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

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).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.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.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

Depression in adults with a chronic physical health problem: treatment and management

The NHS National Institute for Health and Clinical Excellence (NICE, 2009) publication – Depression in adults with a chronic physical health problem: treatment and management – is a clinical practice guideline for the UK which partially updates and extends the earlier depression management in primary and secondary care guideline (NICE, 2004). Like other clinical guidelines, it has been systematically developed from the best available research evidence to assist clinicians and patients, and service commissioners and providers in making decisions about the most appropriate treatment and service organisation for this important area of health care need. The National Collaborating Centre for Mental Health (one of a number of centres established by NICE for the purpose of clinical guideline development) together with a guideline development group, comprising health and social care professionals, lay and patient representatives, and technical experts, worked on the guidance. The process from initial scope preparation to the production of the final guideline took over two years. As with other NICE recommendations, the development of this guidance has involved extensive stakeholder consultations at the initial scoping phase that defined the aspects of care covered and to whom it would apply, and later when the draft guideline was prepared. The aim of this editorial is to bring this important document to the attention of nurses and midwives worldwide who work with depression sufferers

NICE medical technologies guidance: aims for clinical practice

NICE (the National Institute for Health and Care Excellence) produces a range of advice and guidance on medical practice and technologies. NICE was established in 1999, and in 2009 set up its Medical Technologies Evaluation Programme. This assesses new devices in terms of whether their use would offer benefits to the patient and NHS at a lower cost compared with current practice, or increased benefits for equal cost. NICE evaluates single products only, as multiple product assessments are time-consuming and mean that manufacturers have to wait longer for NICE to produce guidance on adoption of their technologies. Research into devices and diagnostics is often sparse and of low quality as there is little regulation requiring good research in this area. As a result, products are often not accepted for evaluation, because the evidence base supporting their claimed benefits is so poor

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

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

Sense and sensitivity: on situated questioning about self-harm and suicidal inclination in the primary care consultation

The link between depression and suicide is, in modern medical knowledge, a ‘given’. The canons of contemporary psychiatry, without exception, specify that ‘suicidal ideation’ (like the physical acts of self-harm and actual suicide) is at once a symptom of the illness and, simultaneously, a ‘characteristic’ (if not inevitable) outcome (American Psychiatric Association, 1994; World Health Organization, 1994). National Health Service directives in the UK, meanwhile, specify that, in any primary care consultation where a patient either demonstrably has - or is suspected to have - a depression, it is incumbent upon a General Practitioner to assess any danger they may present to themselves (National Institute for Clinical Excellence, 2009; NHS Centre for Reviews and Dissemination, 2002). Guidelines recommend this be done through ‘direct questioning’ of the patient (National Institute for Clinical Excellence, 2007) regarding their thoughts or activities relating to self-harm or suicide. Given that 'suicidal ideation' is itself not only classified as a ‘possible outcome’ of depression but also a key symptom of the condition, such a question has, in some cases, to be asked pre-diagnosis as part of diagnostic assessment. In this paper, examples of such questioning in three different consultations are explored in detail using Conversation Analysis (Sacks, 1992a; Sacks, 1992b; Silverman, 1997) with a view to describing some of the organised interactional methods employed by GPs, and patients, in negotiating this potentially highly ‘tricky’ activity. These observations are then used to highlight a range of issues pertinent to the formulation of ‘normative’ frames of ‘good practice with respect of handling such sensitive issues (Petit & Sederer, 2006; Tylee, Priest, & Roberts, 1996). References: American Psychiatric Association. (1994). Diagnostic and statistical manual of mental disorders (4th ed.). Washington: American Psychiatric Association. National Institute for Clinical Excellence. (2007). Depression: Management of depression in primary and secondary care. clinical guideline 23 (amended). London: National Institute For Clinical Excellence. National Institute for Clinical Excellence. (2009). Depression: The NICE guideline on the treatment and management of depression in adults (updated edition). clinical guideline 90. Leicester: The British Psychological Society / The Royal College of Psychiatrists. NHS Centre for Reviews and Dissemination. (2002). Improving the recognition and management of depression in primary care. Effective Health Care, 7(5) Petit, J., & Sederer, L. I. (2006). Detecting and treating depression in adults. City Health Information, 25(1), 1-8. Sacks, H. (1992a). Lectures on conversation, vol. 1. Oxford: Blackwell. Sacks, H. (1992b). Lectures on conversation, vol. 2. Oxford: Blackwell. Silverman, D. (1997). Discourses of counselling: HIV counselling as social interaction. London: Sage. Tylee, A., Priest, R., & Roberts, A. (1996). Depression in general practice. London: Martin Dunitz. World Health Organization. (1994). The ICD-10 classification of mental and behavioural disorders: Diagnostic criteria for research. Geneva: WHO

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.

This is the final version of the article. Available from the publisher via the DOI in this record.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.Access to the QUANTIS database to extract the relevant Hospital Episode Statistics data was funded by Medtronic UK

Calculation Skills: Acne Rosacea

National Institute for Health and Care Excellence (NICE) (2016) define acne rosacea as an inflammatory skin condition, which is chronic in nature. It can involve the forehead, eyes, nose, cheeks and chin. Signs and symptoms include thickened skin, telangiectasia, erythema, pustules, facial flushing, facial swelling and ocular rosacea (Culp and Scheinfeld, 2009). NICE (2016) identify that there are five key types of acne rosacea: •Papulopustular rosacea, which presents as erythema to the centre of the face with papules and/or pustules •Erythematotelangiectatic rosacea, which presents as facial flushing, erythema to the centre of the face, with or without telangiectasia •Ocular rosacea, presenting as inflammation of the eye and eyelid •Granulomatous rosacea, which presents as hard, uniform papules, red, yellow or brown in colour •Phymatous rosacea characterised by irregular, thickened skin. Individuals can experience a number of types concurrently and with differing degrees of severity

Schedules for Self-monitoring Blood Pressure: A Systematic Review

BACKGROUND Self-monitoring of blood pressure better predicts prognosis than clinic measurement, is popular with patients, and endorsed in hypertension guidelines. However, there is uncertainty over the optimal selfmonitoring schedule. We therefore aimed to determine the optimum schedule to predict future cardiovascular events and determine “true” underlying blood pressure. METHODS Six electronic databases were searched from November 2009 (updating a National Institute for Health and Care Excellence [NICE] systematic review) to April 2017. Studies that compared aspects of self-monitoring schedules to either prognosis or reliability/reproducibility in hypertensive adults were included. Data on study and population characteristics, self-monitoring regime, and outcomes were extracted by 2 reviewers independently. RESULTS From 5,164 unique articles identified, 25 met the inclusion criteria. Twelve studies were included from the original NICE review, making a total of 37 studies. Increasing the number of days of measurement improved prognostic power: 72%–91% of the theoretical maximum predictive value (asymptotic maximum hazard ratio) was reached by 3 days and 86%–96% by 7 days. Increasing beyond 3 days of measurement did not result in better correlation with ambulatory monitoring. There was no convincing evidence that the timing or number of readings per day had an effect, or that ignoring the first day’s measurement was necessary. CONCLUSIONS Home blood pressure should be measured for 3 days, increased to 7 only when mean blood pressure is close to a diagnostic or treatment threshold. Other aspects of a monitoring schedule can be flexible to facilitate patient uptake of and adherence with self-monitoring.We thank Siobhan Milner, Nashat Qamar, and Sally Fillingham for their support in screening studies. This article presents independent research commissioned by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research funding scheme (RP-PG-1209–10051). R.J.M. was funded by an NIHR Professorship (NIHR-RP-R2-12–015). R.J.M. and F.D.R.H. receive support from the NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRC) Oxford. The guideline development work undertaken by R.O.M., R.J.M, and B.W. received funding from the National Institute for Health and Care Excellence. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR, the Department of Health, or the National Institute for Health and Care Excellence

The effectiveness of schemes that refine referrals between primary and secondary care - the UK experience with glaucoma referrals: the Health Innovation & Education Cluster (HIEC) Glaucoma Pathways Project

Objectives: A comparison of glaucoma referral refinement schemes (GRRS) in the UK during a time period of considerable change in national policy and guidance. Design: Retrospective multisite review. Setting: The outcomes of clinical examinations by optometrists with a specialist interest in glaucoma (OSIs) were compared with optometrists with no specialist interest in glaucoma (non-OSIs). Data from Huntingdon and Nottingham assessed non-OSI findings, while Manchester and Gloucestershire reviewed OSI findings. Participants: 1086 patients. 434 patients were from Huntingdon, 179 from Manchester, 204 from Gloucestershire and 269 from Nottingham. Results: The first-visit discharge rate (FVDR) for all time periods for OSIs was 14.1% compared with 36.1% from non-OSIs (difference 22%, CI 16.9% to 26.7%; p<0.001). The FVDR increased after the April 2009 National Institute for Health and Clinical Excellence (NICE) glaucoma guidelines compared with pre-NICE, which was particularly evident when pre-NICE was compared with the current practice time period (OSIs 6.2–17.2%, difference 11%, CI −24.7% to 4.3%; p=0.18, non-OSIs 29.2–43.9%, difference 14.7%, CI −27.8% to −0.30%; p=0.03). Elevated intraocular pressure (IOP) was the commonest reason for referral for OSIs and non-OSIs, 28.7% and 36.1%, respectively, of total referrals. The proportion of referrals for elevated IOP increased from 10.9% pre-NICE to 28.0% post-NICE for OSIs, and from 19% to 45.1% for non-OSIs. Conclusions: In terms of ‘demand management’, OSIs can reduce FVDR of patients reviewed in secondary care; however, in terms of ‘patient safety’ this study also shows that overemphasis on IOP as a criterion for referral is having an adverse effect on both the non-OSIs and indeed the OSIs ability to detect glaucomatous optic nerve features. It is recommended that referral letters from non-OSIs be stratified for risk, directing high-risk patients straight to secondary care, and low-risk patients to OSIs

The prevention of fractures in adults

Background General practitioners (GPs) encounter patients who have suffered a fracture or are at an increased risk. Fragility fractures cost Europe 32 billion Euros per year. Recognizing this challenge and understanding its management allows GPs to engage in primary and secondary prevention of fragility fractures. Aim To illustrate lifestyle and pharmacological management options offered by a general practitioner to an adult at increased risk of fractures or low bone mineral density (BMD). The National Osteoporosis Guideline Group (NOGG, 2016), World Health Organisation (WHO), International Osteoporosis Foundation (IOF, 2012), Kidney Disease Improving Global Outcomes (KDIGO, 2009), Scottish Intercollegiate Guidelines Network (SIGN) and National Institute for Health and Care Excellence (NICE) management guidelines are discussed in this regard. Objectives • To provide key definitions in the management of osteoporosis. • To identify groups at risk of developing low BMD, vitamin D deficiency and fragility fractures. • To illustrate the current management options for an adult at increased risk of fractures or low bone mass by a general practitioner. • To discuss current methods of investigation and measurement of low BMD, fracture risk assessment and vitamin D deficiency. • To address dietary requirements of calcium and vitamin D and local formulations available. Method A literature search was conducted using Pubmed and Google search engines. Keywords included: osteoporosis; low bone mineral density; vitamin D; fragility fracture; postmenopausal. The NOGG (2016), WHO, IOF (2012), KDIGO (2009), SIGN and NICE management guidelines were included directly. Treatments ranging from fall prevention, dietary modification, anti-resorptive therapy and tailoring in subgroups were reviewed. Conclusion Guidelines can close the gap between physicians in primary and secondary care, institutions and private practice providing a multifaceted approach for the proper identification, prevention and management of fragility fractures.peer-reviewe