Background Laparoscopic anti-reflux surgery (LARS) remains central to the management of gastro-oesophageal reflux disease but the scale and variation in provision in England is unknown. The aims of this study were firstly to examine the processes and outcomes of anti-reflux surgery in England and compare them to national guidelines and secondly to explore potential variations in practice nationally and establish peer benchmarks. Methods All adult patients who underwent LARSin England during the Financial years FY 2011/2012–FY 2016/2017 were identified in the Surgeon’s Workload Outcomes and Research Database (SWORD), which is based on the Hospital Episode Statistics (HES) data warehouse. Outcomes included activity volume, day-case rate, short-stay rate, 2- and 30-day readmis- sion rates and 30-day re-operation rates. Funnel plots were used to identify national variation in practice. Results In total, 12,086 patients underwent LARS in England during the study period. The operation rate decreased slightly over the study period from 5.2 to 4.6 per 100,000 people. Most outcomes were in line with national guidelines including the conversion rate (0.76%), 30-day re-operation rate (1.43%) and 2- and 30-day readmission rates (1.65 and 8.54%, respec- tively). The day-case rate was low but increased from 7.4 to 15.1% during the 5-year period. Significant variation was found, particularly in terms of hospital volume, and day-case, short-stay and conversion rates. Conclusion Although overall outcomes are comparable to studies from other countries, there is significant variation in anti- reflux surgery activity and outcomes in England. We recommend that units use these data to drive local quality improvement efforts. Keywords Anti-reflux surgery · Variation Gastro-oesophageal reflux disease (GORD) is a signifi- Despite improvements in medical therapy, anti-reflux sur - cant and increasing concern, with an estimated incidence gery remains central to its management. Evidence from of approximately 9–26% in European populations [1, 2]. randomised trials and large cohort studies indicates that surgery is safe and effective with mortality rates of < 0.3% and at least equivalent short- and long-term symptom control * Thomas R. Palser compared to medical management alone [3–6]. In addition, email@example.com it may be more cost-effective over the longer term [6 , 7]. This is set against a background of a rising interest in Department of Upper Gastro-Intestinal Surgery, University Hospitals of Leicester NHS Trust, Leicester, UK the development of national standards and data monitoring to drive improvements in care. In the UK, Europe and the SAPPHIRE, Department of Health Sciences, Centre for Medicine, University of Leicester, University Road, United States, audits and quality improvement programmes Leicester LE1 7RH, UK have been put in place for a number of surgical conditions Methods Analytics Ltd, Sheffield Digital Campus, Electric and procedures, such as emergency laparotomies, bariat- Works, Sheffield S1 2BJ, UK ric surgery and colorectal and oesophago-gastric cancer Department of Hepatico-Pancreatico-Biliary surgery, [8–14]. In line with this, the Association of Upper Gastro- Nottingham University Hospitals NHS Trust, Nottingham, intestinal Surgeons of Great Britain and Ireland (AUGIS) UK has recently both established a web-based data portal (the Department of Cancer Studies, University of Leicester, Surgeon’s Workload Outcomes Audit Database ) and Leicester LE1 7RH, UK Vol:.(1234567890) 1 3 Surgical Endoscopy (2018) 32:3208–3214 3209 published two documents which detail the service require- and discharge with only 1 or 2 overnight stays), readmission ments and propose quality metrics for anti-reflux surgery rates at 10 and 30 days and re-operation within 10 days. [16, 17]. These include minimum annual surgeon volumes In order to estimate the number of procedures per 100,000 (at least five procedures per year with at least two surgeons population, the Office of National Statistics mid-year popu - per unit), a conversion to open surgery rate of < 5%, 30-day lation estimate for 2014 (the latest year available) was used. re-operation and readmission rates of < 5 and 10%, respec- The variation in the day-case rates between hospitals was tively, and that each unit should demonstrate a day-case rate. assessed using funnel plots. This plot tests whether hospital However, the practice patterns and outcomes of anti- rates differ significantly from the overall national rate . reflux surgery have never previously been examined on a The hospital rates are plotted on the vertical axis and the national scale, either in England or elsewhere. The aims of number of operations per hospital is shown on the horizontal this study therefore were firstly to examine the processes and axis. The graph also includes the mean rate for England. The outcomes of anti-reflux surgery in England and secondly to two control limits indicate the ranges within which 95 and identify if there is variation nationally. 99.8% of the rates would be expected to fall if differences from the mean English rate arose from random variation alone. Methods The manuscript was prepared according to the Strength- ening the Reporting of Observational Studies in Epidemiol- Data were obtained from the NHS England Hospital Episode ogy (STROBE) reporting guidelines . Statistics (HES, Copyright © 2017 Re-used with the per- mission of The Health and Social Care Information Centre) data warehouse using the Surgeon’s Workload Outcomes Results Audit Database (SWORD), a national monitoring database devised and run by Methods Analytics Ltd. together with In total, 12,086 patients underwent laparoscopic anti-reflux AUGIS and the Association of Laparoscopic Surgeons of surgery (LARS) in England during the study period. The Great Britain and Ireland (ALSGBI). SWORD is a web- number of procedures was stable throughout the study based portal that allows examination of HES for several period, being 2556 operations at its highest point in FY different metrics in a variety of general surgical conditions 2011/2012 and 2207 at its lowest in FY2015/2016. Based (such as anti-reflux surgery, hernias, cholecystectomy, endo- on an estimated adult English population of 49,501,761 crine and HPB cancer surgery). Access is provided as a free in 2014, this corresponds to rate of anti-reflux surgery of member benefit to all AUGIS and ALS members. Finished between 4.6 and 5.2 operations per 100,000 people. Consultant Episodes are linked together such that a patient’s hospital stay encompasses all the treatment provided during Procedure volume that spell. Duplicates are checked and excluded. For this study, all adult patients (those aged 18 or over) Across the study period, 57 (40%) hospitals had an aver- who underwent a laparoscopic anti-reflux procedure funded age annual volume of fewer than ten procedures per year by the public health system (National Health Service; NHS) and so did not meet the AUGIS volume standard. 183 in an English hospital during the last five fiscal years (i.e. (39.5%) surgeons performing anti-reflux surgery in Eng- between 1 April 2011 and 31 March 2016) were included. land had an annual volume of < 5 procedures per year. This Both public and private hospitals were included, although was unchanged across the study period with the figures in only those patients whose treatment was funded by the FY2011/2012 and FY2015/2016 being 144 (47.2%) and 210 NHS are included in HES and hence were included in the (61.0%), respectively. In total, 906 (7.5%) of patients were study. Patients whose operation was performed by the open operated on by surgeons performing fewer than five proce- approach were excluded from the study. Eligible patients dures per year. were identified by the OPCS-4.7 code G243 (anti-reflux fundoplication using abdominal approach) in association Rate of conversion from laparoscopic to open with the approach codes Y75 (Laparoscopic approach to abdominal cavity) and a primary diagnosis of K21 (Gastro- The mean conversion rate across the study period was oesophageal reflux disease) or K44 (Diaphragmatic hernia). 0.76%. This was consistent across the study period, vary- Both procedure and diagnosis codes needed to be in asso- ing from 0.89% in FY 2012/2013 to 0.45% in FY2015/2016 ciation with one of the laparoscopic approach codes (Y751 (Fig. 1). The conversion rate varied nationally from 0 to or Y752). Measures examined included activity volume, 33% with three units being outside the 95% control limit. day-case rate, (defined as admission and discharge on the Nine of the 174 hospitals had conversion rates above the 5% same calendar day), short-stay rate (defined as admission limit recommended by AUGIS. They were all lower volume 1 3 3210 Surgical Endoscopy (2018) 32:3208–3214 across the study period although the variation remained. In the last year of the study period, 26 (18.3%) hospitals per- formed 20% or more of their LARS procedures as a day- case. However, 105 (73.9%) hospitals had day-case rates of < 5%. Even amongst the highest volume trusts (defined as those in the highest volume quintile), there was large varia- tion. Three trusts performed the majority of their anti-reflux surgery as day-cases (with rates of 83.9, 74.4 and 61.8%, respectively), but fourteen high volume trusts (48.2%) had day-case rates of less than 5%. On univariate analysis, vol- ume was not significantly associated with day-case rate (p = 0.064). Short‑stay rate Fig. 1 Inter-provider variation in the rate of procedures converted from laparoscopic to open: whole study period (FY2011–FY2016) Overall across the study period, 70.3% of patients were dis- charged within 48 h. This rate increased only slightly across hospitals with the largest of them having a mean annual vol- the time period, from 68.8% in FY2011/2012 to 73.1% in ume of 11.6 procedures per year. the final year of the study. As with the day-case rate, there was significant variation in the short-stay rate which per - Day‑case rate sisted across the study period (Fig. 3). In FY2011/2012, 21 (15.2%) of hospitals were below the 99.8% confidence limit. The day-case rate varied significantly between hospitals In FY 2015/2016, the figure was 14 (9.7%). (Fig. 2). Overall, 123 (69.5%) hospitals had day-case rates below the 99.8% confidence limit (i.e. had rates significantly lower than the national mean than would be expected if the 30‑Day re‑operation rates variation were due to chance alone). The overall rate fell slightly over the study period although the variation per- The mean 30-day re-operation rate across the study period sisted, with the figure in the final year of the study being was 1.43%. This was unchanged across time (range 1.63% 77 (53.1)%. in FY2011/2012—1.13% in FY2015/2016 ). The rate varied In the first year of the study (FY2011/2012), 10 (7.2%) between 0 and 25% although no hospitals were outside the hospitals had a day-case rate of 20% or more but 109 (79.0%) 95% control limit. Nine hospitals had 30-day re-operation hospitals did little or no day-case anti-reflux surgery (i.e. had day-case rates of < 5%). Again, the rate increased slightly Fig. 2 Inter-provider variation in the rate of procedures performed as Fig. 3 Inter-provider variation in the short-stay rate for anti-reflux a day-case: whole study period (FY2011–FY2016) surgery: whole study period (FY2011–FY2016) 1 3 Surgical Endoscopy (2018) 32:3208–3214 3211 Fig. 4 Inter-provider variation in the 30-day re-operation rate for anti- Fig. 6 Inter-provider variation in the 30-day readmission rate for anti- reflux surgery: whole study period (FY2011–FY2016) reflux surgery: whole study period (FY2011–FY2016) rates above the 5% AUGIS target. As with the conversion were above the 10% AUGIS target and two hospitals were rate, these were all in lower volume hospitals (Fig. 4). above the upper 95% confidence limit (Fig. 6). 2‑ And 30‑day readmission rates Discussion The mean 2- and 30-day readmission rates across the study period were 1.65 and 8.54%, respectively. This likewise This study has used a national monitoring system based on was unchanged across time being 1.48 and 8.41% in FY administrative data to evaluate the patterns and outcomes 2011/2012 and 1.31 and 8.43% in FY2015/2016, respec- of anti-reflux surgery in England. We found that the overall tively. As with the other indicators, there was significant outcomes in terms of conversion to open, re-operation and variation nationally. The mean 2-day readmission rate readmission were comparable to other studies but that there across the period ranged from 0 to 11.5%, with four cen- was wide variation across the country. tres being above the 5% AUGIS target although no centres The use of HES as the basis for the study (and SWORD were above the 95% control limit (Fig. 5). The 30-day in general) allows complete national coverage during the readmission rate varied between 0 and 37.5%. 60 Hospitals study period and avoids the incomplete coverage and selec- tion bias inherent in national registries [8, 20]. It also allows examination of trends over time. HES has been used to identify treatment patterns and variation in a variety of surgical procedures including surgery for colorectal cancer [21, 22], head and neck cancer , breast cancer  and emergency surgical conditions . It has been shown to be highly accurate for procedure and diagnosis codes and so the treatment patterns and outcomes here are likely to be accurate [26–28]. Amongst the potential weaknesses in the study is the fact that data quality is likely to vary between hospitals with smaller hospitals having been shown to be more affected by data quality issues . We therefore cannot exclude the possibility that some of the variation observed, particu- larly in the smaller hospitals, was due to coding inaccura- cies rather than being a real effect. However, the size of the variation observed, particularly in the day-case, short-stay and readmission rates, makes it unlikely that the findings are artefactual. This particularly applies to the national fig- Fig. 5 Inter-provider variation in the 2-day readmission rate for anti- ures and trends for which even a relatively high level of reflux surgery: whole study period (FY2011–FY2016) 1 3 3212 Surgical Endoscopy (2018) 32:3208–3214 inaccuracy would be unlikely to affect the overall figure benchmark. Little data exist for short-term re-operation significantly [29, 30]. rates after anti-reflux surgery with none of the four RCTs Similarly, although HES has been shown to be highly included in the 2010 Cochrane review explicitly reporting accurate for outcomes such as readmission, re-operation and short-term re-operation rates . The most comparable data length of stay, complications such as pneumonia are reported come from a recent nationwide study from Sweden which poorly in HES. Hence, we have not included them in our reported outcomes on 8947 patients who underwent surgery study and so cannot comment on the type or occurrence rate between 1997 and 2003 . In this study, the 30-day re- of post-operative morbidity. Previous operations may also operation rate was lower than in our study at 0.4%. Both the not be coded in HES, particularly if they occurred abroad or overall rate and the number of trusts with much higher rates a long time ago before the database had matured and we can- are interesting and warrant further investigation. Care must not therefore adjust for this in the analysis. It is unlikely to be taken, however, with over-interpretation of this outcome contribute to the observed variation however, as the degree to avoid potentially introducing perverse incentives for sur- of previous surgery is unlikely to vary systematically. geons to avoid re-operating when it is clinically necessary. Likewise another potential weakness is the time-lag in Interpretation of the readmission rates is more difficult. developing codes for novel procedures. This is potentially On the face of it they were higher and more variable, with relevant here as new techniques such as the LINX system 60 hospitals being above the 10% AUGIS 30-day target and are slowly being introduced . However, these techniques two hospitals being outside the 95% control limit. Relevant are in the early part of their introduction into UK practice data with which to compare it are sparse. Again, none of the and are not widely funded, so the effect of this in practice is RCTs explicitly reported it and there are no other compara- unlikely to be large enough to affect the results. The OPCS-4 ble large cohort studies. A systematic review of ambulatory coding system is also not specific enough to differentiate anti-reflux surgery described a range of 0–12.2% with an between the different types of fundoplication [such as partial extrapolated mean of 3.5%. However, the authors comment (Dor/Toupet) and full (Nissen’s)] so it was not possible to that the evidence available for inclusion was poor qual- determine if the choice of procedure varied by hospital and ity . A cohort study from the same group containing if this had any effect. approximately 300 patients had a 30-day readmission rate More significant is the fact that national patient-reported of 8% , whilst a smaller cohort study of 113 patients outcome measures (PROMs) are currently only collected who underwent day-case anti-reflux surgery in Sheffield nationally for four procedures in the UK and this does not had a rate of 3.5% . The readmission rates may be con- include anti-reflux surgery. PROMs are particularly rele - founded by centres in the early phase of introducing ambula- vant for procedures such as this in which the primary aim is tory anti-reflux surgery, in which readmission rates may be symptom control and improvement of health-related quality appropriately higher due to caution during introduction of of life. Although outcomes such as re-operation and read- the new protocols. Against this however, we did not find any mission rates act as surrogates and are important outcomes correlation between a unit’s unadjusted 30-day readmission in themselves, we cannot definitively comment on the “suc - rate and its day-case rate. cess” rates or “quality” of anti-reflux surgery in England as Due partly to the faster recovery offered by the laparo - we lack these measures. scopic approach, allied to the rising emphasis on reducing The overall outcomes reported here, however, are com- healthcare costs, there is increasing interest in reducing parable to results from other studies. The overall conver- hospital stay and increasing the number of procedures per- sion rate from laparoscopic to open of 0.76% is well below formed as a day-case. Several single-centre case series have the AUGIS target of 5% and compares favourably to that been published which have indicated that day-case LARS published in both cohort studies and randomised controlled can be performed safely in selected patients, with similar trials. For example, in a 20-year cohort composed of over post-operative morbidity and mortality to those who undergo 2200 patients in Australia, the conversion rate was 3.2% an inpatient stay, although no randomised trials have been , whilst in the two largest RCTs it was 1.8 and 2.4% . carried out [34–38]. The one prospective study that exam- However, nine hospitals were above the AUGIS target (and ined cost found an estimated saving of 2367 Euros (assum- one beyond the 99.8% confidence limit). Accepting that we ing day of surgery admission as is standard UK practice) have not adjusted for patient characteristics such as body . Our study has reinforced these findings by demonstrat- mass index or previous abdominal surgery, there does not ing no association between a unit’s day-case or short-stay appear to be any obvious explanation for the higher conver- rate and the readmission or re-operation rates. sion rates at these centres. We found that although the practice of day-case (or Similarly, although no trusts lay outside the statistical ambulatory) anti-reflux surgery increased nationally, with control limits, the variation seen in 30-day re-operation is the overall rate doubling during the 5-year study period, concerning with nine hospitals lying above the 5% AUGIS the overall rate remained low (at 15.1% in the final year 1 3 Surgical Endoscopy (2018) 32:3208–3214 3213 of the study) and practice variation remained widespread. demonstrate the value of national administrative data- A similar picture was found with the short-stay rates. bases in examining variations in care and driving service Although the data are not adjusted for potential confound- improvement. ers such as age, comorbidity or ethnicity, the very large Acknowledgements The Surgical Workload and Outcomes Research degree of variation observed suggests that a difference Database (SWORD) is funded by the Association of Upper Gastro- in local practice and protocols is the underlying reason. intestinal Surgeons of Great Britain and Ireland (AUGIS) and the Given the potential advantages and cost savings of ambu- Association of Laparoscopic Surgeons of Great Britain and Ireland (ALSGBI). Methods Analytics Ltd. was not paid for any of the work latory or short-stay surgery, we believe that this highlights involved in this paper. a potential area of improvement. A potential driver of this could be if the incentivised tariff system (whereby hos- Compliance with ethical standards pitals are paid more if a patient undergoes surgery as a day-case or short-stay) was extended to anti-reflux surgery. Disclosure Dr. Swift is Managing Director of Methods Analytics Ltd. Finally, a large proportion of operations were performed which undertakes paid work on behalf of a variety of organisations by surgeons performing fewer than the recommended including the Royal College of Surgeons of England; Methods Analyt- number of five procedures per year. The volume outcome ics has not been paid for work on this paper. Mr. Ceney and Mr. Knight are paid employee of Methods Analytics Ltd. Their duties include per- relationship has been established in a wide range of proce- forming some of the analysis included in this paper. Dr. Beckingham is dures although disputes do remain. It is interesting to note Past President of the Association of Upper Gastro-Intestinal Surgeons that the funnel plots in this study indicate a trend to better of Great Britain and Ireland (AUGIS), past secretary of the Associa- outcomes in the higher volume centres. As stated earlier, tion of Laparoscopic Surgeons of Great Britain and Ireland and is chair of the AUGIS/Royal College of Surgeons of England Commission- this could be due to poorer coding in smaller hospitals ing Guide for Gallstone disease. Dr. Palser, Dr. Navarro and Professor (although that in itself is relevant and it has been argued Bowrey have no conflicts of interest or financial ties to disclose. that coding is a clinical responsibility in any case). However, it may be a real reflection of treatment and Open Access This article is distributed under the terms of the Creative experience. A study using the National Inpatient Sam- Commons Attribution 4.0 International License (http://creativecom- ple  divided hospitals into terciles according to their mons.org/licenses/by/4.0/), which permits unrestricted use, distribu- tion, and reproduction in any medium, provided you give appropriate annual volume of anti-reflux surgery. They found signifi- credit to the original author(s) and the source, provide a link to the cantly increased complication rates, length of stay and cost Creative Commons license, and indicate if changes were made. in the low-volume tercile compared to the higher volume tercile. The cost difference they estimated to be between $2700 and $3200. We did not explicitly test the volume hypothesis here References as the number of unmeasured confounders was too great. 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“My last article couldn't be possible without the platform @deepdyve that makes journal papers cheaper.”@JoseServera