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Gastrointestinal

Pilonidal sinus disease

Last revised in March 2024

Pilonidal sinus disease is a skin disorder usually found in the midline of the natal cleft.

Pilonidal sinus disease: Summary

  • Pilonidal sinus disease is an inflammatory condition of the skin and subcutaneous tissue. It usually occurs in the midline of the natal cleft but has been reported in other body parts, such as the scalp, axilla, groin, and between the fingers.
  • Opinions differ on how pilonidal sinus disease develops. The current consensus is that it is an acquired condition in which loose hairs in the natal cleft are driven into the natal skin, creating a small midline pit into which more hairs, dead skin, and other debris enter. Chronic inflammation results in the formation of an epithelialized sinus tract, which may become infected. 
  • Risk factors for pilonidal sinus disease include male gender, age 15–30 years, poor hygiene, hirsutism, and obesity.
  • Complications of pilonidal sinus disease include cellulitis, sepsis, chronic or recurrent infection, chronic pain, and altered body image and self-esteem.
  • Pilonidal sinus disease may be asymptomatic or present as an acute abscess, chronic discharging sinus(es), or recurrent disease.
  • The diagnosis of pilonidal sinus disease is usually made clinically based on characteristic findings, including a midline pit in the natal cleft.
  • Investigations may be considered if there is doubt about the diagnosis or to exclude differential diagnoses, such as Crohn's disease and infectious processes (such as tuberculosis and syphilis). 
  • For all people with pilonidal sinus disease, advice should be given on measures that may reduce the risk of recurrence, including meticulous perianal hygiene (with regular baths or showers) and buttock hair removal.
  • The need for further management will depend on the disease manifestation and extent:
    • If the person is asymptomatic, a watch-and-wait approach should be advised, with reassurance that treatment is not necessary.
    • If the person has an acute pilonidal abscess, an urgent same-day referral for incision and drainage should be arranged.
    • If the person has chronic pilonidal sinus disease, referral for surgical treatment should be arranged, with urgency dependent on clinical judgement.
 

Have I got the right topic?

From age 16 years onwards.

This CKS topic covers the primary care management of people with pilonidal sinus disease in the natal cleft.

This CKS topic does not cover secondary care interventions for pilonidal sinus disease or the management of pilonidal sinus disease involving other parts of the body, such as the scalp, axilla, groin, and between the fingers.

There are separate CKS topics on Boils, carbuncles, and staphylococcal carriage and Cellulitis - acute.

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

March 2024 — reviewed. A literature search was conducted in February 2024 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 clinical recommendations have been made, but the topic has been restructured.

Previous changes

March 2019 — reviewed. A literature search was conducted in March 2019 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 clinical recommendations have been made.

October 2018 — minor update. The section on the adverse effects of metronidazole has been updated. 

July 2015 — minor update. The information on the concurrent use of clarithromycin or erythromycin with statins has been clarified.

July to October 2014 — this is a new CKS topic. The evidence base has been reviewed in detail, and recommendations are clearly justified and transparently linked to the supporting evidence.

Update

New evidence

Evidence-based guidelines

No new evidence-based guidelines since 1 March 2024.

HTAs (Health Technology Assessments)

No new HTAs since 1 March 2024.

Economic appraisals

No new economic appraisals relevant to England since 1 March 2024.

Systematic reviews and meta-analyses

No new systematic reviews or meta-analysis which reach the CKS threshold for inclusion since 1 March 2024.

Primary evidence

No new primary evidence which reaches the CKS threshold for inclusion published since 1 March 2024.

New policies

No new national policies or guidelines since 1 March 2024.

New safety alerts

No new safety alerts since 1 March 2024.

Changes in product availability

No changes in product availability since 1 March 2024.

Goals and outcome measures

Goals

To support primary healthcare professionals to:

  • Assess a person with suspected pilonidal sinus disease.
  • Make a diagnosis of pilonidal sinus disease.
  • Offer appropriate information and advice. 
  • Refer to secondary care 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?

  • Pilonidal sinus disease is an inflammatory condition of the skin and subcutaneous tissue. It usually occurs in the midline of the natal cleft but has been reported in other body parts, such as the scalp, axilla, groin, and between the fingers.
  • The term 'pilonidal' originates from the Latin words 'pilo' (hair) and 'nidus' (nest), implying that the condition is related to a collection of hair.

[Choy, 2019; Harries, 2019; Johnson, 2019; BMJ Best Practice, 2020; Seow-Choen, 2022]

What is the cause?

  • The cause of pilonidal disease is not completely understood. It was initially considered a congenital condition, but current consensus supports an acquired aetiology. 
    • One theory is that it is caused by loose hair in the natal cleft.
      • The hair is driven into the midline of the natal skin by a rolling action of the buttocks.
      • A foreign body-type reaction follows, resulting in a small midline pit into which more hairs, dead skin, and other debris enter.
      • Chronic inflammation leads to the formation of an epithelialized sinus tract, which leads to a deep subcutaneous cavity lined with granulation tissue and usually containing a nest of hairs.
      • Secondary tracts may form lateral to the primary pit, with multiple complex sinuses leading to secondary sinus openings.
      • Chronic discharge usually occurs from the pit (rare) or the secondary openings.
      • Infection may result in abscess formation.
    • Alternative pathophysiological theories unrelated to stray-hair insertion do not adequately explain the few reported cases of pilonidal sinus disease involving other body parts, such as the scalp, axilla, groin, or between the fingers.

[Khanna, 2011; Varnalidis, 2014; Kober, 2018; Kuckelman, 2018; Iesalnieks, 2019; Johnson, 2019; Pyon, 2022]

What are the risk factors?

  • Risk factors for pilonidal sinus disease include [Destek, 2017; Cevik, 2018] [Kober, 2018] [Choy, 2019] [BMJ Best Practice, 2020] [Mahmood, 2020] [Seow-Choen, 2022]:
    • Male gender (2–4 times more common in men than women). 
    • Age (more common in people aged 15–30).
    • Being Caucasian (due to hair characteristics and growth patterns).
    • Higher body mass index (BMI).
    • Hirsutism.
    • Coarse hair.
    • Deep natal cleft.
    • Poor hygiene.
    • Lifestyle or occupation that involves sitting for prolonged periods (more than 6 hours a day).
    • Repetitive trauma to the sacrococcygeal region.
    • Family history of pilonidal sinus disease.
  • Pilonidal sinus disease often recurs after surgery. Risk factors for recurrence include [Kanlioz, 2021]:
    • High BMI.
    • Family history of pilonidal sinus disease.
    • Having fewer baths per week.
    • Hair overgrowth.
    • Dark skin colour.
    • Oily skin.
    • Sitting for prolonged periods.
    • Smoking.
    • Presence of active infection or abscess(es) before treatment.
    • Duration of symptoms (the sooner treatment is implemented after the onset of symptoms, the lower the recurrence rate).
    • Type of surgical treatment. 

How common is it?

What are the complications?

  • Possible complications of pilonidal sinus disease include [Kober, 2018; Harries, 2019]:
    • Cellulitis.
    • Sepsis.
    • Chronic pain.
    • Chronic non-healing wounds.
    • Chronic or recurrent infection/abscesses.
  • Malignant transformation is a rare complication of pilonidal sinus disease, occurring in about 0.1% of people with recurrent and complex disease [Michalopoulos, 2017] [Pyon, 2022].
    • Squamous cell carcinoma is the most common carcinoma associated with chronic pilonidal sinus disease (90% of cases) [Pyon, 2022].
    • Basal cell carcinomas, adenocarcinomas, and verrucous carcinomas have also been reported.
    • Malignant transformation should be suspected in chronic pilonidal sinus disease with recurrent episodes of inflammation, repeated purulent discharge, poor healing, and chronic complex fistulas. 
  • Pilonidal sinus disease can negatively affect a person's quality of life and psychological well-being [Stewart, 2012; Harries, 2019; Young, 2019]. 
    • It can impact the person's education or work, relationships, and self-esteem, with the complications of surgery (such as infection and poor wound healing) causing more problems than the primary disease [Harries, 2019].
    • The person may suffer for many years with cycles of healing and recurrence, which can significantly impact their lifestyle [Young, 2019].
    • Complications of pilonidal sinus disease are a considerable cause of morbidity, resulting in loss of productivity in otherwise healthy people [Kober, 2018].

What is the prognosis?

  • Pilonidal sinus disease is rarely self-limiting, and surgery is the mainstay of treatment. However, the disease often recurs after surgery, and wound complications are common [Beal, 2019]. 
    • A retrospective study (n = 609) analyzed the factors leading to the occurrence of pilonidal sinus disease and its recurrence after treatment [Kanlioz, 2021]:
      • The significant factors causing recurrence included high body mass index, smoking, and type of treatment (Limberg flap repair [LFR] was the most successful treatment method, followed by Karydakis flap repair [KFR]).
      • Recurrence rates were 27% in the first 6 months, 58% in the first 12 months, 76% in the first 18 months, and 79% in the first 24 months.
      • The mean recurrence period was about 16 months.
      • The treatment method with the longest duration between treatment and relapse was LFR, followed by KFR.
      • The method with the highest likelihood of recurrence was phenol therapy in women and midline primary closure in men.
      • Of the recurrences, 78.2% of people experienced one recurrence, 19.2% of people experienced two recurrences, and 2.6% of people experienced three or more recurrences.
  • Pilonidal sinus disease is generally benign, with rare reports of malignant transformation [Pyon, 2022].
  • The disease often dissipates after the fourth decade of life [Choy, 2019] and is uncommon after the age of 40 [Destek, 2017; Kober, 2018].

Diagnosis of pilonidal sinus disease

How should I assess a person with suspected pilonidal sinus disease?

  • Take a history. 
    • Ask about the symptoms experienced, including onset, duration, and severity.
      • Pilonidal sinus disease may be asymptomatic or present as an acute abscess, chronic discharging sinus(es), or recurrent disease.
      • Most people present with the onset of symptoms, usually pain and discharge.
      • Occasionally, a person may present with a painless lump or swelling discovered incidentally (for example, whilst washing).
    • Ask about previous episodes of pilonidal sinus disease, including treatments received.
      • There may be a history of prior treatment of pilonidal sinus disease, as the disease is frequently recurrent.
      • A previous history consistent with an abscess that ruptured spontaneously (or had been drained in hospital) is also common. 
    • Identify risk factors for pilonidal sinus disease, such as family history and occupations that involve prolonged sitting. 
  • Examine the person. 
    • Look for signs of pilonidal sinus disease. 
      • Asymptomatic pilonidal sinus disease is characterized by one or more non-tender pits in the midline of the natal cleft, which may have emergent hair. 
      • An acute pilonidal abscess is characterized by a painful, tender lump in or near the natal cleft, which may be fluctuant and have purulent discharge. Fever and/or cellulitis may be present. The primary midline pit(s) may be masked by inflammation and swelling.
      • Chronic pilonidal sinus disease is characterized by one or more secondary sinus openings lateral to the primary pit. Serous or purulent discharge usually occurs from the pit (rare) or the secondary openings. Maceration of the natal skin is common due to chronic irritation caused by the sinus discharge. There may be marked scarring from previous failed interventions. 
    • Consider differential diagnoses, such as hidradenitis suppurative. 
      • Consider the need for a digital rectal examination.
  • The diagnosis of pilonidal sinus disease is usually made clinically based on characteristic findings, including a midline pit in the natal cleft.
    • Investigations are not routinely required but may be considered if there is doubt about the diagnosis or to exclude a differential diagnosis.

Basis for recommendation

These recommendations are based on The Treatment of Pilonidal Disease: Guidelines of the Italian Society of Colorectal Surgery (SICCR) [Segre, 2015], The American Society of Colon and Rectal Surgeons’ Clinical Practice Guidelines for the Management of Pilonidal Disease [Johnson, 2019], and on expert opinion in review articles Pilonidal disease [Khanna, 2011], Treatment Options for Pilonidal Sinus [Kober, 2018], Pilonidal Disease: Management and Definitive Treatment [Kuckelman, 2018], Pilonidal disease practice points: An update [Choy, 2019], The Management of Pilonidal Sinus [Iesalnieks, 2019], Pilonidal disease [BMJ Best Practice, 2020], Pilonidal disease [Murphy, 2022].

What else might it be?

  • Differential diagnoses of pilonidal sinus disease include:
    • A boil — an infection of the hair follicle where there is purulent extension into the subcutaneous tissue, in which a small abscess forms. For more information, see the CKS topic on Boils, carbuncles, and staphylococcal carriage.
    • Hidradenitis suppurativa — a chronic inflammatory skin condition characterized by painful, inflamed nodules and sterile abscesses that culminate in purulent discharge, sinuses, and scarring. It may occur in the perineal/ perianal region but also in the areolar area of the breasts and frequently in the axillae.
    • Anal fissure — a tear or ulcer in the lining of the anal canal, immediately within the anal margin. For more information, see the CKS topic on Anal fissure.
    • Anal fistula — a small tunnel that develops between the anal canal and the perianal skin, most commonly caused by an anorectal abscess.
    • Perianal abscess — an abscess that develops in the perianal region. The skin of the natal cleft is normal.
    • Infected sebaceous cyst — characterized by swelling and pain. There may be a history of a small preceding skin lesion. In about 50% of cases, a punctum will be visible.
    • Sacral osteomyelitis — infection of the underlying sacral bone may also cause pain and tenderness, but the overlying skin should be normal.
    • Crohn's disease — a chronic, relapsing-remitting, non-infectious inflammatory disease of the gastrointestinal tract. May present with perianal pain or tenderness, anal or perianal skin tag, fissure, fistula, or abscess. For more information, see the CKS topic on Crohn's disease.
    • Infectious processes, including tuberculosis, syphilis, and actinomycosis. For more information, see the CKS topics on Tuberculosis and Syphilis.
    • Squamous cell carcinoma —  the second most common form of skin cancer, characterized by abnormal, accelerated growth of squamous cells. It is usually seen as a raised lesion on the skin, but a number of typical features of the lesion have been described. For more information, see the CKS topic on Skin cancers - recognition and referral.

Basis for recommendation

The information on differential diagnoses is based on expert opinion in The Treatment of Pilonidal Disease: Guidelines of the Italian Society of Colorectal Surgery (SICCR) [Segre, 2015], The American Society of Colon and Rectal Surgeons’ Clinical Practice Guidelines for the Management of Pilonidal Disease [Johnson, 2019], and review articles Pilonidal Disease: Management and Definitive Treatment [Kuckelman, 2018], The Management of Pilonidal Sinus [Iesalnieks, 2019],  Pilonidal disease [BMJ Best Practice, 2020] and Pilonidal disease [Murphy, 2022]. 

Management

Scenario: Management

From age 16 years onwards.

How should I manage a person with pilonidal sinus disease?

  • For all people with pilonidal sinus disease: 
    • Advise on long-term measures that may reduce the risk of recurrence, including:
      • Meticulous perianal hygiene (with regular baths or showers.)
      • Buttock hair removal techniques (such as laser treatment, waxing, shaving, and depilatory creams). There is evidence of a lower recurrence rate after laser hair removal compared with shaving and depilatory creams.
    • Provide patient information on pilonidal sinus disease.  
  • The need for further management will depend on the disease manifestation and extent:
    • If the person is asymptomatic:
      • Advise a 'watch and wait' approach.
      • Reassure that treatment is not necessary.
      • Advise the person to seek medical help if symptoms occur.
    • If the person has an acute pilonidal abscess:
      • Refer to a colorectal or general surgical unit for an urgent, same-day incision and drainage. Incision and drainage can be performed in primary care if the lesion is small and superficial and the expertise and facilities are available. 
      • Advise the use of paracetamol and/or ibuprofen for pain and fever. For prescribing information, see the CKS topics on Analgesia - mild-to-moderate pain and NSAIDs - prescribing issues.
    • If the person has chronic pilonidal sinus disease:
      • Refer to a colorectal or general surgical unit for surgical treatment (with urgency dependent on clinical judgement). The choice of surgical treatment will depend on the extent of the disease, the experience and expertise of the surgeon, and the person's wishes. 
      • Advise the use of paracetamol and/or ibuprofen for pain. For prescribing information, see the CKS topics on Analgesia - mild-to-moderate pain and NSAIDs - prescribing issues.
    • If the person has recurrent pilonidal sinus disease:
      • Refer to a colorectal surgeon with appropriate expertise and experience for further assessment and consideration of alternative surgical treatments.

Basis for recommendation

These recommendations are based largely on the German National Guideline on the Management of Pilonidal Disease: Update 2020 [Iesalnieks, 2021], The American Society of Colon and Rectal Surgeons' Clinical Practice Guidelines for the Management of Pilonidal Disease [Johnson, 2019], The Treatment of Pilonidal Disease: Guidelines of the Italian Society of Colorectal Surgery (SICCR) [Segre, 2015], and expert opinion in review articles Treatment Options for Pilonidal Sinus [Kober, 2018], Pilonidal Disease: Management and Definitive Treatment [Kuckelman, 2018], Pilonidal disease practice points: An update [Choy, 2019], The Management of Pilonidal Sinus [Iesalnieks, 2019] and Pilonidal disease [BMJ Best Practice, 2020]. 

Hair removal 
  • The rationale for hair removal relates to the significance of cleft hair in the pathophysiology of pilonidal sinus disease [Johnson, 2019]. However, evidence for the effectiveness of the different hair removal methods is limited.
    • A systematic review of 14 studies (n = 963) found a lower recurrence rate after laser hair removal (9.3% [34 out of 366 people]) than with razor/cream depilation (23.4% [36 out of 154 people]) and no hair removal (19.7% [85 out of 431 people]), but the small sample size and limited methodological quality of the included studies make drawing definitive conclusions difficult [Pronk, 2018].
    • A systematic review of 35 studies suggests that laser hair removal reduces recurrence rates, but the authors noted the heterogeneity and limited generalizability of the available literature [Halleran, 2018].
    • The Italian and American guidelines recommend shaving or laser depilation as a primary treatment or postoperative adjunct to other procedures [Segre, 2015; Johnson, 2019]. However, the German guideline warns of potentially increased recurrence risk when shaving is used postoperatively, stating sharp-ended rootless hairs have been found in the sinus cavities of people with pilonidal sinus disease, shortly after haircut. Therefore, permanent depilation by laser or depilation cream instead of shaving might be, at least theoretically, the preferred method for recurrence prophylaxis [Iesalnieks, 2021].
  • Despite the limited evidence, hair removal remains a compelling and easy approach to managing pilonidal sinus disease.
Providing patient information
  • This recommendation is pragmatic, based on what CKS considers to be good clinical practice.
Managing asymptomatic disease
  • Experts agree that there is no indication for prophylactic treatment in people with asymptomatic pilonidal sinus disease [Segre, 2015; Johnson, 2019; Iesalnieks, 2021].
  • No spontaneous disease progression was observed in an observational study [Iesalnieks, 2021], and the disease often dissipates as the person passes the fourth decade of life [Choy, 2019].
Managing acute abscess
  • The German, American, and Italian guidelines recommend incision and drainage for most people with pilonidal abscess, followed by definitive treatment (elective surgery) after resolution of acute inflammation [Segre, 2015; Johnson, 2019; Iesalnieks, 2021]. People with a pilonidal abscess should be treated with incision and drainage regardless of whether it is a primary or recurring episode [Johnson, 2019].
  • Expert opinion in a review article is that localized source control is the mainstay of treatment for an acute pilonidal abscess. This includes needle aspiration, drainage without curettage of the cavity, and primary drainage and curettage of the cavity to remove any hair follicles or debris [Choy, 2019].
  • The recommendation to use paracetamol and/or ibuprofen for pain and fever is pragmatic, based on what CKS considers to be good clinical practice.
Managing chronic disease
  • Surgery is the standard treatment for chronic pilonidal sinus disease [Segre, 2015; Johnson, 2019; Iesalnieks, 2021].
  • There are many surgical options available [Johnson, 2022]; the choice of surgical treatment will depend on the extent of the disease, the experience and expertise of the surgeon, and the person's wishes. 
  • The recommendation to use paracetamol and/or ibuprofen for pain and fever is pragmatic, based on what CKS considers to be good clinical practice.
Managing recurrent disease  
  • Pilonidal sinus disease often recurs after surgery, and the risk of recurrence depends on the surgical method used and the presence of risk factors.
  • Expert opinion in a review article is that when pilonidal surgery fails to achieve healing, referral to a surgeon with an interest is recommended. According to the review article, careful selection of the operative strategy is needed rather than repeating previously failed procedures, which cause further scarring and tissue loss that makes definitive surgery more complex [Gordon, 2014].
  • The American guideline highlights that recurrent presentations may herald a different problem; therefore, the surgeon must remain vigilant to exclude abnormal underlying aetiologies of chronic perirectal pathology, such as inflammatory bowel disease, immunosuppression, and cutaneous neoplasms [Johnson, 2019].

Supporting evidence

The recommendations in this CKS topic are largely based on the German National Guideline on the management of pilonidal disease: update 2020 [Iesalnieks, 2021], The American Society of Colon and Rectal Surgeons’ Clinical Practice Guidelines for the Management of Pilonidal Disease [Johnson, 2019], The Treatment of Pilonidal Disease: Guidelines of the Italian Society of Colorectal Surgery (SICCR) [Segre, 2015], and expert opinion in review articles on pilonidal sinus disease Treatment Options for Pilonidal Sinus [Kober, 2018], Pilonidal disease practice points: An update [Choy, 2019] and Pilonidal disease [BMJ Best Practice, 2020]. The rationale for recommendations is summarized in the relevant basis for recommendation sections. 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 and systematic reviews on primary care management of pilonidal sinus disease.

Search dates

March 2019 - February 2024

Key search terms

The terms listed below are the core search terms that were used for EBSCOhost MEDLINE (searched 3rd December 2018). All results from the EBSCOhost MEDLINE were screened. The strategy was adapted for The Cochrane Library databases.

S3    S1 OR S2 
S2    AB pilonidal* OR TI pilonidal* 
S1    (MH "Pilonidal Sinus") 

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:

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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:

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  • Second draft internal review
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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
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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.
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  • 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.
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    • 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

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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:

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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.

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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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