German Patient Blood Management Network: effectiveness and safety analysis in 1.2 million patients.

BACKGROUND: Patient Blood Management (PBM) is a patient-centred, systematic, evidence-based approach to improve patient outcomes by managing and preserving a patient's own blood whilst promoting patient safety and empowerment. The effectiveness and safety of PBM over a longer period have not yet been investigated. METHODS: We performed a prospectively designed, multicentre follow-up study with non-inferiority design. Data were retrospectively extracted case-based from electronic hospital information systems. All in-hospital patients (≥18 yr) undergoing surgery and discharged between January 1, 2010 and December 31, 2019 were included in the analysis. The PBM programme focused on three domains: preoperative optimisation of haemoglobin concentrations, blood-sparing techniques, and guideline adherence/standardisation of allogeneic blood product transfusions. The outcomes were utilisation of blood products, composite endpoint of in-hospital mortality and postoperative complications (myocardial infarction/ischaemic stroke/acute renal failure with renal replacement therapy/sepsis/pneumonia), anaemia rate at admission and discharge, and hospital length of stay. RESULTS: A total of 1 201 817 (pre-PBM: n=441 082 vs PBM: n=760 735) patients from 14 (five university/nine non-university) hospitals were analysed. Implementation of PBM resulted in a substantial reduction of red blood cell utilisation. The mean number of red blood cell units transfused per 1000 patients was 547 in the PBM cohort vs 635 in the pre-PBM cohort (relative reduction of 13.9%). The red blood cell transfusion rate was significantly lower (P<0.001) with odds ratio 0.86 (0.85-0.87). The composite endpoint was 5.8% in the PBM vs 5.6% in the pre-PBM cohort. The non-inferiority aim (safety of PBM) was achieved (P<0.001). CONCLUSIONS: Analysis of >1 million surgical patients showed that the non-inferiority condition (safety of Patient Blood Management) was fulfilled, and PBM was superior with respect to red blood cell transfusion. CLINICAL TRIAL REGISTRATION: NCT02147795.

Comparing the validity of different ICD coding abstraction strategies for sepsis case identification in German claims data.

INTRODUCTION: Administrative data are used to generate estimates of sepsis epidemiology and can serve as source for quality indicators. Aim was to compare estimates on sepsis incidence and mortality based on different ICD-code abstraction strategies and to assess their validity for sepsis case identification based on a patient sample not pre-selected for presence of sepsis codes. MATERIALS AND METHODS: We used the national DRG-statistics for assessment of population-level sepsis incidence and mortality. Cases were identified by three previously published International Statistical Classification of Diseases (ICD) coding strategies for sepsis based on primary and secondary discharge diagnoses (clinical sepsis codes (R-codes), explicit coding (all sepsis codes) and implicit coding (combined infection and organ dysfunction codes)). For the validation study, a stratified sample of 1120 adult patients admitted to a German academic medical center between 2007-2013 was selected. Administrative diagnoses were compared to a gold standard of clinical sepsis diagnoses based on manual chart review. RESULTS: In the validation study, 151/937 patients had sepsis. Explicit coding strategies performed better regarding sensitivity compared to R-codes, but had lower PPV. The implicit approach was the most sensitive for severe sepsis; however, it yielded a considerable number of false positives. R-codes and explicit strategies underestimate sepsis incidence by up to 3.5-fold. Between 2007-2013, national sepsis incidence ranged between 231-1006/100,000 person-years depending on the coding strategy. CONCLUSIONS: In the sample of a large tertiary care hospital, ICD-coding strategies for sepsis differ in their accuracy. Estimates using R-codes are likely to underestimate the true sepsis incidence, whereas implicit coding overestimates sepsis cases. Further multi-center evaluation is needed to gain better understanding on the validity of sepsis coding in Germany.

Laparoscopic antireflux surgery with routine mesh-hiatoplasty in the treatment of gastroesophageal reflux disease.

One of the most frequent complications after laparoscopic antireflux surgery is intrathoracic migration of the wrap ("slipped" Nissen fundoplication). The most common reasons for this are inadequate closure of the crura or disruption of the crural closure. The aim of this prospective study was to evaluate surgical outcomes in patients who underwent laparoscopic antireflux surgery with simple nonabsorbable polypropylene sutures for hiatal closure in comparison to patients who underwent routine mesh-hiatoplasty. Between 1993 and 1998, a group of 361 patients underwent primary laparoscopic Nissen or Toupet fundoplication with the use of simple nonabsorbable polypropylene sutures for hiatal closure. Since December 1998, in all patients (n = 170) who underwent laparoscopic antireflux surgery, a 1 x 3 cm polypropylene mesh was placed on the crura behind the esophagus to reinforce them. Functional outcome, symptoms of gastroesophageal reflux disease, and postoperative complications such as recurrent hiatal hernia with or without intrathoracic migration of the wrap have been used for assessment of outcomes. In the initial series of 361 patients, postoperative herniation of the wrap occurred in 22 patients (6.1%). Of these 22 patients, 17 of them (4.7%) had to undergo laparoscopic redo surgery. The remaining five patients were free of symptoms. In comparison to these results, in a second group of 170 patients there was only one (0.6%) who had postoperative herniation of the wrap into the chest. There have been no significant differences in objective data such as DeMeester scores or lower esophageal sphincter pressure between the two groups. Postoperative dysphagia was increased during the early period after surgery in patients undergoing mesh-hiatoplasty but resolved without any further treatment within the first year after laparoscopic antireflux surgery. We concluded that routine hiatoplasty with the use of a polypropylene mesh is effective in preventing postoperative herniation of the wrap and leads to a significantly better surgical outcome than closure of the hiatal crura with simple sutures, without any additional long-term side effects.