Data quality assessment of the Dutch Breast Implant Registry by automated data verification using medical billing data.

Background: The Dutch Breast Implant Registry (DBIR) provides real-time population-based data to monitor and improve the quality and safety of breast implants and to trace patients in the event of an (inter)national recall. To serve these main goals, the capture rate and percentage of implants that are actually registered should be known and data should be complete. This study aimed to describe an automated verification process for capture rates and data completeness using medical billing data as the external source.

Incidence and prevalence of primary biliary cholangitis in the Netherlands - A nationwide cohort study.

Background & Aims: Although primary biliary cholangitis (PBC) is considered a rare disorder, accurate determination of its incidence and prevalence remains challenging due to limited comprehensive population-based registries. We aimed to assess the incidence and prevalence of PBC in the Netherlands over time through the nationwide Dutch PBC Cohort Study (DPCS).

Methods: DPCS retrospectively included every identifiable patient with PBC in the Netherlands from 1990 onwards in all 71 Dutch hospitals.

An open-label randomised-controlled trial of azathioprine vs. mycophenolate mofetil for the induction of remission in treatment-naive autoimmune hepatitis.

Background & Aims: Patients with autoimmune hepatitis (AIH) almost invariably require lifelong immunosuppressive treatment. There is genuine concern about the efficacy and tolerability of the current standard combination therapy of prednisolone and azathioprine. Mycophenolate mofetil (MMF) has emerged as an alternative option.

Ensuring access to post-cancer breast reconstructions: COVID-19 lessons from the Dutch Breast Implant Registry.

Background: COVID-19 has impacted breast implant surgery for oncological and non-oncological patients worldwide. This population-based study aimed to evaluate the impact of the COVID-19 pandemic on access to reconstructive and cosmetic breast implant surgery in the Netherlands using real-world data to describe trends, and to identify lessons to prevent future capacity problems within (inter)national healthcare.

Methods: This longitudinal study included patients undergoing breast implant surgery from the mandatory nationwide Dutch Breast Implant Registry.

Risk Factors for Unplanned Reoperation during the Expansion Phase in Two-Stage Breast Reconstruction in the Dutch Breast Implant Registry.

Background: The majority of postmastectomy breast reconstructions (PMBRs) are currently performed in two stages using a tissue expander (TE). However, complications during the expansion phase occur regularly, leading to unplanned reoperations and/or reconstruction failure. This study aimed to identify risk factors for unplanned reoperation after TE placement, assessed the time until unplanned and planned reoperation, and investigated indications for unplanned reoperation.

Assessing the efficacy and safety of mycophenolate mofetil versus azathioprine in patients with autoimmune hepatitis (CAMARO trial): study protocol for a randomised controlled trial.

Background: Currently, the standard therapy for autoimmune hepatitis (AIH) consists of a combination of prednisolone and azathioprine. However, 15% of patients are intolerant to azathioprine which necessitates cessation of azathioprine or changes in therapy. In addition, not all patients achieve complete biochemical response (CR).

Using a Digital Implant Catalog Improves Data Quality and Reduces Administrative Burden in the Dutch Breast Implant Registry.

Background: Correct registration of implant characteristics is essential to monitor implant safety within implant registries. Currently, in the nationwide Dutch Breast Implant Registry (DBIR), these characteristics are being registered manually by plastic surgeons, resulting in administrative burden and potentially incorrect data entry.

Objectives: This study evaluated the accuracy of manually registered implant data, possible consequences of incorrect data, and the potential of a Digital Implant Catalog (DIC) on increasing data quality and reducing the administrative burden.

Aggressive fluid hydration plus non-steroidal anti-inflammatory drugs versus non-steroidal anti-inflammatory drugs alone for post-endoscopic retrograde cholangiopancreatography pancreatitis (FLUYT): a multicentre, open-label, randomised, controlled trial.

Background: Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Prophylactic rectal administration of non-steroidal anti-inflammatory drugs (NSAIDs) is considered as standard of care to reduce the risk of post-ERCP pancreatitis. It has been suggested that aggressive hydration might further reduce this risk.

Efficacy and Safety of 100 Laparoscopy-Assisted Transgastric Endoscopic Retrograde Cholangiopancreatography Procedures in Patients with Roux-en-Y Gastric Bypass.

Purpose: Laparoscopy-assisted transgastric endoscopic retrograde cholangiopancreatography (LAERCP) is an alternative for the anatomically challenging conventional ERCP in patients with a Roux-en-Y gastric bypass (RYGB) as it allows access to the biliary tree via the gastric remnant. We investigated the efficacy and safety of LAERCP.

Material And Methods: We retrospectively reviewed all charts from RYGB patients who underwent a LAERCP between January 2009 and August 2019 in a non-academic referral center for bariatric surgery.

High discontinuation rate of azathioprine in autoimmune hepatitis, independent of time of treatment initiation.

Background: Guidelines regarding treatment for autoimmune hepatitis (AIH) favour two strategies for azathioprine (AZA) introduction: concurrent with steroids at induction or delayed by 2-4 weeks. The safety and efficacy of both strategies have been unexplored.

Methods: We established a cohort of 900 AIH patients from 12 centres in 7 European countries.

Rapid Response to Treatment of Autoimmune Hepatitis Associated With Remission at 6 and 12 Months.

Background & Aims: Changes in serum levels of transaminases immediately after initiation of treatment for autoimmune hepatitis (AIH) might be associated with biochemical markers of remission and liver-related events. We assessed the outcomes of patients with vs without rapid response to treatment of AIH in a large international cohort.

Methods: We performed a retrospective cohort study, collecting data from 2 independent cohorts of adults with AIH from 12 centers in 7 countries in Europe.

Adverse events related to low dose corticosteroids in autoimmune hepatitis.

Background: Autoimmune hepatitis requires long-term therapy, and systemic corticosteroids are the backbone of therapeutic management. Prolonged use of corticosteroids may lead to adverse events but data from long-term studies are mainly derived from studies in rheumatic diseases.

Aim: To assess cataract, diabetes and fractures in relation to corticosteroid doses in the long-term maintenance treatment of patients with autoimmune hepatitis.

The revised Atlanta criteria more accurately reflect severity of post-ERCP pancreatitis compared to the consensus criteria.

Background And Objective: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most prevalent complication after ERCP with an incidence of 3.5%. PEP severity is classified according to either the consensus criteria or the revised Atlanta criteria.

Predniso(lo)ne Dosage and Chance of Remission in Patients With Autoimmune Hepatitis.

Background & Aims: Patients with autoimmune hepatitis (AIH) commonly receive induction therapy with predniso(lo)ne followed by maintenance therapy with azathioprine. European Association for Study of the Liver clinical practice guidelines advise a predniso(lo)ne dose range of 0.50-1 mg/kg/day, which leaves room for practice variation.

Liver decompensation in HIV/Hepatitis B coinfection in the combination antiretroviral therapy era does not seem increased compared to hepatitis B mono-infection.

Background & Aims: HIV/hepatitis B virus (HBV) coinfected subjects are thought to have faster progression to end-stage liver disease (ESLD) than HBV mono-infected subjects. We assessed whether this remains in the current cART-era.

Methods: Data from subjects with follow-up completion post-2003 were compared between HIV/HBV coinfected subjects in the Dutch HIV Monitoring database and HBV mono-infected subjects from two centres.

Increased Mortality Among Patients With vs Without Cirrhosis and Autoimmune Hepatitis.

Background & Aims: There have been few reproducible studies of mortality in patients with autoimmune hepatitis (AIH) and its variants. We calculated mortality in a large national cohort of patients with AIH, with vs without cirrhosis, in the Netherlands.

Methods: We collected data from 449 patients with established AIH (77% female), from 6 academic and 10 non-academic hospitals in the Netherlands.

Biochemical efficacy of tioguanine in autoimmune hepatitis: a retrospective review of practice in the Netherlands.

Background: Azathioprine (AZA) and mercaptopurine (MP) are the cornerstone of steroid-sparing strategies in autoimmune hepatitis (AIH). Up to 20% of patients do not tolerate or respond to these regimens.

Aim: To evaluate retrospectively the tolerability and efficacy of tioguanine (thioguanine) (TG) therapy in selected patients with AIH and AIH variant syndromes.

Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial.

Background: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication of ERCP and may run a severe course. Evidence suggests that vigorous periprocedural hydration can prevent PEP, but studies to date have significant methodological drawbacks. Importantly, evidence for its added value in patients already receiving prophylactic rectal non-steroidal anti-inflammatory drugs (NSAIDs) is lacking and the cost-effectiveness of the approach has not been investigated.

How the concept of biochemical response influenced the management of primary biliary cholangitis over time.

Background: Criteria assessing biochemical response to ursodeoxycholic acid (UDCA) are established risk stratification tools in primary biliary cholangitis (PBC). We aimed to evaluate to what extent liver tests influenced patient management during a three decade period, and whether this changed over time.

Methods: 851 Dutch PBC patients diagnosed between 1988 and 2012 were reviewed to assess patient management in relation to liver test results during UDCA treatment.