Changes

September 2025 — reviewed. A literature search was conducted in August 2025 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last version of this topic. The topic has been restructured for clarity, and recommendations have been updated in line with current evidence and guidance.

Update

Goals

To support primary healthcare professionals to:

• Recognize features of HIV infection to enable early diagnosis.
• Identify people who require HIV testing.
• Identify people who require hospital admission, urgent referral, or signposting to specialist services.
• Provide appropriate information and advice, including guidance on health promotion and disease prevention, sexual and reproductive health, travel, and support groups.  
• Monitor for adverse effects and drug interactions associated with antiretroviral therapy (ART). 
• Provide care for people with advanced or end-stage HIV disease.
• Refer appropriately for pre- or post-exposure prophylaxis.

Outcome measures

Audit criteria

QOF indicators

QIPP - Options for local implementation

NICE quality standards

HIV testing: encouraging uptake 

• Young people and adults in areas of high or extremely high HIV prevalence are offered an HIV test by their GP practice when registering or when having a blood test if they have not had an HIV test in the past 12 months.
• Young people and adults newly diagnosed with an HIV indicator condition are offered an HIV test.
• Young people and adults in at-risk groups who test negative for HIV are advised that the test should be repeated at least annually.
• People who may have been exposed to HIV by a person newly diagnosed with HIV are offered an HIV test.

 [NICE, 2017]

What is HIV?

• HIV (human immunodeficiency virus) is a lentivirus from the retrovirus subfamily.
  • Lentiviruses have a long latent phase between infection and the development of symptoms.
  • HIV causes immunodeficiency by preferentially infecting and destroying immune cells, particularly CD4 T lymphocytes.
• After initial exposure, HIV infection progresses through distinct stages, which determine both symptoms and the risk of transmission: 
  • Primary HIV infection (or HIV seroconversion illness) is the early phase of HIV disease, occurring about 2–4 weeks after infection.
    • During this stage, some people develop flu-like symptoms, such as fever, sore throat, rash, swollen lymph nodes, and fatigue, while others remain asymptomatic.
    • The virus multiplies rapidly and spreads throughout the body, attacking and destroying the CD4 cells.  
    • The viral load is very high in this phase; the person affected is highly infectious.
  • Asymptomatic phase follows resolution of the primary infection and may persist for several years. 
    • Most people remain well, although HIV continues to replicate at low levels, gradually weakening the immune system as CD4 cells decline.
    • The person remains infectious despite the absence of symptoms.
  • Symptomatic phase develops as immune function further declines.
    • HIV-related complications emerge, including minor opportunistic infections (such as oral thrush or shingles) and multisystem complications (such as respiratory, neuropsychiatric, metabolic, dermatological, and renal problems).
    • These complications result from chronic HIV infection, persistent immune activation, treatment effects, co-infections, comorbidities, and/or lifestyle factors.
  • Advanced HIV disease (or AIDS [acquired immunodeficiency syndrome]) occurs when the immune system is severely weakened.
    
    • It is defined by a CD4 cell count below 200 cells per microlitre or the occurrence of certain opportunistic infections (such as Pneumocystis pneumonia) or malignancies (such as Kaposi’s sarcoma), collectively known as AIDS-defining conditions.
    • The term ‘AIDS’ is now used less frequently, with ‘advanced HIV disease’ being the preferred term.
• The World Health Organization (WHO) clinical staging system for HIV disease classifies adults, adolescents, and children with diagnosed HIV into four stages, each defined by a list of specific clinical conditions that reflect disease progression and increasing severity.

[Pattman, 2010; BHIVA, 2019; aidsmap, 2025; THT, 2025a; WHO, 2025a]

How is HIV infection transmitted?

• In a person infected with HIV, the virus is present in cell-containing body fluids, such as blood, semen, vaginal secretions, breast milk, amniotic fluid, pleural effusions, and cerebrospinal fluid.
• HIV can be transmitted from infected body fluids, including:
  • Sexual activity (vaginal, anal, or oral sex, especially in the presence of oral disease, such as ulceration or gingivitis).
  • Vertically from mother to child (during pregnancy, childbirth, or breastfeeding).
  • By inoculation (via contaminated needles, instruments, blood, or blood products; through direct exposure of mucous membranes or an open wound to infected bodily fluids; or by a human bite that breaks the skin).
• HIV is not transmitted by:
  • Social interactions, such as shaking hands, hugging, or kissing.
  • Routine sharing of household items, such as eating utensils, glasses, and lavatory seats.
  • Insects, such as mosquitoes and lice.

[Pattman, 2010; CDC, 2024; WHO, 2025a]

What factors are associated with a higher risk of HIV acquisition?

• Risk factors for HIV infection include:
  • Sexual behaviour:
    • Unprotected sex.
    • Multiple sexual partners.
    • High-risk sexual practices (such as chemsex).
  • Specific populations:
    • Men who have sex with men (MSM).
    • Trans women
    • Trans men with additional risk factors (such as receptive sex with partners living with HIV).
    • People who inject drugs.
    • Sex workers
    • Black Africans.
    • People in prisons or other closed settings.
    • People from a country with a high diagnosed seroprevalence (more than 1%). Country-specific HIV prevalence data are available from the UNAIDS website (https://aidsinfo.unaids.org).
  • Exposure through partners or family: 
    
    • Female partners of MSM.
    • Sexual partners of people living with HIV.
    • Sexual partners of people from high HIV prevalence countries.
    • People with a mother living with HIV.
  • Other exposures:
    • History of other sexually transmitted infections (such as syphilis, chlamydia, and gonorrhoea).
    • Blood transfusions, transplants, or other invasive procedures in countries without rigorous HIV screening.
    • Occupational exposure (for example, sharps and mucosal splash injuries).
    • Sexual assault or rape.

[NICE, 2016; BHIVA, 2020; WHO, 2021]

How common is it?

• HIV is a major global public health issue, and transmission is ongoing in all countries worldwide. Anyone can acquire HIV, but some populations are at higher risk.
  • According to the World Health Organization [WHO, 2025a]:
    
    • In 2024, an estimated 1.3 million people acquired HIV, and about 630,000 people died from HIV-related causes. 
    • At the end of 2024, an estimated 40.8 million people were living with HIV, 65% of whom are in the WHO African Region.
    • To date, about 44.1 million lives have been lost to HIV.
  • In the UK [THT, 2025b]:
    • An estimated 113,500 people are living with HIV. Of these, over 5200 are undiagnosed. 
    • New diagnoses have been increasing since 2021, following a decline from their peak in 2005.
    • In 2023, there were 6512 HIV diagnoses in the UK (excluding Northern Ireland), representing a 46% increase from 2022. Of these, 6008 were in England, 270 in Scotland, and 119 in Wales.
  • In England:
    • More than half of people with a new HIV diagnosis in 2023 had previously been diagnosed abroad (3198 of 6008) [UKHSA, 2024]. 
    • Of the 2810 people first diagnosed in England, 29% were gay, bisexual, and other men who have sex with men (GBMSM), and about 49% were people exposed through sex between men and women.
    • Of the 1385 heterosexual people diagnosed, 50% were of Black African ethnicity [THT, 2025b].
    • London continues to have the highest rates of HIV, but in 2023, increases were concentrated outside of London (men: 9% increase in London and 51% increase outside; women: 2% decrease in London and 44% increase outside) [THT, 2025b].
• The UK is working toward the 2030 target of zero new HIV transmissions, but current trends show challenges [THT, 2025b].
  • In 2023, the number of first-time HIV diagnoses in England (2810) was nearly the same as in 2019, indicating the 2025 interim target of an 80% reduction in new infections is off track.
  • Improvements in HIV testing, treatment access, and pre-exposure prophylaxis (PrEP) availability are helping, but further efforts are needed to meet the 2030 goal.

What is the prognosis?

• Advances in anti-retroviral therapy (ART) have transformed HIV infection into a manageable chronic disease.
  
  • Prompt initiation of ART preserves CD4 cell counts and markedly reduces the risk of developing advanced HIV disease.
  • Some HIV-related complications (such as opportunistic infections and cardiovascular disease) may still occur due to chronic HIV infection, persistent immune activation, treatment effects, co-infections, comorbidities, and/or lifestyle factors.
  • With timely diagnosis and lifelong adherence to ART, people living with HIV can now expect a near-normal life expectancy. 
  • Those who maintain an undetectable viral load on ART cannot transmit the virus sexually. This approach, known as treatment as prevention (TasP), underpins the public health message 'Undetectable=Untransmittable' (U=U).

[Goldschmidt, 2016; Saag, 2018; Lebari, 2019; BHIVA, 2020; BHIVA, 2023]

What are the complications?

• Early diagnosis and prompt initiation of antiretroviral therapy (ART) greatly reduce, but do not eliminate, the risk of HIV-related complications. 
  
  • Untreated HIV or ART failure leads to advanced HIV disease, defined by opportunistic infections (such as Pneumocystis pneumonia) or malignancies (such as Kaposi’s sarcoma), collectively known as AIDS-defining conditions.
  • Even with effective ART, people with long-standing HIV may develop complications due to chronic infection, immune activation, treatment effects, co-infections, comorbidities, and/or lifestyle factors.
• HIV-related complications include: 
  • Constitutional:
    
    • Fever.
    • Sweats.
    • Weight loss.
    • Swollen lymph nodes.
    • Fatigue.
  • Respiratory:
    
    • Tuberculosis (the leading cause of death among people living with HIV). For more information, see the CKS topic on Tuberculosis.
    • Other bacterial lower respiratory tract infections (such as Streptococcus pneumoniae and Haemophilus influenzae).
    • Chronic obstructive pulmonary disease (COPD). For more information, see the CKS topic on Chronic obstructive pulmonary disease.
  • Neurological:
    • Peripheral neuropathy. For more information, see the Prodiy topic on Neuropathic pain - drug treatment.
    • HIV-associated neurocognitive disorder (HAND).
    • HIV-associated dementia.
    • Distal sensory polyneuropathy.
  • Cardiovascular:
    • Increased risk of atherosclerosis, myocardial infarction, stroke, and heart failure. For more information, see the CKS topics on MI - secondary prevention, Stroke and TIA, and Heart failure.
    • HIV-associated pulmonary hypertension.
  • Metabolic:
    
    • Lipodystrophy.
    • Insulin resistance.
    • Diabetes. For more information, see the CKS topic on Diabetes - type 2.
    • Dyslipidaemia. For more information, see the CKS topic on Lipid modification - CVD prevention.
  • Dermatological:
    
    • Fungal: tinea, onychomycosis, and pityriasis. For more information, see the CKS topics on Fungal skin infection - body and groin, Fungal skin infection - foot, Fungal skin infection - scalp, Fungal nail infection, and Pityriasis versicolor.
    • Viral: herpes simplex, warts, molluscum contagiosum, and shingles. For more information, see the CKS topics on Herpes simplex - genital, Herpes simplex - ocular, Herpes simplex - oral, Warts and verrucae, Molluscum contagiosum, and Shingles.
    • Bacterial: impetigo and folliculitis. For more information, see the CKS topic on Impetigo.
    • Non-infectious dermatosis: seborrhoeic dermatitis and psoriasis. For more information, see the CKS topics on Seborrhoeic dermatitis and Psoriasis.
  • Oral:
    • Oral candidiasis. For more information, see the CKS topic on Candida - oral.
    • Aphthous ulcers. For more information, see the CKS topic on Aphthous ulcer.
    • Gingivitis. For more information, see the CKS topic on Gingivitis and periodontitis.
    • Dental abscess. For more information, see the CKS topic on Dental abscess.
    • Oral herpes simplex. For more information, see the CKS topic on Herpes simplex - oral.
    • Oral hairy leukoplakia.
  • Gastrointestinal:
    • Nausea.
    • Dyspepsia. 
    • Diarrhoea.
    • Idiopathic HIV enteropathy.
  • Renal:
    • HIV-associated nephropathy (HIVAN).
    • Acute kidney injury, including ART-related (for example, tenofovir).
    • Chronic kidney disease. For more information, see the CKS topic on Chronic kidney disease.
  • Hepatic:
    • Hepatitis B and hepatitis C co-infection. For more information, see the CKS topics on Hepatitis B and Hepatitis C.
    • Non-alcoholic fatty liver disease (NAFLD). For more information, see the CKS topic on Non-alcoholic fatty liver disease (NAFLD).
    • Accelerated fibrosis and cirrhosis.
    • ART-related hepatotoxicity.
  • Musculoskeletal:
    
    • Osteomalacia.
    • Osteopenia.
    • Osteoporosis. For more information, see the CKS topic on Osteoporosis - prevention of fragility fractures.
  • Haematological:
    • Neutropenia.
    • Anaemia.
    • Thrombocytopenia.
    • Other blood dyscrasias.
  • Psychological:
    • Depression and anxiety. For more information, see the CKS topics on Depression, Depression in children, and Generalized anxiety disorder.
    • Post-traumatic stress disorder. For more information, see the CKS topic on Post-traumatic stress disorder.
    • Insomnia. For more information, see the CKS topic on Insomnia.
    • Addictions.
    • Self-harm.
  • Sexual and reproductive:
    
    • Loss of libido and erectile dysfunction. For more information, see the CKS topic on Erectile dysfunction.
    • Genital candidiasis, herpes, and warts. For more information, see the CKS topics on Candida - female genital, Herpes simplex - genital, and Warts - anogenital.

[Chu, 2017; Lebari, 2019; BHIVA, 2020; Webel, 2021; Althoff, 2024; BHIVA, 2024; WHO, 2025a; WHO, 2025b]

What are the clinical features of HIV infection?

• The clinical features of HIV vary depending on the stage of infection:
  • Primary HIV infection (or HIV seroconversion illness) is the early phase of HIV disease, occurring about 2–4 weeks after infection.
    • Some people develop flu-like symptoms, such as fever, sore throat, rash, swollen lymph nodes, and fatigue.
    • Less commonly, symptoms may include headache, diarrhoea, and weight loss.
    • Occasionally, acute conditions associated with immunosuppression, such as oral candidiasis or shingles, may occur.
  • Long-standing HIV infection can lead to complications arising from chronic infection, persistent immune activation, treatment effects, co-infections, comorbidities, and/or lifestyle factors.
    
    • Complications include minor opportunistic infections (such as oral candidiasis and shingles) and multisystem complications (such as respiratory, neuropsychiatric, metabolic, dermatological, and renal problems).
    • Symptoms may resolve with treatment but can recur or evolve, and new problems may arise at later stages.
  • HIV indicator conditions are health problems that should always prompt consideration of an HIV test. They include:
    • AIDS-defining conditions (which strongly suggest advanced HIV infection or AIDS).
    • Conditions where the prevalence of undiagnosed HIV is more than 0.1%. 
    • Conditions likely to have an estimated prevalence of HIV lower than 0.1% but where not identifying HIV infection may have significant adverse implications for the person's care.
• The World Health Organization (WHO) clinical staging system for HIV disease classifies adults, adolescents, and children with diagnosed HIV into four stages, each defined by a list of specific clinical conditions that reflect disease progression and increasing severity.

When is HIV testing recommended?

If HIV testing is indicated, appropriate information should be provided to ensure that the person can access testing in a way that meets their needs and preferences. The need for repeat testing should be considered.

• HIV testing is recommended for: 
  • People who request testing.
  • People belonging to groups at increased risk of exposure to HIV, including:
    
    • Men who have sex with men (MSM).
    • Female sexual contacts of MSM.
    • Black Africans.
    • People reporting current or prior injecting drug use.
    • Sex workers.
    • Prisoners.
    • Trans women.
    • Trans men with additional risk factors (such as receptive sex with partners living with HIV).
    • People from a country with a high diagnosed seroprevalence (more than 1%). Country-specific HIV prevalence data are available from the UNAIDS website (https://aidsinfo.unaids.org).
    • People reporting sexual contact with anyone from a country with a high diagnosed seroprevalence, regardless of where the contact occurs.
    • People known to have/have had a mother living with HIV and who do not have documented HIV-negative status.
  • People with clinical features of an HIV indicator condition.
    • People who decline the first offer should have at least one repeat offer made at a subsequent visit.
  • People who have not previously tested for HIV when accessing healthcare in areas of high HIV seroprevalence (2–5 per 1000), if undergoing venepuncture, and in areas of extremely high HIV seroprevalence (more than 5 per 1000) for all attendees.
    
    • Local prevalence rates are available from the UK Health Security Agency and HIV-Lens. 
    • Recommendations for repeat testing should be based on clinical judgement and risk assessment, for example, the emergence of an indicator condition or ongoing risk. 
  • Sexual partners of people diagnosed with HIV. 
    • Repeat testing may not be indicated for monogamous partnerships if subsequent episodes of sexual contact were known to be protected by Treatment as Prevention (TasP; that is, the person living with HIV was on ART with a maintained undetectable viral load).
    • Repeat testing will also be influenced by other potential risk behaviours of the person without HIV.
  • All pregnant women (as part of routine antenatal care). For more information, see the CKS topic on Antenatal care - uncomplicated pregnancy.
  • All children who are at risk of HIV infection.  
    • Testing for children at risk of HIV should be urgently discussed with at least one of the child’s parents or legal guardians, and appropriate testing and follow-up should be arranged with a specialist.
    • For more information, see guidance from the Children’s HIV Association (CHIVA).
• HIV opt-out testing is recommended for all people attending health services whose users have an associated risk of HIV, including:
  • Sexual health services.
  • Addiction and substance misuse services.
  • Antenatal services.
  • Termination of pregnancy services.
  • Hepatitis B and C, tuberculosis, and lymphoma clinics. 

How should I test for HIV?

If HIV testing is indicated:

• Consider the need for hospital admission, for example: 
  • If the person is acutely unwell.
  • If a serious or life-threatening complication is suspected, for example:
    • Respiratory symptoms are suggestive of a serious bacterial lower respiratory tract infection, such as Pneumocystis pneumonia or tuberculosis.
    • Visual symptoms are suggestive of cytomegalovirus (CMV) retinitis.
    • Progressive or acute neurological symptoms or delirium are present — this may indicate a serious HIV-related condition, such as cryptococcal meningitis, cerebral toxoplasmosis, or cerebral lymphoma.
    • Kaposi's sarcoma of the lung or gut is suspected.
• If hospital admission is not indicated, offer HIV testing.
  • Lengthy pre-test discussions are not required. 
  • If the person has mental health problems or additional counselling needs, consider referral to a genitourinary medicine (GUM) clinic for testing.
  • If the person is at sexual or injecting drug risk, refer to a GUM clinic or substance misuse services for testing, ongoing support, or additional care.
  • For all other people, explain test options and access:
    • Venous blood sample (recommended first-line investigation): usually offered in general healthcare settings (GP, hospital, and community clinic). The sample is sent to the laboratory for testing. Results are available within 1–7 days.
    • Point-of-care tests (POCTs): commonly offered in GUM clinics. The person provides a blood sample, and rapid testing is performed on-site. Results are usually available the same day, often within an hour.
    • Self-testing kits: the person collects a sample at home (finger-prick blood or saliva) and performs the test themselves. Results are usually available within about 15 minutes. A positive result must be confirmed by a clinic or laboratory test. For more information, see the Terence Higgins Trust website (www.tht.org.uk).
    • Self-sampling kits (postal tests): the person collects a sample at home (finger-prick blood or saliva) and sends it to the lab for testing. Results are usually available within a few days to a week. For more information, see the NHS Free HIV Testing website (www.freetesting.hiv).
  • Discuss how results will be delivered, preferred contact method, and follow-up appointment options.
  • Advise that the test result will need to be recorded in medical records.
  • Ensure informed consent is obtained; written consent is not required.
• If possible, give results in a face-to-face consultation.
  • If the test is negative:
    • Consider if a further test is needed to cover the window period. Seek specialist advice from GUM if unsure.
    • Reinforce safer sex practices where appropriate.
    • Consider the need for repeat testing.
  • If the test is positive, the laboratory is likely to telephone the result through and ask for a repeat sample.
    • If the diagnosis of HIV is confirmed, see the section on Managing a new diagnosis of HIV for more information.
    • If the person fails to attend an appointment to discuss a positive result, follow the practice's usual recall process.
    • If recall is unsuccessful, seek advice from a local GUM or HIV clinic.

Scenario: How should I manage a new diagnosis of HIV?

From birth onwards.

Scenario: Established HIV infection

From birth onwards.

Scenario: End-stage advanced HIV disease

From birth onwards.

Scenario: HIV prevention

From birth onwards.

Search strategy

Scope of search

A full literature search was not requested as this CKS topic is primarily based on guidelines published by the Medical Foundation for Aids and Sexual Health (MedFASH), the British Association for Sexual Health and HIV (BASHH), the British HIV Association (BHIVA), the Faculty of Sexual and Reproductive Health of the Royal College of Obstetricians and Gynaecologists (FSRH), and the Health Protection Agency (HPA), as well as policies published by the Department of Health.

Search dates

May 2020 - August 2025

Key search terms

The terms listed below are the core search terms that were used for EBSCOhost MEDLINE (searched 27th May 2020). These were combined with filters to identify guidelines and primary care relevant literature in EBSCOhost MEDLINE. The strategy was adapted for The Cochrane Library databases. 

S4    S1 OR S2 OR S3 
S3    TI HIV* 
S2    (MH "Acquired Immunodeficiency Syndrome") 
S1    (MH "HIV") 

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.