INGUINAL HERNIA SURGERY: IMPROVING PATIENT OUTCOMES AND REDUCING VARIATION

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1 HERNIA INGUINAL HERNIA SURGERY: IMPROVING PATIENT AND REDUCING VARIATION

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3 INGUINAL HERNIA SURGERY: IMPROVING PATIENT AND REDUCING VARIATION CONTENTS 4 Executive summary 6 Restricting inguinal hernia repair: a procedure of limited clinical value? 8 Patient reported outcome measures (PROMS) 11 The case for a hernia registry 12 Conclusion 13 References Page 3

4 HERNIA EXECUTIVE SUMMARY Inguinal hernia surgery is the most common surgical procedure for men above the age of 18, with more than 80,000 procedures performed each year. Around 98% of inguinal hernias are found in men because of the vulnerability of the male abdomen to the formation of hernias in this region. i Given the historic lack of data capture on genuine outcomes for patients undergoing inguinal hernia surgery, there is a perception within the NHS that this procedure is of limited clinical value. As a result of this, many Clinical Commissioning Groups (CCGs) are making decisions to limit inguinal hernia surgery. An audit undertaken in September 2017 of the 207 Clinical Commissioning Groups in England found that, of the 120 CCGs that have publicly available commissioning guidance, 65 state that they have adopted a "watchful waiting" approach. This equates to over half of CCGs with publicly available guidance enforcing restricted access to hernia treatment. This leads to not only to an unacceptable regional variation in access to procedures, but also sets a worrying precedent for NHS England in which CCGs are rationing procedures without a thorough assessment of clinical outcomes or appropriate financial projection for the overall health economy. The current method of capturing patient outcomes for those who undergo this procedure is through Patient Reported Outcome Measures (PROMs). This report argues that current PROMs do not capture the relevant information to genuinely determine whether or not the procedure leads to an improvement in patient outcomes. As a result this campaign argues that the PROMs questionnaire should be updated to capture information relevant to making an appropriate judgement about how to commission inguinal hernia surgery. With the current lack of knowledge about patient outcomes for this procedure, we believe that it is unacceptable for the procedure to be moved into the watchful waiting category, which may damage patient outcome and therefore increase financial costs in the long term.. Until sufficient data has been collected to accurately access the impact of inguinal hernia procedures on patient outcomes, it is unacceptable for over a third of CCGs to arbitrarily limit this procedure. What we found: 120 CCGs out of 207 have published policies Of those, 65 have adopted a "watchful waiting" approach Over half (54%) of CCGs with published guidance are reducing access to inguinal hernia surgery Over a third (31%) of all CCGs are reducing access to hernia surgery Page 4

5 INGUINAL HERNIA SURGERY: IMPROVING PATIENT AND REDUCING VARIATION We recommend: The amendment of the PROMs questionnaire to ensure it captures appropriate patient outcomes data in order to determine the clinical effectiveness of the procedure. CCGs to routinely commission inguinal hernia repair, rather than adopting a watchful waiting approach, until robust long term data is collected which allows NHS England to make an informed decision on the clinical effectiveness of the procedure. The development of a national registry on hernias including inguinal hernias to ensure comprehensive data capture and bring the United Kingdom in line with other European countries. This should be a mandatory requirement for all surgeons who perform this procedure and should be adequately funded. A review of international national registries in order to determine best practice from countries which already have a registry in place. A national NHS England strategy to reduce regional variation in access to inguinal hernia procedures. Page 5

6 HERNIA RESTRICTING INGUINAL HERNIA REPAIR: A PROCEDURE OF LIMITED CLINICAL VALUE? What guidance says The National Institute for Health and Care Excellence (NICE) guidance states that surgical repair should be undertaken in most individuals presenting with an inguinal hernia in order to close the defect, alleviate symptoms of discomfort and/or prevent serious complications, such as obstruction or strangulation of the hernia. ii This is supported by guidance from the Royal College of Surgeons and the Association of Surgeons of Great Britain and Ireland (ASGBI), which states that surgical repair should be offered to all patients presenting with symptomatic hernias. iii Patients with totally asymptomatic inguinal hernias are likely to require surgery in the future, although they can be managed conservatively in the first instance. The guidance states that the decision should be based on a patient-by-patient basis through discussion between the patient and clinician. Having this flexibility is tantamount to ensuring a prevention in condition escalation and in order to ensure high quality patient outcomes. restricted commissioning policy can be applied. A decision can be made as to whether or not a procedure is of limited clinical value if it is perceived to have minimal benefits to a patient s health. This decision is made at a local level by CCGs, which can lead to regional variation in access to different procedures. CCGs which have decided that inguinal hernia repair is of limited value, and as such apply a restrictive policy can adopt a watchful waiting approach. This means that a procedure would not take place in minimally symptomatic patients or asymptomatic patients until the emergence of escalated pain or discomfort. An audit of published CCG guidance on perceived PLCV undertaken in September 2017 revealed that 65 of the 120 CCGs that have publicly available guidance, recommend a "watchful waiting" approach for asymptomatic or minimally symptomatic hernia repair, and therefore apply a restricted policy. Procedures of limited clinical value Procedures of limited clinical value (PLCV) are those which are deemed by CCGs to be of value, but only in certain circumstances. Where it is deemed that a procedure does not meet requirements for routine commissioning, a Is watchful waiting the appropriate approach? The World Guidelines for Groin Hernia Management state that most men with minimally symptomatic or asymptomatic inguinal hernias will develop symptoms and require surgery. iv Page 6

7 INGUINAL HERNIA SURGERY: IMPROVING PATIENT AND REDUCING VARIATION Further to this, the Royal College of Surgeons report Is access to surgery a postcode lottery? warns that the majority of patients with an inguinal hernia will develop symptoms requiring surgical intervention over time. v They argue that, more often than not, there is merit in repairing asymptomatic hernias. The World Guidelines for Groin Hernia Management conclude that longterm studies have revealed high levels of patients requiring surgery due to symptom development, mostly in relation to pain. In a prospective study of 700 patients with inguinal hernias, the cumulative probability of increased pain with time was almost 90 per cent at 10 years. vi A retrospective cohort study published in 2014 examined the effect of a local policy change for asymptomatic inguinal hernias, whereby patients underwent watchful waiting instead of elective repair. vii After the policy change, patients were 59 per cent more likely to require an emergency repair and at increased risk of adverse events (18.5 per cent vs. 4.7 per cent) and mortality (5.4 per cent vs. 0.1 per cent). viii Whilst a watchful waiting approach may be appropriate in selected patients, it is evident that there are many associated risks for a large number of patients. The risk is that CCGs will adopt this approach for all minimally symptomatic, asymptomatic patients and some more seriously symptomatic patients, meaning that more and more patients will only be treated when their condition deteriorates to the point where they require emergency intervention. Data has shown that there is a lower morbidity associated with elective surgery than emergency surgery. ix Further to this, the Global Burden of Disease Report concluded that elective hernia surgery was one of the most cost effective measures to reduce avertable morbidity and mortality. x They recommended that it is a fundamental component of any public health system. The decision to operate should always be taken in consideration of the risks and benefits after full discussion with the patient. It is unacceptable to impose restrictive criteria that deny patient access to a procedure that potentially limits pain, improves quality of life and has indirect and direct economic benefits. xi CCGs should follow NICE commissioning guidance in order to provide the best care for their patients. Furthermore, determining whether or not a procedure is of limited clinical value should be based on robust patient outcomes data. This report argues that current data sets for the collection of inguinal hernia patient outcomes in the UK are inadequate, making it impossible to determine whether or not the procedure falls into the category of limited clinical value. Page 7

8 HERNIA PATIENT REPORTED OUTCOME MEASURES (PROMS) The arguments in support of applying a restricted policy for asymptomatic or minimally symptomatic hernia repair include a lack of evidence of clinical or cost effectiveness. A key method of collating this information is through Patient Reported Outcome Measures (PROMs). PROMs measure health gains in patients and have been collected nationally in England since Patients are asked to complete questionnaires before and after their operations to assess the improvement in their health as they EQ 5D Index The EQ-5D Index collates responses given in 5 broad areas: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It then combines these scores into a single value. perceive it. PROMs data are collected for patients having inguinal hernia surgery. There is no condition-specific PROM for hernia repair. In fact this is the only PROM in use that is not disease specific. As a result, patients are required to complete two generic questionnaires: the EQ-5D and the SF-36. It is understandable that commissioning decisions would be based on the results of this data. It is, therefore, crucial that the PROMs questionnaires capture the most pertinent information in order to make an informed decision about whether or not this procedure leads to genuinely improved patient outcomes. This must be within an appropriate length of time to effectively judge the long-term impact of the procedure. The most important purpose of PROMs is to provide data which can be used to improve patient outcomes and to influence a programme of continual improvement of patient experience. This is not currently the case. SF-36 The SF-36 is a measure of health status and is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the costeffectiveness of a health treatment. Ensuring PROMs data are fit for purpose In order to make clinically appropriate decisions about the effectiveness of inguinal hernia repair, it is crucial that the correct patient information is captured in order to determine whether or not a genuine improvement to health has been achieved. Page 8

9 INGUINAL HERNIA SURGERY: IMPROVING PATIENT AND REDUCING VARIATION Chronic pain Chronic pain is often defined as any pain lasting more than 3 months. It is recognised that pain persisting beyond the first few days after groin hernia repair affects small numbers of patients; estimated to be 10 15% of hernias repaired. xiii In nearly all of these patients, the pain subsides postoperatively over the first three months. Chronic, disabling pain persisting at and beyond 3 months is thought to be rare, affecting less than 1% of patients. xiv Given that the timeframe between when the patient has their procedure and when they fill out the second questionnaire is within three months, it is likely that many patients who have postoperative pain, which would subside after three months following surgery, incorrectly record chronic pain when filling out the patient questionnaire. This would skew the data, thereby making the procedure seem less effective in alleviating a patient s chronic pain than if the survey was undertaken after a sufficient amount of time had passed. Recurrence rate When a hernia recurs after surgical repair, further repair operations are more difficult to perform, and the chances of success diminish with each successive attempt. xv The PROMs questionnaires should reflect this fact. For example, the EQ5D could include questions such as Is this your first inguinal hernia repair surgery? If the answer is no, a follow up question could be How long ago did you have your previous hernia repair(s)? This would capture recurrence data which is necessary in order to successfully identify the scope of the problem of recurrent hernias and effectively improve patient outcomes. The data on this is currently lacking due to the fact there is no question requesting this specific data. Discomfort levels Current PROMs questionnaires ask basic questions around discomfort, which are often as simple as I have moderate pain or discomfort and I have extreme pain or discomfort. This does not allow for a comparison between the levels of discomfort. To produce data that can be fairly compared, the questions should be more detailed, clearer and less likely to result in varying answers for patients with similar levels of discomfort. Page 9

10 HERNIA Unlike the other treatments captured within PROMs data (hip replacement, knee replacement, and varicose vein), hernia repair does not have its own condition-specific PROM. As a result, patients are required to complete two separate questionnaires; the EQ-5D and the SF-36. The Hernia Outcome Campaign believes that these questionnaires do not effectively capture all of the necessary information to determine how a procedure impacts on the patients outcomes both in the immediate and longer term. The current PROMs does not effectively capture chronic pain, recurrence rates and discomfort levels. Without a clear understanding of these indicators, it is not possible to determine whether or not the procedure is of limited clinical value, as these factors have a huge impact on patient experience and outcomes. Another problem with the current scoring is that the scores can be assigned in an arbitrary way by the individual, and the weight placed on the issues the patient is facing due to their condition, and the increasing levels of these problems might not reflect their relative importance to the individual patient answering the questions. For example, the second part of the EQ-5D asks patients to indicate how they feel overall on a scale of This might be thought to show how patients value their own health, in that their overall score will reflect the relative importance they place on the different aspects of their health that have been described. xii A viable alternative: the Carolinas Comfort Scale outcomes following a hernia procedure would be the Carolinas Comfort Scale (CCS), which is designed specifically for patients undergoing hernia repair. This scale has been statistically validated against other well studied and validated assessment tools, including the SF-36, and is quickly becoming the gold standard for quality-oflife (QOF) assessments in hernia patients. xvi The CCS sees patients fill out a survey, both before inguinal hernia surgery and after, in which five end points are tested; activity, sensation, pain, movements and total score. The patient s responses are scored using an algorithm developed by CLASP surgeons and researchers which provides a deeper understanding of a patients quality of life, compared with the more simplistic SF-36 survey. Studies comparing CCS to other data collection methods have shown that the test is a validated, sensitive, and robust instrument for assessing quality of life after hernia repair, which has become a predominant outcome measure in this discipline of surgery. xvii With the use of mesh shown to considerably reduce recurrence rates for hernia repair and subsequent improvement in clinical outcomes, focus has now been placed on Quality of Life (QOL) outcomes in patients undergoing these repairs. The CCS is being used all over the world to evaluate the quality of life of patients undergoing complex hernia repairs. The NHS should adopt a more accurate and effective system of capturing patient outcomes, such as the Carolinas Comfort Scale, over the less effective system that is in place currently. A more effective way of capturing true patient Page 10

11 INGUINAL HERNIA SURGERY: IMPROVING PATIENT AND REDUCING VARIATION THE CASE FOR A HERNIA REGISTRY It is important to base a decision regarding the commissioning of inguinal hernia surgery on accurate, relevant and timely information relating to a patient s outcomes. The development and implementation of a national groin hernia registry is promoted within the World Hernia Guidelines. Hernia registries, with high levels of coverage, allow the monitoring of real world clinical practice and provide reliable, external validity, as opposed to randomised control trials which define the effects of a specific intervention with minimal bias and high internal validity. xviii Having a comprehensive source of procedures and patient outcomes would allow for external scrutiny and therefore the promotion and progression of best practice. The guidelines state that registries should include patient follow-up data and account for local healthcare structures. xix This is significant given that several mesh-related complications can manifest in a delayed manner, with occurrence after years or even decades in some cases. As a result, some complication rates are currently underestimated. The World Guidelines for Groin Hernia Management asserts that long-term registry data may provide a more accurate picture of mesh-related complications. xx It would be crucial to ensure that any registry captured relevant information relating to the procedure and the patient s outcome within an appropriate timeframe. The registry should track recurrence of hernias, how long since the previous repair and the level of pain and discomfort both before and after an operation. Working with experts in this area, as well as analysing existing registries, is strongly recommended in order to ensure the registry achieves its objectives. As part of developing this registry, a review of national registries from across the globe should be undertaken, in order to determine best practice from countries which already have a hernia registry in place. A good example is the Swedish National Inguinal Hernia Register, Danish hernia databale and AHSQC which could feed into a blue print for an UK based registry. Furthermore, registries for other clinical areas, such as the National Join Registry, could provide further use. Reviewing and comparing other registries would ensure that an English version for hernias would be better equipped to collect the necessary data from the offset. Page 11

12 HERNIA CONCLUSION NHS England, understandably, bases its decision making around procedures it deems necessary to routinely commission, on data sets which exist to demonstrate the actual clinical value a procedure has. This campaign supports this as a principle, and understands that budget limitations with the NHS mean that decisions must be made around whether or not a procedure is of limited clinical value or can justifiably be commissioned routinely. It is, however, crucial to ensure that this decision is based on appropriate and critically analysed data, which effectively captures all relevant information needed to make the right decision for patients. It has been argued that the current PROMs questionnaires for inguinal hernia repair are unsatisfactory as they fail to capture the relevant information. What is also clear is that rationing inguinal hernia surgery without clear and robust data should be unacceptable and is unlikely to be cost effective. Some CCG s watchful waiting approach towards inguinal hernia surgery leads to undue and unfair regional variation in patient access to the procedure, and probably leads to a worsening of patient outcomes. NHS England should consider that it would not be appropriate to restrict access to this procedure until the necessary data is collected in a sufficient format. Until this time, an appropriate decision cannot be made and so CCGs should routinely commission this procedure. Limiting patient access to a potentially life changing procedure is unacceptable and goes against the founding principles of the NHS In order to ensure effective data is recorded and used in a more long-term manner, a registry should be developed. A registry would also create a bank of data needed to develop clinically defensible commissioning policies. Page 12

13 INGUINAL HERNIA SURGERY: IMPROVING PATIENT AND REDUCING VARIATION REFERENCES i Laparoscopic surgery for inguinal hernia repair, National Institute for Health and Care Excellence, September ii Laparoscopic surgery for inguinal hernia repair, National Institute for Health and Care Excellence, September iii Groin Hernia, Royal College of Surgeons of England, iv World Guidelines for Groin Hernia Management: Key Questions, Statements and Recommendations, The HerniaSurge Group, pg.25. v Is access to surgery a postcode lottery?, Royal College of Surgeons vi Operation compared with watchful waiting in elderly male inguinal hernia patients: a review and data analysis Collaboration, I.T, Journal of the American College of Surgeons, 2011, pp vii Unintended consequences of policy change to watchful waiting for asymptomatic inguinal hernias, Hwang, M.J., et al, Annals of The Royal College of Surgeons of England, July 2014, pp viii Unintended consequences of policy change to watchful waiting for asymptomatic inguinal hernias, Hwang, M.J., et al, Annals of The Royal College of Surgeons of England, July ix World Guidelines for Groin Hernia Management: Key Questions, Statements and Recommendations, The HerniaSurge Group, p.25. x Surgically avertable burden of digestive diseases at first-level hospitals in low and middle-income regions, Higashi, H., et al., 2015, pp.411-9; pp xi Hernia surgery limiting service provision puts patients at risk, Mr David Sander FRCS and Mr Martin Kurzer FRCS, Royal College of Surgeons, September 2015: xii Getting the most out of PROMs: Putting health outcomes at the heart of NHS decision-making, King s Fund, 2010, pg.10. xiii Groin Pain After Hernia Repair, Robert E. Condon, Annals of Surgery, January 2001: xiv Groin Pain After Hernia Repair, Robert E. Condon, Annals of Surgery, January 2001: xv Recurrent, Incisional and Other Complex Hernias, The British Hernia Centre: xvi Comparison of Generic Versus Specific Quality-of-Life Scales for Mesh Hernia Repairs, Heniford et. Al., The American College of Surgeons, xvii Carolinas Comfort Scale as a Measure of Hernia Repair Quality of Life: A Reappraisal Utilizing 3788 International Patients, Heniford, B. Todd MD, et al., Annals of Surgery: Post Author Corrections: September 21, xviii World Guidelines for Groin Hernia Management: Key Questions, Statements and Recommendations, The HerniaSurge Group, p.6. xix World Guidelines for Groin Hernia Management: Key Questions, Statements and Recommendations, The HerniaSurge Group. xx PART1-.pdf Page 13

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15 INGUINAL HERNIA SURGERY: IMPROVING PATIENT AND REDUCING VARIATION The Hernia Outcomes Campaign is supported by Bard Limited. Page 15

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