Full guideline addendum

492 Pages·2015·5.84 MB·English

by  Susannah Moon

National Institute for Health and Care

Excellence

DFoincualm ent information (version number/stage of process)
Prophylaxis against
infective endocarditis
Clinical Guideline 64.1
Methods, evidence and recommendations
September 2015
Final

Developed by the National Institute for
Health and Care Excellence

CClliinniiccaall GGuuiiddeelliinnee 6644 ((PPIIEE))

Contents

Disclaimer
Healthcare professionals are expected to take NICE clinical guidelines fully into account
when exercising their clinical judgement. However, the guidance does not override the
responsibility of healthcare professionals to make decisions appropriate to the circumstances
of each patient, in consultation with the patient and/or their guardian or carer.

Copyright
© National Institute for Health and Care Excellence, 2015. All rights reserved. This material
may be freely reproduced for educational and not-for-profit purposes. No reproduction by or
for commercial organisations, or for commercial purposes, is allowed without the express
written permission of NICE.
Clinical Guideline 64 (PIE)

Contents
Contents
Clinical guidelines update .................................................................................................. 8
1 Summary section.......................................................................................................... 9
1.1 Update information ................................................................................................ 9
1.2 Recommendations .............................................................................................. 11
1.3 Patient-centred care ............................................................................................ 12
1.4 Methods .............................................................................................................. 13
2 Evidence review and recommendations ................................................................... 14
2.1 Epidemiological review ........................................................................................ 14
2.1.1 Overview of epidemiology: incidence and trends of infective
endocarditis ............................................................................................. 14
2.1.2 Critique of Dayer et al. (2014) study ......................................................... 23
2.2 Review question 1a, 1b and 2 ............................................................................. 24
2.2.1 Clinical evidence review ........................................................................... 24
2.2.2 Methods ................................................................................................... 24
2.2.3 Clinical evidence statements .................................................................... 35
2.2.4 Evidence to recommendations ................................................................. 37
2.3 Review question 3 ............................................................................................... 39
2.3.1 Clinical evidence review ........................................................................... 39
2.3.2 Methods ................................................................................................... 40
2.3.3 Clinical evidence statements .................................................................... 46
2.3.4 Evidence to recommendations ................................................................. 46
2.4 Review question 4 ............................................................................................... 48
2.4.1 Clinical evidence review ........................................................................... 48
2.4.2 Methods ................................................................................................... 48
2.4.3 Clinical evidence statements .................................................................... 70
2.4.4 Evidence to recommendations ................................................................. 71
2.5 Review question 5 ............................................................................................... 73
2.5.1 Clinical evidence review ........................................................................... 73
2.5.2 Methods ................................................................................................... 73
2.5.3 Clinical evidence statements .................................................................... 81
2.5.4 Evidence to recommendations ................................................................. 82
2.6 Review question 6a ............................................................................................. 84
2.6.1 Clinical evidence review ........................................................................... 84
2.6.2 Methods ................................................................................................... 84
2.6.3 Clinical evidence statement ...................................................................... 87
2.6.4 Health Economics .................................................................................... 87
2.6.5 Evidence to recommendations ................................................................. 94
2.6.6 Research recommendations .................................................................... 97

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Clinical Guideline 64 (PIE)

Contents
2.7 Review question 7a ........................................................................................... 100
2.7.1 Clinical evidence review ......................................................................... 100
2.7.2 Methods ................................................................................................. 100
2.7.3 Clinical evidence statements .................................................................. 106
2.7.4 Evidence to recommendations ............................................................... 108
2.8 Review question 6b and 7b ............................................................................... 110
2.8.1 Clinical evidence review ......................................................................... 110
2.8.2 Methods ................................................................................................. 110
2.8.3 Clinical evidence statements .................................................................. 115
2.8.4 Evidence to recommendations ............................................................... 117
3 References ................................................................................................................ 119
3.1 Overview of epidemiology ................................................................................. 119
3.2 Review question 1a and 1b ............................................................................... 119
3.3 Review question 2 ............................................................................................. 120
3.4 Review question 3 ............................................................................................. 121
3.5 Review question 4 ............................................................................................. 121
3.6 Review question 5 ............................................................................................. 123
3.7 Review question 6a ........................................................................................... 124
3.8 Review question 7a ........................................................................................... 124
3.9 Review question 7b ........................................................................................... 125
4 Glossary and abbreviations ..................................................................................... 127
Appendices ...................................................................................................................... 128
Appendix A: Standing Committee members and NICE teams .................................. 128
A.1 Core members ............................................................................................ 128
A.2 Topic expert Committee members .............................................................. 128
A.3 NICE project team ...................................................................................... 128
A.4 Clinical guidelines update team .................................................................. 129
Appendix B: Declarations of interest ........................................................................ 130
Appendix C: Review protocol ................................................................................... 138
C.1 Review questions 1a, 1b and 2 ................................................................... 138
C.2 Review questions 3 .................................................................................... 139
C.3 139
C.4 Details ........................................................................................................ 139
C.5 Review question 4 and 5 ............................................................................ 140
C.6 Review question 6a and 7a ........................................................................ 142
C.7 Review question 6b and 7b ........................................................................ 143
Appendix D: Search strategy ................................................................................... 145
D.1 Overview of epidemiology ........................................................................... 145
D.2 Review question 1 and 2 ............................................................................ 145
D.3 Review question 3 ...................................................................................... 149

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Clinical Guideline 64 (PIE)

Contents
D.4 Review question 4 ...................................................................................... 149
D.5 Review question 5 ...................................................................................... 154
D.6 Review question 6a and 7a ........................................................................ 156
D.7 Review question 6b and 7b ........................................................................ 163
Appendix E: Review flowchart.................................................................................. 167
E.1 Overview of epidemiology ........................................................................... 167
E.2 Review questions 1a 1b and 2 .................................................................... 167
E.3 Review questions 3 and 4 ........................................................................... 168
E.4 Review question 5 ...................................................................................... 170
E.5 Review question 6a and 7a ........................................................................ 171
E.6 Review question 6b and 7b ........................................................................ 172
Appendix F: Excluded studies.................................................................................. 173
F.1 Overview of epidemiology ........................................................................... 173
F.2 Review questions 1a, 1b and 2 ................................................................... 176
F.3 Review question 3 and 4 ............................................................................ 186
F.4 Review question 5 ...................................................................................... 191
F.5 Review question 6a and 7a ........................................................................ 193
F.6 Review question 6b and 7b ........................................................................ 197
Appendix G: Evidence tables ................................................................................... 200
G.1 Review question 1a and 1b ........................................................................ 200
G.2 Review question 2 ...................................................................................... 218
G.3 Review question 3 ...................................................................................... 256
G.4 Review question 4 ...................................................................................... 266
G.5 Review question 5 ...................................................................................... 310
G.6 Review question 6a .................................................................................... 329
G.7 Review question 7a .................................................................................... 336
G.8 Review question 7b .................................................................................... 377
Appendix H: GRADE profiles/Result summary tables .............................................. 401
H.1 Review question 1a and 1b ........................................................................ 401
H.2 Review question 2 ...................................................................................... 406
H.3 Review question 6a .................................................................................... 415
H.4 Review question 7a .................................................................................... 416
H.5 Review question 7b .................................................................................... 431
Appendix I: Economic search strategy .................................................................... 438
Appendix J: Economic review flowchart .................................................................. 440
Appendix K: Ecomonic excluded studies ................................................................. 441
Appendix L: Economic evidence tables ................................................................... 442
L.1 Full economic evidence for dental procedures ............................................ 442
L.2 Full economic evidence for non-dental procedures ..................................... 457
Appendix M: Quality assessment ............................................................................. 462

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Clinical Guideline 64 (PIE)

Contents
Appendix N: Supporting information ......................................................................... 466
N.1 Incidence of bacteraemia over time in those receiving antibiotics vs no
prophylaxis/placebo .................................................................................... 466
N.2 Incidence of bacteraemia over time in those receiving chlorhexidine
compared to no prophylaxis/placebo .......................................................... 467
Appendix O: Critique of Dayer et al. (2014) study by Ramsay (2015) ....................... 468
Appendix P: University of Sheffield’s 2015 update of the 2008 NICE economic
model ................................................................................................... 485
P.1 Background ................................................................................................ 485
P.2 Abstract: the cost effectiveness of prophylactic antibiotics for patients at
risk of infective endocarditis ........................................................................ 485
P.2.1 Background ........................................ Error! Bookmark not defined.
P.2.2 Methods ........................................................................................ 485
P.2.3 Results .......................................................................................... 485
P.2.4 Conclusions .................................................................................. 486
Appendix Q: CG64 original scope ............................................................................ 487

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Clinical Guideline 64 (PIE)

Clinical guidelines update
Clinical guidelines update
1
2 The NICE Clinical Guidelines Update Team update discrete parts of published clinical
3 guidelines as requested by NICE’s Guidance Executive.
4 Suitable topics for update are identified through the new surveillance programme (see
5 surveillance programme interim guide).
6 These guidelines are updated using a standing Committee of healthcare professionals,
7 research methodologists and lay members from a range of disciplines and localities. For the
8 duration of the update the core members of the Committee are joined by up to 5 additional
9 members who are have specific expertise in the topic being updated, hereafter referred to as
10 ‘topic expert members’.
11 In this document where ‘the Committee’ is referred to, this means the entire Committee, both
12 the core standing members and topic expert members.
13 Where ‘standing committee members’ is referred to, this means the core standing members
14 of the Committee only.
15 Where ‘topic expert members’ is referred to this means the recruited group of members with
16 topic expertise.
17 All of the core members and the topic expert members are fully voting members of the
18 Committee.
19 Details of the Committee membership and the NICE team can be found in appendix A. The
20 Committee members’ declarations of interest can be found in appendix B.

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Clinical Guideline 64 (PIE)

Summary section
1 Summary section
1
1.1 Update information
2
3 In 2008 NICE published a guideline (CG64) on prophylaxis against infective endocarditis.
4 This 2015 guideline on the same topic updates and replaces the 2008 publication.
5 A UK study published in the BMJ in 2011 (Thornhill et al. 2011) looked at the impact of the
6 NICE guideline and showed an 80% fall in antibiotic prescribing thereby indicating that the
7 guideline had been effectively implemented. A longstanding increase in the incidence of IE
8 was also noted but with no clear evidence of any additional increase following publication of
9 the guideline. This increase in the incidence of IE was not well understood and there were a
10 number of possible reasons for this.
11 The publication of further research by the same research group, covering the period 2000 to
12 2013 (Dayer et al. 2014), suggested that the incidence of IE increased in both low and high
13 risk groups above the baseline trend, in contrast to the 2011 study, following the publication
14 of NICE’s guidance in 2008. Given the uncertainty of the association as suggested by the
15 research, this has triggered an exceptional update to assess all new evidence relevant to this
16 guidance.
17 The objective of this update is to assess new evidence since 2008 for all review questions
18 covered by the original Scope, except the review question on the information needs of
19 patients regarding the benefits and risks of antimicrobial prophylaxis for IE.
20 Strength of recommendations
21 Some recommendations can be made with more certainty than others. The Committee
22 makes a recommendation based on the trade-off between the benefits and harms of an
23 intervention, taking into account the quality of the underpinning evidence. For some
24 interventions, the Committee is confident that, given the information it has looked at, most
25 people would choose the intervention. The wording used in the recommendations in this
26 guideline denotes the certainty with which the recommendation is made (the strength of the
27 recommendation).
28 For all recommendations, NICE expects that there is discussion with the person about the
29 risks and benefits of the interventions, and their values and preferences. This discussion
30 aims to help them to reach a fully informed decision (see also ‘Patient-centred care’).
31 Recommendations that must (or must not) be followed
32 We usually use ‘must’ or ‘must not’ only if there is a legal duty to apply the recommendation.
33 Occasionally we use ‘must’ (or ‘must not’) if the consequences of not following the
34 recommendation could be extremely serious or potentially life threatening.
35 Recommendations that should (or should not) be followed– a ‘strong’
36 recommendation
37 Recommendations that an intervention should be used are made when we are confident that
38 for the vast majority of patients, an intervention will do more good than harm, and be cost
39 effective. Similarly, we recommend that an intervention should not be used when we are
40 confident that an intervention will not be of benefit for most patients.

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Clinical Guideline 64 (PIE)

Summary section
1 Recommendations that could be followed
2 Recommendations that an intervention could be used are made when we are confident that
3 an intervention will do more good than harm for most patients, and be cost effective, but
4 other options may be similarly cost effective. The choice of intervention, and whether or not
5 to have the intervention at all, is more likely to depend on the patient’s values and
6 preferences than for a strong recommendation, and so the healthcare professional should
7 spend more time considering and discussing the options with the patient.
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