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Musculoskeletal

Bunions

Last revised in August 2021

A bunion is a deformity which occurs when the great toe moves towards the second toe (and may sometimes overlie it).

Bunions: Summary

  • A bunion (hallux valgus) describes a toe deformity when the great toe (hallux) laterally deviates away from the midline towards the lesser toes. This causes medial prominence of the first metatarsal head, and the overlying bursa and soft tissues may also become inflamed.
    • A bunion can cause altered joint mechanics, and pain when walking or wearing shoes.
  • Predisposing factors may include:
    • Poorly-fitting and constricting footwear.
    • Increasing age and female gender.
    • Family history.
    • Pes planus (loss of the medial longitudinal arch) and other foot deformities.
    • Achilles tendon contracture and ligamentous laxity.
  • The exact prevalence is unknown, but bunion deformity increases with age and is more common in women than men.
  • Complications of bunion deformity include:
    • Medial forefoot and/or first metatarsophalangeal (MTP) joint pain.
    • Difficulty finding comfortable footwear.
    • Callus or corn formation (at points of overload) such as under the second MTP joint.
    • Osteoarthritis of the first MTP joint (hallux rigidus).
    • Impaired balance and increased risk of falls.
    • Subluxation of the first MTP joint, and dislocation or dorsal subluxation at the second MTP joint ('hammer toe').
    • Skin breakdown and foot ulceration (at points of overload) and risk of osteomyelitis.
  • Assessment of a person with a bunion deformity includes:
    • Asking about the presence and duration of symptoms such as pain; the impact on walking and daily activities; difficulty with wearing footwear; family history; neurovascular comorbidities; previous treatments tried.
    • Observing the person's gait and lower leg alignment.
    • Examining in a standing and seated position, including the degree of hallux valgus deformity; presence of pes planus; skin quality and presence of complications; areas of pain and tenderness; neurovascular insufficiency; and range of joint movement.
    • Examining the type and wear patterns of footwear and shoe fit.
  • Management of a person with a bunion deformity includes:
    • Giving advice on sources of information and support.
    • Giving advice on self-care measures for symptom relief, such as footwear modification; use of insoles, toe spacers and/or bunion pads; use of ice and/or analgesia if needed.
    • Offering referral to podiatry for a footwear assessment and/or consideration of a night splint or orthosis.
    • Considering referral to the local musculoskeletal service for advice on exercises and stretches and possible corticosteroid injection if indicated.
    • Advising that referral is not indicated for cosmetic or prophylactic reasons alone.
  • Referral to an orthopaedic or podiatric surgery specialist should be considered if:
    • There are progressive symptoms and/or deformity.
    • Symptoms persist after three months of conservative treatment.
    • There is second toe involvement.
    • There is significant impact on daily functioning.
    • The person is unable to wear suitable footwear.
  • Urgent referral to an appropriate specialist should be arranged if:
    • There is an impending or non-healing foot ulcer.
    • There is suspected peripheral limb ischaemia.

Have I got the right topic?

From age 18 years onwards.

This CKS topic covers the assessment, management, and referral of adults with bunions (hallux valgus) in primary care.

This CKS topic does not cover the management of bunions in children, tailor's bunion (bunionette), or diabetic foot disease.

There are separate CKS topics on Diabetes - type 1, Diabetes - type 2, and Osteoarthritis.

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

July to August 2021 — reviewed. A literature search was conducted in July 2021 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of the topic. The section on Assessment has been moved to the Diagnosis section to improve clarity and navigation. An additional section on Surgical management has been added to the Management section. The basis for recommendation sections have been updated with current evidence in the literature. No major changes to clinical recommendations have been made.

Previous changes

August 2016 — reviewed. A literature search was conducted in July 2016 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials (RCTs) published since the last revision of the topic. Sections have been added on the prognosis and diagnosis of bunions. No major changes to clinical recommendations have been made.

September 2012 — 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. No changes to clinical recommendations have been made.

February 2010 — minor update to the Definition section. Issued in February 2010.

July to October 2008 — 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 August 2021.

HTAs (Health Technology Assessments)

No new HTAs since 1 August 2021.

Economic appraisals

No new economic appraisals relevant to England since 1 August 2021.

Systematic reviews and meta-analyses

No new systematic reviews or meta-analysis which reach the CKS threshold for inclusion since 1 August 2021.

Primary evidence

No new primary evidence which reaches the CKS threshold for inclusion published since 1 August 2021.

New policies

No new national policies or guidelines since 1 August 2021.

New safety alerts

No new safety alerts since 1 August 2021.

Changes in product availability

No changes in product availability since 1 August 2021.

Goals and outcome measures

Goals

To support primary healthcare professionals to:

  • Accurately diagnose and assess bunions.
  • Provide appropriate information and advice on self-management.
  • Offer appropriate treatment options in primary care.
  • Arrange specialist referral to podiatry and/or orthopaedic surgery if clinically indicated.

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?

  • A bunion (hallux valgus) describes a toe deformity when the great toe (hallux) laterally deviates away from the midline towards the lesser toes. This causes medial prominence of the first metatarsal head, and the overlying bursa and soft tissues may also become inflamed [Choa, 2010; Hecht, 2014; RCS, 2017; Ray, 2019; Andrews, 2021].
    • A bunion can cause altered joint mechanics, and pain when walking or wearing shoes [RCS, 2017; Ray, 2019].
    • Lateral deviation of the proximal phalanx from the first metatarsal (hallux valgus angle) greater than 15 degrees and an intermetatarsal angle greater than 9 degrees on weight-bearing X-rays are considered abnormal [Choa, 2010; Hecht, 2014; Ray, 2019].

What causes it?

The exact cause of bunion development is not well understood. Predisposing factors may include:

How common is it?

Bunions are the most common forefoot problem presenting in adults [Hecht, 2014].

  • The exact prevalence of bunions is unknown, but it increases with age. A systematic review and meta-analysis of 76 international prevalence surveys (n = 496,957) found [Nix, 2010]:
    • A pooled prevalence estimate of 23% in adults aged 18–65 years, and 35.7% in people aged 65 years and older.
    • A higher prevalence of bunions in women (30%) compared with men (13%).

What are the complications?

Possible complications of untreated bunions include:

What is the prognosis?

The prognosis of bunions is uncertain, but toe deformity is often progressive [Hecht, 2014]:

  • There may be a slow rate of progression of deformity [Choa, 2010].
  • A retrospective longitudinal analysis of 268 adults with hallux valgus found that 17% of participants had a progressive deformity with an increase in the hallux valgus angle of 5 degrees or more after a median follow-up period of 49 months [Shinohara, 2021].
    • A large hallux valgus angle on X-ray at baseline was an independent risk factor for progression of the deformity.

Diagnosis of bunions

When should I suspect a bunion deformity?

Suspect a bunion deformity if a person presents with:

  • Progressive pain at the medial aspect of the first metatarsophalangeal (MTP) joint and/or medial aspect of the forefoot.
  • Difficulty wearing shoes.
  • Lateral deviation of the hallux at the first MTP joint. 
  • Medial prominence of the first metatarsal head.

Basis for recommendation

The information on diagnosis is largely based on expert opinion in review articles on hallux valgus [Choa, 2010; Hecht, 2014; Ray, 2019] and on great toe disorders [Andrews, 2021].

How should I assess a person with a bunion?

If a person has a bunion based on initial clinical features:

  • Ask about:
    • The presence and duration of symptoms such as forefoot and/or first metatarsophalangeal (MTP) medial joint pain, which may be worse when wearing shoes and weight-bearing.
    • The impact on walking and the person's lifestyle and activities.
    • Any difficulty fitting into footwear; footwear normally worn; any recent changes in footwear.
    • Any family history.
    • Comorbid vascular disease or neuropathy.
    • Any previous treatments.
  • Observe the person's gait and lower leg alignment.
  • Examine the person's foot/feet in a standing and seated position.
    • Assess the degree of hallux deformity and presence of pes planus while the person is standing.
    • Assess skin quality and examine for associated complications such as calluses, corns, bursitis, skin breakdown, and lesser toe deformities.
    • Palpate the first MTP joint, lesser toes, and forefoot for areas of pain and tenderness.
    • Assess for neurovascular insufficiency.
    • Assess the range of movement of the first MTP joint, other foot joints, and ankle — stiffness and rigidity of the first MTP joint may indicate associated osteoarthritis.
    • Examine for ligamentous laxity or contractures.
  • Examine the type and wear patterns of footwear and assess shoe fit.
  • Do not routinely arrange foot X-ray in primary care.

Basis for recommendation

The recommendations on assessment are largely based on the Royal College of Surgeons of England (RCSEng), British Orthopaedic Foot and Ankle Society and British Orthopaedic Association (BOA) joint publication Commissioning guide: painful deformed great toe in adults [RCS, 2017], and expert opinion in review articles on hallux valgus [Choa, 2010; Hecht, 2014; Fraissler, 2016; Ray, 2019] and on great toe disorders [Andrews, 2021].

Clinical features on history-taking
  • The recommendation to ask about the nature and duration of pain is based on the RCS commissioning guide, which notes that abnormal weight distribution under the lesser toes may cause metatarsalgia [RCS, 2017]. It is supported by expert opinion in review articles [Hecht, 2014; Fraissler, 2016; Ray, 2019].
  • The recommendation to ask about the impact on walking and activities is based on the RCS commissioning guide [RCS, 2017] and expert opinion in a review article [Hecht, 2014].
  • The recommendation to ask about footwear is based on the RCS commissioning guide [RCS, 2017] and expert opinion in review articles [Choa, 2010; Hecht, 2014; Ray, 2019].
  • The recommendation to ask about family history if based on expert opinion in a review article [Hecht, 2014].
  • The recommendation to ask about comorbid neurovascular disease is based on expert opinion in a review article, as this may affect the choice of surgical treatment options [Andrews, 2021]. In addition, comorbid conditions such as diabetes mellitus may increase the risk of skin breakdown and foot ulceration [Choa, 2010].
  • The recommendation to ask about previous treatments is based on expert opinion in a review article [Hecht, 2014].
Clinical features on examination
  • The recommendation to observe the person's gait and lower leg alignment is based on the RCS commissioning guide [RCS, 2017] and expert opinion in review articles [Hecht, 2014; Fraissler, 2016].
  • The recommendation to examine the person in a standing and seated position is based on expert opinion in review articles [Ray, 2019; Andrews, 2021].
  • The recommendation to assess the degree of deformity and for pes planus is based on expert opinion in review articles [Choa, 2010; Fraissler, 2016; Andrews, 2021].
  • The recommendation to assess skin quality and signs of complications is based on the RCS commissioning guide [RCS, 2017] and expert opinion in review articles [Choa, 2010; Hecht, 2014; Fraissler, 2016; Ray, 2019].
  • The recommendation to assess for tenderness is based on the RCS commissioning guide [RCS, 2017] and expert opinion in review articles [Hecht, 2014; Ray, 2019].
  • The recommendation to assess for neurovascular insufficiency is based on the RCS commissioning guide [RCS, 2017] and expert opinion in review articles [Choa, 2010; Ray, 2019; Andrews, 2021].
  • The recommendation to assess joint range of movement is based on expert opinion in review articles [Fraissler, 2016; Ray, 2019]. In addition, identification of osteoarthritis of the first metatarsophalangeal (MTP) joint is important, as this may affect the choice of surgical treatment options [Andrews, 2021].
  • The recommendation to assess for ligamentous laxity or contractures is based on expert opinion in a review article [Ray, 2019].
Assessing footwear and shoe fit
Not arranging foot X-ray in primary care
  • This recommendation is based on the RCS commissioning guide, which notes that weight-bearing X-rays are only indicated if needed to guide therapeutic corticosteroid injection, for example [RCS, 2017]. CKS also notes that weight-bearing X-rays may be arranged in secondary care prior to planned surgery.

What else might it be?

Alternative conditions which may present similarly to a bunion deformity include:

  • Hallux rigidus — osteoarthritis of the metatarsophalangeal (MTP) joint typically causes joint pain, swelling, stiffness, and rigidity. See the CKS topic on Osteoarthritis for more information.
  • Hallux interphalangeus — the tip of the great toe is deviated laterally.
  • Gout. See the CKS topic on Gout for more information.
  • Chronic sesamoiditis — this may affect people who undergo repetitive jumping or running; there is typically gradual onset toe pain below the first MTP joint that is worse on weight-bearing; there may be pronounced wear on the forefoot of the shoe.
  • Fracture — may present with joint deformity and point tenderness.
  • Inflammatory joint disease, such as rheumatoid arthritis. See the CKS topic on Rheumatoid arthritis for more information.
  • Peripheral neuropathy — there may be a high-stepping gait with reduced lower extremity reflexes and sensation. See the CKS topics on Diabetes - type 1 and Diabetes - type 2 for more information.
  • Osteomyelitis — there may be joint redness, swelling, severe pain and tenderness, and the person may be systemically unwell.

Basis for recommendation

The information on differential diagnosis is based on the Royal College of Surgeons of England (RCSEng), British Orthopaedic Foot and Ankle Society and British Orthopaedic Association (BOA) joint publication Commissioning guide: painful deformed great toe in adults [RCS, 2017], and expert opinion in review articles on hallux valgus [Choa, 2010; Fraissler, 2016] and on great toe disorders [Andrews, 2021].

Management

Scenario: Bunions

From age 18 years onwards.

Management

If a person has been diagnosed with a bunion, management depends on symptoms and the severity of deformity:

  • Give advice on sources of information and support:
  • Give advice on self-care measures for symptom relief:
    • Advise to wear low-heeled, wide-fitting shoes with a soft sole and soft toe boxes, and avoid high-heeled or tight-fitting shoes.
    • Consider the use of insoles, toe spacers, and/or bunion pads.
    • Consider the use of ice for relief of pain and inflammation.
    • Advise on the use of analgesia such as paracetamol and/or a nonsteroidal anti-inflammatory drug (NSAID) if needed.
  • Offer referral to podiatry for a footwear assessment and/or consideration of a night splint or orthosis.
  • Consider referral to the local musculoskeletal service for:
    • Advice on balance, proprioception, and core stability, and calf muscle stretches.
    • Treatment of tibialis posterior tendon dysfunction (if needed).
    • Possible corticosteroid injection, if the person is unfit for surgery.
  • If symptoms persist, consider referral to an orthopaedic ankle and foot specialist or podiatric surgery, depending on local referral pathways and clinical judgement, if: 
    • There are progressive symptoms and/or deformity.
    • Symptoms persist after three months of conservative treatment.
    • The second toe is involved.
    • There is significant impact on daily functioning.
    • The person is unable to wear suitable footwear.
  • Arrange urgent referral to an appropriate specialist if:
    • There is an impending or non-healing foot ulcer.
    • There is suspected peripheral limb ischaemia. See the CKS topic on Peripheral arterial disease for more information.
  • Arrange referral to a diabetic foot protection service if the person has diabetes mellitus, the urgency depending on clinical judgement.
  • Advise that specialist referral is not indicated for cosmetic or prophylactic reasons alone.

Surgical management

Specialist surgical management of a bunion may be needed, depending on the severity and location of deformity, and the extent of degenerative changes of the first metatarsophalangeal (MTP) joint [Hecht, 2014] [Fraissler, 2016] [Ray, 2019]:

  • A choice of surgical procedures for hallux valgus correction include first metatarsal osteotomy, proximal phalanx osteotomy, soft tissue procedures, and arthrodesis (fusion) of the first MTP or tarsometatarsal (TMT) joint [NICE, 2010; Ray, 2019]. Arthrodesis may be indicated particularly in people with associated osteoarthritis or neuropathy [Andrews, 2021].
  • Minimally invasive percutaneous techniques are being evaluated, but are not in widespread use due to uncertainties in procedure safety and efficacy [NICE, 2010].
  • Complications after bunion surgery may include infection, scar sensitivity, joint stiffness, transfer metatarsalgia (most commonly to the second metatarsal), hallux varus (overcorrection), bunion recurrence, bony non-union, nerve damage, prolonged swelling, and chronic pain [Choa, 2010; RCS, 2017; Ray, 2019].
    • People with hypermobility, ligamentous laxity, or neuromuscular disorders have a high risk of bunion recurrence following surgery [Fraissler, 2016]. 
  • The British Orthopaedic Foot and Ankle Society (www.bofas.org.uk) patient leaflet A guide to bunion surgery may be helpful.

Basis for recommendation

The recommendations on management are largely based on the National Institute for Health and Care Excellence (NICE) interventional procedures guidance Surgical correction of hallux valgus using minimal access techniques [NICE, 2010] and the NICE clinical guideline Diabetic foot problems: prevention and management [NICE, 2019]; the Royal College of Surgeons of England (RCSEng), British Orthopaedic Foot and Ankle Society and British Orthopaedic Association (BOA) joint publication Commissioning guide: painful deformed great toe in adults [RCS, 2017], a small comparative study of toe separator and night splint devices [Tehraninasr, 2008], and expert opinion in review articles on hallux valgus [Choa, 2010; Hecht, 2014; Fraissler, 2016; Ray, 2019] and on great toe disorders [Andrews, 2021].

Advice on sources of information and support
  • This recommendation is based on the RCS commissioning guide [RCS, 2017] and expert opinion in a review article [Ray, 2019], and is also pragmatic, based on what CKS considers to be good clinical practice.
Advice on self-care measures
  • The recommendations on footwear modification are based on the NICE interventional procedures guidance [NICE, 2010], the RCS commissioning guide [RCS, 2017], and expert opinion in review articles [Choa, 2010; Hecht, 2014; Fraissler, 2016; Ray, 2019; Andrews, 2021].
    • High-heeled or tight-fitting shoes may increase the risk of progression of hallux valgus [Andrews, 2021].
    • Comfortable shoes with a wide toe box help to reduce pressure on the deformity, slow progression, and decrease pain, blistering, and bursitis [Fraissler, 2016; Ray, 2019; Andrews, 2021].
  • The recommendation on use of insoles, toe spacers, and/or bunion pads is based on the NICE interventional procedures guidance [NICE, 2010], the RCS commissioning guide [RCS, 2017], and expert opinion in review articles [Choa, 2010; Hecht, 2014; Fraissler, 2016; Ray, 2019; Andrews, 2021].
    • The RCS commissioning guide recommends use of bunion pads and positional devices if symptoms are mild.
    • These conservative measures may help provide symptom relief, but will not improve the bunion deformity [Hecht, 2014; Fraissler, 2016].
    • CKS notes a small comparative study of the effect of insole with toe separator compared with night splint (n = 30) found that treatment with a toe separator produced significant pain intensity reduction compared with the night splint group. Neither treatment produced an improvement in toe deformity (as measured by the hallux valgus and intermetatarsal angles) [Tehraninasr, 2008].
  • The recommendation on use of ice is based on the RCS commissioning guide [RCS, 2017].
  • The recommendation on the use of analgesia is based on the RCS commissioning guide [RCS, 2017] and expert opinion in review articles [Hecht, 2014; Andrews, 2021].
Offering referral to podiatry
  • The recommendation to offer podiatry referral for a footwear assessment and provision of off-loading orthotics (devices worn in shoes to provide control of the foot position) or night splints is based on the RCS commissioning guide [RCS, 2017] and expert opinion in review articles [Choa, 2010; Fraissler, 2016; Andrews, 2021].
    • Night splints may be used to reduce bunion pain and pressure [Andrews, 2021].
    • Custom-made night splints may improve foot pain, and their initial use are unlikely to adversely affect clinical outcomes as bunions are generally slowly progressive [Choa, 2010].
Considering referral to a local musculoskeletal service
  • The recommendation to consider referral to a local musculoskeletal service for exercises and stretches is based on the RCS commissioning guide [RCS, 2017] and expert opinion in review articles [Hecht, 2014; Fraissler, 2016].
  • The recommendation to consider referral for a possible corticosteroid injection if the person is unfit for surgery is based on the RCS commissioning guide [RCS, 2017].
Considering referral to orthopaedic or podiatric surgery
  • The recommendation if there are progressive symptoms and/or deformity is based on the RCS commissioning guide [RCS, 2017] and expert opinion in review articles [Choa, 2010; Hecht, 2014; Ray, 2019].
  • The recommendation if there are refractory symptoms after three months of conservative treatment is based on the RCS commissioning guide [RCS, 2017] and expert opinion in review articles [Choa, 2010; Hecht, 2014; Ray, 2019].
    • The RCS commissioning guide notes that pre-operative imaging with weight-bearing X-rays, ultrasound, and MRI may be arranged by specialist teams. Expert opinion in a review article also notes that weight-bearing X-rays can help to assess the severity of hallux valgus angle and corresponding severity of any bunion deformity, as well as any first MTP joint degeneration [Ray, 2019]. In addition, X-rays can evaluate for fractures and other structural abnormalities [Andrews, 2021].
    • The RCS commissioning guide notes that surgery is simpler and more successful if performed in the earlier stages of deformity.
  • The recommendation if there is second toe involvement is based on expert opinion in a review article [Choa, 2010].
  • The recommendation if there is impact on daily functioning is based on the RCS commissioning guide [RCS, 2017] and expert opinion in a review article [Ray, 2019].
  • The recommendation if the person is unable to wear footwear is based on the RCS commissioning guide [RCS, 2017] and expert opinion in a review article [Ray, 2019].
Arranging urgent referral
  • The recommendation if there is an impending or non-healing foot ulcer is based on the RCS commissioning guide [RCS, 2017] and expert opinion in a review article [Choa, 2010].
  • The recommendation if there is suspected peripheral limb ischaemia is based on the RCS commissioning guide [RCS, 2017].
Arranging referral to a diabetic foot protection service
  • This recommendation is based on the NICE clinical guideline on diabetic foot problems [NICE, 2019] and expert opinion in a review article [Choa, 2010]. It is also pragmatic, based on what CKS considers to be good clinical practice.
Advising when specialist referral is not indicated
  • This recommendation is based on the RCS commissioning guide [RCS, 2017] and expert opinion in a review article [Ray, 2019].

Supporting evidence

This CKS topic is largely based on the National Institute for Health and Care Excellence (NICE) interventional procedures guidance Surgical correction of hallux valgus using minimal access techniques [NICE, 2010], the Royal College of Surgeons of England (RCSEng), British Orthopaedic Foot and Ankle Society and British Orthopaedic Association (BOA) joint publication Commissioning guide: painful deformed great toe in adults [RCS, 2017], and expert opinion in review articles. The rationale for recommendations is summarized in the relevant basis for recommendation sections.

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 bunions.

Search dates

July 2016 – June 2021

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 Hallux Valgus/, (hallux ADJ valgus).tw., (hallux ADJ abductovalgus).tw., bunion$.tw.
  • exp metatarsophalangeal joint/
  • orthotic devices/
  • splints/
  • (bunion$ or hallux valgus).ti,ab.

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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  • Fraissler, L., Konrads, C., Hoberg, M., Rudert, M. et al. (2016) Treatment of hallux valgus deformity. EFORT open reviews 1(8), 295-302. [Abstract]
  • Hecht, P.J. and Lin, T.J. (2014) Hallux valgus. Medical clinics of North America 98(2), 227-232. [Abstract]
  • NICE (2010) Surgical correction of hallux valgus using minimal access techniques. National Institute of Health and Care Excellence. http://www.nice.org.uk [Free Full-text]
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  • Nix, S., Smith, M. and Vicenzino, B. (2010) Prevalence of hallux valgus in the general population: a systematic review and meta-analysis. Journal of Foot and Ankle Research 3(21). [Abstract] [Free Full-text]
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  • Ray, J.J., Friedmanm, A.J., Hanselman, A.E., et al. (2019) Hallux Valgus. Foot & Ankle Orthopaedics, 10.1177/2473011419838500. [Free Full-text]
  • RCS (2017) Commissioning guide: Painful deformed great toe in adults. Royal College of Surgeons of England. http://www.rcseng.ac.uk [Free Full-text]
  • Shinohara, M., Yamaguchi, S., Ono, Y., Kimura, S. et al. (2021) Anatomical factors associated with progression of hallux valgus. Foot and Ankle Surgery(21). [Abstract]
  • Tehraninasr, A., Saeedi, H., Forogh, B., Bahramizadeh, M. et al. (2008) Effects of insole with toe-separator and night splint on patients with painful hallux valgus: a comparative study. Prosthetics and Orthotics International 32(1), 79-83. [Abstract]
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