•Quality of care and data validity improved when the program was introduced.•The program also leads to a stricter quality assurance in inpatient care.•Effects on capacity and allocation of hospitals ...have not yet occurred.•The link between hospital capacity planning and quality has to be improved.•To reach this goal the law has to be changed.
In Germany, the use of quality data to support hospital capacity planning was introduced in 2017. On behalf of the Federal Joint Committee, IQTIG suggested 11 quality indicators and developed a program on how to collect, evaluate and report data for the clinical areas gynaecological surgery, obstetrics and breast surgery. By analysing data from 2015 to 2021, effects of the introduction of the program on indicator results, statistical discrepancies and impact on care quality are examined. Effects on capacity planning are discussed.
Since the program started, indicator results improved in all clinical areas, and statistical discrepancies and the number of assessments with insufficient quality decreased due to enhanced adherence to quality standards and data validity. Effects on capacity planning or the allocation of hospitals have not occurred.
Thus, a change of the legal basis to allow a better link between quality and hospital planning is recommended. The approach to use quality data on hospital regulation in Germany is evolving. The current hospital reform in Germany also addresses other approaches to quality-based regulation. Already now, there have been clear improvements in specific indicators as well as lessons for quality assurance and its link to capacity planning provided by the program, which are also applicable to other countries.
Background: Endoscopic extraction of bile duct stones after sphincterotomy has a success rate of up to 95%. Failures occur in patients with extremely large stones, intrahepatic stones, and bile duct ...strictures. This study examined the efficacy and the safety of extracorporeal shock-wave lithotripsy in a large cohort of patients in whom routine endoscopic measures including mechanical lithotripsy had failed to extract bile duct stones. Methods: Out of 1587 consecutive patients, endoscopic stone extraction including mechanical lithotripsy was unsuccessful in 313 (20%). These 313 patients (64% women, median age, 73 years) underwent high-energy extracorporeal shock-wave lithotripsy. Stone targeting was performed fluoroscopically (99%) or by ultrasonography (1%). Results: Complete clearance of bile duct calculi was achieved in 281 (90%) patients. In 80% of the patients, the fragments were extracted endoscopically after shock-wave therapy; spontaneous passage was observed in 10%. For patients with complete clearance compared with those without there were no differences with regard to size or number of the stones, intrahepatic or extrahepatic stone location, presence or absence of bile duct strictures, or type of lithotripter. Cholangitis (n = 4) and acute cholecystitis (n = 1) were the rare adverse effects. Conclusions: In patients with bile duct calculi that are difficult to extract endoscopically, high-energy extracorporeal shock-wave lithotripsy is a safe and effective therapy regardless of stone size, stone location, or the presence of bile duct stricture. (Gastrointest Endosc 2001;53:27-32.)
Highlights • Cross-sectoral quality assurance (QA) is being developed for the national QA-scheme in Germany. • It aims at measuring quality across health care interfaces. • Technical and problems of ...acceptance challenge the implementation of cross-sectoral QA. • To overcome them, new data-sources for QA are proposed: routine data, patient surveys, peer reviews using indicators.
The number of catheter related bloodstream infections (CRBSI) could be reduced and the outcome improved if specific standards in the quality of care were maintained. Therefore, the development of ...quality assurance (QA) procedures was commissioned to be included in the national mandatory QA programme in Germany.
Indicators representing quality deficiencies and potential for improvement of quality in relation to prevention and management of central venous catheters (CVC) were developed by (1) evidence-based literature searches and the compiling of an indicator register; (2) a multi-professional expert panel including patient representatives who selected indicators from this register by using a modified RAND/UCLA Appropriateness Method; (3) defining methods for data assessment, risk adjustment and feedback of indicator results to service providers; and (4) consulting all relevant medical societies and other stakeholders with regard to the QA procedures that had been developed.
Thirty-two indicators for CRBSI prevention and management were eventually approved by the expert panel. These indicators represent quality of care at predefined points with regard to indication, insertion and care of CVCs, management of sepsis, general hygiene and training of health care personnel. Fourteen indicators represent processes, together with 7 representing structures and 11 outcomes. For assessing these indicators, data was obtained from four sources: claims data from health insurance funds, routine claims data from hospital electronic information systems, case specific longitudinal documentation from service providers and cross-sectional annual assessment of structures.
It was possible to develop indicators for mandatory QA procedures on CRBSI that take into account the different perspectives of all stakeholders involved. Despite efforts to use routine data for documentation wherever possible, most indicators required extra documentation.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
To evaluate the long-term results of three types of shock wave treatment in patients with radiolucent gallbladder stones.
Cohort study.
Single-center trial.
Of 5824 patients with gallstones, 19% were ...eligible; 711 patients were treated.
Patients received extracorporeal shock wave lithotripsy as well as adjuvant therapy with bile acids.
Lithotripsy was done in three ways, using a water-tank lithotriptor (group A), a water-cushion lithotriptor at low energy levels (group B), and a water-cushion lithotriptor at high energy levels (group C). The rate of complete fragment clearance 9 to 12 months after lithotripsy was done differed significantly among the three groups: Among patients with single stones of 20 mm or less in diameter, the rate of fragment clearance for group A was 76%; for group B, it was 60%; and for group C, it was 83% (P = 0.03). Among patients with single stones of 21 to 30 mm, the rate of fragment clearance for group A was 63%; for group B, it was 32%; and for group C, it was 58% (P less than 0.005). Among patients with two or three stones, the rate of fragment clearance for group A was 38%; for group B, it was 16%; and for group C, it was 46% (P = 0.01). Patients with fragments of 3 mm or less 24 hours after lithotripsy was done showed a higher probability of fragment disappearance than did those with larger fragments (P less than 0.001). The clearance rate was higher in patients who were compliant than in those who were noncompliant with bile acid therapy (P less than 0.001). Adverse effects included liver hematoma in 1 patients, biliary pain attacks in 253 patients (36%), mild biliary pancreatitis in 13 patients (2%), and cholestasis in 7 patients (1%). Elective cholecystectomy was done in 16 patients (2%), and endoscopic sphincterotomy was done in 4 patients (1%).
The rate of complete disappearance of stones after shock wave therapy depends on the size and the number of the initial stones, the diameter of the largest fragment, and the mode of shock wave treatment. Adjuvant therapy with bile acids appears to be important for complete fragment clearance.
Beneficial effects of ursodeoxycholic acid in chronic cholestatic liver diseases have been attributed to displacement of hydrophobic bile acids from the endogenous bile acid pool. To test this ...hypothesis, we determined pool sizes, fractional turnover rates, synthesis/input rates and serum levels of deoxycholic acid and chenodeoxycholic acid before and 1 mo after the start of treatment with ursodeoxycholic acid (13 to 15 mg/kg body wt/day) in four healthy volunteers and five patients with chronic cholestatic liver diseases (three with primary biliary cirrhosis and two with primary sclerosing cholangitis). Bile acid kinetics were determined by combined capillary gas chromatography-isotope ratio mass spectrometry in serum samples after administration of 2H4 deoxycholic acid and 13Cchenodeoxycholic acid. In healthy volunteers, deoxycholic acid pool sizes decreased during administration of ursodeoxycholic acid by 72%. In patients with cholestatic liver diseases, deoxycholic acid pool sizes before ursodeoxycholic acid treatment were only 13% of those in healthy volunteers and were unaffected by ursodeoxycholic acid treatment. Chenodeoxycholic acid pool sizes were not different in healthy volunteers and in patients with cholestatic liver disease, and were not altered by ursodeoxycholic acid treatment. In both healthy volunteers and patients with cholestatic liver disease, synthesis/input rates and serum levels of deoxycholic acid and chenodeoxycholic acid were not altered by ursodeoxycholic acid treatment. Because in our patients improvement of serum liver tests during short-term ursodeoxycholic acid treatment was noted without a decrease of the pool sizes of the major hydrophobic bile acids, we conclude that displacement of hydrophobic endogenous bile acids is not the mechanism of action of ursodeoxycholic acid in chronic cholestatic liver disease.
The long-term outcome of nonoperative gallstone therapy depends on both absence of stones and absence of biliary pain. The aim of the present study was to determine the rate of stone recurrence and ...the rate of symptoms within 5 years after successful shock wave lithotripsy combined with bile acid therapy.
One hundred consecutive patients (single stones, n = 89; 2 or 3 stones, n = 11) were followed up for a median of 4.3 years after stone disappearance and discontinuation of bile acids.
Twenty-three of the 100 patients developed recurrent stones. Calculated by actuarial analysis, the recurrence rate was 7% +/- 3%, 11% +/- 3%, 13% +/- 4%, 20% +/- 5%, and 31% +/- 7% (mean +/- SD) at 1, 2, 3, 4, and 5 years, respectively. The recurrent stones were small (6 +/- 5 mm) and were associated with recurrent biliary pain in 14 (61%) of the 23 patients. Repeated shock wave lithotripsy and/or bile acid medication resulted in stone disappearance in only 10 of 20 patients with recurrence.
The long-term rate of stone recurrence after lithotripsy of primarily solitary gallbladder calculi is lower than expected from post-bile acid dissolution trials. Recurrence of stones frequently is associated with recurrence of biliary pain.
Patients with long-standing inflammatory bowel disease (IBD) are at increased risk of developing colonic dysplasias. By conventional colonoscopy dysplasias may be difficult to detect. Laser induced ...flourescence endoscopy (LIFE) helps to differentiate between normal colonic mucosa and dysplasia. We present results of a pilot study using LIFE with and without 5-Aminolevulinic acid in patients with IBD. Methods: 15 patients with IBD were screened for colonic dysplasias with LIFE using autofluorescence (group A, 5 patients) or 5-ALA induced fluorescence (group B, 10 patients) combined with white light colonoscopy during a routine endoscopic examination. 5-ALA was given orally at a dose of 20mg/kg 3 hours before examination. All patients were examined by conventional white light colonoscopy and by LIFE using a blue light source (400-410 nm) and a sensitive camera to detect the laser induced fluorescence (D-Light/Tricam SL, Storz, Germany). All procedures were documentated with video. All lesions were judged to be suspicious or non-suspicious (regarding dysplasia) by both conventional colonoscopy and LIFE. The LIFE images were classified as positive for dysplasia (“red” flourescence) or negative (“green” or “blue” fluorescence like normal mucosa). Biopsies were taken, from all suspicious areas for histological assessment. Results: In both group A and group B no dysplasias or carcinomas were detectet histopathologically. In 4 patients of group B white light colonoscopy showed suspicious areas (4 false positive results), one of these suspicious lesions was also positive in the 5-ALA fluorescence (1 false positive). No suspicious lesions or dysplasias were detected in the autofluorescence group. Conclusions: In this small series of patients LIFE from colonic mucosa with or without 5-ALA combined with routine white light colonoscopy shows a good correlation with the histopathological findings and a high sensitivity. Due to the absence of dysplasias or carcinomas in this population the specifity cannot be determined. If the high sensitivity of LIFE compared to conventional colonoscopy will be confirmed in further studies, routine random biopsies in the surveillance of IBD patients may be avoided by Life.
To determine the rate and characteristics of gallstone recurrence after direct contact dissolution with methyl tert-butyl ether, 60 consecutive patients were followed for up to 4.5 years (median 2.2 ...years) after complete disappearance of all stone residues and debris and cessation of adjuvant bile acid therapy. Initial gallstones had been multiple in all but four patients. Twenty-eight of the 60 patients developed recurrent gallstones. The cumulative risk of gallstone recurrence (actuarial analysis) was 23 +/- 6%, 34 +/- 7%, 55 +/- 8%, and 70 +/- 9% at one, two, three, and four years, respectively. The recurrent stones were usually multiple and small (6 +/- 4 mm). Gallstone recurrence was associated with recurrent biliary pain in two patients, one of whom developed acute cholecystitis. Recurrent stones were cleared completely by bile acid medication with or without shock-wave lithotripsy in 61 +/- 15% of patients at one year (actuarial analysis). In conclusion, gallstone recurrence after successful contact dissolution of multiple stones with methyl tert-butyl ether has to be expected in a high percentage of patients. Most patients, however, remain free of biliary pain during long-term follow-up.
A prospective, double-blind, randomized, single-center study was conducted to compare ursodeoxycholic acid alone with the combination of ursodeoxycholic acid and chenodeoxycholic acid for dissolution ...therapy of gallstone fragments after shock wave lithotripsy. Patients with single radiolucent gallstones up to 30 mm in diameter or up to three stones of similar total volume received either 750 mg ursodeoxycholic acid alone (group A, n = 138) or the combination of 500 mg ursodeoxycholic acid and 500 mg chenodeoxycholic acid (group B, n = 144) in a single bedtime dose. The bile acids were administered from 2 wk before electrohydraulic lithotripsy until 3 mo beyond complete disappearance of all fragments. Patient's characteristics, stones (group A, 82% single stones, maximum diameter 19 +/- 5 mm, mean +/- S.D.; group B, 82% single stones, 18 +/- 5 mm), lithotripsy treatment and follow-up period were not different between the two groups. Between the two groups, no statistically significant difference was found in the time required for complete clearance of the fragments (group A, median time = 15 mo; group B, median time = 13 mo; p = 0.7). At 12 mo after lithotripsy, the probability of complete clearance was 46% +/- 5% in group A and 49% +/- 5% in group B. Diarrhea occurred significantly more often in group B than in group A (p less than 0.001) and was the main reason for withdrawal of randomized medication. Severe adverse effects of the bile acids were not observed. It is concluded that monotherapy with ursodeoxycholic acid is as efficient as the combination of ursodeoxycholic acid and chenodeoxycholic acid for fragment dissolution after lithotripsy.
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