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Infections and infestations Neurological Skin and nail

Post-herpetic neuralgia

Last revised in August 2024

Post-herpetic neuralgia occurs when the pain associated with shingles becomes chronic.Symptoms include constant or intermittent stabbing or burning

Post-herpetic neuralgia: Summary

  • Post-herpetic neuralgia is defined as pain associated with shingles which persists for more than three months.
    • Symptoms can include constant or intermittent stabbing or burning pain, allodynia (pain induced by a non-painful stimulus), hyperalgesia (severe pain from a mildly painful stimulus), and intense itching.
    • The risk of post-herpetic neuralgia increases with age, presence and severity of prodromal pain, severity of acute shingles pain, and with other comorbidities.
    • There may be significant associated adverse impact on physical, social, and psychological function.
  • Symptoms can resolve after a few months, or may persist for longer. Interventions may not completely resolve the pain, but may reduce it.
  • A person with post-herpetic neuralgia should be signposted to further information, advice, and support.
  • Initial treatment with paracetamol should be offered, either alone or in combination with codeine, although these options are usually of minimal benefit on their own. Topical and systemic drugs used to treat neuropathic pain may also be prescribed, and combinations of drugs may be needed.
  • Referral to a specialist pain clinic or a relevant clinical speciality is recommended if:
    • The person has severe pain.
    • Their pain significantly limits their daily activities and participation.
    • Their underlying health condition has deteriorated.

Have I got the right topic?

From age 16 years onwards.

This CKS topic covers the management of post-herpetic neuralgia.

This CKS topic does not cover the management of Shingles (including prevention of post-herpetic neuralgia), for which there is a separate CKS topic; or other types of neuropathic pain.

There are separate CKS topics on Chickenpox, Herpes simplex - genital, Herpes simplex - ocular, Herpes simplex - oral, Neuropathic pain - drug treatment, Shingles, and Trigeminal neuralgia.

The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare.

How up-to-date is this topic?

Changes

August 2024 — minor update. Removed capsaicin cream recommendation, as this is currently unavailable. 

Previous changes

April 2022 — reviewed. A literature search was conducted in March 2022 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.

February 2022 — minor update. Links to key therapeutic topic guidance removed as service has been retired.

July 2017 — minor update. Minor typographical corrections.

February to March 2017 — reviewed. A literature search was conducted in February 2017 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of this topic. The topic has undergone restructuring. No major changes to the recommendations have been made.

March 2014 — minor update. With the exception of simple analgesics, the information on the pharmacological treatment of post-herpetic neuralgia has been removed and a link to the CKS topic on Neuropathic Pain - Drug treatment inserted. The referral node has been rewritten in line with the updated NICE guideline on the pharmacological treatment of neuropathic pain.

October 2012 to March 2013 — reviewed. A literature search was conducted in September 2012 to identify evidence-based guidelines, UK policy, systematic reviews, and key RCTs published since the last revision of the topic. Changes to clinical recommendations have been made to reflect guidance on neuropathic pain published by the National Institute for Health and Care Excellence (NICE).

August 2012 — minor update. Minor typographical error corrected.

September 2010 — the choice of drug treatment for neuropathic pain has been updated in line with the NICE clinical guideline, Neuropathic pain. The pharmacological management of neuropathic pain in adults in non-specialist settings. Issued in September 2010.

November 2009 — minor update to reflect that nonsteroidal anti-inflammatory drugs are not recommended because there is no evidence on their use in post-herpetic neuralgia. Issued in November 2009.

March 2009 — minor update to include a link to the CKS topic on Neuropathic Pain - Drug treatment. Issued in April 2009.

May to August 2008 — converted from CKS guidance to CKS topic structure. The evidence-base has been reviewed in detail, and recommendations are more clearly justified and transparently linked to the supporting evidence. This topic previously incorporated the management of shingles, for which a separate CKS topic is now available. There have been changes to the treatment recommendations.

April 2008 — minor update. Update to the text in medicines management to reflect recent MHRA advice regarding genetic testing for carbamazepine. Issued May 2008.

June 2007 — update. Gabapentin is now licensed up to a maximum dose of 3600 mg per day for the treatment of peripheral neuropathic pain. Issued in June 2007.

October 2005 — minor technical update. Issued in November 2005.

February 2005 — reviewed. Validated in June 2005 and issued in July 2005.

December 2001— reviewed and guidance renamed Shingles and postherpetic neuralgia (previously called Herpes zoster). Validated in March 2002 and issued in April 2002.

August 1998 — written.

Update

New evidence

Evidence-based guidelines

No new evidence-based guidelines since 1 April 2022.

HTAs (Health Technology Assessments)

No new HTAs since 1 April 2022.

Economic appraisals

No new economic appraisals relevant to England since 1 April 2022.

Systematic reviews and meta-analyses

No new systematic reviews or meta-analysis which reach the CKS threshold for inclusion since 1 April 2022.

Primary evidence

No new primary evidence which reaches the CKS threshold for inclusion published since 1 April 2022.

New policies

No new national policies or guidelines since 1 April 2022.

New safety alerts

No new safety alerts since 1 April 2022.

Changes in product availability

Capsaicin cream is currently unavailable. This is likely to be the case until June 2026. 

Goals and outcome measures

Goals

To support primary healthcare professionals to:

  • Make a diagnosis of post-herpetic neuralgia.
  • Prescribe medication for pain relief where appropriate.
  • Provide appropriate advice and information.
  • Arrange referral to a neurologist, or to a specialist pain service, where appropriate.

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.

Background information

What is it?

Post-herpetic neuralgia is usually described as pain in a dermatomal distribution which persists for three months or more after either onset or healing of the shingles rash [Johnson, 2014; Saguil, 2017; Gross, 2020]. It is caused by herpes zoster-induced peripheral and central neuronal damage [Schutzer-Weissmann, 2017].

How common is it?

  • The overall lifetime risk for herpes zoster (shingles) in Europe has been estimated at 23–30%. The risk in people aged 80 years and older may be as high as 50% [Johnson, 2015].
  • Post-herpetic neuralgia has been reported in 5–30% of people following herpes zoster infection, with differences in observed rates ascribed to study design, age distribution of study populations, and disease definition [Kawai, 2014]. 
  • Since the introduction of the shingles vaccine in 2013 in the UK for those aged 70–79 years, the incidence of post-herpetic neuralgia in the vaccinated cohort has decreased. A study in England evaluating the first five years of the programme suggests the vaccine is 66–75% effective in preventing post-herpetic neuralgia [Andrews, 2020].

What are the risk factors?

Risk factors for post-herpetic neuralgia include:

  • Increasing age.
  • Prodromal pain prior to acute herpes zoster attack.
  • Severe pain, the degree of spread of the rash (particularly if it extends beyond a single dermatome), severity of pain, and ophthalmic involvement during the acute attack.
  • Comorbidities such as diabetes mellitus, respiratory disease, autoimmune disease, and severe immunosuppression.

[Paisley, 2015; Forbes, 2016; Zhou, 2021]

What is the prognosis?

  • The duration of post-herpetic neuralgia is highly variable, with up to 50% of people experiencing pain for more than one year [Mick, 2013; Zorzoli, 2018].
  • Satisfactory pain relief is challenging, and may only be achieved in less than half of cases [Schutzer-Weissmann, 2017].

What are the complications?

  • The pain associated with post-herpetic neuralgia can adversely affect quality of life and physical functioning, and can cause sleep disturbance, reduced socialization, anxiety, and depression [Hadley, 2016; Schutzer-Weissmann, 2017].

Diagnosis of post-herpetic neuralgia

When should I suspect post-herpetic neuralgia?

  • Suspect post-herpetic neuralgia in a person with aching, burning, itching, lancinating, or sharp pain, unilaterally and in a dermatomal distribution. Pain may be intermittent or constant.
  • Carry out an examination, including a comparison of sensory function in the affected dermatome with that on the contralateral side. Features indicative of post-herpetic neuralgia include:
    • Deficits in thermal, tactile, pinprick, or vibration sensation within or extending beyond margins of affected dermatomes.
    • Areas of anaesthesia.
    • Hyperalgesia — excessive pain in response to noxious stimuli.
    • Allodynia — pain precipitated by non-painful stimulus such as touch or pressure.
  • In most cases, post-herpetic neuralgia is associated with a recent history of herpes zoster, with pain at the site of the previous rash. However, be aware that the person may not remember the herpes zoster rash or associate current pain with it, and post-herpetic neuralgia may rarely occur some time after resolution of an acute herpes zoster episode.

Basis for recommendation

The information on the diagnosis of post-herpetic neuralgia is based on expert opinion in narrative review articles [Johnson, 2014; Hadley, 2016].

Management

Scenario: Management

From age 16 years onwards.

How should I manage a person with post-herpetic neuralgia?

  • Offer self-management advice, including information on the nature of post-herpetic neuralgia. Patient information leaflets are available from the Shingles Support Society. Advise people with post-herpetic neuralgia they may find it helpful to:
    • Wear cotton or silk fabrics, as these may cause the least irritation.
    • Protect sensitive areas by applying a protective layer (such as a firm bandage, compression clothing, cling film, or a plastic wound dressing such as Opsite®).
    • Consider frequent application of cold packs, unless this causes pain (allodynia).
  • When deciding a treatment plan, consider:
    • The degree and nature of the pain (whether constant or intermittent, and the presence or absence of allodynia).
    • The impact of the pain on participation in daily living activities (including self-care, general tasks and demands, interpersonal interactions and relationships, mobility, and sleeping).
    • The person's mood (in particular, consider whether they have signs of depression or anxiety). For more information, see the CKS topic on Depression.
  • Offer analgesia to manage pain:
    • Be aware this cohort of patients are more likely to be elderly, with comorbidities and on other medication. Consider and discuss the potential for risks, interactions, and side effects when choosing an analgesic option.
    • Offer paracetamol with or without codeine if the person's pain is mild or moderate, and there are no contraindications. Be aware this is unlikely to be entirely effective alone, but may contribute to pain relief.
    • If pain remains uncontrolled, consider offering a drug to treat neuropathic pain, such as amitriptyline, duloxetine, gabapentin, or pregabalin, depending on local prescribing policies, and titrate the dosage according to response and tolerability. For more information on prescribing these drugs, see the CKS topic on Neuropathic pain - drug treatment.
    • Consider prescribing a topical treatment such as lidocaine plasters if pain is mild, if allodynia is a prominent feature, in older people if there are concerns about central nervous system side effects of oral medications, or as an adjunct to oral therapy if pain is severe. For more information on prescribing lidocaine plasters, see the section on Prescribing information.
    • Tramadol may be considered if acute rescue therapy is required, but should not be prescribed long term without specialist supervision.
  • Arrange early follow up to assess the progress made with dose titration, and the tolerability and effectiveness of neuropathic pain treatments. Use clinical judgement to decide how soon to follow up the person.
  • Advise the person:
    • On the importance of dosage titration, and the titration process, providing written information if possible. Explain that the treatment does not work immediately; it commonly takes weeks to titrate up to an effective dose.
    • That a daily pain diary may be useful to help people learn to manage their pain.
  • Consider referring the person for cognitive behavioural therapy, and/or to a neurologist or specialist pain service if:
    • They have severe pain.
    • Their pain significantly limits their participation in daily activities (including self care, general tasks and demands, interpersonal interactions and relationships, mobility, and sleeping).

Basis for recommendation

The recommendations on management of people with post-herpetic neuralgia are largely based on the National Institute for Health and Care Excellence (NICE) guideline Neuropathic pain in adults: pharmacological management in non-specialist settings [NICE, 2020] and Guidelines for general practitioners on treatment of pain in post-herpetic neuralgia published by the Shingles Support Society [Panickar, 2018].

Self-management advice
  • These recommendations are largely based on suggestions given by the Shingles Support Society, which are collated from patient experience. The recommendation to offer patient information leaflets is pragmatic, based on what CKS considers to be good medical practice.
Assessing pain and impact when deciding on the treatment 
  • The recommendation to consider the type of pain and whether allodynia is a prominent feature is based on evidence suggesting pain phenotype may be able to guide therapeutic choice [Schutzer-Weissmann, 2017; Forstenpointner, 2018] and on advice in Guidelines for general practitioners on treatment of pain in post-herpetic neuralgia published by the Shingles Support Society [Panickar, 2018].
  • The recommendation to assess people with post-herpetic neuralgia for social and psychological impact and signs of depression is based on the National Institute for Health and Care Excellence (NICE) guideline Neuropathic pain in adults: pharmacological management in non-specialist settings [NICE, 2020] and on expert opinion and evidence that post-herpetic neuralgia is associated with significant physical, psychological, and social impact [Schutzer-Weissmann, 2017; Zorzoli, 2018].
Use of paracetamol with or without codeine
  • The advice to offer paracetamol with or without codeine is based on expert opinion that this may be effective in the treatment of mild to moderate post-herpetic neuralgia, and that there is no evidence of benefit from non-steroidal anti-inflammatory drugs (NSAIDs) [Moore, 2015; Paisley, 2015].
Use of lidocaine plasters
  • The advice to offer lidocaine plasters either as sole or adjunctive therapy depending on the person's age, risk of side effects from oral therapies, and level of pain is based on expert opinion in narrative and systematic review articles [Schutzer-Weissmann, 2017; Gross, 2020; Voute, 2021]. Although high quality studies are lacking and evidence quality remains low for efficacy in neuropathic pain, there is evidence for some degree of pain relief, particularly where allodynia is a feature, and the low risk of side effects may allow use in situations where oral medication options are avoided.
Keeping a pain diary
  • The advice relating to keeping a pain diary is based on feedback from an expert reviewer of the CKS topic on Trigeminal neuralgia. It was suggested that keeping a pain diary may help people to feel in control, to understand how their pain responds to medication, and when they may be experiencing a remission or relapse. CKS has extrapolated this information to also apply to the management of post-herpetic neuralgia.
Early follow up
  • In the expert opinion of the NICE guideline development group, an early clinical review is important to assess the progress made with titration as well as the effectiveness and tolerability of treatment. This allows any necessary treatment adjustments to be made promptly in order to ensure optimal pain control [NICE, 2020].
  • CKS recommends using clinical judgement to decide how soon to follow up a person with neuropathic pain. This pragmatic advice is based on the fact that the urgency of a follow up will depend on several factors including the cause of neuropathic pain, severity of pain, and the complexity of the titration process.
Referral for cognitive behavioural therapy
  • NICE recommends that psychological therapies may be useful in the management of neuropathic pain [NICE, 2020]. CKS has specifically recommended cognitive behavioural therapy as this is recommended by NICE for the management of neuropathic pain associated with sciatica [NICE, 2016].

How should I follow up a person with post-herpetic neuralgia?

  • Assess the effectiveness of any treatment by asking about:
    • The degree of pain.
    • The impact of the pain on participation in daily activities (including self care, general tasks and demands, interpersonal interactions and relationships, mobility, and sleeping).
    • The person's mood (in particular, whether the person is depressed or anxious).
  • If the person is not using a neuropathic pain treatment and pain remains uncontrolled, consider prescribing a drug for neuropathic pain. For more information, see the CKS topic on Neuropathic pain - drug treatment.
  • Assess the progress made with dose titration, and the tolerability and effectiveness of any prescribed neuropathic pain treatments.
    • Ask about the current dose of the medication used, any problems they have experienced titrating the dose upwards, and confirm that they understand the titration process.
    • Ask about tolerability and adverse effects, and whether these tend to improve or persist with time following each dose increase.
  • If the treatment is poorly tolerated, use clinical judgement to decide whether to:
    • Titrate the dose more slowly upwards (especially if adverse effects incrementally worsen following each dose increase).
    • Switch to an alternative medication.
    • Refer to a specialist pain service or a neurologist.
  • If the treatment is reasonably well tolerated, continue titrating the dose upwards until either pain is well controlled or the maximum tolerated dose has been reached.
    • If pain is poorly controlled on the maximum tolerated dose, consider switching to an alternative neuropathic pain drug, adding in a further neuropathic pain drug, or referring the person to a specialist pain service or a neurologist.
    • If pain is well controlled, continue treatment. Consider gradually reducing the dose over time if the person remains pain free.
  • Consider referring the person for cognitive behavioural therapy, or to a specialist pain service or neurologist at any stage, if:
    • They have severe pain.
    • Their pain significantly limits their participation in daily activities (including self care, general tasks and demands, interpersonal interactions and relationships, mobility, and sleeping).
    • Treatment options available to primary care have been exhausted, and symptoms remain significant. Treatments which may be available from specialist pain clinics or neurologists include more specialist medications, such as the stronger capsaicin 8% patch, nerve blocks, injections or stimulation, sub-cutaneous Botulinum Toxin A injections, transcutaneous electrical nerve stimulation (TENS), and other psychological interventions.

Basis for recommendation

The recommendations on how to follow up a person with post-herpetic neuralgia are largely based on the National Institute for Health and Care Excellence (NICE) guideline Neuropathic pain in adults: pharmacological management in non-specialist settings [NICE, 2020].

Reviewing the person's pain medication if they are not yet taking a neuropathic pain drug
  • This recommendation is pragmatic, based on what CKS considers to be good medical practice.
Poorly tolerated treatment
  • CKS recommends using clinical judgement if a neuropathic pain treatment is poorly tolerated. This pragmatic advice is based on the fact that slower titration or switching drugs may reduce the risk of intolerable adverse effects for some people, whilst others may need to be referred.
Polytherapy if pain remains uncontrolled on a single neuropathic pain drug
  • In the expert opinion of the NICE guideline development group (GDG), combination therapy may be a helpful option as a stepwise approach if initially used drugs are insufficient at reducing pain. Combination therapy may also result in better tolerability because smaller doses of individual drugs are often used when combined with other drugs [NICE, 2020].
Referral for cognitive behavioural therapy
  • NICE recommends that psychological therapies may be useful in the management of neuropathic pain. CKS has specifically recommended cognitive behavioural therapy as this is recommended by NICE for the management of neuropathic pain associated with sciatica [NICE, 2016].

Prescribing information

Important aspects of prescribing information relevant to primary healthcare are covered in this section specifically for the drugs recommended in this CKS topic. For further information on contraindications, cautions, drug interactions, and adverse effects, see the electronic Medicines Compendium (eMC), or the British National Formulary (BNF).

Neuropathic pain treatments

For detailed prescribing information on amitriptyline, capsaicin cream, duloxetine, gabapentin, pregabalin, and tramadol, please see the CKS topic on Neuropathic pain - drug treatment. Note that since 1 April 2019, pregabalin and gabapentin are controlled under the Misuse of Drugs Act 1971 as Class C substances and scheduled under the Misuse of Drugs Regulations 2001 as Schedule 3. Patients should be evaluated carefully for a history of drug abuse before prescribing pregabalin and gabapentin and observed for development of signs of abuse and dependence [MHRA, 2019].

Paracetamol and codeine

For detailed prescribing information on paracetamol and codeine, please see the CKS topic on Analgesia - mild-to-moderate pain.

Lidocaine plasters

Dose

  • The painful area should be covered with a plaster once daily for up to 12 hours within a 24 hour period. Only the number of plasters that are needed for effective treatment should be used.
    • When needed, the plasters may be cut into smaller sizes with scissors prior to removal of the release liner.
    • No more than three plasters should be used at the same time.
  • Each plaster must be worn for no longer than 12 hours. The subsequent plaster-free interval must be at least 12 hours.
  • Treatment outcome should be re-evaluated after 2–4 weeks. If there has been no response after this period, treatment must be discontinued as potential risks may outweigh benefits.
    • Long-term use in clinical studies showed that the number of plasters used decreased over time. Therefore treatment should be reassessed at regular intervals to decide whether the amount of plasters needed to cover the painful area can be reduced, or if the plaster-free period can be extended.

[ABPI, 2021a; ABPI, 2021b]

Adverse effects

The most common adverse effects of lidocaine plasters are application site reactions, including burning, dermatitis, erythema, pruritus, rash, skin irritation, and vesicles.

[ABPI, 2021a; ABPI, 2021b]

Contraindications and cautions

  • Do not prescribe lidocaine plasters to people with known hypersensitivity to other local anaesthetics of the amide type, for example, bupivacaine, etidocaine, mepivacaine, and prilocaine.
    • The plaster must not be applied to inflamed or injured skin, such as active herpes zoster lesions, atopic dermatitis, or wounds.
  • Prescribe lidocaine plasters with caution to people with severe cardiac, renal, or hepatic impairment.

[ABPI, 2021a; ABPI, 2021b]

Drug interactions

  • No clinically relevant interactions have been observed in clinical studies with lidocaine plasters.
  • The manufacturer states that since the maximum lidocaine plasma concentrations observed in clinical trials with the plaster were low, clinically relevant pharmacokinetic interactions are unlikely.

[ABPI, 2021a; ABPI, 2021b]

Supporting evidence

This CKS topic is largely based on the National Institute of Health and Care Excellence guideline Neuropathic pain in adults: pharmacological management in non-specialist settings [NICE, 2020], the Shingles Support Society Guidelines for general practitioners on treatment of pain in post-herpetic neuralgia [Panickar, 2018], and from information in narrative review articles [Johnson, 2014; Hadley, 2016; Schutzer-Weissmann, 2017]. The recommendations relevant to primary care were developed from the expert opinion of the guideline development group and authors of these reviews, following narrative reviews of the evidence, where available. The evidence for specialist management strategies is not discussed as they are beyond the scope of this CKS topic.

How this topic was developed

This section briefly describes the processes used in developing and updating this topic. Further details on the full process can be found in the About Us section and on the Clarity Informatics website.

Search strategy

A literature search was conducted for guidelines, systematic reviews and randomized controlled trials on primary care management of post-herpetic neuralgia since the last update.

Search dates

January 2017 - March 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 Neuralgia/ exp Neuralgia, Postherpetic/, exp Herpes Zoster/, herpes zoster.tw, shingles.tw, postherpetic itch.tw

Sources of guidelines

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

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

Sources of national policy

Patient experiences

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.

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.

References

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