Changes

August 2025 — minor update. Definition of extensively drug-resistant tuberculosis has been updated in line with the 2021 updated WHO definition.

Update

Goals

To support primary healthcare professionals to:

• Be aware of who is at risk of tuberculosis (TB) and when to suspect TB.
• Make an accurate assessment of a person with suspected TB.
• Be aware of who needs screening for latent TB.
• Arrange urgent admission or specialist referral, depending on clinical judgement, for people with suspected active TB to confirm the diagnosis and ongoing management.
• Provide appropriate information and advice to people and/or parents/carers with confirmed TB in primary care.

Outcome measures

Audit criteria

QOF indicators

QIPP - Options for local implementation

NICE quality standards

The following NICE Quality Statements are relevant to this CKS topic:

• People aged 16 to 35 years who have arrived in the country within the past 5 years, from countries with a high incidence of tuberculosis (TB), are tested for latent TB infection when they register with a GP.
• Adults aged under 65 years who are diagnosed with HIV, are tested for latent tuberculosis (TB) infection.
• People who are referred to a tuberculosis (TB) service, who meet specific criteria, have rapid diagnostic nucleic acid amplification tests (NAATs).
• People who have imaging features suggestive of active pulmonary tuberculosis (TB) are assessed by the next working day.
• People with active tuberculosis (TB) from under-served groups are offered directly observed therapy.
• People with active pulmonary tuberculosis (TB) who are homeless are offered accommodation for the duration of their treatment.

[NICE, 2017]

What is it?

• Tuberculosis (TB) is an infectious disease caused by bacteria of the Mycobacterium tuberculosis complex, a group of related Mycobacterium species,  predominantly Mycobacterium tuberculosis and less commonly Mycobacterium bovis or africanum [NICE, 2019; UKHSA, 2023].
• Almost all cases of infection in the UK occur through inhaling the bacterium in respiratory droplets released when a person with infectious active pulmonary or laryngeal TB coughs [NICE, 2019].
  • Transmission is dependent on the degree of infectivity of the person with active pulmonary or laryngeal TB, the infection susceptibility of the exposed individual, and exposure factors such as proximity to the infected person, length of exposure, and degree of ventilation in the exposure environment [BMJ Best Practice, 2023a].
• Active disease describes where there is evidence of symptomatic or progressive disease of the lung and/or other organs [Behr, 2018]. If left untreated, one person with active pulmonary TB may infect as many as 10 to 15 people every year [NICE, 2019].
  • Active pulmonary TB is the most common presentation, accounting for 52.8% of all cases in the UK in 2021 [UKHSA, 2023].
  • Active extrapulmonary TB presents with symptoms specific to the site involved, such as the central nervous system (typically the meninges), peripheral lymph nodes, bones and joints, pericardium, skin, eyes, gastrointestinal, and genitourinary systems [Kon, 2022; BMJ Best Practice, 2023b].
  • Disseminated TB is when two or more organ systems are affected, and was previously observed almost exclusively in children or the immunosuppressed, but is now increasingly observed in adults with no apparent immune deficiency [Suárez, 2019].
• Latent disease is defined as a state of persistent immune response to stimulation by Mycobacterium tuberculosis antigens, with no evidence of clinically active TB (the person is asymptomatic and not infectious) [WHO, 2018; BMJ Best Practice, 2023a].
  • Active disease may occur from reactivation of previously latent infection [BMJ Best Practice, 2023b].
  • There is a 5–10% lifetime risk of progression to active (symptomatic) disease if, for example, the person becomes immunocompromised or has intercurrent illness [WHO, 2022a; BMJ Best Practice, 2023a].
  • The majority of TB disease occurs soon after the initial infection, with disease rarely occurring more than two years after infection [Furin, 2019; Suárez, 2019; BMJ Best Practice, 2023a]. In countries with a low TB burden where ongoing transmission is minimal, such as the UK, the interval between initial infection and active disease may be longer [Behr, 2018].
  • Some people with latent TB are at increased risk of developing active TB, including those who [NICE, 2019; WHO, 2022a]:
    • Have chronic medical conditions, such as HIV, solid organ transplantation, diabetes, chronic kidney disease, silicosis, jejunoileal bypass or gastrectomy, haematological malignancy, or those receiving chemotherapy or treatment with biologic immunosuppressants.
    • Are younger than 5 years old.
    • Have excessive alcohol intake, or are injecting drug users.
• Multidrug-resistant TB refers to a strain of TB that is resistant to two first-line drugs (isoniazid and rifampicin), with or without any other drug resistance [NICE, 2019; NHS England, 2020; Liebenberg, 2022]
  
  • Taking medication in the wrong dose or combination, irregularly or too short a time can lead to drug resistance. These drug‑resistant strains of TB are much harder to treat and significantly increase a person's risk of long‑term complications or death [NICE, 2019].
• Extensively drug-resistant TB (XDR-TB) refers to multidrug-resistant TB that are also resistant to any fluoroquinolone and at least one additional Group A drug (bedaquiline or linezolid) [WHO, 2021a]

How common is it?

The reported prevalence of tuberculosis (TB) is complicated by a 'detection gap' of undiagnosed or unreported cases worldwide.

• The World Health Organization (WHO) continues to state there is a global TB epidemic:
  • The incidence rate for new cases of TB infection increased in 2021, reversing decades of decline. This was considered likely due to the impact of disruptions to essential TB services during the COVID-19 pandemic [WHO, 2022b].
  • An estimated 10.6 million people (range 9.9–11 million) developed TB disease in 2021, however, only 6.4 million (64%) cases were reported to the WHO [WHO, 2022b].
    • Overall, approximately 90% were adults (aged 15 years or more), and 6.7% were people with HIV.
  • There was an estimated 450,000 people (range 399,000-501,000) with new cases of rifampicin-resistant TB in 2021 [WHO, 2022b].
  • An estimated 1.4 million (range 1.3-1.5 million) human immunodeficiency virus (HIV) negative people died of TB in 2021 and an estimated 187,000 TB deaths (range 158,000-218,000) occurred among HIV-positive people in 2021 [WHO, 2022b].
    • These total TB death estimates implicate TB as a leading cause of death due to a single infectious agent, second only to COVID-19 in 2021.
    • Globally, children have a disproportionately high mortality rate, with those <15 years old accounting for approximately 10% of total TB cases but approximately 14% of TB-related deaths. 
  • In 2019, about 1.8 billion people (23.7% of the world's population) were estimated to have a latent TB infection [Ding, 2022], and were at risk of developing active TB disease during their lifetime.
  • Globally, 86% of those who started first-line TB treatment in 2020 experienced treatment success. People living with HIV are expected to have a lower level of treatment success (77% in 2020), and children (aged 0–14 years) may experience a higher level of treatment success (88% in 2020) [WHO, 2022b].

• In England [UKHSA, 2023]:
  • Between 2000 and 2011, there was an increase in the annual incidence of TB. Since 2012, there has been a steady decline in the number of cases per year, until 2019 when there was a slight increase.
  • Notifications subsequently decreased in 2020, coinciding with the first wave of the COVID-19 pandemic.
    • This was largely attributed to people being unable to access care and receive a diagnosis, pandemic control measures, and a change in global travel patterns.
  • In 2021, the annual TB incidence in England was 7.8 per 100,000.
    • More than half (52.8%) of people notified with TB in England had a pulmonary infection.
    • England remains a low-incidence country according to the WHO definition (less than or equal to 10 cases per 100,000 population).
    • People born outside of the UK accounted for 76.4% of the notifications.
    • The TB notification rate for people born in the UK was 2.1 per 100,000 compared with 37.6 per 100,000 for people born outside the UK.
    • Notification rates were much higher among non-white ethnic groups for both UK-born and people born outside the UK.
    • The main burden of disease in England remains concentrated in large urban areas, with 35% of TB cases being reported in London. 
    • TB continues to be more common in males than females, with males accounting for 60.6% of TB notifications.
    • TB notifications are strongly correlated with deprivation — there is an incidence of 13.1 per 100,000 among those living in the 10% most deprived areas compared with 2.1 per 100,000 in the 10% least deprived areas.
    • Several social characteristics and medical co-morbidities are also associated with TB notifications — social characteristics include alcohol misuse, drug misuse, homelessness, imprisonment, mental health needs and asylum seeker status; medical co-morbidities include diabetes, immunosuppression, cancer, steroid use, and autoimmune disease.

What are the risk factors?

• Risk factors for tuberculosis (TB) infection include:
  • Being born in high prevalence areas (defined as more than 40 cases per 100,000 population per year). In 2021 [UKHSA, 2023]:
    • People born outside the UK had a TB incidence rate approximately 18 times higher than people born in the UK.
    • The most common countries of origin for non-UK-born people with TB cases were India, Pakistan, Romania, Somalia, and Eritrea — there is a continued elevated risk of TB in the settled migrant population of the UK. The UK Health Security Agency (UKHSA) document Tuberculosis rates by country has detailed information on worldwide tuberculosis rates.
  • Children younger than 5 years of age.
    • Young children are at increased risk of developing more severe active disease, in particular extrapulmonary TB.
  • Close contacts.
    • Close contacts of a person with active pulmonary or laryngeal TB are at increased risk of TB infection, for example, a person living in the same household, or colleagues working in close proximity.
  • History of untreated or inadequately treated active TB infection.
    • Taking medication in the wrong dose or combination, irregularly or for too short a time can lead to drug resistance, which has a poorer prognosis than fully drug-susceptible TB [NICE, 2019].
  • Co-morbid conditions.
    • These include HIV, diabetes mellitus, end-stage chronic kidney disease receiving renal replacement therapy, previous gastrectomy or jejunoileal bypass surgery, occupational lung disease (for example, silicosis), haematological malignancy, history of solid organ transplantation, and malnutrition.
    • Children with HIV infection are 20 times more likely to develop TB and have a 6 times greater risk of dying from TB than HIV-uninfected children [Whittaker, 2015].
  • Immunosuppressive drugs.
    • People taking prolonged duration of high-dose corticosteroids, chemotherapy or some biologic immunosuppressive treatments (such as infliximab, an anti-tumour necrosis factor (TNF)-alpha biologic treatment for inflammatory conditions), are at increased risk of reactivation of latent TB.
  • Under-served groups.
    • The most deprived 10% of the UK population have a TB rate more than 6 times higher than the least deprived 10% of the population [UKHSA, 2023].
    • People using homeless hostels, shelters, and day centres; and people living in prison or detention centres are particularly at risk.
    • In 2021, approximately 14.5% of people diagnosed with TB in England had one or more social risk factor [UKHSA, 2023].
  • History of excessive alcohol, injecting drug users, and smokers.
  • Sex. TB infection is more common in males than females.
    • In 2021, males accounted for 60.6% of TB notifications in England — the overall male-to-female ratio for people with TB in England has been stable over time and is in line with global trends [UKHSA, 2023].
• Additional risk factors that have been identified for extrapulmonary TB include female sex and people with haematological or head/neck malignancies, and cirrhosis [BMJ Best Practice, 2023b].
• Be aware that TB infection may also occur in people without any risk factors.

[Whittaker, 2015; Dheda, 2016; Migliori, 2018; NICE, 2019; BHIVA, 2023; BMJ Best Practice, 2023a; BMJ Best Practice, 2023b; UKHSA, 2023]

What is the prognosis?

The prognosis of tuberculosis (TB) varies according to the geographical burden of disease, drug resistance patterns, the person's risk factors, and treatment uptake [WHO, 2022b].

• If untreated, active TB is a slowly progressive disease in most people, which may be potentially fatal, particularly if the diagnosis is delayed [BMJ Best Practice, 2023a].
  • A systematic review found the 10-year weighted-mean case fatality rates were 70% for untreated smear-positive (infectious) TB and were estimated to be 20% for smear-negative TB. It found the duration of disease from symptom onset to cure or death was about 3 years and appeared to be similar for smear-positive and smear-negative cases [Tiemersma, 2011].
• Increasing age, more extensive disease, and HIV co-infection are associated with a worse prognosis, recurrent infection and/or reinfection, and increased mortality [Dheda, 2016].
  • Globally, it is estimated that the proportion of deaths among people with TB and HIV co-infection is close to double the proportion of people who are HIV-negative [WHO, 2022b].
• Multidrug-resistant TB has a poorer prognosis than fully drug-susceptible TB, and risk factors include [Millard, 2015; Furin, 2019; NICE, 2019]:
  • Previous TB drug treatment (especially if there is a history of poor adherence or treatment failure).
  • Contact with a known index case of multidrug-resistant TB.
  • Country of origin with a high proportion of multidrug-resistant new TB cases.
    • In 2021, the majority of people with extensively drug-resistant TB in England were born outside the UK, predominantly coming from Nigeria, Lithuania, Pakistan, India, and Romania [UKHSA, 2023].
• There may be an increased risk of poorer outcomes among pregnant women and new mothers with TB [UKHSA, 2019; Orazulike, 2021].
  • Risks may be highest among women who:
    • Have lived in parts of the world where TB is endemic.
    • Have been in prolonged close contact with a case of active TB disease.
    • Are immunosuppressed (particularly those with HIV).
  • TB symptoms may mimic natural physiological adaptations that occur during pregnancy (e.g. increased respiratory rate, loss of appetite and fatigue), which can lead to a delayed diagnosis.
  • Untreated tuberculosis in pregnancy has been associated with miscarriage, impaired fetal growth, preterm labour, maternal pre-eclampsia and postpartum haemorrhage, transmission of TB to the newborn, and neonatal mortality.

What are the complications?

Complications of tuberculosis (TB) include:

• Reduced quality of life — a diagnosis of TB may be associated with fear of stigmatisation [NICE, 2019], anxiety, and social isolation [WHO, 2022c].
• Transmission to others — if left untreated, one person with active pulmonary TB may infect as many as 10 to 15 people every year [NICE, 2019].
• Drug resistance — in 2021, globally 450,000 people (range 399,000-501,000) people were estimated to have developed TB resistant to rifampicin (the most effective first-line drug) [WHO, 2022b].
  • The risk of drug-resistant TB appears to be highest among people who have previously been treated for TB (11-26%) compared with new cases of TB (2.7-4.4%) [WHO, 2022b].
  • In 2019, globally 60% of people with multidrug-resistant TB or rifampicin-resistant TB successfully completed treatment (cured or treatment completed). The treatment outcomes for the remainder were not reported [WHO, 2022b].
  • In the UK, 9.9% of people with TB confirmed by culture were identified as having bacteria resistance to at least one of the 4 first-line treatment options (7.3% isoniazid, 1.9% rifampicin, 2.0% ethambutol, and 3.2% pyrazinamide) [UKHSA, 2023].
• Post-TB bronchiectasis, chronic obstructive pulmonary disease, and aspergillomas (occur in residual lung cavities) [Dheda, 2016]. See the CKS topics on Bronchiectasis and Chronic obstructive pulmonary disease for more information.
• Post-TB cor pulmonale/respiratory failure — this may result from lung cavitation, scarring, and fibrosis following pulmonary TB [Dheda, 2016].
• Death — in 2020, 5.2% of people notified in England were reported to have died at the last recorded outcome, and TB is known to have caused or contributed to 43.8% of these deaths [UKHSA, 2023]. Globally, there was an estimated 1.6 million deaths due to TB in 2021. TB remains one of the top causes of death worldwide and is a leading cause of death for a single infectious agent [WHO, 2022b].

When should I suspect active tuberculosis?

Be aware that the onset of active tuberculosis (TB) can be insidious, and early stages of the disease can be difficult to detect, leading to diagnostic delays or misdiagnosis.

• Suspect active TB in any person who is at high risk of developing TB and has general symptoms of weight loss, fever, night sweats, anorexia, or malaise.
  • Consider pulmonary involvement if the person has a persistent productive cough, which may be associated with breathlessness and haemoptysis (usually late features), and alternative causes have been excluded.
  • Consider extrapulmonary involvement (especially in children, people from countries with a high prevalence of TB, and people with HIV), if they have organ-specific symptoms and signs, such as:
    • Lymphadenopathy (typically painless lymph node swelling with a rubbery texture, often affecting the cervical or supraclavicular lymph node chains) — may suggest lymphatic TB.
    • Bone or joint pains, back pain, and joint swelling — may suggest joint or skeletal TB. The most common affected sites are the vertebral column (especially the lower thoracic and lumbar regions), hip, and knee).
    • Abdominal or pelvic pain, constipation, bowel obstruction — may suggest genitourinary or gastrointestinal TB.
    • Urinary symptoms (dysuria, haematuria, and increased urinary frequency) — may suggest genitourinary TB.
    • Sterile pyuria — may suggest renal TB.
    • Headache, vomiting, irritability, confusion, cranial nerve abnormalities — may suggest TB meningitis. See the CKS topic on Meningitis - bacterial meningitis and meningococcal disease for more information.
    • Skin lesions — for example, erythema nodosum (a hypersensitivity reaction triggered by TB infection), lupus vulgaris (painful nodular lesions affecting the face) may suggest cutaneous TB.
    • Breathlessness, chest pain, or ankle swelling — may suggest TB pericarditis.
    • Ocular inflammation or visual disturbances — ocular TB is a rare extrapulmonary manifestation.
• Be aware that children may present with non-specific symptoms and signs, such as poor weight gain, faltering growth, fatigue, or persistent fever. See the CKS topic on Faltering growth for more information.

How should I investigate a person with suspected active tuberculosis?

If there is suspected active tuberculosis (TB), arrange investigations in primary care depending on the likely site of infection and local availability of tests.

• If a person has suspected active pulmonary TB:
  • Arrange a chest X-ray.
    • This may show signs of cavitation, pleural effusion, mediastinal or hilar lymphadenopathy, or parenchymal infiltrates, mainly in the upper lobes.
  • Consider arranging three respiratory samples, particularly if chest X-ray appearances suggest TB infection.
    • Ideally, specimens should be spontaneously produced, deep cough sputum samples, with preferably one early morning sample, for microscopy for acid-fast bacilli, mycobacteria culture, and specialist molecular tests/drug sensitivity testing, depending on local laboratory protocols.
• If a person has suspected active extrapulmonary TB:
  • Arrange a chest X-ray and a spontaneously-produced respiratory sample, if possible, and consider additional investigations depending on the likely site of disease (and specialist referral):
    • Joint or spinal plain X-rays; abdominal, renal tract, or lymph node ultrasound scans, early morning urine samples for dipstick testing, microscopy (looking for sterile pyuria) and Mycobacteria culture, echocardiogram (pericardial disease), CT scans of the chest, central nervous system, or bones/joints, lumbar puncture (central nervous system TB).
• Be aware that false negative results are more common in children and the immunocompromised, such as people with HIV.

Who should be screened for tuberculosis?

Asymptomatic people who are at high risk of infection should be screened for tuberculosis (TB) through active case-finding.

• Be aware that targeted screening programmes may be co-ordinated by local multidisciplinary TB teams in high-prevalence settings of under-served groups, such as in prisons, homeless hostels or shelters, or substance misuse services; and in high-prevalence parts of the UK, such as London or Birmingham.
• People who have been in contact with a person with active pulmonary or laryngeal TB should have screening for latent TB arranged through the local multidisciplinary TB team. High-risk contacts who need contact tracing include:
  • All household members.
  • Close contacts (such as partners, house visitors, and close workplace contacts) if the person with TB has a positive sputum smear result.
  • Casual contacts (such as most work colleagues) if the index person with TB is particularly infectious (known transmission to close contacts), or if casual contacts are at increased risk of infection (such as immunocompromised people).
• People who are immunocompromised at high risk for latent TB infection (for example, people who are severely immunocompromised with HIV or following solid organ or allogeneic stem cell transplant) should have screening for latent TB following a risk assessment.
  • Screening is usually arranged by the person's specialist. See the CKS topic on HIV infection and AIDS for more information.
  • People starting specialist biologic immunosuppressant treatment (particularly anti-tumour necrosis factor [TNF]-alpha agents such as infliximab), should be screened for active and latent TB. This should be arranged by the person's specialist before treatment is started.
    • People on biologic immunosuppressant treatment should be monitored for TB before, during, and after treatment, depending on the half-life of the biologic drug. See the CKS topic on DMARDs for more information.
• For people who are new entrants to the UK from a high TB prevalence country who present to healthcare services and have not had pre-entry screening (such as vulnerable migrants or refugees), arrange referral to the local multidisciplinary TB team.
  • People resident in a country with high TB prevalence applying for a UK visa for more than 6 months are required to have pre-entry screening for active TB in their country of origin in a Home Office-approved clinic.
  • The UK Health Security Agency leaflets TB screening for the UK and Latent TB testing and treatment: information for patients may be helpful.
• People who are new NHS employees who will be working with patients or clinical specimens should not start work until they have completed a TB screen or health check. This will usually be arranged by the Occupational Health department.
• For people who have evidence of TB scarring or untreated fibrotic changes on chest X-ray but have not completed treatment as planned, arrange urgent referral to the local multidisciplinary TB team for further assessment and management.

What else might it be?

• Alternative conditions that may present similarly to active pulmonary tuberculosis (TB) include:
  • Viral upper respiratory tract infection, including COVID-19 — see the CKS topics on Cough, Cough - acute with chest signs in children and COVID-19 for more information.
  • Asthma — see the CKS topic on Asthma for more information.
  • Chest infection — see the CKS topics on Chest infections - adult and Cough - acute with chest signs in children for more information.
  • Chronic obstructive pulmonary disease — see the CKS topic on Chronic obstructive pulmonary disease for more information.
  • Lung fibrosis — such as fibrosing alveolitis, idiopathic pulmonary fibrosis, sarcoidosis, pneumoconiosis, and silicosis.
  • Lung cancer — see the CKS topic on Lung and pleural cancers - recognition and referral for more information.
  • Pulmonary sarcoidosis — common features which overlap with pulmonary TB include breathlessness, a persistent (though typically dry rather than productive) cough and chest pain. Lymphadenopathy and arthralgia may also present.
• Alternative conditions that may present similarly to active extrapulmonary TB include:
  • Lymphoma — in addition to lymphadenopathy, common features which overlap with extrapulmonary TB include fever, weight loss and fatigue.
  • Malignant pleural effusion — see the CKS topic on Lung and pleural cancers - recognition and referral for more information.
  • Inflammatory bowel disease — see the CKS topics on Crohn's disease and Ulcerative colitis for more information.

Scenario: Management of tuberculosis

From age 1 month onwards.

Search strategy

Scope of search

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

Search dates

December 2018 - June 2023

Key search terms

The terms listed below are the core search terms that were used for EBSCOhost MEDLINE. These terms were combined with search filters for systematic reviews and guidelines in EBSCOhost MEDLINE. The strategy was adapted for The Cochrane Library databases. 

S4    S1 OR S2 OR S3
S3    AB tuberculosis OR TI tuberculosis
S2    (MH "Mycobacterium tuberculosis")
S1    (MH "Tuberculosis+")

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.