Date of Meeting: ……13Th September 2019…………

NHS BOLTON CLINICAL COMMISSIONING GROUP Public Board Meeting

AGENDA ITEM NO: ………7………………

Date of Meeting: ……13th September 2019…………

TITLE OF REPORT: GM Effective Use of Resources Policy for Board Approval

AUTHOR: GMSS Effective Use of Resources Team/ Michael Robinson, Associate Director Integrated Governance & Policy

PRESENTED BY: Dr Jane Bradford, Clinical Director Clinical Governance and Safety

PURPOSE OF PAPER: To present the newly developed policies relating to:0 (Linking to Strategic Objectives) • GM059 - Surgical Repair of Hernias – should lead to a reduction in activity and ineffective procedures. A mix of funding mechanisms dependent on hernia type as detailed in the policy. • GM058 - Surgical Correction of Adult Strabismus (squint) – will increase awareness as this is currently in the aesthetic policy but there should be no activity increase. Functional squint will be monitored approval (MA) and non-functional individual prior approval (IPA) • GM060 - Photorefractive (laser) surgery for the correction of refractive errors – also in aesthetic policy this should keep activity at or below current level and avoid increase due to increasing popularity. Individual funding requests (IFR) required. • GM050 – Surgical management of Ankyloglossia (tongue tie) – relates to frenectomy and designed to ensure procedures occur in the community. Activity neutral impact with MA for feeding problems and older children with speech problems IFR.

LINKS TO CORPORATE OBJECTIVES Delivery of Year 3 Locality Plan. (tick relevant boxes): Joint collaborative working with Bolton FT and the Council. Supporting people in their home and community. Shared health care records across Bolton. Regulatory Requirement √ Standing Item

RECOMMENDATION TO THE BOARD: The Board is asked to approve the policies which will (Please be clear if decision required, or be varied in to our contract with providers and for noting) disseminated throughout primary care thereafter.

COMMITTEES/GROUPS PREVIOUSLY Greater Manchester Effective Use of Resources CONSULTED: Steering Group and associated clinical consultation. Greater Manchester Directors of Commissioning. CCG Executive.

REVIEW OF CONFLICTS OF Conflicts of Interest are reviewed through the GM INTEREST: governance and consultation processes.

VIEW OF THE PATIENTS, CARERS OR Full clinical consultation undertaken as part of this THE PUBLIC, AND THE EXTENT OF review process. THEIR INVOLVEMENT:

EQUALITY IMPACT ASSESSMENT EIA and an assessment undertaken as part of the (EIA) COMPLETED & OUTCOME OF GM policy development process. ASSESSMENT:

Greater Manchester EUR Policy Statement on: Surgical repair of hernias GM Ref: GM059 Version: 1.0 (29 August 2019)

Commissioning Statement

Surgical repair of hernias

Policy All hernias where incarceration is suspected (the hernia cannot be reduced) or where Exclusions there are symptoms of strangulation (the hernia is incarcerated and the blood supply is (Alternative compromised) should be referred as emergencies. commissioning arrangements apply) All suspected groin hernias (includes femoral and inguinal hernias) in female patients should be referred urgently for surgical assessment due to the increased risk of incarceration/ strangulation.

All suspected femoral hernias (men and women) should be referred for surgical assessment due to the increased risk of incarceration/strangulation.

All children under the age of 18 (i.e. before their 18th birthday) should be referred to the relevant paediatric / adolescent specialist provider.

Treatment/procedures undertaken as part of an externally funded trial or as a part of locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathway for this exclusion to take effect).

Fitness for NOTE: All patients should be assessed as fit for surgery before going ahead with Surgery treatment, even though funding has been approved.

Best Practice All providers are expected to follow best practice guidelines (where available) in the Guidelines management of these conditions.

Policy Inguinal hernia in men (for women and children see ‘Policy Exclusions’ above) Inclusion For asymptomatic or minimally symptomatic hernias not covered by the exclusions Criteria above, a watchful waiting approach should be taken. This should include reassurance and the provision of information on the signs and symptoms requiring treatment.

Watchful waiting should also be used for patients with minimally symptomatic inguinal hernias who have significant comorbidity (ASA 4) AND do not want to have surgical repair (after appropriate information has been provided). Similarly, ASA 1-3 patients who DO NOT want surgical repair after appropriate information has been provided DO NOT require referral. Refer suspected primary or recurrent inguinal hernias for surgical assessment if any of the following apply: • symptomatic i.e. symptoms are such that they cause significant functional impairment OR • the hernia is difficult or impossible to reduce (i.e. history of incarceration or real difficulty reducing the hernia confirmed by ultrasound) OR • it is an inguino-scrotal hernia OR • the hernia increases in size month on month OR • The patient has developed symptoms during a period of watchful waiting and now wishes surgical repair

3. GM Hernia Policy v1.0 FINAL Page 2 of 23

Funding Mechanism: Monitored approval: Referrals may be made in line with the criteria without seeking funding. NOTE: May be the subject of contract challenges and/or audit of cases against commissioned criteria. NOTE: If the procedure involves the use of mesh and the one to be used is not on the PBR Exclusions list OR the cost exceeds the list price, then an individual funding request (exceptional case) should be submitted for consideration: Requests must be submitted with all relevant supporting evidence.

For the following hernia types the risk of strangulation and or other complications is low so they should be managed as follows:

Umbilical hernia Surgical treatment will only be commissioned when one or more of the following apply: • pain/discomfort that causes significant functional impairment OR • increase in size month on month OR • a small hernial opening at high risk of incarceration or strangulation of bowel

Funding Mechanism: Individual prior approval provided the patient meets the above criteria. Requests must be submitted with all relevant supporting evidence. NOTE: If the procedure involves the use of mesh and the one to be used is not on the PBR Exclusions list OR the cost exceeds the list price, then an individual funding request (exceptional case) should be submitted for consideration: Requests must be submitted with all relevant supporting evidence.

Incisional hernia Surgical treatment will only be commissioned when both of the following criteria are met: • pain/discomfort that causes significant functional impairment AND • appropriate conservative management has been tried first e.g. weight reduction where appropriate

Other asymptomatic or minimally symptomatic hernias (including divarification recti) unless specifically mentioned above should be managed as follows: The following should not be referred for a surgical opinion unless deemed exceptional following an IFR request: • Small, asymptomatic hernias • Minimally symptomatic hernias

3. GM Hernia Policy v1.0 FINAL Page 3 of 23 • Large, wide necked hernias unless there is demonstrable evidence it is causing significant symptoms • Groin pain, including ‘athletic pubalgia’ sometimes known as ‘sports hernia’ or ‘Gilmore’s groin’ • Impalpable hernias / abdominal wall weakness

Funding Mechanism: Individual funding request (exceptional case) approval: Requests must be submitted with all relevant supporting evidence. NOTE: If the procedure involves the use of mesh and the one to be used is not on the PBR Exclusions list OR the cost exceeds the list price, then an individual funding request (exceptional case) should be submitted for consideration: Requests must be submitted with all relevant supporting evidence.

Clinical Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if Exceptionality they feel there is a good case for exceptionality. More information on determining clinical exceptionality can be found in the Greater Manchester (GM) Effective Use of Resources (EUR) Operational Policy. Link to GM EUR Operational Policy

3. GM Hernia Policy v1.0 FINAL Page 4 of 23 Contents

Commissioning Statement ...... 2 Policy Statement ...... 6 Equality & Equity Statement ...... 6 Governance Arrangements ...... 6 Aims and Objectives ...... 6 Rationale behind the policy statement ...... 7 Treatment / Procedure ...... 7 Some of the more types of hernia are described below: ...... 7 Epidemiology and Need ...... 8 Adherence to NICE Guidance ...... 8 Audit Requirements ...... 8 Date of Review ...... 8 Glossary ...... 9 References ...... 10 Governance Approvals ...... 10 Appendix 1 – Evidence Review ...... 12 Appendix 2 – Table of ASA classification ...... 18 Appendix 3 – Diagnostic and Procedure Codes ...... 19 Appendix 4 – Version History ...... 19

3. GM Hernia Policy v1.0 FINAL Page 5 of 23 Policy Statement

The GM Effective Use of Resources (EUR) Policy Team, in conjunction with the GM EUR Steering Group, have developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester, who will commission treatments/procedures in accordance with the criteria outlined in this document.

In creating this policy the GM EUR Steering Group has reviewed this clinical condition and the options for its treatment. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources.

This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester.

This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR).

Equality & Equity Statement

CCGs have a duty to have regard to the need to reduce health inequalities in access to health services and health outcomes achieved, as enshrined in the Health and Social Care Act 2012. CCGs are committed to ensuring equality of access and non-discrimination, irrespective of age, gender, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, gender or sexual orientation. In carrying out its functions, CCGs will have due regard to the different needs of protected characteristic groups, in line with the Equality Act 2010. This document is compliant with the NHS Constitution and the Human Rights Act 1998. This applies to all activities for which they are responsible, including policy development, review and implementation.

In developing policy the GM EUR Policy Team will ensure that equity is considered as well as equality. Equity means providing greater resource for those groups of the population with greater needs without disadvantage to any vulnerable group.

The Equality Act 2010 states that we must treat disabled people as more equal than any other protected characteristic group. This is because their ‘starting point’ is considered to be further back than any other group. This will be reflected in CCGs evidencing taking ‘due regard’ for fair access to healthcare information, services and premises.

An Equality Analysis has been carried out on the policy. For more information about the Equality Analysis, please contact [email protected].

Governance Arrangements

The Greater Manchester Joint Commissioning Board has given delegated authority to the Greater Manchester Directors of Commissioning and Directors of Finance to approve GM EUR treatment policies for implementation. Further details of the governance arrangements can be found in the GM EUR Operational Policy.

Aims and Objectives

This policy document aims to ensure equity, consistency and clarity in the commissioning of treatments/procedures by CCGs in Greater Manchester by: • reducing the variation in access to treatments/procedures.

3. GM Hernia Policy v1.0 FINAL Page 6 of 23 • ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness. • reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester. • promoting the cost-effective use of healthcare resources.

Rationale behind the policy statement

Abdominal herniation is relatively common, and most abdominal wall hernias do not cause functional issues or pain. This policy aimed to target the resource for surgical intervention to those cases where the individual will gain the most benefit.

Treatment / Procedure

A hernia occurs when an internal part of the body pushes through a weakness in the muscle or surrounding tissue wall.

A hernia usually develops in the area of the body between the chest and the hips. In many cases, it causes no or very few symptoms, although patients may notice a swelling or lump in the abdomen or groin.

The lump can often be pushed back in or disappears when they lie down. Coughing or straining may make the lump appear.

Some of the more types of hernia are described below:

Inguinal hernias Inguinal hernias occur when fatty tissue or a part of your bowel pokes through into the groin at the top of the inner thigh. This is the most common type of hernia and it mainly affects men. It's often associated with ageing and repeated strain on the abdomen.

Femoral hernias Femoral hernias also occur when fatty tissue or a part of the bowel pokes through into the groin at the top of the inner thigh. They're much less common than inguinal hernias and tend to affect more women than men.

Like inguinal hernias, femoral hernias are also associated with ageing and repeated strain on the abdomen.

Umbilical hernias Umbilical hernias occur when fatty tissue or a part of the bowel pokes through the abdomen near the umbilicus (navel / belly button).

This type of hernia can occur in babies if the opening in the abdomen through which the umbilical cord passes doesn't seal properly after birth. Adults can also be affected, possibly as a result of repeated strain on the abdomen.

Hiatus hernias Hiatus hernias occur when part of the stomach pushes up into the chest by squeezing through an opening in the diaphragm (the thin sheet of muscle that separates the chest from the abdomen).

This type of hernia may not have any noticeable symptoms, although it can cause heartburn in some people.

3. GM Hernia Policy v1.0 FINAL Page 7 of 23

It's not exactly clear what causes hiatus hernias, but it may be the result of the diaphragm becoming weak with age or pressure on the abdomen.

Other types of hernia Other types of hernia that can affect the abdomen include: • incisional hernias – where tissue pokes through a surgical wound in the abdomen that hasn't fully healed. • epigastric hernias – where fatty tissue pokes through the abdomen, between the navel and the lower part of the sternum (breastbone). • spigelian hernias – where part of the bowel pokes through the abdomen at the side of the abdominal muscle, below the umbilicus. • diaphragmatic hernias – where organs in the abdomen move into the chest through an opening in the diaphragm; this can also affect babies if their diaphragm doesn't develop properly in the womb. • muscle hernias – where part of a muscle pokes through the abdomen; they also occur in leg muscles as the result of a sports injury. • divarification rectii – also referred to as diastasis recti, may appear as a ridge running down the midline of the abdomen, anywhere from the xiphoid process to the umbilicus. It becomes more prominent with straining and may disappear when the abdominal muscles are relaxed. This allows tissue from inside the abdomen to herniate anteriorly.

Surgery for hernias There are two main ways surgery for hernias can be carried out: • open surgery – where an incision is made to allow the surgeon to push the lump back into the abdomen and the opening is closed by either suturing or using a “mesh repair” • keyhole (laparoscopic) surgery – this is a less invasive, but more difficult, technique where several smaller cuts are made, allowing the surgeon to use various special instruments to repair the hernia using the same methods as in open repair

Most people are carried out as day case surgery.

Epidemiology and Need

Abdominal wall hernias are common, classically taught to occur in at least 2% of men while statistics from the USA estimate 15 per 1000 population (1.5%). More than 20 million hernias are estimated to be repaired every year around the world. Per year approximately 100,000 hernia repairs are carried out in the UK.2

Adherence to NICE Guidance

There is no NICE guidance for abdominal hernia repair.

Audit Requirements

There is currently no national database. Service providers will be expected to collect and provide audit data on request.

Date of Review

One year from the date of approval by the governance process and thereafter at a date agreed by the Greater Manchester EUR Steering Group, unless new evidence or technology is available sooner.

3. GM Hernia Policy v1.0 FINAL Page 8 of 23 The evidence base for the policy will be reviewed and any recommendations within the policy will be checked against any new evidence. Any operational issues will also be considered at this time. All available additional data on outcomes will be included in the review and the policy updated accordingly. The policy will be continued, amended or withdrawn subject to the outcome of that review.

Glossary

Term Meaning

Abdominal wall hernia An abdominal wall hernia is a weakness in the muscles of the abdominal wall. When a hernia occurs, it can cause pain, and sometimes fat or intestines from the abdominal wall can bulge out.

Abdominal wall See ‘Abdominal wall hernia’ weakness

Anteriorly To the front (of the body).

Asymptomatic Where a condition is present but it is causing no ill effects.

Athletic pubalgia (AKA A sports hernia is a painful, soft tissue injury that occurs in the groin area. ‘sports hernia’ or Because different tissues may be affected and a traditional hernia may not ‘Gilmore’s groin’) exist, the term ‘athletic pubalgia’ to refer to this type of injury is preferred.

Conservative Utilizing non-surgical treatment options. management

Diaphragm The thin sheet of muscle that separates the chest from the abdomen.

Diaphragmatic hernia Where organs in the abdomen move into the chest through an opening in the diaphragm; this can also affect babies if their diaphragm doesn't develop properly in the womb.

Divarification recti / Commonly defined as a gap of roughly 2.7 cm or greater between the two diastasis recti (also sides of the rectus abdominis muscle. In pregnant or postpartum women, the known as abdominal condition is caused by the stretching of the rectus abdominis by the growing separation) uterus.

Epigastric hernia Where fatty tissue pokes through the abdomen, between the navel and the lower part of the sternum (breastbone).

Femoral hernia If a portion of tissue pushes through the wall of the femoral canal, it's called a femoral hernia. A femoral hernia will appear as a bulge near the groin or thigh. The femoral canal houses the femoral artery, smaller veins, and nerves. It's located just below the inguinal ligament in the groin.

Groin hernia An alternative term for an inguinal hernia.

Heartburn A form of indigestion felt as a burning sensation in the chest, caused by acid regurgitation into the oesophagus.

Hernia / Herniate / A condition in which part of an organ is displaced and protrudes through the herniation wall of the cavity containing it (often involving the intestine at a weak point in the abdominal wall).

Hiatus hernia The protrusion of an organ, typically the stomach, through the oesophageal opening in the diaphragm (the muscle between the chest and the abdomen used in breathing.

3. GM Hernia Policy v1.0 FINAL Page 9 of 23 Impalpable hernias A hernia that cannot be felt on examination.

Incarceration Abnormal retention or confinement of a body part.

Incisional hernia Where tissue pokes through a surgical wound in the abdomen that hasn't fully healed.

Inguinal hernia A protrusion of abdominal-cavity contents through the inguinal canal in the groin.

Inguino-scrotal Relating to the groin and the scrotum.

Keyhole (laparoscopic) Surgery carried out through a very small incision. surgery

Large, wide necked A hernia where the weakness in the abdominal wall etc. is large and unlikely hernia to cause incarceration.

Mesh repair Surgical mesh is a loosely woven sheet which is used as either a permanent or temporary support for organs and other tissues during surgery.

Muscle hernia Where part of a muscle pokes through the abdomen; they also occur in leg muscles as the result of a sports injury.

Open surgery Surgery carried out through a large incision.

Spigelian hernia Where part of the bowel pokes through the abdomen at the side of the abdominal muscle, below the umbilicus.

Strangulation Where the blood supply of the herniated bowel or other tissue is so constricted by swelling and congestion that it is cut off.

Suturing Stitching

Symptomatic Where a condition is present and is causing ill effects.

Umbilical hernia A hernia that occurs through the opening behind the navel (which normally closes after birth).

Umbilicus Navel / belly button.

Xiphoid process The cartilaginous section at the lower end of the sternum.

References 1. GM EUR Operational Policy 2. Frequency of abdominal wall hernias: is classical teaching out of date?, Natalie Dabbas et al, JRSM Short Rep. 2011 Jan; 2(1): 5. 3. Commissioning Guide: Groin Hernia, The Royal College of Surgeons and British Hernia Society (Date of revised publication: November 2016)

Governance Approvals

Name Date Approved

Greater Manchester Effective Use of Resources Steering Group 21/11/2018

3. GM Hernia Policy v1.0 FINAL Page 10 of 23 Greater Manchester Directors of Commissioning / Greater Manchester Chief 29/08/2019 Finance Officers (Delegated authority given to approve policy by Greater Manchester Joint Commissioning Board)

Bolton Clinical Commissioning Group Awaiting approval

Bury Clinical Commissioning Group 29/08/2019

Heywood, Middleton & Rochdale Clinical Commissioning Group 29/08/2019

Manchester Clinical Commissioning Group 29/08/2019

Oldham Clinical Commissioning Group 29/08/2019

Salford Clinical Commissioning Group 29/08/2019

Stockport Clinical Commissioning Group 29/08/2019

Tameside & Glossop Clinical Commissioning Group 29/08/2019

Trafford Clinical Commissioning Group 29/08/2019

Wigan Borough Clinical Commissioning Group 29/08/2019

3. GM Hernia Policy v1.0 FINAL Page 11 of 23 Appendix 1 – Evidence Review Surgical repair of hernias GM059

Search Strategy

The following databases are routinely searched: NICE Clinical Guidance and full website search; NHS Evidence and NICE CKS; SIGN; Cochrane; York; and the relevant Royal College and any other relevant bespoke sites. A Medline / Open Athens search is undertaken where indicated and a general google search for key terms may also be undertaken. The results from these and any other sources are included in the table below. If nothing is found on a particular website it will not appear in the table below:

Database Result

NICE Evidence and Royal Commissioning Guide: Groin Hernia, The Royal College of Surgeons and College of Surgeons British Hernia Society (Date of revised publication: November 2016) Website

NICE Evidence and BMJ Hernia surgery is cost effective, finds UK study, Zosia Kmietowicz library BMJ 2013;346:f3498

BMJ Clinical Evidence Review: Inguinal hernia (Search date: September 2007), Andre Chow, Sanjay Purkayastha, Thanos Athanasiou, Paris Tekkis, and Ara Darzi

NICE Evidence Management of Asymptomatic Inguinal Hernia: A Systematic Review of the Evidence, Hagar Mizrahi, MD; Michael C. Parker, FRCS, Arch Surg. 2012;147(3):277-281

Summary of the evidence

Evidence suggests that in symptomatic patients the repair of abdominal hernias is cost effective and the reported recurrence rate is low3. Evidence also suggests that the majority of abdominal hernias are asymptomatic and do not require surgical intervention. For asymptomatic inguinal hernias a period of watchful waiting appears as effective as early referral although many will become symptomatic over time.

The evidence

Levels of evidence

Level 1 Meta-analyses, systematic reviews of randomised controlled trials

Level 2 Randomised controlled trials

Level 3 Case-control or cohort studies

Level 4 Non-analytic studies e.g. case reports, case series

Level 5 Expert opinion

3. GM Hernia Policy v1.0 FINAL Page 12 of 23 1. LEVEL N/A: COMMISSIONING GUIDE Commissioning Guide: Groin Hernia, The Royal College of Surgeons and British Hernia Society (Date of revised publication: November 2016)

2. HIGH VALUE CARE PATHWAY FOR GROIN HERNIA 2.1 Primary Care Primary Care Referral Guidelines: • All patients with an overt or suspected primary or recurrent inguinal or femoral hernias to a surgical provider except for patients with minimally symptomatic inguinal hernias who have significant comorbidity (ASA 4) AND do not want to have surgical repair (after appropriate information has been provided). Similarly, ASA 1-3 patients who do not want surgical repair after appropriate information has been provided do not require referral. • CCGs should not set criteria for referral and treatment for inguinal hernias outside that recommended in this guidance, as this approach produces worse clinical outcomes and has not been shown to be cost effective • Irreducible and partially reducible inguinal hernias, and all groin hernias in women should be ‘’urgent referrals’ • Patients with suspected strangulated or obstructed inguinal hernia should be ‘emergency referrals’ • All children <18 years with inguinal hernia should be referred to a paediatric surgical provider • Modifiable risk factors such as smoking cessation, diabetic control and weight reduction should be optimised in the primary care setting prior to elective surgery Imaging • Diagnostic imaging should not be arranged at primary care level Whom to refer to: • Patients with primary groin hernias meeting referral criteria can be referred generically to an appropriate secondary care provider • Patients with bilateral groin hernias should be referred to a surgeon who performs both open and laparoscopic repair • Patients with recurrent inguinal or femoral hernias meeting referral criteria should be referred to a surgeon who performs both open and laparoscopic repair and where possible to the named surgeon who performed the first repair (providing the patient does not request otherwise) • Patients with multiply recurrent (more than one recurrence) groin hernias should be referred to a named surgeon who has subspecialty interest in hernia repair and performs both open and laparoscopic repair • Patients should be directed to appropriate supporting patient information e.g. as available on the British Hernia Society website (http://www.britishherniasociety.org/) 2.2 Secondary Care Medical Imaging • Medical imaging should be considered in patients in whom there is diagnostic uncertainty or to exclude other pathology • Dynamic ultrasound scan (dUSS) is recommended as the first line investigation. (ultrasound under valsalva manoeuvre or any position to increase the intra-abdominal pressure) • Herniography is rarely performed but can be utilised if local expertise is available as an alternative to dUSS • Magnetic resonance imaging (MRI) should be considered if USS is negative and groin pain persists, OR if the cause of pain is not deemed likely to be due to a hernia by the surgeon. The MRI is to assess for causes of groin pain other than a hernia Which patients require an operation? • Surgical repair should be offered to patients with a symptomatic inguinal hernia and should be considered in patients less than 65 years of age with an asymptomatic inguinal hernia

3. GM Hernia Policy v1.0 FINAL Page 13 of 23 • Patients with asymptomatic hernias should be referred to a surgeon; asymptomatic hernias can be managed conservatively (watch and wait approach)* but there is a likelihood of requiring surgery in the future, outcomes are worse and conservative management is not cost effective for the healthcare community • Patients should always be warned of the potential complications of repair including chronic pain. Five years after an inguinal hernia repair only a small proportion of patients, between 2% and 3.5%, report moderate to severe chronic pain. Laparoscopic inguinal hernia repair has been reported to result in less chronic pain than open repair * A watch and wait approach describes conservative management in patients with an asymptomatic hernia after discussion of the risks and benefits of surgery with a surgeon, but if the hernia becomes symptomatic then the risks and benefits are re-evaluated at that stage Peri operative management • All patients should be pre-assessed in keeping with NHS and NICE guidelines • All patients should be considered for day case surgery. The pre-assessment process and surgical infrastructure are important in ensuring appropriate selection and effective day case services • A small number of individuals require post-operative in-patient care because of co-morbidity, social reasons or for complex inguinal hernias • There is no indication for the routine use of antibiotic prophylaxis in elective open or laparoscopic groin hernia repair in low-risk patients. In high risk patients i.e. recurrent hernias or immunosuppression a single dose of broad spectrum antibiotic should be given Open vs. laparoscopic repair • In the management of unilateral primary inguinal hernias (general population) there is conflicting information on whether laparoscopic repair reduces the incidence of chronic pain and improves other outcomes. The majority of meta analyses conclude that the incidence and severity of pain (both acute and chronic) is lower after laparoscopic repair compared to open repair but there are limitations in the studies used • The laparoscopic approach may be beneficial in patients at risk of chronic pain. This group includes younger patients, patients with other chronic pain problems, or patients who present with severe groin pain and with only a small hernia on examination and these patients should be given the choice of laparoscopic repair • Groin hernias in women should preferentially be repaired laparoscopically because of the risk of undiagnosed femoral or contralateral inguinal hernias • Bilateral inguinal hernias should be repaired laparoscopically from a cost-utility and patient perspective • The open approach under local anaesthesia (LA) is a very acceptable and cost effective technique in suitable patients, and may be particularly beneficial in older patients or those with significant comorbidity • The resource cost at the time of surgery is higher for laparoscopic surgery (Total Extraperitoneal (TEP) and Transabdominal Pre-peritoneal (TAPP)) compared to open surgery, however the laparoscopic approach is more cost effective in the long-term • There is no evidence supporting TEP ahead of TAPP or vice versa • The technique used in the index hernia repair should be taken into account when choosing the technique for repair of recurrence. If the initial approach was an open anterior repair then the recurrent operation should be a laparoscopic repair and vice versa • All adult inguinal hernias should be repaired using flat mesh (or non-mesh Shouldice repair, if experience is available) • A cost effective ‘so called lightweight’ (large pore) mesh should be used Follow Up • Routine outpatient follow up is not required after inguinal hernia repair 8.3 Evidence base (NOTE: This is a selection from the full list)

3. GM Hernia Policy v1.0 FINAL Page 14 of 23 • Kingsnorth, A., Controversial topics in surgery. The case for open repair. Annals of the Royal College of Surgeons of England, 2005. 87(1): p. 57-60; discussion 57-60. • Kurzer, M., A.E. Kark, and T. Hussain, Hernia repair: Outcomes other than recurrence should be analysed. BMJ, 2008. 336(7652): p. 1033. 3. Collaboration, I.T., Operation compared with watchful waiting in elderly male inguinal hernia patients: a review and data analysis. J Am Coll Surg, 2011. 212(2): p. 251-259 e1-4. • Collaboration, I.T. Operation compared with watchful waiting in elderly male inguinal hernia patients: a review and data analysis. J Am Coll Surg. 2011; 212(2): 251-259 e1-4. DOI: 10.1016/j.jamcollsurg.2010.09.030. • Chung, L., J. Norrie, and P.J. O'Dwyer, Long-term follow-up of patients with a painless inguinal hernia from a randomized clinical trial. Br J Surg, 2011. 98(4): p. 596-9. • Bay-Nielsen, M., et al., Quality assessment of 26,304 herniorrhaphies in Denmark: a prospective nationwide study. Lancet, 2001. 358(9288): p. 1124-8. • Nilsson, H., et al., Mortality after groin hernia surgery. Ann Surg, 2007. 245(4): p. 656-60. • Simons, M.P., et al., European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia : the journal of hernias and abdominal wall surgery, 2009. 13(4): p. 343-403. • Robinson, P., et al., Inguinofemoral hernia: accuracy of sonography in patients with indeterminate clinical features. AJR Am J Roentgenol, 2006. 187(5): p. 1168-78. • Khan, W., A.C. Zoga, and W.C. Meyers, Magnetic resonance imaging of athletic pubalgia and the sports hernia: current understanding and practice. Magn Reson Imaging Clin N Am, 2013. 21(1): p. 97-110. • Mullens, F.E., et al., Review of MRI technique and imaging findings in athletic pubalgia and the "sports hernia". Eur J Radiol, 2012. 81(12): p. 3780-92. • Gallegos, N.C., et al., Risk of strangulation in groin hernias. Br J Surg, 1991. 78(10): p. 1171-3. • NHS Institute for Innovation and Improvement. Pre-operative Assessment and Planning. 2008; Available from: http://www.institute.nhs.uk/quality_and_service_improvement_tools/quality_and_service_improveme nt_tools/pre-operative_assessment_and_planning.html. • NICE. CG3 The use of routine preoperative tests for elective surgery. 2003; Available from: http://guidance.nice.org.uk/CG3. • Ruckley, C.V., et al., Day care after operations for hernia or varicose veins: a controlled trial. Br J Surg, 1978. 65(7): p. 456-9. • De Lathouwer, C. and J.P. Poullier, How much ambulatory surgery in the World in 1996-1997 and trends? Ambul Surg, 2000. 8(4): p. 191-210. • Jarrett, P.E., Day care surgery. Eur J Anaesthesiol Suppl, 2001. 23: p. 32-5. • Sanchez-Manuel, F.J., J. Lozano-Garcia, and J.L. Seco-Gil, Antibiotic prophylaxis for hernia repair. Cochrane database of systematic reviews, 2012. 2: p. CD003769.

2. LEVEL N/A: REVIEW OF COST EFFECTIVENESS Hernia surgery is cost effective, finds UK study, Zosia Kmietowicz BMJ 2013;346:f3498

Elective hernia surgery presents value for money for the NHS, a study has found, contradicting recent guidelines suggesting that the operation was of “low clinical value” and that commissioners should consider restricting it. The latest analysis used patient reported outcome measures (PROMs) from nearly 17 500 patients who had a hernia operation in England between 1 April 2009 and 31 Match 2010. These data have been collected routinely in the NHS since 2009, before and at least three months after patients undergo hernia repair. Researchers from the think tank the King’s Fund and Imperial College London combined these outcomes with costs of the surgery as reported by hospitals to estimate the cost effectiveness of surgery

3. GM Hernia Policy v1.0 FINAL Page 15 of 23 for hernia repair. The results, expressed as a cost per quality adjusted life year (QALY), were published in the Journal of the Royal Society of Medicine.1 The results suggest that hernia surgery is cost effective, costing an average £1881 (€2200; $2834) per QALY. The National Institute for Health and Care Excellence (NICE) normally recommends treatments costing up to £20 000 to £30 000 per QALY. The actual mean change in QALYs after surgery was 0.826 (95% confidence interval 0.793 to 0.859) compared with no treatment, and was estimated to be higher after laparoscopic surgery (0.923 (0.859 to 0.988)) than after open surgery (0.817 (0.782 to 0.852)). Quality of life, as measured by the EQ-5D questionnaire, was also significantly higher after laparoscopic surgery (index change 0.0915 (95% confidence interval 0.850 to 0.0979) than after open surgery (0.0806 (0.0771 to 0.0841)). The index asks questions about mobility, self care, usual activity, pain, and anxiety or depression. In 2011, the Audit Commission—the public spending watchdog—included some hernia operations among those procedures that commissioners could stop funding as a means of saving the NHS millions of pounds a year because they were of low clinical value.2 The researchers say that commissioners need to “demonstrate clearly whether a procedure is genuinely of low clinical value to justify any access restrictions they wish to impose.” The methodology they have used provides a means of comparing the cost effectiveness of interventions and could be used to inform “healthcare purchasing decisions,” they said. The same methods could compare outcomes at different hospitals, they suggested. Sophie Coronini-Cronberg, from the School of Public Health at Imperial College London and who led the study, said: “Our results challenge the idea that hernia surgery has low clinical value. Based on what patients tell us about how the treatments help them, it would seem that hernia surgery not only improves people’s lives substantially but also represents good value for NHS spending. “At present, PROMs are only being collected for a few procedures. We’ve shown that these reports can allow us to quantify the benefits that patients experience and also estimate the cost effectiveness of treatments. If the government is serious about producing information on the health benefits of NHS services, then we need to collect more and properly make use of this kind of data.” 1. Coronini-Cronberg S, Appleby J, Thompson J. Application of patient-reported outcome measures (PROMs) data to estimate cost-effectiveness of hernia surgery in England. J R Soc Med 2013, doi:10.1177/0141076813489679. 2. Mooney H. Cut useless medical treatments, says Audit Commission.

3. LEVEL 1: EVIDENCE REVIEW BMJ Clinical Evidence Review: Inguinal hernia (Search date: September 2007), Andre Chow, Sanjay Purkayastha, Thanos Athanasiou, Paris Tekkis, and Ara Darzi

ABSTRACT Introduction: The main risk factors for inguinal hernia are male sex and increasing age. Complications of inguinal hernia include strangulation, intestinal obstruction, and infarction. Recurrence can occur after surgery. Methods and outcomes: We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of elective treatments for primary unilateral, primary bilateral, and recurrent inguinal hernia in adults? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2007 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review).We included harms alerts from relevant organisations, such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Results: We found 24 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. Conclusions: In this systematic review, we present information relating to the effectiveness and safety of the following interventions: expectant management, open mesh repair, open suture repair, totally extraperitoneal (TEP) laparoscopic repair, and transabdominal preperitoneal (TAPP) laparoscopic repair. Complications of inguinal hernia include strangulation, intestinal obstruction, and infarction. Recurrence can occur after surgery.

3. GM Hernia Policy v1.0 FINAL Page 16 of 23 The consensus is that surgery is the treatment of choice for inguinal hernia, although few good-quality studies have compared surgery with expectant management. Open suture repair is a well-established surgical treatment for people with unilateral inguinal hernia, but seems less effective at preventing recurrence, and prolongs recovery, compared with other techniques. Open mesh repair reduces the risk of recurrence compared with open suture repair, without increasing the rate of surgical complications. Totally extraperitoneal (TEP) laparoscopic repair may lead to less pain, faster recovery, and similar recurrence rates compared with open mesh repair, but studies have given inconclusive results. Transabdominal preperitoneal (TAPP) laparoscopic repair reduces pain and speeds up recovery compared with open mesh repair, but both procedures have similar recurrence rates. Open suture repair may be associated with longer recovery times compared with open mesh repair or TAPP laparoscopic repair in people with bilateral inguinal hernia. Open mesh repair seems as effective as TEP laparoscopic repair, but may prolong recovery and increase complication rates compared with TAPP laparoscopic repair. Open suture repair may be associated with an increased recovery time compared with open mesh repair in people with recurrent inguinal hernia. We don't know how open suture repair compares with TEP or TAPP laparoscopic repair in people with recurrent inguinal hernia. TAPP and TEP laparoscopic repair may both reduce recovery time compared with open mesh repair, but complication rates seem to be similar. Comment: Clinical guide: Most clinicians believe surgical intervention to be the first-line treatment for inguinal hernia. However, there is some (albeit limited) evidence that watchful waiting (expectant management) is a safe option for men with minimally symptomatic or asymptomatic unilateral inguinal hernia. However, if these hernias become symptomatic they should be repaired. There is strong evidence that open mesh repair significantly reduces recurrence rates compared with open suture repair, but there is no significant difference in perioperative complication rates between the two methods.

4. LEVEL 1: SYSTEMATIC REVIEW Management of Asymptomatic Inguinal Hernia: A Systematic Review of the Evidence, Hagar Mizrahi, MD; Michael C. Parker, FRCS, Arch Surg. 2012;147(3):277-281

Objective: To establish a literature-based surgical approach to asymptomatic inguinal hernia (IH). Data Sources: PubMed, the Cochrane Library database, Embase, national guidelines (including the National Library of Guidelines Specialist Library), National Institute for Health and Clinical Excellence guidelines, and the National Research Register were searched for prospective randomized trials comparing surgical treatment of patients with asymptomatic IH with conservative treatment. Study Selection: The literature search retrieved 216 article headlines, and these articles were analyzed. Of those studies, a total of 41 articles were found to be relevant and 2 large well-conducted randomized controlled studies that published their results in several articles were reviewed. Data Extraction: The pain and discomfort, general health status, complications, and life-threatening events of patients with asymptomatic IH managed by surgery or watchful waiting were determined. Data Synthesis: No significant difference in pain scores and general health status were found when comparing the patients who were followed up with the patients who had surgery.A significant crossover ratio ranging between 23% and 72% from watchful waiting to surgery was found. In patients with watchful waiting, the rates of IH strangulation were 0.27% after 2 years of follow-up and 0.55% after 4 years of follow-up. In patients who underwent elective surgery, the range of operative complications was 0% to 22.3% and the recurrence rate was 2.1%. Conclusion: Both treatment options for asymptomatic IH are safe, but most patients will develop symptoms (mainly pain) over time and will require operation.

3. GM Hernia Policy v1.0 FINAL Page 17 of 23 Appendix 2 – Table of ASA classification Surgical repair of hernias GM059

3. GM Hernia Policy v1.0 FINAL Page 18 of 23 Appendix 3 – Diagnostic and Procedure Codes Surgical repair of hernias GM059

(All codes have been verified by Mersey Internal Audit’s Clinical Coding Academy)

GM059 – Surgical repair of hernias

OPCS-4 Procedure Codes:

Primary repair of inguinal hernia using insert of natural material T201

Primary repair of inguinal hernia using insert of prosthetic material T202

Primary repair of inguinal hernia using sutures T203

Primary repair of inguinal hernia and reduction of sliding hernia T204

Other specified primary repair of inguinal hernia T208

Unspecified primary repair of inguinal hernia T209

Repair of recurrent inguinal hernia using insert of natural material T211

Repair of recurrent inguinal hernia using insert of prosthetic material T212

Repair of recurrent inguinal hernia using sutures T213

Other specified repair of recurrent inguinal hernia T218

Unspecified repair of recurrent inguinal hernia T219

Primary repair of femoral hernia using insert of natural material T221

Primary repair of femoral hernia using insert of prosthetic material T222

Primary repair of femoral hernia using sutures T223

Other specified primary repair of femoral hernia T228

Unspecified primary repair of femoral hernia T229

Repair of recurrent femoral hernia using insert of natural material T231

Repair of recurrent femoral hernia using insert of prosthetic material T232

Repair of recurrent femoral hernia using sutures T233

Other specified repair of recurrent femoral hernia T238

Unspecified repair of recurrent femoral hernia T239

Repair of umbilical hernia using insert of natural material T241

Repair of umbilical hernia using insert of prosthetic material T242

Repair of umbilical hernia using sutures T243

Other specified repair of umbilical hernia T248

3. GM Hernia Policy v1.0 FINAL Page 19 of 23 Unspecified repair of umbilical hernia T249

Primary repair of incisional hernia using insert of natural material T251

Primary repair of incisional hernia using insert of prosthetic material T252

Primary repair of incisional hernia using sutures T253

Other specified primary repair of incisional hernia T258

Unspecified primary repair of incisional hernia T259

Repair of recurrent incisional hernia using insert of natural material T261

Repair of recurrent incisional hernia using insert of prosthetic material T262

Repair of recurrent incisional hernia using sutures T263

Other specified repair of recurrent incisional hernia T268

Unspecified repair of recurrent incisional hernia T269

Repair of ventral hernia using insert of natural material T271

Repair of ventral hernia using insert of prosthetic material T272

Repair of ventral hernia using sutures T273

Other specified repair of ventral hernia T278

Unspecified repair of ventral hernia T279

Repair of recurrent umbilical hernia using insert of natural material T971

Repair of recurrent umbilical hernia using insert of prosthetic material T972

Repair of recurrent umbilical hernia using sutures T973

Other specified repair of recurrent umbilical hernia T978

Unspecified repair of recurrent umbilical hernia T979

Repair of recurrent ventral hernia using insert of natural material T981

Repair of recurrent ventral hernia using insert of prosthetic material T982

Repair of recurrent ventral hernia using sutures T983

Other specified repair of recurrent ventral hernia T988

Unspecified repair of recurrent ventral hernia T989

With the following ICD-10 diagnosis codes:

Bilateral inguinal hernia, without obstruction or gangrene K402

Unilateral or unspecified inguinal hernia, without obstruction or gangrene K409

Bilateral femoral hernia, without obstruction or gangrene K412

3. GM Hernia Policy v1.0 FINAL Page 20 of 23 Unilateral or unspecified femoral hernia, without obstruction or gangrene K419

Umbilical hernia without obstruction or gangrene K429

Incisional hernia without obstruction or gangrene K432

Other and unspecified ventral hernia without obstruction or gangrene K439

Diaphragmatic hernia without obstruction or gangrene K449

Other specified abdominal hernia without obstruction or gangrene K458

Unspecified abdominal hernia without obstruction or gangrene K469

ICD-10 diagnosis codes: (Exceptions)

Bilateral inguinal hernia, with obstruction, without gangrene K400

Bilateral inguinal hernia, with gangrene K401

Unilateral or unspecified inguinal hernia, with obstruction, without gangrene K403

Unilateral or unspecified inguinal hernia, with gangrene K404

Bilateral femoral hernia, with obstruction, without gangrene K410

Bilateral femoral hernia, with gangrene K411

Unilateral or unspecified femoral hernia, with obstruction, without gangrene K413

Unilateral or unspecified femoral hernia, with gangrene K414

Umbilical hernia with obstruction, without gangrene K420

Umbilical hernia with gangrene K421

Incisional hernia with obstruction, without gangrene K430

Incisional hernia with gangrene K431

Parastomal hernia with obstruction, without gangrene K433

Parastomal hernia with gangrene K434

Other and unspecified ventral hernia with obstruction without gangrene K436

Other and unspecified ventral hernia with gangrene K437

Diaphragmatic hernia with obstruction, without gangrene K440

Diaphragmatic hernia with gangrene K441

Other specified abdominal hernia with obstruction, without gangrene K450

Other specified abdominal hernia with gangrene K451

Unspecified abdominal hernia with obstruction, without gangrene K460

Unspecified abdominal hernia with gangrene K461

3. GM Hernia Policy v1.0 FINAL Page 21 of 23 Appendix 4 – Version History Surgical repair of hernias GM059

The latest version of this policy can be found here GM Hernia Repair Policy

Version Date Summary of Changes

0.1 23/04/2018 Initial draft

0.2 16/05/2018 The GM EUR Steering Group requested the following amendments: • Commissioning Statement o Policy Exclusions: '(includes femoral and inguinal hernias)' added after 'All suspected groin hernias'; '(i.e. before their 18th birthday)' added after '18'; '/ adolescent' added after 'relevant paediatric' o Policy Inclusion Criteria: First paragraph moved under first heading; first heading amended to read 'Inguinal hernia in men (for women and children see 'Policy Exclusions' above'; second paragraph added around 'Watchful waiting...'. o Recommended GMEURSG funding mechanisms added for 'Inguinal hernia in men' (MA), 'Umbilical hernia' (IPA), ‘Incisional hernia’ (IPA) and 'Other asymptomatic or minimally symptomatic hernias' (Exceptionality) o Final paragraph in final section reading 'Additional costs over and above the Hernia NHS PBR tariff relating to the type of mesh used by the provider will require a request for funding via the EUR route.' moved to bottom of funding mechanism for every section o 'Asymptomatic or minimally symptomatic hernias' heading amended to read 'Other asymptomatic or minimally symptomatic hernias (including divarification recti) unless specifically mentioned above should be managed as follows:' • Appendices: ‘Appendix 2 – Table of ASA classification’ added

0.3 18/07/2018 The GM EUR Steering Group approved the changes made to the policy at the last meeting and agreed that the policy could now go out for a period of clinical engagement.

0.4 01/10/2018 Branding changed to reflect change of service from Greater Manchester Shared Services to Greater Manchester Health and Care Commissioning.

0.5 21/11/2018 GM EUR Steering Group reviewed the Clinical Engagement feedback and agreed the following amendments to the policy: • Commissioning Statement o Best practice guidelines section added o Note added to funding mechanisms around the type of mesh used o ‘For the following hernia types the risk of strangulation and or other complications is low so they should be managed as follows:’ added above ‘Umbilical hernias’.

Subject to the above amendments being made the GM EUR Steering Group approved the policy to go through the CCG governance process.

0.6 05/02/2019 Diagnostic and Procedure Codes added to Appendix 3

3. GM Hernia Policy v1.0 FINAL Page 22 of 23 0.7 01/08/2019 Clinical Exceptionality Section updated to read: Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. More information on determining clinical exceptionality can be found in the Greater Manchester (GM) Effective Use of Resources (EUR) Operational Policy. Link to GM EUR Operational Policy

1.0 29/08/2019 Policy approved for implementation by the Greater Manchester Directors of Commissioning / Greater Manchester Chief Finance Officers.

3. GM Hernia Policy v1.0 FINAL Page 23 of 23

Greater Manchester EUR Policy Statement on: Surgical Correction of Adult Strabismus (Squint) GM Ref: GM058 Version: 1.0 (29 August 2019)

Commissioning Statement

Surgical Correction of Adult Strabismus (Squint) Policy Strabismus surgical procedures in children and young adults under the age of 18 are Exclusions excluded from this policy. (Alternative commissioning The use of botulinum toxin to manage squint (this is included in the GMMMG guidance arrangements apply) for the use of botulinum toxin)

Fitness for NOTE: All patients should be assessed as fit for surgery before going ahead with Surgery treatment, even though funding has been approved.

Best Practice All providers are expected to follow best practice guidelines (where available) in the Guidelines management of these conditions. Policy Correction of adult (aged over 18 years - i.e. after their 18th Birthday) squint for purely Inclusion aesthetic reasons is not routinely commissioned but may be considered where the Criteria squint is severe (see below for the criteria).

Correction of strabismus recurring in adulthood following corrective surgery in childhood will be considered for the same reasons but will not be commissioned for purely aesthetic reasons.

Prior to referral Prior to referral all conservative measures should have been tried (including prisms) for a period of at least 3 months and failed despite full compliance.

Symptomatic/functional strabismus (squint) Patients can be referred for consideration of surgery for treatment of Strabismus when the following occurs AND corrective lenses and exercise fail to correct it: • to treat amblyopia, present since childhood, that has decompensated • to treat loss of 3-dimensional vision • to reduce visual confusion (see description above) • to stop abnormal head posture

Funding Mechanism Monitored approval: Referrals may be made in line with the criteria without seeking funding. NOTE: May be the subject of contract challenges and/or audit of cases against commissioned criteria. Individual Funding request for exceptionality for patients in the asymptomatic/non- functional group.

If the requested procedure is NOT commissioned clinicians can submit an individual funding request outside of this guidance if they feel there is a good case for clinical exceptionality. Requests must be submitted with all relevant supporting evidence.

3. GM Strabismus Policy v1.0 FINAL Page 2 of 18

Asymptomatic / non-functional strabismus (squint) Correction of adult (aged over 18 years) squint for purely aesthetic reasons is not routinely commissioned unless the squint is severe, see below:-.

Correction of this type of adult squint will only be commissioned where: • The squint is equal to or more than 20 prism diopters. NOTE: The medical definition of prism diopter: ‘An arbitrary standard of prismatic deflection equal to that of a prism that deflects a beam of light one centimeter on a plane placed at a distance of one meter. Which can be converted to deviation using the following mathematical calculation - 1 degree of deviation = 1.75 prism diopters.’

Funding Mechanism Individual prior approval provided the patient meets the above criteria. Requests must be submitted with all relevant supporting evidence. If the patient does not meet the criteria: an individual funding request can be made if there is a good case for clinical exceptionality. Requests must be submitted with all relevant supporting evidence.

3. GM Strabismus Policy v1.0 FINAL Page 3 of 18

Contents

Commissioning Statement ...... 2 Policy Statement ...... 5 Equality & Equity Statement ...... 5 Governance Arrangements ...... 5 Aims and Objectives ...... 5 Rationale behind the policy statement ...... 6 Treatment / Procedure ...... 6 Epidemiology and Need ...... 7 Adherence to NICE Guidance ...... 7 Audit Requirements ...... 7 Date of Review ...... 8 Glossary ...... 8 References ...... 9 Governance Approvals ...... 9 Appendix 1 – Evidence Review ...... 11 Appendix 2 – Measuring degree of Strabismus using a prism ...... 13 Appendix 3 – Diagnostic and Procedure Codes ...... 15 Appendix 4 – Version History ...... 17

3. GM Strabismus Policy v1.0 FINAL Page 4 of 18 Policy Statement

This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester.

Equality & Equity Statement

An Equality Analysis has been carried out on the policy. For more information about the Equality Analysis, please contact [email protected].

Governance Arrangements

Aims and Objectives

This policy document aims to ensure equity, consistency and clarity in the commissioning of treatments/procedures by CCGs in Greater Manchester by:

3. GM Strabismus Policy v1.0 FINAL Page 5 of 18 • reducing the variation in access to treatments/procedures. • ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness. • reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester. • promoting the cost-effective use of healthcare resources.

Rationale behind the policy statement

Asymptomatic/ non-functional strabismus or strabismus that is being effectively managed in adults does not require surgical intervention for clinical reasons. As with all surgery, correction of strabismus is not without risk(s) therefore these procedures are either restricted or are not commissioned when being done for aesthetic (i.e. There are no visual or other symptoms associated with the squint that need corrected) reasons.

This policy has been developed to ensure that the resources needed are available to treat those adult patients with strabismus where it is causing visual and other functional problems.

Treatment / Procedure

Strabismus Strabismus, or squint, is defined as a misalignment of the two eyes. It may be present from birth or arise at any time in life. In many cases, no clear cause is identified. However, it is more common in those with a family history of the condition, refractive errors and some syndromic or neurological conditions. A smaller number arise from a range of identifiable pathologies including orbital, neurological and muscular conditions affecting ocular muscle control. Strabismus can be constant or intermittent, whereby the eyes are straight some of the time. The most common types of strabismus are horizontal and can be classified as esotropia (convergent, the eye turns in) and exotropia (divergent, the eye turns out); vertical strabismus includes hypertropia (upward turn) and hypotropia (downward turn). Less commonly, eyes can be rotated (torsional strabismus).

Correction surgery Strabismus surgery is performed as a day case procedure under general anaesthetic in most cases and takes up to 1 hour of surgical time. By altering the point of the insertion of an extra-ocular muscle into the sclera, or by shortening an extra-ocular muscle, the misalignment of a squinting eye can be corrected. There are various techniques, and the muscle(s) operated on depend on the type of squint. Surgery may be performed on one or both eyes. Sometimes two or more operations are required to achieve a successful alignment of the eyes.

Strabismus (squint) may be considered symptomatic / functional when one of the following applies: • Strabismus can cause diplopia (double vision) when patients (older children and adults) are unable to suppress the image from the squinting eye. Referral should be made for recently developed diplopia to prevent it becoming persistent. Referral must be made before there is any evidence of loss of vision. • Amblyopia, also known as lazy eye, is a vision development disorder in which an eye fails to achieve normal visual acuity, despite glasses or contact lenses, due to a failure of adequate stimulation of the nerve pathways between the brain and eye in early childhood. Once established, amblyopia will persist for life. Referral should be made for recently developed amblyopia to prevent it becoming persistent. Referral must be made before there is any evidence of loss of vision. • The ability to perceive 3-dimensional objects is known as stereopsis and requires the brain to use the slightly differing images from the two eyes looking at the same point to reconstruct a perception of a

3. GM Strabismus Policy v1.0 FINAL Page 6 of 18 3-D world. 3-D vision assists in our ability to navigate and mobilise, coordinate fine movements and judge depth. In later onset strabismus, whilst the eyes are misaligned, sufferers will usually see two objects and lose the ability to appreciate 3-D. • Adults with strabismus may experience visual confusion, where they perceive two different images superimposed onto the same space. This can be due to a new-onset squint or a deterioration of a long-standing squint visual confusion is particularly debilitating when driving as patients may perceive cars to be heading towards them. • Adults with strabismus may turn their face or tilt their head to eliminate and/or reduce their double vision. This compensatory head posture is frequently associated with neck muscle discomfort and even contracture.

Epidemiology and Need

Strabismus affects approximately 4% of adults and 2% of all children.

Strabismus (squint) is a misalignment of the two eyes, uncorrected this may cause functional visual problems including double vision, visual confusion, loss of stereopsis (3D vision) and binocularity (the coordinated use of the two eyes together), asthenopia (eye strain) and headaches and the requirement to adopt an abnormal head posture for vision.

Untreated visual issues related to strabismus may lead to: • A loss of independence as sudden loss of 3-D vision prevents individuals from carrying out ordinary everyday tasks. Patients with double vision often feel overwhelmed in public areas due to disorientation and an inability to navigate or avoid collisions with objects. It can make cooking and even pouring hot water into a cup from a kettle hazardous. • Loss of a patient’s ability to drive. The DVLA states that patients cannot drive if they have double vision however they can legally drive once they overcome their double vision by using prism lens spectacles, covering the squinting eye (NOTE: This can cause poor depth perception) • A risk of falls: Patients with diplopia or reduced binocularity (difficulty using both eyes together) secondary to strabismus are at risk of other health problems such as falls, fractures and musculoskeletal injuries. In a study of over two million patients, it was found that adults with binocular vision disorders were 27% more likely suffer from falls, fractures and injuries than those without1. • Asthenopia: (Eye strain) is a common complaint amongst adults with strabismus and can cause headaches, blurred vision and pain around the eyes.

Non-surgical management options include prism lenses, eye exercise and botulinum toxin procedures which can correct the visual issues in some patients without the need for surgery. There is good evidence that surgery is safe, although all surgery carries risk(s), and highly effective in addressing these issues in clinically suitable cases.

Adherence to NICE Guidance

NICE have not issued clinical guidance for the surgical management of Strabismus.

There is a NICE Clinical Knowledge Summary for the management of squint in children.

Audit Requirements

1Pineles S et al., (2015) Risk of Musculoskeletal Injuries, Fractures, and Falls in Medicare Beneficiaries With Disorders of Binocular Vision. JAMA Ophthalmol; 133(1): 60-65.

3. GM Strabismus Policy v1.0 FINAL Page 7 of 18 There is currently no national database. Service providers will be expected to collect and provide audit data on request.

Date of Review

One year from the date of approval by the governance process and thereafter at a date agreed by the Greater Manchester EUR Steering Group, unless new evidence or technology is available sooner.

The evidence base for the policy will be reviewed and any recommendations within the policy will be checked against any new evidence. Any operational issues will also be considered at this time. All available additional data on outcomes will be included in the review and the policy updated accordingly. The policy will be continued, amended or withdrawn subject to the outcome of that review.

Glossary

Term Meaning

3-dimensional vision The ability to perceive 3-dimensional objects is known as stereopsis and requires the brain to use the slightly differing images from the two eyes looking at the same point to reconstruct a perception of a 3-D world. 3-D vision assists in our ability to navigate and mobilise, coordinate fine movements and judge depth. In later onset strabismus, whilst the eyes are misaligned, sufferers will usually see two objects and lose the ability to appreciate 3-D.

Abnormal head posture Putting the head into a position it would not normally be in – often tilted and to the side in the context of strabismus.

Amblyopia Also known as lazy eye, is a vision development disorder in which an eye fails to achieve normal visual acuity, even with prescription eyeglasses or contact lenses, affect one eye.

Asthenopia Also known eye strain, an eye condition that manifests through nonspecific symptoms such as fatigue, pain in or around the eyes, blurred vision, headache, and occasional double vision. Symptoms often occur after reading, computer work, or other close activities that involve tedious visual tasks.

Asymptomatic When a disease or abnormality is present in the body but is not causing any symptoms (signs of its presence, e.g. pain).

Binocularity The ability to focus upon an object with both eyes and create a single stereoscopic image.

Botulinum toxin A neurotoxic protein produced by the bacterium Clostridium botulinum and related species. It prevents the release of the neurotransmitter acetylcholine from axon endings at the neuromuscular junction and thus causes flaccid paralysis.

Contracture A condition of shortening and hardening of muscles, tendons, or other tissue, often leading to deformity and rigidity.

Convergent In this context when the pupil of the eye(s) normal position moves towards the nose – (the adjective describing the noun estropia).

Diplopia Double vision

Divergent In this context when the pupil of the eye(s) normal position moves away from

3. GM Strabismus Policy v1.0 FINAL Page 8 of 18 the nose.

Esotropia Is a form of strabismus in which one or both eyes turns inward. The condition can be constantly present, or occur intermittently, and can give the affected individual a ‘cross-eyed’ appearance (the noun describing the adjective convergent).

Exotropia Is a form of strabismus in which one or both eyes turns outward. The condition can be constantly present, or occur intermittently, and can give the affected individual a ‘wall-eyed’ appearance (the noun describing the adjective divergent).

Hypertropia Elevation of the line of vision of one eye above that of the other: upward strabismus.

Hypotropia Strabismus in which the line of vision of one eye turns downward.

Musculoskeletal Pertaining to the bone and muscle system of the body

Neurological Pertaining to the nervous system (brain, spine and nerves)

Ocular Pertaining to the eye

Orbital Pertaining to the bony recess in which the eye sits.

Pathologies Abnormalities in a body system caused by disease etc.

Prism lenses A prism bends light. Prisms in glasses can make the brain think the eyes are working together. Prisms can also help with double vision by aligning the two images into one.

Refractive Pertaining to the measurement of the focusing characteristics of an eye or eyes.

Squint A permanent deviation in the direction of the gaze of one or both eye

Stereopsis The perception of depth produced by the reception in the brain of visual stimuli from both eyes in combination; binocular vision.

Strabismus A squint (see above)

Syndromic The identification of a group of symptoms and signs that characterize a clinical condition.

Torsional The act of twisting; the state of being twisted.

Visual confusion The perception of two different images superimposed onto the same space. This can be due to a new onset squint or a deterioration of a longstanding squint.

References 1. Greater Manchester Effective Use of Resources Operational Policy

Governance Approvals

Name Date Approved

Greater Manchester Effective Use of Resources Steering Group 20/03/2019

3. GM Strabismus Policy v1.0 FINAL Page 9 of 18 Greater Manchester Directors of Commissioning / Greater Manchester Chief 29/08/2019 Finance Officers (Delegated authority given to approve policy by Greater Manchester Joint Commissioning Board).

Bolton Clinical Commissioning Group Awaiting approval

Bury Clinical Commissioning Group 29/08/2019

Heywood, Middleton & Rochdale Clinical Commissioning Group 29/08/2019

Manchester Clinical Commissioning Group 29/08/2019

Oldham Clinical Commissioning Group 29/08/2019

Salford Clinical Commissioning Group 29/08/2019

Stockport Clinical Commissioning Group 29/08/2019

Tameside & Glossop Clinical Commissioning Group 29/08/2019

Trafford Clinical Commissioning Group 29/08/2019

Wigan Borough Clinical Commissioning Group 29/08/2019

3. GM Strabismus Policy v1.0 FINAL Page 10 of 18 Appendix 1 – Evidence Review

Surgical Correction of Adult Strabismus (Squint) GM058

Search Strategy

NOTE: In this instance there were very few metanalyses or commissioning guidelines with evidence of effectiveness available.

Database Result

Royal College of Commissioning Guidance: Strabismus surgery for adults in the United Ophthalmologists website Kingdom: indications, evidence base and benefits (Published: Aug 2017)

Summary of the evidence

There is very little evidence of effectiveness available as this is a well-established intervention for a relatively common problem.

The evidence

Levels of evidence

Level 1 Meta-analyses, systematic reviews of randomised controlled trials

Level 2 Randomised controlled trials

Level 3 Case-control or cohort studies

Level 4 Non-analytic studies e.g. case reports, case series

Level 5 Expert opinion

1. LEVEL N/A: MIX OF EVIDENCE REVIEW AND CLINICAL OPINION Commissioning Guidance: Strabismus surgery for adults in the United Kingdom: indications, evidence base and benefits (Published: Aug 2017)

Summary (full document is available on request) Strabismus (squint) is a misalignment of the two eyes affecting 4% of adults. Uncorrected this may cause functional visual problems including double vision, visual confusion, loss of stereopsis (3D vision) and binocularity (the coordinated use of the two eyes together), asthenopia (eye strain) and headaches and the requirement to adopt an abnormal head posture for vision. There are negative effects in terms of reduced ability to drive and independence, and increased risk of falls. Even in the absence of functional visual issues, strabismus in adults is associated with psychosocial difficulties including low self-esteem, abnormal mood, reduced quality of life, reduced employment opportunities, discrimination and psychiatric issues.

3. GM Strabismus Policy v1.0 FINAL Page 11 of 18 Non-surgical management options include prism lenses, eye exercise and botulinum toxin procedures in a small percentage but many cases will require surgery to achieve significant improvement. There is good evidence that surgery is very safe and highly effective in addressing these issues in clinically suitable cases. Current evidence shows that even patients with longstanding strabismus without diplopia demonstrate measurable benefits in binocularity, function, quality of life and psychosocial interactions after strabismus surgery. There is excellent cost-utility for strabismus surgery at between approximately £1,000-1600 dollars/QALY (NICE cut off for cost effectiveness is less than £20,000 per QALY). Strabismus surgery in adults should not be rationed on non-clinical grounds and patients with strabismus should be considered as candidates for surgical treatment whether or not they experience double vision.

3. GM Strabismus Policy v1.0 FINAL Page 12 of 18 Appendix 2 – Measuring degree of Strabismus using a prism

(other methods may be used if more clinically appropriate) but a description of how it was done must be added to the request

Ophthalmic prisms are made of two nonparallel refracting surfaces that intersect at the apex and deflect (refract) light rays passing through them, with the rays always bending toward the base (opposite to the apex) of the prism. Strabismic deviations are commonly quantified in prism diopters, a measure of the power of an ophthalmic prism, which is quite different from degrees. The power of an ophthalmic prism (glass or plastic) in prism diopters (Δ) is equal to the deviation, in centimeters (cm), of a light ray passing through the prism, measured one meter, or 100 cm, away from the prism Note that one should not refer to 15Δ as 15 “diopters.” Although one may occasionally come across 15 “prisms,” the correct term is 15 prism diopters.

Figure 1

Degrees of deviation are related to prism diopters of deviation not in a linear but a trigonometric manner (degrees = tan-1(Δ/100) ×180/π). For angles smaller than 45° (or 100Δ), each degree equals approximately 2Δ. For angles larger than 45° (or 100Δ), however, this approximation of 2Δ per degree is no longer valid; as one approaches 90°, the number of prism diopters per degree rises to infinity

The amount of strabismic deviation produced or measured by a prism depends on the position in which it is held. It is thus critical to understand how to hold prisms correctly. Ophthalmic prisms made of glass are calibrated for use in the Prentice position and should be held with one surface, usually the back surface perpendicular to the patient's line of sight [Figure 2a]. Plastic prisms, including plastic prism bars, on the other hand, are calibrated for use in the minimum deviation position, in which, as the name implies, the least amount of total deviation is produced, with equal amounts of bending occurring at each prism surface [Figure 2b]. In clinical practice, it may be difficult to position prisms accurately according to the angle of minimum deviation, but holding them in the frontal plane position, with the back surface flat to the face of the patient, closely approximates the minimum deviation position for distant fixation objects [Figure 2c]. For near fixation objects, the back prism surface should be angled in slightly, so that it is perpendicular to the fixation object. In general, if plastic prisms are held with the back surface perpendicular to the direction of the fixation object, essentially equal angles of bending occur at both surfaces, serving as an ideal surrogate for the minimum deviation position at all times.

Figure 2

3. GM Strabismus Policy v1.0 FINAL Page 13 of 18

Positioning of prisms. (a) Prentice position. Glass prisms are calibrated for use in this position, so the line of sight makes a right angle with one of the surfaces. (b) Minimum deviation position. Plastic prisms, including plastic prism bars, are calibrated in this position, so the line of sight makes an equal angle with each prism surface. (c) Frontal plane position. Holding plastic prisms in this position, with the back surface flat to the face of the patient, closely approximates the minimum deviation position, which would otherwise be difficult to estimate in clinical practice

Measurements should be made without the use of corrective lenses as glasses have an effect on the measurement of strabismus, which becomes clinically significant especially with high power spectacle lenses.6 This is because in a strabismic patient, only one line of sight at a time passes through the corresponding spectacle lens at its optical center (where there is no prismatic power). The other line of sight, on the other hand, passes through the corresponding spectacle lens at a position away from its optical center, where it encounters prismatic power (that is equal to the distance of that point from the optical axis in centimeters multiplied by the power of the lens in diopters, Prentice's rule), causing a prismatic change of the deviation as measured in front of the glasses

Alternatively where available binocular anterior segment OCT (optical coherence tomography) imaging can provide clinicians with a precise measurement of strabismus

3. GM Strabismus Policy v1.0 FINAL Page 14 of 18

Appendix 3 – Diagnostic and Procedure Codes

Surgical Correction of Adult Strabismus (Squint) GM058

(All codes have been verified by Mersey Internal Audit’s Clinical Coding Academy)

GM058 – Surgical Correction of Strabismus (squint)

OPCS-4 Procedure Codes:

Recession of medial rectus muscle and resection of lateral rectus muscle of eye C311

Recession of lateral rectus muscle and resection of medial rectus muscle of eye C316

Recession of medial rectus muscle of eye NEC C321

Recession of lateral rectus muscle of eye NEC C322

Recession of superior rectus muscle of eye C323

Recession of inferior rectus muscle of eye C324

Recession of superior oblique muscle of eye C325

Recession of inferior oblique muscle of eye C326

Recession of combinations of muscles of eye C327

Other specified recession of muscle of eye C328

Unspecified recession of muscle of eye C329

Resection of medial rectus muscle of eye NEC C331

Resection of lateral rectus muscle of eye NEC C332

Resection of superior rectus muscle of eye C333

Resection of inferior rectus muscle of eye C334

Resection of superior oblique muscle of eye C335

Resection of combinations of muscles of eye C337

Other specified resection of muscle of eye C338 resection of muscle of eye C339

With the following ICD-10 diagnosis codes:

3. GM Strabismus Policy v1.0 FINAL Page 15 of 18 Convergent concomitant strabismus H500

Divergent concomitant strabismus H501

Vertical strabismus H502

Intermittent heterotropia H503

Other and unspecified heterotropia H504

Heterophoria H505

Mechanical strabismus H506

Other specified strabismus H508

Strabismus, unspecified H509

Diplopia (secondary to strabismus) H532

Amblyopia ex anopsia (secondary to strabismus) H530

Subjective visual distrubances (secondary to strabismus) H531

Other disorders of binocular vision (secondary to strabismus) H533

Other visual disturbances (secondary to strabismus) H538

Contracture of muscle – Other (secondary to strabismus) M6248

Myalgia (secondary to strabismus) M7918

3. GM Strabismus Policy v1.0 FINAL Page 16 of 18 Appendix 4 – Version History

Surgical Correction of Adult Strabismus (Squint) GM058

The latest version of this policy can be found here GM Strabismus Policy (squint surgery)

Version Date Summary of Changes

0.1 28/02/2018 Initial draft

0.2 21/03/2018 The GM EUR Steering Group agreed following amendments to the policy: • Commissioning Statement: o ‘(Alternative commissioning arrangements apply)’ added after ‘Policy Exclusions’ heading o Link added to GMMMG Botulinum Toxin guidance where appropriate o Asymptomatic strabismus section added • Glossary: ‘spin’ corrected to ‘spine’ under definition for ‘Neurological’ Policy approved at GM EUR Steering Group to progress to Clinical Engagement once amendments have been made.

0.3 18/07/2018 The GM EUR Steering Group reviewed the Clinical Engagement Feedback and agreed following amendments to the policy: • Title of policy: ‘Adult’ added for clarity • Policy Inclusion criteria: th o ‘i.e. after their 18 Birthday’ added to first paragraph o ‘Prior to referral; section added o ‘Referral should be made for recently developed diplopia to prevent it becoming persistent. Referral must be made before there is any evidence of loss of vision.’ added to the end of the first bullet point under ‘Symptomatic Strabismus’. o ‘Referral should be made for recently developed amblyopia to prevent it becoming persistent. Referral must be made before there is any evidence of loss of vision.’ added to the end of the second bullet point under ‘Symptomatic Strabismus’ o ‘Asymptomatic strabismus’ section reworded for clarity. o ‘before it becomes persistent’ added to the first bullet point under ‘What is commissioned’ section. o Recommended funding mechanism agreed for Monitored Approval Following the above changes the GM EUR Steering Group agreed the policy could progress through the governance process.

0.4 01/10/2018 Branding changed to reflect change of service from Greater Manchester Shared Services to Greater Manchester Health and Care Commissioning.

0.5 21/11/2018 The GM EUR Steering Group agreed the following amendments: • Commissioning Statement: o Fitness for Surgery and Best Practice Guidelines sections added o ‘Asymptomatic strabismus’ section amended, including the recommended funding mechanism. o ‘Correction of squint’ section added Branding also changed to reflect change of service from Greater Manchester Shared Services to Greater Manchester Health and Care Commissioning.

3. GM Strabismus Policy v1.0 FINAL Page 17 of 18

0.6 20/03/2019 The GM EUR Steering reviewed the draft policy and agreed the following changes:-

Commissioning Criteria • Headings changed from ‘Symptomatic strabismus’ to ‘Symptomatic/functional strabismus’ and ‘Asymptomatic strabismus’ to ‘Asymptomatic / non-functional strabismus. • First paragraph amended from

‘Correction of adult (aged over 18 years - i.e. after their 18th Birthday) squint for purely aesthetic reasons is not routinely commissioned but may be considered where the squint is having an excessive effect on the individual. Supporting evidence must be provided with the application. ‘ TO ‘Correction of adult (aged over 18 years - i.e. after their 18th Birthday) squint for purely aesthetic reasons is not routinely commissioned but may be considered where the squint is severe (see below for the criteria).’

• The section describing symptomatic strabismus moved to the ‘Treatment /Procedures’ section. • Symptomatic/functional strabismus (squint) - The following 2 bullet points removed . to treat diplopia before it becomes persistent . to treat amblyopia before it becomes persistent and replaced with . to treat amblyopia, present since childhood, that has decompensated’

• Asymptomatic / non-functional strabismus (squint) - Amended from ‘Correction of adult squint will be commissioned where:’ to read ‘Correction of this type of adult squint will only be commissioned where:’ The words ‘equal to or’ added before ‘more than 20 prism diopters’. • Rationale behind the policy statement – The words non-functional added after Asymptomatic.

• Glossary – Visual confusion - The following sentence has been added ‘This can be due to a new onset squint or a deterioration of a longstanding squint.’

• Appendix 2 Measuring degree of Strabismus using a prism added.

Subject to the above amendments being made the GM EUR Steering Group approved the policy to go through the CCG governance process.

0.7 01/08/2019 Clinical Exceptionality Section updated to read: Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. More information on determining clinical exceptionality can be found in the Greater Manchester (GM) Effective Use of Resources (EUR) Operational Policy. Link to GM EUR Operational Policy

1.0 29/08/2019 Policy approved for implementation by the Greater Manchester Directors of Commissioning / Greater Manchester Chief Finance Officers.

3. GM Strabismus Policy v1.0 FINAL Page 18 of 18

Greater Manchester EUR Policy Statement on: Photorefractive (laser) surgery for the correction of refractive errors GM Ref: GM060 Version: 1.0 (29 August 2019)

Commissioning Statement

Photorefractive (laser) surgery for the correction of refractive errors

Policy The treatment of symptomatic corneal surface irregularities arising from a range of Exclusions pathologies including band keratopathy, corneal scarring, nodular degeneration, (Alternative epithelial basement membrane dystrophy or other dystrophies are excluded from this commissioning policy. arrangements apply) Treatment/procedures undertaken as part of an externally funded trial or as a part of locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathway for this exclusion to take effect).

Fitness for NOTE: All patients should be assessed as fit for surgery before going ahead with Surgery treatment, even though funding has been approved.

Policy Photorefractive errors Inclusion Photorefractive (laser) surgery is not routinely commissioned for refractive errors Criteria leading to reduced vision as the standard non-invasive treatment for these is corrective lenses in either glasses or contact lenses.

Funding Mechanism: Individual funding request (exceptional case) approval: Requests must be submitted with all relevant supporting evidence.

Difficult to correct refractive errors following surgery Refractive errors (myopia, hyperopia or astigmatism) occuring as a result of non- refractive ophthalmic surgery such as cataract surgery or corneal transplantation may be commissioned provided: • that they cannot be corrected by glasses or contact lenses AND • that the surgery was carried out for clinical reasons

Current evidence on the safety and efficacy of laser correction of refractive error following non-refractive ophthalmic surgery is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit. Patient selection and treatment should be carried out only by ophthalmologists who specialise in corneal surgery.

Funding Mechanism: Individual prior approval provided the patient meets the above criteria. Requests must be submitted with all relevant supporting evidence.

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 2 of 17 Contents

Commissioning Statement ...... 2 Policy Statement ...... 4 Equality & Equity Statement ...... 4 Governance Arrangements ...... 4 Aims and Objectives ...... 4 Rationale behind the policy statement ...... 5 Treatment / Procedure ...... 5 Epidemiology and Need ...... 5 Adherence to NICE Guidance ...... 6 Audit Requirements ...... 6 Date of Review ...... 6 Glossary ...... 6 References ...... 8 Governance Approvals ...... 8 Appendix 1 – Evidence Review ...... 10 Appendix 2 – Diagnostic and Procedure Codes ...... 16 Appendix 3 – Version History ...... 17

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 3 of 17 Policy Statement

This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester.

Equality & Equity Statement

An Equality Analysis has been carried out on the policy. For more information about the Equality Analysis, please contact [email protected].

Governance Arrangements

Aims and Objectives

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 4 of 17 • ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness. • reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester. • promoting the cost-effective use of healthcare resources.

Rationale behind the policy statement

Photorefractive (laser) surgery for the treatments of defects of the cornea – including defects in shape leading to reduced vision is now an accepted and safe procedure. This policy is intended to target the use of the resource available for this procedure to those patients with conditions that require treatment in an NHS secondary care provider.

Treatment / Procedure

The commonest types of laser correction are: photorefractive keratectomy (PRK), laser epithelial keratomileusis (LASEK) and laser in situ keratomileusis (LASIK), all performed with the patient under local anaesthesia. If required, they can be performed on both eyes during the same treatment session.

PRK involves removal of the corneal epithelium by surgical dissection followed by excimer laser ablation of a calculated amount of the stromal bed of the cornea.

LASEK is a modification of PRK in which dilute alcohol is used to loosen the corneal epithelium before it is lifted from the treatment zone as a hinged sheet, and then replaced at the end of the procedure.

In LASIK, a flap is created with a microkeratome, lifted before laser ablation and then repositioned. Patients may be given pre- or postoperative antibiotics as prophylaxis against infection.

Clinical indications Symptomatic corneal surface irregularities may result from a range of pathologies including band keratopathy, corneal scarring, nodular degeneration, epithelial basement membrane dystrophy or other dystrophies. Symptoms may include loss of vision, pain, sensitivity to light and foreign body sensation. Treatment aims to restore a normal regular corneal surface and adherence between the epithelium and Bowman's membrane (a basement membrane that lies between the outer layer of stratified epithelium and the substance of the cornea) with associated improvement in vision and comfort.

Alternative treatments include lubrication of the ocular surface, bandage contact lens placement or topical medication. Surgical procedures may include anterior stromal puncture, mechanical debridement, lamellar keratoplasty or resurfacing keratectomy using a diamond burr. Corneal transplantation may be considered in eyes refractory to treatment.

Visual indications Refractive errors such as myopia, astigmatism and hyperopia.

Refractive errors are usually corrected by wearing spectacles or contact lenses.

Epidemiology and Need

A recent review estimated the prevalence of common refractive areas in all of the WHO regions. This study found a prevalence in Europe for Astigmatism of 39.7%, Hyperopia of 23.1% and Myopia of 27%.

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 5 of 17 Adherence to NICE Guidance

The policy adheres to the following NICE Guidance: • IPG385: Laser correction of refractive error following non-refractive ophthalmic surgery • IPG358: Phototherapeutic laser keratectomy for corneal surface irregularities • IPG164: Photorefractive (laser) surgery for the correction of refractive errors

Audit Requirements

There is currently no national database. Service providers will be expected to collect and provide audit data on request.

Date of Review

One year from the date of approval by the governance process and thereafter at a date agreed by the Greater Manchester EUR Steering Group, unless new evidence or technology is available sooner.

Glossary

Term Meaning

Anterior A needle is used to puncture (perpendicularly to cornea), through loose epithelium and stromal Bowman's layer deep into the anterior half of the stroma. puncture

Astigmatism A defect in the eye or in a lens caused by a deviation from spherical curvature, which results in distorted images, as light rays are prevented from meeting at a common focus.

Band A corneal disease derived from the appearance of calcium on the central cornea which keratopathy occurs in the presence of hypercalcemia.

Bandage A bandage contact lens is designed to protect an injured or diseased cornea from the contact lens mechanical rubbing of the blinking eyelids, therefore allowing it to heal. The bandage lens often makes the eye feel more comfortable. It is usually a soft lens.

Basement The epithelium is the cornea's outermost layer, and the basement membrane is the layer membrane that the epithelium attaches to.

Bowman's A smooth, acellular, non-regenerating layer, located between the superficial epithelium membrane and the stroma in the cornea of the eye.

Cataract Surgery to remove a cataract. surgery

Cornea The cornea is the transparent front part of the eye that covers the iris, pupil, and anterior chamber.

Corneal The corneal epithelium is the outermost layer of the cornea. epithelium

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 6 of 17 Corneal Scarring occurring on the outermost layer of the front of the eye. scarring

Corneal Abnormalities in the corneal layer in front of the eye. surface irregularities

Corneal Transplant (from a donor) of the cornea of the eye. transplantati on

Diamond A rotary device of differing shapes and sizes to shape and prepare the surface of the burr cornea (similar to the one used by dentists to reshape teeth).

Dystrophies Disorders in which an organ or tissue of the body wastes away.

Epithelial Wasting away of the layer that the corneal epithelium (cell layer) attaches to. basement membrane dystrophy

Epithelium The thin tissue forming the outer layer of a body's surface and lining the alimentary canal and other hollow structures.

Excimer A type of laser used in eye surgery. laser ablation

Foreign body The feeling that there is ‘something in the eye’. sensation

Hyperopia Long sightedness also called Hypermetropia.

Lamellar Lamellar keratoplasty (LKP) is an alternative surgical procedure requiring removal of only keratoplasty the damaged or diseased epithelium and stroma, leaving the endothelium intact, in cases where only the more superficial layers are damaged.

LASEK A ‘blister’ is caused on the surface of the eye by using some alcohol held in a cup on the (laser eye. The roof of this ‘blister’, the epithelium, is pushed aside as a flap without any cutting. epithelial The laser is then applied and then the epithelium placed back down. keratomileusi s) laser The use of a laser to destroy tissue. ablation

Laser The use of a laser to carry out surgery. surgery

LASIK (laser Commonly referred to as laser eye surgery or laser vision correction, is a type of in situ refractive surgery for the correction of myopia, hyperopia, and astigmatism. keratomileusi s)

Mechanical The use of instruments to remove dead skin and foreign bodies. debridement

Microkerato An instrument for removing a thin slice, or creating a thin hinged flap, on the surface of me the cornea.

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 7 of 17 Myopia Short-sightedness

Nodular Slowly progressive condition in which gray-white to bluish nodules measuring 1-3 mm degeneration are seen anterior to Bowman's layer of the cornea, usually bilaterally.

Non- Surgery carried out on the eye for reasons other than the correction of vision refractive ophthalmic surgery

Normal The normal appearance of the outer layer of the front of the eye. regular corneal surface

Ocular The surface of the eye. surface

Pathologies The causes and effects of diseases.

Photorefracti Of or relating to a change in the index of refraction by spatial variations of the light intensi ve ty, as in a laser.

PRK A kind of laser eye surgery designed to change the shape of the cornea to eliminate (or (photorefracti reduce) the need for glasses and contact lenses. The laser is used to remove the outer ve layer of the cornea and flatten the cornea. keratectomy)

Prophylaxis Prevention

Refractive Errors in the way light is bent into the eye affecting the focal point of vision. errors

Resurfacing a type of eye surgery that uses a laser to treat various ocular disorders by removing keratectomy tissue from the cornea.

Stratified A stratified epithelium consists of (flattened) epithelial cells arranged in layers upon a epithelium basal membrane. Only one layer is in contact with the basement membrane; the other layers adhere to one another to maintain structural integrity.

Stromal bed The supporting framework of an animal organ typically consisting of connective tissue.

Surgical The process of cutting apart or separating tissue. dissection

Symptomatic Exhibiting or involving medical symptoms.

Visual acuity Commonly refers to the clarity of vision. Visual acuity is dependent on optical and neural factors, i.e., (i) the sharpness of the retinal focus within the eye, (ii) the health and functioning of the retina, and (iii) the sensitivity of the interpretative faculty of the brain.

References 1. GM EUR Operational Policy 2. Global and regional estimates of prevalence of refractive errors: Systematic review and meta- analysis Hassan Hashemi et al.; Journal of Current Ophthalmology 30 (2018) 3e22

Governance Approvals

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 8 of 17

Name Date Approved

Greater Manchester Effective Use of Resources Steering Group 19/09/2019

Greater Manchester Directors of Commissioning / Greater Manchester Chief Finance Officers (Delegated authority given to approve policy by Greater Manchester Joint 29/08/2019 Commissioning Board)

Bolton Clinical Commissioning Group Awaiting approval

Bury Clinical Commissioning Group 29/08/2019

Heywood, Middleton & Rochdale Clinical Commissioning Group 29/08/2019

Manchester Clinical Commissioning Group 29/08/2019

Oldham Clinical Commissioning Group 29/08/2019

Salford Clinical Commissioning Group 29/08/2019

Stockport Clinical Commissioning Group 29/08/2019

Tameside & Glossop Clinical Commissioning Group 29/08/2019

Trafford Clinical Commissioning Group 29/08/2019

Wigan Borough Clinical Commissioning Group 29/08/2019

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 9 of 17 Appendix 1 – Evidence Review Photorefractive (laser) surgery for the correction of refractive errors GM060

Search Strategy

Database Result

NICE NICE IPG164: Photorefractive (laser) surgery for the correction of refractive errors (Published: 22 Mar 2006)

NICE IPG358: Phototherapeutic laser keratectomy for corneal surface irregularities (Published: 22 Sep 2010)

NICE IPG385: Laser correction of refractive error following non-refractive ophthalmic surgery (Published 23 Mar 2011)

The systematic reviews for each of the IPGs (Interventional Procedures Guidance) were found but not included as they are summarised in the IPGs.

The Royal College of Ophthalmologists sets standards for the delivery of these procedures but these are not cited here as this is a commissioning policy and not a clinical one.

Summary of the evidence

There is sufficient evidence of efficacy and safety of photorefractive (laser) surgery which aims to restore a normal regular corneal surface and adherence between the epithelium and Bowman's membrane (a basement membrane that lies between the outer layer of stratified epithelium and the substance of the cornea) with associated improvement in vision and comfort. These symptomatic corneal surface irregularities may result from a range of pathologies including band keratopathy, corneal scarring, nodular degeneration, epithelial basement membrane dystrophy or other dystrophies. Symptoms may include loss of vision, pain, sensitivity to light and foreign body sensation. Patient selection and treatment should be carried out only by ophthalmologists who specialise in corneal surgery.

Alternative treatments to photorefractive (laser) surgery include lubrication of the ocular surface, bandage contact lens placement or topical medication. Surgical procedures may include anterior stromal puncture, mechanical debridement, lamellar keratoplasty or resurfacing keratectomy using a diamond burr. Corneal transplantation may be considered in eyes refractory to treatment.

There is sufficient evidence for the safety and efficacy of photorefractive (laser) surgery to correct refractory disorders following non-refractive ophthalmic surgery, provided that normal arrangements are in place for clinical governance, consent and audit. Patient selection and treatment should be carried out only by ophthalmologists who specialise in corneal surgery.

There is sufficient evidence for the safety and efficacy of photorefractive (laser) surgery to correct refractory disorders leading to a reduction in vision however the prevalence of these disorders makes commissioning Photorefractive (laser) surgery for these indications untenable.

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 10 of 17 The evidence

Levels of evidence

Level 1 Meta-analyses, systematic reviews of randomised controlled trials

Level 2 Randomised controlled trials

Level 3 Case-control or cohort studies

Level 4 Non-analytic studies e.g. case reports, case series

Level 5 Expert opinion

1. LEVEL 1: NICE SYSTEMATIC REVIEW FOR IPGS NICE IPG164: Photorefractive (laser) surgery for the correction of refractive errors (Published: 22 Mar 2006)

1 Guidance 1.1 Current evidence suggests that photorefractive (laser) surgery for the correction of refractive errors is safe and efficacious for use in appropriately selected patients. 1.2 Clinicians undertaking photorefractive (laser) surgery for the correction of refractive errors should ensure that patients understand the benefits and potential risks of the procedure. Risks include failure to achieve the expected improvement in unaided vision, development of new visual disturbances, corneal infection and flap complications. These risks should be weighed against those of wearing spectacles or contact lenses. 1.3 Clinicians should audit and review clinical outcomes of all patients who have photorefractive (laser) surgery for the correction of refractive errors. Further research will be useful and clinicians are encouraged to collect longer-term follow-up data. 1.4 Clinicians should have adequate training before performing these procedures. The Royal College of Ophthalmologists has produced standards for laser refractive surgery. 2 The procedure 2.1 Indications 2.1.1 Photorefractive (laser) surgery is used to treat refractive errors such as myopia, astigmatism and hyperopia. 2.1.2 Refractive errors are usually corrected by wearing spectacles or contact lenses. Surgical treatments have been developed to improve refraction by re-shaping the cornea. 2.2 Outline of the procedure 2.2.1 In photorefractive surgery, corneal re-shaping is achieved using excimer laser ablation. Excimer laser techniques include photorefractive keratectomy (PRK), laser epithelial keratomileusis (LASEK) and laser in situ keratomileusis (LASIK). 2.2.2 PRK involves the removal of the corneal epithelium by surgical dissection and excimer laser ablation of a calculated amount of the stromal bed of the cornea. LASEK is a modification of PRK; dilute alcohol is used to loosen the corneal epithelium before it is lifted from the treatment zone as a hinged sheet, and then replaced at the end of the procedure. In LASIK, a flap is created with a microkeratome; this is lifted before laser ablation and then repositioned. 2.3 Efficacy 2.3.1 A systematic review of the published evidence on these procedures was commissioned by the Institute. 2.3.2 In seven randomised controlled trials (RCTs) included in the review, there were no significant differences between the three procedures in the proportion of eyes treated for myopia or myopic astigmatism achieving the predicted refractive outcome.

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 11 of 17 Data from more than 2000 eyes treated with PRK for myopia showed that a median of 69% of eyes had achieved within 0.5 D of their intended correction, and that 89% had achieved within 1.0 D. Data from case series of more than 1800 eyes undergoing LASEK for myopia or astigmatism showed that a median of 75% of eyes were within 0.5 D and a median of 92% of eyes were within 1.0 D of their intended correction at 3–6 months follow-up. Data from eyes treated with LASIK for myopia or astigmatism showed that 77% (7309/9542) were within 0.5 D and 91% (8109/8885) were within 1.0 D of their intended correction at 3–12 months. One RCT found LASEK to be significantly more accurate than PRK for eyes with hyperopia. 2.3.3 Final uncorrected visual acuity achieved was similar for all three techniques. 2.4 Safety 2.4.1 In eyes treated for myopia, loss of two lines of best spectacle-corrected visual acuity was seen in a median of 0.5% (0–20.5%) of eyes treated with PRK, 0% (0–8.2%) of eyes treated with LASEK and 0.6% (0–3%) of eyes treated with LASIK. Patients with high myopia were more likely to lose two or more lines of best spectacle-corrected visual acuity than those with moderate to low myopia. 2.4.2 Flap complications may occur during LASIK and LASEK, requiring conversion to PRK or postponement of ablation (with LASIK), and occasionally there may be loss of best spectacle- corrected visual acuity. Epithelial in-growth was reported in LASIK in a median of 1.3% (0.0–4.4%) of eyes. 2.4.3 Ectasia, a condition that can result from corneal thinning, is a serious complication related to refractive surgery that can lead to loss of vision. Data from the review estimated the risk of ectasia following LASIK as a median of 0.2% (range 0 to 0.87%; overall rate of 40/10,806 eyes). However, many of the affected eyes may have been selected inappropriately for LASIK treatment, and with appropriate patient selection the rate might have been lower. Rates of ectasia were not reported following PRK, and very little information was reported about LASEK, with no cases of ectasia described in one case series of 171 eyes. 2.4.4 Microbial keratitis was only reported in LASIK studies and occurred in 0–0.16% of eyes. This incidence was similar to, or lower than, that reported for contact lens wearers. 2.4.5 Other patient-reported problems included visual difficulty in low light conditions, corneal haze, light halos and problems with glare. Significant corneal haze was reported following all three procedures (in 0–31% of eyes treated with PRK, 0–25% with LASEK and 0–2% with LASIK). Glare and night vision difficulties were less common after LASIK. 2.5 Other comments 2.5.1 These procedures can make it more difficult to measure accurately the intraocular pressure used to detect glaucoma, and the intraocular lens power required for cataract surgery. Techniques are available to address these difficulties, provided it is known that photorefractive surgery has previously been done. 2.5.2 It was recognised that this is a rapidly evolving procedure and that new techniques are emerging. 2.5.3 The current difficulties for patients in identifying properly trained practitioners for this procedure were noted. A working group of the Royal College of Opthalmologists is currently devising a set of defined learning outcomes and assessments for all those wishing to undertake laser refractive surgery.

2. LEVEL 1: NICE SYSTEMATIC REVIEW FOR IPGS NICE IPG358: Phototherapeutic laser keratectomy for corneal surface irregularities (Published: 22 Sep 2010)

1 Guidance 1.1 Current evidence on the safety and efficacy of phototherapeutic laser keratectomy for corneal surface irregularities is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit. 1.2 Patient selection and treatment should be carried out only by ophthalmologists who specialise in corneal surgery. 2 The procedure

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 12 of 17 2.1 Indications and current treatments 2.1.1 Symptomatic corneal surface irregularities may result from a range of pathologies including band keratopathy, corneal scarring, nodular degeneration, epithelial basement membrane dystrophy or other dystrophies. Symptoms may include loss of visual acuity, pain, sensitivity to light and foreign body sensation. 2.1.2 Treatment aims to restore a normal regular corneal surface and adherence between the epithelium and Bowman's membrane (a basement membrane that lies between the outer layer of stratified epithelium and the substance of the cornea) with associated improvement in visual acuity and comfort. 2.1.3 Standard treatment includes lubrication of the ocular surface, bandage contact lens placement or topical medication. Surgical procedures may include anterior stromal puncture, mechanical debridement, lamellar keratoplasty or resurfacing keratectomy using a diamond burr. Corneal transplantation may be considered in eyes refractory to treatment. 2.2 Outline of the procedure 2.2.1 The aim of phototherapeutic laser keratectomy for corneal surface irregularities is to create a smooth stromal surface to improve postoperative corneal clarity, decrease existing scarring and facilitate subsequent epithelial adhesion. 2.2.2 Local anaesthetic eye drops are applied, and the corneal epithelium is mechanically removed. A laser is used to sequentially ablate uniformly thin layers of corneal tissue, creating a smooth surface which then becomes reepithelialised. Postoperative management consists of an eye pad, topical antibiotics, sedatives and non-steroidal anti-inflammatory drugs. 2.3 Efficacy 2.3.1 A non-randomised controlled study of 39 patients (42 eyes) reported no significant difference in overall change in best corrected visual acuity (BCVA) between patients treated by phototherapeutic laser keratectomy and those treated by diamond burr polishing at 7-month follow- up (p = 0.6): BCVA improved in 36% (5/14) and 14% (3/21) of eyes, remained unchanged in 64% (9/14) and 81% (17/21) of eyes and worsened in 0% (0/14) and 5% (1/21) of eyes respectively. 2.3.2 In a case series of 211 patients (232 eyes) mean BCVA improved by 1.4 lines from baseline at 2- year follow-up (p < 0.002). No significant difference was reported in BCVA improvement between subgroups of patients with corneal dystrophy, nodular degeneration, corneal scar, or band keratopathy (absolute figures not stated) (p = 0.15). 2.3.3 In a case series of 216 patients (252 eyes), among eyes with recurrent erosion at baseline, further recurrent erosion was reported in 9% (9/103) of eyes at 12-month follow-up. 2.3.4 The case series of 216 patients reported that 100% (29/29) of eyes with bandlike keratopathy were pain free by 6-day follow-up. 2.3.5 A case series of 191 patients (203 eyes) reported that significantly fewer patients with bullous keratopathy had severe symptoms of pain, photosensitivity and/or watering at 6-month follow-up (n = 15) compared with baseline (n = 56) (p < 0.017). Similarly, significantly fewer patients with corneal scarring had severe symptoms at 6-month follow-up (n = 4) compared with baseline (n = 13) (p < 0.0001). 2.3.6 The Specialist Advisers listed key efficacy outcomes as visual acuity, ocular surface health, ocular comfort and pain relief. 2.4 Safety 2.4.1 Recurrent keratitis requiring penetrating keratoplasty was reported in 1% (3/232) of eyes at up to 2-year follow-up in the case series of 211 patients. 2.4.2 One occurrence each of progressing keratolysis at 8-day follow-up, circular subepithelial corneal scarring at 5-month follow-up (both requiring penetrating keratoplasty), progressive kerectasia at 6 months (sequelae not reported), and a sterile corneal immune ring at 4-day follow-up, were described in 4 separate case reports. 2.4.3 A loss of BCVA of 2 lines or more was reported in 13% (3/24) of patients at 2-year follow-up in the case series of 211 patients. 2.4.4 Idiopathic iritis and a marginal corneal ulcer developed in 1 eye each at up to 2-year follow-up in the case series of 211 patients.

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 13 of 17 2.4.5 Mild postoperative haze was reported in 11% (22/203) of eyes in the case series of 191 patients; this resolved in 12 eyes by 6-month follow-up. There was no significant difference in the occurrence of mild haze between patients treated by laser phototherapeutic keratectomy (33% [5/15] of eyes) or by diamond burr polishing (26% [7/27] of eyes) in the non-randomised controlled study of 39 patients at 7-month follow-up (p = 0.38). 2.4.6 The Specialist Advisers identified corneal infection as an adverse event reported in the literature. They considered theoretical adverse events to include epithelial defect, corneal ectasia, scarring and induction of astigmatism or refractive error. 2.5 Other comments 2.5.1 The Committee noted that the published evidence comprised a mixture of different indications and outcomes, but nevertheless they considered that the case for safety and efficacy was adequately supported by this evidence and by specialist advice. 2.5.2 NICE received 3 completed questionnaires from patients treated by the procedure. They reported improvements in quality of life including reduced photosensitivity (which had required sunglasses) and the ability to walk with more confidence.

3. LEVEL 1: NICE SYSTEMATIC REVIEW FOR IPGS NICE IPG385: Laser correction of refractive error following non-refractive ophthalmic surgery (Published: 23 Mar 2011)

1 Guidance 1.1 Current evidence on the safety and efficacy of laser correction of refractive error following non- refractive ophthalmic surgery is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit. 1.2 Patient selection and treatment should be carried out only by ophthalmologists who specialise in corneal surgery. 2 The procedure 2.1 Indications and current treatments 2.1.1 Refractive errors (myopia, hyperopia or astigmatism) can result from nonrefractive ophthalmic surgery such as cataract surgery or corneal transplantation. 2.1.2 Refractive errors are usually managed by wearing spectacles or contact lenses. In patients for whom spectacles and contact lenses do not adequately correct the refractive error, other options include corneal relieving incisions, intraocular surgery such as cataract extraction with standard or toric intraocular lenses and laser corrective procedures. 2.2 Outline of the procedure 2.2.1 Three types of laser correction are considered in this guidance: photorefractive keratectomy (PRK), laser epithelial keratomileusis (LASEK) and laser in situ keratomileusis (LASIK), all performed with the patient under local anaesthesia. If required, they can be performed on both eyes during the same treatment session. 2.2.2 PRK involves removal of the corneal epithelium by surgical dissection followed by excimer laser ablation of a calculated amount of the stromal bed of the cornea. LASEK is a modification of PRK in which dilute alcohol is used to loosen the corneal epithelium before it is lifted from the treatment zone as a hinged sheet, and then replaced at the end of the procedure. In LASIK, a flap is created with a microkeratome, lifted before laser ablation and then repositioned. Patients may be given pre- or postoperative antibiotics as prophylaxis against infection. 2.3 Efficacy 2.3.1 A case series of 62 patients (87 eyes) who had LASIK after non-refractive ophthalmic surgery or refractive surgery reported that mean spherical equivalent refraction (MSER; a negative reading indicates myopia, a positive reading indicates hyperopia) improved from −5.25 D preoperatively to −0.70 D at 1-year follow-up. 2.3.2 A case series of 59 patients (85 eyes) who had LASIK after multifocal intraocular lens implantation reported that MSER improved from −0.34 D preoperatively to −0.07 D at 6-month follow-up (p = 0.004).

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 14 of 17 2.3.3 A case series of 48 patients (57 eyes) who had LASIK after penetrating keratoplasty (PK) reported that MSER improved from −3.94 D preoperatively to −0.61 D at 2-year follow-up. 2.3.4 A case series of 38 patients (46 eyes) who had LASIK after PK reported improvement in preoperative mean spherical refraction in myopic eyes (n = 40) and hyperopic eyes (n = 3) from −5.16 D to −0.44 D and 5.75 D to 1.67 D respectively, and improvement in mean preoperative cylindrical refraction in eyes with mixed astigmatism (n = 3) from −5.50 D to −2.42 D at 5-year followup. Overall, at 5-year follow-up, 63% (29/46) had a refractive error within 1.00 D of emmetropia. 2.3.5 The case series of 62 patients reported that the proportion of patients' eyes with uncorrected visual acuity of 0.5 or better increased from 5% (4/87) preoperatively to 70% (61/87) at 1-year follow-up. 2.3.6 Case series of 62, 59 and 48 patients who had LASIK after non-refractive ophthalmic surgery reported LASIK re-operation in 22% (19/87), 6% (5/85) and 9% (5/57) of eyes because of residual refractive errors, at follow-ups of 12, 6 and 24 months respectively. 2.3.7 The Specialist Advisers listed key efficacy outcomes as uncorrected visual acuity, reduced refractive error, maintained best-corrected spectacle vision and improved quality of life. 2.4 Safety 2.4.1 The case series of 48 patients reported that 15% (8/52) of eyes had lost ≥ 2 Snellen lines of best- corrected visual acuity at 1-year. 2.4.2 A case series of 41 patients (44 eyes) who had PRK after PK reported 3 eyes with grade 2 haze all requiring retreatment. 2.4.3 The case series of 59 patients reported 4 eyes with moderate or marked dry eye developing between 3 and 6 months follow-up. All eyes were treated frequently with lubricant. The case series of 48 patients treated with LASIK after PK reported persistent dry eye in 3 eyes at a mean follow- up of 21 months. 2.4.4 The case series of 48 patients reported: 4 eyes with epithelial ingrowth (requiring removal) between 1 week and 12 months; 2 eyes that required repeat graft for persistent astigmatism between 1 and 3 years; 3 eyes needing repeat graft for oedema between 8 months and 3 years; and 5 eyes with flap dislocation between 1 day and 1 week (2 required sutures, 1 flap was removed and 1 was repositioned without sutures). 2.4.5 A case series of 57 eyes reported: 2% (1/57) of eyes with macular haemorrhages 7 days after LASIK; 7% (4/57) of eyes with epithelial ingrowth; 4% (2/57) of eyes with induced astigmatism; 4% (2/57) of eyes with a free cap; and 25% (14/57) of eyes with night vision problems at a mean follow-up of 9 months. 2.4.6 The case series of 38 patients who had LASIK after PK reported endothelial rejection, which was successfully treated in 1 eye. 2.4.7 The Specialist Advisers considered theoretical adverse events to include ectasia, recurrent epithelial erosion syndrome, epithelial defects, bleeding from the flap edge, interface haemorrhage, interface debris, flap striae, diffuse lamellar keratitis, corneal scarring, glare, infection and pain after treatment. 2.5 Other comments 2.5.1 These procedures can make it more difficult to measure accurately the intraocular pressure used to detect glaucoma, and the intraocular lens power required for cataract surgery. Techniques are available to address these difficulties, provided it is known that photorefractive surgery has previously been done.

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 15 of 17 Appendix 2 – Diagnostic and Procedure Codes Photorefractive (laser) surgery for the correction of refractive errors GM060

(All codes have been verified by Mersey Internal Audit’s Clinical Coding Academy)

GM060 – Photorefractive (laser) surgery for the correction of refractive errors

OPCS-4 Procedure Codes:

Laser in situ keratomileusis C442

Photorefractive keratectomy C444

Laser subepithelial keratomileusis C445

Superficial keratectomy C451

With the following ICD-10 diagnosis codes:

Myopia H521

Degenerative myopia H442

Hypermetropia H520

Astigmatism H522

OPCS-4 Procedure Codes: (Exceptions)

Lamellar graft to cornea NEC C462

ICD-10 diagnosis codes: (Exceptions)

Corneal degeneration H184

Hereditary corneal dystrophies H185

Other corneal scars and opacities H178

Corneal scar and opacity, unspecified H179

Corneal pigmentations and deposits H180

Bullous keratopathy H181

Other corneal oedema H182

Changes in corneal membranes H183

Keratoconus H186

Other corneal deformities H187

Other specified disorders of cornea H188

Disorder of cornea, unspecified H189

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 16 of 17 Appendix 3 – Version History Photorefractive (laser) surgery for the correction of refractive errors GM060

The latest version of this policy can be found here GM Laser Eye Surgery Policy

Version Date Summary of Changes

0.1 30/04/2018 Initial draft

0.2 16/05/2018 The GM EUR Steering Group requested the following amendments: • ‘visual acuity’ changed to ‘vision’ throughout the policy Policy Inclusion Criteria: • Headings for 'Photorefractive errors' and 'Difficult to correct refractive errors following surgery' added to 'Policy Inclusion Criteria' section • Paragraph now under 'Difficult to correct refractive errors following surgery' heading reworded for clarity to include bullet points and bullet point added to read 'that the surgery was carried out for clinical reasons' • Recommended GMEURSG funding mechanisms added for 'Photorefractive errors' (Exceptional) and 'Difficult to correct refractive errors following surgery' (IPA) Following the above changes the group agreed the policy could go out for a period of clinical engagement.

0.3 19/09/2018 GM EUR Steering Group reviewed the feedback received during the period of Clinical Engagement and agreed that no changes were necessary and the policy could progress through the governance process.

0.4 01/10/2018 Branding changed to reflect change of service from Greater Manchester Shared Services to Greater Manchester Health and Care Commissioning.

0.5 26/11/2018 Diagnostic and Procedure Codes added to Appendix 2.

0.6 01/08/2019 Clinical Exceptionality Section updated to read: Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. More information on determining clinical exceptionality can be found in the Greater Manchester (GM) Effective Use of Resources (EUR) Operational Policy. Link to GM EUR Operational Policy

1.0 29/08/2019 Policy approved for implementation by the Greater Manchester Directors of Commissioning / Greater Manchester Chief Finance Officers.

3. GM Laser Eye Surgery Policy v1.0 FINAL Page 17 of 17

Greater Manchester EUR Policy Statement on: Surgical management of Ankyloglossia (tongue tie) GM Ref: GM050 Version: 1.0 (29 August 2019)

Commissioning Statement

Surgical management of Ankyloglossia (tongue tie)

Policy This policy applies to children before their 18th Birthday. Exclusions (Alternative Frenuloplasty is commissioned for babies with fusion of the tongue to the floor of the commissioning mouth. arrangements apply) Treatment/procedures undertaken as part of an externally funded trial or as a part of locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathway for this exclusion to take effect).

Policy Frenectomy for infants with feeding problems Inclusion Division of the frenulum should only be conducted when: Criteria • The infant is under 3 months of age at the time of referral AND • There are perceived breastfeeding difficulties AND • Mother and baby have been have been assessed by a health visitor or midwife with specialist expertise in breast feeding who have confirmed tongue tie as the likely cause of the problem

NOTE: Frenectomy to address the above should be performed as an outpatient procedure or within a suitable community service.

Onward referral to Tier 2 or Secondary care • If referral is to a tier 2 or secondary care provider then all of the points above should apply AND • An assessment of the degree of ankyloglossia should have been carried out by an appropriately trained clinician (usually midwife or health visitor) using the Hazelbaker Assessment Tool (see Appendix 3) which gives a score of less than or equal to 11

Frenectomy for older children with speech problems In rare cases a tight frenulum may lead to speech problems. Where this is suspected the child should be assessed by speech and language services to ensure that there is no other underlying diagnosis that is interfering with the child’s language development.

In the case of these older children an application for exceptionality is required prior to referral for frenectomy.

3. GM Tongue Tie Policy v1.0 FINAL Page 2 of 22 The application should include: • A written assessment from a speech and language therapist stating that they believe the tongue tie to be a significant contributor to the speech problem(s). • A score of the degree of tongue tie using the Hazelbaker Assessment Tool (see Appendix 3)

Funding Mechanism: Recommended by GMEURSG: Individual funding request (exceptional case) approval: Requests must be submitted with all relevant supporting evidence.

Tongue tie and folic acid In the development of this policy a search was carried out to find evidence linking tongue tie and folic acid. Most of the information found was anecdotal and there was no strong evidence for an association between tongue tie and the use of folic acid before or during pregnancy. This policy supports the use of folic acid in line with the Scientific Advisory Committee on Nutrition (SACN): Update on folic acid (Published: 12 July 2017) (this is summarised at the end of Appendix 1 for ease of referral).

3. GM Tongue Tie Policy v1.0 FINAL Page 3 of 22 Contents

Commissioning Statement ...... 2 Policy Statement ...... 5 Equality & Equity Statement ...... 5 Governance Arrangements ...... 5 Aims and Objectives ...... 5 Rationale behind the policy statement ...... 6 Treatment / Procedure ...... 6 Epidemiology and Need ...... 6 Adherence to NICE Guidance ...... 6 Audit Requirements ...... 7 Date of Review ...... 7 Glossary ...... 7 References ...... 7 Governance Approvals ...... 8 Appendix 1 – Evidence Review ...... 9 Appendix 3 – Hazelbaker Assessment Tool for Lingual Frenulum Function ...... 19 Appendix 2 – Diagnostic and Procedure Codes ...... 21 Appendix 3 – Version History ...... 22

3. GM Tongue Tie Policy v1.0 FINAL Page 4 of 22 Policy Statement

This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester.

Equality & Equity Statement

An Equality Analysis has been carried out on the policy. For more information about the Equality Analysis, please contact [email protected].

Governance Arrangements

Aims and Objectives

This policy document aims to ensure equity, consistency and clarity in the commissioning of treatments/procedures by CCGs in Greater Manchester by:

3. GM Tongue Tie Policy v1.0 FINAL Page 5 of 22 • reducing the variation in access to treatments/procedures. • ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness. • reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester. • promoting the cost-effective use of healthcare resources.

Rationale behind the policy statement

In most cases the degree of tongue tie does not cause the individual any problems however in some cases it can interfere with breast feeding and in rare cases with speech development in older children. This policy aims to target the resource available to manage tongue tie to those cases that gain the most benefit.

Treatment / Procedure

Ankyloglossia Ankyloglossia, also known as tongue-tie, is a congenital anomaly characterised by an abnormally short lingual frenulum, which may restrict mobility of the tongue. It varies in degree, from a mild form in which the tongue is bound only by a thin mucous membrane to a severe form in which the tongue is completely fused to the floor of the mouth. Breastfeeding difficulties may arise as a result of the inability to suck effectively, causing sore nipples and poor infant weight gain.. If necessary, tongue-tie can be treated with a surgical cut to release the frenulum (frenotomy). If additional repair is needed or the lingual frenulum is too thick for frenotomy, a more extensive procedure known as frenuloplasty is used.

Tongue-tie is usually diagnosed on examination of the mouth. For infants, the doctor might use the Hazlebaker assessment tool to score various aspects of the tongue's appearance and ability to move.

This policy is concerned with the issues associated with the lingual frenulum when it is shorter and thicker than usual and can cause issues with breast feeding and in some instances difficulty with speech.

Frenectomy If division of the tongue-tie is performed in early infancy, it is usually performed without anaesthesia, although local anaesthetic is sometimes used. In an older infant or child, however, general anaesthesia is usually required. The baby is swaddled and supported at the shoulders to stabilise the head and sharp, blunt-ended scissors are used to divide the lingual frenulum. There should be little or no blood loss and feeding may be resumed immediately.

Frenuloplasty The release of the tissue (lingual frenulum) that attaches the tongue to the floor of the mouth and closure of the wound with stitches. It is the preferred surgery for tongue-tie in a child older than 1 year of age.

Epidemiology and Need

Tongue-tie is present in 4% to 11% of newborns.

Adherence to NICE Guidance

The policy adheres to NICE IPG149: Division of ankyloglossia (tongue-tie) for breastfeeding.

3. GM Tongue Tie Policy v1.0 FINAL Page 6 of 22 Audit Requirements

There is currently no national database. Service providers will be expected to collect and provide audit data on request.

Date of Review

One year from the date of approval by the governance process and thereafter at a date agreed by the Greater Manchester EUR Steering Group, unless new evidence or technology is available sooner.

Glossary

Term Meaning

Ankyloglossia Tongue tie

Congenital anomaly An abnormality in anatomy present at birth.

Folic acid A vitamin of the B complex found especially in leafy green vegetables, liver, and kidney.

Frenotomy A simple splitting (cutting) of the frenulum.

Frenuloplasty A more complex procedure to release the tongue from the floor of the mouth where the tongue is fully attached.

Frenulotomy A surgical procedure for excising a frenum or frenulum.

Frenulum A small fold or ridge of tissue which supports or checks the motion of the part to which it is attached.

Fusion Joining together of tissues or organs.

Lingual frenulum The vertical fold of mucous membrane under the tongue.

Swaddled Having wrapped (someone, especially a baby) in garments or cloth.

Tongue tie When the frenulum linguae is shorter (and may be thicker) than normal preventing normal movement of the tongue.

References 1. GM EUR Operational Policy 2. The Cochrane Database of Systematic Reviews 2013-4-2: Folic acid supplementation during pregnancy for maternal health and pregnancy outcomes, Zohra S Lassi et al 3. Scientific Advisory Committee on Nutrition (SACN): Update on folic acid (Published: 12 July 2017) - extract cited below evidence review

3. GM Tongue Tie Policy v1.0 FINAL Page 7 of 22 Governance Approvals

Name Date Approved

Greater Manchester Effective Use of Resources Steering Group 19/09/2018

Greater Manchester Directors of Commissioning / Greater Manchester Chief 29/08/2019 Finance Officers (Delegated authority given to approve policy by Greater Manchester Joint Commissioning Board) Bolton Clinical Commissioning Group Awaiting approval

Bury Clinical Commissioning Group 29/08/2019

Heywood, Middleton & Rochdale Clinical Commissioning Group 29/08/2019

Manchester Clinical Commissioning Group 29/08/2019

Oldham Clinical Commissioning Group 29/08/2019

Salford Clinical Commissioning Group 29/08/2019

Stockport Clinical Commissioning Group 29/08/2019

Tameside & Glossop Clinical Commissioning Group 29/08/2019

Trafford Clinical Commissioning Group 29/08/2019

Wigan Borough Clinical Commissioning Group 29/08/2019

3. GM Tongue Tie Policy v1.0 FINAL Page 8 of 22 Appendix 1 – Evidence Review Surgical management of Ankyloglossia (tongue tie) GM050

Search Strategy

Database Result

NICE NICE IPG149: Division of ankyloglossia (tongue-tie) for breastfeeding (Published: 14 Dec 2005)

DARE (was York) Prevalence, diagnosis, and treatment of ankyloglossia a Methodologic review, L M. Segal et al Can Fam Physician 2007;53:1027-1033

Cochrane Frenotomy for tongue-tie in newborn infants, O’Shea JE, Foster JP, O’Donnell CPF, Breathnach D, Jacobs SE, Todd DA, Davis PG, Cochrane Database of Systematic Reviews 2017, Issue 3. Art. No.: CD011065.

NICE Evidence Treatments for ankyloglossia and ankyloglossia with concomitant lip-tie, Francis DO, Chinnadurai S, Morad A, Epstein RA, Kohanim S, Krishnaswami S, Sathe NA, McPheeters ML., Rockville: Agency for Healthcare Research and Quality (AHRQ). Comparative Effectiveness Review No. 149. 2015

Treatment of Ankyloglossia for Reasons Other Than Breastfeeding: A Systematic Review, S Chinnadurai et al, Pediatrics, Volume 135, number 6, June 2015

Tongue-tie division. Is it worth it? A retrospective cohort study, S Braccio et al, British Journal of Midwifery, 2016, vol./is. 24/5(317-321), 09694900

RCM website Tongue-tied (Advice page) – indications for intervention as given on this page cited below

Summary of the evidence

Ankyloglossia (tongue tie) is relatively common, occurring in around 10% of babies. In most cases this causes no issues at all for the individual and is harmless. The evidence suggests that the following can be associated with tongue tie: • Maternal pain from feeding • Difficulties with latching and then feeding • Failure to thrive

There is also low level evidence for a slight association with speech and language difficulties in older children.

It appears that most babies with a degree of tongue tie can successfully breast feed if the mother receives support from a health visitor or midwife with specialist expertise in breast feeding. For a smaller group frenectomy may be needed for successful breast feeding. Complications of frenectomy are rare and manageable.

3. GM Tongue Tie Policy v1.0 FINAL Page 9 of 22

More extreme tongue tie where the tongue is tethered to the floor of the mouth will require surgical intervention. For this group frenuloplasty is the treatment of choice.

There is no evidence to support the current view that tongue tie is caused by folic acid supplements during pregnancy.

The evidence

Levels of evidence

Level 1 Meta-analyses, systematic reviews of randomised controlled trials

Level 2 Randomised controlled trials

Level 3 Case-control or cohort studies

Level 4 Non-analytic studies e.g. case reports, case series

Level 5 Expert opinion

1. LEVEL 1: NICE Interventional procedures guidance NICE IPG149: Division of ankyloglossia (tongue-tie) for breastfeeding (Published: 14 Dec 2005)

1 Guidance 1.1 Current evidence suggests that there are no major safety concerns about division of ankyloglossia (tongue-tie) and limited evidence suggests that this procedure can improve breastfeeding. This evidence is adequate to support the use of the procedure provided that normal arrangements are in place for consent, audit and clinical governance. 1.2 Division of ankyloglossia (tongue-tie) for breastfeeding should only be performed by registered healthcare professionals who are properly trained. 1.3 Publication of further controlled trials on the effect of the procedure on successful long-term breastfeeding will be useful. 2 The procedure 2.1 Indications 2.1.1 Ankyloglossia, also known as tongue-tie, is a congenital anomaly characterised by an abnormally short lingual frenulum, which may restrict mobility of the tongue. It varies from a mild form in which the tongue is bound only by a thin mucous membrane, to a severe form in which the tongue is completely fused to the floor of the mouth. Breastfeeding difficulties may arise, such as problems with latching (getting the mother and baby appropriately positioned to breastfeed successfully), sore nipples and poor infant weight gain. 2.1.2 Many tongue-ties are asymptomatic and cause no problems. Some babies with tongue-tie have breastfeeding difficulties. Conservative management includes breastfeeding advice, and careful assessment is important to determine whether the frenulum is interfering with feeding and whether its division is appropriate. Some practitioners believe that if division is required, this should be undertaken as early as possible. This may enable the mother to continue to breastfeed, rather than having to feed artificially. 2.2 Outline of the procedure 2.2.1 In early infancy, division of the tongue-tie is usually performed without anaesthesia, although local anaesthetic is sometimes used. The baby's head is stabilised, and sharp, blunt-ended scissors are used to divide the lingual frenulum. There should be little or no blood loss and feeding may be resumed immediately. After the early months of life, general anaesthesia is usually required. 2.3 Efficacy

3. GM Tongue Tie Policy v1.0 FINAL Page 10 of 22 2.3.1 One randomised controlled trial was reported, comparing division of tongue-tie with 48 hours of intensive support from a lactation consultant. The study reported that 95% (19/20) of babies had improved breastfeeding 48 hours after tongue-tie division, compared with 5% (1/20) of babies in the control group (p < 0.001). 2.3.2 In one case-series, 80% (173/215) of babies had improved breastfeeding at 24 hours after the procedure. In another case-series, 100% (123/123) babies had an improved latch after the procedure and there was a significant decrease in maternal nipple pain. In a third case-series, 100% (36/36) of babies had a normal tongue motion at 3 months. 2.3.3 Some of the Specialist Advisors stated that it is difficult to ascertain that any improvement in breastfeeding is actually due to the procedure. 2.4 Safety 2.4.1 Few adverse effects were reported. One case-series reported that 2% (4/215) of babies had an ulcer under the tongue for more than 48 hours and 0.5% (1/215) of babies had soreness for more than 24 hours. 2.4.2 Two studies, including a total of 159 babies, stated that there were no complications. Two studies reported that 8% (3/36) and 18% (39/215) of babies slept through the entire procedure. 2.4.3 The Specialist Advisors listed bleeding, infection, ulceration, pain, damage to the tongue and submandibular ducts, and recurrence of the tongue-tie as potential adverse effects of the procedure but several advisors stated that these were likely to be very rare events. List of studies included in the overview This overview is based on five studies (see references). One randomised controlled trial was reported, comparing division of tongue-tie with 48 hours of intensive support from a lactation consultant.1 Three case-series were identified, including a total of 374 babies.2,3,4 One cross-over study, comparing division with a sham procedure, was reported as an abstract only.5 Existing reviews on this procedure No systematic reviews on this procedure were identified. Validity and generalisability of the studies • The main outcome measures in four of the five studies were subjective and based on reports by the mother.1,2,3,5 • The randomised controlled trial did not attempt to blind either the mother or the investigator as to which group the baby had been allocated to.1 • The randomised controlled trial offered division to the control group after 48 hours because it was considered unethical to withhold this option, so there was no comparison to indicate whether any of the babies would have improved spontaneously. • The prospective cross-over trial was only reported as an abstract and included a small number of cases.5 Specialist advisors’ opinions Specialist advice was sought from consultants who have been nominated or ratified by their Specialist Society or Royal College. • Most of the advisors consider the procedure to be established practice. • A more common indication for this procedure is the treatment of speech difficulties in older children, when a general anaesthetic is used. • Careful case selection is important to ensure that only those tongue-ties that are likely to be causing problems are divided. • The current alternative treatment is breastfeeding advice and counselling from a lactation consultant. • Most of the advisors believe that the potential impact of this procedure on the NHS is minor. Issues for consideration by IPAC There appears to be considerable controversy regarding the significance of tongue tie in relation to breastfeeding difficulties and about the appropriate management of the condition.6

3. GM Tongue Tie Policy v1.0 FINAL Page 11 of 22 References 1 Hogan M, Westcott C, Griffiths M. A randomised, controlled trial of division of tongue-tie in infants with feeding problems. Journal of Paediatrics and Child Health; 2005: in press. 2 Griffiths DM. Do tongue ties affect breastfeeding? Journal of Human Lactation 2004; 20:409–14. 3 Ballard JL, Auer CE, Khoury JC. Ankyloglossia: assessment, incidence, and effect of frenuloplasty on the breastfeeding dyad. Pediatrics 2002; 110: e63. 4 Masaitis NS, Kaempf JW. Developing a frenotomy policy at one medical center: a case study approach. Journal of Human Lactation 1996; 12: 229–32. 5 Dolberg S, Botzer E, Grunis E et al. A randomized, prospective, blinded clinical trial with cross-over of frenotomy in ankyloglossia: effect on breast-feeding difficulties. Pediatric Research 2002; 52: 822. 6 Messner AH, Lalakea ML. Ankyloglossia: controversies in management. International Journal of Pediatric Otorhinolaryngology 2000; 54: 123–31.

2. LEVEL 1: REVIEW Prevalence, diagnosis, and treatment of ankyloglossia a Methodologic review, L M. Segal et al Can Fam Physician 2007;53:1027-1033

ABSTRACT Objective: To review the diagnostic criteria for, the prevalence of, and the effectiveness of frenotomy for treatment of ankyloglossia. Data Sources: MEDLINE and CINAHL databases were searched for articles suitable for a methodologic review of studies on various aspects of ankyloglossia. Study Selection: Studies that presented data on patients and addressed ankyloglossia in relation to breastfeeding were selected. Case reports, case series, retrospective studies, prospective controlled studies, and randomized controlled trials were included in the analysis. Opinion pieces, literature reviews, studies without data on patients, studies that did not focus on breastfeeding, position statements, and surveys were excluded. Synthesis: There is no well-validated clinical method for establishing a diagnosis of ankyloglossia. Five studies using different diagnostic criteria found a prevalence of ankyloglossia of between 4% and10%. The results of 6 non-randomized studies and 1 randomized study assessing the effectiveness of frenotomy for improving nipple pain, sucking, latch, and continuation of breastfeeding all suggested frenotomy was beneficial. No serious adverse events were reported. Conclusion: Diagnostic criteria for ankyloglossia are needed to allow for comparative studies of treatment. Frenotomy is likely an effective treatment, but further randomized controlled trials are needed to confirm this. A reliable frenotomy decision rule is also needed.

3. LEVEL 1: SYSTEMATIC REVIEW Frenotomy for tongue-tie in newborn infants, O’Shea JE, Foster JP, O’Donnell CPF, Breathnach D, Jacobs SE, Todd DA, Davis PG, Cochrane Database of Systematic Reviews 2017, Issue 3. Art. No.: CD011065.

ABSTRACT Background: Tongue-tie, or ankyloglossia, is a condition whereby the lingual frenulum attaches near the tip of the tongue and may be short, tight and thick. Tongue-tie is present in 4% to 11% of newborns. Tongue-tie has been cited as a cause of poor breastfeeding and maternal nipple pain. Frenotomy, which is commonly performed, may correct the restriction to tongue movement and allow more effective breastfeeding with less maternal nipple pain. Objectives: To determine whether frenotomy is safe and effective in improving ability to feed orally among infants younger than three months of age with tongue-tie (and problems feeding). Also, to perform subgroup analysis to determine the following: • Severity of tongue-tie before frenotomy as measured by a validated tool (e.g. Hazelbaker Assessment Tool for Lingual Frenulum Function (ATLFF) scores < 11; scores ≥ 11) (Hazelbaker 1993).

3. GM Tongue Tie Policy v1.0 FINAL Page 12 of 22 • Gestational age at birth (< 37 weeks’ gestation; 37 weeks’ gestation and above). • Method of feeding (breast or bottle). • Age at frenotomy (≤ 10 days of age; > 10 days to three months of age). • Severity of feeding difficulty (infants with feeding difficulty affecting weight gain (as assessed by infant’s not regaining birth weight by day 14 or falling off centiles); infants with symptomatic feeding difficulty but thriving (greater than birth weight by day 14 and tracking centiles). Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and CINAHL up to January 2017, as well as previous reviews including cross- references, expert informants and journal handsearching. We searched clinical trials databases for ongoing and recently completed trials. We applied no language restrictions. Randomised, quasi-randomised controlled trials or cluster-randomised trials that compared frenotomy versus no frenotomy or frenotomy versus sham procedure in newborn infants. Data collection and analysis: Review authors extracted from the reports of clinical trials data regarding clinical outcomes including infant feeding, maternal nipple pain, duration of breastfeeding, cessation of breastfeeding, infant pain, excessive bleeding, infection at the site of frenotomy, ulceration at the site of frenotomy, damage to the tongue and/or submandibular ducts and recurrence of tongue-tie.We used the GRADE approach to assess the quality of evidence. Main results: Five randomised trials met our inclusion criteria (n = 302). Three studies objectively measured infant breastfeeding using standardised assessment tools. Pooled analysis of two studies (n = 155) showed no change on a 10-point feeding scale following frenotomy (mean difference (MD) -0.1, 95% confidence interval (CI) -0.6 to 0.5 units on a 10-point feeding scale). A third study (n = 58) showed objective improvement on a 12-point feeding scale (MD 3.5, 95% CI 3.1 to 4.0 units of a 12-point feeding scale). Four studies objectively assessed maternal pain. Pooled analysis of three studies (n = 212) based on a 10-point pain scale showed a reduction in maternal pain scores following frenotomy (MD - 0.7, 95% CI -1.4 to -0.1 units on a 10-point pain scale). A fourth study (n = 58) also showed a reduction in pain scores on a 50-point pain scale (MD -8.6, 95% CI -9.4 to -7.8 units on a 50-point pain scale). All studies reported no adverse effects following frenotomy. These studies had serious methodological shortcomings. They included small sample sizes, and only two studies blinded both mothers and assessors; one did not attempt blinding for mothers nor for assessors. All studies offered frenotomy to controls, and most controls underwent the procedure, suggesting lack of equipoise. No study was able to report whether frenotomy led to long-term successful breastfeeding. Authors’ conclusions: Frenotomy reduced breastfeeding mothers’ nipple pain in the short term. Investigators did not find a consistent positive effect on infant breastfeeding. Researchers reported no serious complications, but the total number of infants studied was small. The small number of trials along with methodological shortcomings limits the certainty of these findings. Further randomised controlled trials of high methodological quality are necessary to determine the effects of frenotomy.

4. LEVEL 1: SYSTEMATIC REVIEW The effect of tongue-tie division on breastfeeding and speech articulation: a systematic review Webb AN, Hao W, Hong P.. International Journal of Pediatric Otorhinolaryngology 2013; 77(5): 635-646

CRD summary: This review concluded that tongue-tie division for ankyloglossia was well tolerated, and provided objective and subjective benefits for breastfeeding, but the evidence was limited. There were no significant data to suggest that ankyloglossia was a cause of speech articulation problems. These conclusions were appropriately cautious, but may be overly positive given the severe limitations of the included evidence. Authors' objectives: To systematically review the outcomes of tongue-tie division procedures for patients with ankyloglossia (tongue tie). Searching: MEDLINE, EMBASE, and The Cochrane Library were searched for relevant publications from 1966 to June 2012. Search terms were reported and reference lists of retrieved articles were hand searched for further relevant publications. No language restrictions were applied. Study selection: Two reviewers independently selected studies that reported measures of breastfeeding, speech, or adverse events, for patients who had undergone tongue-tie release. Case

3. GM Tongue Tie Policy v1.0 FINAL Page 13 of 22 series (with at least five patients), case-control studies, cohort studies, and randomised controlled trials were eligible for inclusion. Participants in the included studies were aged from one day to 23 years and underwent frenotomy (frenectomy; removal of the frenulum – tongue-tie tissue) or frenuloplasty (alteration of the frenulum), following a clinical diagnosis of ankyloglossia or breastfeeding problems. Where authors disagreed on study selection, a third reviewer was consulted. Assessment of study quality: Study quality was assessed on seven criteria: inclusion and exclusion criteria clearly stated; validated assessment method; appropriate comparison group (within-patient or control group); blinded observers; adequate sample size or power analysis; well-defined, consecutive sample; and less than 5% of participants lost at follow-up. The authors did not state how many reviewers performed this assessment. Data extraction: The data were extracted on study characteristics, with mean or median values, standard deviations, confidence intervals or probabilities, or several of these measures, extracted for quantitative outcomes. The authors did not state how many reviewers extracted the data. Methods of synthesis: The study results were combined in a narrative synthesis. Results of the review: Twenty studies (15 observational and five randomised controlled trials) with 1,012 participants were included. Studies met between two and six of the quality criteria. Tongue-tie division provided statistically significant objective improvements in Latch, Audible swallowing, Type of nipple, Comfort, and Hold (LATCH) scores (two studies), the Short Form McGill Pain Questionnaire (two studies), the Infant Breastfeeding Assessment Tool (one study), milk production and feeding characteristics (three studies), and infant weight gain (one study). Subjective improvements were reported for maternal perception of breastfeeding (14 studies) and maternal pain (four studies). No significant improvements in speech function were reported (four studies). Adverse events were infrequently reported, the most serious being the need for a repeat procedure. Authors' conclusions: Tongue-tie division was well tolerated and provided objective and subjective benefits for breastfeeding, but there was little high-quality evidence. There were no significant data to suggest that ankyloglossia was a cause of speech articulation problems. CRD commentary: This review attempted to identify evidence to address a broadly defined research question. Attempts were made to minimise bias and errors in the selection of studies, but it was not clear if such measures were taken for other processes. The diversity of the included studies suggests that a narrative synthesis was appropriate, but few details of the included studies were given. The authors' conclusions follow from the results found, but this evidence might be biased due to small samples, selected participant groups, subjective outcome measures, lack of blinding, and the absence of comparators. The discussion section of the review appeared to suggest that the largest (and highest quality) randomised study found no significant effect on LATCH score, but this study did not appear in the summary tables, nor in the narrative synthesis of results. Given the limitations of the primary evidence and the lack of clarity in some aspects of reporting, the authors' conclusions on the efficacy of tongue-tie division were appropriately cautious, but may be overly positive. Implications of the review for practice and research: Practice: The authors stated that tongue-tie division should only be performed by a trained healthcare professional, on newborns with significant ankyloglossia and associated breastfeeding problems, who had failed to respond to conservative management; it should not be used to prevent articulation problems. Research: The authors stated that long-term studies were needed and they should use validated measures of ankyloglossia severity and breastfeeding outcomes. Funding: No external funding received.

5. LEVEL 1: REVIEW Treatments for ankyloglossia and ankyloglossia with concomitant lip-tie, Francis DO, Chinnadurai S, Morad A, Epstein RA, Kohanim S, Krishnaswami S, Sathe NA, McPheeters ML., Rockville: Agency for Healthcare Research and Quality (AHRQ). Comparative Effectiveness Review No. 149. 2015

3. GM Tongue Tie Policy v1.0 FINAL Page 14 of 22 ABSTRACT Objectives: We systematically reviewed the literature on surgical and nonsurgical treatments for infants and children with ankyloglossia and ankyloglossia with concomitant lip-tie. Data sources: We searched MEDLINE® (PubMed®), PsycINFO®, Cumulative Index of Nursing and Allied Health Literature (CINAHL®) and Embase (Excerpta Medica Database), as well as the reference lists of included studies and recent systematic reviews. We conducted the searches between September 2013 and August 2014. Review methods: We included studies of interventions for ankyloglossia published in English. Two investigators independently screened studies against predetermined inclusion criteria and independently rated the quality of included studies. We extracted data into evidence tables and summarized them qualitatively. Results: We included 58 unique studies comprising 6 randomized controlled trials (RCTs) (3 good, 1 fair, 2 poor quality), 3 cohort studies (all poor quality), 33 case series, 15 case reports, and 1 unpublished thesis. Most studies assessed the effects of frenotomy (a procedure in which the lingual frenulum is divided) on breastfeeding-related outcomes. Four RCTs reported improvements in breastfeeding efficacy using either maternally reported or observer ratings, while two RCTs using observer ratings found no improvement. Mothers consistently reported improved breastfeeding effectiveness after frenotomy, but outcome measures were heterogeneous and short term. Future studies could provide additional data to confirm or change the measure of effectiveness; thus, we consider the strength of evidence (SOE; confidence in the estimate of effect) to be low at this time. Furthermore, this literature is characterized by (1) a lack of details about the surgical procedure, (2) cointerventions allowed variably in control groups, and (3) diversity of provider settings. Pain outcomes improved for mothers of frenotomized infants compared with control in one study of 6-day old infants but not in studies of infants a few weeks older. Given these inconsistencies and the small number of comparative studies and participants, the SOE is low for an immediate reduction in nipple pain. Three studies with significant limitations reported improvements in other feeding outcomes with frenotomy, and four poor-quality studies reported some improvements in speech articulation but mixed results related to overall speech sound production. Three poor-quality comparative studies noted some improvements in social concerns and gains in tongue mobility in treated participants. SOE for all of these outcomes is insufficient. SOE is moderate for minor and short-term bleeding following surgery and insufficient for other harms (reoperation, pain). Conclusions: A small body of evidence suggests that frenotomy may be associated with improvements in breastfeeding as reported by mothers, and potentially in nipple pain, but with small short-term studies, inconsistently conducted, SOE is generally low to insufficient. Comparative studies reported improvements in some measures of speech, but assessment of outcomes was inconsistent. Few studies addressed tongue mobility and self-esteem issues. Research is lacking on nonsurgical interventions, as well as on outcomes other than breastfeeding.

6. LEVEL 1: REVIEW Treatment of Ankyloglossia for Reasons Other Than Breastfeeding: A Systematic Review, S Chinnadurai et al, Pediatrics, Volume 135, number 6, June 2015

ABSTRACT Background and Objective: Children with ankyloglossia, an abnormally short, thickened, or tight lingual frenulum, may have restricted tongue mobility and sequelae, such as speech and feeding difficulties and social concerns. We systematically reviewed literature on feeding, speech, and social outcomes of treatments for infants and children with ankyloglossia. Methods: Medline, PsycINFO, Cumulative Index of Nursing and Allied Health Literature, and Embase were searched. Two reviewers independently assessed studies against predetermined inclusion/exclusion criteria. Two investigators independently extracted data on study populations, interventions, and outcomes and assessed study quality. Results: Two randomized controlled trials, 2 cohort studies, and 11 case series assessed the effects of frenotomy on feeding, speech, and social outcomes. Bottle feeding and social concerns, such as ability to use the tongue to eat ice cream and clean the mouth, improved more in treatment groups in comparative studies. Supplementary bottle feedings decreased over time in case series. Two cohort

3. GM Tongue Tie Policy v1.0 FINAL Page 15 of 22 studies reported improvement in articulation and intelligibility with treatment. Other benefits were unclear. One randomized controlled trial reported improved articulation after Z-frenuloplasty compared with horizontal-to-vertical frenuloplasty. Numerous noncomparative studies reported speech benefits posttreatment; however, studies primarily discussed modalities, with outcomes including safety or feasibility, rather than speech. We included English-language studies, and few studies addressed longer term speech, social, or feeding outcomes; nonsurgical approaches, such as complementary and alternative medicine; and outcomes beyond infancy, when speech or social concerns may arise. Conclusions: Data are currently insufficient for assessing the effects of frenotomy on non-breast feeding outcomes that may be associated with ankyloglossia.

7. LEVEL 3: COHORT STUDY Tongue-tie division. Is it worth it? A retrospective cohort study, S Braccio et al, British Journal of Midwifery, 2016, vol./is. 24/5(317-321), 09694900

Abstract Background: Breastfeeding is a complex process, influenced by various factors. Tongue tie may be an impediment to breastfeeding, so division of tongue tie (frenotomy) is routinely recommended to improve breastfeeding. Aims: This study aimed to assess the value of frenotomy based on its impact on breastfeeding-related problems. Methods: A 1-year retrospective cohort study was undertaken of all the patients referred to a London- based tongue-tie service with breastfeeding difficulties. A telephone survey was performed using a standardised questionnaire. Findings: The rate of exclusively breastfed babies increased from 36.7% before frenotomy to 53.8% at 48 hours post-procedure. All the breastfeeding-related problems significantly reduced by 48 hours post- procedure. There was no major bleeding, infection or ulceration reported. Of babies that had frenotomy, 3.2% underwent a second procedure. Conclusions: Frenotomy is a well-tolerated surgical procedure accompanied by very low complication rates. It significantly increases the exclusive breastfeeding rate in the short-term period and reduces breastfeeding-related problems.

8. LEVEL N/A: PROFESSIONAL GUIDANCE Tongue-tied, RCM website (Extract from advice page)

Problems that can lead to referral for tongue-tie division: Mother • Painful nipples • Recurrent mastitis or breast abscesses • Diminished milk supply • Exhaustion from frequent feeding • Psychological effects. Baby • Difficulty in breast attachment • Fussing during feeds • Prolonged or frequent feedings • Prolonged jaundice • Excessive weight loss. In bottle-fed infants • Difficulty taking a teat • Prolonged feeds • Excessive dribbling or wind.

3. GM Tongue Tie Policy v1.0 FINAL Page 16 of 22

Scientific Advisory Committee on Nutrition (SACN): Update on folic acid (Published: 12 July 2017)

4) Current recommendations on folate intake Reference nutrient intakes for folate 34. The reference nutrient intake (RNI) is the amount of a nutrient that is considered sufficient to meet the requirements of 97.5% of the population. For adults, the RNI for folate is 200 μg/d. For infants and children, the RNIs per day are: 0-12 months, 50 μg; 1-3y, 70 μg; 4-6y, 100 μg; 7-10y, 150 μg; for children 11y and above, the RNI is the same as that for adults. Recommended upper intake levels for folic acid 35. Although folates occur naturally in a wide range of foods, they are present in relatively low amounts. This means that it is hard to achieve high folate intakes from consumption of naturally occurring folates alone. In addition, the absorption of naturally occurring folates is approximately 50% lower than that of folic acid. Concerns regarding the safety of high intakes are therefore restricted to folic acid. 36. In the USA and Europe, a Tolerable Upper Intake Level (UL) of 1 mg/d of folic acid was set for adults (Food and Nutrition Board, 1998; Scientific Committee on Food, 2000). The UL represents the highest level of a nutrient that is likely to pose no risk of adverse health effects to almost all individuals in the general population. It applies to long-term exposure on a daily basis. The UL was based on the risk of progression of neurological symptoms in vitamin B12 deficient patients. ULs for children in the USA11 and Europe12 were extrapolated from the UL for adults on the basis of relative body weight. 37. In the UK, safe levels of intake for vitamins and minerals in food supplements and fortified foods were set by the Expert Group on Vitamins and Minerals (2003). Safe Upper Levels (SULs) were set when supported by adequate data. SULs represent intakes that can be consumed over a lifetime without significant risk to health. A Guidance Level (GL) was set when there were insufficient data to determine an SUL. GLs represent an approximate indication of intakes that would not be expected to cause adverse effects. An SUL was not set for folic acid intake as the available evidence on adverse effects of folic acid was not considered to be sufficiently robust but a GL of 1 mg/d was set based on concerns that intakes above this level may mask signs of vitamin B12 deficiency. GLs were not set for children as there were no data reporting adverse effects in children. 7) Overall summary and conclusions Background 133. Conclusive evidence from RCTs has shown that folic acid supplementation during the early stages of pregnancy can reduce the risk of the fetus developing NTDs. All women planning a pregnancy are therefore advised to take a daily supplement of folic acid (400 μg) prior to conception and until the 12th week of pregnancy. Women with a previous pregnancy affected by NTDs or women with spina bifida themselves are advised to take folic acid supplements of 5 mg/d19. 134. Evidence indicates that this advice has not been followed. It has been estimated that the proportion of women who reported taking folic acid supplements prior to pregnancy has declined from 35% in 1999-2001 to 31% in 2011-12y. Another limitation to the value of recommending folic acid supplementation prior to conception is that only about half of all pregnancies in Britain are planned. Importantly, significant reductions in NTD prevalence have been reported in countries where mandatory folic acid fortification has been introduced. For example, in the USA, where mandatory fortification was introduced in 1998, there was a corresponding 28% reduction in prevalence of anencephaly and spina bifida post-fortification (1999-2011). 135. In 2006, SACN recommended mandatory fortification of flour with folic acid to improve the folate status of women most at risk of NTD-affected pregnancies in the UK (SACN, 2006). It stipulated, however, that it should only be introduced alongside restrictions on voluntary fortification of foods with folic acid. This was to ensure no increase in the numbers of people with intakes above the GL/UL and no substantial increase in mean folic acid intakes or folate status of the UK population.

3. GM Tongue Tie Policy v1.0 FINAL Page 17 of 22 136. In 2007, following publication of two studies suggesting potential adverse effects of folic acid on colorectal cancer risk, SACN was requested by the Chief Medical Officer to conduct a detailed review of these data. In 2009, the Committee concluded that there were uncertainties regarding folic acid and cancer risk but reiterated its previous recommendation for mandatory folic acid fortification together with controls on voluntary fortification, guidance on supplement use and appropriate population monitoring procedures. In addition, people aged over 50y and those with a previous history of colorectal adenomas were advised not to consume supplements containing folic acid above the RNI for folate (200 μg/d). 137. In February 2016, FSS informed SACN that in the absence of progress regarding mandatory folic acid fortification in the UK, Scottish Ministers were considering whether to proceed unilaterally with mandatory folic acid fortification of flour in Scotland. FSS requested advice on whether SACN’s 2006 and 2009 recommendations on mandatory folic acid fortification remained applicable. In response, SACN agreed to conduct a review of evidence published since its previous risk assessments.

3. GM Tongue Tie Policy v1.0 FINAL Page 18 of 22 Appendix 3 – Hazelbaker Assessment Tool for Lingual Frenulum Function Surgical management of Ankyloglossia (tongue tie) GM050

Name: DOB: NHS No: Hospital No:

Appearance Items Function Items Appearance of tongue when lifted: Lateralization:  2: Round or square  2: Complete  1: Slight cleft in tip apparent  1: Body of tongue but no tongue tip  0: Heart- or V-shaped  0: None Elasticity of frenulum: Lift of tongue:  2: Very elastic  2: Tip to mid-mouth  1: Moderately elastic  1: Only edges to mid-mouth  0: Little or no elasticity  0: tip stays at lower alveolar ridge or rises to mid- mouth only with jaw closure Length of lingual frenulum when tongue lifted: Extension of tongue:  2: > 1 cm  2: tip over lower lip  1: 1 cm  1: Tip over lower gum only  0: < 1 cm  0: Neither of the above, or anterior or mid-tongue humps Attachment of lingual frenulum to tongue: Spread of anterior tongue:  2: Posterior to tip  2: Complete  1: At tip  1: Moderate or partial  0: Notched tip  0: Little or none Attachment of lingual frenulum to inferior Cupping: alveolar ridge:  2: Attached to the floor or well below ridge  2: Entire edge, firm cup  1: attached just below ridge  1: Side edges only, moderate cup  0: attached at ridge  0: poor or no cup Peristalsis: Total Appearance Score = ______ 2: Complete, anterior to posterior

 1: partial, originating posterior to tip Total Functional Score = ______ 0: None or reverse motion Significant ankyloglossia diagnosed when appearance score total is 8 or less and/or function score total is 11 or Snapback: less.  2: None Severe maternal nipple pain during breastfeeding, without alternate explanation as assessed by a Lactation Consultant, is  1: Periodic also grounds to consider FRENULOTOMY if a tight anterior frenulum is noted.  0: frequent or with each suck

ASSESSMENT COMPLETED BY (PRINT NAME):

SIGNATURE:

DATE OF ASSESSMENT: DESIGNATION:

3. GM Tongue Tie Policy v1.0 FINAL Page 19 of 22 Appearance of the tongue when lifted is determined by inspecting the anterior edge of the tongue as the infant cries or tries to lift or extend the tongue. The elasticity of the frenulum is determined by palpating the frenulum for elasticity while lifting the infant’s tongue. The length of the lingual frenulum is determined by noting its approximate length in centimetres as the tongue is lifted. Attachment of the frenulum to the tongue is determined by noting its origin on the inferior aspect of the tongue. It should be approximately 1 cm posterior to the tip. The attachment of the lingual frenulum to the inferior alveolar ridge is determined by noting the location of the anterior attachment of the frenulum. It should insert proximal to or into the genioglossus muscle on the floor of the mouth. Lateralization is measured by eliciting the transverse tongue reflex by tracing the lower gum ridge and brushing the lateral edge of the tongue with the examiner’s finger. Lift of the tongue is noted when the finger is removed from the infant’s mouth. If the infant cries, then the tongue tip should lift to mid-mouth without jaw closure. Extension of the tongue is measured by eliciting the tongue extrusion reflex by brushing the lower lip downward toward the chin. Spread of anterior tongue is determined by first eliciting a rooting reflex, just before cupping, by tickling the upper and lower lips and looking for even thinning of the anterior tongue. Cupping is a measure of the degree to which the tongue hugs the finger as the infant sucks on it. Peristalsis is a backward, wave-like motion of the tongue during sucking that should originate at the tip of the tongue and is felt with the back of the examiner’s finger. Snapback is heard as a clucking sound when the tethered tongue loses it grasp on the finger or breast when the infant tries to generate negative pressure. Ballard, J.L., Auer, C.E., Khoury, J.C. (2002). Ankyloglossia: Assessment, Incidence, and Effect of Frenuloplasty on the Breastfeeding Dyad. Pediatrics 2002;110;e63

Ankyloglossia Grading: Class I: mild ankyloglossia, 12-16 mm Class II: moderate ankyloglossia, 8-11mm Class III: severe ankyloglossia, 3-7 mm Class IV: complete ankyloglossia, less than 3 mm

3. GM Tongue Tie Policy v1.0 FINAL Page 20 of 22 Appendix 2 – Diagnostic and Procedure Codes Surgical management of Ankyloglossia (tongue tie) GM050

(All codes have been verified by Mersey Internal Audit’s Clinical Coding Academy)

GM050 – Surgical management of Ankyloglossia (tongue tie)

OPCS-4 Procedure Codes:

Excision of frenulum of tongue F262

Incision of frenulum of tongue F263

Other specified other operations on tongue (might be used for frenuloplasty) F268

Unspecified other operations on tongue (might be used for frenuloplasty) F269

With the following ICD-10 diagnosis codes:

Ankyloglossia Q381

3. GM Tongue Tie Policy v1.0 FINAL Page 21 of 22 Appendix 3 – Version History Surgical management of Ankyloglossia (tongue tie) GM050

The latest version of this policy can be found here GM Tongue Tie Policy

Version Date Summary of Changes

0.1 24/04/2018 Initial draft

0.2 16/05/2018 The GM EUR Steering Group requested the following amendments: Commissioning Statement • Frenuloplasty paragraph reworded and moved to ‘Policy Exclusions’ section • ‘at the time of referral’ added to end of ‘The infant is under 3 months of age’ • ‘Frenectomy’ added to start of heading for ‘For infants with feeding problems’ and first bullet point reworded • Heading added for 'Frenectomy for older children with speech problems' and paragraph rewritten • Recommended GMEURSG funding mechanisms added for infants (MA) and Frenectomy for older children with speech problems (Exceptionality) Following the above changes the group agreed the policy could go out for a period of clinical engagement.

0.3 19/09/2018 GM EUR Steering Group reviewed the feedback received during the period of Clinical Engagement and agreed the following amendments: • Policy Exclusions: ‘This policy applies to children before their 18th Birthday’ added. • Policy Inclusion Critiera: o The first bullet point ‘An assessment of the degree of ankyloglossia has been carried out using the Hazelbaker Assessment Tool (see Appendix 3) which gives a score of less than or equal to 11’ removed. • The ‘NOTE’ in this section reworded from ‘The procedure should be performed as an outpatient procedure or suitable community service.’ to ‘Frenectomy to address the above should be performed as an outpatient procedure or within a suitable community service.’ • Subheading and two bullet points added for ‘Onward referral to Tier 2 or Secondary care’. • Glossary: Definition of ‘Frenulotomy’ added. GM EUR Steering Group agreed that following the above amendments the policy could progress through the governance process.

0.4 01/10/2018 Branding changed to reflect change of service from Greater Manchester Shared Services to Greater Manchester Health and Care Commissioning.

0.5 26/11/2018 Diagnostic and Procedure Codes added to Appendix 2.

1.0 29/08/2019 Policy approved for implementation by the Greater Manchester Directors of Commissioning / Greater Manchester Chief Finance Officers.

3. GM Tongue Tie Policy v1.0 FINAL Page 22 of 22