Drs Alex Coupland and Gavin Flatt and Professor Gerard Stansby show how using the quality standard will improve the diagnosis and management of VTE
In 2005, it was estimated that in England 25,000 people a year die in hospital from preventable hospital-acquired venous thromboembolic (VTE) disease.1 Venous thromboembolic disease covers a range of conditions, but the two most common are:
- deep vein thrombosis (DVT)
- pulmonary embolism (PE).
Because of the potentially fatal consequences of developing a DVT or PE, their prevention and management has become an NHS priority.2 Until recently, there was no systematic approach to the diagnosis and management of patients at risk of developing VTE.3 This situation has improved with the development and publication of NICE Clinical Guideline 92 (CG92), Reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital (see www.nice.org.uk/guidance/CG92),4 and NICE Clinical Guideline 144 (CG144), Venous thromboembolic diseases: the management of venous thromboembolic diseases and the role of thrombophilia testing (see www.nice.org.uk/guidance/CG144).5 To complement these guidelines, NICE has now produced quality standards to help ensure the delivery of best practice.
NICE quality standards
As set out in the Health and Social Care Act 2012,6 the Government is committed to improving the quality of NHS services and has instigated a new drive towards outcome-based quality assessment.7, 8 To uphold this commitment, the recently renamed National Institute for Health and Care Excellence (NICE) has developed a range of quality standards to highlight key areas for quality improvement within particular areas of care.
Quality standards provide a set of aspirational, but achievable aims for:
- healthcare and public health and social care practitioners
- patients, service users, and the public
- service providers
NICE quality standards do not provide a comprehensive service specification; rather, they define priority areas for quality improvement based on consideration of the topic area. They are a final distillation of accredited guidance from NICE and other organisations, and are intended to provide a clear description (in usually less than 10 statements) of what a high quality service should look like. Quality standards enable organisations to move towards improving quality and delivering excellence.11 Lord Darzi has described high-quality care as being that which is ‘clinically effective, personal, and safe’.9 This definition has been expanded and formalised into five high-level national outcome domains contained in the NHS Outcomes Framework 2013/14 (see Box 1). 8
By providing statements that are underpinned by structure, process, and outcome measures, NICE quality standards can influence the entire health service, from provision of services to clinical execution. If used and audited correctly, they will guide systemic improvements in healthcare. Furthermore, their implementation is as relevant to general practitioners as it is for hospital clinicians, commissioners, and patients alike.
Quality standard for diagnosis and management of venous thromboembolic diseases
NICE Quality Standard (QS) 29 for the diagnosis and management of venous thromboembolic diseases9 comprises nine quality statements (see Table 1, below) designed to improve the quality of care for adults (excluding pregnant women) who are being investigated and treated for VTE. The standard contributes toward meeting national outcome domains 1, 3, and 5 of the NHS Outcomes Framework (see below).
NICE QS29 is:
- designed to have a wider focus than other related NICE clinical guidance4, 5
- aimed at providers and commissioners as well as clinicians
- part of a whole-system approach to promoting quality.12, 13
Improving the management of people with VTE requires a diligent approach to diagnosis and treatment, and effective design of health systems. Responsibility lies not only with physicians and other healthcare professionals, but also with local service providers and NHS commissioners.
NICE QS29 has been produced to help improve NHS services. It does not represent new clinical guidance, and should be used as a point of reference for improving service delivery and developing audit criteria to monitor quality improvement.
Best practice: guidance source
The delivery of best practice requires the development and implementation of measures that are based on the most up-to-date clinical evidence. The source guidance for each quality statement within NICE QS29 is derived from:9
- NICE CG1445
- NICE Technology Appraisal 261 (TA261), Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism (see www.nice.org.uk/TA261).14
For the quality statements and their corresponding NICE recommendations, see Table 2. 4, 14
Box 1: NHS Outcomes Framework 'five domains'8
- Domain 1—preventing people from dying prematurely
- Domain 2—enhancing quality of life for people with long-term conditions
- Domain 3—helping people to recover from episodes of ill health, or following injury
- Domain 4—ensuring that people have a positive experience of care
- Domain 5—treating and caring for people in a safe environment; and protecting them from avoidable harm.
|1||People with suspected deep vein thrombosis are offered an interim therapeutic dose of anticoagulation therapy if diagnostic investigations are expected to take longer than 4 hours from the time of first clinical suspicion.|
|2||People with suspected deep vein thrombosis have all diagnostic investigations completed within 24 hours of first clinical suspicion.|
|3||People with suspected pulmonary embolism are offered an interim therapeutic dose of anticoagulation therapy if diagnostic investigations are expected to take longer than 1 hour from the time of first clinical suspicion.|
|4||People with proximal deep vein thrombosis are offered below-knee graduated compression stockings within
3 weeks of diagnosis.
|5||People with unprovoked deep vein thrombosis or pulmonary embolism who are not already known to have cancer are offered timely investigations for cancer.|
|6||People with provoked deep vein thrombosis or pulmonary embolism are not offered testing for thrombophilia.|
|7||People with active cancer and confirmed proximal deep vein thrombosis or pulmonary embolism are offered anticoagulation therapy.|
|8||People without cancer who receive anticoagulation therapy have a review within 3 months of diagnosis of confirmed proximal deep vein thrombosis or pulmonary embolism to discuss the risks and benefits of continuing anticoagulation therapy.|
|9||People with active cancer who receive anticoagulation therapy have a review within 6 months of confirmed proximal deep vein thrombosis or pulmonary embolism to discuss the risks and benefits of continuing anticoagulation therapy.|
|Source5,14||Quality Statement||Quality |
|CG144 (1.1.1)||If a patient presents with signs or symptoms of DVT, carry out an assessment of their general medical history and a physical examination to exclude other causes.||1, 2|
|CG144 (1.1.2)||If DVT is suspected, use the two-level DVT Wells score15 to estimate the clinical probability of DVT.||1, 2|
|CG114 (1.1.3)||Offer patients in whom DVT is suspected and with a likely two-level DVT Wells score either:
|CG114 (1.1.4)||Offer patients in whom DVT is suspected and with an unlikely two-level DVT Wells score, a D-dimer test and if the result is positive offer either:
|CG114 (1.1.7)||If a patient presents with signs or symptoms of PE, carry out an assessment of their general medical history, a physical examination, and a chest X-ray to exclude other causes.||3|
|CG114 (1.1.8)||If PE is suspected, use the two-level PE Wells score to estimate the clinical probability of PE.||3|
|CG114 (1.1.9)||Offer patients in whom PE is suspected and with a likely two-level PE Wells score either:
|CG114 (1.1.10)||Offer patients in whom PE is suspected and with an unlikely two-level PE Wells score a D-dimer test and if the result is positive offer either:
|CG114 (1.1.14)||If a patient presents with signs or symptoms of both DVT (for example a swollen and/or painful leg) and PE (for example chest pain, shortness of breath or haemoptysis), carry out initial diagnostic investigations for either DVT or PE, basing the choice of diagnostic investigations on clinical judgement.||2|
|CG114 (1.2.2)||Offer LMWH to patients with active cancer and confirmed proximal DVT or PE, and continue the LMWH for 6 months. At 6 months, assess the risks and benefits of continuing anticoagulation.||7, 9|
|CG114 (1.2.3)||Offer a VKA to patients with confirmed proximal DVT or PE within 24 hours of diagnosis and continue the VKA for 3 months. At 3 months, assess the risks and benefits of continuing VKA treatment (see recommendations 1.2.4 and 1.2.5).||8|
|CG114 (1.2.9)||Offer below-knee graduated compression stockings with an ankle pressure greater than 23 mmHg to patients with proximal DVT a week after diagnosis or when swelling is reduced sufficiently and if there are no contraindications, and:
|CG114 (1.5.1)||Offer all patients diagnosed with unprovoked DVT or PE who are not already known to have cancer the following investigations for cancer:
|CG114 (1.6.4)||Do not offer thrombophilia testing to patients who have had provoked DVT or PE.||6|
|TA261 (1.1)||Rivaroxaban is recommended as an option for treating deep vein thrombosis and preventing recurrent deep vein thrombosis and pulmonary embolism after a diagnosis of acute deep vein thrombosis in adults.||7, 8, 9|
Diagnosis and initial management—statements 1–3
Interim anticoagulation therapy for suspected deep vein thrombosis—statement 1
NICE CG1445, 14 states that all patients with a suspected DVT should undergo:
- general assessment
- physical examination (to exclude other causes)
- a two-level DVT Wells score.16
If the person is likely to have a DVT (Wells score ?2), then a proximal leg vein ultrasound scan should be performed within 4 hours of request, and a D-dimer test if the scan is negative. If this is not possible, then parenteral anticoagulation should be provided.
Diagnosis of deep vein thrombosis—statement 2
If a patient is given parenteral anticoagulation because of a greater than 4-hour delay in receiving an ultrasound scan, that scan must be performed within 24 hours of request. This is to reduce the risk of patients receiving a second dose of anticoagulation therapy, thereby increasing the bleeding risk.
Interim therapeutic dose of anticoagulation therapy for suspected pulmonary embolism—statement 3
This statement reflects the increased risk of adverse events if treatment is delayed for those people who have a PE.
Later management and review—statements 4–9
Mechanical interventions—statement 4
Statement 4 links with NICE CG144, recommendation 1.2.9,5 but provides further clarification. In its original guidance,5 NICE recommends supplying compression stockings within 1 week of diagnosis, or when swelling has reduced sufficiently. The quality standard further defines the period over which swelling should reduce, and compression stockings be applied, to be within 3 weeks of diagnosis. This 3-week time frame also provides a clear indicator for auditing standards.
Investigations for cancer—statement 5
Quality statement 5 is further expanded upon in NICE CG144, which states that people diagnosed with an unprovoked DVT or PE should be offered a full physical examination, chest X-ray, and blood tests (i.e. full blood count, serum calcium, and liver function tests), as well as urinalysis.5 An abdomino-pelvic computed tomography scan (and a mammogram for women) should also be considered for patients aged over 40 years, even if they do not have signs or symptoms of cancer following initial investigations. There is evidence to suggest that up to 10% of patients with an idiopathic VTE who are apparently cancer-free will have an underlying malignancy.17
Thrombophilia testing—statement 6
Thrombophilia testing does not provide benefit and is unnecessary for people with provoked DVT or PE.
Treatment and follow up of people with active cancer—statements 7 and 9
The recommended anticoagulation agent for the treatment of DVT or PE differs for those people who have active cancer and those who do not. People known to have active cancer and either a DVT or PE should be offered low molecular weight heparin (LMWH). A further review should be undertaken within 6 months to consider the risks and benefits of longer-term treatment.
Treatment and follow up of people without cancer—statement 8
Quality statement 8 relates to the management of patients with DVT or PE but who do not have cancer; these patients should be offered a vitamin K antagonist (VKA). A further review should be undertaken within 3 months to consider the risks and benefits of longer-term treatment. It is important to note that LMWH should be continued for at least 5 days when commencing a VKA, or until the international normalised ratio (INR) is >2 for at least 24 hours, whichever is longer.5 In addition, rivaroxaban is now a recommended alternative treatment for DVT. It offers superior lifestyle benefits to warfarin by removing the need for regular INR monitoring.
NICE QS29 for the diagnosis and management of venous thromboembolic diseases provides a set of clinical aims that, if achieved, will improve the quality of patient care. They have relevance to all healthcare professionals committed to achieving best practice, from commissioners to practising doctors in all specialties.
GP commissioning messages and key points are located below
- NICE Quality Standard 29 sets stretching targets for commissioners and providers in ensuring that rapid diagnostic tests are available where DVT is suspected
- These targets will require commissioners to set up daily diagnostic clinics (including at weekends) for utrasonography, and access to D-dimer tests
- Local care pathways should be established that describe how a patient presenting with symptoms suggestive of DVT can access these necessary investigations within the prescribed timescales, whenever and wherever they present
- These pathways should be built into contracts with providers, and subject to regular audit
- CCGs should consider educational programmes for GP practices (and out-of- hours providers) in the use of the Wells test, and suitable anticoagulants
- Local formularies should describe anticoagulants of choice and where new anticoagulants like rivaroxaban should be used.
- Department of Health. Report of the independent expert working group on the prevention of venous thromboembolism in hospitalised patients. London: DH, 2007. Available at: webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/
- House of Commons Health Committee. The prevention of venous thromboembolism in hospitalised patients: second report of session 2004–2005. London: Stationery Office, 2005. Available at: www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/99/99.pdf
- Secretary of State for Health. Government response to the House of Commons health committee report on the prevention of venous thromboembolism in hospitalised patients: second report of session 2004–2005. London: Stationery Office, 2005. Available at: www.official-documents.gov.uk/document/
- NICE. Venous thromboembolism: reducing the risk. Clinical Guideline 92. London: NICE, 2010. Available at: www.nice.org.uk/nicemedia/live/12695/47195/47195.pdf
- NICE. Venous thromboembolic diseases: the management of venous thromboembolic diseases and the role of thrombophilia testing. Clinical Guideline 144. London: NICE, 2012. Available at: www.nice.org.uk/nicemedia/live/13767/59720/59720.pdf
- Health and Social Care Act 2012. Available at: www.legislation.gov.uk/ukpga/2012/7/contents/enacted (accessed 26 June 2013).
- Department of Health. Equity and excellence: liberating the NHS. London: Stationery Office, 2010. Available at: www.gov.uk/government/uploads/system/
- Department of Health. The NHS outcomes framework 2013/14. London: Stationery Office, 2012. Available at: www.gov.uk/government/uploads/system
- NICE. Quality standard for diagnosis and management of venous thromboembolic diseases. Quality Standard 29. London: NICE, 2013. Available at: publications.nice.org.uk/quality-standard-for-diagnosis-and-management-of-venous-thromboembolic-diseases-qs29
- NICE. Quality standard scope: management of venous thromboembolic diseases. London: NICE, 2012. Available at: www.nice.org.uk/nicemedia/live/13986/61949/61949.pdf
- Department of Health. High quality care for all: NHS next stage review final report. London: Stationery Office, 2008. Available at: www.official-documents
- NICE. NICE support for commissioners using the quality standard for diagnosis and management of venous thromboembolic diseases. London: NICE, 2013. Available at: www.nice.org.uk/nicemedia/live/14117/63350/63350.pdf
- Department of Health. Venous thromboembolism prevention: a patient safety priority. London: King’s Thrombosis Centre, 2009. Available at: www.kingsthrombosiscentre.org.uk/kings/12.pdf
- NICE. Venous thromboembolism (treatment and long term secondary prevention)—rivaroxaban. Technology Appraisal 261. London: NICE, 2012. Available at: www.nice.org/TA261
- Sala Tenna A, Harrison S, Avital L, Stansby G. The two-level Wells scores should be used in suspected VTE cases. Guidelines in Practice 2012; 15 (9): 29–35. Available at: https://www.guidelinesinpractice.co.uk/sep_12_tenna_vte_sep12
- Wells P, Anderson D, Rodger M et al. Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis. N Engl J Med 2003; 349 (13): 1227–1235.
- Piccioli A, Lensing A, Prins M et al. Extensive screening for occult malignant disease in idiopathic venous thromboembolism: a prospective randomized clinical trial. J Thromb Haemost 2004; 2 (6): 884–889. G