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Primary Care Clinical Effectiveness Bulletin December - February 2011 Edition no. 2 Welcome to the second edition of South West London Primary Care Clinical Effectiveness Bulletin, a digest of information focusing on primary care and public health evidence, guidelines and new research with the aim of informing and enabling best practice. The information has been collated from National Institute of Health & Clinical Excellence (NICE), NHS Evidence (formerly National Library for Health), Scottish Intercollegiate Guidelines (SIGN) and Clinical Knowledge Summaries (CKS). The title of each piece of guidance is also a hyperlink to the Website (e.g. NICE) where the complete document(s) are available for reading/downloading. This Bulletin (as well as previous editions) is also available via NHS Wandsworth Website CEMMaG page. CONTENTS 1. Clinical Guidelines and Care Pathways - NICE clinical guidelines: Sedation in children and young people Generalised anxiety disorder Anaemia management in people with chronic kidney disease Alcohol use disorders: diagnosis, assessment and management of harmful drinking and alcohol dependence in adults and in young people aged 10–17 years Food allergy in children and young people - SIGN clinical guideline on the Management of early rheumatoid arthritis - Updated topics on Clinical Knowledge Summaries (CKS) - ‘Eyes on Evidence’ (NHS Evidence) 2. Public Health Guidance - NICE Public Health guidance on skin cancer prevention 3. SW London Effective Commissioning Initiative 4. Local Guidelines and Shared care prescribing guidelines 5. NICE Technology Appraisals and Interventional Procedure Guidance 6. Other useful information NICE consultations for your comments NICE News SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 1 of 17 1. Clinical Guidelines and Care Pathways CG112 Sedation for diagnostic and therapeutic procedures in children and young people (Dec 10) (Relevant to primary and secondary care) This guideline will ensure that anxious young NHS patients do not receive ineffective or unsafe sedation drugs ahead of any therapeutic or diagnostic procedure. Large numbers of children undergo single or repeated procedures which may require sedation. These can include diagnostic tests, like a biopsy or MRI scan, or therapeutic procedures such as correcting a dislocated joint or dental treatment. While the NHS uses numerous sedation techniques there is little guidance on which are most effective and what resources, including staff training, are needed to administer them safely. This guideline gives clear recommendations and promotes best practice on the use of sedation techniques to standardise the level of care children, young people and their families can expect from the NHS. The following is extracted from the NICE CG112 Quick Reference Guide and should be read in the context NICE guidance documents (also available via the hyperlink above): SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 2 of 17 CG113 Generalised anxiety disorder and panic disorder in adults (Jan 11) (Relevant to primary care) This clinical guideline updates and replaces NICE clinical guideline 22 (published December 2004; amended April 2007). It offers evidence-based advice on the care and treatment of adults with generalised anxiety disorder (GAD) or panic disorder (with or without agoraphobia). New and updated recommendations on the management of GAD were included in 2011. Generalised anxiety disorder is a very common but under-recognised condition characterised by endless worrying, which results in substantial disability for many sufferers, affecting their capacity to work and to live fulfilled and meaningful lives. Many develop secondary disorders, such as panic and depression, and it's much more common in people with chronic physical ill-health. GAD can vary in its severity and complexity for each person, and for this reason it is very important to consider how each patient should be treated individually. The new recommendations include health professionals considering a diagnosis of GAD in patients presenting with anxiety or significant worry, and in those frequently attending primary care who have a chronic physical health problem, or do not have a physical health problem but are seeking re-assurance about somatic symptoms or are repeatedly worrying about a range of different issues. The following is copied from the NICE CG113 QRG (also available via the hyperlink above): The key priorities for implementation have been chosen from the updated recommendations on the management of GAD. Step 1: All known and suspected presentations of GAD Identification Identify and communicate the diagnosis of GAD as early as possible to help people understand the disorder and start effective treatment promptly. Consider the diagnosis of GAD in people presenting with anxiety or significant worry, and in people who attend primary care frequently who: o have a chronic physical health problem or o do not have a physical health problem but are seeking reassurance about somatic symptoms (particularly older people and people from minority ethnic groups) or o are repeatedly worrying about a wide range of different issues. Step 2: Diagnosed GAD that has not improved after step 1 interventions Low-intensity psychological interventions for GAD For people with GAD whose symptoms have not improved after education and active monitoring in step 1, offer one or more of the following as a first-line intervention, guided by the person’s preference: o individual non-facilitated self-help o individual guided self-help o psychoeducational groups. Step 3: GAD with marked functional impairment or that has not improved after step 2 interventions Treatment options For people with GAD and marked functional impairment, or those whose symptoms have not responded adequately to step 2 interventions: Offer either: o an individual high-intensity psychological intervention (see page 12) or o drug treatment (see page 13). o Provide verbal and written information on the likely benefits and disadvantages of each mode of treatment, including the tendency of drug treatments to be associated with side effects and withdrawal syndromes. Base the choice of treatment on the person’s preference as there is no evidence that either mode of treatment (individual high-intensity psychological intervention or drug treatment) is better. High-intensity psychological interventions If a person with GAD chooses a high-intensity psychological intervention, offer either cognitive behavioural therapy (CBT) or applied relaxation. Drug treatment If a person with GAD chooses drug treatment, offer a selective serotonin reuptake inhibitor (SSRI). Consider offering sertraline first because it is the most cost-effective drug, but note that at the time of publication (January 2011) sertraline did not have UK marketing authorisation for this indication. Informed consent should be obtained and documented. Monitor the person carefully for adverse reactions. Do not offer a benzodiazepine for the treatment of GAD in primary or secondary care except as a short-term measure during crises. Follow the advice in the ‘British national formulary’ on the use of a benzodiazepine in this context. Do not offer an antipsychotic for the treatment of GAD in primary care. Inadequate response to step 3 interventions Consider referral to step 4 if the person with GAD has severe anxiety with marked functional impairment in conjunction with: o a risk of self-harm or suicide or o significant comorbidity, such as drug misuse, personality disorder or complex physical health problems or o self-neglect or o an inadequate response to step 3 interventions. SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 3 of 17 CG114 Anaemia management in people with chronic kidney disease (Feb 11) (Relevant to primary and secondary care) New evidence has prompted the NICE to update its recommendations on the levels of haemoglobin that help doctors determine when their patients with chronic kidney disease should receive treatment, as well as the safe haemoglobin limits that they should aspire to keep their patients within. In 2006, NICE advised healthcare professionals to maintain the haemoglobin levels of their patients with CKD between 10.5 and 12.5 g/dl for adults, teenagers and children aged 2 and above, and between 10 and 12 g/dl for children under two years. Further studies have since been published which indicate that having haemoglobin levels above 12 g/dl doesn't bring any additional clinical benefit and may even possibly cause some health risks. In response, NICE has updated these recommendations and is now advising healthcare professionals treating anaemia of CKD with erythropoiesis stimulating agents to maintain the haemoglobin range between 10 and 12g/dl for adults, teenagers and children over two years, and to between 9.5 and 11.5 g/dl for those under two years of age. NICE is also urging doctors to not wait until their patients' haemoglobin levels are outside of these ranges before adjusting their treatments (e.g. they should act when their patient's haemoglobin levels are within 0.5 g/dl of the range's limit). Other updated recommendations from NICE on the management of anaemia in CKD include: Consider investigating and managing anaemia in people with CKD if: o Their haemoglobin (Hb) level falls to 11g/dl or less (or 10.5 g/dl[1]or less if younger than 2 years) or o They develop symptoms attributable to anaemia, e.g. tiredness, shortness of breath, lethargy and palpitations. When determining individual Hb ranges for people with anaemia in CKD, take into account patient preferences, symptoms and comorbidities and the required treatment. Consider accepting Hb levels below the agreed aspirational range if: High doses of ESAs are required to achieve the aspirational range, or The aspirational range is not achieved despite escalating ESA doses. Consider accepting Hb levels above the agreed aspirational range when: These develop with iron therapy alone or These develop with low doses of ESAs or It is thought that the person might benefit (e.g. if they have a physically demanding job) or The absolute risk of cerebrovascular disease is thought to be low. [see next page for flow chart copied from the NICE Quick Reference Guide (also available via the hyperlink above)] SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 4 of 17 This overview of the management of anaemia of CKD provides an outline of the key stages of managing anaemia of CKD. It does not cover all of the recommendations in the NICE guideline, and additional information is summarised elsewhere in the QRG. SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 5 of 17 CG115 Alcohol use disorders: diagnosis, assessment and management of harmful drinking and alcohol dependence (Feb 11) (Relevant to primary care) This guideline makes recommendations on the diagnosis, assessment and management of harmful drinking and alcohol dependence in adults and in young people aged 10–17 years. The following Key Recommendations are taken directly from the NICE Quick Reference Guide (also available via the hyperlink above). Identification and assessment in all settings Staff working in services provided and funded by the NHS who care for people who potentially misuse alcohol should be competent to identify harmful drinking and alcohol dependence. They should be competent to initially assess the need for an intervention or, if they are not competent, they should refer people who misuse alcohol to a service that can provide an assessment of need. Assessment in specialist alcohol services Consider a comprehensive assessment for all adults referred to specialist services who score more than 15 on the Alcohol Use Disorders Identification Test (AUDIT). A comprehensive assessment should assess multiple areas of need, be structured in a clinical interview, use relevant and validated clinical tools, and cover the following areas: o alcohol use, including: consumption: historical and recent patterns of drinking (using, for example, a retrospective drinking diary), and if possible, additional information (for example, from a family member or carer) dependence (using, for example, SADQ or Leeds Dependence Questionnaire [LDQ]) alcohol-related problems (using, for example, Alcohol Problems Questionnaire [APQ]) other drug misuse, including over-the-counter medication physical health problems psychological and social problems cognitive function (using, for example, the Mini-Mental State Examination [MMSE]) readiness and belief in ability to change. General principles for all interventions Consider offering interventions to promote abstinence and prevent relapse as part of an intensive structured community-based intervention for people with moderate and severe alcohol dependence who have: o very limited social support (for example, they are living alone or have very little contact with family or friends) or o complex physical or psychiatric comorbidities or o not responded to initial community-based interventions. All interventions for people who misuse alcohol should be delivered by appropriately trained and competent staff. Pharmacological interventions should be administered by specialist and competent staff. Psychological interventions should be based on a relevant evidence-based treatment manual, which should guide the structure and duration of the intervention. Staff should consider using competence frameworks developed from the relevant treatment manuals and for all interventions should: o receive regular supervision from individuals competent in both the intervention and supervision o routinely use outcome measurements to make sure that the person who misuses alcohol is involved in reviewing the effectiveness of treatment o engage in monitoring and evaluation of treatment adherence and practice competence, for example, by using video and audio tapes and external audit and scrutiny if appropriate. Interventions for harmful drinking and mild alcohol dependence For harmful drinkers and people with mild alcohol dependence, offer a psychological intervention (such as cognitive behavioural therapies, behavioural therapies or social network and environment-based therapies) focused specifically on alcohol-related cognitions, behaviour, problems and social networks. Assessment for assisted alcohol withdrawal For service users who typically drink over 15 units of alcohol per day, and/or who score 20 or more on the AUDIT, consider offering: o an assessment for and delivery of a community-based assisted withdrawal, or o assessment and management in specialist alcohol services if there are safety concerns about a community-based assisted withdrawal. Interventions for moderate and severe alcohol dependence After a successful withdrawal for people with moderate and severe alcohol dependence consider offering acamprosate or oral naltrexone in combination with an individual psychological intervention (cognitive behavioural therapies, behavioural therapies or social network and environment-based therapies) focused specifically on alcohol misuse. Assessment and interventions for children and young people who misuse alcohol For children and young people aged 10–17 years who misuse alcohol offer: o individual cognitive behavioural therapy for those with limited comorbidities and good social support o multicomponent programmes (such as multidimensional family therapy, brief strategic family therapy, functional family therapy or multisystemic therapy) for those with significant comorbidities and/or limited social support. SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 6 of 17 Interventions for conditions comorbid with alcohol misuse For people who misuse alcohol and have comorbid depression or anxiety disorders, treat the alcohol misuse first as this may lead to significant improvement in the depression and anxiety. If depression or anxiety continues after 3 to 4 weeks of abstinence from alcohol, undertake an assessment of the depression or anxiety and consider referral and treatment in line with the relevant NICE guideline for the particular disorder. 1. 2. 3. If a drug is used at a dose or for an application that does not have UK marketing authorisation, informed consent should be obtained and documented. At the time of publication (February 2011), oral naltrexone did not have UK marketing authorisation for this indication. Informed consent should be obtained and documented. See ‘Depression in adults’ NICE clinical guideline 90 (2009) and ‘Anxiety’, NICE clinical guideline 113 CG116 Food allergy in children and young people (Feb 11) (Relevant to primary care) This guideline gives clear recommendations on the diagnosis and assessment of children and young people with suspected food allergy. It warns against the use of some alternative and high street testing. Reactions can be extremely severe; hospital admissions in the UK for food allergies have increased by 500% since 1990, and there has been a dramatic increase in prevalence in the last twenty years, ranging from 6% to 8% in children up to the age of 3 years across Europe and North America. The most common foods to which children and young people are allergic include cow's milk; fish and shellfish; hen's eggs; peanuts, tree nuts and sesame; soy; wheat and kiwi fruit. Food allergy in children can manifest itself in a range of symptoms, and so the guideline recommends that it should be considered if the child has one or a combination of the following, including: - Skin conditions such as eczema or acute urticaria (itchy rash) - Gastrointestinal problems such as vomiting, nausea or constipation - Respiratory complaints such as sneezing, or shortness of breath - Anaphylaxis (severe, hyper-sensitive reaction) and other allergic reactions. Food allergy should also be considered in children in some other circumstances. If a food allergy is suspected, the GP or other healthcare professional should take an allergy-focused clinical history, tailored to the presenting symptoms and age of the patient. This should include a family history of allergies, an assessment of the symptoms, details of any foods that are avoided and reasons why, and feeding history as an infant. A physical examination (dependent on the allergy-focused clinical history) should pay particular attention to growth, and physical signs of malnutrition. The guideline also recommends offering the patient appropriate information based on the type of allergy suspected, the risk of severe allergic reaction, and the diagnostic process. This may include excluding specific foods from the diet and reintroducing these foods with reoccurrence of the allergic reaction confirming diagnosis. Diagnosis may also include skin prick and/or blood tests for IgE (immunoglobulin) antibodies because specific antibodies suggest particular allergic reactions. Alternative methods of diagnosis readily available on the high street or via the internet are not recommended. There is currently very little evidence to show that these tests work. This guideline has been produced to help provide consistency in the way that food allergy is diagnosed. Of those children who report an allergy, there are at present up to 20% who wrongly self-report diagnoses of various food allergies and do not eat certain foods because they think they are allergic to them, but have not had a confirmed diagnosis. Referral to secondary care should be considered if the child has ongoing problems including faltering growth, vomiting, abdominal pain, loose or frequent stools, or constipation, in combination with other gastrointestinal symptoms. The following Care Pathway is copied directly from the NICE Quick Reference Guide (also available via the hyperlink above). Place the 3 pages vertically on top of each other to view. SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 7 of 17 SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 8 of 17 SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 9 of 17 SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 10 of 17 SIGN Guideline 123 – Management of early rheumatoid arthritis (Feb 11) This guideline will be of particular interest to rheumatologists, general practitioners rheumatology nurse specialists, physiotherapists, occupational therapists, dietitians, podiatrists and pharmacists. It provides advice on the treatment of early RA (<5 years duration from symptom onset and background information, recommendations and discussion on: diagnosis of early RA principles of management of RA disease modifying anti-rheumatic drug therapy the role of the multidisciplinary team. The guideline does not address the treatment of comorbidities (e.g. anaemia, osteoporosis), complications of drug therapy and their management, or treatment of extra-articular disease ’Eyes on Evidence’ (NHS Evidence) Issue 20 Issue 21 Issue 22 - December 2010 January 2011 February 2011 This monthly bulletin covers major new evidence as it emerges with an explanation about what it means for current practice. NHS Clinical Knowledge Summaries (CKS) (formerly PRODIGY) are a reliable source of evidencebased information and practical 'know how’ about the common conditions managed in primary care. February 2011 Alopecia, androgenetic - female (new) Alopecia, androgenetic - male (new) Benign paroxysmal positional vertigo (new) Breastfeeding problems (new) Delirium (new) Hypothyroidism Pruritus vulvae Pulmonary embolism (new) Vestibular neuronitis (new) January 2011 Bedwetting (enuresis) Hyponatraemia (new) Prostate cancer (new) December 2010 Cervical cancer and HPV (new) Diabetes - type 1 (new) Diarrhoea - adults assessment (new) Insulin therapy in type 1 diabetes (new) Pancreatitis - acute (new) Pancreatitis - chronic (new) Pityriasis rosea (new) Whooping cough (new) SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 11 of 17 2. Public Health Guidance PH32 Skin cancer prevention: information, resources and environmental changes (Jan 11) This guidance encourages a balanced approach to sun exposure protection, helping to ensure that skin cancer prevention activities do not discourage outdoor physical activity, while encouraging people to use sensible skin protection. It focuses on how the NHS and local authorities can help prevent skin cancer using public information, sun protection resources and by making changes to the natural and built environment. Malignant melanoma is the most serious type of skin cancer and causes the majority of skin cancer deaths - around 2,500 per year. It is estimated that the NHS spends approximately £70 million on skin cancer each year. Recommendations cover: Information provision including national prevention campaigns and integrating campaign messages within existing national health promotion programmes: Protecting children, young people and outdoor workers: Consideration of providing shade when designing and constructing new buildings and communal outdoor areas. The following recommendations relevant to primary care are taken directly from the NICE QRG (also available via the hyperlink above): Recommendation 3: Information provision: message content Ensure messages include a simple explanation of how UV exposure can damage the skin and how environmental factors can affect the level of sun exposure. (Factors include: geographical location, cloud cover, seasonal variations, UV forecasts or solar UV index and the availability of shade.) Ensure messages explain how someone can assess their own level of risk (for example, if they have pale skin, red hair, freckles or lots of moles then they should take extra care). They should also stress the importance of checking the skin regularly for any changes (such as changes to any moles) and where to go for further advice if changes are detected. Ensure messages give a balanced picture of both the risks of overexposure and the benefits of being out in the sun. (The risks include skin cancer, the benefits include boosting vitamin D levels and increasing the likelihood of being physically active.) (Further information on vitamin D can be obtained from the Department of Health or the Food Standards Agency.) Ensure messages include a range of options to help protect the skin against UV damage (including details of where to get further advice and information). This could include the following: o Avoid getting sunburnt Avoid excess or prolonged sun exposure. This includes staying in the sun until the skin goes red. If you need to be out in the sun (for example, for work purposes), then protect your skin as much as possible to avoid burning. o When and how to protect Protect the skin when it is sunny, both in the UK and abroad, by spending time in the shade between 11am and 3pm. Where possible, wear clothing that protects areas which may be vulnerable to burning and apply sunscreen. This includes a broad-brimmed hat that shades the face, neck and ears, a long-sleeved top and trousers. Where possible, choose close-weave fabrics that don’t allow the sun through. o Sunscreens Sunscreens should not be used as an alternative to clothing and shade, rather they should offer additional protection. (Note, no sunscreen product provides 100% protection against the sun.) Choose a ‘broad spectrum’ sunscreen which offers both UVA and UVB protection. It should be at least SPF 15 to protect against UVB and offer high UVA protection (in the UK, this is indicated by at least four stars and the circular UVA logo). Use water resistant products if sweating or contact with water is likely. o Sunscreen application Apply liberally half an hour before and after going out in the sun (don’t forget your head, neck and ears). Re-apply at least every 2 hours and immediately after being in water, even if the sunscreen is ‘water resistant’. Also re-apply after towel drying. If applied adequately, SPF 15 should be sufficient. Recommendation 4 Information provision: tailoring the message Ensure messages are simple, succinct and tailored for the target group. For example, they should be tailored for those with different skin types, those who work outdoors, those taking winter and summer holidays in the sun and the parents of children and young people. Ensure messages take account of cognitive ability (in particular, in relation to children). They should also encourage people to be sensible in the sun. For example, they could appeal to carer or parental concerns for their child, or tap into general concerns about the ageing effects of the sun. Ensure messages address the social and practical barriers to using sun protection. This includes: o acknowledging the common perception that a sun-tanned appearance is attractive o acknowledging that sunshine is a good source of vitamin D o acknowledging that sunshine encourages people to be physically active SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 12 of 17 stressing how easy it is for people to apply sunscreen and that ‘protective’, loose fitting and light clothing can be attractive and comfortable to wear o acknowledging that people mistakenly believe that the health risks of overexposure are minimal, and that malignant melanoma and squamous cell carcinoma are not serious conditions. Phrase messages in such a way that they enhance people’s belief in their ability to change – and encourage them to make those changes. Use positive statements such as: ‘Using sunscreen with high UVA protection (as indicated by UVA stars and the UVA circle logo) increases the chances of keeping skin healthy and young looking’. Note: negative messages are not so effective. These include, for example, ‘Not using sunscreen increases the risk of skin cancer and sun exposure prematurely ages the skin’. Ensure messages are delivered in a way that meets the target audience’s preferences (for example by radio, text messaging or leaflets). o 3. SW London Effective Commissioning Initiative (ECI) The ECI provides sets of patient criteria to inform the commissioning of a range of surgical interventions in South West London. The interventions can be classified into four groups: Procedures with limited evidence of effectiveness. Procedures where initial conservative therapy is possible. Effective procedures where a threshold for intervention may be appropriate. Procedures where NHS provision may be inappropriate The ECI policy document has recently been expanded and updated. It is also currently available on front page of both the NHSW Website and Intranet. Primary Care clinicians should consult the ECI document to ensure that they are aware of the procedures and the criteria (if any) used for approving them. If you have any queries regarding this ongoing project, please contact [email protected] (consultant in Public Health). 4. Local Guidelines and Shared care prescribing guidelines NHSW Clinical Effectiveness and Medicines Management Group (CEMMaG) met at the beginning of March and approved the following local guidelines: ADHD Shared Care Prescribing Guideline Somatropin Shared Care Prescribing Guideline Antibiotic Prescribing Guidelines for Primary Care – updated Shared Care Guideline on Leflunomide for active Rheumatoid Arthritis and Psoriatic Arthritis in Adults Prescribing Guidelines of Infant Formula for Infants with Cow’s Milk Protein Allergy (CMPA) or Lactose Intolerance (NB this should be read in conjunction with NICE CG116 Food allergy in children and young people - see above) Gluten-free Foods Prescribing Guideline Referral criteria for Suspected Sleep Disorders (and referral form for Obstructive Sleep Apnoea service) These guidelines can be accessed directly via this hyperlink to the CEMMaG webpage on the NHS Wandsworth Website. 5. NICE Technology Appraisals and Interventional Procedures Guidance TA210 Clopidogrel and modified-release dipyridamole for the prevention of occlusive vascular events (Review of TA90) (Dec 10) (Relevant to secondary care) The guidance is for people at high risk of occlusive vascular events because they have previously had an ischaemic stroke, a heart attack, a transient ischaemic attack, or have been diagnosed with a condition called peripheral arterial disease. It makes specific recommendations for people who have cardiovascular disease in more than one vascular site (multivascular disease): SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 13 of 17 Clopidogrel (initiated with the least costly licensed preparation) as an option for people who have had an ischaemic stroke, who have peripheral arterial disease or who have multivascular disease. Clopidogrel is only recommended as an option for people who have had a heart attack if they cannot take aspirin. Modified-release dipyridamole plus aspirin as an option for people who have had a transient ischaemic attack. For people who have had an ischaemic stroke, modified-release dipyridamole plus aspirin should only be used where clopidogrel is contraindicated or not tolerated. Modified-release dipyridamole alone as an option for people who have had an ischaemic stroke or a transient ischaemic attack, only where treatment with aspirin and clopidogrel is contraindicated or not tolerated. TA211 Constipation (women) - prucalopride (Dec 10) (Relevant to primary & secondary care) NICE recommends prucalopride (Resolor, Movetis) as a treatment option for some women with chronic constipation in whom laxatives have not provided adequate relief and that prucalopride should only be considered in women: who have tried at least two different types of laxatives from different classes (at the highest tolerated recommended doses) for at least six months, but have not had relief from constipation, and in whom invasive treatment is being considered. Prucalopride should only be prescribed by a clinician with experience of treating chronic constipation, and who has reviewed the woman's previous course of laxatives. If treatment with prucalopride is not effective after four weeks, the benefit of continuing treatment should be reconsidered. TA212 Colorectal cancer (metastatic) - bevacizumab (Dec 10) (Relevant to secondary care) NICE does not recommend bevacizumab (Avastin, Roche) in combination with chemotherapy (oxaliplatin and either fluorouracil or capecitabine) for treating metastatic colorectal cancer. NICE Chief Executive, Sir Andrew Dillon, said: "We have recommended several treatments for various stages of colorectal cancer, including cetuximab for the first-line treatment of metastatic colorectal cancer. The evidence we reviewed for bevacizumab in combination with chemotherapy suggests that patients receiving it for colorectal cancer may on average live for six weeks longer than patients receiving standard chemotherapy and a placebo. We know how important this could be to patients and we are disappointed not to able to recommend this drug combination, but we have to be confident that its benefits justify its considerable cost." TA213 Aripiprazole for schizophrenia in people aged 15 to 17 years (Jan 11) (Relevant to secondary care mental health) NICE has recommended aripiprazole (Abilify, Bristol-Myers Squibb and Otsuka Pharmaceuticals) as an option for the treatment of schizophrenia in people aged 15 to 17 years who are intolerant of risperidone, or for whom risperidone is contraindicated, or whose schizophrenia has not been adequately controlled with risperidone. Osteoporosis - primary prevention (TA160) Osteoporosis - secondary prevention including strontium ranelate (TA161) (Both relevant for primary & secondary care) This guidance is re-issued following a high court ruling. There are no changes to the recommendations on strontium ranelate, compared with the guidance issued in 2008 and updated in January 2010. The guidance published today updates the previous guidance as it includes an indepth explanation of the reconsideration. The two pieces of guidance for both primary and SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 14 of 17 secondary prevention of osteoporotic fractures recommend that strontium ranelate should be used in circumstances where patients are unable to tolerate oral bisphosphonates, and who are at high risk of osteoporotic fractures. TA214 Bevacizumab in combination with a taxane for the first-line treatment of metastatic breast cancer (Feb 11) (Relevant to secondary care) NICE does not recommend bevacizumab in combination with a taxane as first treatment for people with metastatic breast cancer. This guidance replaces terminated technology appraisal number 147 Bevacizumab in combination with paclitaxel for the first-line treatment of metastatic breast cancer, issued June 2008. TA215 Renal cell carcinoma (first line metastatic) - pazopanib (Feb 11) (Relevant to secondary care) Pazopanib (Votrient, GlaxoSmithKline), is recommended as a first-line treatment option for people with advanced renal cell carcinoma who have not received prior cytokine therapy and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. As agreed under the patient access scheme the manufacturer will also provide pazopanib with a 12.5% discount on the list price and a possible future rebate linked to the outcome of the head-to-head trial, known as the COMPARZ trial, comparing pazopanib and sunitinib, details of which will be confirmed when the COMPARZ trial data are made available. In March 2009, NICE recommended sunitinib for people with advanced renal cell carcinoma TA216 Leukaemia (lymphocytic) - bendamustine (Feb 11) (Relevant to secondary care) NICE recommends bendamustine as a possible treatment for some people with chronic lymphocytic leukaemia of Binet stage B or C. You should be able to have bendamustine if you have chronic lymphocytic leukaemia of Binet stage B or C that has not been treated before and you cannot have chemotherapy with a drug called fludarabine. Interventional Procedures - all mainly relevant to acute care Normal arrangement Special arrangement Other (see guidance) Research only Do not use Apply normal consent, audit and clinical governance arrangements plus any additional recommendations, for example, on training, service delivery or data collection. Notify clinical governance leads, ensure patients understand the uncertainties referred to in the guidance, and audit and review clinical outcomes of all patients having the procedure plus any additional recommendations, for example, on training, service delivery or data collection. Guidance recommends a combination of normal or special arrangements. Use only in the context of a formal research protocol. The procedure should not be used in the National Health Service (NHS) IPG369 Cryotherapy for the treatment of liver metastases (Dec 10) - Special arrangements IPG370 Percutaneous closure of patent foramen ovale for recurrent migraine (Dec 10) - Special arrangements IPG371 Percutaneous closure of patent foramen ovale for the secondary prevention of recurrent paradoxical embolism in divers (Dec 10) - Special arrangements IPG372 Percutaneous radiofrequency ablation for primary and secondary lung cancers (Dec 10) (Replaces IPG185) - Normal arrangements SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 15 of 17 IPG373 Selective dorsal rhizotomy for spasticity in cerebral palsy (Dec 10) (Replaces IPG195) Normal arrangements IPG374 Low intensity pulsed ultrasound to promote fracture healing (Dec 10) - Normal arrangements IPG375 Distal iliotibial band lengthening for refractory greater trochanteric pain syndrome (Jan 11) - Research only IPG376 Extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome (Jan11) - Special arrangements IPG377 Off-pump coronary artery bypass grafting (Jan 11) - Normal arrangements IPG378 Percutaneous laser coronary angioplasty (Jan 11) - Normal arrangements IPG 379 Thoracoscopic repair of congenital diaphragmatic hernia in neonates (Jan 11) - Normal arrangements IPG380 Percutaneous atherectomy of femoropopliteal arterial lesions with plaque excision devices (Feb 11) - Special arrangements Medical technologies guidance - all mainly relevant to acute care SeQuent Please balloon catheter for in-stent coronary restenosis (MTG1), Dec 2010 In the first ever piece of medical technology guidance NICE recommends that SeQuent Please be considered for use in patients with in-stent restenosis in bare metal coronary artery stents, and in patients with other types of stent where there are clinical reasons to minimise how long clopidogrel treatment is used. It should also be considered as an option for use in patients in whom it isn't technically possible to insert further stents. 6. Other useful Information NICE consultations for your comments: Multiple pregnancy: guideline consultation 9 February - 6 April 2011 Smokeless tobacco - South Asians: draft scope consultation 21 March - 18 April 2011 Thrombocytopenic purpura - romiplostim: final appraisal determination 17 March - 31 March 2011 BRAHMS Copeptin assay: appraisal consultation 7 March - 4 April 2011 Quality and Outcome Framework Indicators 28 February - 28 March 2011 Details of all NICE consultations can also be accessed. Implementation tools NICE provides tools to support the implementation of guidance e.g. audit and costing tools which can be accessed via the NICE website SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 16 of 17 News NICE launches online resource for general practice NICE has launched a new section of its website, designed to help staff in general practice get the most out of evidence and guidance provided by NICE. Specifically created to support the use of evidence-based medicine and public health practice, this online resource offers solutions to enable the uptake of NICE and other national guidance in primary care, and contains a section on how NICE can help GP consortia. NICE gives evidence on the Health and Social Care Bill Last month, Sir Andrew Dillon, Chief Executive of NICE, gave evidence to the Public Bill Committee, as part of the Committee stage of the Bill's progress through the House of Commons. Editorial team As always your feedback on the usefulness of this bulletin would be much appreciated. Dr. Usman Khan, NHS Richmond & NHS Kingston, [email protected] Tracy Steadman, NHS Croydon, [email protected] Alastair Johnston, NHS Wandsworth, [email protected] Livia Royle, NHS Kingston, [email protected] Fran Mautadin, NHS Sutton & Merton [email protected] SW London Primary Care Clinical Effectiveness Bulletin 2nd Edition Mar11 Page 17 of 17