Changes

July 2024 — minor update. Added information from the NHS England Adult breathlessness pathway (pre-diagnosis): diagnostic pathway support tool relating to referral of people with uncertain cause of breathlessness. 

Update

Goals

To support primary healthcare professionals to:

• Determine the underlying cause of the breathlessness.
• Appropriately refer the person for further investigation and treatment.
• Decide if emergency admission is required.

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

No NICE Quality standards were found during the review of this topic.

What is it?

• Breathlessness, also known as dyspnoea, is a highly subjective, uncomfortable or distressing sensation that occurs when actual ventilation is perceived not to satisfy demand.  
  • The American Thoracic Society defines it as a subjective experience of breathing discomfort that consists of qualitatively distinct sensations that vary in intensity [American Thoracic Society, 2012].
• Breathlessness can be classified by speed of onset:
  • Acute — when it develops suddenly or in a matter of minutes. 
  • Subacute — when it develops over hours or days. 
  • Chronic — when it develops over weeks or months. 

[Kemp, 2020; BMJ, 2022]

What causes it?

• Acute breathlessness may occur in people with no known underlying cause, or in those with a known chronic condition and worsening symptoms. For people with known underlying disease, it is important to ascertain whether their breathlessness is due to their condition or is an emerging new problem.
• Acute and subacute breathlessness most commonly have a pulmonary or cardiac cause.
  • Pulmonary causes include:
    • Acute asthma. 
    • Acute exacerbation of bronchiectasis. 
    • Acute exacerbation of chronic obstructive pulmonary disease (COPD). 
    • Acute pneumonitis. 
    • Lung or lobar collapse.
    • Pleural effusion.
    • Pneumonia. 
    • Pneumothorax.
    • Pulmonary embolism.
    • Upper airway obstruction (for example by a foreign body or acute epiglottitis) causing stridor. 
  • Cardiac causes include pulmonary oedema secondary to:
    • Acute deterioration of chronic heart failure. 
    • Acute valvular dysfunction. 
    • Cardiac tamponade. 
    • Coronary artery disease (including an atypical presentation of myocardial infarction). 
    • Sudden-onset cardiac arrhythmia (for example supraventricular tachycardia). 
  • Other causes include:
    • Acute blood loss. 
    • Hyperventilation syndrome (often due to anxiety). 
    • Metabolic causes (including aspirin overdose, diabetic ketoacidosis, and renal failure). 
    • Neuromuscular disease (including Guillan-Barré Syndrome, and myasthenia gravis). 
    • Thyrotoxicosis.
• Chronic breathlessness most commonly has a pulmonary or cardiac cause.
  • Pulmonary causes include:
    • COPD, asthma, or bronchiectasis. 
    • Cystic fibrosis.
    • Interstitial lung disease (including asbestosis, idiopathic pulmonary fibrosis). 
    • Lung cancer.
    • Occupational lung disease. 
    • Pulmonary vascular disease. 
    • Pleural infiltration by mesothelioma. 
  • Cardiac causes include chronic heart failure caused by:
    • Cardiac arrhythmia. 
    • Cardiomyopathy. 
    • Congenital heart disease. 
    • Hypertension.  
    • Ischaemic heart disease. 
    • Valvular heart disease. 
  • Other causes include:
    • Anaemia. 
    • Chest wall disease (including ankylosing spondylitis).
    • Deconditioning/obesity.
    • Diaphragmatic splinting (due to obesity, pregnancy, or ascites).
    • Hypothyroidism. 
    • Hypoventilation (caused by neuromuscular conditions such as Guillain–Barré syndrome or motor neurone disease).

[American Thoracic Society, 2012; BTS, 2019; Kemp, 2020; Simon, 2020; Weatherall, 2020; ESC, 2021a; BMJ, 2022]

How should I assess a person with breathlessness?

Perform an initial Airway, Breathing, Circulation assessment, and determine the need for emergency admission.

• Assess the person's blood pressure, pulse rate, respiratory rate, temperature, level of consciousness, and oxygen saturation.  
• Note: vital signs may be normal even if there is a life-threatening underlying cause. 

For people who do not require emergency admission:

• Take a medical history and ask about:
  • Duration and onset — acute dyspnoea typically indicates acute and severe conditions that may be life-threatening.
  • Severity — this is highly subjective and varies widely for a given level of functional impairment. 
  • Factors that exacerbate or alleviate breathlessness — for example, positional changes.  
    • Dyspnoea on lying flat and relieved by sitting up is associated with left heart dysfunction.
    • Paroxysmal nocturnal dyspnoea — the person is woken from sleep and needs to sit upright or stand for relief. This is associated with pulmonary oedema.
  • Exercise tolerance — distance they can walk, climbing stairs. 
  • Impact on daily activities — for example, dressing.
  • Pattern of dyspnoea — for example, mornings, the working week (potential occupational exposure), seasonal dyspnoea (exposure to cold), and extrinsic triggers (pets, perfumes). 
  • Associated symptoms — for example, chest pain, palpitations, syncope, fever, wheezing, cough. 
  • Comorbidities — for example respiratory, gastrointestinal, cardiovascular or rheumatological conditions. 
  • Recent surgery. 
  • Drug history (including any illegal drug use) — for example, beta-blockers, digoxin, calcium-channel blockers. 
  • Smoking, alcohol intake, physical activity. 
  • Travel history. 
• Examine the person  — conduct cardiovascular, respiratory, and neurological examinations and look for signs of possible cardiac, pulmonary or other underlying causes.
• Arrange additional investigations that may be appropriate depending on the presentation, examination and suspected underlying cause.

What investigations should I consider for a person with breathlessness?

If emergency admission is not required: 

• Offer an urgent chest X-ray (to be performed within 2 weeks) to assess for lung cancer in people aged 40 years and over if they have two or more of the following unexplained symptoms, or if they have ever smoked and have one or more of the following unexplained symptoms: 
  • Cough.
  • Fatigue.
  • Shortness of breath.
  • Chest pain.
  • Weight loss.
  • Appetite loss.
• Investigations which may be appropriate include:  
  • Abdominal ultrasound — to confirm the presence of ascites and to exclude or confirm liver cirrhosis and peritoneal cancer.
  • B-type natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP) — to assess for heart failure. These may also be elevated in other conditions, for example, sepsis, coronary artery disease, pulmonary embolism and COPD.
  • Chest x-ray — to look for signs of heart failure, pulmonary pathology (including pleural effusion, lung collapse), pneumothorax, and to exclude other causes (for example in people with suspected pneumonia or bronchiectasis). 
  • C-reactive protein — to check for infection and inflammatory conditions.
  • Electrocardiogram (ECG) — for example, to look for signs of heart failure, pulmonary hypertension, arrhythmia, cardiac tamponade, and pulmonary embolism.
  • Full blood count — to check for anaemia, evidence of infection.
  • Kidney function tests —  to exclude renal impairment. 
  • Liver function tests — bilirubin may be elevated in liver failure, heart failure, chronic kidney disease. Transaminases may be elevated in liver failure, atypical pneumonia and myocardial infarction. 
  • Peak expiratory flow rate (PEFR) and spirometry — to assess for possible asthma or obstructive airway disease.
  • Pulse oximetry — hypoxaemia may occur in a range of conditions, including pneumonia, pulmonary oedema, COPD, asthma, and interstitial lung disease.    
  • Thyroid function test — to detect thyroid disease. 

Cardiac causes of breathlessness

Cardiac and vascular causes of breathlessness include:

• Acute pulmonary oedema 
  • Risk factors — chronic heart failure, ischaemic heart disease, valvular heart disease, arrhythmia, pulmonary embolism.
  • Symptoms — severe breathlessness, orthopnoea, coughing (rarely with frothy blood-stained sputum).
  • Signs — elevated jugular venous pressure, gallop rhythm, crackles, central cyanosis, and occasionally wheeze, peripheral oedema. 
• Cardiac arrhythmia 
  • Risk factors — heart failure, valvular heart disease, coronary artery disease, previous arrhythmia.
  • Symptoms — may be sudden onset, palpitations, breathlessness, chest pain, syncope (or near syncope).
  • Signs — bradycardia or tachycardia.
  • Electrocardiogram (ECG) — diagnosis of the specific arrhythmia relies on ECG obtained during the arrhythmia.
    • Typical ECG features of supraventricular tachycardia (SVT) include regular narrow QRS complex tachycardia and a rate greater than 100 beats per minute (bpm). Wide complex tachycardias may have a supraventricular or ventricular origin.
• Cardiac tamponade   
  • Risk factors — malignancy, collection of fluid after cardiac surgery, trauma, autoimmune disease, myxoedema, myocardial infarction.
  • Symptoms — breathlessness, collapse.
  • Signs — tachycardia, pulsus paroxodus, tachypnoea, engorgement of neck veins and face, peripheral cyanosis, shock.
• Chronic heart failure 
  • Risk factors — advanced age, hypertension, coronary heart disease, valvular heart disease, chronic cardiac arrhythmia, diabetes, obesity, family history of cardiomyopathy or sudden death.
  • Symptoms — fatigue and breathlessness, orthopnoea, paroxysmal nocturnal dyspnoea, reduced exercise tolerance. 
  • Signs — oedema, basal crepitations, laterally displaced apical pulse, third heart sound (gallop rhythm), elevated jugular venous pressure, ankle swelling, weight changes, hepatojugular reflex and hepatomegaly.
• Silent myocardial infarction (MI) 
  • Risk factors — coronary artery disease, smoking, hyperlipidaemia, hypertension, obesity, diabetes, family history.
    • Atypical presentations of myocardial infarction such as isolated breathlessness or fatigue are more common in the elderly, in women and in people with diabetes, chronic renal disease or dementia.
  • Symptoms — breathlessness, general malaise, sudden collapse, upper body discomfort, nausea.
  • Signs — abnormal pulse rate, sweating, reduced peripheral perfusion, hypotension.
  • ECG — features suggestive of acute MI include ST depression with T-wave inversion, persistent ST elevation, or new left bundle branch block. Q-waves do not give an indication of the age of an MI as remain permanent following infarction. A normal ECG does not exclude myocardial infarction. 
• Superior vena cava syndrome
  • Risk factors — lung cancer, history of smoking, lymphoma, metastatic tumours. 
  • Symptoms — breathlessness, chest pain, cough, headache worse on stopping, hoarseness.
  • Signs — neck and facial swelling, dilated collateral chest veins, facial plethora, fixed elevation of jugular venous pressure, anorexia. 

Pulmonary causes of breathlessness

Pulmonary causes of breathlessness include:

• Asthma 
  • Risk factors — personal history of rhinitis or eczema, or family history of atopy or asthma. 
  • Symptoms — wheeze, breathlessness, chest tightness, cough. Symptoms are variable (often worse at night, first thing in the morning, and upon exercise or exposure to cold or allergens, or taking some medications such as nonsteroidal anti-inflammatory [NSAID] medication and beta-blockers). 
  • Signs — during an acute episode, the respiratory rate is increased, wheeze is usually present, and peak expiratory flow rate (PEFR) is reduced. 
    • Life-threatening features of acute asthma include: PEFR less than 33% of best or predicted; oxygen saturation less than 92%; silent chest, cyanosis, or poor respiratory effort; arrhythmia or hypotension; exhaustion, or impaired level of consciousness.
    • Severe features of acute asthma include PEFR 33–50% of best or predicted, respiratory rate of 25 breaths per minute or greater, pulse 110 beats per minute or greater, or inability to complete full sentences in one breath.
    • Moderate features of acute asthma include PEFR 50%-75% of predicted, without any features of severe or life-threatening acute asthma.
  • For more information, see the CKS topic on Asthma.
• Bronchiectasis 
  • History — suspect in people with a history of recurrent or chronic productive cough, absence of smoking history, previous pulmonary infections.  
  • Symptoms — cough with daily sputum production, progressive breathlessness, haemoptysis, non-pleuritic chest pain between exacerbations.
  • Signs — coarse crackles, rhonchi, wheeze, prolonged expiratory phase. Finger clubbing, cyanosis and hypoxia may be present. 
  • For more information, see the CKS topic on Bronchiectasis.
• Chronic obstructive pulmonary disease (COPD) 
  • History — typically, the person is older than 35 years of age, is a smoker (or past smoker) and reports slowly progressive breathlessness. 
  • Symptoms — persistent progressive exertional breathlessness that is often associated with wheezing and a cough (productive of sputum). Acute exacerbations of symptoms are common, and are frequently caused by respiratory tract infection. Frequent winter 'bronchitis' may be described. 
  • Signs — there may be no abnormal signs but they can include wheeze, hyperinflated chest, purse lip breathing, cachexia, cyanosis, peripheral oedema, increased jugular venous pressure (JVP), peripheral oedema, tachypnoea, and use of accessory muscles. Crackles may be present when exacerbation is infective.
  • For more information, see the CKS topic on Chronic obstructive pulmonary disease.
• COVID-19 infection 
  • For information on the signs and symptoms of COVID-19 and long COVID, see the CKS topic on Coronavirus - COVID 19. 
• Interstitial lung disease (ILD) 
  • Causes — smoking, idiopathic pulmonary fibrosis, sarcoidosis, pneumoconiosis, medication, connective tissue disease, hypersensitivity pneumonitis/extrinsic allergic alveolitis (following sensitization to inhaled environmental allergens). 
  • Symptoms — cough and slowly progressive breathlessness. There may be symptoms of the underlying cause (for example joint pains if associated with connective tissue disease).
  • Signs — dry crackles, hypoxaemia, there may be finger clubbing and cyanosis.
• Lung/lobar collapse 
  • Causes — airway compression (for example by enlarged lymph nodes caused by cancer or tuberculosis) or blockage (secondary to pneumonia or an inhaled foreign body). 
  • Symptoms — breathlessness, cough.
  • Signs — reduced chest wall movement on the affected side, dull percussion note with bronchial breathing, reduced or diminished breath sounds, mediastinal displacement towards the collapse.
• Pleural effusion 
  • Causes — heart failure, liver cirrhosis, hypothyroidism, pneumonia, pulmonary embolism, cancer (including mesothelioma), tuberculosis, pleural infection (empyema), and autoimmune disease.
  • Symptoms — these depend on the rate of fluid accumulation and volume, but include progressive breathlessness and pleuritic pain, as well as symptoms of the underlying condition. 
  • Signs — reduced chest wall movements on the affected side, stony dull percussion note, diminished or absent breath sounds, decreased tactile vocal fremitus/vocal resonance and bronchial breathing just above the effusion. If the pleural effusion is large, the trachea may deviate away from the effusion. There may be signs of the underlying condition.
• Pneumonia 
  • Symptoms — cough associated with at least one other symptom of lower respiratory tract infection, such as purulent sputum, pleurisy, wheeze, or pleuritic pain.
  • Signs — new focal chest signs (such as dull percussion note, bronchial breathing, coarse crackles and /or pleural rub, or increased vocal fremitus/resonance) plus at least one systemic feature (such as fever, sweating, shivers or myalgia), with or without a temperature of 38°C or higher. There may be signs of an associated pleural effusion.
    • Note: elderly people may present atypically, with non-specific features (for example, acute confusion). 
  • For more information, see the section on Community acquired pneumonia in the CKS topic on Chest infections - adult. 
• Pneumothorax/tension pneumothorax 
  • Risk factors — smoking, tall, previous pneumothorax, chronic respiratory disease (such as chronic obstructive pulmonary disease or asthma), trauma to chest wall (including therapeutic procedures such as injections and aspirations).
  • Symptoms — collapse, sudden-onset pleuritic pain, breathlessness.
  • Signs — reduced chest wall movements, unilateral reduced or absent breath sounds, reduced vocal fremitus, and increased resonance of the percussion note on the affected side. Tension pneumothorax can result in a rapid development of severe symptoms associated with tracheal deviation away from the pneumothorax, pulse rate can exceed 140 beats/min, and hypotension, cyanosis, or pulseless electrical activity may occur. 
• Pulmonary embolism (PE) 
  • Risk factors — immobilization, surgery within the last month, cancer, major trauma, obesity, prolonged travel, symptoms or signs of deep vein thrombosis (DVT), previous DVT, thrombophilia, or age over 65 years.
  • Symptoms — acute-onset breathlessness, chest pain (which may be pleuritic), palpitations, syncope, haemoptysis. 
  • Signs — tachycardia, hypotension, tachypnoea, hypoxaemia, hypocapnia, cyanosis, neck vein engorgement and lower extremity oedema. There may also be an atrial arrhythmia (most commonly atrial fibrillation).
  • For more information, see the CKS topic on Pulmonary embolism.
• Lung or pleural cancer 
  • Risk factors — smoking, asbestos exposure. 
  • Symptoms — cough, shortness of breath, haemoptysis, chest pain, weight loss, appetite loss, fatigue, hoarseness, persistent chest infections symptoms relating to bone or brain metastases.
  • Signs — chest examination is often normal but there may be unilateral wheeze, decreased breath sounds, or signs of pleural effusion. Other signs include finger clubbing, and supraclavicular or cervical lymphadenopathy.
  • For more information, see the CKS topic on Lung and pleural cancers - recognition and referral.

Other causes

• Anaemia 
  • Symptoms — mild anaemia may be asymptomatic or cause mild fatigue. Symptoms in more severe anaemia include light-headedness, faintness, exertional breathlessness, palpitations and angina. Rapid blood loss presents with features of intravascular volume depletion. 
  • Signs — pallor, tachycardia, signs of cardiac failure. 
  • For more information, see the CKS topics on Anaemia - iron deficiency and Anaemia - B12 and folate deficiency.
• Anaphylaxis 
  • Symptoms — rapidly developing, difficulty breathing/swallowing, stridor, nausea, diarrhoea, itching. 
  • Signs — increased respiratory rate, wheeze, hoarseness, oxygen saturation below 92%, flushing, erythema, urticaria/angioedema, pallor, clammy, tachycardia, faintness, confusion, loss of consciousness. 
  • For more information, see the CKS topic on Angio-oedema and anaphylaxis.
• Anxiety-related breathlessness 
  • History — there may be a history of anxiety, panic or phobia, most commonly young to middle-aged women.  
  • Symptoms — paraesthesia, dizziness, chest pain, discomfort in various locations, choking sensation, and feelings of fear may occur.   
  • Signs — no signs of a physical cause for breathlessness. Hyperventilation accompanied by sighing, tachycardia, tachypnoea and sweating may occur. 
  • For more information, see the CKS topic on Generalized anxiety disorder.
• Diaphragmatic splinting (due to ascites, obesity, or pregnancy) 
  • Symptoms — chronic breathlessness that develops in association with increasing abdominal size. 
  • Signs — ascites or obesity. People with ascites may have stigmata of liver disease, jaundice, abdominal distension and distended abdominal wall superficial veins. 

Scenario: Breathlessness

From age 18 years onwards.

Scenario: COVID-19 Management

From birth onwards.

Search strategy

Scope of search

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

Search dates

October 2016 - January 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.

• exp Dyspnea/, dyspnea or dyspnoea or tachypnea or bradypnea.tw,ti,ab.  breathless$.tw
• exp Respiration Disorders/, Pulmonary consolidation.tw, exp Hemothorax/, exp Pneumothorax/, exp Lung Neoplasms/, exp Pulmonary Edema/, exp Airway Obstruction/, exp Pulmonary Embolism/, exp Pleural Effusion/, exp Pneumonia/
• exp Oximetry/, exp X-Rays/, exp Fibrin Fibrinogen Degradation Products/, exp Spirometry/
• exp Panic Disorders/, psychogenic breathlessness.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.