[Economics of operating room use at a university eye hospital]. / Wirtschaftlichkeit der Operationssaalnutzung an einer Universitäts-Augenklinik.

BACKGROUND: In ophthalmologic surgery, there are usually short operation times and thus many changes between the individual operations, which are not subject to remuneration. As in maximum care hospitals consecutive different operations with different durations are often performed, emergency operations have to be inserted and further training of colleagues is practiced, it is particularly important to generate the shortest possible transfer times in order to have both sufficient operation time and to be able to treat as many cases as possible. The aim of this work is to evaluate the efficiency of the surgical performance of a university eye hospital. MATERIAL AND METHOD: The surgeries performed in 2021 at the MHH Eye Clinic were evaluated with respect to the spectrum, number, surgery duration, transfer times and process times. In terms of personnel, each operating room was staffed with one assistant anesthesiologist, one nurse anesthetist, two operating room nurses, one surgeon, and 20% senior anesthesiologist supervision. Based on a theoretical concept, which provides an increased staffing ratio while maintaining the same infrastructure, it was calculated how many more surgeries could be performed if the transfer time was halved and whether the additional financial expense could be compensated. RESULTS: With a total of n = 2712 surgeries performed during regular duty hours (244 working days) in 2 operating rooms (average daily n = 11.1; weekly n = 53.6 and monthly n = 237.1), the average surgery duration was 37 min and the transition time 43 min. This means that the operating rooms were used for surgery for 51% of the total operating time. Main procedures were vitrectomy with n = 1350 and cataract surgery with n = 1308. The new personnel concept provided one additional operating room nurse per operating room and one additional anesthesiologist for both operating rooms. The additional costs for this personnel expenditure were calculated at approx. 300,000 € per year. The halving of the transfer time from 43 min to about 21 min through possible overlapping induction and parallel work, which was not possible until now, results in an additional operation time of about 100 min per operating room, so that at least 4 additional operations can be planned and performed. In this way, with stringent implementation and the same spatial structures with stable fixed costs, n = 976 more operations could be performed, which, minus the personnel costs, the additional material costs for surgery and anesthesia of 557,042 € and the inpatient hotel costs of 600,663 €, with an average length of stay of 2.8 days, would result in an additional revenue of about 2.4 times the additional personnel costs at the current flat rate of 3739.40 € and an average case mix index of the MHH Eye Hospital of 0.649 (total revenue: 2,155,449 €; profit margin II: 701,389 €) for the considered surgical patient collective in 2021. CONCLUSION: An increase of the personnel expenditure in the operating room for surgical subjects such as ophthalmology with shorter interventions and many changes is economically worthwhile also for a large hospital in order to enable and optimize overlapping transfers of anesthesia and surgical care. This should therefore also be considered separately, contrary to standardized staffing of the overall hospital, in order to use existing resources with their fixed costs as optimally as possible.

Pre-endoscopy SARS-CoV-2 testing strategy during COVID-19 pandemic: the care must go on.

BACKGROUND: In response to the COVID-19 pandemic, endoscopic societies initially recommended reduction of endoscopic procedures. In particular non-urgent endoscopies should be postponed. However, this might lead to unnecessary delay in diagnosing gastrointestinal conditions. METHODS: Retrospectively we analysed the gastrointestinal endoscopies performed at the Central Endoscopy Unit of Saarland University Medical Center during seven weeks from 23 March to 10 May 2020 and present our real-world single-centre experience with an individualized rtPCR-based pre-endoscopy SARS-CoV-2 testing strategy. We also present our experience with this strategy in 2021. RESULTS: Altogether 359 gastrointestinal endoscopies were performed in the initial period. The testing strategy enabled us to conservatively handle endoscopy programme reduction (44% reduction as compared 2019) during the first wave of the COVID-19 pandemic. The results of COVID-19 rtPCR from nasopharyngeal swabs were available in 89% of patients prior to endoscopies. Apart from six patients with known COVID-19, all other tested patients were negative. The frequencies of endoscopic therapies and clinically significant findings did not differ between patients with or without SARS-CoV-2 tests. In 2021 we were able to unrestrictedly perform all requested endoscopic procedures (> 5000 procedures) by applying the rtPCR-based pre-endoscopy SARS-CoV-2 testing strategy, regardless of next waves of COVID-19. Only two out-patients (1893 out-patient procedures) were tested positive in the year 2021. CONCLUSION: A structured pre-endoscopy SARS-CoV-2 testing strategy is feasible in the clinical routine of an endoscopy unit. rtPCR-based pre-endoscopy SARS-CoV-2 testing safely allowed unrestricted continuation of endoscopic procedures even in the presence of high incidence rates of COVID-19. Given the low frequency of positive tests, the absolute effect of pre-endoscopy testing on viral transmission may be low when FFP-2 masks are regularly used.

[Performance and cost calculation for a university ophthalmological outpatient clinic]. / Leistungs- und Kostenkalkulation für eine universitäre, augenheilkundliche Hochschulambulanz.

BACKGROUND: Outpatient procedures at a university hospital are generally considered to be unprofitable. In the present publication we evaluate the turnover and costs of the university eye outpatient department of the Hannover Medical School (MHH) in terms of a cost unit accounting as well as providing a summary of the workload. MATERIAL AND METHOD: Given the data of the hospital information system (IS-H/i.s.h.med from SAP) and a proprietary software (TimeElement), all patient contacts in the year 2019 were evaluated. The latter software is applied in a standardized manner to record the patient flow of our outpatient service in real time electronically. The total costs consist of personnel, material and room costs including infrastructure of the MHH and are compared to the flat-rate revenues according to the university outpatient contract (HSA) as well as further revenues from internal referral services, self-pay patients, outpatient surgery and cooperation contracts for intravitreal injections (IVOM). RESULTS: With an average full-time equivalent (FTE) headcount of 10.63 assistant physicians, 3.6 specialist physicians, and 21 nonphysicians (plus 4 Federal Volunteer Service, BUFDI) in our policlinic, we have determined €â€¯2,927,022 in personnel costs, including overheads, for the entire year. Including infrastructure (€â€¯524,942), material and equipment costs with overheads and internal cost allocation of €â€¯258.657, the total costs in 2019 resulted in €â€¯3,710,621. In contrast, the total income in 2019 was €â€¯3,524,737 generated through the abovementioned patient segments, resulting in a deficit of €â€¯-185,884 (5%). Our data provide evidence that regular outpatient revenues are insufficient and are mainly balanced by outpatient surgery, IVOMs and self-pay patients. In total, there were 19,453 patient contacts during regular office hours (with 17,305 billable cases). At n = 9943, the majority of the contacts were HSA visits; however, only 82% of the cases could effectively be charged due to multiple visits per quarter. The median total patient attendance was 3.21 h (mean 3.38 h). On average, 78 patient contacts were counted per working day. The analysis with TimeElement unveiled a median of n = 2 physician contacts per patient (mean n = 1.91). The median duration per interaction with a physician was 17.98 min (mean 23.23 min). For diagnostics, we counted a median of n = 2 interactions per patient (mean n = 2.31), with an entire interaction lasting a median of 18.30 min (mean 22.60 min). In total n = 37,363 individual diagnostic procedures were recorded in 2019, with SD-OCT being the primary procedure at n = 10,888. CONCLUSION: The cost/turnover calculation showed a marginal financial loss through our ophthalmological outpatient department. Thus, the costs of a university eye outpatient department in Lower Saxony do not seem to be sufficiently covered by direct outpatient revenues. Maintaining quarterly flat rates for all cases of the outpatient department would require a fee of about €â€¯214 in our setting to remain cost neutral. Currently, the lower flat rates in the HSA area are compensated by other areas. Obviously, the high content-related workload in our setting requires a high personnel expenditure with a considerable personnel cost contribution of nearly 80%.

Genetic variant c.711A>T in the hepatobiliary phospholipid transporter ABCB4 is associated with significant liver fibrosis.

Liver fibrosis is the common consequence of chronic liver diseases (CLD). Recently liver stiffness measurements (LSM) ≥ 9.1 kPa, as determined by transient elastography (TE), were demonstrated to predict significant fibrosis (stages ≥ F2) in a population-based setting. The PNPLA3 (adiponutrin) p.I148M polymorphism enhances the risk of liver injury. The aim of our study was to investigate the association between the procholestatic ABCB4 polymorphism c.711A>T and LSM ≥ 9.1 kPa in humans as well as the interaction between ABCB4 and PNPLA3 in a mouse model of chronic cholestasis. Prospectively, we recruited 712 patients with CLD (278 women, age 50 ± 13 years) with available TE results; liver biopsy results were available in 165 individuals. The ABCB4 c.711 genotype was determined by PCR-based assays. PNPLA3 expression and liver injury were studied in Abcb4-/- mice and wild-type controls. Overall, median LSM in our cohort was 6.7 kPa, and 226 individuals had LSM ≥ 9.1 kPa. Carriers of the ABCB4 variant c.711A presented more frequently with LSM ≥ 9.1 kPa (OR = 1.33, P = 0.020) and FIB-4 score ≥ 2.67 (OR = 1.38, P = 0.040). The presence of the risk allele was associated (P = 0.002) with FIB-4. In a multivariate model, the ABCB4 variant (OR = 1.43, P = 0.047) as well as BMI (P = 0.043, OR = 1.04) and age (OR = 1.02, P < 0.010) were independent risk factors for fibrosis stage ≥ F2. Abcb4 deficiency in mice led to enhanced liver injury, coupled with a decrease (P = 0.020) of hepatic PNPLA3 expression. To conclude, the procholestatic variant ABCB4 c.711A>T might represent a new genetic risk factor for clinically significant liver fibrosis. Lower expression of PNPLA3 in fibrotic Abcb4-/- livers points to the interaction between phospholipid metabolism and PNPLA3 in progressive liver injury.

CONKO-006: A randomised double-blinded phase IIb-study of additive therapy with gemcitabine + sorafenib/placebo in patients with R1 resection of pancreatic cancer - Final results.

BACKGROUND: CONKO-006 was designed for patients with pancreatic adenocarcinoma with postsurgical R1 residual status to evaluate the efficacy and safety of the combination of gemcitabine and sorafenib (GemSorafenib) compared with those of gemcitabine + placebo (GemP) for 12 cycles. PATIENTS AND METHODS: This randomised, double-blind, placebo-controlled, multicenter study was planned to detect an improvement in recurrence-free survival (RFS) from 42% to 60% after 18 months. Secondary objectives were overall survival (OS), safety and duration of treatment. RESULTS: 122 patients were included between 02/2008 and 09/2013; 57 were randomised to GemSorafenib and 65 to GemP. Patient characteristics were wellbalanced (GemSorafenib/GemP) in terms of median age (63/63 years), tumour size (T3/T4: 97/97%), and nodal positivity (86/85%). Grade 3/4 toxicities comprised diarrhoea (GemSorafenib: 12%; GemP: 2%), elevated gamma-glutamyl transferase (GGT) (19%; 9%), fatigue (5%; 2%) and hypertension (5%; 2%), as well as neutropenia (18%; 25%) and thrombocytopenia (9%; 2%). By August 2017, 118 (97%) RFS event had occurred. There were no difference in RFS (median GemSorafenib: 8.5 versus GemP: 9.4 months; p = 0.730) nor OS (median GemSorafenib: 17.6 versus GemP: 17.5 months; p = 0.481). Landmark analyses suggest that patients who received more than six cycles of postoperative chemotherapy had significantly longer OS (p = 0.021). CONCLUSION: CONKO-006 is the first randomised clinical trial to include exclusively patients with PDAC with postsurgical R1 status thus far. Sorafenib added to gemcitabine did neither improve RFS nor OS. However, postoperative treatment exceeding six months seemed to prolong survival and should be further investigated in these high-risk patients. CLINICAL TRIAL INFORMATION: German Tumor Study Registry (Deutsches Krebsstudienregister), DRKS00000242.

Medication adherence among patients with chronic diseases: a survey-based study in pharmacies.

BACKGROUND: Poor adherence to medication leads to worsening of the disease, increased mortality and substantial rise in health care costs. AIM: It was our aim to evaluate drug adherence and influencing factors in a cohort of non-selected adult pharmacy customers with various chronic diseases and following long-term treatment. DESIGN AND METHODS: We conducted an 8 week anonymized survey in 152 German pharmacies using the Morisky Medication Adherence Scale to measure medication adherence and a questionnaire comprising questions on multiple factors with potential impact on adherence. Depression was assessed applying the Patient Health Questionnaire-9. RESULTS: In total, 1192 patients were included showing an overall adherence rate of 59.1%. A positive association to drug adherence was found in univariate analysis for non-smoking status, retirement, less disease related complaints, positive belief in drug effects, comprehensive knowledge about the disease and high quality of care by the physician and pharmacist. Multivariate regression analysis revealed that no or minimal depression (odds ratio (OR) 2.3, 95% confidence interval (CI) 1.7-3.0), higher patient age (>63 years) (OR 2.2, CI 1.7-2.8), high perceived importance of the medication (OR 2.0, CI 1.5-2.6), good tolerability of the medication (OR 2.0, CI 1.2-3.5) and drug effect as expected or better (OR 1.6, CI 1.1-2.3) were positively correlated with adherence. CONCLUSIONS: Suboptimal adherence to medication is common in pharmacy customers with chronic diseases. The determined factors influencing adherence may help to identify patients at risk for nonadherence and support the need of improvement in physicians' communication with patients to achieve adequate adherence rates.

How to improve success rates of endoscopic management for buried bumper syndrome.

BACKGROUND: Buried bumper syndrome (BBS) is a rare complication of percutaneous endoscopic gastrostomy. Complete BBS without visible parts of the inner bumper is a challenge for endoscopic treatment. METHODS AND AIMS: Data base analysis of all procedures performed at our tertiary university endoscopy center between 2000 and 2015 was conducted. Our aim was to improve the success rates of endoscopic treatment using a standardized approach and a pull-modification of the papillotome-based extraction technique in a prospective cohort. RESULTS: Retrospectively, 55 patients were identified (37 men; age 54 ± 16 years). The prospective series comprised 11 patients (8 men; age 63 ± 27 years). Patients with partial BBS were effectively treated by endoscopy in both cohorts (24/25 and 4/4 patients, respectively). For complete BBS (Cyrany grade 3), success rates of endoscopic therapy differed significantly between the cohorts (P = 0.017). In the retrospective cohort, only 38% of patients (9/24 patients) were successfully treated. In the prospective cohort, all six patients (deep-type in five cases) were managed without complications. Patients with extra-gastric tubes underwent primary surgery in both cohorts (six and one patients, respectively). CONCLUSION: A structured approach improved success rates of endoscopic treatment. All patients with an internal bumper verified to lie within the gastric wall can be treated by an experienced investigator using a papillotome-based technique.

Genetic background influences susceptibility to chemotherapy-induced hematotoxicity.

Hematotoxicity is a life-threatening side effect of many chemotherapy regimens. Although clinical factors influence patient responses, genetic factors may also play an important role. We sought to identify genomic loci that influence chemotherapy-induced hematotoxicity by dosing Diversity Outbred mice with one of three chemotherapy drugs; doxorubicin, cyclophosphamide or docetaxel. We observed that each drug had a distinct effect on both the changes in blood cell subpopulations and the underlying genetic architecture of hematotoxicity. For doxorubicin, we mapped the change in cell counts before and after dosing and found that alleles of ATP-binding cassette B1B (Abcb1b) on chromosome 5 influence all cell populations. For cyclophosphamide and docetaxel, we found that each cell population was influenced by distinct loci, none of which overlapped between drugs. These results suggest that susceptibility to chemotherapy-induced hematotoxicity is influenced by different genes for different chemotherapy drugs.

Treatment of refractory ascites with an automated low-flow ascites pump in patients with cirrhosis.

BACKGROUND: Refractory ascites (RA) is a frequent complication of cirrhosis, requiring large volume paracentesis or placement of a transjugular intrahepatic portosystemic shunt (TIPSS). The automated low-flow ascites pump (alfapump, Sequana Medical AG, Zurich, Switzerland) is an innovative treatment option for patients with RA. AIM: To assess safety and efficacy of this treatment in patients with a contraindication to TIPSS. METHODS: Fifty-six patients (43 males; mean age 62 years) from centres in Germany, Switzerland, UK and Spain were included and followed for up to 24 months. Complications, device deficiencies, paracentesis frequency and patient survival were recorded. RESULTS: At the time of this analysis, 3 patients completed the 24-month observation period, monitoring of 3 was ongoing, 9 underwent liver transplantation, 17 patients were withdrawn due to serious adverse events and 23 patients died. Most frequently observed technical complication was blocking of the peritoneal catheter. Twenty-three pump-related reinterventions (17 patients) and 12 pump exchanges (11 patients) were required during follow-up. The pump system was explanted in 48% of patients (in 17 patients due to serious adverse events, in 9 at the time of liver transplantation and in 1 due to recovery from RA). Median frequency of paracentesis dropped from 2.17 to 0.17 per month. CONCLUSIONS: The alfapump can expand therapeutic options for cirrhotic patients with RA. Continuous drainage of ascites in a closed loop automated system led to significant reduction in paracentesis frequency. Technical and procedural improvements are required to reduce the rate of adverse events and reinterventions. https://clinicaltrials.gov/ct2/show/NCT01532427.

[Prevalence and risk factors of drug induced liver disease: a survey based study in pharmacies]. / Häufigkeit und Risikofaktoren medikamentös-toxischer Leberschäden: eine umfragebasierte Studie in Apotheken.

AIM: The reported incidence of drug-induced liver injury (DILI) ranges from 1 in 10,000 to 1 in 100,000 patients for most drugs, but the true incidence is expected to be much higher. Several risk factors for DILI susceptibility have been suggested, however there is insufficient data to define an individual risk profile. Therefore it was our aim to study the prevalence of DILI and potential risk factors within adult pharmacy customers in Germany. METHODS: We conducted two 6 week-survey studies in 30 pharmacies in 2011 and 2012, respectively, using a newly developed questionnaire comprising questions on demography, (liver) diseases, liver enzyme activities, and drug history. In each study, anonymized questionnaires were presented to non-selected adult customers taking (non-)prescription drugs. RESULTS: Combining the datasets from the 2011 and 2012 surveys, in total 1098 questionnaires were evaluated (mean age 57.7 ±â€Š17.1 years; 62.6 % females, return rate 15.25 %). Overall, 141 individuals (12.8 %) reported elevated liver enzymes due to drugs, in 65 cases (5.9 %) the medication had to be stopped, and 20 customers (1.8 %) reported that they had been admitted to hospital due to DILI. Compared to individuals without adverse hepatic drug reactions (n = 957), the 141 persons with potential DILI presented more often the following risk factors in multivariate analysis: chronic liver disease (14.4 % vs. 2.4 %, odds ratio [OR] 4.2, 95 % confidence interval [CI] 2.0 - 9.0), chronic renal insufficiency (20.0 vs. 6.8 %, OR 2.2, 95 % CI 1.3 - 3.7), diabetes (34 vs. 15.3 %, OR 2.0, 95 % CI 1.3 - 3.2), family history of chronic liver disease (19.9 vs. 7.7 %, OR 2.1, 95 % CI 1.2 - 3.6), and continuous drug intake for more than 5 years (80.9 vs. 59.3 %, OR 2.1, 95 % CI 1.3 - 3.5). CONCLUSION: These studies show an unexpected high prevalence of DILI in pharmacy customers and identify multiple potential risk factors.

The safety and efficacy of nasobiliary drainage in the treatment of refractory cholestatic pruritus: a multicentre European study.

BACKGROUND: Pruritus is a common symptom associated with cholestatic liver diseases. To date only small single centre case series have suggested efficacy of nasobiliary drainage in relieving cholestatic pruritus. AIM: To perform a multicentre study to evaluate the safety and efficacy of nasobiliary drainage in cholestatic pruritus. METHODS: This was a retrospective study of all patients treated with nasobiliary drainage for refractory cholestatic pruritus between 2006 and 2015 at five European centres. Pruritus was quantified using a visual analogue scale (VAS) and liver enzymes, serum bilirubin and total serum bile salts (TBS) were measured before (pre-NBD) and after nasobiliary drainage (post-NBD). We analysed the duration of treatment response and associated complications. RESULTS: In total, 27 patients (59% females) underwent 29 nasobiliary drainage procedures. The median duration of NBD was 7 days. NBD decreased pruritus in 89.6% of cases (VAS from 10.0 to 0.3, P < 0.0001). The median percentage decline in pruritus VAS was 94% and 33% of patients were free of pruritus within 24 h of starting drainage. The duration of treatment response was independent of duration of drainage (P = 0.12) and bile output. Significant improvements were seen in the median levels of serum alkaline phosphatase (P = 0.001) and serum bilirubin (P = 0.03) but not in serum TBS (P = 0.07). Mild post-endoscopic retrograde cholangiopancreatography pancreatitis (31%) was the most frequent complication. CONCLUSIONS: Nasobiliary drainage is effective in relieving cholestatic pruritus in most patients and has favourable effect on biomarkers of cholestasis. Nasobiliary drainage may be associated with high risk of adverse events, especially pancreatitis. Prospective studies are needed to confirm our findings.