Changes

August 2026 — minor update. Removed the recommendations on psychological therapy for low back pain with or without sciatica, and combined physical and psychological programmes, in line with the update to NICE guideline Low back pain and sciatica in over 16s: assessment and management.

Update

Goals

To support primary healthcare professionals to:

• Be aware of when to suspect sciatica, and to identify and manage potentially serious alternative causes of back pain.
• Provide symptomatic relief.
• Provide appropriate advice and information.
• Arrange referral for exercise therapy, physiotherapy, cognitive behavioural therapy, or to a specialist low back pain and sciatica service for assessment for surgical options, where appropriate.

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

Low back pain and sciatica in over 16s

• Primary care services have an approach to risk stratification for young people and adults presenting with a new episode of low back pain with or without sciatica.
• Young people and adults with low back pain with or without sciatica do not have imaging requested by a non-specialist service unless a serious underlying pathology is suspected.
• Young people and adults with low back pain with or without sciatica are given advice and information to self-manage their condition.
• Young people and adults are not given paracetamol alone, anticonvulsants or antidepressants to treat low back pain without sciatica.
• Young people and adults are not given opioids to treat chronic low back pain without sciatica.
• Young people and adults do not have spinal injections for low back pain without sciatica with the exception of radiofrequency denervation for people who meet the criteria.

[NICE, 2017]

What is it?

• Sciatica describes radiating leg pain caused by inflammation or compression of the lumbosacral nerve roots (usually L4–S1) forming the sciatic nerve.
• The pain can have a sudden or slow onset and vary in severity. It is felt in the back or buttocks and radiates down the leg below the knee into the foot and toes in the distribution of the sciatic nerve.
  • Other symptoms which may be associated include tingling or numbness and loss of muscle strength in the same leg. 
• The term 'sciatica' is not clearly defined and is used inconsistently. It tends to encompass a range of conditions originating in the spine, including radicular pain (pain in a nerve root distribution) and painful radiculopathy (when the involvement of the nerve root causes neurological deficit, such as weakness or numbness). Radicular pain may occur with or without radiculopathy, and radiculopathy may be associated with radicular pain or may be pain-free.
  • A working group commissioned by the Neuropathic Pain Special Interest Group (NeuPSIG) of the International Association for the Study of Pain (IASP) has recommended the use of the term 'spine-related leg pain' as an umbrella term to include radicular pain with and without radiculopathy (nerve-related pain) as well as somatic-referred pain.
    • The paper points out that the sciatic nerve is typically not affected as the cause is compression/irritation of the higher nerve roots, which are anatomically prior to the formation of the sciatic nerve itself. It does, however, acknowledge that the term 'sciatica' is likely to be retained due to its historical hold.
  • The guideline from the National Institute for Health and Care Excellence (NICE) on low back pain and sciatica acknowledges that it uses the term 'sciatica' to describe leg pain secondary to lumbosacral nerve root pathology rather than the terms 'radicular pain' or 'radiculopathy' even though these are more accurate. It states this is because 'sciatica' is a term that patients and clinicians understand, and because of its wide use in the literature to describe neuropathic leg pain secondary to compressive spinal pathology.

[Jensen, 2019; NICE, 2020; Schmid, 2023]

How common is it?

• Studies report widely varying estimates of the prevalence of sciatica due to differences in the definitions of sciatica, data collection methods, and the populations studied.
  • Lifetime prevalence — the proportion of people who experience sciatica at some point during their lifetime ranges from 1.2–43%.
  • Period prevalence — the proportion of people who are diagnosed with sciatica over a year ranges from 2–34%.
  • Point prevalence — the proportion of people with self-reported radiating leg pain ranges from 2–13%.
• It is estimated that about 5–10% of people with non-specific low back pain also have sciatica. 
• The incidence of sciatica is related to age, peaking in the 5th decade before declining. Sciatica is rarely seen in people aged under 20 years.

[Koes, 2007; Konstantinou, 2008; NICE, 2020; Schmid, 2023]

What are the causes?

• Sciatica is caused by compression or irritation of one or more nerve roots in the lumbosacral spine. The compression can be caused by:
  • A herniated intervertebral disc ('slipped disc') — about 90% of cases. This most commonly occurs at the L5/S1 level.
    • The most common cause is age-related degenerative changes, but, rarely, it can be caused by trauma. 
  • Spondylolisthesis — when a proximal vertebra moves forward relative to a distal vertebra.
  • Spinal stenosis — narrowing of the central and/or lateral spinal canals (typically causes pain, which is relieved by sitting and forward flexion and exacerbated with standing and lumbar extension).
    • Causes of spinal stenosis include congenital stenosis and spondylolisthesis.
    • It is usually due to degenerative thinning and bulging of discs and thickening of bone and ligaments. 
    • Less commonly, soft tissue stenosis is caused by cysts, tumours, or extraspinal pathology.
  • Infection (rare) — for example, discitis, vertebral osteomyelitis, or spinal epidural abscess. 
  • Cancer (rare) — more often due to metastatic disease of the spine than a primary tumour.
    • Breast, prostate, and lung cancer are most commonly the cause of metastatic bone disease, and the spine is the most common site of bone metastasis.

[Koes, 2007; Henschke, 2013; Lurie, 2016; Jensen, 2019; Van den Brande, 2022]

What are the complications?

• Complications of sciatica can include:
  • Chronicity, which may include persisting pain, progressive and/or permanent nerve damage, and persistent muscle weakness.
  • Poor quality of life.
  • Disability and increased use of health resources.
  • Time off work, reduced productivity, and loss of employment.

[Konstantinou, 2013; Jensen, 2019; NICE, 2020; Fairag, 2022]

What are the risk factors?

• Modifiable factors which may be associated with a first onset of sciatica include: 
  • Smoking. 
  • Overweight and obesity. 
  • Occupational factors.
    
    • Whole body vibration — for example, due to driving or operating machinery. 
    • Strenuous physical activity — for example, manual labour with frequent heavy lifting, especially while bending and twisting.
  • Physical inactivity.
  • Multimorbidity (presence of two or more chronic diseases). 
• Other risk factors include: 
  • Older age — peak incidence is in people aged 45–64 years.
    • A 15-year longitudinal study in Finland found that the odds of experiencing sciatica more than doubled between the ages of 31 and 46 years.
    • Radiographic evidence of disc degeneration commences as early as the third decade of life. 
  • Genetic factors — may be involved through influence on spinal anatomy, disc degeneration, inflammatory response and pain perception.
  • Social class — lower education or lower socioeconomic class is associated with a higher risk.

[Koes, 2007; Cook, 2014; Jensen, 2019; Fairag, 2022; Anttila, 2024]

What is the prognosis?

• Studies aiming to determine prognosis and prognostic factors for sciatica vary widely, probably due to the lack of consensus on definition, and variations in methodology and study populations.
  • Few studies are based in primary care, where most patients are managed, and most relate to low back pain with or without leg pain, thus mixing prognosis information with that of non-specific back pain alone [Konstantinou, 2018]. Outcomes for people with associated leg pain are worse than those for people with back pain alone [Konstantinou, 2013].
• Although prognosis is generally quoted to be good, recent evidence, such as it is, does not necessarily support this belief.
  • In a UK primary care-based prospective cohort study of people with back-related leg pain (n = 609), 55% of people with lower back pain and sciatica reported a 30% or more improvement in disability at 12 months [Konstantinou, 2018].
    • Factors associated with improvement in disability in people with sciatica were shorter pain duration, fewer other symptoms associated with the back and leg pain (lower identity score), the person's belief that the problem will be short-lived, and initially having myotomal weakness. 
  • Another UK primary care-based study of patients treated conservatively for low back pain with and without leg pain (n = 782 for those with leg pain), 34% experienced very or extremely bothersome symptoms at 6 months follow up [Hill, 2011].
  • In a 5-year follow up of a Dutch randomized controlled trial (n = 231), 8% of people with sciatica showed no recovery, and 23% reported ongoing symptoms that fluctuated over time [Lequin, 2013].
  • A 2016 systematic review of 39 cohort studies (n = 13,883) concluded that people with sciatica treated surgically experienced a rapid reduction in pain and disability in the first 3 months after surgery, but still had mild to moderate symptoms 5 years later [Machado, 2016].
  • A 2020 Cochrane review of epidural corticosteroid injections for lumbosacral radicular pain concluded there was evidence of only slight improvement in pain and disability at short-term follow up [Oliveira, 2020].
  • A 2023 systematic review and meta-analysis of surgical versus non-surgical treatment for sciatica also found little evidence of long-term benefit to surgery, and found the trials of non-surgical treatments to be heterogeneous and evidence for long-term benefit scarce [Liu, 2023].
• Severity and duration of symptoms, radiological findings, or patient characteristics do not consistently predict recovery of pain and function with conservative management [Ashworth, 2011]. 
• A systematic review of seven studies (n = 1408), which reviewed prognostic factors for work participation in people with sciatica who received conservative or surgical treatment for clinically diagnosed sciatica, found moderate to very low-quality evidence for a wide range of factors to predict return to work. Favourable factors for return to work included younger age; better general health; lower level of low back pain or sciatica bothersomeness; better physical function; negative straight leg raise test; physician expecting surgery to be beneficial; better pain coping; lower levels of depression and psychological distress; less fear of movement; and low physical workload [Oosterhuis, 2019].  

When should I suspect sciatica?

• Suspect sciatica in people with relevant signs and symptoms, including:
  • Unilateral leg pain radiating below the knee to the foot or toes. 
    • Pain may be worsened with flexion of the lumbar spine, twisting, bending or coughing.
    • Pain may be described as burning, sharp, stabbing or shooting, and may be associated with heavy or tight sensations.
  • Low back pain — if present, which is less severe than any leg pain. 
  • Numbness, tingling (paraesthesia) in the distribution of a nerve root (dermatome).
  • Weakness or reflex changes, or both in a myotomal distribution. 
  • A positive result in a straight leg raise test. With the person lying supine, the hip is flexed gradually with the knee extended. Pain reproduced below 60 degrees of hip flexion on the ipsilateral side indicates a positive test.

How should I assess a person with suspected sciatica?

• Take a medical history.
  • Ask about:
    • Pain symptoms — onset, duration, location, radiation, character, progression, severity, aggravating and alleviating factors (for example, postural changes).
    • Neurological symptoms, including numbness, weakness, impaired sensation of urinary flow or rectal fullness, or altered perianal, perineal or genital sensation. 
    • Other symptoms (for example, urinary retention).
    • A history of back pain or sciatica and any previous treatments. 
    • A history of malignancy.
    • Recent trauma.
    • Comorbidities and current medication. 
    • The person's occupation and work activities (if relevant).
    • The impact of symptoms on sleep, family, activity, and work. 
    • Risk factors for sciatica.
  • Conduct a psychosocial assessment for modifiable risk factors for recovery. Consider using the STarT Back Tool to inform shared decision-making about stratified management. 
    • The STarT Back Screening Tool is a nine item questionnaire designed to be used in primary care. It generates an overall score and psychosocial sub-score that divides people into low, medium, and high risk of persistent back pain-related disability. Quality of life, pain severity, function, and psychological distress are the most important factors to guide the person's management.
    • People with sciatica who are likely to improve quickly generally need less intensive support, while people at higher risk of a poor outcome may require more complex and intensive support. 
• Examine the person.
  • Conduct a focused musculoskeletal and neurological examination:
    • Observe the spine for deformity and abnormal curvatures and palpate to localize any tenderness and detect any abnormalities.
    • Observe gait, ability to walk, and pain behaviour. A high-stepping gait with an inability to lift the foot when walking may suggest weakness of the muscles required for ankle dorsiflexion.
    • Assess the passive and active range of motion — from a standing position, ask the person to actively flex, extend, and laterally bend as far as they can. Pain on flexion that radiates to the leg suggests disc herniation with impingement on a nerve root; pain on extension can suggest either facet arthropathy or spinal stenosis.
    • Examine the hips and assess passive range of motion with the person lying supine — there should be normally 130 degrees of flexion, extension to 15 degrees beyond neutral, and approximately 45 degrees of internal and external rotation. Pain in any of these motions suggests hip pathology.
    • Assess for neurological signs — numbness, paraesthesia, muscle weakness, or loss of tendon reflexes in the distribution of usually a single nerve root.
      • Perform a straight leg raising test — with the person lying supine, flex the hip gradually with the knee extended. The test is positive if pain is reproduced below 60 degrees of hip flexion on the ipsilateral side.
    • Other assessments to consider include:
      • Extensor plantar response — Babinski's sign is positive if the toes extend and fan outwards when the lateral part of the sole of the foot is stimulated, which may indicate an upper motor neuron lesion.
      • Femoral stretch or contralateral femoral stretch test — to assess for upper lumbar disc herniation. With the patient prone, flex the knee and extend the leg. The test is positive if it reproduces the leg pain. 
  • Perform a general physical examination if appropriate (depending on history and initial examination). 
• Assess for the presence of red flag symptoms and signs that may suggest a serious underlying cause.
• Consider possible differential diagnoses. 
• Investigations are not usually required unless there is diagnostic uncertainty or a serious underlying cause is suspected.
  • Do not routinely offer imaging to confirm the diagnosis. 
  • Consider appropriate investigations if infection, malignancy, or inflammatory conditions are suspected — this may include full blood count, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), or urinalysis and culture depending on the suspected cause.   

Red flag symptoms and signs

Red flags in isolation may not be diagnostic or informative, but where present, raise suspicion of serious pathology. Red flags for people with sciatica include: 

• Bowel/bladder dysfunction.
• Progressive neurological weakness. 
• Saddle anaesthesia.
• Sudden onset of bilateral radicular leg pain/radiculopathy or unilateral radicular pain progressing to bilateral pain. 
• Suspected spinal infection.
• New significant motor loss (less than 3/5 Medical Research Council [MRC] grade, meaning unable to move the examined foot or leg against resistance or gravity, or no muscle movement or contraction).
• History of cancer with new onset of spinal pain. 
• Recent unexplained weight loss.
• Immunosuppression (use of steroids, chemotherapy or intravenous drugs, HIV and AIDS).
• Known osteoporosis with new spinal pain. 
• History of trauma.
• Objectively unwell with spinal pain.
• Incapacitating pain.
• Unrelenting night pain.

Serious conditions with signs and symptoms that may overlap with sciatica include:

• Cauda equina syndrome (CES). Although no single symptom or combination of symptoms has good diagnostic accuracy, red flags include: 
  • Sudden onset of bilateral radicular pain or unilateral radicular pain progressing to bilateral pain.  
    • Note: this is not by itself a feature of CES but can be a warning that CES may occur. 
  • Severe or progressive bilateral neurological deficit of the legs, such as major motor weakness with knee extension, ankle eversion, or foot dorsiflexion. 
  • Gait disturbance or difficulty walking. 
  • Difficulty initiating micturition or impaired sensation of urinary flow, if untreated, this may lead to irreversible urinary retention with overflow urinary incontinence. (Urinary incontinence without impaired sensation of urinary flow and/or saddle anaesthesia is likely to be due to other causes such as infection or stress/urge incontinence.)
  • Loss of sensation of rectal fullness; if untreated, this may lead to irreversible faecal incontinence. 
  • Perianal, perineal, or genital sensory loss (saddle anaesthesia or paraesthesia).
  • Sexual dysfunction (erectile dysfunction, loss of ability to ejaculate, loss of genital sensation). 
• Spinal fracture. Evidence is weak for most red flags being informative in screening for fracture, and they may be more useful in combination. Red flags to consider include:
  • Older age, women over 65 years and men over 75 years.
  • History of osteoporosis or history of osteoporotic or low-impact spinal fracture.
  • Prolonged steroid use.
  • Major trauma at any age (such as a road traffic collision or fall from a height), mild trauma in people aged over 74 years, or with prolonged corticosteroid use or history of osteoporosis. 
  • Structural deformity of the spine (such as a step from one vertebra to an adjacent vertebra) may be present. 
  • Contusion or abrasion.
  • There may be point tenderness over a vertebral body. 
  • History of cancer, particularly of the breast, prostate, lung, kidney or thyroid.
• Cancer. Red flags suggesting spinal metastasis include:
  • Age over 60 years or under 15 years with first ever episode of back pain. 
  • Gradual onset of symptoms or progressive pain.
  • Severe unremitting pain that remains when the person is supine or at rest, aching night pain that prevents or disturbs sleep, pain aggravated by straining (for example, at stool, or when coughing or sneezing), and thoracic pain.
  • Mechanical pain (aggravated by standing, sitting or moving). 
  • Localized spinal tenderness.
  • Claudication (muscle pain or cramping in the legs when walking or exercising). 
  • No symptomatic improvement with therapy. 
  • Unexplained weight loss.
  • History of cancer or suspected diagnosis of cancer — breast, lung, gastrointestinal, prostate, renal, and thyroid cancers are more likely to metastasize to the spine.
• Infection (such as discitis, vertebral osteomyelitis, or spinal epidural abscess). Red flags include:
  • Fever. 
  • History of tuberculosis or exposure to it, or recent urinary tract infection.
  • Diabetes mellitus.
  • History of intravenous drug use. 
  • Immunosuppression.
  • Recent spinal surgery.
  • Pain at rest. 
  • Unexplained weight loss.
  • Raised inflammatory markers. 

What else might it be?

Setting out differential diagnoses for sciatica is dependent on the definition used, which is not consistent in the literature or in everyday use. Assuming, however, that 'sciatica' refers to nerve-related pain (radicular) and/or dysfunction (radiculopathy) in the distribution of the sciatic nerve caused by nerve root pathology, then the differential diagnostic process involves:

• Ruling out serious spinal pathologies: Cauda equina syndrome, cancer, infection, vertebral fracture. See Red flags symptoms and signs.
• Differentiating between sciatic pain from nerve root compression or irritation (sciatica) and:
  
  • Sciatic pain from pathology at other points along the path of the sciatic nerve (extra-spinal sciatica).
  • Other conditions which may cause pain in the leg similar to sciatica.
  • Referred pain.

Using this scheme, other conditions which may cause leg pain, which could be confused with sciatica, include:

• Extra-spinal sciatica
  • Piriformis syndrome (the sciatic nerve is compressed or irritated where it is covered by the piriformis muscle). Also called deep gluteal syndrome or pyramidal syndrome. There is no or minimal associated back pain, the pain is felt primarily in the buttocks and hips, and is worse on sitting.
  • Pain caused by entrapment or inflammation within the pelvis (tumours, inflammation, infection).
  • Wallet neuritis — pressure from outside the body on the sciatic nerve.
  • Sacro-iliac joint pathology.
  • Post-injection sciatica  — A complication of intramuscular injection into the buttock.
  • Sciatic nerve tumour.
  • Trauma (such as fractures).
  • Pregnancy.
• Other conditions which may mimic sciatica
  • Peripheral arterial disease. Pain in the lower leg on walking, relieved by rest (intermittent claudication) — for more information, see the CKS topic on Peripheral arterial disease. 
  • Meralgia paraesthetica. A numbness, tingling or burning pain in the anterolateral thigh area, due to compression of the lateral cutaneous nerve.
  • Peroneal neuropathy — caused by damage to the peroneal nerve behind the knee, may lead to lower leg numbness, tingling, pain, or weakness, causing foot drop.
  • Osteoarthritis or other pathology of the hip, such as avascular necrosis and greater trochanteric pain syndrome — for more information, see the CKS topics on Greater trochanteric pain syndrome and  Osteoarthritis.
  • Pathology of the sacro-iliac joint, such as inflammatory sacro-iliitis.
  • Myo-fascial pain syndrome — deep muscular pain with tight, tender muscular trigger points on examination.
  • Inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis — for more information, see the CKS topics on Rheumatoid arthritis and Ankylosing spondylitis.
  • Sensory neuropathy, due to a number of causes, such as diabetes mellitus, Vitamin B12 and other nutritional deficiencies, paraproteinaemias, alcohol misuse, infection, and side effects of medication. This presents with numbness and paraesthesia (burning, tingling, pins and needles or electric shock sensations). For more information, see the CKS topic on Sensory neuropathy.
  • Shingles. Pain may precede the typical rash  — for more information, see the CKS topic on Shingles.
• Somatic-referred pain. 
  • This is pain due to stimulation of nerve endings in somatic structures such as discs, facet joints, muscles, tendons, ligaments, fascia and bones.
  • Typically, pain in the back is worse than the leg, pain is described as a dull ache, pressing or gnawing pain, and is poorly localised. 
  • Usually, pain is in the gluteal area or thigh and only occasionally in the lower leg.
  • Tests such as the straight leg raise are negative, and the pain is not dermatomal in distribution.
• Visceral referred pain.
  • Pain referred from internal organs, for example, due to inflammatory bowel conditions, kidney stones, and pelvic inflammatory disease. or inflammation of the bladder or uterus.
  • Pain may be referred to the leg, particularly the gluteal or groin areas.
  • Usually accompanied by systemic signs or symptoms and local pain in the area of origin.
• Note: Some of these conditions may overlap with the categories above and may cause leg pain through more than one mechanism.

Scenario: Management

From age 16 years onwards.

Nonsteroidal anti-inflammatory drugs (NSAIDs)

For detailed information on prescribing a nonsteroidal anti-inflammatory drug (NSAID), see the CKS topics on Analgesia - mild-to-moderate pain and NSAIDs - prescribing issues.

Search strategy

Scope of search

A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of Sciatica (lumbar radiculopathy).

Search dates

October 2021 - June 2026

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 sciatica/, radiculopathy/, spinal nerve roots/, sciatic nerve/, intervertebral disk displacement/, sciatica.tw, radiculopathy.tw, herniated dis$.tw.
• Exp cognitive behavioural therapy/ or cbt.ti,ab.
• Exp Physical therapy modalities/ or physiotherapy$.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
• 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.
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• 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.

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• 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).
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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.