Changes

January 2025 — reviewed. A literature search was conducted in January 2025 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of this topic. No major changes to the recommendations have been made.

Update

Goals

To support primary healthcare professionals to:

• Assess people with chronic pain.
• Offer appropriate management options.
• Refer people with chronic pain, when appropriate, to other healthcare professionals.
• Follow up people with chronic pain.

Outcome measures

No outcome measures were found during the review of this topic.

Audit criteria

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

QOF indicators

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

QIPP - Options for local implementation

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

NICE quality standards

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

What is it?

• Chronic pain is:
  • An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage.
  • Pain that persists or recurs for more than 3 months.
  • Multifactorial — biological, psychological, and social factors contribute to the pain syndrome.
• Chronic primary pain is: 
  • Pain in one or more anatomical regions that is characterized by significant emotional distress (anxiety, anger/frustration, or depressed mood) or functional disability (interference in daily life activities and reduced participation in social roles). The diagnosis is appropriate independently of identified biological or psychological contributors unless another diagnosis would better account for the presenting symptoms.
  • Multifactorial — biological, psychological, and social factors contribute to the pain syndrome.

[WHO, 2024]

How is pain classified?

The International Classification of Diseases (ICD-11) definition of chronic pain includes [WHO, 2024]:

• Chronic primary pain.
• Chronic cancer-related pain.
• Chronic post-surgical or post-traumatic pain.
• Chronic secondary musculoskeletal pain — due to inflammation, associated with structural changes, or due to nervous system disease.
• Chronic secondary visceral pain — from mechanical factors, vascular mechanisms, or inflammation.
• Chronic neuropathic pain — central neuropathic pain or peripheral neuropathic pain.
• Chronic secondary headache or orofacial pain — due to oral facial disorders, dental pain, neuropathic orofacial pain, or secondary temporomandibular disorders.

The ICD-11 definition of chronic primary pain includes [WHO, 2024]:

• Chronic widespread pain (CWP) — diffuse pain in at least four of five body regions.
• Complex regional pain syndrome (CRPS) — CRPS is preceded by a noxious event and is characterized by spontaneous pain or hyperalgesia/hyperesthesia not limited to a single nerve territory and disproportionate to the inciting event. There is accompanying oedema, skin blood flow (temperature) or sudomotor abnormalities, motor symptoms, or trophic changes.
• Chronic primary headache or orofacial pain — headache or orofacial pain that occurs on at least 50% of the days during at least 3 months.
• Chronic primary visceral pain — pain localized in the thoracic, abdominal, or pelvic region.  
• Chronic primary musculoskeletal pain — pain in the muscles, bones, joints, or tendons.

How common is it?

• The prevalence of pain in the literature varies depending on the criteria and definitions used [BMA, 2017].
• Chronic pain is a common reason for seeking healthcare — up to 50% of GP consultations are related to pain [Kang, 2023].
• The prevalence of chronic primary pain is unknown, but is estimated to be between 1 and 6% in England [NICE, 2022].
• Among the three most common types of pain are [BMJ Best Practice, 2024]:
  • Back pain. 
  • Headache.
  • Joint pain — arthritis (osteoarthritis and rheumatoid arthritis) is one of the most common chronic pain disorders, diagnosed in 8–16% of the population in Europe and the US.
• An NHS Digital survey found that [NHS Digital, 2019]: 
  • The prevalence of chronic pain amongst adults was 34%, and it was more common in women (38%) than in men (30%). 
  • Prevalence of chronic pain increased with age, ranging from 16% among people aged 16–24 years to 53% among those aged 75 years and over.
• A systematic review and meta-analysis found that [Fayaz, 2016]:
  • Between one-third and one-half of the UK population (just under 28 million adults) are affected by chronic pain. 
  • The UK prevalence ranged from: 
    • 35.0–51.3% for chronic pain.
    • 10.4–14.3% for moderate to severely disabling pain.
  • The prevalence in people aged: 
    • 18–25 years was 14.3%, although the prevalence in those aged 18–39 years may be as high as 30%.
    • Over 75 years was 62%.
  • The prevalence of different types of pain was: 
    • 14.2% for chronic widespread pain.
    • 8.2% for chronic neuropathic pain. 
    • 5.4% for fibromyalgia.
  • Chronic pain was more common in women than in men. 
• Across Europe, approximately 18% of the population are currently affected by moderate to severe chronic pain [SIGN, 2019].

What causes it?

• There are many possible causes of chronic pain. It may be caused by:
  • An acute injury.
  • An ongoing degenerative illness.
  • A primary condition.
  • Surgery or medical interventions.
• Chronic pain may be due to: 
  
  • Musculoskeletal causes, including:
    • Ankylosing spondylitis — for more information, see the CKS topic on Ankylosing spondylitis.
    • Chronic or repetitive overuse.
    • Connective tissue disorders (for example, Ehlers-Danlos syndrome, systemic lupus erythematosus).
    • Faulty posture.
    • Fractures.
    • Mechanical low back pain — for more information, see the CKS topic on Back pain - low (without radiculopathy).
    • Muscular strains.
    • Myofascial diseases (for example, a temporomandibular disorder) — for more information, see the CKS topic on Temporomandibular disorders. 
    • Osteoarthritis — for more information, see the CKS topic on Osteoarthritis.
    • Osteomyelitis.
    • Polymyalgia rheumatica — for more information, see the CKS topic on Polymyalgia rheumatica.
    • Polymyositis.
    • Rheumatoid arthritis — for more information, see the CKS topic on Rheumatoid arthritis.
  • Neurological causes, including:
    • Brachial plexus traction injury.
    • Complex regional pain syndrome.
    • Infections (for example, HIV) — for more information, see the CKS topic on HIV infection and AIDS.
    • Pernicious anaemia — for more information, see the CKS topic on Anaemia - B12 and folate deficiency.
    • Polyneuropathies.
    • Polyradiculopathies.
    • Post-herpetic neuralgia — for more information, see the CKS topic on Post-herpetic neuralgia.
    • Thoracic outlet syndrome.
    • Thyroid disease — for more information, see the CKS topics on Hyperthyroidism and Hypothyroidism.
    • Trigeminal neuralgia — for more information, see the CKS topic on Trigeminal neuralgia.
  • Headache causes, including:
    • Medication overuse — for more information, see the CKS topic on Headache - medication overuse.
    • Giant cell (temporal) arteritis — for more information, see the CKS topic on Giant cell arteritis.
    • Glaucoma — for more information, see the CKS topic on Glaucoma.
    • Migraine — for more information, see the CKS topic on Migraine.
    • Temporomandibular joint dysfunction — for more information, see the CKS topic on Temporomandibular disorders. 
    • Trigeminal neuralgia — for more information, see the CKS topic on Trigeminal neuralgia.
  • Psychological causes, including: 
    • Anxiety — for more information, see the CKS topic on Generalized anxiety disorder.
    • Depression — for more information, see the CKS topic on Depression.
    • Personality disorders. 
    • Sleep disturbances — for more information, see the CKS topic on Insomnia.
• Localized or regional pain may involve specific sites or regions. 
  
  • Cardiovascular — for example, angina. For more information, see the CKS topic on Angina. 
  • Dermatological — for example, pressure ulcers.
  • Gastrointestinal — for example, irritable bowel disease. For more information, see the CKS topic on Irritable bowel syndrome.
  • Pulmonary — for example, chronic obstructive pulmonary disease. For more information, see the CKS topic on Chronic obstructive pulmonary disease.
  • Urological — for example, chronic cystitis. For more information, see the CKS topic on Urinary tract infection (lower) - women.
• Widespread pain may occur with systemic conditions, such as:
  • Cancer — for example, multiple myeloma. For more information see the CKS topic on Multiple myeloma. 
  • Endocrinological disease — for example, diabetes mellitus. For more information see the CKS topics on Diabetes - type 1 and Diabetes - type 2. 
  • Haematological disease — for example, non-Hodgkin's lymphoma, including Waldenström's macroglobulinaemia (lymphoplasmacytic lymphoma). For more information, see the CKS topic on Haematological cancers - recognition and referral. 
  • Infectious disease — for example, HIV. For more information, see the CKS topic on HIV infection and AIDS.
  • Rheumatological disease — for example, Ankylosing spondylitis.

[Reid, 2015; BMJ Best Practice, 2024] 

What are the risk factors?

• Demographic risk factors for chronic pain include:
  • Female sex — men are less likely to report or experience chronic pain.
  • Age over 45 years.
  • Socio-economic status — people experiencing socio-economic deprivation are more likely to experience chronic pain, and it is more likely to be severe and result in a greater level of pain-related disability. Unemployment has also been identified as a risk factor.
  • Occupational factors — higher risk occupations include those that involve prolonged standing or sustained low-level movements. Those noted to be at increased risk include healthcare assistants, nurses, dentists, chiropractors, people undertaking heavy manual work, mechanics, housekeepers, hairstylists, and soldiers.
• Lifestyle risk factors include:
  • Cigarette smoking.
  • Drinking alcohol.
  • Inactive lifestyle — exercise and physical activity have positive effects on chronic pain with improved quality of life and physical function, reducing pain severity, and few adverse effects.
• Clinical risk factors include:
  • Acute back pain with neurological signs.
  • Multimorbidity.
  • Comorbid personality disorder.
  • Psychological distress.
  • Pain-related disability.
  • History of trauma or chronic pain.
  • Sleep disorders — poor sleep increases the intensity and duration of chronic pain.
  • Surgical and medical interventions.
  • Obesity. 
• Other risk factors include:
  • Family history of chronic pain syndromes (for example, migraine, fibromyalgia).
  • Pregnancy — there is an increased risk of musculoskeletal and neuropathic pain conditions.
  • Attitudes and beliefs about pain — people who have an active strategy to cope with pain (for example, exercise) are less affected than those with a passive approach (resting and taking medication).

[Mills, 2019; BMJ Best Practice, 2024]

What is the prognosis?

• People with chronic pain usually experience symptoms lasting several months to years [BMJ Best Practice, 2024].
  • Back pain that persists beyond the acute period often persists long term. 
  • Myofascial pain symptoms normally persist long-term with fluctuating severity.
  • Fibromyalgia — complete remission rarely occurs, although most people experience substantial symptomatic improvement and reduced reliance on medicines when followed over 3 years. 
• Non-pharmacological treatment may be effective in reducing symptoms in some people with chronic pain [NICE, 2022].
• A longitudinal pain study that followed a random sample of participants (n = 4782) from a Norwegian health survey (HUNT3) to monitor the development and course of chronic pain over 4 years found that [Landmark, 2018]: 
  • Among those without chronic pain at baseline, the probability of developing moderate to severe chronic pain (cumulative incidence) during the first year was 5%, a pain status that was maintained among 38% of people at the second follow up.
    • The probability of developing chronic pain diminished substantially for those who maintained a status of no chronic pain over several years.
  • Subjects with moderate to severe chronic pain at baseline had an 8% probability of recovery into no chronic pain, a status that was maintained for 52% of people on the second follow up.
    • The probability of recovery diminished substantially as a status of chronic pain was prolonged for several years.
  • Pain severity, widespread pain, pain catastrophizing, depression, and sleep were significant predictors of future moderate to severe chronic pain, both among subjects with and without chronic pain at baseline.
• Another longitudinal study of people with chronic pain at baseline (n = 1905) identified from the HUNT3 study found that [Glette, 2020]: 
  
  • Most had a stable pain trajectory, and identified five discrete trajectories:
    • Persistent mild (24%).
    • Persistent moderate (22%).
    • Persistent severe (13%).
    • Fluctuating between mild and severe (31%).
    • Gradual improvement (11%). 
  • Comorbid disease, sleep difficulties, catastrophizing, poorer mental health, and chronic widespread pain were associated with persistent severe pain.
  • Those with persistent moderate pain had a tendency towards a higher probability of severe pain at the later follow-up time points.
  • In the improving group, most substantial improvement occurred within the first 3–6 months. 
• Factors associated with a poorer prognosis include [Reid, 2015]: 
  • Higher levels of pain severity and disability.
  • Longer duration of pain.
  • Multiple pain sites.
  • History of anxiety and depression.
  • Maladaptive coping strategy (for example, worry, avoidance).
  • Inadequate social support at the time of diagnosis.

What are the complications?

• Complications of chronic pain include:
  • Disability — if poorly controlled, chronic pain can lead to significant disability.  
  • Psychological distress — for example, depression and anxiety. Referral to occupational therapy and psychology may be required. 
    • It is estimated that around 48% of people with chronic pain also suffer from depression.
  • Medicine misuse — particularly in people taking opioids. 
  • Sleep impairment.
  • Adverse effects from medication (for example, nonsteroidal anti-inflammatory drugs and opioids). 
  • Reduced quality of life — daily living, family and social relationships, and employment can be negatively affected by chronic pain. 

[Reid, 2015; BMA, 2017; SIGN, 2019; NICE, 2022; BMJ Best Practice, 2024]

How should I assess someone with chronic pain?

• Identify any red flag clinical signs and symptoms of serious underlying conditions that require urgent referral. 
• Offer a person-centred assessment to people presenting with chronic pain (chronic primary pain, chronic secondary pain, or both), to identify factors contributing to the pain and how the pain affects the person’s life.
• When assessing and managing any type of chronic pain, follow the recommendations in the National Institute for Health and Care Excellence (NICE) guideline Patient experience in adult NHS services, particularly relating to: 
  • Knowing the person as an individual. 
  • Enabling people to actively participate in their care, including: 
    • Communication — ensure that people with sensory impairment and people with impaired cognition are offered appropriate assistance. 
    • Information. 
    • Shared decision-making. 
• Foster a collaborative and supportive relationship.
• Take a medical history and carry out a biopsychosocial assessment. Ask the person:
  • About the location, the intensity, and the type of pain.
    • Ask the person to point to the pain on themselves and use pain maps to define the location and extent of pain. 
    • Ask about the intensity of pain and if this has changed over time — consider using a standardized intensity rating scale (such as a verbal rating scale, a visual analogue scale, or a numerical rating scale, for example the British Pain Society numerical pain rating scale).
    • Ask about the characteristics of pain (for example, aching or stabbing) and any other accompanying symptoms (for example, numbness, weakness) to help identify the type of pain (for example, neuropathic, nociceptive, or mixed). 
  • About factors that help alleviate pain, or which exacerbate it (for example, rest or movement). 
  • About comorbidities and use of prescribed or over-the-counter medication. 
  • To describe how chronic pain affects their life, and that of their family, carers and significant others, and how aspects of their life may affect their chronic pain. This might include effects on: 
    • Lifestyle and day-to-day activities, including work and sleep.
    • Physical and psychological wellbeing — a chronic physical health problem, such as pain, can both cause and exacerbate depression. For more information, see the CKS topics on Depression and Generalized anxiety disorder.
    • Stressful life events, including previous or current physical or emotional trauma.
    • Current or past history of substance misuse.
    • Social interaction and relationships.
    • Difficulties with employment, housing, income, and other social concerns.
  • About their understanding of their condition, and that of their family, carers, and significant others. This might include:
    • Their understanding of what causes the pain.
    • Their expectations of what might happen in the future in relation to their pain.
    • Their understanding of the outcome of possible treatments.  
• Assess the person's health-related quality of life — for example, using the EuroQol 5D (EQ-5D-3L) descriptive system.
• Explore the person’s strengths as well as the impact of pain on their life. This might include talking about:
  • Their views on living well.
  • The skills they have for managing their pain 
  • What helps when their pain is difficult to control.
• When assessing chronic pain in people aged 16–25 years, take into account:
  • Any age-related differences in presentation of symptoms.
  • The impact of the pain on family interactions and dynamics.
  • The impact of the pain on education and social and emotional development.
• Conduct a physical examination to identify any treatable causes — for example, a musculoskeletal examination if there is evidence of inflammation, or a neurological examination if there is evidence of weakness or neuropathy. 
• Consider a diagnosis of chronic primary pain if there is no clear underlying (secondary) cause or the pain or its impact is out of proportion to any observable injury or disease, particularly when the pain is causing significant distress and disability.
• Use clinical judgement to determine the necessity of identifying any injury or disease that may be causing the pain, and about whether the pain or its impact are out of proportion to any identified injury or disease, in discussion with the person with chronic pain.
  • Arrange any necessary investigations if the history and examination findings identify abnormalities that suggest a specific diagnosis, or underlying cause for pain.
• Be sensitive to the person’s socioeconomic, cultural and ethnic background, and faith group, and how these might influence their symptoms, understanding, and choice of management.
• Recognize that:
  • Living with pain can be distressing (acknowledge this to the person with chronic pain).
  • An initial diagnosis of chronic primary pain may change with time.
    • Re-evaluate the diagnosis if the presentation changes.
  • Chronic primary pain can coexist with chronic secondary pain.

Red flag signs and symptoms

• Be aware of the signs and symptoms of serious underlying conditions that can lead to pain. These conditions include:
  • Cauda equina syndrome — for more information, see the section on Red flags in the CKS topic Back pain - low (without radiculopathy) and Red flag symptoms and signs in the CKS topic Sciatica (lumbar radiculopathy).
  • Giant cell arteritis — for more information, see the CKS topic on Giant cell arteritis.
  • Lung carcinoma — this may present as severe shoulder pain accompanied by Horner's syndrome. For more information, see the section on Assessment in the CKS topic on Shoulder pain, and the CKS topic on Lung and pleural cancers - recognition and referral.
  • Multiple myeloma — for more information, see the CKS topic on Multiple myeloma.
  • Subarachnoid haemorrhage — for more information, see the section on Diagnosis in the CKS topic on Headache - assessment.  
  • Bone and soft tissue sarcoma — for more information, see the CKS topic on Bone and soft tissue sarcoma - recognition and referral.
  • Haematological cancers — for more information, see the section on Diagnosis in the CKS topic on Haematological cancers - recognition and referral.
  • Gastrointestinal tract cancers — for more information, see the CKS topics on Gastrointestinal tract (lower) cancers - recognition and referral and Gastrointestinal tract (upper) cancers - recognition and referral.
  • Pancreatitis — for more information, see the CKS topic on Pancreatitis - chronic
• For people with:
  • Neck pain — see the section on Red flags in the CKS topic on Neck pain - non-specific.
  • Trigeminal neuralgia — see the section on Diagnosis in the CKS topic on Trigeminal neuralgia.
  • Knee pain — see the section on Red flags in the CKS topic on Knee pain - assessment.
  • Shoulder pain — see the section on Diagnosis in the CKS topic on Shoulder pain.
  • Migraine — see the CKS topic on Headache - assessment.
  • Temporomandibular disorders — see the section on Red flag symptoms and signs in the CKS topic on Temporomandibular disorders.
• Red flag features to be aware of in people with pain include:
  • Those that may suggest cancer — such as fever, sweats, chills, unexplained weight loss, older age and new onset of symptoms, history of cancer, persistent, non-mechanical bone pain, and/or pain that worsens at night or when supine.
  • Those that may suggest, or increase the risk of, infection — such as fever, sweats, chills, immunosuppression, and/or history of IV drug use. 
  • Neurological features in people with lower back pain — suggests cauda equina syndrome. 

What investigations should I arrange for a person with chronic pain?

• Investigations for people with chronic pain will be determined by history and examination findings, but may include:
  
  • Cancer screening tests.
  • Erythrocyte sedimentation rate (ESR) or C-reactive protein.
  • Full blood count.
  • Thyroid function test.
  • Ultrasound or magnetic resonance imaging (MRI) scan.
  • X-ray.

Scenario: Management

From age 16 years onwards.

Search strategy

Scope of search

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

Search dates

September 2020 - January 2025

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 Chronic Pain/

• Pain and (chronic or persistent or long term).ti,ab.

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
• Health Protection Agency
• World Health Organization
• National Guidelines Clearinghouse
• Guidelines International Network
• TRIP database
• GAIN
• NHS Scotland National Patient Pathways
• New Zealand Guidelines Group
• 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
• University of Michigan Medical School
• Michigan Quality Improvement Consortium
• Singapore Ministry of Health
• National Resource for Infection Control
• Patient UK Guideline links
• UK Ambulance Service Clinical Practice Guidelines
• 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

• Healthtalkonline
• BMJ - Patient Journeys
• Patient.co.uk - Patient Support Groups

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.