Changes

July 2022 — reviewed. A literature search was conducted in July 2022 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of this topic. Minor structural changes have been made to this topic, recommendations on non-melanoma lesions have been removed and the topic title has been changed to Melanoma. There have been no major changes to the recommendations.

Update

Goals

To support primary healthcare professionals to:

• Assess people with pigmented lesions.
• Recognize the features of melanoma.
• Refer people with suspected melanoma to dermatology within the appropriate timescale.
• Provide appropriate advice for people at increased risk of melanoma.
• Offer self-care advice on the prevention of melanoma.

Outcome measures

Audit criteria

QOF indicators

QIPP - Options for local implementation

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

NICE quality standards

• Local health promotion activities on preventing skin cancer and recognising early signs are consistent with the messages in any national campaigns.
• GPs who manage low-risk basal cell carcinoma, including GPs with a special interest (GPwSI), maintain and audit records of their caseload.
• People with suspected malignant melanoma are referred using a suspected cancer pathway for an appointment within 2 weeks.
• People with pigmented skin lesions undergoing a specialist assessment have the lesions examined using dermoscopy.
• People with malignant melanoma or squamous cell carcinoma have access to a skin cancer clinical nurse specialist.
• People with stage IB-IIC melanoma with a Breslow thickness of more than 1 mm have a discussion about the advantages and disadvantages of sentinel lymph node biopsy as a staging procedure.
• People with unresectable or metastatic melanoma are offered genetic testing of the tumour.

[NICE, 2016, Quality standard, Skin cancer]

What is it?

• Melanoma is a malignant tumour arising from melanocytes [SIGN, 2017; BMJ, 2022]. 
• Melanoma is described as 'in situ' if confined to the epidermis, 'invasive' if spread to the dermis, and 'metastatic' if spread to other tissues from the skin [DermNet NZ, 2015a]. 
• The four common subtypes are: superficial spreading melanoma (60–70%), nodular melanoma (15–30%), lentigo maligna melanoma (5–15%), and acral lentiginous melanoma (5–10%) [Cancer Research UK, 2020a].

What are the risk factors for melanoma?

Factors that increase the risk of melanoma include:

• A personal history of skin cancer, melanoma, or atypical naevi. 
• A family history of melanoma. 
• Pale skin (Fitzpatrick Skin Type I and II) that burns easily. 
• Red or light-coloured hair (for example, blonde). 
• High freckle density. 
• Light coloured eyes (for example, blue eyes).
• History of sunburn, particularly blistering sunburn in childhood.
• A large number of moles, or large congenital naevi.
• Sun exposure — the risk is higher with intermittent sun exposure than cumulative chronic exposure. 
• Use of tanning beds or sun beds, particularly if 10 or more sessions. 
• Increasing age — the incidence of malignant melanoma increases with age during adolescence and is highest in the elderly. 
• Outdoor occupation. 
• Immunosuppression.
• Genetic syndromes with skin cancer predisposition (for example, xeroderma pigmentosum). 

[NICE, 2016a; SIGN, 2017; BMJ, 2022]

How common is melanoma?

• Melanoma is the fifth most common cancer in the UK, accounting for around 4% of all new cancer cases and more cancer deaths than all other skin cancers combined [NICE, 2022]. 
• On average between 2016 to 2018, 16,744 new cases of melanoma were diagnosed each year in the UK [Cancer Research UK, 2022].
• Over 25% of cases are diagnosed in people aged over 75 years, with peak incidence in people aged 85–89 years [NICE, 2022]. 
• Over the last decade, melanoma skin cancer incidence rates have increased by 32% in the UK. Rates in females have increased by 27%, and rates in males have increased by 38%. Incidence rates are projected to rise by 7% in the UK between 2014 and 2035, to 32 cases per 100,000 [Cancer Research UK, 2022].
• Although concerns about moles or other pigmented skin lesions account for many GP consultations, few will be diagnosed as melanoma and most will be benign [Walter et al, 2010].
  • Moles (melanocytic naevi) are very common and most people have 20–50 moles, varying in size, shape, and colour. Malignant change is uncommon; even in higher-risk groups, such as men older than 60 years of age, fewer than 1 in 33,000 moles are estimated to become malignant [Walter et al, 2010]. 

What is the prognosis of melanoma?

• Prognosis is highly dependent on the stage at diagnosis — the most important prognostic indicators are Breslow's thickness of the tumour and lymph node status [SIGN, 2017; BMJ, 2022].
  • Melanoma, especially when diagnosed at advanced stage, can cause serious morbidity and may be fatal despite treatment [SIGN, 2017].
  • For people with stage 1 melanoma (thickness is 2 mm or less, no sign that it has spread) the 5-year survival is almost 100% compared with 30% for people with stage 4 melanoma (spread to distant lymph nodes or other parts of the body) [Cancer Research UK, 2020b].
• There are around 2300 deaths every year in the UK due to melanoma [Cancer Research UK, 2022].  
• The survival rate for people with melanoma has doubled in the last 40 years — the 10-year survival rate is 87% [Cancer Research UK, 2022]. 
  • The survival rate is highest in people aged 15–39 years, and women [Cancer Research UK, 2020b].
• Over 99% of patients with in-situ melanoma will be cured with simple excision [BMJ, 2022].
• The annual risk of recurrence is related to the thickness of the lesion [SIGN, 2017].
  • For tumours less than 1.5 mm thick it is less than 6% for the first 5 years and under 1% for the following 5 years.
  • For tumours over 1.5 mm thick there is higher risk of recurrence in the first year, but less than 2% after 5 years.
  • Overall about 80% of recurrences occur within the first 3 years, but up to 16% have been reported to occur after 5 years.

What are the clinical features of melanoma?

• The appearance of a malignant melanoma depends on its type and site.
• Superficial spreading melanoma, nodular melanoma, and lentigo maligna melanoma are the most commonly diagnosed malignant melanomas.
  • Superficial spreading melanoma is the most common type of melanoma (60–70% of melanomas).
    • It often stays within the epidermis for long periods (months to decades) and usually spreads horizontally — this is referred to as the “radial growth phase”.
    • Superficial spreading melanoma may present as a flat pigmented lesion with asymmetrical or irregular borders.
    • Incidence increases with age, peaking in people aged 70–79 years, and is most commonly found on sun-exposed sites (particularly the torso in men and legs in women). 
    • Images are available at www.dermnetnz.org.
  • Nodular melanoma is the second most common subtype of melanoma (15–30% of melanomas).
    • It often presents as an atypical nodule that may ulcerate and bleed easily.
    • It can present as a pigmented lesion (a single colour or variable pigmentation) or it may not be pigmented (one-third of modular melanomas) and lacks ABCDE features.
    • It usually presents from the fifth or sixth decade and can penetrate deep within the skin within a few months of its first appearance.
    • Images of nodular melanoma are available at www.dermnetnz.org.
  • Lentigo maligna melanoma (5–15% of melanomas) develops from a pre­invasive phase lentigo maligna.
    • It is an irregularly ­shaped brown macule which grows slowly, and over time may develop irregular colours (dark brown, black). 
    • Lentigo maligna melanoma usually grows horizontally initially, but can form nodules once it enters the vertical growth phase.
    • It is most commonly diagnosed in people aged over 60 years on sun-damaged skin, particularly the head and neck. 
    • Images are available at www.dermnetnz.org.  
• Other forms of melanoma include: 
  • Acral lentiginous melanoma is most common on the soles of the feet but can also occur in the palms of hands and in the nail bed.
    • It presents with a flat pigmented area, slowly increasing in size. Smooth at first, it later becomes thicker with an irregular surface that may be dry or warty.
    • There is variable pigmentation, most often a mixture of brown, blue-grey, black, and red colours. 
    • There may be ulceration and bleeding, and in some cases a rapidly developing nodular melanoma may develop. 
    • It can occur in all ethnic groups but is most common in darker skin types and people aged over 40 years.
    • Images are available at www.dermnetnz.org.  
  • Amelanotic melanoma is a form of melanoma with little to no pigment. Early lesions present as asymmetrical macular lesions that may be uniformly pink or red and many have a faint light tan, brown, or grey pigmentation at the periphery. Any subtype of melanoma can be amelanotic. 
  • Lentigo maligna is also known as Hutchinson’s melanotic freckle and is a precursor to lentigo maligna melanoma.
    • It presents as a slow-growing or changing patch of discoloured skin and often resembles a freckle in its early stages. The cancerous cells of lentigo maligna are described as 'in-situ', meaning they are present in the epidermis and not yet invading deeper tissue.
    • It occurs on sun-damaged skin, so commonly affects the face or neck, particularly the nose and cheek.
    • Lesions usually grow slowly over 5–20 years.
    • It is most common in people aged over 40 years, peaking in people aged 60–80 years.  
    • Images are available at www.dermnetnz.org.  
• Other more rare forms of melanoma include:
  • Desmoplastic. 
  • Malignant blue naevus.   
  • Mucosal. 
  • Neurotropic. 
  • Ocular melanoma.  
  • Spitzoid. 

How should I assess a lesion?

• Take a medical history and ask about:
  • The lesion:
    • When it was first noticed.
    • If it has changed in shape, size, or colour.
    • If it has ulcerated.
    • If it is itchy or has bled.
  • Associated symptoms, such as cough, weight loss, fatigue, night sweats, or headache. 
  • A history or family history of melanoma. 
  • Risk factors for melanoma. 
• Examine the lesion in good light, with or without magnification.
  • Atypical melanocytic lesions that are different from the person's surrounding moles (the 'Ugly Duckling sign') should raise suspicion. 
  • A dermatoscope can be used to examine skin lesions and may more accurately distinguish between benign and malignant lesions, but this should only be done by a primary healthcare professional who has had appropriate training.
• Examine the entire surface of the skin including the scalp and mucous membranes. 
  • Palpate major lymph nodes in the regional drainage area if the lesion is suspicious of melanoma. 
• Use the weighted 7-point checklist for assessment of pigmented skin lesions, and to determine the need for referral. 
  • Major features of the lesion (2 points each):
    • Change in size.
    • Irregular shape.
    • Irregular colour.
  • Minor features of the lesion (1 point each):
    • Largest diameter 7 mm or more.
    • Inflammation.
    • Oozing.
    • Change in sensation (including itch).
• Do not biopsy in primary care if melanoma is suspected or the diagnosis is uncertain — if a lesion is suspected to be melanoma, refer the person urgently using a suspected cancer pathway (for an appointment within 2 weeks). 

What else could it be?

Angiomas and haemangiomas

• These are benign vascular lesions caused by proliferating endothelial cells — they can arise in early life (infantile haemangioma) or in later life.
  • The most common type is a cherry angioma, which is a small firm papular angioma, red, blue, or purple in colour and 1–10 mm in diameter.
  • They are usually multiple and can be distributed over any part of the body, but rarely the hands and feet.  
  • Images are available at www.dermnetnz.org.

Angiokeratomas

• These present as asymptomatic hyperkeratotic vascular skin lesions. A number of varieties of this condition exist and they can occur anywhere on the skin. 
  • They are small (rarely more than 5 mm in diameter), dark red to purple papules, nodules, and plaques.
  • The surface can be smooth, rough and scaly, or warty.
  • Lesions are prone to thrombosis resulting in a sudden colour change to dark purple or black. 
  • Images are available at www.dermnetnz.org.

Dermatofibromas 

• A dermatofibroma is a benign fibrous nodule usually found on the lower legs in adults, but they can occur anywhere on the skin.
  • They are tethered to the surface, mobile over subcutaneous tissue, and usually 5–15 mm in diameter with most lesions 7–10 mm.
  • Pink to light brown in white skin, and dark brown to black in dark skin, some appear paler in the centre. 
  • Dermatofibromas classically dimple on pinching the lesion (sometimes called the 'button hole' sign).
• Images of dermatofibromas are available at www.dermnetnz.org.

Freckles

• Freckles (ephelides) are light to dark brown flat macules 3–10 mm in diameter. 
  • They are very common and appear more numerous when the skin is exposed to ultraviolet (UV) radiation in sunlight. 
    • They are more prominent in summer and fade in winter.
  • They are poorly defined, may merge into large patches and particularly affect people with red hair, fair hair, or fair skin. 
• Images are available at www.dermnetnz.org

Kaposi's sarcoma

• Kaposi's sarcoma is a malignant growth of blood vessels which is most commonly associated with HIV disease (but can occur without HIV disease).
  • Lesions are reddish, purple, or bluish-black macules or papules which develop into nodules or plaques. 
  • There are usually multiple lesions (in contrast to melanoma) which may occasionally ulcerate or bleed. 
  • Lesions can appear anywhere on the skin or mucous membranes lining the mouth, nose and throat; lymph nodes or other organs. 
• Images are available at www.dermnetnz.org.

Lentigines

• A lentigo is a pigmented flat or raised lesion with a clearly defined edge (which may be smooth or jagged), but unlike freckles they do not fade in the winter. 
  • They may be solitary, but more often they are multiple and smaller than 5 mm in diameter (especially in people with red hair). 
  • They have a darker colour than freckles and wider distribution (skin, mucosal surfaces, conjunctiva).
  • There are several kinds of lentigo, including:
    • Solar lentigo — most common type of lentigines, often known as 'age spots' or 'liver spots'. Caused by chronic sun exposure. Flat, uniform, brown macules which can slowly enlarge to several centimetres in diameter. Mainly occur on the sun-exposed areas of skin (such as the face, forearms, and dorsal aspects of the hands). 
    • Simple lentigo (lentigo simplex) — small (less than 5 mm) dense black macule which may have an irregular edge. Follows sunburn in fair-skinned people. 
    • Ink-spot lentigo —  a small, densely black macule which usually appears on sun-exposed skin. It may also have an irregular margin, causing diagnostic confusion with melanoma.
• Images of lentigines are available at www.dermnetnz.org.

Moles (naevi) 

• Benign common moles can appear anywhere on the body and differ in appearance depending on the site. 
  • They are of uniform appearance and may be flat or protruding. 
  • They vary in colour, from pink or flesh tones to dark brown, steel blue, or black (light-skinned individuals have lighter moles, dark-skinned individuals have darker moles), and size from a couple of millimetres to several centimetres in diameter. 
  • They are mostly round or oval, but can also be irregular shapes. 
• Atypical moles or naevi are usually flat and more than 5 mm in diameter.
  • They have ill-defined or irregular borders and varying shades of colour.
  • They usually occur in fair-skinned people due to sun exposure and can be solitary or numerous.
  • They can be found anywhere on the body, but most commonly on the trunk, upper limbs, scalp, and buttocks. 
• Halo naevi are surrounded by a white patch and fade away over several years. This is considered an autoimmune process against the melanocytes.  
  • They present most frequently in older children and young adults and are uncommon in people aged over 30 years. 
  • Lesions can be single or multiple and can occur anywhere on the body, but most frequently on the trunk. 
• Spitz naevi are raised, firm, pink-red or pigmented papules/nodules which grow rapidly to around 1 cm in diameter. Lesions then tend to become static at around 6 months.
  • They can occur anywhere on the body, but most frequently on the face, and are most common in children and young adults.
• Meyerson's naevi are benign melanocytic naevi surrounded by eczema.  
  • They are itchy and dry, usually solitary, but can be multiple. 
  • They can occur anywhere, but the trunk is the most common site.
  • They affect younger people and are three times more common in males than in females. 
• Blue naevi are slightly raised (although they may also be flat), smooth, blue-black papules. 
  • They have a regular shape and tend to be less than 1 cm in diameter. 
  • They present mainly in older children and young adults and remain unchanged throughout life. 
  • They can occur anywhere, but are common on the face.  
• Congenital melanocytic naevi (birthmarks) are present from birth or develop shortly after birth. They are usually larger than acquired naevi and are dark brown or black in colour, they can be raised, bumpy, or hairy. They usually grow proportionally with the child. 
  • Small congenital melanocytic naevi are more common and are usually less than 1.5 cm in diameter.
  • Medium congenital melanocytic naevi are 1.5–10 cm in diameter. 
  • Large congenital melanocytic naevi are 11–20 cm in diameter. 
  • Giant congenital melanocytic naevi can be more than 20 cm in diameter and have malignant potential, with a 5–10% lifetime risk of developing melanoma.
  • Naevus spilus (speckled lentiginous naevus) is a type of congenital naevus. It is lentiginous in infancy and early childhood and develops darker palpable components around puberty in a speckled distribution. It can affect any part of the body, and the affected patch of skin can be several centimetres in diameter, with individual macules and papules measuring 1–3 mm in diameter.  
• Images of moles are available at www.dermnetnz.org.

Pigmented basal cell carcinoma 

• These have a pearly appearance, with less pigmentation than a typical melanoma.
  • It may be nodular or superficial and vary in size from a few millimetres to several centimetres in diameter.
  • There are also prominent branching telangiectatic vessels.
• Images of basal cell carcinomas are available at www.dermnetnz.org. 

Pyogenic granulomas 

• A pyogenic granuloma is an acquired benign proliferation of capillary blood vessels of the skin and oral cavity which can develop in response to trauma, hormonal changes, medication, or infection.
  • It is a painless red fleshy nodule, typically 5–10 mm in diameter, that grows rapidly over a few weeks. The most common sites are the fingers and face. 
  • The surface is initially smooth but can ulcerate, become crusty, or verrucous 
  • It is usually solitary, but multiple nodules and satellite lesions can erupt. 
  • Pyogenic granulomas are fragile and may bleed on minimal trauma.
• Images are available at www.dermnetnz.org.

Seborrhoeic keratoses 

• Seborrhoeic keratoses are also known as seborrhoeic warts or basal cell papilloma and are a common sign of ageing.
  • They can occur on any area of skin (most commonly on the trunk and face) except the palms and soles and mucous membranes and have a highly variable appearance. 
  • They can be flat or raised papules or plaques, 1 mm to several centimetres in diameter, skin-coloured, yellow, grey, light brown, dark brown, or mixed colours and have a smooth, waxy, or warty surface and have a 'stuck on' appearance.
  • There may be multiple lesions. 
• Images of seborrhoeic keratoses are available at www.dermnetnz.org.

Other conditions which may present similarly to nail melanomas include:

• Subungual haematoma. 
• Fungal infections — for more information see the CKS topic on Fungal nail infection. 
• Melanonychia (longitudinal brown to black banding of the nails) — nearly all Afro-Caribbean people will develop black-brown pigmentation of the nails by the age of 50 years. Melanochyia occurs in around 20% of people of Japanese origin.  

Scenario: Management

From age 1 month onwards.

Search strategy

Scope of search

A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of melanoma and pigmented lesions.

Search dates

March 2017 - July 2022

Key search terms

Various combinations of searches were carried out. The terms listed below are the core search terms that were used for Medline.

• melanoma/, melanoma.tw, exp nevus/, nevus, pigmented/, nevus.tw, nevi.tw, naevi.tw, naevus.tw

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
• Institute for Clinical Systems Improvement
• 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

• Bandolier
• 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)
• LactMed
• 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.