development to best use the limited available resources, personnel and time in settings such as South Africa.

Application developer's tutorial for the CSM testbed architecture

NASA Technical Reports Server (NTRS)

Underwood, Phillip; Felippa, Carlos A.

1988-01-01

This tutorial serves as an illustration of the use of the programmer interface on the CSM Testbed Architecture (NICE). It presents a complete, but simple, introduction to using both the GAL-DBM (Global Access Library-Database Manager) and CLIP (Command Language Interface Program) to write a NICE processor. Familiarity with the CSM Testbed architecture is required.

When Nice Won't Suffice: Honest Discourse Is Key to Shifting School Culture

ERIC Educational Resources Information Center

MacDonald, Elisa

2011-01-01

The "culture of nice" is the underlying culture that inhibits a team of teachers from reaching a level of rigorous collaborative discourse where teachers are challenging each other's and their own thinking, beliefs, assumptions, and practice. This article discusses how honest discourse can be the key to shifting school culture. The act of…

Nice to Your Heart: A Pilot Community-Based Intervention to Improve Heart Health Behaviours in Urban Residents

ERIC Educational Resources Information Center

Carter, Stephanie R.; Walker, Alia; Abdul-Latif, Safiyah; Maurer, Laurie; Masunungure, Daniel; Tedaldi, Ellen; Patterson, Freda

2016-01-01

Objective: Efforts to improve cardiovascular health among adult African American populations, particularly through organised physical activity, have met with limited success. This study pilot-tested a novel soul line dancing and nutrition education programme ("Nice to Your Heart") that was designed and implemented as part of an academic…

Generating Nice Linear Systems for Matrix Gaussian Elimination

ERIC Educational Resources Information Center

Homewood, L. James

2004-01-01

In this article an augmented matrix that represents a system of linear equations is called nice if a sequence of elementary row operations that reduces the matrix to row-echelon form, through matrix Gaussian elimination, does so by restricting all entries to integers in every step. Many instructors wish to use the example of matrix Gaussian…

Collaboration Promotes Proportional Reasoning about Resource Distribution in Young Children

ERIC Educational Resources Information Center

Ng, Rowena; Heyman, Gail D.; Barner, David

2011-01-01

The authors investigated how children and adults evaluate the "niceness" of individuals who engage in resource distribution, with a focus on their sensitivity to the proportion of resources given. Across 3 experiments, subjects evaluated the niceness of a child who gave a quantity of pennies to another child. In Study 1 (N = 30), adults showed…

The SQUIRE (Standards for QUality Improvement Reporting Excellence) guidelines for quality improvement reporting: explanation and elaboration

PubMed Central

Ogrinc, G; Mooney, S E; Estrada, C; Foster, T; Goldmann, D; Hall, L W; Huizinga, M M; Liu, S K; Mills, P; Neily, J; Nelson, W; Pronovost, P J; Provost, L; Rubenstein, L V; Speroff, T; Splaine, M; Thomson, R; Tomolo, A M; Watts, B

2008-01-01

As the science of quality improvement in health care advances, the importance of sharing its accomplishments through the published literature increases. Current reporting of improvement work in health care varies widely in both content and quality. It is against this backdrop that a group of stakeholders from a variety of disciplines has created the Standards for QUality Improvement Reporting Excellence, which we refer to as the SQUIRE publication guidelines or SQUIRE statement. The SQUIRE statement consists of a checklist of 19 items that authors need to consider when writing articles that describe formal studies of quality improvement. Most of the items in the checklist are common to all scientific reporting, but virtually all of them have been modified to reflect the unique nature of medical improvement work. This “Explanation and Elaboration” document (E & E) is a companion to the SQUIRE statement. For each item in the SQUIRE guidelines the E & E document provides one or two examples from the published improvement literature, followed by an analysis of the ways in which the example expresses the intent of the guideline item. As with the E & E documents created to accompany other biomedical publication guidelines, the purpose of the SQUIRE E & E document is to assist authors along the path from completion of a quality improvement project to its publication. The SQUIRE statement itself, this E & E document, and additional information about reporting improvement work can be found at http://www.squire-statement.org. PMID:18836062

Explanation and elaboration of the SQUIRE (Standards for Quality Improvement Reporting Excellence) Guidelines, V.2.0: examples of SQUIRE elements in the healthcare improvement literature

PubMed Central

Goodman, Daisy; Ogrinc, Greg; Davies, Louise; Baker, G Ross; Barnsteiner, Jane; Foster, Tina C; Gali, Kari; Hilden, Joanne; Horwitz, Leora; Kaplan, Heather C; Leis, Jerome; Matulis, John C; Michie, Susan; Miltner, Rebecca; Neily, Julia; Nelson, William A; Niedner, Matthew; Oliver, Brant; Rutman, Lori; Thomson, Richard

2016-01-01

Since its publication in 2008, SQUIRE (Standards for Quality Improvement Reporting Excellence) has contributed to the completeness and transparency of reporting of quality improvement work, providing guidance to authors and reviewers of reports on healthcare improvement work. In the interim, enormous growth has occurred in understanding factors that influence the success, and failure, of healthcare improvement efforts. Progress has been particularly strong in three areas: the understanding of the theoretical basis for improvement work; the impact of contextual factors on outcomes; and the development of methodologies for studying improvement work. Consequently, there is now a need to revise the original publication guidelines. To reflect the breadth of knowledge and experience in the field, we solicited input from a wide variety of authors, editors and improvement professionals during the guideline revision process. This Explanation and Elaboration document (E&E) is a companion to the revised SQUIRE guidelines, SQUIRE 2.0. The product of collaboration by an international and interprofessional group of authors, this document provides examples from the published literature, and an explanation of how each reflects the intent of a specific item in SQUIRE. The purpose of the guidelines is to assist authors in writing clearly, precisely and completely about systematic efforts to improve the quality, safety and value of healthcare services. Authors can explore the SQUIRE statement, this E&E and related documents in detail at http://www.squire-statement.org. PMID:27076505

Employee health.

PubMed

2015-09-01

The National Institute for Health and Care Excellence has produced a new guideline looking at improving the health and wellbeing of employees, with a particular focus on organisational culture and context, and the role of line managers.

In Vitro Assessment of the Antimicrobial Efficacy of Optimized Nitroglycerin-Citrate-Ethanol as a Nonantibiotic, Antimicrobial Catheter Lock Solution for Prevention of Central Line-Associated Bloodstream Infections.

PubMed

Reitzel, Ruth A; Rosenblatt, Joel; Hirsh-Ginsberg, Cheryl; Murray, Kimberly; Chaftari, Anne-Marie; Hachem, Ray; Raad, Issam

2016-09-01

The rapid, broad-spectrum, biofilm-eradicating activity of the combination of 0.01% nitroglycerin, 7% citrate, and 20% ethanol and its potential as a nonantibiotic, antimicrobial catheter lock solution (ACLS) were previously reported. Here, a nitroglycerin-citrate-ethanol (NiCE) ACLS optimized for clinical assessment was developed by reducing the nitroglycerin and citrate concentrations and increasing the ethanol concentration. Biofilm-eradicating activity was sustained when the ethanol concentration was increased from 20 to 22% which fully compensated for reducing the citrate concentration from 7% to 4% as well as the nitroglycerin concentration from 0.01% to 0.0015% or 0.003%. The optimized formulations demonstrated complete and rapid (2 h) eradication of methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-intermediate Staphylococcus aureus (VISA), methicillin-resistant Staphylococcus epidermidis (MRSE), vancomycin-resistant enterococci (VRE), multidrug-resistant (MDR) Pseudomonas aeruginosa, MDR Klebsiella pneumoniae, MDR Enterobacter cloacae, MDR Acinetobacter baumannii, MDR Escherichia coli, MDR Stenotrophomonas maltophilia, Candida albicans, and Candida glabrata biofilms. The optimized NiCE lock solutions demonstrated anticoagulant activities comparable to those of heparin lock solutions. NiCE lock solution was significantly more effective than taurolidine-citrate-heparin lock solution in eradicating biofilms of Staphylococcus aureus and Candida glabrata The optimized, nonantibiotic, heparin-free NiCE lock solution demonstrates rapid broad-spectrum biofilm eradication as well as effective anticoagulant activity, making NiCE a high-quality ACLS candidate for clinical assessment. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

The Role of Nice and Nasty Theory of Mind in Teacher-Selected Peer Models for Adolescents with Autism Spectrum Disorders

ERIC Educational Resources Information Center

Laghi, Fiorenzo; Lonigro, Antonia; Levanto, Simona; Ferraro, Maurizio; Baumgartner, Emma; Baiocco, Roberto

2016-01-01

The study aimed at verifying if nice and nasty theory of mind behaviors, in association with teachers' peer buddy nomination, could be used to correctly select peer models for adolescents with autism spectrum disorder. Mentalizing abilities and emotional and behavioral characteristics of 601 adolescents were assessed. Results suggest that teachers…

Graduate Students Rate Institutional Websites: The Must Have, Nice to Have, and Delighted to Have Services

ERIC Educational Resources Information Center

Meyer, Katrina A.; Jones, Stephanie J.

2012-01-01

The graduate students admitted to the online and blended programs in higher education at Texas Tech University and the University of Memphis were surveyed about their respective university websites, or the institution's "virtual face." A total of 42 students rated 30 web-based services as "must have," "nice to have," "delighted to have (but not…

Golimumab for the treatment of psoriatic arthritis: a NICE single technology appraisal.

PubMed

Yang, Huiqin; Craig, Dawn; Epstein, David; Bojke, Laura; Light, Kate; Bruce, Ian N; Sculpher, Mark; Woolacott, Nerys

2012-04-01

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of golimumab (Schering-Plough/Centocor) to submit evidence for the clinical and cost effectiveness of this drug for the treatment of active and progressive psoriatic arthritis (PsA) in patients who have responded inadequately to previous disease-modifying anti-rheumatic drugs (DMARDs). The Centre for Reviews and Dissemination and the Centre for Health Economics at the University of York were commissioned to act as the Evidence Review Group (ERG) to critically appraise the evidence presented by the manufacturer. This article provides a description of the company submission, the ERG review and the resulting NICE guidance. The ERG critically reviewed the evidence presented in the manufacturer's submission and identified areas requiring clarification, for which the manufacturer provided additional evidence. The main clinical effectiveness data were derived from a single phase III randomized controlled trial (GO-REVEAL) that compared golimumab with placebo for the treatment of active and progressive patients who were symptomatic despite the use of previous DMARDs or NSAIDs. The 14-week data showed that, compared with placebo, golimumab 50 mg significantly improved joint disease response as measured by American College of Rheumatology (ACR) 20 (relative risk [RR] 5.73, 95% CI 3.24, 10.56) and Psoriatic Arthritis Response Criteria (PsARC) [RR 3.45, 95% CI 2.49, 4.87], and significantly improved skin disease response as measured by Psoriasis Area and Severity Index (PASI) 75 (RR 15.95, 95% CI 4.62, 59.11). The 24-week absolute data showed that these treatment benefits were maintained. There was a significant improvement in patients' functional status as measured by Health Assessment Questionnaire change from baseline at 24 weeks (-0.33; p < 0.001). The open-label extension data showed that these beneficial effects were also maintained at 52 and 104 weeks. The ERG identified several issues relating to the clinical effectiveness results. Analyses of the 24-week data were less robust, failing to adjust for treatment contamination due to patient crossover at week 16. It was also unclear if these results were generalizable to clinical practice. No randomized controlled trial compared the effectiveness of different biologic therapies head-to-head. To compare the effectiveness of the biologics etanercept, infliximab, adalimumab and golimumab, the manufacturer conducted a network meta-analysis, including the comparator palliative care (usual care including use of NSAIDs or DMARDs). The ERG considered the assumption of exchangeability between the trials for the purpose of the network meta-analysis to be acceptable and the statistical approach to be reliable. The results indicated somewhat lower efficacy with golimumab than with comparator biologics. The ERG identified a number of issues relating to the cost-effectiveness results. The manufacturer calculated incremental cost-effectiveness ratios (ICERs) incorrectly by comparing golimumab with palliative care instead of the most cost-effective alternative (etanercept). Despite the manufacturer's claim that golimumab was a cost-effective treatment option, the manufacturer's own model showed that golimumab was unlikely to be cost effective, relative to currently accepted thresholds, when the ICERs were correctly calculated using an incremental analysis (i.e. comparing each treatment to the next best alternative). None of the sensitivity analyses carried out by the manufacturer or the ERG regarding uncertainty in the estimates of clinical effectiveness, the acquisition and administration cost of drugs, the cost of treating psoriasis and the utility functions estimated to generate health outcomes changed this conclusion. However, a key area in determining the cost effectiveness of biologics was whether they should be treated as a class. The ERG concluded that if all biologics were considered equally effective, then etanercept, adalimumab and golimumab had almost equal costs and equal QALYs, and all had an ICER of about £15 000 per QALY versus palliative care, whilst infliximab, with a higher acquisition cost, was dominated by the other biologics. The Appraisal Committee altered its position between the Appraisal Consultation Document and the Final Appraisal Determination. It ultimately recommended that golimumab be provided as an option for the treatment of active and progressive PsA in adults only if (i) it is used as described for other tumour necrosis factor inhibitor treatments in 'Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis' (NICE clinical guideline 199); and (ii) the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose.

Preparing data for analysis using microsoft Excel.

PubMed

Elliott, Alan C; Hynan, Linda S; Reisch, Joan S; Smith, Janet P

2006-09-01

A critical component essential to good research is the accurate and efficient collection and preparation of data for analysis. Most medical researchers have little or no training in data management, often causing not only excessive time spent cleaning data but also a risk that the data set contains collection or recording errors. The implementation of simple guidelines based on techniques used by professional data management teams will save researchers time and money and result in a data set better suited to answer research questions. Because Microsoft Excel is often used by researchers to collect data, specific techniques that can be implemented in Excel are presented.

Doppler-broadened NICE-OHMS beyond the cavity-limited weak absorption condition - II: Experimental verification

NASA Astrophysics Data System (ADS)

Hausmaninger, Thomas; Silander, Isak; Ma, Weiguang; Axner, Ove

2016-01-01

Doppler-broadened (Db) noise-immune cavity-enhanced optical heterodyne molecular spectrometry (NICE-OHMS) is normally described by an expression, here termed the conventional (CONV) description, that is restricted to the conventional cavity-limited weak absorption condition (CCLWA), i.e. when the single pass absorbance is significantly smaller than the empty cavity losses, i.e. when α0 L < < π / F. To describe NICE-OHMS signals beyond this limit two simplified extended descriptions (termed the extended locking and extended transmission description, ELET, and the extended locking and full transmission description, ELFT), which are assumed to be valid under the relaxed cavity-limited weak absorption condition (RCLWA), i.e. when α0 L < π / F, and a full description (denoted FULL), presumed to be valid also when the α0 L < π / F condition does not hold, have recently been derived in an accompanying work (Ma W, et al. Doppler-broadened NICE-OHMS beyond the cavity-limited weak absorption condition - I. Theoretical Description. J Quant Spectrosc Radiat Transfer, 2015, http://dx.doi.org/10.1016/j.jqsrt.2015.09.007). The present work constitutes an experimental verification and assessment of the validity of these, performed in the Doppler limit for a set of Fα0 L / π values (up to 3.5); it is shown under which conditions the various descriptions are valid. It is concluded that for samples with Fα0 L / π up to 0.01, all descriptions replicate the data well. It is shown that the CONV description is adequate and provides accurate assessments of the signal strength (and thereby the analyte concentration) up to Fα0 L / π of around 0.1, while the ELET is accurate for Fα0 L / π up to around 0.3. The ELFT description mimics the Db NICE-OHMS signal well for Fα0 L / π up to around unity, while the FULL description is adequate for all Fα0 L / π values investigated. Access to these descriptions both increases considerably the dynamic range of the technique and facilitates calibration using certified reference gases, which thereby significantly broadens the applicability of the Db NICE-OHMS technique.

Ponatinib for Treating Chronic Myeloid Leukaemia: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

PubMed

Pandor, Abdullah; Stevenson, Matt; Stevens, John; James, Marrissa Martyn-St; Hamilton, Jean; Byrne, Jenny; Rudin, Claudius; Rawdin, Andrew; Wong, Ruth

2018-02-26

As part of its single technology appraisal process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures ponatinib (Inclusig ® ; Incyte Corporation) to submit evidence for the clinical and cost effectiveness for previously treated chronic myeloid leukaemia (CML) and Philadelphia-chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL). This paper focusses on the three phases of CML: the chronic phase (CP), the accelerated phase (AP) and the blast crisis phase (BP). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). This article presents the critical review of the company's submission by the ERG and the outcome of the NICE guidance. Clinical evidence for ponatinib was derived from a phase II, industry-sponsored, single-arm, open-label, multicentre, non-comparative study. Despite the limited evidence and potential for biases, this study demonstrated that ponatinib was likely to be an effective treatment (in terms of major cytogenetic response and major haematological response) with an acceptable safety profile for patients with CML. Given the absence of any head-to-head studies comparing ponatinib with other relevant comparators, the company undertook a matching-adjusted indirect comparison (MAIC) of ponatinib with bosutinib. The approach was only used for patients with CP-CML because comprehensive data were not available for the AP- or BP-CML groups to allow the matching technique to be used. Despite the uncertainty about the MAIC approach, ponatinib was considered likely to offer advantages over bosutinib in the third-line setting, particularly for complete cytogenetic response. The company developed two health economic models to assess the cost effectiveness of ponatinib for the treatment of patients in CP-CML or in advanced CML (AP- or BP-CML, which were modelled separately). The company did not adequately explore the uncertainty in the survivor functions. As a result, the ERG believed the uncertainty in the decision problem was underestimated. Exploratory analyses undertaken by the ERG produced the following results for ponatinib. In CP-CML, from £18,246 to £27,667 per quality-adjusted life-year (QALY) gained compared with best supportive care (BSC), from £19,680 to £37,381 per QALY gained compared with bosutinib and from £18,279 per QALY gained to dominated compared with allogeneic stem cell transplant (allo-SCT). In AP-CML, the cost per QALY gained for ponatinib ranged from £7123 to £17,625 compared with BSC, and from dominating to £61,896 per QALY gained compared with allo-SCT. In BP-CML, the cost effectiveness of ponatinib ranged from £5033 per QALY gained to dominated compared with allo-SCT, although it was likely to be at the more favourable end of this range, and dominant in all scenarios compared with BSC. The NICE appraisal committee concluded that ponatinib is a cost-effective use of NHS resources in the considered population, subject to the company providing the agreed discount in the Patient Access Scheme.

Validation of a DICE Simulation Against a Discrete Event Simulation Implemented Entirely in Code.

PubMed

Möller, Jörgen; Davis, Sarah; Stevenson, Matt; Caro, J Jaime

2017-10-01

Modeling is an essential tool for health technology assessment, and various techniques for conceptualizing and implementing such models have been described. Recently, a new method has been proposed-the discretely integrated condition event or DICE simulation-that enables frequently employed approaches to be specified using a common, simple structure that can be entirely contained and executed within widely available spreadsheet software. To assess if a DICE simulation provides equivalent results to an existing discrete event simulation, a comparison was undertaken. A model of osteoporosis and its management programmed entirely in Visual Basic for Applications and made public by the National Institute for Health and Care Excellence (NICE) Decision Support Unit was downloaded and used to guide construction of its DICE version in Microsoft Excel ® . The DICE model was then run using the same inputs and settings, and the results were compared. The DICE version produced results that are nearly identical to the original ones, with differences that would not affect the decision direction of the incremental cost-effectiveness ratios (<1% discrepancy), despite the stochastic nature of the models. The main limitation of the simple DICE version is its slow execution speed. DICE simulation did not alter the results and, thus, should provide a valid way to design and implement decision-analytic models without requiring specialized software or custom programming. Additional efforts need to be made to speed up execution.

A first experience with digital complete overdentures.

PubMed

Bajunaid, Salwa Omar

2016-07-01

The development of computer-aided design/computer-aided manufacturing systems for dentistry in the 1980s resulted in the successful fabrication of crowns, fixed dental prostheses, and superstructures for both natural teeth and dental implants. Today, this technology is available for constructing digitally designed and milled, completely removable dental prostheses. The procedure uses clinical and laboratory protocols that allow fabrication of completely removable prostheses within two clinical appointments. The aim of this clinical report is to present the author's first experience with digital complete overdentures, the practicality of this technology, and patient feedback. Compared with conventional overdentures, the fit of the digital prostheses was improved because the cameo and flanges of the prostheses were nicely shaped and rolled, and this enhanced their stability and retention. Occlusion was also excellent. However, aesthetics in terms of the alignment, shape, and size of the maxillary overdenture teeth were inacceptable. Despite some of the drawbacks identified in our study, the use of removable digital dentures does provide excellent adaptation of the denture base and requires fewer clinic visits. We anticipate that the unsatisfactory aesthetic outcomes presented in this report can be corrected with more experience. We also believe that acquiring an in-house scanning machine would be beneficial. We highly recommend including this technique in dental school curriculums at both the undergraduate and graduate levels in order to keep students and residents up to date on the latest technology available.

Dietary Guidelines for Adults Starting on Hemodialysis

MedlinePlus

... fish are rich in heart-healthy “omega-3” fats. Tuna and salmon (rinsed or canned without salt) and shellfish are excellent heart healthy protein choices. Snack/Dessert Milk, 4 ounces Slice of apple pie This meal ...

The computational structural mechanics testbed architecture. Volume 4: The global-database manager GAL-DBM

NASA Technical Reports Server (NTRS)

Wright, Mary A.; Regelbrugge, Marc E.; Felippa, Carlos A.

1989-01-01

This is the fourth of a set of five volumes which describe the software architecture for the Computational Structural Mechanics Testbed. Derived from NICE, an integrated software system developed at Lockheed Palo Alto Research Laboratory, the architecture is composed of the command language CLAMP, the command language interpreter CLIP, and the data manager GAL. Volumes 1, 2, and 3 (NASA CR's 178384, 178385, and 178386, respectively) describe CLAMP and CLIP and the CLIP-processor interface. Volumes 4 and 5 (NASA CR's 178387 and 178388, respectively) describe GAL and its low-level I/O. CLAMP, an acronym for Command Language for Applied Mechanics Processors, is designed to control the flow of execution of processors written for NICE. Volume 4 describes the nominal-record data management component of the NICE software. It is intended for all users.

Use of economic evaluation in local health care decision-making in England: a qualitative investigation.

PubMed

Eddama, Oya; Coast, Joanna

2009-03-01

To explore decision-making and the use of economic evaluation at the local health care decision-making level in England (UK). Data collection was over a 16-month period (January 2003 to April 2004). Data collection comprised 29 in-depth interviews with a range of decision makers, 13 observations of decision-making meetings, and analysis of documents produced at meetings. A constant comparative approach was used to identify broad themes and sub-themes arising from the data. Data were analysed using Microsoft Word. National Institute for Health and Clinical Excellence (NICE) guidance provides the main way in which economic evaluation is used at a local level in the UK, although following NICE guidance is often regarded as detrimental to pursuing local priorities. Other than through NICE, economic evaluation is not considered at the local level; we found no evidence for use at the meeting group (by individuals). Although decision makers appear to understand notions of scarcity, with some also referring to value for money, the process of decision-making departs from these principles in practice. Disinvestment decisions are not made nor are decisions weighted against pre-defined criteria. Options appraisal is conducted, but it does not embody the principles of economic evaluation, since options are not considered in terms of their costs and benefits and opportunity cost is not accounted for. There appear to be two reasons why economic evaluation is not used at the local level: (1) the nature of management decisions concerned with the employment of extra staff and new equipment, rather than the choice of medicines or specific interventions usually assessed in published economic evaluation; (2) lack of awareness of the economic evaluation approach to decision-making. These two factors point to a lack of freedom in decision-making at the local level and a lack of understanding of how priority setting can be achieved in practice. A more detailed and rigorous approach to prioritisation at the local level is required. Whilst, PCTs have been given greater responsibility for priority setting, they lack the necessary power and understanding of the ways in which long term solutions to problems in health care can be achieved. Economics can be a valuable asset to priority setting and has already filtered into the jargon used by decision makers. Whilst most concepts are understood, the leap to adopting these concepts into the practice of decision-making needs to be made.

Fifteen-minute consultation: Modern-day art and science of managing cerebral palsy.

PubMed

Cadwgan, Jill; Goodwin, Jane; Fairhurst, Charlie

2018-06-15

While there remains limited intervention to address the damage to the developing brain, current multidisciplinary management of cerebral palsy (CP) needs to minimise the impact of secondary musculoskeletal complications. A focus on comorbidities to maximise function for activity and participation by supporting the child and family in their environment is required. Comprehensive clinical guidance was published by National Institute for Health and Care Excellence (NICE) earlier this year. This article aims to provide a practical clinical approach to the child and family based on:(1) art: empathy, listening and weighing up the clinical picture of the child and family in context; diagnosis, the need for support and space; and care coordination at the right time; and (2) science: the current science in CP care is rapidly expanding in terms of plasticity, pathophysiology, functional assessments and treatments. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Creep and fracture of a model yoghurt

NASA Astrophysics Data System (ADS)

Manneville, Sebastien; Leocmach, Mathieu; Perge, Christophe; Divoux, Thibaut

2014-11-01

Biomaterials such as protein or polysaccharide gels are known to behave qualitatively as soft solids and to rupture under an external load. Combining optical and ultrasonic imaging to shear rheology we show that the failure scenario of a model yoghurt, namely a casein gel, is reminiscent of brittle solids: after a primary creep regime characterized by a macroscopically homogeneous deformation and a power-law behavior which exponent is fully accounted for by linear viscoelasticity, fractures nucleate and grow logarithmically perpendicularly to shear, up to the sudden rupture of the gel. A single equation accounting for those two successive processes nicely captures the full rheological response. The failure time follows a decreasing power-law with the applied shear stress, similar to the Basquin law of fatigue for solids. These results are in excellent agreement with recent fiber-bundle models that include damage accumulation on elastic fibers and exemplify protein gels as model, brittle-like soft solids. Work funded by the European Research Council under Grant Agreement No. 258803.

Revision of the ICH guideline on detection of toxicity to reproduction for medicinal products: SWOT analysis.

PubMed

Barrow, Paul

2016-09-01

SWOT analysis was used to gain insights and perspectives into the revision of the ICH S5(R2) guideline on detection of toxicity to reproduction for medicinal products. The current ICH guideline was rapidly adopted worldwide and has an excellent safety record for more than 20 years. The revised guideline should aim to further improve reproductive and developmental (DART) safety testing for new drugs. Alternative methods to animal experiments should be used whenever possible. Modern technology should be used to obtain high quality data from fewer animals. Additions to the guideline should include considerations on the following: limit dose setting, maternal toxicity, biopharmaceuticals, vaccines, testing strategies by indication, developmental immunotoxicity, and male-mediated developmental toxicity. Emerging issues, such as epigenetics and the microbiome, will most likely pose challenges to DART testing in the future. It is hoped that the new guideline will be adopted even outside the ICH regions. Copyright © 2016 Elsevier Inc. All rights reserved.

[Latest international guidelines for screening, prevention and treatment of familial breast cancer - implications for the relevant practice in Hungary].

PubMed

Romics, László; Kocsis, Judit; Ormándi, Katalin; Molnár, Béla Ákos

2016-07-01

Screening, prevention and treatment of familial breast cancer require a multidisciplinary approach. New guidelines were published in the United Kingdom for the management of familial breast cancer. The authors summarise these new guidelines and analyse the relevant practice in Hungary. Relevant guidelines of the National Institute for Health and Care Excellence and Familial Breast Cancer Report (NHS Scotland) are described. New guidelines will increase the number of genetic tests as well as genetic counselling. An increase in the number of breast magnetic resonance imaging is expected, too. Chemoprevention can be offered for individuals with medium risk and above. Promising trials are underway with platinum based chemotherapy and polyADP-ribose polimerase inhibitors for the systemic treatment of familial breast cancer. The increase in the number of genetic tests, counselling, and breast magnetic resonance imaging may have a significant impact on health care budget. These guidelines will change some aspects of the current management of familial breast cancer. Orv. Hetil., 2016, 157(28), 1117-1125.

Improving the Quality of Oral and Maxillofacial Surgical Notes in an Indian Public Sector Hospital in Accordance with the Royal College of Surgeons Guidelines: A Completed Audit Loop Study.

PubMed

Krishnan, B; Prasad, G Arun; Madhan, B

2016-09-01

Proper and adequate documentation in operation notes is a basic tool of clinical practice with medical and legal implications. An audit was done to ascertain if oral and maxillofacial surgery operative notes in an Indian public sector hospital adhered to the guidelines published by the Royal College of Surgeons England. Fifty randomly selected operative notes were evaluated against the guidelines by RCS England with regards to the essential generic components of an operation note. Additional criteria relevant to oral and Maxillofacial Surgery were also evaluated. Changes were introduced in the form of Oral and Maxillofacial Surgery specific consent forms, diagram sheets and a computerized operation note proforma containing all essential and additional criteria along with prefilled template of operative findings. Re-audit of 50 randomly selected operation notes was performed after a 6 month period. In the 1st audit cycle, excellent documentation ranging from 94 to 100 % was seen in 9 essential criteria. Unsatisfactory documentation was observed in criteria like assistant name, date of surgery. Most consent forms contained abbreviations and some did not provide all details. Additional criteria specific to Oral and Maxillofacial Surgery scored poorly. In the 2nd Audit for loop completion, excellent documentation was seen in almost all essential and additional criteria. Mean percentage of data point inclusion improved from 84.6 to 98.4 % (0.001< P value <0.005). The use of abbreviations was seen in only 6 notes. Regular audits are now considered a mandatory quality improvement process that seeks to improve patient care and outcomes. To the best of our knowledge, this is the first completed audit on operation notes documentation in Oral and Maxillofacial Surgery from India. The introduction of a computerized operation note proforma showed excellent improvement in operation note documentation. Surgeons can follow the RCS guidelines to ensure standardization of operation notes.

Venous thromboembolism prophylaxis risk assessment in a general surgery cohort: a closed-loop audit.

PubMed

McGoldrick, D M; Redmond, H P

2017-08-01

Venous thromboembolism (VTE) is a potential source of morbidity and mortality in surgical in-patients. A number of guidelines exist that advise on prophylactic measures. We aimed to assess VTE prophylaxis prescribing practices and compliance with a kardex-based risk assessment tool in a general surgery population. Data on general surgery in-patients were collected on two separate wards on two separate days. Drug kardexes were assessed for VTE prophylaxis measures and use of the risk assessment tool. NICE and SIGN guidelines were adopted as a gold standard. The audit results and information on the risk assessment tool were presented as an educational intervention at two separate departmental teaching sessions. A re-audit was completed after 3 months. In Audit A, 74 patients were assessed. 70% were emergency admissions. The risk assessment tool was completed in 2.7%. 75 and 97% of patients were correctly prescribed anti-embolic stockings (AES) and low-molecular weight heparin (LMWH), respectively. 30 patients were included in Audit B, 56% of whom were emergency admissions. 66% had a risk assessment performed, a statistically significant improvement (p < 0.0001). Rates of LMWH prescribing were similar (96%), but AES prescribing was lower (36%). Rates of LMWH prescribing are high in this general surgical population, although AES prescribing rates vary. Use of the VTE risk assessment tool increased following the initial audit and intervention.

"I didn't know if it would work, but I tried it anyway".

PubMed

Davidhizar, R

1996-03-01

To be an excellent manager, daring, creative, and innovative solutions should be tried for management problems. A manager may feel he or she is treading on ground where no one walked before; however, the manager who takes no risk will never come up with the novel and original solutions. This article supplies guidelines for the evaluation of creative and innovative solutions. These guidelines are especially appropriate for the employee who needs a smooth transition into management.

[Prevention and management of refeeding syndrome in patients with chronic critical illness].

PubMed

Chen, Jun; Fan, Chaogang

2016-07-01

Nutritional support is an important means to treat the patients with chronic critical illness for commonly associated malnutrition. Refeeding syndrome is a serious complication during the process, mainly manifested as severe electrolyte with hypophosphataemia being the most common. Refeeding syndrome is not uncommon but it is often ignored. In our future clinical work, we need to recognize this chinical situation and use preventative and treatment measures. According to NICE clinical nutrition guideline, we discussed the risk factors, treatment methods and preventive measures of refeeding syndrome in patients with chronic critical illness. We argued that for patients with high risk refeeding syndrome, nutritional support treatment should be initially low calorie and slowly increased to complete requirement. Circulation capacity should be recovered, fluid balance must be closely monitored and supplement of vitamins, microelement, electrolytes should be noted. After the emergence of refeeding syndrome, we should reduce or even stop the calorie intake, give an active treatment for electrolyte disorder, provide vitamin B, and maintain the functions of multiple organs.

Randomized controlled trials vs. observational studies: why not just live together?

PubMed

Faraoni, David; Schaefer, Simon Thomas

2016-10-21

Randomized controlled trials (RCTs) are considered the gold standard for clinical research, thus having a high impact on clinical guidelines and our daily patients' care. However, various treatment strategies which we consider "evidence based" have never been subject to a prospective RCT, as we would rate it unethical to withheld an established treatment to individuals in an placebo controlled trial.In a recent BMC Anesthesiology publication, Trentino et al. analyzed the usefulness of observational studies in assessing benefit and risk of different transfusion strategies. The authors nicely reviewed and summarized similarities and differences, advantages and limitations, between different study types frequently used in transfusion medicine. In this interesting article, the authors conclude, that 'when comparing the results of observational studies with RCTs assessing transfusion outcomes, it is important that one consider not only the study method, but also the key elements of the study design'. Thus, in this commentary we now discuss the pro's and con's of different study types, even irrespective of transfusion medicine.

Continuous subcutaneous insulin infusion therapy for Type 1 diabetes mellitus in children.

PubMed

Mavinkurve, M; Quinn, A; O'Gorman, C S

2016-05-01

Continuous subcutaneous insulin pump therapy (CSII or pump therapy) is a well-recognised treatment option for Type 1 diabetes mellitus (T1DM) in paediatrics. It is especially suited to children because it optimises control by improving flexibility across age-specific lifestyles. The NICE guidelines (2008) recognise that pump therapy is advantageous and that it should be utilised to deliver best practice. In Ireland, the National Clinical Program for Diabetes will increase the availability and uptake of CSII in children and thus more clinicians are likely to encounter children using CSII therapy. This is a narrative review which discusses the basic principles of pump therapy and focuses on aspects of practical management. Insulin pump management involves some basic yet important principles which optimise the care of diabetes in children. This review addresses the principles of insulin pump management in children which all health care professionals involved in caring for the child with diabetes, shoud be familiar with.

[Guidelines for the prescription of mood stabilizers for adolescents: A literature review].

PubMed

Munch, G; Godart, N

2017-10-01

Adolescence is a unique phase of the human developmental process. In adolescents, psychotropic medications may have different efficacy and tolerance profiles compared to those at other stages of the lifespan. Mood stabilizers are a complex pharmacological category including lithium, some anticonvulsants, and some second generation antipsychotics. Focusing on this class of pharmacological agents, we aim to answer the following questions: in which indications and according to which modalities should mood stabilizers be prescribed during adolescence? Information was sought from the websites of the French Haute Autorité de santé (HAS) and Agence nationale de sécurité du médicament et des produits de santé (ANSM), the American Food and Drug Administration (FDA) and the British National Institute for Health and Clinical Excellence (NICE). Guidelines from the American Academy of Child and Adolescent Psychiatry (AACAP) were also reviewed. Additional articles were found using PubMed and Google Scholar. We assumed that guidelines published by a national institute were the most relevant, second information from medical academies, then literature reviews, and finally single studies. Practical prescription data were also sought from the French Vidal Drug Dictionary. For bipolar disorder in adolescents, lithium has been the first drug licensed in France (from the age of 16) and in the USA (from the age of 12), with indications for acute mania and preventive treatment. Benefits for impulsive and self-aggressive behaviour disorders (especially relevant in case of borderline personality disorder) have also been documented, although lithium has not been licensed in any country for those indications. Extended-release tablets are usually used, at doses targeting for a lithiemia between 0.8 and 1.2mEq/L 12hours after last intake. Because of a narrow therapeutic window and potential side effects (especially nephrotoxicity), lithium prescription requires regular blood tests and good treatment compliance. None of the anticonvulsants has been licensed by a national drug administration as a mood stabilizer in adolescents. However, the AACAP recommends valproate as a first line treatment for mania, even though the NICE and the ANSM caution that valproate should not be used by women of child bearing age. Besides its teratogenic and endocrine side effects, valproate exposes one to the risk of hepatic toxicity. That is why regular liver function tests should be prescribed when valproate is chosen. According to the AACAP, carbamazepine (which is licensed for the treatment of mania in adults) is not a first line treatment for adolescents. Indeed, no clinical study has demonstrated its efficacy on manic episodes in adolescents. Moreover, carbamazepine exposes one to the risk of agranulocytosis. Lamotrigine has not been approved for adolescents, but some studies suggest its efficacy for bipolar depression (often a treatment-resistant phase) in this age group. Major side effects are the risk of Lyell or Stevens-Johnsons syndrome (which usually occur within the first eight weeks of treatment). There is no need for biological tests, just clinical monitoring. Pharmacological interactions between lamotrigine and oral contraceptives require caution. Finally, the use of some second generation antipsychotics for bipolar disorder in adolescents has been approved by national drug administrations. In France, only aripiprazole is licensed for acute mania (from the age of 13). In the USA, aripiprazole is licensed from the age of 10 for acute mania and preventive treatment, while risperidone and quetiapine are licensed from the age of 10 for acute mania, and olanzapine is licensed from the age of 13 for acute mania. The AACAP recommends second generation antipsychotics as a first line treatment for bipolar disorder. Moreover, the AACAP and the NICE recommend second generation antipsychotics for behavioural disorders in adolescents. Recommended doses are usually lower and titration slower than for adults. As in adults, adverse effects are metabolic, motor and cognitive disorders. Moreover, hyperprolactinemia, sedation and weight gain are more frequent than in adults. Epidemiologic data for prescription of mood stabilizers in adolescents only partially concord with recommendations from drug administrations and scientific societies. On the one hand, there is a trend toward preferential prescription of second generation antipsychotics, on the other hand lithium is hardly prescribed to adolescents, less often than anticonvulsants. Thus, without approval from any drug administration, the anticonvulsants are often preferred to lithium (because of lithium's potential risks due to noncompliance or voluntary poisoning) and to second generation antipsychotics (because of their tolerance profile). Nevertheless, for prescribers it is a complex matter to compare side effects: the frequency and intensity of adverse effects is quite variable from one mood stabilizer to another, and such a thing as an expected value is therefore hard to define. Regardless of the medication chosen, compliance and therapeutic alliance are major issues. Compliance is especially low during adolescence (less than 40% according to a study on bipolar disorder). This lack of compliance has multiple determinants: poor acceptance or misunderstanding of the psychiatric disorder, indirect effects of bad relationships with parents and more generally adults, but also reckless behaviour or death wishes. Improving therapeutic alliance appears as a major challenge for health practitioners dealing with youth. One interesting path of research could be the therapeutic education programs using humanistic communication techniques (addressing both adolescents and their parents) which have already produced encouraging results. Copyright © 2016. Published by Elsevier Masson SAS.

Publication guidelines for quality improvement in health care: evolution of the SQUIRE project

PubMed Central

Davidoff, F; Batalden, P; Stevens, D; Ogrinc, G; Mooney, S

2008-01-01

In 2005, draft guidelines were published for reporting studies of quality improvement interventions as the initial step in a consensus process for development of a more definitive version. This article contains the full revised version of the guidelines, which the authors refer to as SQUIRE (Standards for QUality Improvement Reporting Excellence). This paper also describes the consensus process, which included informal feedback from authors, editors and peer reviewers who used the guidelines; formal written commentaries; input from a group of publication guideline developers; ongoing review of the literature on the epistemology of improvement and methods for evaluating complex social programmes; a two-day meeting of stakeholders for critical discussion and debate of the guidelines’ content and wording; and commentary on sequential versions of the guidelines from an expert consultant group. Finally, the authors consider the major differences between SQUIRE and the initial draft guidelines; limitations of and unresolved questions about SQUIRE; ancillary supporting documents and alternative versions that are under development; and plans for dissemination, testing and further development of SQUIRE. PMID:18836063

The computational structural mechanics testbed architecture. Volume 5: The Input-Output Manager DMGASP

NASA Technical Reports Server (NTRS)

Felippa, Carlos A.

1989-01-01

This is the fifth of a set of five volumes which describe the software architecture for the Computational Structural Mechanics Testbed. Derived from NICE, an integrated software system developed at Lockheed Palo Alto Research Laboratory, the architecture is composed of the command language (CLAMP), the command language interpreter (CLIP), and the data manager (GAL). Volumes 1, 2, and 3 (NASA CR's 178384, 178385, and 178386, respectively) describe CLAMP and CLIP and the CLIP-processor interface. Volumes 4 and 5 (NASA CR's 178387 and 178388, respectively) describe GAL and its low-level I/O. CLAMP, an acronym for Command Language for Applied Mechanics Processors, is designed to control the flow of execution of processors written for NICE. Volume 5 describes the low-level data management component of the NICE software. It is intended only for advanced programmers involved in maintenance of the software.

Quality and reporting of guidelines on the diagnosis and management of dystonia.

PubMed

Tamás, G; Abrantes, C; Valadas, A; Radics, P; Albanese, A; Tijssen, M A J; Ferreira, J J

2018-02-01

The quality of clinical practice guidelines on dystonia has not yet been assessed. Our aim was to appraise the methodological quality of guidelines worldwide and to analyze the consistency of their recommendations. We searched for clinical practice guidelines on dystonia diagnosis/treatment in the National Guideline Clearinghouse, PubMed, National Institute for Health and Care Excellence, Guidelines International Network and Web of Science databases. We also searched for guidelines on homepages of international neurological societies. We asked for guidelines from every Management Committee member of the BM1101 Action of the Cooperation between Science and Technology European framework and every member of the International Parkinson and Movement Disorders Society with special interest in dystonia. Fifteen guidelines were evaluated. Among guidelines on treatment, only one from the American Academy of Neurology could be considered as high quality. Among guidelines on diagnosis and therapy, the guideline from the European Federation of Neurological Societies was recommended by the appraisers. Clinical applicability and reports of editorial independence were the greatest shortcomings. The rigor of development was poor and stakeholder involvement was also incomplete in most guidelines. Discrepancies among recommendations may result from the weight given to consensus statements and expert opinions due to the lack of evidence, as well as inaccuracy of disease classification. The quality of appraised guidelines was low. It is necessary to improve the quality of guidelines on dystonia, and the applied terminology of dystonia also needs to be standardized. © 2017 EAN.

Psychosocial issues in evidence-based guidelines on inflammatory bowel diseases: A review

PubMed Central

Häuser, Winfried; Moser, Gabriele; Klose, Petra; Mikocka-Walus, Antonina

2014-01-01

AIM: To study statements and recommendations on psychosocial issues as presented in international evidence-based guidelines on the management of inflammatory bowel diseases (IBD). METHODS: MEDLINE, guidelines International Network, National Guideline Clearing House and National Institute for Health and Care Excellence were searched from January 2006 to June 30, 2013 for evidence-based guidelines on the management of IBD. RESULTS: The search yielded 364 hits. Thirteen guidelines were included in the review, of which three were prepared in Asia, eight in Europe and two in the United States. Eleven guidelines made statements and recommendations on psychosocial issues. The guidelines were concordant in that mental health disorders and stress do not contribute to the aetiology of IBD, but that they can influence its course. It was recommended that IBD-patients should be screened for psychological distress. If indicated, psychotherapy and/or psychopharmacological therapy should be recommended. IBD-centres should collaborate with mental health care specialists. Tobacco smoking patients with Crohn’s disease should be advised to quit. CONCLUSION: Patients and mental health specialists should be able to participate in future guideline groups to contribute to establishing recommendations on psychosocial issues in IBD. Future guidelines should acknowledge the presence of psychosocial problems in IBD-patients and encourage screening for psychological distress. PMID:24707152

[Guideline on brain metastases: not a cookbook].

PubMed

Reijneveld, Jaap C

2011-01-01

The guideline 'Brain Metastases', which was revised on behalf of the Dutch Society for Neuro-Oncology (LWNO), provides an excellent overview of levels of scientific evidence on diagnosis and treatment of patients with parenchymal brain metastases of solid tumours. I would like to emphasize, however, that this guideline is not a cookbook for facilitating individual physicians to treat patients on their own. It is important that every patient suffering from brain metastases is discussed by a multidisciplinary tumour board consisting of at least a neurologist, a neurosurgeon, a medical oncologist, a radiation oncologist, a pathologist and a radiologist, and that several crucial questions need to be explicitly asked and answered about every single patient.

Engine & Vehicle Mechanics Curriculum.

ERIC Educational Resources Information Center

Alaska State Dept. of Education, Juneau. Div. of Adult and Vocational Education.

This competency-based curriculum includes all competencies a student will acquire in an engine and vehicle mechanics educational program. It follows guidelines established for automobile technician training programs leading toward certification and addresses requirements of the National Institute for Automotive Service Excellence (ASE). The…

Explanation and elaboration of the SQUIRE (Standards for Quality Improvement Reporting Excellence) Guidelines, V.2.0: examples of SQUIRE elements in the healthcare improvement literature.

PubMed

Goodman, Daisy; Ogrinc, Greg; Davies, Louise; Baker, G Ross; Barnsteiner, Jane; Foster, Tina C; Gali, Kari; Hilden, Joanne; Horwitz, Leora; Kaplan, Heather C; Leis, Jerome; Matulis, John C; Michie, Susan; Miltner, Rebecca; Neily, Julia; Nelson, William A; Niedner, Matthew; Oliver, Brant; Rutman, Lori; Thomson, Richard; Thor, Johan

2016-12-01

Since its publication in 2008, SQUIRE (Standards for Quality Improvement Reporting Excellence) has contributed to the completeness and transparency of reporting of quality improvement work, providing guidance to authors and reviewers of reports on healthcare improvement work. In the interim, enormous growth has occurred in understanding factors that influence the success, and failure, of healthcare improvement efforts. Progress has been particularly strong in three areas: the understanding of the theoretical basis for improvement work; the impact of contextual factors on outcomes; and the development of methodologies for studying improvement work. Consequently, there is now a need to revise the original publication guidelines. To reflect the breadth of knowledge and experience in the field, we solicited input from a wide variety of authors, editors and improvement professionals during the guideline revision process. This Explanation and Elaboration document (E&E) is a companion to the revised SQUIRE guidelines, SQUIRE 2.0. The product of collaboration by an international and interprofessional group of authors, this document provides examples from the published literature, and an explanation of how each reflects the intent of a specific item in SQUIRE. The purpose of the guidelines is to assist authors in writing clearly, precisely and completely about systematic efforts to improve the quality, safety and value of healthcare services. Authors can explore the SQUIRE statement, this E&E and related documents in detail at http://www.squire-statement.org. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Positioning and spinal bracing for pain relief in metastatic spinal cord compression in adults.

PubMed

Lee, Siew Hwa; Grant, Robin; Kennedy, Catriona; Kilbride, Lynn

2015-09-24

This is an updated version of the original Cochrane review published in Issue 3 (Lee 2012) on patient positioning (mobilisation) and bracing for pain relief and spinal stability in adults with metastatic spinal cord compression.Many patients with metastatic spinal cord compression (MSCC) have spinal instability, but their clinician has determined that due to their advanced disease they are unsuitable for surgical internal fixation. Mobilising may be hazardous in the presence of spinal instability as further vertebral collapse can occur. Current guidance on positioning (whether a patient should be managed with bed rest or allowed to mobilise) and whether spinal bracing is helpful, is contradictory. To investigate the correct positioning and examine the effects of spinal bracing to relieve pain or to prevent further vertebral collapse in patients with MSCC. For this update, we searched for relevant studies from February 2012 to 31 March 2015. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and MEDLINE In Process, EMBASE, AMED, CINAHL, TRIP, SIGN, NICE, UK Clinical Research Network, National Guideline Clearinghouse and PEDro database. We also searched the metaRegister of Controlled Trials (mRCT), ClinicalTrials.gov, UK Clinical Trials Gateway (UKCTG), WHO International Clinical Trials Registry Platform (ICTRP) and Australia New Zealand Clinical Trials Registry (ANZCTR).For the original version, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, CANCERLIT, NICE, SIGN, AMED, TRIP, National Guideline Clearinghouse, and PEDro database, in February 2012. We selected randomised controlled trials (RCTs) of adults with MSCC of interventions on positioning (mobilisation) and bracing. Two review authors independently assessed each possible study for inclusion and quality. For the original version of the review, we screened 1611 potentially relevant studies. No studies met the inclusion criteria. Many papers identified the importance of mobilisation, but no RCTs of bed rest versus mobilisation have been undertaken. We identified no RCTs of bracing in MSCC.For this update, we identified 347 potential titles. We screened 300 titles and abstracts after removal of duplicates. We did not identify any additional studies for inclusion. Since publication of the original version of this review, no new studies were found and our conclusions remain unchanged.There is a lack of evidence-based guidance around how to correctly position and when to mobilise patients with MSCC or if spinal bracing is an effective technique for reducing pain or improving quality of life. RCTs are required in this important area.

Preparing Brigade Combat Team Soldiers for Mission Readiness Through Research on Intangible Psychological Constructs and their Applications: Validation and Pilot

DTIC Science & Technology

2015-01-01

and their Applications: Validation and Pilot Steven N. Aude Kenneth Nicely Michael A. Lodato ICF International Christopher L. Vowels...CONTRACT OR GRANT NUMBER W5J9CQ-11-0009 5b. PROGRAM ELEMENT NUMBER 622785 6. AUTHOR(S) Steven N. Aude, Kenneth Nicely, Michael A... Michael A. Lodato ICF International Christopher L. Vowels U.S. Army Research Institute Fort Hood Research Unit Brian T. Crabb

TH-D-204-00: The Pursuit of Radiation Oncology Performance Excellence

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

The Malcolm Baldrige National Quality Improvement Act was signed into law in 1987 to advance U.S. business competitiveness and economic growth. Administered by the National Institute of Standards and Technology NIST, the Act created the Baldrige National Quality Program, now renamed the Baldrige Performance Excellence Program. The comprehensive analytical approaches referred to as the Baldrige Healthcare Criteria, are very well suited for the evaluation and sustainable improvement of radiation oncology management and operations. A multidisciplinary self-assessment approach is used for radiotherapy program evaluation and development in order to generate a fact based knowledge driven system for improving quality of care,more » increasing patient satisfaction, building employee engagement, and boosting organizational innovation. The methodology also provides a valuable framework for benchmarking an individual radiation oncology practice against guidelines defined by accreditation and professional organizations and regulatory agencies. Learning Objectives: To gain knowledge of the Baldrige Performance Excellence Program as it relates to Radiation Oncology. To appreciate the value of a multidisciplinary self-assessment approach in the pursuit of Radiation Oncology quality care, patient satisfaction, and workforce commitment. To acquire a set of useful measurement tools with which an individual Radiation Oncology practice can benchmark its performance against guidelines defined by accreditation and professional organizations and regulatory agencies.« less

TH-D-204-01: The Pursuit of Radiation Oncology Performance Excellence

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sternick, E.

The Malcolm Baldrige National Quality Improvement Act was signed into law in 1987 to advance U.S. business competitiveness and economic growth. Administered by the National Institute of Standards and Technology NIST, the Act created the Baldrige National Quality Program, now renamed the Baldrige Performance Excellence Program. The comprehensive analytical approaches referred to as the Baldrige Healthcare Criteria, are very well suited for the evaluation and sustainable improvement of radiation oncology management and operations. A multidisciplinary self-assessment approach is used for radiotherapy program evaluation and development in order to generate a fact based knowledge driven system for improving quality of care,more » increasing patient satisfaction, building employee engagement, and boosting organizational innovation. The methodology also provides a valuable framework for benchmarking an individual radiation oncology practice against guidelines defined by accreditation and professional organizations and regulatory agencies. Learning Objectives: To gain knowledge of the Baldrige Performance Excellence Program as it relates to Radiation Oncology. To appreciate the value of a multidisciplinary self-assessment approach in the pursuit of Radiation Oncology quality care, patient satisfaction, and workforce commitment. To acquire a set of useful measurement tools with which an individual Radiation Oncology practice can benchmark its performance against guidelines defined by accreditation and professional organizations and regulatory agencies.« less

The impact of the National Institute for Health Research Health Technology Assessment programme, 2003-13: a multimethod evaluation.

PubMed

Guthrie, Susan; Bienkowska-Gibbs, Teresa; Manville, Catriona; Pollitt, Alexandra; Kirtley, Anne; Wooding, Steven

2015-08-01

The National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme supports research tailored to the needs of NHS decision-makers, patients and clinicians. This study reviewed the impact of the programme, from 2003 to 2013, on health, clinical practice, health policy, the economy and academia. It also considered how HTA could maintain and increase its impact. Interviews (n = 20): senior stakeholders from academia, policy-making organisations and the HTA programme. Bibliometric analysis: citation analysis of publications arising from HTA programme-funded research. Researchfish survey: electronic survey of all HTA grant holders. Payback case studies (n = 12): in-depth case studies of HTA programme-funded research. We make the following observations about the impact, and routes to impact, of the HTA programme: it has had an impact on patients, primarily through changes in guidelines, but also directly (e.g. changing clinical practice); it has had an impact on UK health policy, through providing high-quality scientific evidence - its close relationships with the National Institute for Health and Care Excellence (NICE) and the National Screening Committee (NSC) contributed to the observed impact on health policy, although in some instances other organisations may better facilitate impact; HTA research is used outside the UK by other HTA organisations and systematic reviewers - the programme has an impact on HTA practice internationally as a leader in HTA research methods and the funding of HTA research; the work of the programme is of high academic quality - the Health Technology Assessment journal ensures that the vast majority of HTA programme-funded research is published in full, while the HTA programme still encourages publication in other peer-reviewed journals; academics agree that the programme has played an important role in building and retaining HTA research capacity in the UK; the HTA programme has played a role in increasing the focus on effectiveness and cost-effectiveness in medicine - it has also contributed to increasingly positive attitudes towards HTA research both within the research community and the NHS; and the HTA focuses resources on research that is of value to patients and the UK NHS, which would not otherwise be funded (e.g. where there is no commercial incentive to undertake research). The programme should consider the following to maintain and increase its impact: providing targeted support for dissemination, focusing resources when important results are unlikely to be implemented by other stakeholders, particularly when findings challenge vested interests; maintaining close relationships with NICE and the NSC, but also considering other potential users of HTA research; maintaining flexibility and good relationships with researchers, giving particular consideration to the Technology Assessment Report (TAR) programme and the potential for learning between TAR centres; maintaining the academic quality of the work and the focus on NHS need; considering funding research on the short-term costs of the implementation of new health technologies; improving the monitoring and evaluation of whether or not patient and public involvement influences research; improve the transparency of the priority-setting process; and continuing to monitor the impact and value of the programme to inform its future scientific and administrative development.

Local action on outdoor air pollution to improve public health.

PubMed

Vardoulakis, Sotiris; Kettle, Rachel; Cosford, Paul; Lincoln, Paul; Holgate, Stephen; Grigg, Jonathan; Kelly, Frank; Pencheon, David

2018-06-01

The National Institute for Health and Care Excellence, jointly with Public Health England, have developed a guideline on outdoor air pollution and its links to health. The guideline makes recommendations on local interventions that can help improve air quality and prevent a range of adverse health outcomes associated with road-traffic-related air pollution. The guideline was based on a rigorous assessment of the scientific evidence by an independent advisory committee, with input from public health professionals and other professional groups. The process included systematics reviews of the literature, expert testimonies and stakeholder consultation. The guideline includes recommendations for local planning, clean air zones, measures to reduce emissions from public sector transport services, smooth driving and speed reduction, active travel, and awareness raising. The guideline recommends taking a number of actions in combination, because multiple interventions, each producing a small benefit, are likely to act cumulatively to produce significant change. These actions are likely to bring multiple public health benefits, in addition to air quality improvements.

Prevalence of Risk Factors for the Refeeding Syndrome in Older Hospitalized Patients.

PubMed

Pourhassan, M; Cuvelier, I; Gehrke, I; Marburger, C; Modreker, M K; Volkert, D; Willschrei, H P; Wirth, R

2018-01-01

The incidence of refeeding syndrome (RFS) in older patients is not well-known. The aim of the study was to determine the prevalence of known risk factors for RFS in older individuals during hospitalization at geriatric hospital departments. 342 consecutive older participants (222 females) who admitted at acute geriatric hospital wards were included in a cross-sectional study. We applied the National Institute for Health and Clinical Excellence (NICE) criteria for determining patients at risk of RFS. In addition, Mini Nutritional Assessment Short Form (MNA®-SF) was used to identify patients at risk of malnutrition. Weight and height were assessed. The degree of weight loss was obtained by interview. Serum phosphate, magnesium, potassium, sodium, calcium, creatinine and urea were analyzed according to standard procedures. Of 342 older participants included in the study (mean age 83.1 ± 6.8, BMI range of 14.7-43.6 kg/m2), 239 (69.9%) were considered to be at risk of RFS, in which 43.5% and 11.7% were at risk of malnutrition and malnourished, respectively, according to MNA-SF. Patients in the risk group had significantly higher weight loss, lower phosphate and magnesium levels. In a multivariate logistic regression analysis, low levels of phosphate and magnesium followed by weight loss were the major risk factors for fulfilling the NICE criteria. The incidence of risk factors for RFS was relatively high in older individuals acutely admitted in geriatric hospital units, suggesting that, RFS maybe more frequent among older persons than we are aware of. Patients with low serum levels of phosphate and magnesium and higher weight loss are at increased risk of RFS. The clinical characteristics of the older participants at risk of RFS indicate that these patients had a relatively poor nutritional status which can help us better understand the potential scale of RFS on admission or during the hospital stay.

The safety, efficacy and cost-effectiveness of stress echocardiography in patients with high pretest probability of coronary artery disease.

PubMed

Papachristidis, Alexandros; Demarco, Daniela Cassar; Roper, Damian; Tsironis, Ioannis; Papitsas, Michael; Byrne, Jonathan; Alfakih, Khaled; Monaghan, Mark J

2017-01-01

In this study, we assess the clinical and cost-effectiveness of stress echocardiography (SE), as well as the place of SE in patients with high pretest probability (PTP) of coronary artery disease (CAD). We investigated 257 patients with no history of CAD, who underwent SE, and they had a PTP risk score >61% (high PTP). According to the National Institute for Health and Care Excellence guidance (NICE CG95, 2010), these patients should be investigated directly with an invasive coronary angiogram (ICA). We investigated those patients with SE initially and then with ICA when appropriate. Follow-up data with regard to Major Adverse Cardiac and Cerebrovascular Events (MACCE, defined as cardiovascular mortality, cerebrovascular accident (CVA), myocardial infarction (MI) and late revascularisation for acute coronary syndrome/unstable angina) were recorded for a period of 12 months following the SE. The tariff for SE and ICA is £300 and £1400, respectively. 106 patients had a positive SE (41.2%) and 61 of them (57.5%) had further investigation with ICA. 15 (24.6%) of these patients were revascularised. The average cost per patient for investigations was £654.09. If NICE guidance had been followed, the cost would have been significantly higher at £1400 (p<0.001). Overall, 5 MACCE (2.0%) were recorded; 4 (3.8%) in the group of positive SE (2 CVAs and 2 MIs) and 1 (0.7%) in the group of negative SE (1 CVA). There was no MI and no need for revascularisation in the negative SE group. Our approach to investigate patients who present with de novo chest pain and high PTP, with SE initially and subsequently with ICA when appropriate, reduces the cost significantly (£745.91 per patient) with a very low rate of MACCE. However, this study is underpowered to assess safety of SE.

Cautions regarding the fitting and interpretation of survival curves: examples from NICE single technology appraisals of drugs for cancer.

PubMed

Connock, Martin; Hyde, Chris; Moore, David

2011-10-01

The UK National Institute for Health and Clinical Excellence (NICE) has used its Single Technology Appraisal (STA) programme to assess several drugs for cancer. Typically, the evidence submitted by the manufacturer comes from one short-term randomized controlled trial (RCT) demonstrating improvement in overall survival and/or in delay of disease progression, and these are the pre-eminent drivers of cost effectiveness. We draw attention to key issues encountered in assessing the quality and rigour of the manufacturers' modelling of overall survival and disease progression. Our examples are two recent STAs: sorafenib (Nexavar®) for advanced hepatocellular carcinoma, and azacitidine (Vidaza®) for higher-risk myelodysplastic syndromes (MDS). The choice of parametric model had a large effect on the predicted treatment-dependent survival gain. Logarithmic models (log-Normal and log-logistic) delivered double the survival advantage that was derived from Weibull models. Both submissions selected the logarithmic fits for their base-case economic analyses and justified selection solely on Akaike Information Criterion (AIC) scores. AIC scores in the azacitidine submission failed to match the choice of the log-logistic over Weibull or exponential models, and the modelled survival in the intervention arm lacked face validity. AIC scores for sorafenib models favoured log-Normal fits; however, since there is no statistical method for comparing AIC scores, and differences may be trivial, it is generally advised that the plausibility of competing models should be tested against external data and explored in diagnostic plots. Function fitting to observed data should not be a mechanical process validated by a single crude indicator (AIC). Projective models should show clear plausibility for the patients concerned and should be consistent with other published information. Multiple rather than single parametric functions should be explored and tested with diagnostic plots. When trials have survival curves with long tails exhibiting few events then the robustness of extrapolations using information in such tails should be tested.

Canadian Practice Guidelines for Comprehensive Community Treatment for Schizophrenia and Schizophrenia Spectrum Disorders.

PubMed

Addington, Donald; Anderson, Elizabeth; Kelly, Martina; Lesage, Alain; Summerville, Chris

2017-09-01

The objective of this review is to identify the features and components of a comprehensive system of services for people living with schizophrenia. A comprehensive system was conceived as one that served the full range of people with schizophrenia and was designed with consideration of the incidence and prevalence of schizophrenia. The system should provide access to the full range of evidence-based services, should be recovery oriented, and should provide patient-centred care. A systematic search was conducted for published guidelines for schizophrenia and schizophrenia spectrum disorders. The guidelines were rated by at least 2 raters, and recommendations adopted were primarily drawn from the National Institute for Clinical Excellence (2014) Guideline on Psychosis and Schizophrenia in adults and the Scottish Intercollegiate Guidelines Network guidelines on management of schizophrenia. The recommendations adapted for Canada cover the range of services required to provide comprehensive services. Comprehensive services for people with schizophrenia can be organized and delivered to improve the quality of life of people with schizophrenia and their carers. The services need to be organized in a system that provides access to those who need them.

Severe Weather Guide - Mediterranean Ports. 11. Nice

DTIC Science & Technology

1988-03-01

CAPTAIN’S SUMMARY Nice is located on the south coast of France in the region known as the French Riviera (Figure 2-1), about 12 n mi west of the Italian...southern coast of France in the region known as the French Riviera approximately 12 n mi west of the Italian border. High mountains back the coastline...CA 93943-5006 9. PROCUREMENT INSTRUMENT IDENTIFICATION NUMBER N00228-84-D-3187 10. SOURCE OF FUNDING NUMBERS PROGRAM ELEMENT NO. PROJECT NO

The Gordon Conference on Inorganic Chemistry Held in Wolfboro, New Hampshire on 30 July-3 August 1990

DTIC Science & Technology

1991-06-01

Amgerst, MA 01002 Facultad De Ciencias Exactas Y Naturales Pabellon 1 - C Universitaria Dissado, Leonard N4 Buenos Aires 1428 Kings College Argentina...Laboratories 6 Universitatstrasse 2nd Floor B-2 Zurich Switzerland CH-8092 Rochester NY 14652-3208 Diebold, Michael P. Dunham, Stephen Dupont De Nemours...Laboratoire De Chimie Moleculaire Univ. of Paris-Sud URAAU CNRS Laboratoire De Chimie Theorique Univ. De Nice, Parc Vairose Batiment 490 Nice France 06034

Mepolizumab for Treating Severe Eosinophilic Asthma: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

PubMed

Bermejo, Iñigo; Stevenson, Matt; Cooper, Katy; Harnan, Sue; Hamilton, Jean; Clowes, Mark; Carroll, Christopher; Harrison, Tim; Saha, Shironjit

2018-02-01

As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the company (GlaxoSmithKline) that manufactures mepolizumab (Nucala ® ) to submit evidence on the clinical and cost effectiveness of mepolizumab for the treatment of severe eosinophilic asthma. The School of Health and Related Research Technology Appraisal Group (ScHARR-TAG) at the University of Sheffield was commissioned to act as the independent evidence review group (ERG). The ERG produced a review of the evidence for the clinical and cost effectiveness of mepolizumab as add-on to standard of care (SoC) compared with SoC and omalizumab, based upon the company's submission to NICE. The clinical-effectiveness evidence in the company's submission was based predominantly on three randomised controlled trials (DREAM, MENSA and SIRIUS) comparing add-on mepolizumab with placebo plus SoC. The relevant population was defined in terms of degree of asthma severity (four or more exacerbations in the previous year and/or dependency on maintenance oral corticosteroids [mOCS]) and degree of eosinophilia (a blood eosinophil count of ≥ 300 cells/µl in the previous year) based on post hoc subgroup analyses of the pivotal trials. Other subpopulations were considered throughout the appraisal, defined by different eosinophil measurements, number of exacerbations and dependency (or lack thereof) on mOCS. Statistically significant reductions in clinically significant exacerbations were observed in patients receiving mepolizumab compared with SoC meta-analysed across MENSA and DREAM in the modified intention-to-treat (ITT) population (rate ratio [RR] 0.51; 95% confidence interval [CI] 0.42-0.62) as well as in the relevant population (RR 0.47; 95% CI 0.36-0.62). In terms of quality of life, differences on the St. George's Respiratory Questionnaire in MENSA for add-on subcutaneous mepolizumab 100 mg vs. placebo were 7 and 7.5 units in the modified ITT and relevant populations, respectively. A number of issues in the clinical evidence base warrant caution in its interpretation. The ERG noted that the definition of SoC used in the trials differed from that in clinical practice, where patients with severe uncontrolled asthma start treatment with a mOCS. The company's economic post-consultation analysis incorporating a confidential patient access scheme (PAS) estimated that the incremental cost-effectiveness ratio (ICER) for add-on mepolizumab compared with SoC was £27,418 per quality-adjusted life-year (QALY) gained in the relevant population if patients stopped mepolizumab after 1 year unless (1) the number of exacerbations decreased at least 50% or (2) a reduction in corticosteroids dose was achieved whilst maintaining asthma control. The ERG applied an age adjustment to all utilities and corrected the post-continuation assessment utilities, which resulted in an ICER for add-on mepolizumab compared with SoC of £29,163 per QALY gained. The ERG noted that this ICER was not robust for patients who continued treatment due to a corticosteroid dose reduction where exacerbations had decreased by less than 50%, because corticosteroid dose reduction was not allowed in the main trial in which the evidence was gathered (MENSA). The NICE appraisal committee (AC) concluded that add-on mepolizumab could be recommended as an option for treating severe refractory eosinophilic asthma in adults for the relevant population when the stopping rule suggested by the company was applied. The AC also concluded that the comparison between mepolizumab and omalizumab was not clinically relevant or methodologically robust.

Olaparib for Maintenance Treatment of BRCA 1 or 2 Mutated, Relapsed, Platinum-Sensitive Ovarian, Fallopian Tube and Peritoneal Cancer in People Whose Relapsed Disease has Responded to Platinum-Based Chemotherapy: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

PubMed

Tappenden, Paul; Harnan, Sue; Ren, Shijie; Thokala, Praveen; Wong, Ruth; Mukuria, Clara; Green, Clare; Pledge, Simon; Tidy, John

2017-01-01

As part of its Single Technology Appraisal process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of olaparib (AstraZeneca) to submit evidence on the clinical and cost effectiveness of olaparib for the maintenance treatment of BRCA1/2 mutated (BRCAm), platinum-sensitive relapsed (PSR) ovarian, fallopian tube and peritoneal cancer in people whose relapsed disease has responded to platinum-based chemotherapy. The Evidence Review Group (ERG) produced a critical review of the evidence contained within the company's submission (CS) to NICE. The clinical evidence related to one phase II, double-blind randomised controlled trial that recruited 265 patients with PSR serous ovarian cancer (OC) regardless of BRCAm status. Patients received olaparib 400 mg twice daily (b.i.d.) or matched placebo. In the whole population, the primary endpoint of progression-free survival (PFS) was met (hazard ratio [HR] 0.35; 95 % confidence interval [CI] 0.25-0.49, p < 0.01) for olaparib versus placebo. The BRCAm subgroup analysis (added after the study commenced but 1 month before the primary analysis was undertaken) reported an HR for PFS of 0.18 (95 % CI 0.10-0.31, p < 0.0001) for olaparib versus placebo, though interaction tests appeared inconclusive. Overall survival was not statistically significant in the whole group (HR 0.88; 95 % CI 0.64-1.21; p = 0.44) or the BRCAm subgroup (0.73; 95 % CI 0.45-1.17; p = 0.19), though treatment switching may have confounded results. The exclusion of data from sites allowing crossover resulted in an HR for overall survival (OS) of 0.52 (95 % CI 0.28-0.97, p = 0.039) in the BRCAm group. Health-related quality-of-life measures were not significantly different between groups. All post hoc exploratory outcomes (time to treatment discontinuation/death, time to first subsequent therapy/death, and time to second subsequent therapy/death) were statistically significantly better in the olaparib arm in the whole population and the BRCAm subgroup analyses. Adverse events were more frequent for olaparib but were largely minor or manageable. The company's semi-Markov model assessed the cost effectiveness of olaparib versus routine surveillance in patients with BRCAm PSR OC from a National Health Service (NHS) and Personal Social Services (PSS) perspective over a lifetime horizon. The model suggests that the incremental cost-effectiveness ratio (ICER) for olaparib versus routine surveillance is expected to be approximately £49,146 per quality-adjusted life-year (QALY) gained. The ERG did not consider the company's cost-effectiveness estimates to be credible. Additional ERG analyses suggested that the ICER is likely to be more than £92,214 per QALY gained. Additional analyses provided by the company in patients who received three or more lines of chemotherapy suggested a more favourable cost-effectiveness profile for olaparib. The NICE Appraisal Committee recommended olaparib for this subgroup provided the cost of olaparib for people who continue to receive treatment after 15 months will be met by the company.

Certolizumab Pegol for Treating Rheumatoid Arthritis Following Inadequate Response to a TNF-α Inhibitor: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

PubMed

Bermejo, Iñigo; Stevenson, Matt; Archer, Rachel; Stevens, John W; Goka, Edward; Clowes, Mark; Scott, David L; Young, Adam

2017-11-01

As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer (UCB Pharma) of certolizumab pegol (CZP; Cimzia ® ) to submit evidence of its clinical and cost effectiveness for the treatment of rheumatoid arthritis (RA) following inadequate response to a tumour necrosis factor-α inhibitor (TNFi). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a detailed review of the evidence for the clinical and cost effectiveness of the technology, based upon the company's submission to NICE. The clinical effectiveness evidence in the company's submission for CZP was based predominantly on six randomised controlled trials (RCTs) comparing the efficacy of CZP against placebo. The clinical effectiveness review identified no head-to-head evidence on the efficacy of CZP against the comparators within the scope; therefore, the company performed a network meta-analysis (NMA). The company's NMA concluded that CZP had a similar efficacy to that of its comparators. The company submitted a Markov model that assessed the incremental cost effectiveness of CZP versus comparator biologic disease-modifying antirheumatic drugs (bDMARDs) for the treatment of RA from the perspective of the National Health Service for three decision problems, each of which followed an inadequate response to a TNFi. These were (1) a comparison against rituximab (RTX) in combination with methotrexate (MTX); (2) a comparison against bDMARDs when RTX was contraindicated or withdrawn due to an adverse event; and (3) a comparison against bDMARDs when MTX was contraindicated or withdrawn due to an adverse event. Results from the company's economic evaluation showed that CZP resulted in a similar number of quality-adjusted life years (QALYs) produced at similar or lower costs compared with comparator bDMARDs. The commercial-in-confidence patient access schemes for abatacept and tocilizumab could not be incorporated by the company, but were incorporated by the ERG in a confidential appendix for the NICE Appraisal Committee (AC). The company estimated that the addition of CZP before RTX in a sequence for patients who could receive MTX produced more QALYs at an increased cost, with a cost per QALY of £33,222. Following a critique of the model, the ERG undertook exploratory analyses that did not change the conclusions reached based on the company's economic evaluation in relation to the comparison with bDMARDs. The ERG estimated that where CZP replaced RTX, CZP was dominated, as it produced fewer QALYs at an increased cost. The AC concluded that there was little difference in effectiveness between CZP and comparator bDMARDs and that equivalence among bDMARDs could be accepted. The AC consequently recommended CZP plus MTX for people for whom RTX is contraindicated or not tolerated and CZP monotherapy for people for whom MTX is contraindicated or not tolerated. The AC concluded that CZP plus MTX could not be considered a cost-effective use of National Health Service resources when RTX plus MTX is a treatment option.

The Clinical and Cost Effectiveness of Aflibercept in Combination with Irinotecan and Fluorouracil-Based Therapy (FOLFIRI) for the Treatment of Metastatic Colorectal Cancer Which has Progressed Following Prior Oxaliplatin-Based Chemotherapy: a Critique of the Evidence.

PubMed

Wade, Ros; Duarte, Ana; Simmonds, Mark; Rodriguez-Lopez, Rocio; Duffy, Steven; Woolacott, Nerys; Spackman, Eldon

2015-05-01

The National Institute for Health and Care Excellence (NICE) invited the manufacturer of aflibercept (Sanofi) to submit clinical and cost-effectiveness evidence for aflibercept in combination with irinotecan and fluorouracil-based therapy [irinotecan/5-fluorouracil/folinic acid (FOLFIRI)] for the treatment of metastatic colorectal cancer which has progressed following prior oxaliplatin-based chemotherapy, as part of the Institute's Single Technology Appraisal process. The Centre for Reviews and Dissemination and Centre for Health Economics at the University of York were commissioned to act as the independent Evidence Review Group (ERG). This article provides a description of the company submission, the ERG review and the resulting NICE guidance TA307 issued in March 2014. The ERG critically reviewed the evidence presented in the manufacturer's submission and identified areas requiring clarification, for which the manufacturer provided additional evidence. The clinical effectiveness data were derived from one good-quality double-blind randomised controlled trial (RCT), the VELOUR trial, which compared aflibercept plus FOLFIRI with placebo plus FOLFIRI. This RCT found a small but statistically significant increase in overall survival (OS); the difference in median OS was 1.44 months (13.5 months in the aflibercept group and 12.06 months in the placebo group). There was also a statistically significant increase in progression-free survival (PFS) with aflibercept; the difference in median PFS was 2.23 months (6.9 months in the aflibercept group and 4.67 months in the placebo group). However, grade 3-4 adverse events were more frequent in the aflibercept group than the placebo group: 83.5% compared with 62.5%. Treatment-emergent adverse events led to permanent discontinuation of treatment in 26.8% of patients in the aflibercept group and 12.1% of patients in the placebo group. The manufacturer's submission included an estimation of mean OS benefit based on extrapolation of the data, which was considerably longer than the median OS benefit reported (4.7 vs. 1.44 months). The ERG considered this to be an over estimate. The base-case incremental cost-effectiveness ratio (ICER) for the overall population was reported by the manufacturer to be £36,294 per quality-adjusted life-year (QALY). After correcting the model programming and updating the model to include the ERG's preferred parameter estimates, the ICER from the ERG's alternative base case was £54,368 per QALY. The extrapolation of the OS curves was the key cost-effectiveness driver and a major source of uncertainty in the model. Additional scenarios related to the extrapolation of OS undertaken by the ERG resulted in ICERs between £62,894 and £92,089 per QALY. After consideration of the manufacturer's submission and the ERG's critique, and submissions from other stakeholders, the NICE Appraisal Committee concluded that aflibercept in combination with irinotecan and fluorouracil-based therapy could not be considered a cost effective use of National Health Service resources for treating metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regimen. Aflibercept in combination with irinotecan and fluorouracil-based therapy is not recommended for the treatment of metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regimen in NICE guidance TA307.

Sipuleucel-T for the Treatment of Metastatic Hormone-Relapsed Prostate Cancer: A NICE Single Technology Appraisal; An Evidence Review Group Perspective.

PubMed

Simpson, Emma L; Davis, Sarah; Thokala, Praveen; Breeze, Penny R; Bryden, Peter; Wong, Ruth

2015-11-01

The National Institute for Health and Care Excellence (NICE) invited Dendreon, the company manufacturing sipuleucel-T, to submit evidence for the clinical and cost effectiveness of sipuleucel-T for asymptomatic or minimally symptomatic, metastatic, non-visceral hormone-relapsed prostate cancer patients in whom chemotherapy is not yet clinically indicated, as part of NICE's single technology appraisal process. The comparator was abiraterone acetate (AA) or best supportive care (BSC). The School of Health and Related Research at the University of Sheffield was commissioned to act as the Evidence Review Group (ERG). This paper describes the company submission (CS), ERG review, and subsequent decision of the NICE Appraisal Committee (AC). The ERG produced a critical review of the clinical and cost-effectiveness evidence of sipuleucel-T based upon the CS. Clinical-effectiveness data relevant to the decision problem were taken from three randomised controlled trials (RCTs) of sipuleucel-T and a placebo (PBO) comparator of antigen-presenting cells (APC) being re-infused (APC-PBO) (D9901, D9902A and D9902B), and one RCT (COU-AA-302) of AA plus prednisone vs. PBO plus prednisone. Two trials reported a significant advantage for sipuleucel-T in median overall survival compared with APC-PBO: for trial D9901, an adjusted hazard ratio (HR) 0.47; (95 % confidence interval [CI] 0.29, 0.76) p < 0.002; for D9902B, adjusted HR 0.78 (95 % CI 0.61, 0.98) p = 0.03. There was no significant difference between groups in D9902A, unadjusted HR 0.79 (95 % CI 0.48, 1.28) p = 0.331. Sipuleucel-T and APC-PBO groups did not differ significantly in time to disease progression, in any of the three RCTs. Most adverse events developed within 1 day of the infusion, and resolved within 2 days. The CS included an indirect comparison of sipuleucel-T (D9902B) and AA plus prednisone (COU-AA-302). As trials differed in prior use of chemotherapy, an analysis of only chemotherapy-naïve patients was included, in which the overall survival for sipuleucel-T and AA was not significantly different, HR 0.94 (95 % CI 0.69, 1.28) p = 0.699. The ERG had several concerns regarding the data and assumptions incorporated within the company's cost-effectiveness analyses and conducted exploratory analyses to quantify the impact of making alternative assumptions or using alternative data inputs. The deterministic incremental cost-effectiveness ratio (ICER) for sipuleucel-T vs. BSC when using the ERG's preferred data and assumptions was £ 108,585 per quality-adjusted life-year (QALY) in the whole licensed population and £ 61,204/QALY in the subgroup with low prostate-specific antigen at baseline. The ERG also conducted an incremental analysis comparing sipuleucel-T with both AA and BSC in the chemotherapy-naïve subgroup. Sipuleucel-T had a deterministic ICER of £ 111,682/QALY in this subgroup, when using the ERG's preferred assumptions, and AA was extendedly dominated. The ERG also concluded that estimates of costs and benefits for AA should be interpreted with caution given the limitations of the indirect comparison. The AC noted that the ICER for sipuleucel-T was well above the range usually considered cost effective, and did not recommend sipuleucel-T for the treatment of asymptomatic or minimally symptomatic, metastatic, non-visceral hormone-relapsed prostate cancer.

Flexible and Lightweight Pressure Sensor Based on Carbon Nanotube/Thermoplastic Polyurethane-Aligned Conductive Foam with Superior Compressibility and Stability.

PubMed

Huang, Wenju; Dai, Kun; Zhai, Yue; Liu, Hu; Zhan, Pengfei; Gao, Jiachen; Zheng, Guoqiang; Liu, Chuntai; Shen, Changyu

2017-12-06

Flexible and lightweight carbon nanotube (CNT)/thermoplastic polyurethane (TPU) conductive foam with a novel aligned porous structure was fabricated. The density of the aligned porous material was as low as 0.123 g·cm -3 . Homogeneous dispersion of CNTs was achieved through the skeleton of the foam, and an ultralow percolation threshold of 0.0023 vol % was obtained. Compared with the disordered foam, mechanical properties of the aligned foam were enhanced and the piezoresistive stability of the flexible foam was improved significantly. The compression strength of the aligned TPU foam increases by 30.7% at the strain of 50%, and the stress of the aligned foam is 22 times that of the disordered foam at the strain of 90%. Importantly, the resistance variation of the aligned foam shows a fascinating linear characteristic under the applied strain until 77%, which would benefit the application of the foam as a desired pressure sensor. During multiple cyclic compression-release measurements, the aligned conductive CNT/TPU foam represents excellent reversibility and reproducibility in terms of resistance. This nice capability benefits from the aligned porous structure composed of ladderlike cells along the orientation direction. Simultaneously, the human motion detections, such as walk, jump, squat, etc. were demonstrated by using our flexible pressure sensor. Because of the lightweight, flexibility, high compressibility, excellent reversibility, and reproducibility of the conductive aligned foam, the present study is capable of providing new insights into the fabrication of a high-performance pressure sensor.

NICeSim: an open-source simulator based on machine learning techniques to support medical research on prenatal and perinatal care decision making.

PubMed

Cerqueira, Fabio Ribeiro; Ferreira, Tiago Geraldo; de Paiva Oliveira, Alcione; Augusto, Douglas Adriano; Krempser, Eduardo; Corrêa Barbosa, Helio José; do Carmo Castro Franceschini, Sylvia; de Freitas, Brunnella Alcantara Chagas; Gomes, Andreia Patricia; Siqueira-Batista, Rodrigo

2014-11-01

This paper describes NICeSim, an open-source simulator that uses machine learning (ML) techniques to aid health professionals to better understand the treatment and prognosis of premature newborns. The application was developed and tested using data collected in a Brazilian hospital. The available data were used to feed an ML pipeline that was designed to create a simulator capable of predicting the outcome (death probability) for newborns admitted to neonatal intensive care units. However, unlike previous scoring systems, our computational tool is not intended to be used at the patients bedside, although it is possible. Our primary goal is to deliver a computational system to aid medical research in understanding the correlation of key variables with the studied outcome so that new standards can be established for future clinical decisions. In the implemented simulation environment, the values of key attributes can be changed using a user-friendly interface, where the impact of each change on the outcome is immediately reported, allowing a quantitative analysis, in addition to a qualitative investigation, and delivering a totally interactive computational tool that facilitates hypothesis construction and testing. Our statistical experiments showed that the resulting model for death prediction could achieve an accuracy of 86.7% and an area under the receiver operating characteristic curve of 0.84 for the positive class. Using this model, three physicians and a neonatal nutritionist performed simulations with key variables correlated with chance of death. The results indicated important tendencies for the effect of each variable and the combination of variables on prognosis. We could also observe values of gestational age and birth weight for which a low Apgar score and the occurrence of respiratory distress syndrome (RDS) could be less or more severe. For instance, we have noticed that for a newborn with 2000 g or more the occurrence of RDS is far less problematic than for neonates weighing less. The significant accuracy demonstrated by our predictive model shows that NICeSim might be used for hypothesis testing to minimize in vivo experiments. We observed that the model delivers predictions that are in very good agreement with the literature, demonstrating that NICeSim might be an important tool for supporting decision making in medical practice. Other very important characteristics of NICeSim are its flexibility and dynamism. NICeSim is flexible because it allows the inclusion and deletion of variables according to the requirements of a particular study. It is also dynamic because it trains a just-in-time model. Therefore, the system is improved as data from new patients become available. Finally, NICeSim can be extended in a cooperative manner because it is an open-source system. Copyright © 2014 Elsevier B.V. All rights reserved.

Doppler-broadened NICE-OHMS beyond the cavity-limited weak absorption condition - I. Theoretical description

NASA Astrophysics Data System (ADS)

Ma, Weiguang; Silander, Isak; Hausmaninger, Thomas; Axner, Ove

2016-01-01

Doppler-broadened (Db) noise-immune cavity-enhanced optical heterodyne molecular spectrometry (NICE-OHMS) is conventionally described by an expression (here referred to as the CONV expression) that is restricted to the case when the single-pass absorbance, α0L, is much smaller than the empty cavity losses, π/F [here termed the conventional cavity-limited weak absorption (CCLWA) condition]. This limits the applicability of the technique, primarily its dynamic range and calibration capability. To remedy this, this work derives extended descriptions of Db NICE-OHMS that are not restricted to the CCLWA condition. First, the general principles of Db NICE-OHMS are scrutinized in some detail. Based solely upon a set of general assumptions, predominantly that it is appropriate to linearize the Beer-Lambert law, that the light is modulated to a triplet, and that the Pound-Drever-Hall sidebands are fully reflected, a general description of Db NICE-OHMS that is not limited to any specific restriction on α0L vs. π/F, here referred to as the FULL description, is derived. However, this description constitutes a set of equations to which no closed form solution has been found. Hence, it needs to be solved numerically (by iterations), which is inconvenient. To circumvent this, for the cases when α0L<π/F but without the requirement that the stronger CCLWA condition needs to be fulfilled, a couple of simplified extended expressions that are expressible in closed analytical form, referred to as the extended locking and extended transmission description, ELET, and the extended locking and full transmission description, ELFT, have been derived. An analysis based on simulations validates the various descriptions and assesses to which extent they agree. It is shown that in the CCLWA limit, all extended descriptions revert to the CONV expression. The latter one deviates though from the extended ones for α0L around and above 0.1π/F. The two simplified extended descriptions agree with the FULL description for a larger range of α0 L than the CONV expression, viz. for the ELET description for α0L up to 0.3π/F and for ELFT for α0L up to 0.6 or 1.0 π/F (depending on the mode of detection). It is then demonstrated that the conventional view of Db NICE-OHMS, which states that the out-of-phase and the in-phase signals can be referred to as a pure absorption and dispersion signal, respectively, breaks down when the CCLWA condition does not hold. In this case, the out-of-phase signal is additionally affected by the phase shifts of the laser components (i.e. dispersion) while the in-phase signal is also influenced by their attenuation. Access to new descriptions broadens considerably the dynamic range of Db NICE-OHMS and facilitates calibration using standard references samples, and thereby its applicability.

PREPARE: guidelines for planning animal research and testing

PubMed Central

Smith, Adrian J; Clutton, R Eddie; Lilley, Elliot; Hansen, Kristine E Aa; Brattelid, Trond

2017-01-01

There is widespread concern about the quality, reproducibility and translatability of studies involving research animals. Although there are a number of reporting guidelines available, there is very little overarching guidance on how to plan animal experiments, despite the fact that this is the logical place to start ensuring quality. In this paper we present the PREPARE guidelines: Planning Research and Experimental Procedures on Animals: Recommendations for Excellence. PREPARE covers the three broad areas which determine the quality of the preparation for animal studies: formulation, dialogue between scientists and the animal facility, and quality control of the various components in the study. Some topics overlap and the PREPARE checklist should be adapted to suit specific needs, for example in field research. Advice on use of the checklist is available on the Norecopa website, with links to guidelines for animal research and testing, at https://norecopa.no/PREPARE. PMID:28771074

Revised American Thyroid Association guidelines for the management of medullary thyroid carcinoma.

PubMed

Wells, Samuel A; Asa, Sylvia L; Dralle, Henning; Elisei, Rossella; Evans, Douglas B; Gagel, Robert F; Lee, Nancy; Machens, Andreas; Moley, Jeffrey F; Pacini, Furio; Raue, Friedhelm; Frank-Raue, Karin; Robinson, Bruce; Rosenthal, M Sara; Santoro, Massimo; Schlumberger, Martin; Shah, Manisha; Waguespack, Steven G

2015-06-01

The American Thyroid Association appointed a Task Force of experts to revise the original Medullary Thyroid Carcinoma: Management Guidelines of the American Thyroid Association. The Task Force identified relevant articles using a systematic PubMed search, supplemented with additional published materials, and then created evidence-based recommendations, which were set in categories using criteria adapted from the United States Preventive Services Task Force Agency for Healthcare Research and Quality. The original guidelines provided abundant source material and an excellent organizational structure that served as the basis for the current revised document. The revised guidelines are focused primarily on the diagnosis and treatment of patients with sporadic medullary thyroid carcinoma (MTC) and hereditary MTC. The Task Force developed 67 evidence-based recommendations to assist clinicians in the care of patients with MTC. The Task Force considers the recommendations to represent current, rational, and optimal medical practice.

Revised American Thyroid Association Guidelines for the Management of Medullary Thyroid Carcinoma

PubMed Central

Asa, Sylvia L.; Dralle, Henning; Elisei, Rossella; Evans, Douglas B.; Gagel, Robert F.; Lee, Nancy; Machens, Andreas; Moley, Jeffrey F.; Pacini, Furio; Raue, Friedhelm; Frank-Raue, Karin; Robinson, Bruce; Rosenthal, M. Sara; Santoro, Massimo; Schlumberger, Martin; Shah, Manisha; Waguespack, Steven G.

2015-01-01

Introduction: The American Thyroid Association appointed a Task Force of experts to revise the original Medullary Thyroid Carcinoma: Management Guidelines of the American Thyroid Association. Methods: The Task Force identified relevant articles using a systematic PubMed search, supplemented with additional published materials, and then created evidence-based recommendations, which were set in categories using criteria adapted from the United States Preventive Services Task Force Agency for Healthcare Research and Quality. The original guidelines provided abundant source material and an excellent organizational structure that served as the basis for the current revised document. Results: The revised guidelines are focused primarily on the diagnosis and treatment of patients with sporadic medullary thyroid carcinoma (MTC) and hereditary MTC. Conclusions: The Task Force developed 67 evidence-based recommendations to assist clinicians in the care of patients with MTC. The Task Force considers the recommendations to represent current, rational, and optimal medical practice. PMID:25810047

PREPARE: guidelines for planning animal research and testing.

PubMed

Smith, Adrian J; Clutton, R Eddie; Lilley, Elliot; Hansen, Kristine E Aa; Brattelid, Trond

2018-04-01

There is widespread concern about the quality, reproducibility and translatability of studies involving research animals. Although there are a number of reporting guidelines available, there is very little overarching guidance on how to plan animal experiments, despite the fact that this is the logical place to start ensuring quality. In this paper we present the PREPARE guidelines: Planning Research and Experimental Procedures on Animals: Recommendations for Excellence. PREPARE covers the three broad areas which determine the quality of the preparation for animal studies: formulation, dialogue between scientists and the animal facility, and quality control of the various components in the study. Some topics overlap and the PREPARE checklist should be adapted to suit specific needs, for example in field research. Advice on use of the checklist is available on the Norecopa website, with links to guidelines for animal research and testing, at https://norecopa.no/PREPARE .

A Theoretically Based Behavioral Nutrition Intervention for Community Elders at High Risk: The B-NICE Randomized Controlled Clinical Trial

PubMed Central

LOCHER, JULIE L.; BALES, CONNIE W.; ELLIS, AMY C.; LAWRENCE, JEANNINE C.; NEWTON, LAURA; RITCHIE, CHRISTINE S.; ROTH, DAVID L.; BUYS, DAVID L.; VICKERS, KRISTIN S.

2012-01-01

We conducted a study designed to evaluate the efficacy and feasibility of a multilevel self-management intervention to improve nutritional intake in a group of older adults receiving Medicare home health services who were at especially high risk for experiencing undernutrition. The Behavioral Nutrition Intervention for Community Elders (B-NICE) trial used a prospective randomized controlled design to determine whether individually tailored counseling focused on social and behavioral aspects of eating resulted in increased caloric intake and improved nutrition-related health outcomes in a high-risk population of older adults. The study was guided by the theoretical approaches of the Ecological Model and Social Cognitive Theory. The development and implementation of the B-NICE protocol, including the theoretical framework, methodology, specific elements of the behavioral intervention, and assurances of the treatment fidelity, as well as the health policy implications of the trial results, are presented in this article. PMID:22098180

Do children go for the nice guys? The influence of speaker benevolence and certainty on selective word learning.

PubMed

Bergstra, Myrthe; DE Mulder, Hannah N M; Coopmans, Peter

2018-04-06

This study investigated how speaker certainty (a rational cue) and speaker benevolence (an emotional cue) influence children's willingness to learn words in a selective learning paradigm. In two experiments four- to six-year-olds learnt novel labels from two speakers and, after a week, their memory for these labels was reassessed. Results demonstrated that children retained the label-object pairings for at least a week. Furthermore, children preferred to learn from certain over uncertain speakers, but they had no significant preference for nice over nasty speakers. When the cues were combined, children followed certain speakers, even if they were nasty. However, children did prefer to learn from nice and certain speakers over nasty and certain speakers. These results suggest that rational cues regarding a speaker's linguistic competence trump emotional cues regarding a speaker's affective status in word learning. However, emotional cues were found to have a subtle influence on this process.

The topography of generosity: asymmetric evaluations of prosocial actions.

PubMed

Klein, Nadav; Epley, Nicholas

2014-12-01

Prosociality is considered a virtue. Those who care for others are admired, whereas those who care only for themselves are despised. For one's reputation, it pays to be nice. Does it pay to be even nicer? Four experiments assess reputational inferences across the entire range of prosocial outcomes in zero-sum interactions, from completely selfish to completely selfless actions. We observed consistent nonlinear evaluations: Participants evaluated selfish actions more negatively than equitable actions, but they did not evaluate selfless actions markedly more favorably than equitable actions. This asymptotic pattern reflected monotonic evaluations for increasingly selfish actions and insensitivity to increasingly selfless actions. It pays to be nice but not to be really nice. Additional experiments suggest that this pattern stems partly from failing to make spontaneous comparisons between varying degrees of selflessness. We suggest that these reputational incentives could guide social norms, encouraging equitable actions but discouraging extremely selfless actions. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Memories of good deeds past: The reinforcing power of prosocial behavior in children.

PubMed

Tasimi, Arber; Young, Liane

2016-07-01

Does considering one's past prosociality affect future behavior? Prior research has revealed instances in which adults engage in additional prosocial behavior-moral reinforcement-as well as instances in which adults engage in worse behavior-moral licensing. The current study examined the developmental origins of these effects by testing whether 6- to 8-year-old children (N=225) are more or less generous after recalling their own good deeds. Children were asked to recount a time when they were nice, were mean, or watched a movie. Children behaved more generously after recalling a time when they were nice. We show that this boost in generosity was not simply the result of instructing children to consider nice behavior; children's giving did not increase after recalling others' good deeds. We also show that, even after recounting multiple instances of their past goodness, children continue to behave more generously. These findings suggest that doing good leads to more good in children. Copyright © 2016 Elsevier Inc. All rights reserved.

The food choice at work study: effectiveness of complex workplace dietary interventions on dietary behaviours and diet-related disease risk - study protocol for a clustered controlled trial

PubMed Central

2013-01-01

Background Dietary behaviour interventions have the potential to reduce diet-related disease. Ample opportunity exists to implement these interventions in the workplace. The overall aim is to assess the effectiveness and cost-effectiveness of complex dietary interventions focused on environmental dietary modification alone or in combination with nutrition education in large manufacturing workplace settings. Methods/design A clustered controlled trial involving four large multinational manufacturing workplaces in Cork will be conducted. The complex intervention design has been developed using the Medical Research Council’s framework and the National Institute for Health and Clinical Excellence (NICE) guidelines and will be reported using the TREND statement for the transparent reporting of evaluations with non-randomized designs. It will draw on a soft paternalistic “nudge” theoretical perspective. Nutrition education will include three elements: group presentations, individual nutrition consultations and detailed nutrition information. Environmental dietary modification will consist of five elements: (a) restriction of fat, saturated fat, sugar and salt, (b) increase in fibre, fruit and vegetables, (c) price discounts for whole fresh fruit, (d) strategic positioning of healthier alternatives and (e) portion size control. No intervention will be offered in workplace A (control). Workplace B will receive nutrition education. Workplace C will receive nutrition education and environmental dietary modification. Workplace D will receive environmental dietary modification alone. A total of 448 participants aged 18 to 64 years will be selected randomly. All permanent, full-time employees, purchasing at least one main meal in the workplace daily, will be eligible. Changes in dietary behaviours, nutrition knowledge, health status with measurements obtained at baseline and at intervals of 3 to 4 months, 7 to 9 months and 13 to 16 months will be recorded. A process evaluation and cost-effectiveness economic evaluation will be undertaken. Discussion A 'Food Choice at Work’ toolbox (concise teaching kit to replicate the intervention) will be developed to inform and guide future researchers, workplace stakeholders, policy makers and the food industry. Trial registration Current Controlled Trials, ISRCTN35108237 PMID:24192134

UK Renal Registry 16th annual report: chapter 10 haemoglobin, ferritin and erythropoietin amongst UK adult dialysis patients in 2012: national and centre-specific analyses.

PubMed

Rao, Anirudh; Gilg, Julie; Williams, Andrew

2013-01-01

Anaemia treatment in chronic kidney disease (CKD) patients has changed dramatically since the implementation of erythropoietin stimulating agents (ESAs) and has shifted the emphasis from treating severe anaemia in dialysis patients to preventing anaemia. The aim of this chapter is to determine the extent to which the UK Renal Association (RA) and National Institute for Health and Care Excellence (NICE) guidelines for anaemia management are met in the UK. Quarterly data were obtained for haemoglobin (Hb) and factors that influence Hb from UK renal centres for the incident and prevalent renal replacement therapy (RRT) cohorts for 2012. In the UK, in 2012, 51% of patients commenced dialysis therapy with Hb 100 g/L (median Hb 100 g/L). Of patients in the early presentation group, 54% started dialysis with Hb 100 g/L whilst 34% of patients presenting late started dialysis with Hb 100 g/L. The UK median Hb of haemodialysis (HD) patients was 112 g/L, with 82% of patients having Hb 100 g/L. The median Hb of peritoneal dialysis (PD) patients in the UK was 114 g/L, with 85% of patients having Hb 100 g/L. The median ferritin in HD patients in the UK was 431 µg/L and 95% of HD patients had a ferritin 100 µg/L. In EW&NI the median ferritin in PD patients was 285 µg/L (IQR 164-466) with 88% of PD patients having a ferritin 100 µg/L. In EW&NI the median ESA dose was higher for HD than PD patients (7,248 vs. 4,250 IU/week). The percentage of patients treated with an ESA and having Hb >120 g/L ranged between centres from 7-39% for HD and from 0-33% for PD. There was poor correlation between median Hb achieved and median ferritin and ESA usage across the EW&NI centres. There was also a significant variation between centres in the percentages of patients treated with an ESA and having Hb >120 g/L. © 2014 S. Karger AG, Basel.

Epidemiology of children with head injury: a national overview

PubMed Central

Trefan, L; Houston, R; Pearson, G; Edwards, R; Hyde, P; Maconochie, I; Parslow, RC; Kemp, A

2016-01-01

Background The National Confidential Enquiry describes the epidemiology of children admitted to hospital with head injury. Method Children (<15 years old) who died or were admitted for >4 h with head injury were identified from 216 UK hospitals (1 September 2009 to 28 February 2010). Data were collected using standard proformas and entered on to a database. A descriptive analysis of the causal mechanisms, child demographics, neurological impairment, CT findings, and outcome at 72 h are provided. Results Details of 5700 children, median age 4 years (range 0–14.9 years), were analysed; 1093 (19.2%) were <1 year old, 3500 (61.4%) were boys. There was a significant association of head injury with social deprivation 39.7/100 000 (95% CI 37.0 to 42.6) in the least deprived first quintile vs. 55.1 (95% CI 52.1 to 58.2) in the most deprived fifth quintile (p<0.01). Twenty-four children died (0.4%). Most children were admitted for one night or less; 4522 (79%) had a Glasgow Coma Scale score of 15 or were Alert (on AVPU (Alert, Voice, Pain, Unresponsive)). The most common causes of head injury were falls (3537 (62.1%); children <5 years), sports-related incidents (783 (13.7%); median age 12.4 years), or motor vehicle accidents (MVAs) (401 (7.1%); primary-school-aged children). CT scans were performed in 1734 (30.4%) children; 536 (30.9%) were abnormal (skull fracture and/or intracranial injury or abnormality): 269 (7.6%) were falls, 82 (10.5%) sports related and 100 (25%). A total of 357 (6.2%) children were referred to social care because of child protection concerns (median age 9 months (range 0–14.9 years)). Conclusions The data described highlight priorities for targeted age-specific head injury prevention and have the potential to provide a baseline to evaluate the effects of regional trauma networks (2012) and National Institute of Health and Care Excellence (NICE) head injury guidelines (2014), which were revised after the study was completed. PMID:26998632

Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD-'Assessing QbTest Utility in ADHD' (AQUA): a randomised controlled trial.

PubMed

Hall, Charlotte L; Walker, Gemma M; Valentine, Althea Z; Guo, Boliang; Kaylor-Hughes, Catherine; James, Marilyn; Daley, David; Sayal, Kapil; Hollis, Chris

2014-12-01

The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current 'gold standard' ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome. This multisite randomised controlled trial will recruit young people (aged 6-17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice. The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young people with ADHD. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval. NCT02209116. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The food choice at work study: effectiveness of complex workplace dietary interventions on dietary behaviours and diet-related disease risk - study protocol for a clustered controlled trial.

PubMed

Geaney, Fiona; Scotto Di Marrazzo, Jessica; Kelly, Clare; Fitzgerald, Anthony P; Harrington, Janas M; Kirby, Ann; McKenzie, Ken; Greiner, Birgit; Perry, Ivan J

2013-11-06

Dietary behaviour interventions have the potential to reduce diet-related disease. Ample opportunity exists to implement these interventions in the workplace. The overall aim is to assess the effectiveness and cost-effectiveness of complex dietary interventions focused on environmental dietary modification alone or in combination with nutrition education in large manufacturing workplace settings. A clustered controlled trial involving four large multinational manufacturing workplaces in Cork will be conducted. The complex intervention design has been developed using the Medical Research Council's framework and the National Institute for Health and Clinical Excellence (NICE) guidelines and will be reported using the TREND statement for the transparent reporting of evaluations with non-randomized designs. It will draw on a soft paternalistic 'nudge' theoretical perspective. It will draw on a soft paternalistic "nudge" theoretical perspective. Nutrition education will include three elements: group presentations, individual nutrition consultations and detailed nutrition information. Environmental dietary modification will consist of five elements: (a) restriction of fat, saturated fat, sugar and salt, (b) increase in fibre, fruit and vegetables, (c) price discounts for whole fresh fruit, (d) strategic positioning of healthier alternatives and (e) portion size control. No intervention will be offered in workplace A (control). Workplace B will receive nutrition education. Workplace C will receive nutrition education and environmental dietary modification. Workplace D will receive environmental dietary modification alone. A total of 448 participants aged 18 to 64 years will be selected randomly. All permanent, full-time employees, purchasing at least one main meal in the workplace daily, will be eligible. Changes in dietary behaviours, nutrition knowledge, health status with measurements obtained at baseline and at intervals of 3 to 4 months, 7 to 9 months and 13 to 16 months will be recorded. A process evaluation and cost-effectiveness economic evaluation will be undertaken. A 'Food Choice at Work' toolbox (concise teaching kit to replicate the intervention) will be developed to inform and guide future researchers, workplace stakeholders, policy makers and the food industry. Current Controlled Trials, ISRCTN35108237.

Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD—‘Assessing QbTest Utility in ADHD’ (AQUA): a randomised controlled trial

PubMed Central

Hall, Charlotte L; Walker, Gemma M; Valentine, Althea Z; Guo, Boliang; Kaylor-Hughes, Catherine; James, Marilyn; Daley, David; Sayal, Kapil; Hollis, Chris

2014-01-01

Introduction The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current ‘gold standard’ ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome. Methods and analysis This multisite randomised controlled trial will recruit young people (aged 6–17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice. Ethics and dissemination The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young people with ADHD. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval. Trial registration number NCT02209116. PMID:25448628

Quality assessment of clinical practice guidelines for eosinophilic esophagitis using the AGREE II instrument.

PubMed

Lucendo, Alfredo J; Arias, Ángel; Redondo-González, Olga; Molina-Infante, Javier

2017-04-01

High-quality evidence-based clinical practice guidelines can guide diagnosis and treatment to optimize outcomes. We aimed to systematically review the quality of international guidelines on eosinophilic esophagitis (EoE). MEDLINE and Scopus databases were searched for appropriate guidelines up to 2016. Two gastroenterologists and two methodologists independently evaluated the documents using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. Amongst the 25 records initially retrieved, four guidelines developed by recognized scientific organizations met inclusion criteria. AGREE II results varied widely across domains, but none achieved an overall assessment score of over 60%. Scope and purpose (61.82 ± 19.24%), clarity of presentation (57.13 ± 40.56%) and editorial independence (93.75 ± 1.69%) showed the highest mean rating, whereas stakeholder involvement (28.82 ± 11.19%), rigor of development (32.29 ± 12.02%) and applicability (21.62 ± 7.14%) did not reach quality thresholds. Intraclass correlation coefficients for agreement was excellent among appraisers (0.903), between gastroenterologists and methodologists (0.878) and for each individual guideline (0.838 to 0.955). Clinical practice guidelines for EoE vary significantly in quality, are invariably limited and currently, none can be 'strongly recommended'.

Guideline of guidelines: asymptomatic microscopic haematuria.

PubMed

Linder, Brian J; Bass, Edward J; Mostafid, Hugh; Boorjian, Stephen A

2018-02-01

The aim of the present study was to review major organizational guidelines on the evaluation and management of asymptomatic microscopic haematuria (AMH). We reviewed the haematuria guidelines from: the American Urological Association; the consensus statement by the Canadian Urological Association, Canadian Urologic Oncology Group and Bladder Cancer Canada; the American College of Physicians; the Joint Consensus Statement of the Renal Association and British Association of Urological Surgeons; and the National Institute for Health and Care Excellence. All guidelines reviewed recommend evaluation for AMH in the absence of potential benign aetiologies, with the evaluation including cystoscopy and upper urinary tract imaging. Existing guidelines vary in their definition of AMH (role of urine dipstick vs urine microscopy), the age threshold for recommending evaluation, and the optimal imaging method (computed tomography vs ultrasonography). Of the reviewed guidelines, none recommended the use of urine cytology or urine markers during the initial AMH evaluation. Patients should have ongoing follow-up after a negative initial AMH evaluation. Significant variation exists among current guidelines for AMH with respect to who should be evaluated and in what manner. Given the patient and health system implications of balancing appropriately focused and effective diagnostic evaluation, AMH represents a valuable future research opportunity. © 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.

Structured syncope care pathways based on lean six sigma methodology optimises resource use with shorter time to diagnosis and increased diagnostic yield.

PubMed

Martens, Leon; Goode, Grahame; Wold, Johan F H; Beck, Lionel; Martin, Georgina; Perings, Christian; Stolt, Pelle; Baggerman, Lucas

2014-01-01

To conduct a pilot study on the potential to optimise care pathways in syncope/Transient Loss of Consciousness management by using Lean Six Sigma methodology while maintaining compliance with ESC and/or NICE guidelines. Five hospitals in four European countries took part. The Lean Six Sigma methodology consisted of 3 phases: 1) Assessment phase, in which baseline performance was mapped in each centre, processes were evaluated and a new operational model was developed with an improvement plan that included best practices and change management; 2) Improvement phase, in which optimisation pathways and standardised best practice tools and forms were developed and implemented. Staff were trained on new processes and change-management support provided; 3) Sustaining phase, which included support, refinement of tools and metrics. The impact of the implementation of new pathways was evaluated on number of tests performed, diagnostic yield, time to diagnosis and compliance with guidelines. One hospital with focus on geriatric populations was analysed separately from the other four. With the new pathways, there was a 59% reduction in the average time to diagnosis (p = 0.048) and a 75% increase in diagnostic yield (p = 0.007). There was a marked reduction in repetitions of diagnostic tests and improved prioritisation of indicated tests. Applying a structured Lean Six Sigma based methodology to pathways for syncope management has the potential to improve time to diagnosis and diagnostic yield.

Structured Syncope Care Pathways Based on Lean Six Sigma Methodology Optimises Resource Use with Shorter Time to Diagnosis and Increased Diagnostic Yield

PubMed Central

Martens, Leon; Goode, Grahame; Wold, Johan F. H.; Beck, Lionel; Martin, Georgina; Perings, Christian; Stolt, Pelle; Baggerman, Lucas

2014-01-01

Aims To conduct a pilot study on the potential to optimise care pathways in syncope/Transient Loss of Consciousness management by using Lean Six Sigma methodology while maintaining compliance with ESC and/or NICE guidelines. Methods Five hospitals in four European countries took part. The Lean Six Sigma methodology consisted of 3 phases: 1) Assessment phase, in which baseline performance was mapped in each centre, processes were evaluated and a new operational model was developed with an improvement plan that included best practices and change management; 2) Improvement phase, in which optimisation pathways and standardised best practice tools and forms were developed and implemented. Staff were trained on new processes and change-management support provided; 3) Sustaining phase, which included support, refinement of tools and metrics. The impact of the implementation of new pathways was evaluated on number of tests performed, diagnostic yield, time to diagnosis and compliance with guidelines. One hospital with focus on geriatric populations was analysed separately from the other four. Results With the new pathways, there was a 59% reduction in the average time to diagnosis (p = 0.048) and a 75% increase in diagnostic yield (p = 0.007). There was a marked reduction in repetitions of diagnostic tests and improved prioritisation of indicated tests. Conclusions Applying a structured Lean Six Sigma based methodology to pathways for syncope management has the potential to improve time to diagnosis and diagnostic yield. PMID:24927475

Auckland City Hospital's Ortho-Geriatric Service: an audit of patients aged over 65 with fractured neck of femur.

PubMed

Wimalasena, Bodhi; Harris, Roger

2016-07-01

The aims of this audit were to collect the Minimum Data Set outlined by the Australia New Zealand Hip Fracture Registry (ANZHFR), assess patient characteristics, analyse process of care, and evaluate how this compares to NICE guidelines for hip fracture care, as well as to Auckland Hospital data from 2007. Retrospective case record audit of patients with fractured neck of femur aged 65 years and over admitted under Orthopaedics over a 4-month period in 2013. Ninety-one patients were audited; mean age was 83 years, 68% were female. Both inpatient and 30-day mortality was 5%. 120-day mortality was 15%. Seventy-six percent of patients were admitted from ED within the national health target prescribed period of 6 hours. Only one patient was treated non-surgically. Eighty-six percent had surgery within 48 hours of admission. Eighty-two percent of patients had rehabilitation and treatment by Older People's Health. Of those living at home pre-fracture, 76% returned home on discharge. Thirty-seven percent of patients were able to walk unaided prior to hip fracture, but only 1% on discharge. Average overall length of stay was 22 days. Bisphosphonates were prescribed for 56% of patients. Compared to 2007, Auckland City Hospital has demonstrated a significant improvement in the rate of provision of timely surgery for hip fracture patients. Most patients are receiving the guideline recommended fracture-specific surgical interventions. The assessment and treatment of osteoporosis needs further attention.

Kentucky's Automotive Certification Program.

ERIC Educational Resources Information Center

Kentucky State Dept. of Education, Frankfort. Office of Vocational Education.

The state of Kentucky recognized a need to standardize automotive mechanics training throughout the state and to establish minimum guidelines for the quality of instruction in such programs. To meet these needs, the Office of Vocational Education selected the National Institute for Automotive Service Excellence (ASE) and began the certification…

Deliberating Tarceva: A case study of how British NHS managers decide whether to purchase a high-cost drug in the shadow of NICE guidance.

PubMed

Hughes, David; Doheny, Shane

2011-11-01

This paper examines audio-recorded data from meetings in which NHS managers decide whether to fund high-cost drugs for individual patients. It investigates the work of a Welsh individual patient commissioning (IPC) panel responsible for sanctioning the purchase of 'un-commissioned' treatments for exceptional cases. The case study presented highlights the changing rationales used for approving or denying a cancer drug, Tarceva, during a period when NICE first suggested it was not cost effective, but then changed its position in a final technology appraisal recommending use when the cost did not exceed that of an alternative product. Our data show how decisions taken in the shadow of NICE guidance remain complex and subject to local discretion. Guidance that takes time to prepare, is released in stages, and relates to particular disease stages, must be interpreted in the context of particular cases. The case-based IPC panel discourse stands in tension with the standardised population-based recommendations in guidance. Panel members, who based their decisions on the central notions of 'efficacy' and 'exceptionality', often struggled to apply NICE information on cost-effectiveness to their deliberations on efficacy (clinical effectiveness). The case study suggests that the complex nature of decision making makes standardization of outcomes very difficult to achieve, so that local professional judgement is likely to remain central to health care rationing at this level. Copyright © 2011 Elsevier Ltd. All rights reserved.

What and How Are We Evaluating? Meta-Evaluation Study of the NASA Innovations in Climate Education (NICE) Portfolio

NASA Astrophysics Data System (ADS)

Martin, A. M.; Barnes, M. H.; Chambers, L. H.; Pippin, M. R.

2011-12-01

As part of NASA's Minority University Research and Education Program (MUREP), the NASA Innovations in Climate Education (NICE) project at Langley Research Center has funded 71 climate education initiatives since 2008. The funded initiatives span across the nation and contribute to the development of a climate-literate public and the preparation of a climate-related STEM workforce through research experiences, professional development opportunities, development of data access and modeling tools, and educational opportunities in both K-12 and higher education. Each of the funded projects proposes and carries out its own evaluation plan, in collaboration with external or internal evaluation experts. Using this portfolio as an exemplar case, NICE has undertaken a systematic meta-evaluation of these plans, focused primarily on evaluation questions, approaches, and methods. This meta-evaluation study seeks to understand the range of evaluations represented in the NICE portfolio, including descriptive information (what evaluations, questions, designs, approaches, and methods are applied?) and questions of value (do these evaluations meet the needs of projects and their staff, and of NASA/NICE?). In the current climate, as federal funders of climate change and STEM education projects seek to better understand and incorporate evaluation into their decisions, evaluators and project leaders are also seeking to build robust understanding of program effectiveness. Meta-evaluations like this provide some baseline understanding of the current status quo and the kinds of evaluations carried out within such funding portfolios. These explorations are needed to understand the common ground between evaluative best practices, limited resources, and agencies' desires, capacity, and requirements. When NASA asks for evaluation of funded projects, what happens? Which questions are asked and answered, using which tools? To what extent do the evaluations meet the needs of projects and program officers? How do they contribute to best practices in climate science education? These questions are important to ask about STEM and climate literacy work more generally; the NICE portfolio provides a broad test case for thinking strategically, critically, and progressively about evaluation in our community. Our findings can inform the STEM education, communication, and public outreach communities, and prompt us to consider a broad range of informative evaluation options. During this presentation, we will consider the breadth, depth and utility of evaluations conducted through a NASA climate education funding opportunity. We will examine the relationship between what we want to know about education programs, what we want to achieve with our interventions, and what we ask in our evaluations.

What and How Are We Evaluating? Meta-Evaluation Study of the NASA Innovations in Climate Education (NICE) Portfolio

NASA Astrophysics Data System (ADS)

Martin, A. M.; Barnes, M. H.; Chambers, L. H.; Pippin, M. R.

2013-12-01

As part of NASA's Minority University Research and Education Program (MUREP), the NASA Innovations in Climate Education (NICE) project at Langley Research Center has funded 71 climate education initiatives since 2008. The funded initiatives span across the nation and contribute to the development of a climate-literate public and the preparation of a climate-related STEM workforce through research experiences, professional development opportunities, development of data access and modeling tools, and educational opportunities in both K-12 and higher education. Each of the funded projects proposes and carries out its own evaluation plan, in collaboration with external or internal evaluation experts. Using this portfolio as an exemplar case, NICE has undertaken a systematic meta-evaluation of these plans, focused primarily on evaluation questions, approaches, and methods. This meta-evaluation study seeks to understand the range of evaluations represented in the NICE portfolio, including descriptive information (what evaluations, questions, designs, approaches, and methods are applied?) and questions of value (do these evaluations meet the needs of projects and their staff, and of NASA/NICE?). In the current climate, as federal funders of climate change and STEM education projects seek to better understand and incorporate evaluation into their decisions, evaluators and project leaders are also seeking to build robust understanding of program effectiveness. Meta-evaluations like this provide some baseline understanding of the current status quo and the kinds of evaluations carried out within such funding portfolios. These explorations are needed to understand the common ground between evaluative best practices, limited resources, and agencies' desires, capacity, and requirements. When NASA asks for evaluation of funded projects, what happens? Which questions are asked and answered, using which tools? To what extent do the evaluations meet the needs of projects and program officers? How do they contribute to best practices in climate science education? These questions are important to ask about STEM and climate literacy work more generally; the NICE portfolio provides a broad test case for thinking strategically, critically, and progressively about evaluation in our community. Our findings can inform the STEM education, communication, and public outreach communities, and prompt us to consider a broad range of informative evaluation options. During this presentation, we will consider the breadth, depth and utility of evaluations conducted through a NASA climate education funding opportunity. We will examine the relationship between what we want to know about education programs, what we want to achieve with our interventions, and what we ask in our evaluations.

The use of isotretinoin in acne

PubMed Central

2009-01-01

Systemic isotretinoin remains the most efficacious treatment for severe acne as well as many cases of more moderate disease that are unresponsive to other treatment modalities. The current chapter outlines the mechanisms behind the excellent efficacy, describes how to optimize treatment, reviews the recommended guidelines for monitoring and summarizes adverse effects. PMID:20436884

Health and Wellbeing: A Policy Context for Physical Education in Scotland

ERIC Educational Resources Information Center

Horrell, Andrew; Sproule, John; Gray, Shirley

2012-01-01

The "Curriculum for Excellence" (CfE) guidelines and associated learning experiences and outcomes have been developed following a national debate on the purposes of education in Scotland. The recent development shifts physical education's (PE) role in Scottish education, changing from contributing to the "Expressive Arts" area…

Going Beyond, Going Further: Preparative Exercises in General Chemistry.

ERIC Educational Resources Information Center

Kauffman, George B.

1987-01-01

Proposes that preparative chemistry is an important and integral part of chemistry as a whole, and an excellent way to introduce students to descriptive chemistry. Provides an outline for students to follow for converting and transforming salts. Suggests a set of general guidelines for studying anion and cation transformations. (TW)

78 FR 43925 - Solicitation for a Cooperative Agreement-Executive Excellence a Training and Development Program...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-22

... leadership skill building, exposure to ethical and value based issues, self-awareness, strategic thinking... development, communication, feedback, Type Theory, emotional intelligence, self awareness and group dynamics... Requirements: Documents or other media that are produced under this award must follow these guidelines: Prior...

External cavity diode laser-based detection of trace gases with NICE-OHMS using current modulation.

PubMed

Centeno, R; Mandon, J; Cristescu, S M; Axner, O; Harren, F J M

2015-03-09

We combine an external cavity diode laser with noise-immune cavity-enhanced optical heterodyne molecular spectroscopy (NICE-OHMS) using current modulation. With a finesse of 1600, we demonstrate noise equivalent absorption sensitivities of 4.1 x 10(-10) cm(-1) Hz(-1/2), resulting in sub-ppbv detection limits for Doppler-broadened transitions of CH(4) at 6132.3 cm(-1), C(2)H(2) at 6578.5 cm(-1) and HCN at 6541.7 cm(-1). The system is used for hydrogen cyanide detection from sweet almonds.