Changes

July 2025  — reviewed. A literature search was conducted in July 2025 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of this topic. 

Update

Goals

To support primary healthcare professionals to:

• Advise people at high risk of primary open angle glaucoma to have their eyes examined by an optometrist regularly.
• Provide shared care for people who are being treated for primary open angle glaucoma or ocular hypertension in secondary care.
• Recognize and admit people urgently with suspected acute angle closure.

Outcome measures

Audit criteria

No audit criteria were found during the review of this topic.

QOF indicators

No QOF indicators were found during the review of this topic.

QIPP - Options for local implementation

No QIPP indicators were found during the review of this topic.

NICE quality standards

 Serious eye disorders

• Adults with signs of possible glaucoma or related conditions on a routine sight test have additional tests before they are referred for a diagnosis.

• Adults with chronic open angle glaucoma or related conditions have reassessment at specific intervals.

• Adults with serious eye disorders are given a certificate of vision impairment as soon as they are eligible.

• People are referred to a consultant ophthalmologist for further assessment and definitive diagnosis if the optometrist or other healthcare professional suspects chronic open angle glaucoma (COAG). There are local agreements in place for referral refinement.

• People with elevated intraocular pressure alone are referred to an appropriately qualified healthcare professional for further assessment on the basis of perceived risk of progression to COAG. There are agreements in place for repeat measures.

• People with COAG, suspected COAG, or with ocular hypertension (OHT) are diagnosed and have a management plan formulated by a suitably trained healthcare professional with competencies and experience in accordance with NICE guidance.

• People with COAG, suspected COAG, or with OHT have a regular review of management options with their healthcare professional, taking into account comorbidity and other changed circumstances, including a discussion of the benefits and risks of stopping treatment for those at low risk of progressing to visual impairment.

• Healthcare professionals involved in the care of a person with COAG, suspected COAG, or with OHT have appropriate documentation and records available at each clinical encounter in accordance with NICE guidance.

• People with COAG who are progressing to loss of vision despite treatment or who present with advanced visual loss are offered surgery with pharmacological augmentation (MMC) as indicated and information on the risks and benefits associated with surgery.

• People with COAG, suspected COAG, or with OHT are given the opportunity to discuss their diagnosis, prognosis, and management, and are provided with relevant and accessible information and advice at initial and subsequent visits in accordance with NICE guidance.

• People with suspected COAG or with OHT who are not recommended for treatment are discharged from formal monitoring with a patient-held management plan and their discharge summary is sent to their GP and primary eye care professional.

[NICE, 2019] 

What is it?

• Glaucoma is a group of eye diseases that cause progressive optic neuropathy, and in which intraocular pressure (IOP) is a key modifiable factor. Glaucoma is commonly associated with raised IOP and is characterized by:
  • Visual field defects.
  • Changes to the optic nerve head such as pathological cupping or, as a late sign, pallor of the optic disc.
• Ocular hypertension is where there is consistently or recurrently elevated IOP (greater than 21 mmHg) but with no signs of glaucoma.

   [Jonas, 2017; Michels, 2023; Dietze, 2024]

What is the anatomy and physiology of the eye relevant to glaucoma?

• The descriptions of the anatomy and physiology of the eye may be more easily understood when read with the aid of a diagram of the eye, such as that on the website of the American Academy of Ophthalmology.
  • Anterior chamber
    • The anterior chamber is the fluid-filled space between the iris and the cornea.
    • The anterior chamber angle is the angle between the iris and the cornea where they join the sclera towards the outside of the eye.
    • The trabecular meshwork is situated in the apex of the anterior chamber angle and is the main outflow route for aqueous humour.
  • Aqueous humour
    • Aqueous humour is the fluid produced from plasma by the ciliary epithelium of the ciliary body (the circular structure just behind the iris). The enzyme carbonic anhydrase plays a key role in its production. 
    • Aqueous humour is secreted into the posterior chamber, which is the relatively small fluid-filled space between the lens and iris. It then flows through the pupil into the anterior chamber and out of the eye primarily through the trabecular meshwork. Also, a small percentage drains out via the venous circulation of the iris, ciliary body, choroid, and sclera (the uveoscleral outflow).
    • Secretion of aqueous humour is increased by stimulation of beta-2 receptors and decreased by stimulation of alpha-2 receptors of the sympathetic nervous system that are located on cells of the ciliary body.
  • Intraocular pressure (IOP)
    • IOP keeps the eye in the shape of a globe and is maintained by the balance between production and outflow of aqueous humour.
    • Raised IOP is the main risk factor for developing glaucoma, as the raised pressure may damage nerve fibres of the optic nerve, or blood vessels supplying these nerve fibres.
    • A pressure between 11–21 mmHg is considered normal. However, some people develop glaucoma at a pressure below 21 mmHg, and some people have pressures well above this level without showing signs of glaucoma.
    • Drugs used to treat glaucoma aim to reduce IOP and work by either reducing the production of aqueous humour or increasing its outflow.

 [Jonas, 2017; Michels, 2023; Dietze, 2024]

How is glaucoma classified?

• Glaucoma can be classified according to:
  • Age of onset: congenital, infantile, juvenile, or adult.
  • Cause: primary (no known cause) or secondary with a known underlying cause.
  • Rate of onset: acute, subacute, or chronic.
  • The anterior chamber angle between the iris and cornea being either open or closed.
• In open-angle situations, the angle between the iris and the cornea is normal.
  • Primary open-angle glaucoma (POAG) is, by far, the most common type of glaucoma. POAG:
    • Mainly affects people over the age of 40 years.
    • Is usually insidious in onset and follows a chronic course. 
    • Usually affects both eyes, but one eye may be more affected than the other. 
    • Is typically associated with raised intraocular pressure (IOP).
  • Normal tension (pressure) glaucoma occurs in a significant minority of people with POAG, where glaucoma develops with normal IOP. It seems that the optic nerve fibres are more susceptible to damage in some people with intraocular pressures considered to be normal.
  • Suspected POAG is when the appearance of the optic nerve head is suggestive of glaucoma but the visual fields appear normal, or conversely, where a visual field defect exists yet the optic nerve appears healthy.
  • Secondary open-angle glaucoma is uncommon and may be due to a number of causes. 
• In angle closure situations, the angle between the iris and the cornea is at least partially closed.
  • Primary angle closure glaucoma (PACG) is the most common type of angle closure glaucoma. Onset may be acute, subacute, or chronic. Terms used prior to PACG developing include:
    • Primary angle closure suspect (PACS) where gonioscopy (examination of the anterior chamber angle) shows some angle closure but the person has normal IOP and no signs of glaucoma.
    • Primary angle closure (PAC) where there is more extensive angle closure seen on gonioscopy, often with raised IOP, but with no signs of glaucoma.
  • Secondary angle closure glaucoma is uncommon and may be due to a number of causes. 
  • Symptom development in primary or secondary angle closure can be classified as:
    • Acute: this occurs when there is abrupt onset of symptoms (most notably, eye pain) associated with a marked elevation of IOP due to a total closure of the angle. This is a sight-threatening medical emergency that is not self-limiting. 
    • Subacute (or intermittent): where there is abrupt onset of symptoms and elevation of IOP due to closure of the angle, but which is self-limiting. It is often recurrent. Glaucoma may develop.
    • Chronic: with gradually elevated IOP resulting from angle closure that is asymptomatic. This is the most common closed angle situation and glaucoma typically develops if not recognised and treated. 

   [EGS, 2021; Joshi, 2022; Michels, 2023]

What are the causes of glaucoma?

• Primary open-angle glaucoma (POAG)
  • The reason why POAG develops is not clear, but there are various risk factors. Many people with POAG have raised intraocular pressure (IOP) due to reduced drainage of aqueous humour from the anterior chamber. The cause of the reduced drainage is not clear. There may be subtle age-related changes in the structure of the trabecular meshwork that affect the drainage.
  • The visual loss owing to POAG is due to damage to retinal ganglion cells as a result of the raised IOP, causing mechanical pressure damage to the axons (nerve fibres) of the cells as they pass over the optic nerve head. However, ischaemic damage may contribute owing to pressure on the blood vessels that supply the cells.
• Secondary causes of open-angle glaucoma include:
  • Pseudoexfoliative glaucoma — cellular organelles (pseudoexfoliative material) deposited on the trabecular meshwork restricts outflow of the aqueous humour. 
  • Pigmentary glaucoma — pigment from the back of the iris deposited in the trabecular meshwork (pigment dispersion syndrome) restricts outflow of the aqueous humour. 
  • Neovascular glaucoma — new blood vessels (neovascularization) formed in response to ischaemia (for example, with diabetic retinopathy or central retinal vein occlusion) block the outflow of aqueous humour through the trabecular meshwork. 
  • Uveitic glaucoma — in uveitis (inflammation of the uvea: the iris, ciliary body, and choroid plexus), inflammatory cells and proteins block the outflow of aqueous humour through the trabecular meshwork. 
  • Steroid-induced glaucoma — in susceptible people, corticosteroids increase the resistance to outflow of the aqueous humour by affecting the transport of aqueous by trabeculocytes in the trabecular meshwork. Raised IOP induced by corticosteroids is most common with eye drop preparations, but it may develop when corticosteroids are administered by other routes (for example, inhaled, topical, oral, or intravenous). 
  • Angle-recession glaucoma — trauma to the drainage angle structures reduces outflow of the aqueous humour. 
  • Childhood secondary glaucoma — several uncommon congenital and acquired conditions cause glaucoma in children. 
• Primary angle closure glaucoma (PACG):
  • The angle between the iris and the cornea is at least partially closed. That is, the peripheral iris comes into contact with the trabecular meshwork. This restricts the drainage of aqueous humour from the eye. As aqueous humour continues to be produced, the pressure within the eye increases, which can then lead to damage to optic nerve fibres. 
  • PACG occurs in people with anatomically predisposed eyes where the iris tends to push forward onto the trabecular meshwork. There are a number of risk factors.
• Secondary causes of angle closure glaucoma can occur as a result of various rare eye conditions, such as a subluxated lens and chronic anterior uveitis.  

[Schuster, 2020; Hsu, 2023; Michels, 2023; Dietze, 2024]

What are the risk factors for developing primary glaucoma?

• Risk factors for developing primary open-angle glaucoma (POAG) include:
  • Raised intraocular pressure — the main treatable risk factor [NICE, 2022]. 
    • Approximately 10% of patients with an elevated IOP develop glaucoma after five years, and 30% at 20 years [Michels, 2023].
  • Age — the prevalence increases with age [Jonas, 2017].
  • Family history and genetic factors — first-degree relatives (parent, sibling, child) of a person with POAG are at increased risk [Shan, 2024]. The risk to a sibling is about eight times, and that of a child is about twice, the population risk [Bowling, 2024]. 
    • The most common single gene variant forms of POAG are caused by mutations in the myocilin (MYOC) gene. The prevalence of MYOC mutations has been estimated as 2–4% in POAG patients, but if patients are preferentially selected based on young age of onset, high IOP and strong family history the prevalence rises to 16–40% [EGS, 2021].
  • Ethnicity — POAG is about two to three times more common in black people than in white people [Michels, 2023] and PACG is more common in people of East Asian and Chinese origin [EGS, 2021].
  • Corticosteroids — including oral, inhaled, or high-potency topical corticosteroids. The mechanism is unclear but may be due to changes in the stiffness of the trabecular meshwork caused by corticosteroids that inhibit aqueous humour outflow [Raghunathan, 2015]. 
  • Myopia — it is speculated that mechanical factors associated with myopia are the reason for the increased risk [Shan, 2024].
  • Type 2 diabetes mellitus, hypertension, and cardiovascular disease — associated with increased risk, but this increase may be small [Hsu, 2023].
  • Obstructive sleep apnoea — associated with a higher risk of glaucoma, as well as more severe ocular findings characteristic of the glaucomatous disease process [Cheong, 2023].

• Risk factors for developing primary angle closure glaucoma (PACG) include:
  • Age — the prevalence increases with age [Day, 2012]. This is thought to be due to the size of the lens that gradually increases with age, thus crowding the region of the anterior chamber angle, making it shallower [Khondkaryan, 2013].
  • Sex — PACG is 2–3 times more common in women than in men, as women tend to have shallower anterior chambers than men [Quigley, 2006]. 
  • Ethnicity — PACG is much more common in people from an Asian background than a European background [Jonas, 2017]. Worldwide, the prevalence of PACG is highest in China [EGS, 2021; Dietze, 2024].
  • Eye size — people with short, hyperopic eyes have an increased risk. PACG is rare in people with myopia [Wright, 2016].
  • Family history and genetic factors — most cases of PACG are sporadic but a hereditary element may play a role in some people [Wright, 2016]. Studies have revealed a number of gene variants associated with PACG [Sakurada, 2015].

How common is it?

• Ocular hypertension affects 3–5% of people, over 40 years of age, in the UK  [NICE, 2022].
• Primary open-angle glaucoma (POAG):
  • Affects about 2% of people in the UK older than 40 years [NICE, 2022].
  • The prevalence increases with increasing age. POAG affects approximately 10% of those over 75 years in the UK [NICE, 2022].
  • Several population-based studies have reported that at least 50% of glaucoma cases remain undiagnosed in Europe, and glaucoma associated with a normal range of IOP is more likely to be underdiagnosed [EGS, 2021].
• Primary angle closure glaucoma (PACG) affects about 0.4% of people, older than 40 years, in the UK [Day, 2012; Foster, 2022]. 
  • In the UK, PACG is responsible for 1 in 6 cases of glaucoma [Michelessi, 2022]. 
  • The prevalence increases with increasing age, and PACG affects about 0.94% of those aged 70 years and older [Day, 2012]. 
  • About 130,000 people in the UK are estimated to have PACG [Day, 2012; Foster, 2022].
  • PACG is more common in women and people from East Asia  [Michelessi, 2022].
• Worldwide [EGS, 2021]
  • The estimated global prevalence of open-angle glaucoma (OAG) is 3.5% in 40–80 year olds.
  • The global prevalence of angle closure glaucoma (ACG) is estimated as 0.50%.
  • The number of people with glaucoma was estimated to be 60–76 million in 2020 and expected to increase to 112 million by 2040 [Michels, 2023; Dietze, 2024].

What is the prognosis?

• Ocular hypertension
  • The risk of progression of ocular hypertension to glaucoma depends on various factors, most notably, the severity of the intraocular pressure (IOP), the corneal thickness, and age [Bowling, 2024].
  • Appropriate monitoring and treatment, where necessary, reduces the risk of progression to glaucoma [NICE, 2022]. 
    • A 2018 study showed that at 60 months, the cumulative frequency of developing POAG was 4.4% in the medication group and 9.5% in the observation group (hazard ratio for medication, 0.40; 95% CI, 0.27–0.59; P <.0001) [Gordon, 2018].
  • • At 13 years, the cumulative proportion of participants who developed POAG was 0.22 (95% CI 0.19–0.25) in the original observation group and 0.16 (95% CI 0.13–0.19) in the original medication group.
    • A 5-factor model (older age, higher IOP, thinner central cornea thickness, larger cup/disc ratio and higher visual field pattern standard deviation) separated participants at high and low risk of developing POAG [Gordon, 2018].
•  Primary open-angle glaucoma
  • Without treatment, POAG typically progresses slowly, over years, and most people are asymptomatic until late in the disease. Visual field defects do not appear until most of the optic nerve fibres have been damaged. However, the rate of progression is variable [Bowling, 2024].
    • Typically, as glaucoma progresses, visual loss is peripheral at first. Peripheral vision is important for detecting movement outside the area of focus and is therefore necessary for safe driving. Severe loss of the peripheral visual field results in tunnel vision. 
    • Central vision tends to be affected later, which affects reading and other activities that require focused vision. 
    • Most people with POAG will not go blind (blindness of both eyes eventually develops in about 5–10% of people with POAG) but will develop varying degrees of visual loss and visual field defects. 
    • Any vision that is lost because of glaucoma cannot be restored. 
  • With treatment, there is a delay in the progression of glaucoma, and most people on treatment will not go blind [Bowling, 2024].
  • One study followed up 20 people who were still alive 20 years after being diagnosed with (and had been receiving appropriate treatment for) POAG. On visual field analysis, nearly half (48.9%) of eyes did not deteriorate, but 28.3% of eyes deteriorated by more than two stages. The authors concluded that 'in most older patients with glaucoma, the overall goal of preventing visual handicap and blindness is achievable 20 years after diagnosis' [King, 2018].
    • Note: a main factor to a poorer outcome is non-adherence with topical medical treatment. Research suggests up to 50% of patients fail to receive the intended benefits of the treatment [Zaharia, 2022]. Many potential barriers have been identified including factors depending on the type of medication (and regime) administered, communication between physician and patients, and factors dependent on patients’ behaviour and lifestyle.
• Primary angle closure glaucoma
  • Without treatment — although PACG is much less common than POAG, it accounts for half of glaucoma-related blindness in the world [Michels, 2023].
  • With prompt treatment, the outlook is good. Outlook can depend on how early the condition is diagnosed and treated [Michelessi, 2022]. 
  • An untreated fellow eye (the eye not currently affected) has a 40–80% chance of developing an acute episode of angle closure over the next 5–10 years [Khondkaryan, 2013].

What are the possible complications of glaucoma?

• Irreversible loss of vision (partial or complete) is the main complication of untreated glaucoma.
  • About 10% of UK blindness registrations are due to glaucoma [NICE, 2022].
  • Globally, glaucoma is the leading cause of irreversible blindness [Tham, 2014] and the second most common cause of blindness (after cataracts) [Michels, 2023].
  • It is estimated that there are about 66 million people in the world with glaucoma, and about 12.5 million people are blind due to glaucoma [NICE, 2022].
  • Angle closure glaucoma is considerably more likely than open-angle glaucoma to cause blindness [Jonas, 2017; EGS, 2021].
• For people with primary open-angle glaucoma (POAG), the main risk factor for blindness is advanced glaucoma at presentation [King, 2024].
  • The main risk factor for advanced glaucoma at presentation is socio-economic deprivation [King, 2024].

How is primary angle closure glaucoma diagnosed?

• Acute angle closure
  • Suspect acute angle closure (which may lead to glaucoma) in a person with an acute, painful red eye. In particular, a person with risk factors and/or a history of:
    • Previous episodes of blurred vision, headaches, or eye pain associated with nausea and seeing halos around lights. These symptoms may have been due to intermittent angle closure, typically occur in the evening, and are relieved by sleeping.
    • A precipitating factor, such as watching television in a darkened room, adopting a semi-prone position (for example, reading), use of an adrenergic drug (for example, phenylephrine), or use of an antimuscarinic drug (for example, a tricyclic antidepressant).
  • Typical symptoms and signs include:
    • Eye pain, often severe, and associated with headache, nausea, and vomiting (caused by the pain).
    • A red eye.
    • Impaired visual acuity and lights are seen surrounded by halos — caused by a hazy oedematous cornea.
    • Semi-dilated and fixed pupil. Classically, the pupil becomes fixed in a vertically oval shape.
    • A tender, hard eye (palpate very gently). When measured by an optometrist or ophthalmologist, the intraocular pressure (IOP) is typically very high.
• Subacute (intermittent) angle closure
  • This causes similar symptoms to acute angle closure, but symptoms may be less severe and often soon resolve, typically on lying supine and closing the eyes, or after sleeping.
• Chronic primary angle closure glaucoma (PACG)
  • Chronic PACG is typically asymptomatic until severe visual field defects affect vision. 
  • The diagnosis is usually made by an optometrist during routine eye examinations. 
    • Typical features that may be detected by an optometrist are: increased IOP, visual field defects, a cupped optic disc, and signs of angle closure as detected by gonioscopy. 
    • An optometrist will normally refer a person with chronic PACG to a consultant ophthalmologist for confirmation of the diagnosis.
  • A GP should suspect chronic glaucoma in a person with a visual field defect without other eye symptoms, or when ophthalmoscopy reveals a cupped optic disc in one or both eyes. 
    • People are often not aware that they have a visual field defect, even when it is severe. This is because the visual fields of each eye overlap, and so a visual field defect in one eye may be well compensated for by the other eye until that too becomes affected.
    • Refer the person to an optometrist for preliminary confirmation of the diagnosis, and to a consultant ophthalmologist for final confirmation of the diagnosis.

How is ocular hypertension and primary open angle glaucoma diagnosed?

• Diagnoses of ocular hypertension and primary open angle glaucoma (POAG) are usually made by an optometrist during routine eye examinations. 
  • Typical features of POAG are: increased intraocular pressure, visual field defects, and a cupped optic disc.
  • An optometrist will normally refer a person with POAG to a consultant ophthalmologist for confirmation of the diagnosis.
  • With regard to ocular hypertension, an optometrist may refer the person to a consultant ophthalmologist depending on the degree of ocular pressure and other criteria. Some people may just require monitoring by the optometrist.
  • Note: differentiating myopia-related optic neuropathy and normal tension glaucoma (NTG) can be very challenging due to the clinical findings associated with severe myopia. It is known that myopic patients with normal intraocular pressures (IOPs) can present with glaucomatous visual field defects, which can be attributed to myopia rather than to glaucoma.

• A GP should suspect POAG in a person with a visual field defect without other eye symptoms, or when ophthalmoscopy reveals a cupped optic disc in one or both eyes.
  • People are often not aware that they have a visual field defect, even when it is severe. This is because the visual fields of the eyes overlap, and so a visual field defect in one eye may be well compensated for by the other eye until that too becomes affected.
  • Refer the person to an optometrist for preliminary confirmation of the diagnosis, and to a consultant ophthalmologist for final confirmation of the diagnosis.

When would I advise opportunistic testing for glaucoma?

• If any of the following risk factors for glaucoma are present, consider advising people to have their eyes examined by an optometrist:
  • Older age. People 60 years of age or older should be examined every 2 years until they are 70 years of age, when they should be examined annually — free examination is available through the NHS.
  • Family history of glaucoma. People older than 40 years of age who have a first-degree relative (parent, sibling, or child) with open-angle glaucoma should be examined annually — free examination is available through the NHS.
  • Ethnicity. People older than 40 years of age who are of black African or East Asian family origin.
  • Myopia. People who are very short-sighted should have a regular eye assessment.
• Certain people are entitled to free NHS-funded eye examinations by optometrists. 
  • Full criteria for people eligible to receive free eye examinations can be found on the NHS website. These include people:
    • With a family history of glaucoma as described above.
    • Aged 60 years or older.
    • In receipt of certain benefits.
    • Who have been advised by an ophthalmologist that they are at risk of developing glaucoma.

Scenario: acute angle closure and angle closure glaucoma

From age 16 years onwards.

Scenario: Primary open angle glaucoma and ocular hypertension

From age 16 years onwards.

Topical prostaglandin analogues and prostamides

Topical beta-blockers

Topical sympathomimetics

Carbonic anhydrase inhibitors

Topical miotics

Search strategy

Scope of search

A literature search was conducted for guidelines and systematic reviews on the primary care management of glaucoma.

Search dates

May 2020 - July 2025

Key search terms

The terms listed below are the core search terms that were used for EBSCOhost MEDLINE (searched 6th May 2020). These were combined with filters to identify guidelines, systematic reviews and primary care relevant literature in EBSCOhost MEDLINE. The strategy was adapted for The Cochrane Library databases. 

S6    S1 OR S2 OR S3 OR S4 OR S5 
S5    TI intraocular pressure 
S4    TI ocular hypertension 
S3    AB glaucoma* OR TI glaucoma* 
S2    (MH "Ocular Hypertension+") 
S1    (MH "Glaucoma+") 

Sources of guidelines

• National Institute for Health and Care Excellence (NICE)
• Scottish Intercollegiate Guidelines Network (SIGN)
• Royal College of Physicians
• Royal College of General Practitioners
• Royal College of Nursing
• NICE Evidence
• World Health Organization
• Guidelines International Network
• TRIP database
• Agency for Healthcare Research and Quality
• National Health and Medical Research Council (Australia)
• Royal Australian College of General Practitioners
• British Columbia Medical Association
• Canadian Medical Association
• Alberta Medical Association
• Michigan Quality Improvement Consortium
• Singapore Ministry of Health
• National Resource for Infection Control
• RefHELP NHS Lothian Referral Guidelines
• Medline (with guideline filter)
• Driver and Vehicle Licensing Agency
• NHS Health at Work (occupational health practice)

Sources of systematic reviews and meta-analyses

• The Cochrane Library:
  • Systematic reviews
  • Protocols
  • Database of Abstracts of Reviews of Effects
• Medline (with systematic review filter)
• EMBASE (with systematic review filter)

Sources of health technology assessments and economic appraisals

• NIHR Health Technology Assessment programme
• The Cochrane Library:
  • NHS Economic Evaluations
  • Health Technology Assessments
• Canadian Agency for Drugs and Technologies in Health
• International Network of Agencies for Health Technology Assessment

Sources of randomized controlled trials

• The Cochrane Library:
  • Central Register of Controlled Trials
• Medline (with randomized controlled trial filter)
• EMBASE (with randomized controlled trial filter)

Sources of evidence based reviews and evidence summaries

• Drug and Therapeutics Bulletin
• TRIP database
• Central Services Agency COMPASS Therapeutic Notes

Sources of national policy

• Department of Health
• Health Management Information Consortium (HMIC)

Patient experiences

• Healthtalk
• BMJ - Patient Journeys

Sources of medicines information

The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are not freely available and require subscriptions to access content.

• British National Formulary (BNF)
• electronic Medicines Compendium (eMC)
• European Medicines Agency (EMEA)
• Medicines and Healthcare products Regulatory Agency (MHRA)
• REPROTOX
• Scottish Medicines Consortium
• Stockley's Drug Interactions
• TERIS
• TOXBASE
• Micromedex
• UK Medicines Information

Stakeholder engagement

Our policy

The external review process is an essential part of CKS topic development. Consultation with a wide range of stakeholders provides quality assurance of the topic in terms of:

• Clinical accuracy.
• Consistency with other providers of clinical knowledge for primary care.
• Accuracy of implementation of national guidance (in particular NICE guidelines).
• Usability.

Principles of the consultation process

• The process is inclusive and any individual may participate.
• To participate, an individual must declare whether they have any competing interests or not. If they do not declare whether or not they have competing interests, their comments will not be considered.
• Comments received after the deadline will be considered, but they may not be acted upon before the clinical topic is issued onto the website.
• Comments are accepted in any format that is convenient to the reviewer, although an electronic format is encouraged.
• External reviewers are not paid for commenting on the draft topics.
• Discussion with an individual or an organization about the CKS response to their comments is only undertaken in exceptional circumstances (at the discretion of the Clinical Editor or Editorial Steering Group).
• All reviewers are thanked and offered a letter acknowledging their contribution for the purposes of appraisal/revalidation.
• All reviewers are invited to be acknowledged on the website. All reviewers are given the opportunity to feedback about the external review process, enabling improvements to be made where appropriate.

Stakeholders

• Key stakeholders identified by the CKS team are invited to comment on draft CKS topics. Individuals and organizations can also register an interest to feedback on a specific topic, or topics in a particular clinical area, through the Getting involved section of the Clarity Informatics website.
• Stakeholders identified from the following groups are invited to review draft topics:
  • Experts in the topic area.
  • Professional organizations and societies (for example, Royal Colleges).
  • Patient organizations, Clarity has established close links with groups such as Age UK and the Alzheimer’s Society specifically for their input into new topic development, review of current topic content and advice on relevant areas of expert knowledge.
  • Guideline development groups where the topic is an implementation of a guideline.
  • The British National Formulary team.
  • The editorial team that develop MeReC Publications.
• Reviewers are provided with clear instructions about what to review, what comments are particularly helpful, how to submit comments, and declaring interests.

Patient engagement

Clarity Informatics has enlisted the support and involvement of patients and lay persons at all stages in the process of creating the content which include:

• Topic selection
• Scoping of topic
• Selection of clinical scenarios
• First draft internal review
• Second draft internal review
• External review
• Final draft and pre-publication

Our lay and patient involvement includes membership on the editorial steering group, contacting expert patient groups, organizations and individuals.

Evidence exclusion criteria

Our policy

Scoping a literature search, and reviewing the evidence for CKS is a methodical and systematic process that is carried out by the lead clinical author for each topic. Relevant evidence is gathered in order that the clinical author can make fully informed decisions and recommendations. It is important to note that some evidence may be excluded for a variety of reasons. These reasons may be applied across all CKS topics or may be specific to a given topic.

Studies identified during literature searches are reviewed to identify the most appropriate information to author a CKS topic, ensuring any recommendations are based on the best evidence. We use the principles of the GRADE and PICOT approaches to assess the quality of published research. We use the principles of AGREE II to assess the quality of published guidelines.

Standard exclusions for scoping literature:

• Animal studies
• Original research is not written in English

Possible exclusions for reviewed literature:

• Sample size too small or study underpowered
• Bias evident or promotional literature
• Population not relevant
• Intervention/treatment not relevant
• Outcomes not relevant
• Outcomes have no clear evidence of clinical effectiveness
• Setting not relevant
• Not relevant to UK
• Incorrect study type
• Review article
• Duplicate reference

Organizational, behavioural and financial barriers

Our policy

The CKS literature searches take into consideration the following concepts, which are discussed at the initial scoping of the topic.

• Feasibility
  • Studies are selected depending on whether the intervention under investigation is available in the NHS and can be practically and safely undertaken in primary care.
• Organizational and Financial Impact Analysis
• Studies are selected and evaluated on whether the intervention under investigations may have an impact on local clinical service provision or national impact on cost for the NHS. The principles of clinical budget impact analysis are adhered to, evaluated and recorded by the author. The following factors are considered when making this assessment and analysis.
  • Eligible population
  • Current interventions
  • Likely uptake of new intervention or recommendation
  • Cost of the current or new intervention mix
  • Impact on other costs
  • Condition-related costs
  • In-direct costs and service impacts
  • Time dependencies
• Cost-effectiveness or cost-benefit analysis studies are identified where available. 

We also evaluate and include evidence from NICE accredited sources which provide economic evaluations of recommendations, such as NICE guidelines. When a recommended action may not be possible because of resource constraints, this is explicitly indicated to healthcare professionals by the wording of the CKS recommendation.

Declarations of interest

Our policy

Clarity Informatics requests that all those involved in the writing and reviewing of topics, and those involved in the external review process to declare any competing interests. Signed copies are securely held by Clarity Informatics and are available on request with the permission of the individual. A copy of the declaration of interest form which participants are asked to complete annually is also available on request. A brief outline of the declarations of interest policy is described here and full details of the policy is available on the Clarity Informatics website. Declarations of interests of the authors are not routinely published, however competing interests of all those involved in the topic update or development are listed below. Competing interests include:

• Personal financial interests
• Personal family interest
• Personal non-financial interest
• Non-personal financial gain or benefit

Although particular attention is given to interests that could result in financial gains or losses for the individual, competing interests may also arise from academic competition or for political, personal, religious, and reputational reasons. An individual is not obliged to seek out knowledge of work done for, or on behalf of, the healthcare industry within the departments for which they are responsible if they would not normally expect to be informed.

Who should declare competing interests?

Any individual (or organization) involved in developing, reviewing, or commenting on clinical content, particularly the recommendations should declare competing interests. This includes the authoring team members, expert advisers, external reviewers of draft topics, individuals providing feedback on published topics, and Editorial Steering Group members. Declarations of interest are completed annually for authoring team and editorial steering group members, and are completed at the start of the topic update and development process for external stakeholders.

Competing interests declared for this topic:

None.