Cholecystectomy for the elderly: no hesitation for otherwise healthy patients.

BACKGROUND: The number of Danish inhabitants older than 65 years is increasing, and cholecystectomy is one of the most common surgical procedures performed for this age group. This study aimed to analyze the role of age as an independent predictor of outcome for elderly cholecystectomy patients. METHODS: Data from the Danish Cholecystectomy Database (2006-2010) were used. The outcomes of interest were conversion rate for laparoscopic cholecystectomy, outpatient rate, postoperative hospital length of stay, readmission rate, and frequency of additional procedures and death within 30 days postoperatively. RESULTS: In this study, 697 patients 80 years of age or older and 4,915 patients ages 65-70 years were compared with 8,805 patients ages 50-64 years. Significantly more patients age 80 years or older underwent surgery for acute cholecystitis, and the conversion rate from laparoscopic to open surgery was significantly higher in the oldest group. The older patients had longer postoperative hospital stays, but nearly 30 % of the patients age 80 years or older were admitted for only 0-1 day and not readmitted, and nearly half of the patients were admitted for only 0-3 days without readmission. Also, the mortality rate and the number of patients who underwent additional procedures within 30 days were higher in the oldest group (6 vs 0.1 and 28 vs 15 %, respectively). A subanalysis of the patients age 80 years or older classified as American Society of Anesthesiology 1 and 2 without acute cholecystitis showed that 44 % left the hospital within 1 day and 63 % within 3 days without readmission and that the 30-day mortality rate was only 2 %. CONCLUSIONS: Age is an independent predictor for worse outcome after cholecystectomy. However, among otherwise healthy patients age 80 years or older who underwent surgery before acute inflammatory complications occurred, 63 % had a fast and uncomplicated course. Thus, it seems fair to recommend elective laparoscopic cholecystectomy when repeated gallstone symptoms have occurred also for the older patient, particularly before the patient experiences acute cholecystitis.

The quality of cholecystectomy in Denmark: outcome and risk factors for 20,307 patients from the national database.

BACKGROUND: Laparoscopic cholecystectomy is the standard treatment for symptomatic gallstones. The quality of the procedure frequently is included in quality improvement programs, but outcome values have not been described to define the standard of care for a general population. This study included 20,307 cholecystectomies from a national prospective database that combines administrative data with clinical data. This report states the quality of cholecystectomy in Denmark, establishes benchmarks, and identifies significant risk factors. METHODS: The Danish Cholecystectomy Database was queried for data from 2006 to 2009. The outcome measures included conversion rate, hospital length of stay (LOS), readmission, additional procedures, and 30-day mortality. Patient characteristics and operative findings were analyzed as risk factors using stepwise backward logistic regression. RESULTS: The study included 20,307 patients (82% of all cholecystectomies). The conversion rate was 7.6%. Male sex, acute cholecystitis, and previous upper abdominal surgery were risk factors for conversion, with respective odds ratios of 1.50, 4.61, and 3.54. The mean LOS was 1.5 days, and 37.3% of the patients had same-day surgery. The readmission rate was 9.6%. Nearly 70% had a LOS of 1 day or less and no readmission; 17.3% had a LOS longer than 3 days and/or readmission; 5.6% had an additional procedure within 30 days; and 0.2% had a bile duct injury requiring reconstructive surgery. The 30-day mortality rate was 0.27%. Age older than 60 years, American Society of Anesthesiology (ASA) score exceeding 1, and open procedure were significant risk factors for all the outcomes. Body mass index (BMI) was not a risk factor for any of the outcomes. CONCLUSION: The quality of cholecystectomy is high in Denmark, with a low conversion rate and a high frequency of short admissions without readmission. Acute cholecystitis and open procedure are important risk factors for poorer outcomes.The results of this study analyzing a large, unbiased population can be used to benchmark outcomes of cholecystectomy.

Does the EU's Paediatric Regulation work for new medicines for children in Denmark, Finland, Norway and Sweden? A cross-sectional study.

OBJECTIVE: The aim of this study was to assess the marketing status of the new paediatric medicinal products listed in the 10-year report as initially authorised between 2007 and 2016, reflecting the product availability in four Nordic countries. DESIGN: This is a cross-sectional study. SETTING: Analysis of the national medicine agency's databases in Denmark, Finland, Norway and Sweden. DATA SOURCE: New medicinal products with paediatric indications and new paediatric formulations listed in the Annex of European Medicines Agency's EU Paediatric Regulation 10-year report. DATA ANALYSIS: The products were classified according to national marketing status between January 2019 and March 2019, whether a product was authorised and whether the product was marketed. MAIN OUTCOME MEASURES: The percentages of the new medicinal products with paediatric indications and new paediatric formulations having a valid marketing authorisation and being marketed, both in terms of the sums of all countries and separately for each country. RESULTS: Across the four countries, 21%-32% (16/76-24/76) of the new medicinal products were not marketed. Of the new formulations relevant to children, 29%-50% (16/56-28/56) were not marketed, and a significant proportion of these products had never been marketed. CONCLUSIONS: This study reflects the reality of the implementation of the Paediatric Regulation. The results show that several new paediatric medicines and new formulations are not marketed. This affects the product availability. Similar data from other countries are needed to evaluate the overall European status to find remedies to current situation and increase the availability of the medicines for children.

Validation of data and indicators in the Danish Cholecystectomy Database.

OBJECTIVE: In The Danish Cholecystectomy Database (DCD), quality indicators are derived from clinical data in combination with administrative data from the National Patient Registry. The indicators 'Length of postoperative stay < or =1 day and no readmission', 'Length of stay (LOS) >3 days and/or readmission', 'Additional procedures within 30 days', 'Reconstructive bile duct surgery', 'Other surgery of the bile duct' and 'Death within 30 days' are all derived from administrative data. This study investigates the validity of the administrative data and evaluates the association between these indicators and postoperative complications. RESEARCH DESIGN AND SUBJECTS: Data from 1360 medical records of patients undergoing cholecystectomy were compared with the relevant administrative data from the National Patient Registry. The medical records served as the 'gold standard'. The association between the individual indicators and the occurrence of a postoperative complication was assessed. MEASURES: Validation of administrative data against the gold standard was done by the calculation of per cent agreement (including kappa-values) sensitivity/specificity and predictive values. The association between indicators and complications was analysed with crude event rates and odds ratios. RESULTS: The validity of the administrative data was excellent (97.1-100% agreement, kappa = 0.73-1.00). All of the indicators except 'Other bile duct surgery' were significantly associated with postoperative complications. A subdivision of some indicators strengthened the associations. CONCLUSIONS: The DCD is a valid method for monitoring the quality of cholecystectomy in Denmark.

An adverse drug event manager facilitates spontaneous reporting of adverse drug reactions.

INTRODUCTION: Spontaneous reporting of adverse drug reactions (ADRs) is used for continuous risk-benefit evaluation of marketed pharmaceutical products and for signal detection. The Adverse Drug Event Manager (ADEM) is a service offered to clinicians employed at hospitals in the Capital Region of Denmark. The ADEM assists healthcare professionals in reporting suspected ADRs to the Danish Health Authority. The aim of this retrospective observational study was to quantify and describe ADRs reported via the ADEM in 2014. METHODS: All ADR reports handled by the ADEM in 2014 were recorded anonymously and analysed descriptively. RESULTS: A total of 484 ADRs were reported through the ADEM in 2014 (the median number of reports per month was 37; range: 17-78). The majority of the reports came from departments of internal medicine (61%), psychiatry (14%) and dermatology, ophthalmology or otorhinolaryngology (11%). The drugs most frequently reported were lisdexamphetamine (n = 40), rivaroxaban (n = 16) and warfarin (n = 15) (vaccines excluded). In 13 out of 484 reports, the ADR was associated with a fatal outcome. CONCLUSION: The findings of this study indicate that an ADEM promotes and facilitates spontaneous ADR reporting and helps raise awareness about ADRs, including how and why they should be reported. Hopefully, this will assist national and European spontaneous reporting systems in their work to increase patient safety nationally and abroad. FUNDING: none. TRIAL REGISTRATION: not relevant. .

Gamma-hydroxybutyrate and cocaine intoxication in a Danish child.

GHB intoxication must be considered in children with coma and a suspicion of drug intoxication. Furthermore, mixed intoxication with several substances and the possibility of unpredictable symptom profiles should be anticipated to ensure optimal symptomatic treatment of patients.

[Neurological symptoms following infusion of infliximab]. / Neurologiske symptomer som bivirkning af infliximab.

Infliximab is indicated for treatment of plaque psoriasis when traditional systemic therapy is inadequate or inappropriate. The treatment is efficient but also carries a risk of serious adverse drug events. We describe a case of neurological symptoms following the first infusion of infliximab in a patient treated for plaque psoriasis. The patient fully recovered after sensation of the therapy. We believe the symptoms could be related to infliximab and stress the importance of thorough information of patients treated with tumour necrosis factor-α-inhibitors, also about the risk of serious adverse events.