Introduction In the Netherlands, the number of bariatric procedures increased exponentially in the 90s. To ensure and improve the quality of bariatric surgery, the nationwide Dutch Audit for Treatment of Obesity (DATO) was established in 2014. The audit was coordinated by the Dutch Institute for Clinical Auditing (DICA). This article provides a review of the aforementioned process in establishing a nationwide registry in the Netherlands. Materials and Methods In collaboration with the DATO’s scientific committee and other stakeholders, an annual list of several external quality indicators was formulated. This list consists of volume, process, and outcome indicators. In addition to the annual external indicators, the database permits individual hospitals to analyze their own data. The dash- board provides several standardized reports and detailed quality indicators, which are updated on a weekly base. Results Since the start, all 18 Dutch bariatric centers participated in the nationwide audit. A total of 21,941 cases were registered between 2015 and 2016. By 2016, the required variables were registered in 94.3% of all cases. A severe complicated course was seen in 2.87%, and mortality in 0.05% in 2016. The first-year follow-up shows a > 20% TWL in 86.1% of the registered cases. Discussion The DATO has become rapidly a mature registry. The well-organized structure of the national audit institution DICA and governmental funding were essential. However, most important were the bariatric teams themselves. The authors believe reporting the results from the registry has already contributed to more knowledge and acceptance by other health care providers. This manuscript was written on behalf of the Dutch Audit for Treatment of Obesity (DATO) Group: E.J. Hazebroek, MD, PhD (Rijnstate Hospital, Arnhem); L.M. de Brauw, MD, PhD (MC Slotervaart, Amsterdam); A. Demirkiran, MD, PhD (Red Cross Hospital, Beverwijk); M. Dunkelgrün, MD, PhD (Franciscus Gasthuis & Vlietland, Rotterdam); I.F. Faneyte, MD, PhD (ZGT Hospital, Hengelo); J.W.M. Greve, MD, PhD (Zuyderland MC, Heerlen); M.J. Wiezer, MD, PhD (St. Antonius Hospital, Nieuwegein); E.H. Jutte, MD (MC Leeuwarden, Leeuwarden); R.A. Klaassen, MD (Maasstad Hospital, Rotterdam); E.A.G.L. Lagae, MD (ZorgSaam Zorggroep Zeeuws-Vlaanderen, Terneuzen); B. Lamme, MD, PhD (Albert Schweitzer Hospital, Dordrecht); R.S.L. Liem, MD (Groene Hart Hospital, Gouda); J.K. Maring, MD, PhD (Elisabeth-TweeSteden Hospital, Tilburg); S.W. Nienhuijs, MD, PhD (Catharina Hospital, Eindhoven); R. Schouten, MD, PhD (MC Zuiderzee, Lelystad); D.J. Swank, MD, PhD (Dutch Obesity Clinic West, The Hague); G. van ‘t Hof, MD (Dutch Obesity Clinic South-West Netherlands, Bergen op Zoom); R.N. van Veen, MD, PhD (OLVG Hospital, Amsterdam); and M.W.J.M. Wouters, MD, PhD (Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam). * Youri Q.M. Poelemeijer Department of Surgery, Leiden University Medical Center, Y.Q.M.Poelemeijer@lumc.nl Albinusdreef 2, 2333 ZA Leiden, Netherlands Department of Surgery, Groene Hart Hospital, Gouda, Netherlands Dutch Institute for Clinical Auditing, Scientific Bureau, Leiden, Netherlands Department of Surgery, Catharina Hospital, Eindhoven, Netherlands OBES SURG (2018) 28:1602–1610 1603 . . . . . . Keywords Clinical auditing Registry Nationwide Bariatric surgery Netherlands DATO Dutch Audit for Treatment of . . . Obesity DICA Dutch Institute for Clinical Auditing Obesity Introduction incomparable data, the results were difficult to interpret for each individual hospital. Bariatric surgery has already been proven as the only long- Most bariatric centers, not using POMT, had their own term effective treatment option for morbid obesity in terms of hospital ICT system or used Microsoft Excel as a database weight loss and comorbidities reduction [1–4]. Although this management system. Derived from POMT or homemade sys- effect is nowadays embedded in several guidelines and accept- tems, data could be used for iBAR (international BAriatric ed by most practitioners, still some resistance exists [5, 6]. Registry). This European registry was launched in 2008 by Especially for bariatric surgery, showing outcome transparent- the European Accreditation Council for Bariatric Surgery ly by clinical auditing is of utmost importance . This should (EAC-BS). The aim of this registry was the creation of guide- not only consist of the clinical outcomes, but also process lines that could be applied to different global areas and define indicators and patient-reported outcomes should be included surgeon’s credentials and institutional requirements for safe as well [8, 9]. For this purpose, a registry was necessary for and efficient management of morbidly obese patients. The structured evaluation of bariatric surgical care. implementation of these guidelines would be applied by IFSO regional chapters in collaboration with the national bar- iatric and metabolic societies. In Europe, Middle East, and History Africa, the IFSO European Chapter (IFSO-EC) was autho- rized to approve these BCenters of Excellence^ (COE) in col- In the Netherlands, the number of bariatric procedures in- laboration with the European Accreditation Council for creased exponentially in the 90s . To deal with this in- Bariatric Surgery (EAC-BS). crease, various health insurers started to keep track of their Despite the promising start, the international data were too own individual quality indicators. The result was a fragmented difficult to interpret and comparison between countries was and incomparable list of outcomes between various healthcare complicated by European laws. In addition, the mandatory set providers. contained too many variables. Due to this large number of In order to define comparable outcomes, healthcare profes- variables, there was an insufficient focus on the processes sionals took the initiative themselves. In 1996, the bariatric and outcomes of the delivered care. Therefore, this registry institutions of Belgium, the Netherlands, and Luxembourg was not suitable for a nationwide mandatory registry (Fig. 1). united into the BeNeLux Association of Bariatric Surgeons (BABS). This was an improvement for scientific research. However, for the improvement of quality in healthcare, the DICA differences between countries seemed to be a burden. This led to the formation of a national working group for A successful Dutch example of clinical auditing was the bariatric surgeons in the Netherlands, initiated by the Dutch Dutch Surgical Colorectal Audit (DSCA), born from the de- Society for Gastrointestinal Surgery (DSGS), which was a mand for national quality registries in the surgical field . subsidiary association of the Association of Surgeons of the From this initiative, the Dutch Institute for Clinical Auditing Netherlands (ASN). This working group continued in April (DICA) was founded in 2009. DICA now has 23 national 2011 as the Dutch Society for Metabolic and Bariatric Surgery registries, which facilitates clinical audits for 15 surgical and (DSMBS) and is now also the official national chapter of the non-surgical societies. DICA consists of a directional board, International Federation for the Surgery of Obesity and management board, methodological board providing supervi- Metabolic Disorders (IFSO). sion of applied methodology, privacy committee providing supervision on privacy issues, and a scientific bureau facilitat- Registries ing a sound board for the registries (Fig. 2). At the end of the 90s, only a few local initiatives were launched echoing various European registries. A commonly Aim used system in the early 2000’s was the Patients Outcome Measurement Tool (POMT), originally co-funded by a medi- The aim of this manuscript was to provide a review of the cal device supplier. Some users regarded the interference of aforementioned process in establishing a nationwide registry industry as a restriction, others experienced some technical in the Netherlands, with the Dutch Audit of Treatment of drawbacks. Due to the large input of international Obesity (DATO) as a result. 1604 OBES SURG (2018) 28:1602–1610 Fig. 1 A timeline about the DATO’sorigin Methods registry. Any decision taken by the CAB must be officially reported to the scientific committee. Funding Patient Selection One of the important goals of the DSMBS was to establish a nationwide registry. In 2012, the DSMBS announced the start The nationwide database covers all bariatric procedures in the of a new nationwide mandatory registry. The funding arose Netherlands. The inclusion criteria for primary bariatric sur- from a special quality improvement grant from the umbrella gery in the Netherlands are linked to stringent requirements organization of nine health insurers in the Netherlands, called which are bundled in the Dutch Morbid Obesity Directive BZorgverzekeraars Nederland^ (ZN). ZN offered a financial . These inclusion criteria were defined by international structure to establish and maintain this nationwide audit. In literature and expert opinions [4, 13, 14]. cooperation with DICA, the Dutch Audit for Treatment of Patients must be 18 years or older and must be sufficiently Obesity (DATO) was established in 2014. Structural funding healthy to undergo general anesthesia and surgery. In addition, is currently provided by the same umbrella organization. The they must have a body mass index (BMI) of ≥ 40.0 kg/m ,or a audit has officially started on January 1, 2015. BMI ≥ 35.0 kg/m in combination with at least one of the 6 major obese-related comorbidities: diabetes mellitus [1, 2, 15], hypertension [1, 15], dyslipidemia , obstructive sleep ap- Scientific Committee nea syndrome (OSAS) , gastroesophageal reflux disease (GERD) , and musculoskeletal pain . Weight loss as a A scientific committee and a clinical audit board (CAB) was result of intensive treatment prior to surgery (in patients who put in charge of overseeing its long-term goals and monitoring reached a weight below the minimum BMI indication for sur- the quality of the registry. gery) is not a contraindication for planned bariatric surgery. The scientific committee represents all 18 bariatric centers Bariatric surgery is contraindicated if patients suffer from and all members are mandated from the practicing hospital severe psychological problems, been addicted to alcohol , where they are employed. As a result, all practicing hospitals drugs  or other substances, an active gastrointestinal dis- have an influence on the decision making within the scientific ease, or a disease that is life threatening on short terms. committee. In addition, the scientific committee has the task of assessing the quality and feasibility of (international) scientific Registration applications. The scientific committee provides three mandated deputies The surgical department is primarily responsible for all the for the CAB. The CAB consists of a chairman, a secretary, and data entry. Some hospitals decided to transfer the responsibil- a treasurer and is responsible for day-to-day running of the ity of screening and follow-up data to other institutions like OBES SURG (2018) 28:1602–1610 1605 Fig. 2 Organisational structure of the Dutch Institute for Clinical Auditing (DICA) the Dutch Obesity Clinics (NOK). An overview of parameters To chart the surgical history, 10 main surgical areas are recorded in DATO was given in Table 1. specified: surgical interventions of hernias, stomach, duode- For identification of unique patients, social security num- num, liver, biliary tract, pancreas, small intestine, appendix, ber, surname, date of birth, and sex are mandatory and regis- colon, and rectum. In addition, a second item registers which tered. This patient’s traceable data is anonymized by a data bariatric procedure has taken place in the past. processing company before analyzes taken place. Therefore, all data is anonymous for people outside the hospital. Procedure and Follow-up Screening Registration of the operation date and type of procedure with corresponding details is mandatory. A maximum of 5 The registration of the pre-operative comorbidities occurs when procedure-specific items are requested per procedure. the specific condition is present on the day of screening. Complications are scored using the Clavien-Dindo Comorbidity is thus given in the registry as a yes/no option. To Classification of Surgical Complications (CDC) . predict the postoperative mortality, the Charlson Comorbidity The follow-up consists of postoperative weight registra- Index (CCI) is registered [21, 22]. As for diabetes mellitus, hy- tion, monitoring of pre-operative registered comorbidities, pertension, dyslipidemia, GERD, and OSAS, a few sub-items and any (long-term) complications (Table 1). The follow-up are registered like the use of medication and laboratory tests. will be recorded at 3, 6, 9, 12, 24, 36, 48, and 60 months, 1606 OBES SURG (2018) 28:1602–1610 Table 1 Variables recorded in Section (dataset) Variable Baseline Follow-up DATO Patient characteristics Social security number M – Date of birth M – Sex M – Alive/dead status M M Screening Weight M M Highest weight R – Length M – Hypertension M M Diabetes mellitus M M Dyslipidemia M M GERD M M OSAS M M Musculoskeletal pain M M Charlson Comorbidity Index R – Abdominal history If yes—8 sub-items could be answered R – Bariatric history If yes—5 sub-items could be answered R – Procedure Date of operation M – Name/code of surgeon R – ASA score M – Type of surgical procedure M – Clavien-Dindo Classification of Surgical Complications M – Follow-up Evaluation comorbidities – M Complications during previous period – M PROMs RAND-36 M M ASA American Society of Anesthesiologists, M mandatory, R recommended Surgical interventions of hernias, stomach, duodenum, liver, biliary tract, pancreas, small intestine, appendix, colon, and/or rectum by laparoscopy or laparotomy Year of operation, type of surgery, type of technique, and/or hospital As defined by Clavien-Dindo Classification of Surgical Complications depending on the hospital and the applicable protocol. Each itself extracts the necessary data from its own electronic health patient must be seen at least once a year (Table 2). records software. A second option uses a secure web-based reg- istration interface, offered by DICA. The PROs are measured in RAND-36 a separate database and can be cross-matched with the clinical database. Patient-reported outcomes (PROs) are measured with the RAND 36-item Health Survey (RAND-36). The RAND-36 Data Quality has been developed within the framework of the RAND Health Science Program in the USA. The questionnaire is To increase data quality, a clear definition is set for identical to the MOS SF-36 questionnaire, but contains anoth- each data entry point with an additional explanation er scoring algorithm. The RAND-36 measures 8 health do- mark. If impracticable values or the data yields outside mains: physical functioning, role limitations caused by phys- its predefined range, an error message occurs. A second ical health problems, and role limitations caused by emotional safety measure is an automatic generated alert list, with problems, social functioning, emotional well-being, vitality, a list of all incomplete mandatory variables for each pain, and general health perception [24–26]. patient record. Once every 2 years, DICA facilitates monitoring of data Data Entry quality by an external organization. Trained personnel ran- domly verify hospital data entered in DATO with their own There are two methods to provide the required data for DATO. electronic patient records. The results of all randomly chosen The first method is by a so-called batch file, where the hospital hospitals are discussed and assessed by an external quality OBES SURG (2018) 28:1602–1610 1607 Table 2 Annual quality indicator Number Indicator 2015 2016 DATO report ND % ND % Process 2 Percentage of complete registered patient 9534 10,355 92.1 10,922 11,586 94.3 records regarding primary and/or secondary surgery. 3 Percentage of primary operated patients, 8371 8756 95.6 9625 10,028 96.0 meeting the inclusion criteria on the basis of BMI and age. 4 Percentage of primary operated patients, –– – 131 6433 2.04 who are lost to follow-up in the first year after primary surgery. Outcome 5 Percentage of primary and/or secondary 305 10,355 2.92 332 11,586 2.87 operated patients, with severe complications (CDC grade 3 or higher) within 30 days after surgery. 6 Percentage of primary and/or secondary 294 10,355 2.84 316 11,586 2.73 operated patients, with a postoperative intervention within 30 days after surgery. 7 Percentage of primary operated patients, –– – 5346 6433 83.1 with more than 50% excess weight loss (%EWL) in the first year after primary surgery. 8 Percentage of primary operated patients, –– – 5538 6433 86.1 with more than 20% total weight loss (%TWL) in the first year after primary surgery. N numerator, D denominator, CDC Clavien-Dindo Classification of Surgical Complications, BMI body mass index committee. The results and recommendations will eventually The lost to-follow-up indicator provides insight into the be presented in an online accessible report. number of patients who are no longer visiting the outpatient clinic in their own hospital. The registration year for indicators Quality Indicators with follow-up data runs from September to September. In these cases, there are no patients wrongly considered missing when their appointment falls within 12 to 14.5 months after In collaboration with the DATO’s scientific committee, pro- the primary surgery date. This also applies to the indicator fessional societies, hospital organizations, Dutch Patient excess weight loss (EWL) and total weight loss (TWL). Federation (DPF), and the health insurance companies, an Excess weight loss (EWL) is calculated using the formula annual list of external quality indicators is formulated. initial weight−postoperative weight Indicators were derived from the international literature or , with reference point α as an ideal initial weight−α written on a consensus-based development process within BMI of 25 kg/m . Total weight loss (TWL) is calculated with the scientific committee. The list is annually approved and initial weight−postoperative weight the formula [5, 27]. initial weight accredited by various stakeholders. In relation to quantity and quality, the minimum volume was set by DSMBS at 100 procedures per individual hospital in 2015 and 2016. Benchmark To analyze the different aspects of the surgical process, there are three types of quality indicators. The structure indi- The database permits individual hospitals to analyze their own cator provides information about the amount of bariatric pro- data. The dashboard provides several standardized reports and cedures. The process indicators provide information about the detailed quality indicators, which are updated on a weekly completeness of registered (mandatory) variables to calculate basis in a secured web-based environment, called myDATO. all other indicators, correctness of the individual indication for Participating hospitals recognize their own results in these bariatric surgery, and the lost to follow-up. The outcome indi- funnel plots from a highlighted dot. The results of any other cators focus on clinical outcomes after bariatric surgery and hospital are shown with an anonymous gray dot (Fig. 3). possible surgical and non-surgical complications. 1608 OBES SURG (2018) 28:1602–1610 Fig. 3 Percentage of primary operated patients in 2016, registered in the Dutch Audit for Treatment of Obesity (DATO), with severe complications (Clavien-Dindo grade 3 or higher) within 30 days after surgery, as reported per hospital Analysis Process Indicators Differences between patient and treatment characteristics were The process indicator defined as completeness of the regis- described using frequency tables. Categorical variables were tered patient, which means all mandatory variables were reg- compared using the chi-square trend test. Results of quality istered in DATO to calculate the indicators, revealed a 92.1% indicators and outcomes were presented concerning patients (n = 9534) completeness in 2015, which increased in 2016 to who had primary and/or secondary surgery from January 1, 94.3% (n = 11,586). 2015, until December 31, 2016. Differences in quality indica- In 2015, 95.6% (n = 8371) of the cases met the require- tor results over time were calculated with the chi-square trend ments for bariatric surgery, which increased in 2016 to test. 96.0% (n =9625). In 0.8% (n = 169) of all registered cases, R version 3.4.1 is used for statistical analysis in combina- the BMI were unknown, 2.0% (n = 431) had an unknown tion with the BCompanion to Applied Regression^-package presence of any comorbidity, and in 0.02% (n =5), the age (car 2.1–5) and BA Grammar of Data Manipulation^-package could not be calculated. (dplyr 0.7.2). In 2016, the lost to-follow-up percentage was 2.04% (n = 131) of the 6433 primary bariatric procedures performed from January to October 2015. Results Outcome Indicators Between 2015 and 2016, a total of 21,634 unique patients The first measured outcome indicator was mortality, also mea- were registered in the DATO, with a total record count of sured as CDC grade 5, within 30 days after surgery or during 21,941. Of these, 18,784 (85.6%) operations were primary the same hospital stay. In 2015, 10 patients (0.1%) died after procedures. The mean age was 43.8 years (± 11.2 SD), with surgery; whereas, 6 patients (0.05%) died in 2016. a median of 44 years. The mean BMI was 43.3 kg/m (± 5.4 The postoperative complicated course within 30 days after SD) and median of 42.3 kg/m . surgery or during the same hospital stay was measured by The largest group of procedures involved patients with a CDC grade 3 or higher. Grade 4 was described as life- Roux-en-Y gastric bypass (RYGB) (72.4%; n = 15,889), threatening complications requiring intensive care admission, followed by gastric sleeve (GS) (17.7%; n = 3885), one anas- which occurred 65 times (0.6%) in 2015 and 91 times (0.8%) tomosis gastric bypass (OAGB) (5.9%; n =1298) and other in 2016. Requiring surgical, endoscopic, or radiological inter- procedures (4.0%; n =869). vention (grade 3) had to take place 230 times (2.2%) in 2015 and 235 times (2.0%) in 2016. Added together, any compli- cation during admission occurred in 3.0% (n = 305) of the Structure Indicator cases in 2015 and 2.8% (n = 322) in 2016. In 2016, 83.1% (n = 5346) of the operated patients from All 18 bariatric centers met the quality indicator regarding a January 2015 till October 2015 had reached more than 50% minimum of 100 bariatric procedures per individual hospital, EWL after primary surgery. The group with the highest per- with a range of 171 to 1153 procedures. centage of > 50% EWL was OAGB (86.8%; n =275), OBES SURG (2018) 28:1602–1610 1609 followed by RYGB (85.0%; n = 4218), GS (72.3%; n =825), When compared to international literature, the number of se- and other procedures (34.5%; n =29). rious complications was significantly lower in DATO [4, 31]. From January 2015 till October 2015, 86.1% (n =5538) of the operated patients succeeded more than 20% Total Weight Limitations Loss (TWL) after primary surgery at the first-year follow-up in 2016. The highest percentage of >20% TWL, was mea- The DATO dataset contains a large set of data points to cover a sured at OAGB (90.2%; n = 286), followed by RYGB wide variety of bariatric treatment characteristics. This is as- (87.2%; n =4325), GS (78.8%; n = 899) and other procedures sociated with a substantial administrative burden, because bar- (34.5%; n =29). iatric surgeons are responsible for providing their own surgical and follow-up data. Nevertheless, the dataset is limited and needs careful evaluation on a yearly base to prevent adverse grow. Technological innovation will contribute to higher data Discussion quality and smoother registration processes. In addition, it will be possible to get more useful information from other sources This manuscript provided an extensive and complete over- of registration to improve patient care. view of the aforementioned process in establishing a nation- Because the data provided by hospitals is self-reported, data wide registry in the Netherlands, with the Dutch Audit of fraud is a possible adverse effect. Therefore, an independent third- Treatment of Obesity (DATO) as a result. party visits bariatric centers and produces discrepancy reports to DATO was mandatory for all bariatric centers, and there- validate the data of individual centers. Bariatric centers receive the fore it was required to register all bariatric procedures. This report and use it to improve the quality of data entry by their was a requirement of the insurance companies to carry out bariatric surgeons or trained personnel. A third limitation concerns bariatric surgery. DATO provided a nationwide transparent the content of the DATO. From the start, the audit aimed to work overview and results of bariatric procedures. By identifying together with paramedics and post-bariatric care providers. positive outliers based on benchmarked indicators, DATO can However, there are some privacy issues, and therefore it has been provide healthcare professionals with actable information to decided to focus primarily on bariatric surgery for now. improve their care and patients with valid information to choose a hospital of their preference. Future Perspectives Clinical Auditing DATO was designed with the idea that registering clinical information is not sufficient to give a total view of the out- The cornerstone of effective auditing is to provide high quality comes of the treatment of bariatric surgery. It was immediately standards for entering data in an online accessible tool, using decided by the scientific bureau to measure PROs as well. uniform international definitions, and producing interactive Because these two instruments could technically not directly feedback charts for individual healthcare centers to improve be linked, the PROs are measured in a separate database. A care where necessary. Only when all surgeons and healthcare cross-matching with the clinical database is planned. For fur- centers are participating in the registry, valid conclusion can ther improvement, initiatives are currently being undertaken be drawn from the provided benchmark information [11, 28, for comparison with other European registries. 29]. In the first years of registration, DATO succeed in the mission of high quality data, national coverage, and providing useful benchmark information for the individual clinic . Conclusion Complicated Course The Dutch Audit for Treatment of Obesity has become rapidly a mature registry. The well-organized structure of the national Bariatric procedures were considered relatively safe, regard- audit, the cooperation with DICA, and governmental funding ing to other surgical interventions, where mortality and mor- are essential. However, most importantly were the bariatric bidity were considered acceptable [1, 4, 31, 32]. With 16 surgeons themselves: unconditional nationwide participation deaths out of 21,634 unique patients in the past 2 years, bar- including very high response for PROMs. The authors believe iatric surgery in the Netherlands can be considered relatively reporting the results from the registry has already contributed safe. A severe complication during admission was character- to more knowledge and acceptance by other health care pro- ized by CDC grade 3 or higher. This occurs in 2.9% of pa- viders, improved quality as each center got feedback about its tients. It is remarkable that in about 0.8% of cases, the performance, and improved discussion with health organiza- Bcomplication^ involved a diagnostic laparoscopy. In bariatric tions such as insurance companies about quality and indica- surgery, however, this is considered a valuable diagnostic tool. tors. This provides enthusiasm for the future. 1610 OBES SURG (2018) 28:1602–1610 Funding Paid research position was within the Department of Surgery of 15. Ricci C, Gaeta M, Rausa E, et al. Long-term effects of bariatric the Leiden University Medical Center (LUMC), the Netherlands. surgery on type II diabetes, hypertension and hyperlipidemia: a meta-analysis and meta-regression study with 5-year follow-up. Obes Surg. 2015;25(3):397–405. https://doi.org/10.1007/s11695- Compliance with Ethical Standards 014-1442-4. 16. Sarkhosh K, Switzer NJ, El-Hadi M, et al. 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Published: Dec 22, 2017