Venous thromboembolism guideline consultation - appendices to full guideline

432 Pages·2007·2.5 MB·English

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1

2
3 National Clinical Guideline developed by the National Collaborating
4 Centre for Acute Care.

5

6
Venous Thromboembolism
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The prevention of venous
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thromboembolism (deep vein thrombosis
9
and pulmonary embolism) in patients
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undergoing orthopaedic surgery and other
11
high-risk surgical procedures.
12

13
Appendices A–G
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Contents
1
2
3 A SCOPE 218
4 B DECLARATIONS OF INTERESTS 224
5 C SEARCH STRATEGIES 226
6 D EVIDENCE TABLES 243
7 E META-ANALYSES FOREST PLOTS 531
8 F MIXED TREATMENT COMPARISON META-ANALYSIS
9 METHODS 626
10 G COST-EFFECTIVENESS ANALYSIS METHODS 633
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APPENDIX A
1
2
3 NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE
SCOPE
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1 Guideline title
5
6 Venous thromboembolism: the prevention of venous thromboembolism (deep
7 vein thrombosis and pulmonary embolism) in patients undergoing orthopaedic
8 surgery and other high-risk surgical procedures.
1.1 Short title
9
10 Venous thromboembolism
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2 Background
12
13 (a) The National Institute for Clinical Excellence (‘NICE’ or ‘the Institute’)
14 has commissioned the National Collaborating Centre for Acute Care to
15 develop a clinical guideline on the prevention of venous thromboembolism for
16 use in the NHS in England and Wales. This follows referral of the topic by the
17 Department of Health and Welsh Assembly Government (see Appendix
18 [section 6]). The guideline will provide recommendations for good practice that
19 are based on the best available evidence of clinical and cost effectiveness.
20 (b) The Institute’s clinical guidelines will support the implementation of
21 National Service Frameworks (NSFs) in those aspects of care where a
22 Framework has been published. The statements in each NSF reflect the
23 evidence that was used at the time the Framework was prepared. The clinical
24 guidelines and technology appraisals published by the Institute after an NSF
25 has been issued will have the effect of updating the Framework.
26 (c) NICE clinical guidelines support the role of healthcare professionals in
27 providing care in partnership with patients, taking account of their individual
28 needs and preferences, and ensuring that patients (and their carers and
29 families, where appropriate) can make informed decisions about their care
30 and treatment.
31
3 Clinical need for the guideline
32
33 (a) Deep vein thrombosis occurs in about 30% of surgical patients and is
34 commonly asymptomatic. However, the condition can lead to sudden death
35 due to pulmonary embolism, or cause long-term morbidity due to chronic
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1 venous insufficiency, potentially leading to venous ulceration and
2 development of a post-thrombotic limb.
3 (b) Most thrombi occur in the deep veins of the legs. Formation of thrombi
4 is associated with inactivity and high-risk surgical procedures. The risk is
5 particularly high in patients undergoing orthopaedic surgery and lengthy
6 operations. Previous studies have estimated the risk of fatal pulmonary
7 embolism following high-risk surgery to be between 1 and 5%.
8 (c) Current preventative measures for patients undergoing high-risk
9 surgical procedures include mechanical prophylaxis (such as graduated
10 elastic compression stockings) and pharmaceutical prophylaxis (such as low
11 molecular weight heparin). Clinical practice varies and it is estimated that 4
12 out of 10 orthopaedic patients do not receive any form of prophylaxis1.
13 (d) This guideline will examine the risk of venous thromboembolism and
14 assess the evidence for preventative measures. It will provide
15 recommendations on the most clinically and cost effective measures to
16 reduce adverse events and morbidity and mortality.
17
4 The guideline
18
19 (a) The guideline development process is described in detail in two
20 publications which are available from the NICE website (see ‘Further
21 information’). ‘The Guideline Development Process – An Overview for
22 Stakeholders, the Public and the NHS describes how organisations can
23 become involved in the development of a guideline. Guideline Development
24 Methods – Information for National Collaborating Centres and Guideline
25 Developers provides advice on the technical aspects of guideline
26 development.
27 (b) This document is the scope. It defines exactly what this guideline will
28 (and will not) examine, and what the guideline developers will consider. The
29 scope is based on the referral from the Department of Health and Welsh
30 Assembly Government (see Appendix [section 6]).
31 (c) The areas that will be addressed by the guideline are described in the
32 following sections.
4.1 Population
33
34 4.1.1 Groups that will be covered
35 (a) The guidelines will cover adults (age 18 and older) undergoing surgical
36 procedures that carry a high risk of venous thromboembolism, including:

1 Department of Health (2003) Further action to tackle post-code lottery in care [press
release]. http://www.dh.gov.uk
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1 • orthopaedic surgery (for example, total hip or knee replacement,
2 surgery for hip fracture)
3 • major general surgery
4 • major gynaecological surgery (but not elective or emergency
5 Caesarean)
6 • urological surgery (including major or open urological procedures)
7 • neurosurgery
8 • cardiothoracic surgery
9 • major peripheral vascular surgery.
10 4.1.2 Groups that will not be covered
11 (a) Patients under the age of 18 will not be covered.
12 (b) Adult patients who are at a high risk of developing venous
13 thromboembolism but are not undergoing surgery will not be covered. For
14 example, the following circumstances and patients will be excluded from the
15 guideline (unless patients are undergoing one of the surgical procedures
16 listed in section 4.1.1):
17 • patients with acute myocardial infarction
18 • patients who have had an acute stroke
19 • patients with cancer, including those being treated with chemotherapy
20 • pregnancy and the puerperium
21 • use of oral contraceptives and hormone replacement therapy
22 • long-distance travel.
4.2 Healthcare setting
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24 The guideline will offer guidance for use in primary, secondary and tertiary
25 care.
4.3 Clinical management
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27 (a) The guideline will assess the risk factors associated with development
28 of venous thromboembolism in the surgical procedures listed in section 4.1.1.
29 The likelihood of developing venous thromboembolism will be assessed
30 according to risk factors associated with the individual as well as the type of
31 surgical procedure, and this will involve categorising patients according to
32 their level of risk of developing venous thromboembolism post-operatively.
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1 (b) The guideline will assess the type of prophylaxis each individual patient
2 will require and the duration for which it should be carried out.
3 (c) The guideline will review the clinical and cost effectiveness, and
4 possible morbidity, of interventions to prevent venous thromboembolism in
5 patients undergoing the high-risk surgical procedures outlined in section 4.1.1.
6 (d) Interventions that will be considered include, for example:
7 • mechanical:
8 - graduated elastic compression stockings
9 - intermittent pneumatic compression devices (for example,
10 foot pumps)
11 - vena caval filters
12 • drugs/pharmacological:
13 - aspirin
14 - low-dose unfractionated heparin
15 - low molecular weight heparin
16 - synthetic pentasaccharide
17 - oral anticoagulants (warfarin)
18 - dextrans
19
20 • nursing care/physiotherapy:
21 - early mobilisation
22 - foot elevation
23 - hydration
24
25 • recent advances:
26 - for example, drugs licensed during the course of
27 guideline development.
28
29 (e) Note that guideline recommendations on prescribing will normally fall
30 within licensed indications; exceptionally, and only where clearly supported by
31 evidence, use outside a licensed indication may be recommended. The
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1 guideline will assume that prescribers will use the Summary of Product
2 Characteristics to inform their decisions for individual patients.
4.4 Status
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4 4.4.1 Scope
5 This is the final draft of the scope.
6 4.4.2 Guideline
7 The development of the guideline recommendations will begin in March 2005.
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5 Further information
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10 The Scottish Intercollegiate Guidelines Network issued guidance on the use of
11 prophylaxis of venous thromboembolism in 20022.
12 Information on the guideline development process is provided in:
13 • The Guideline Development Process – An overview for Stakeholders, the
14 public and the NHS
15 • Guideline Development Methods – Information for National Collaborating
16 Centres and Guideline Developers
17 These booklets are available as PDF files from the NICE website
18 (www.nice.org.uk). Information on the progress of the guideline will also be
19 available from the website.

2 Scottish Intercollegiate Guidelines Network (2002) Prophylaxis of venous thromboembolism.
SIGN Publication No. 62. Edinburgh: Scottish Intercollegiate Guidelines Network.
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6 Appendix – Referral from the Department of
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Health and Welsh Assembly Government
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3 The Department of Health and Welsh Assembly Government asked the
4 Institute to develop a guideline with the following title and remit:
5 Title: Venous thrombo-embolism: the prevention of venous thrombo-
6 embolism in patients undergoing orthopaedic surgery and other high-risk
7 surgical procedures.
8 Remit: To develop safety guidance for the NHS in England and Wales on
9 prophylaxis against venous thrombo-embolism (VTE) for patients undergoing
10 orthopaedic surgery and other surgical procedures for which there is a high
11 risk of VTE. The guidance should set out the principles of clinical and cost
12 effective practice and in particular should address:
13 i the assessment of risk for particular procedures and for individual patients,
14 ii the circumstances in which prophylaxis can be recommended as clinically
15 and cost effective, and
16 iii the appropriate selection of interventions including both pharmaceutical
17 and mechanical methods of prophylaxis.
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APPENDIX B
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GDG members, expert advisors and staff declarations
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of interest
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Name Interest

GDG Members
Tom Treasure No interests were declared that required action

Ricky Autar No interests were declared that required action

Colin Baigent No interests were declared that required action

Robin Offord No interests were declared that required action

David Farrell None

Adam Thomas None

John Luckit No interests were declared that required action

Nigel Acheson None

Simon Carter No interests were declared that required action

Kim Carter No interests were declared that required action

David Goldhill No interests were declared that required action

Expert Advisors
Frank Smith No interests were declared that required action

Tim Lees No interests were declared that required action

David Whillier No interests were declared that required action

Nihal Gurusinghe None
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Name Interest

NCC-AC Staff
Jennifer Hill None

Phillipa Davies No interests were declared that required action

Carlos Sharpin None

David Wonderling None

Enrico De Nigris None

Peter B Katz None

Clare Jones No interests were declared that required action

Veena Mazarello Paes None

Kathryn Oliver None

Louise Thomas None

Rifna Aktar None

Susan Murray No interests were declared that required action

Arash Rashidian None

Sophie Capo-Bianco None

Nishanthi Talawila None

Kelly Dickinson None

2
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