Appendices

297 Pages·2008·7.24 MB·English

by  Carlos Sharpin

APPENDICES - (DRAFT FOR CONSULTATION)

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Glaucoma: diagnosis and
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management of chronic open angle
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glaucoma and ocular hypertension
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Appendices A – G
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DRAFT FOR CONSULTATION
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APPENDICES

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Produced by the National Collaborating Centre for Acute Care
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APPENDICES - (DRAFT FOR CONSULTATION)
Contents
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2 Appendix A Scope 3
3 Appendix B Declarations of interest 9
4 Appendix C Search Strategies 23
5 Appendix D Evidence tables 55
6 Appendix E Forest plots 217
7 Appendix F Cost-effectiveness analysis 242
8 Appendix G Recommendations for research 278
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APPENDIX A - SCOPE - (DRAFT FOR CONSULTATION)
Appendix A
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SCOPE
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1 Guideline title
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4 Glaucoma: diagnosis and management of chronic open angle glaucoma and ocular
5 hypertension
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7 1.1 Short title
8 Glaucoma
2 Background
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10 a) The National Institute for Health and Clinical Excellence (‘NICE’ or ‘the Institute’) has
11 commissioned the National Collaborating Centre for Acute Care to develop a clinical
12 guideline on the diagnosis and management of chronic open angle glaucoma and ocular
13 hypertension for use in the NHS in England and Wales. This follows referral of the topic
14 by the Department of Health (see section 6). The guideline will provide recommendations
15 for good practice that are based on the best available evidence of clinical and cost
16 effectiveness.
17 b) The Institute’s clinical guidelines will support the implementation of National Service
18 Frameworks (NSFs) in those aspects of care where a Framework has been published. The
19 statements in each NSF reflect the evidence that was used at the time the Framework was
20 prepared. The clinical guidelines and technology appraisals published by the Institute
21 after an NSF has been issued will have the effect of updating the Framework.
22 c) NICE clinical guidelines support the role of healthcare professionals in providing care
23 in partnership with patients, taking account of their individual needs and preferences,
24 and ensuring that patients (and their carers and families, where appropriate) can make
25 informed decisions about their care and treatment.
3 Clinical need for the guideline
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27 a) Approximately 10% of UK blindness registrations are ascribed to glaucoma. It is
28 estimated that in the UK about 2% of people older than 40 have chronic open angle
29 glaucoma, and this rises to almost 10% in people older than 75. With changes in
30 population demographics the number of people affected by glaucoma is expected to
31 rise.
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APPENDIX A - SCOPE - (DRAFT FOR CONSULTATION)
1 b) Chronic open-angle glaucoma tends to be asymptomatic and therefore many people
2 will not notice any symptoms until severe visual damage has occurred. Population-based
3 screening programmes are being considered and the Department of Health’s National
4 Screening Committee is undertaking a review of screening programmes due to be
5 published in 2007.
6 c) Recent national guidelines on glaucoma include ‘Guidelines for the management of
7 open angle glaucoma and ocular hypertension’ (Royal College of Ophthalmologists,
8 2004). The Department of Health Do Once And Share project has also developed a
9 glaucoma pathway and dataset (2006).
10 d) There is a clinical need for a guideline on diagnosis and management of chronic open
11 angle glaucoma because this is a common and potentially blinding condition associated
12 with uncertainty and variation in clinical practice in a number of areas. These include:
13 • an agreed case definition for ocular hypertension and chronic open angle
14 glaucoma
15 • an agreed terminology incorporating the influence of raised intraocular pressure
16 (that is, primary open angle glaucoma compared with normal tension glaucoma)
17 • agreement on when to treat chronic open angle glaucoma and how aggressively
18 to do so
19 • agreement on whether to treat (simple) ocular hypertension
20 • which tests should be standard or optional for purposes of diagnosis and chronic
21 disease monitoring
22 • how frequently patients should be followed up for chronic disease monitoring
23 purposes and whether this interval should vary with perceived disease ‘severity’
24 • who should monitor glaucoma, where this should be undertaken and whether
25 different care providers should be used depending on perceived disease
26 ‘severity’
4 The guideline
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28 a) The guideline development process is described in detail in two publications that are
29 available from the NICE website (see ‘Further information’). ‘The guideline development
30 process: an overview for stakeholders, the public and the NHS’ describes how
31 organisations can become involved in the development of a guideline. ‘The guidelines
32 manual’ provides advice on the technical aspects of guideline development.
33 b) This document is the scope. It defines exactly what this guideline will (and will not)
34 examine, and what the guideline developers will consider. The scope is based on the
35 referral from the Department of Health (see appendix).
36 c) The areas that will be addressed by the guideline are described in the following
37 sections.
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APPENDIX A - SCOPE - (DRAFT FOR CONSULTATION)
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2 4.1 Population
3 4.1.1 Groups that will be covered
4 a) Adults (18 and older) with a diagnosis of chronic open angle glaucoma or ocular
5 hypertension. That is, individuals who, in the presence of open or narrow (but not
6 occludable or closed) anterior chamber angles have one or more of the following
7 features:
8 • glaucomatous visual field loss
9 • glaucomatous optic neuropathy
10 • raised intraocular pressure.
11 b) People with chronic open angle glaucoma or ocular hypertension associated with
12 pseudoexfoliation or pigment dispersion.
13 c) People who have higher prevalence of glaucoma and may have worse clinical
14 outcomes including:
15 • people with a family history of glaucoma,
16 • younger people (<50 years)
17 • people who are of black African or black Caribbean descent
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19 4.1.2 Groups that will not be covered
20 a) People younger than 18 years.
21 b) People with secondary glaucoma (for example neovascular or uveitic) except for
22 those described in 4.1.1 b.
23 c) People with, or at risk of, primary or secondary angle closure glaucoma.
24 d) Adults with primary congenital, infantile or childhood glaucoma.
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26 4.2 Healthcare setting
27 a) Community, primary care, secondary care outpatient and day treatment services, and
28 tertiary care specialist services
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APPENDIX A - SCOPE - (DRAFT FOR CONSULTATION)
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2 4.3 Clinical management
3 a) The diagnosis of chronic open angle glaucoma and ocular hypertension in patients
4 presenting at community optometrists and those referred to hospital eye services using
5 one or more of the tests below:
6 • measurement of intraocular pressure
7 • visual field test
8 • optic nerve head assessment
9 • anterior chamber angle assessment.
10 b) The appropriate use of pharmacological interventions, for example effectiveness, cost
11 effectiveness, initiation and duration of treatment. Pharmacological treatments
12 considered will include:
13 • eye drops
14 - beta blockers
15 - prostaglandin related drugs
16 - sympathomimetics
17 - carbonic anhydrase inhibitors
18 - miotics
19 • systemic medications
20 - carbonic anhydrase inhibitors
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22 Note that guideline recommendations will normally fall within licensed indications;
23 exceptionally, and only where clearly supported by evidence, use outside a licensed
24 indication may be recommended. The guideline will assume that prescribers will use a
25 drug’s summary of product characteristics to inform their decisions for individual patients.
26 c) The effectiveness of penetrating and nonpenetrating surgical drainage procedures
27 with and without pharmacological augmentation or drainage devices.
28 d) The effectiveness of postsurgical drain manipulation with and without the use of
29 pharmacological augmentation.
30 e) The effectiveness of laser procedures to facilitate aqueous outflow or reduce aqueous
31 production.
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APPENDIX A - SCOPE - (DRAFT FOR CONSULTATION)
1 f) The information, education and support needs of patients to achieve treatment
2 concordance will be considered.
3 g) The most appropriate service models, where evidence of clinical and cost
4 effectiveness is available.
5 h) The guideline development group will consider making recommendations on the
6 principal complementary and alternative interventions or approaches to care relevant to
7 the guideline topic.
8 i) The guideline development group will take reasonable steps to identify ineffective
9 interventions and approaches to care. If robust and credible recommendations for re-
10 positioning the intervention for optimal use, or changing the approach to care to make
11 more efficient use of resources can be made, they will be clearly stated. If the resources
12 released are substantial, consideration will be given to listing such recommendations in
13 the ‘Key priorities for implementation’ section of the guideline.
14 j) Population based screening programmes for glaucoma are not within the remit of this
15 guideline.
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17 4.4 Status
18 4.4.1 Scope
19 This is the final scope.
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21 4.4.2 Guideline
22 The development of the guideline recommendations will begin in June 2007.
23 Associated NICE Guidance Medicines Concordance (in development) for publication
24 December 2008.
5 Further information
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26 Information on the guideline development process is provided in:
27 • ‘The guideline development process: an overview for stakeholders, the public and
28 the NHS’
29 • ‘The guidelines manual’.
30 These booklets are available as PDF files from the NICE website
31 (www.nice.org.uk/guidelinesmanual). Information on the progress of the guideline will
32 also be available from the website.
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APPENDIX A - SCOPE - (DRAFT FOR CONSULTATION)
6 Referral from the Department of Health
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2 The Department of Health asked the Institute:
3 ‘To prepare a clinical guideline on the diagnosis and management of chronic open angle
4 glaucoma and ocular hypertension (raised intraocular pressure). The guideline should
5 include recommendations on the most appropriate service models where evidence of
6 effectiveness is available.’
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APPENDIX B – DECLARATION OF INTERESTS - (DRAFT FOR CONSULTATION)
Appendix B
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1 Declarations of interests
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3 1.1 Introduction
4 All members of the GDG and all members of the NCC-AC staff were required to make
5 formal declarations of interest at the outset, and these were updated at every
6 subsequent meeting throughout the development process. No interests were declared that
7 required actions.
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9 1.2 Declarations of interests of the GDG members
10 Ms Cecilia Fenerty……………………………………………………… …………p. 10
11 Ms Wendy Franks…………………………………………………………… …….p. 11
12 Ms Mary Freeman…………………………………………………………… …….p. 12
13 Mr Dennis Keight……………………………………………………………………p. 13
14 Ms Susana Ramirez-Florez………………………………………………………….p. 14
15 Ms Safina Rashid …………………………………………………………… …….p. 15
16 Mr John Sparrow (Chair) …………………………………………………… ……..p. 16
17 Mr Paul Spry……………………………………………………… …………… …p. 17
18 Mr Chris Steele …………………………………………… …………………….p. 18
19 Ms Sheila Urquhart… … ……………………………………… …………………p. 19
20 Mr Richard Wormald …………………...… …………………… … …………….p. 20
21 Mr David Wright…………………………… ……………..………………………p. 21
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APPENDIX B – DECLARATION OF INTERESTS - (DRAFT FOR CONSULTATION)
1 1.2.1 Ms Cecilia Fenerty
GDG meeting Declaration of Interests
First GDG meeting She declared a personal pecuniary interest: she is a glaucoma speciality
(4th June 2007) ophthalmic consultant working for the NHS with a subspecialty interest in
glaucoma.
She declared two non-personal pecuniary interests: her place of work,
Manchester Royal Eye Hospital, received an award from Allergan in 2006
for £2500. She also received a Pfizer grant for research into persistence
with glaucoma therapy (this research was not product specific).
She declared no personal family interests or personal non-pecuniary
interests.
Second GDG Meeting No change to declarations
(25th June 2007)
Third GDG Meeting No change to declarations
(26th July 2007)
Fourth GDG Meeting No change to declarations
(11th September 2007)
Fifth GDG Meeting No change to declarations
(24th October 2007)
Sixth GDG Meeting The declarations above plus:
(5th December 2007) She declared a non-personal pecuniary interest: she received a donation of
drop aids from Alcon for a study into compliance. This device is product
specific as it can only be used with Travatan/Duotrav. The trial itself was
not funded by Alcon.
Seventh GDG Meeting No change to declarations
(29th January 2008)
Eight GDG Meeting No change to declarations
(13th March 2008)
Ninth GDG Meeting No change to declarations
(25th April 2008)
Tenth GDG Meeting No change to declarations
(19th May 2008)
Eleventh GDG Meeting No change to declarations
(3rd June 2008)
Twelfth GDG Meeting No change to declarations
(9th July 2008)
Thirteenth GDG Meeting No change to declarations
(31st July 2008)
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