Etiology of nosocomial infections in intensive care patients in German hospitals: An analysis of trends between 2008 and 2022.

PURPOSE: Data from the intensive care component of the German hospital infection surveillance system (KISS) was used to investigate the epidemiology of pathogens responsible for the most frequent device-associated infections and their development over time. METHOD: The 10 most common pathogens were identified for ventilator-associated lower respiratory tract infections (VALRTI), catheter associated urinary tract infections (CAUTI), and central venous catheter associated bloodstream infections (CVC-BSI). The development over time was analyzed based on three five-year time periods: 2008-2012, 2013-2017, 2018-2022. RESULTS: Data from 1425 ICUs were included together with 121,762 device-associated infections with 138,299 isolated pathogens. A remarkable and significant increase in the frequency of Klebsiella spp. was found for VALRTI, that was almost twice as high during 2018-2022 compared to 2008-2012. For CAUTI, there was a significant increase of all Enterobacterales with the most prominent increase in Klebsiella spp. With regard to CVC-BSI, the situation for coagulase-negative staphylococci and E. coli was relatively stable; while there was a significant increase in Enterococcus spp. and Klebsiella spp. and a decrease in S. aureus. CONCLUSION: Knowledge about the current frequency of pathogens responsible for nosocomial infections in intensive care units is important for guiding empirical antimicrobial therapy. Data from national nosocomial infection surveillance systems can provide relevant information about the development of pathogens.

Deficits in blood culture collection in the emergency department if sepsis is suspected: results of a retrospective cohort study.

PURPOSE: Blood cultures (BCs) are key for pathogen detection in septic patients. We investigated the extent to which sampling was performed and what factors were associated with the absence of general or inadequate BC sampling. METHODS: We conducted a retrospective cohort study of hospitalized patients with sepsis admitted to one of three EDs in 2018. Primary outcome was the extent of general BC collection of at least 1 set. Secondary outcome was the extent of adequate BC sampling, defined as ≥ 2 sets before antibiotic therapy (AT). Multivariable logistic regression analysis was performed to identify factors associated with deficits in both outcomes. RESULTS: 1143 patients were analyzed. BCs were collected from 946 patients. Single BCs were taken from 520 patients, ≥ 2 sets from 426 patients. Overall, ≥ 2 BCs were taken from 349 patients before AT. BC sampling before AT occurred significantly more frequently when ≥ 2 BC sets were taken rather than a single one (81.9%, versus 68.4%, p < 0.001) and this also led to the highest pathogen detection rate in our cohort (65.6%). A body temperature of ≥ 38 °C was the a supporting factor for general and adequate BC collection in all three EDs. Retrospective analysis of 533 patients showed that the qSOFA score had no influence on general or adequate BC collection. CONCLUSION: Data on everyday clinical practice in the pre-analytical phase of microbiological diagnostics shows considerable deficits and indicates the need for more implementation of best practice. The variations identified in BC sampling between EDs should be further investigated.

Risk factors for transmission of carbapenem-resistant Acinetobacter baumannii in outbreak situations: results of a case-control study.

BACKGROUND: An increase in patients with multidrug-resistant organisms and associated outbreaks during the COVID-19 pandemic have been reported in various settings, including low-endemic settings. Here, we report three distinct carbapenem-resistant Acinetobacter baumannii (CRAB) outbreaks in five intensive care units of a university hospital in Berlin, Germany during the COVID-19 pandemic. METHODS: A case-control study was conducted with the objective of identifying risk factors for CRAB acquisition in outbreak situations. Data utilized for the case-control study came from the investigation of three separate CRAB outbreaks during the COVID-19 pandemic (August 2020- March 2021). Cases were defined as outbreak patients with hospital-acquired CRAB. Controls did not have any CRAB positive microbiological findings and were hospitalized at the same ward and for a similar duration as the respective case. Control patients were matched retrospectively in a 2:1 ratio. Parameters routinely collected in the context of outbreak management and data obtained retrospectively specifically for the case-control study were included in the analysis. To analyze risk factors for CRAB acquisition, univariable and multivariable analyses to calculate odds ratios (OR) and 95% confidence intervals (CI) were performed using a conditional logistic regression model. RESULTS: The outbreaks contained 26 cases with hospital-acquired CRAB in five different intensive care units. Two exposures were identified to be independent risk factors for nosocomial CRAB acquisition by the multivariable regression analysis: Sharing a patient room with a CRAB patient before availability of the microbiological result was associated with a more than tenfold increase in the risk of nosocomial CRAB acquisition (OR: 10.7, CI: 2.3-50.9), while undergoing bronchoscopy increased the risk more than six times (OR: 6.9, CI: 1.3-38.1). CONCLUSIONS: The risk factors identified, sharing a patient room with a CRAB patient and undergoing bronchoscopy, could point to an underperformance of basic infection control measure, particularly hand hygiene compliance and handling of medical devices. Both findings reinforce the need for continued promotion of infection control measures. Given that the outbreaks occurred in the first year of the COVID-19 pandemic, our study serves as a reminder that a heightened focus on airborne precautions should not lead to a neglect of other transmission-based precautions.

Mechanisms of lumbar spine "flattening" in adult spinal deformity: defining changes in shape that occur relative to a normative population.

PURPOSE: Previous work comparing ASD to a normative population demonstrated that a large proportion of lumbar lordosis is lost proximally (L1-L4). The current study expands on these findings by collectively investigating regional angles and spinal contours. METHODS: 119 asymptomatic volunteers with full-body free-standing radiographs were used to identify age-and-PI models of each Vertebra Pelvic Angle (VPA) from L5 to T10. These formulas were then applied to a cohort of primary surgical ASD patients without coronal malalignment. Loss of lumbar lordosis (LL) was defined as the offset between age-and-PI normative value and pre-operative alignment. Spine shapes defined by VPAs were compared and analyzed using paired t-tests. RESULTS: 362 ASD patients were identified (age = 64.4 ± 13, 57.1% females). Compared to their age-and-PI normative values, patients demonstrated a significant loss in LL of 17 ± 19° in the following distribution: 14.1% had "No loss" (mean = 0.1 ± 2.3), 22.9% with 10°-loss (mean = 9.9 ± 2.9), 22.1% with 20°-loss (mean = 20.0 ± 2.8), and 29.3% with 30°-loss (mean = 33.8 ± 6.0). "No loss" patients' spine was slightly posterior to the normative shape from L4 to T10 (VPA difference of 2°), while superimposed on the normative one from S1 to L2 and became anterior at L1 in the "10°-loss" group. As LL loss increased, ASD and normative shapes offset extended caudally to L3 for the "20°-loss" group and L4 for the "30°-loss" group. CONCLUSION: As LL loss increases, the difference between ASD and normative shapes first occurs proximally and then progresses incrementally caudally. Understanding spinal contour and LL loss location may be key to achieving sustainable correction by identifying optimal and personalized postoperative shapes.

A comparative cohort study of surgical approaches for adult spinal deformity at a minimum 2-year follow-up.

STUDY DESIGN: This study was a retrospective multi-center comparative cohort study. MATERIALS AND METHODS: A retrospective institutional database of operative adult spinal deformity patients was utilized. All fusions > 5 vertebral levels and including the sacrum/pelvis were eligible for inclusion. Revisions, 3 column osteotomies, and patients with < 2-year clinical follow-up were excluded. Patients were separated into 3 groups based on surgical approach: 1) posterior spinal fusion without interbody (PSF), 2) PSF with interbody (PSF-IB), and 3) anteroposterior (AP) fusion (anterior lumbar interbody fusion or lateral lumbar interbody fusion with posterior screw fixation). Intraoperative, radiographic, and clinical outcomes, as well as complications, were compared between groups with ANOVA and χ2 tests. RESULTS: One-hundred and thirty-eight patients were included for study (PSF, n = 37; PSF-IB, n = 44; AP, n = 57). Intraoperatively, estimated blood loss was similar between groups (p = 0.171). However, the AP group had longer operative times (547.5 min) compared to PSF (385.1) and PSF-IB (370.7) (p < 0.001). Additionally, fusion length was shorter in PSF-IB (11.4) compared to AP (13.6) and PSF (12.9) (p = 0.004). There were no differences between the groups in terms of change in alignment from preoperative to 2 years postoperative. There were no differences in clinical outcomes. While postoperative complications were largely similar between groups, operative complications were higher in the AP group (31.6%) compared to the PSF (5.4%) and PSF-IB (9.1) groups (p < 0.001). CONCLUSION: While there were differences in intraoperative outcomes (operative time and fusion length), there were no differences in postoperative clinical or radiographic outcomes. AP fusion was associated with a higher rate of operative complications.

Defining modern iatrogenic flatback syndrome: examination of segmental lordosis in short lumbar fusion patients undergoing thoracolumbar deformity correction.

PURPOSE: Understanding the mechanism and extent of preoperative deformity in revision procedures may provide data to prevent future failures in lumbar spinal fusion patients. METHODS: ASD patients without prior spine surgery (PRIMARY) and with prior short (SHORT) and long (LONG) fusions were included. SHORT patients were stratified into modes of failure: implant, junctional, malalignment, and neurologic. Baseline demographics, spinopelvic alignment, offset from alignment targets, and patient-reported outcome measures (PROMs) were compared across PRIMARY and SHORT cohorts. Segmental lordosis analyses, assessing under-, match, or over-correction to segmental and global lordosis targets, were performed by SRS-Schwab coronal curve type and construct length. RESULTS: Among 785 patients, 430 (55%) were PRIMARY and 355 (45%) were revisions. Revision procedures included 181 (23%) LONG and 174 (22%) SHORT corrections. SHORT modes of failure included 27% implant, 40% junctional, 73% malalignment, and/or 28% neurologic. SHORT patients were older, frailer, and had worse baseline deformity (PT, PI-LL, SVA) and PROMs (NRS, ODI, VR-12, SRS-22) compared to primary patients (p < 0.001). Segmental lordosis analysis identified 93%, 88%, and 62% undercorrected patients at LL, L1-L4, and L4-S1, respectively. SHORT patients more often underwent 3-column osteotomies (30% vs. 12%, p < 0.001) and had higher ISSG Surgical Invasiveness Score (87.8 vs. 78.3, p = 0.006). CONCLUSIONS: Nearly half of adult spinal deformity surgeries were revision fusions. Revision short fusions were associated with sagittal malalignment, often due to undercorrection of segmental lordosis goals, and frequently required more invasive procedures. Further initiatives to optimize alignment in lumbar fusions are needed to avoid costly and invasive deformity corrections. LEVEL OF EVIDENCE: IV: Diagnostic: individual cross-sectional studies with consistently applied reference standard and blinding.

The transmission risk of multidrug-resistant organisms between hospital patients and their pets - a case-control study, Germany, 2019 to 2022.

BackgroundCarriage of multidrug-resistant organisms (MDROs) in humans constitutes an important public health concern. Cross-transmission of bacteria between animals and humans has been demonstrated before.AimOur aim was to quantify the risk factor 'pet ownership' for MDRO colonisation in hospital patients.MethodsWe performed a matched case-control study from 2019 to 2022 in Berlin, Germany and compared MDRO-positive and MDRO-negative patients in terms of contact with pets and other risk factors for MDRO acquisition. Patients completed a questionnaire-based interview and provided nasal and rectal swabs. Pet owners provided swab samples from the throat and stool of their pets (dogs and cats). Phenotypically matching samples of owners and pets were analysed via whole genome sequencing.ResultsThe analyses included 2,891 patients. Reported pet ownership was 17.7% in MDRO-positives (154/871) and 23.4% in MDRO-negatives (472/2,020). Among 397 owner-pet pairs, we identified one pair sharing genotypically indistinguishable pathogens (0.3%). A risk factor analysis of pet ownership was performed for carriers of meticillin-resistant Staphylococcus aureus (MRSA) (OR = 0.662; 95% CI: 0.343-1.277), vancomycin-resistant enterococci (VRE) (OR = 0.764; 95% CI: 0.522-1.118) and multidrug-resistant Gram-negative bacteria (MDR-GNB) (OR = 0.819; 95% CI: 0.620-1.082). Colonisation with MDRO was rare in pets, and dogs were more often colonised than cats (MRSA: 0% vs 0%, VRE: 1.5% vs 1.0%, MDR-GNB: 17.2% vs 3.6%).ConclusionTransmission of MDROs between humans and pets is possible though rare. In an urban living space, neither cat nor dog ownership appears as a relevant risk factor for MDRO carriage in hospital patients.

Effect of postpartum pessary use on pelvic floor function: a prospective multicenter study.

PURPOSE: This study evaluates the restitution of pelvic floor function in postpartum women using the Restifem® pessary in a preventive and therapeutic approach. METHODS: In this multicentre study all postpartum women independently of their parity, mode of delivery and existing pelvic floor symptoms were offered to use the Restifem® pessary from 6 weeks postpartum for 3 to 6 months. They completed the validated German pelvic floor questionnaire (GPFQpp) via online survey at 6 weeks, 6 months and 12 months postpartum and were divided, by their own choice, into users and non-users of the pessary. RESULTS: Initially 857 women were enrolled. After 6 weeks 137 pessary users and 133 non-users, after 12 months 53 pessary users and 45 non-users submitted a completed questionnaire. Pessary users had significantly higher (worse) scores in all domains of the GPFQpp at 6 weeks postpartum. At 12 months postpartum pessary users still had a significantly higher bladder score, compared to non-users. There was a greater improvement in the bladder score (p = 0.005) and the pelvic organ prolapse score (p < 0.001) from 6 weeks to 12 months postpartum, among pessary users compared to non-users. CONCLUSION: Pessary users had a significantly greater improvement in pelvic floor function from 6 weeks to 12 months postpartum, compared to non-users. This effect might be in part due to wearing the pessary but also due to greater scope for recovery, given the higher level of pelvic floor dysfunction in the pessary user group. TRIAL REGISTRATION: The trial was registered in the German Clinical Trials Register (DRKS00024733) on 19 of April 2021.

Trauma history and course of therapy in a naturalistic cognitive behavior therapy outpatient sample: An archive data study.

OBJECTIVE: Cognitive Behavior Therapy (CBT) is an effective treatment for anxiety and depression disorders. Nonetheless, nearly 50% of all patients do not respond. Besides other factors, nonresponse may be linked to traumatic life events. This study aims to assess the relationship between trauma history, applied therapy interventions, and therapy outcomes. METHODS: We analyzed data from 340 CBT outpatients diagnosed with a depression or anxiety disorder and possibly a trauma history treated under naturalistic conditions. Based on their therapy files, we collected information on trauma history, diagnoses, applied interventions, and severity of depression and anxiety symptoms at the start and end of therapy. The relationship between trauma, diagnoses, and intervention use and the development of depression and anxiety symptoms was analyzed using Linear Mixed Models. RESULTS: Patients with a trauma history reported higher pre- and posttreatment symptom severity than those without trauma. No differences in applied interventions or decrease in symptom severity were found between patients with and without a trauma history. Specialized interventions were seldom applied. CONCLUSION: Although no differences between patients with and without a trauma history were found in therapy response, patients with a trauma history maintained higher levels of symptom severity. These results indicate a need for more personalized interventions and evidence-based guidelines to personalize CBT for patients with a trauma history and high symptom severity.

Association of ward-level antibiotic consumption with healthcare-associated Clostridioides difficile infections: an ecological study in five German university hospitals, 2017-2019.

OBJECTIVES: To analyse the influence of antibiotic consumption on healthcare-associated healthcare onset (HAHO) Clostridioides difficile infection (CDI) in a German university hospital setting. METHODS: Monthly ward-level antibiotic consumption measured in DDD/100 patient days (pd) and CDI surveillance data from five university hospitals in the period 2017 through 2019 were analysed. Uni- and multivariable analyses were performed with generalized estimating equation models. RESULTS: A total of 225 wards with 7347 surveillance months and 4 036 602 pd participated. With 1184 HAHO-CDI cases, there was a median incidence density of 0.17/1000 pd (IQR 0.03-0.43) across all specialties, with substantial differences among specialties. Haematology-oncology wards showed the highest median incidence density (0.67/1000 pd, IQR 0.44-1.01), followed by medical ICUs (0.45/1000 pd, IQR 0.27-0.73) and medical general wards (0.32/1000 pd, IQR 0.18-0.53). Multivariable analysis revealed carbapenem (mostly meropenem) consumption to be the only antibiotic class associated with increased HAHO-CDI incidence density. Each carbapenem DDD/100 pd administered increased the HAHO-CDI incidence density by 1.3% [incidence rate ratio (IRR) 1.013; 95% CI 1.006-1.019]. Specialty-specific analyses showed this influence only to be valid for haematological-oncological wards. Overall, factors like ward specialty (e.g. haematology-oncology ward IRR 2.961, 95% CI 2.203-3.980) or other CDI cases on ward had a stronger influence on HAHO-CDI incidence density (e.g. community-associated CDI or unknown association case in same month IRR 1.476, 95% CI 1.242-1.755) than antibiotic consumption. CONCLUSIONS: In the German university hospital setting, monthly ward-level carbapenem consumption seems to increase the HAHO-CDI incidence density predominantly on haematological-oncological wards. Furthermore, other patient-specific factors seem to be equally important to control HAHO-CDI.

SAPS2, APACHE2, SOFA, and Core-10-TISS upon admission as risk indicators for ICU-acquired infections: a retrospective cohort study.

PURPOSE: Early identification of high-risk patients is an important component in improving infection prevention. The SAPS2, APACHE2, Core-10-TISS, and SOFA scores are already widely used to estimate mortality, morbidity and nursing workload, but this study evaluated their usefulness in assessing a patient's risk of ICU-acquired infection. METHODS: We conducted a retrospective cohort study by analyzing all patient admissions to seven ICUs at Charité Berlin, Germany in 2017 and 2018. The four scores were documented by physicians on the day of admission. The infection control staff monitored daily whether the patients experienced lower respiratory tract infections (LRTIs), urinary tract infections (UTIs), or primary blood stream infections (PBSIs). For each combination of scoring system and infection type, an adjusted Fine and Gray model was fitted. RESULTS: We analyzed 5053 ICU admissions and observed at least one ICU-acquired infection in N = 253 patients (incidence density: 4.73 per 1000 days). 59.0% (N = 2983) of the patients were male, median age was 66 years (IQR 55-77) and median length of stay was 6 days (IQR 4-12). All models showed that patients with a higher score value were at higher risk for ICU-acquired first PBSI, LRTI, or UTI, except for the model of APACHE2 and PBSI. Patients with a SAPS2 score of > 50 points showed an increased risk of infection of sHR = 2.34 for PBSIs (CI 1.06-5.17, p < 0.05), sHR = 2.33 for LRTIs (1.53-2.55, p < 0.001) and sHR = 2.25 for UTIs (1.23-4.13, p < 0.01) when compared to the reference group with 0-30 points. CONCLUSIONS: The result of this study showed that admission scores of SAPS2, Core-10-TISS, APACHE2, and SOFA might be adequate indicators for assessing a patient's risk of ICU-acquired infection.

Age as a risk factor for surgical site infections: German surveillance data on total hip replacement and total knee replacement procedures 2009 to 2018.

BackgroundOlder age is frequently cited as a risk factor for healthcare-associated infections in general, and surgical site infections (SSIs) specifically.AimWe aimed to investigate the correlation between age and SSI occurrence.MethodsData on total hip replacement (THR) and total knee replacement (TKR) surgeries and resulting SSIs documented in the German national surveillance network from a 10-year period from 2009 to 2018 were selected for analysis. SSI rates and adjusted odds ratios (AOR) were calculated and a multivariable analysis to determine risk factors for SSI occurrence was conducted.ResultsA total of 418,312 THR procedures resulting in 3,231 SSIs, and 286,074 TKR procedures with 1,288 SSIs were included in the analyses. For THR, SSI rates were higher in older age groups when compared with the reference age group of 61-65 years. A significantly higher risk was observed in the 76-80 years age group (AOR: 1.21, 95% CI: 1.05-1.4). An age of ≤ 50 years was associated with a significantly lower SSI risk (AOR: 0.64, 95% CI: 0.52-0.8). For TKR, a similar correlation was observed, with the exception of the youngest age group (≤ 52 years), which was shown to have an SSI risk equal to that of the knee prosthesis reference age group (78-82 years).ConclusionA strong correlation between increasing age and SSI occurrence was observed for both procedure types. The results of our analyses provide a basis to consider future targeted SSI prevention measures for different age groups.

Evaluating compliance and applicability of postpartum pessary use for preventing and treating pelvic floor dysfunction: a prospective multicenter study.

PURPOSE: Pelvic floor disorders are common and associated with pregnancy and childbirth. For restitution of pelvic floor connective tissue and thereby therapy of postpartum pelvic organ prolapse and stress urinary incontinence, the Restifem® pessary is approved. It supports the anterior vaginal wall behind the symphysis, the lateral sulci and the sacro-uterine ligaments and stabilises the connective tissue. We evaluated the compliance and applicability of Restifem® use in women postpartum in a preventive and therapeutic approach. METHODS: Restifem® pessary was handed out to 857 women. Six weeks after birth, they started the pessary use. After 8 weeks, 3 and 6 months postpartum, women received a questionnaire via online survey for evaluation of pessary applicability and efficacy. RESULTS: After 8 weeks, 209 women answered the questionnaire. 119 women used the pessary. Common problems were discomfort, pain and the pessary use was to circuitous. Vaginal infections were rare. After 3 months, 85 women and after 6 months, 38 women still used the pessary. 3 months postpartum, 94% of women with POP, 72% of women with UI and 66% of women with OAB stated to have an improvement of their symptoms using the pessary. 88% women without any disorder felt an improvement of stability. CONCLUSIONS: Use of the Restifem® pessary in the postpartum period is feasible and accompanied with less complications. It reduces POP and UI and leads to an increased sense of stability. So, Restifem® pessary can be offered to women postpartum to improve pelvic floor dysfunction.

Comparable satisfaction and clinical outcomes after surgery for adolescent idiopathic scoliosis in the adult (AISA) between the US and Japan.

BACKGROUND: The impact of ethnicity on the surgery outcomes of adolescent idiopathic scoliosis in the adult (AISA) is poorly understood. This study aimed to compare the surgery outcomes for AISA between the United States (US) and Japan (JP). METHODS: 171 surgically treated AISA (20-40y) were consecutively collected from 2 separate multicenter databases. Patients were propensity-score matched for age, gender, curve type, levels fused, and 2y postop spinal alignment. Demographic and radiographic parameters were compared between the US and JP at baseline and 2y post-op. RESULTS: A total of 108 patients were matched by propensity score (age; US vs. JP: 29 ± 6 vs. 29 ± 7y, females: 76 vs. 76%, curve type [Schwab-SRS TypeT; TypeD; TypeL; TypeN]: 35; 35; 30; 0 vs. 37; 33; 30; 0%)] levels fused: 10 ± 4 vs. 10 ± 4, 2y thoracic curve:17 ± 13 vs. 17 ± 12°, 2y CSVL: 10 ± 8 vs. 11 ± 9 mm). Similar clinical improvement was achieved between US and JP (function; 4.2 ± 0.9 vs 4.3 ± 0.6, p = 0.60, pain; 3.8 ± 0.9 vs 4.1 ± 0.8, p = 0.13, satisfaction; 4.3 ± 0.9 vs 4.2 ± 0.7, p = 0.61, total; 4.0 ± 0.8 vs 4.1 ± 0.5, p = 0.60). The correlation analyzes indicated that postoperative SRS-22 subdomains correlated differently with satisfaction (all subdomains moderately correlated with satisfaction in the US while only pain and mental health correlated moderately with satisfaction in JP ([function: r = 0.61 vs 0.29, pain: r = . 72 vs 0.54, self-image: r = 0.72 vs 0.37, mental health: r = 0.64 vs 0.55]). CONCLUSIONS: Surgery for AISA was similarly effective in the US and JP. Satisfaction for spinal surgery among patients in different countries may not be different unless the procedure limits an individual's unique lifestyle that the patient expected to resume.

Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction.

BACKGROUND: Restorative neurostimulation is a rehabilitative treatment for patients with refractory chronic low back pain (CLBP) associated with dysfunction of the lumbar multifidus muscle resulting in impaired neuromuscular control. The ReActiv8-B randomized, sham-controlled trial provided evidence of the effectiveness and safety of an implanted, restorative neurostimulator. The two-year analysis previously published in this journal demonstrated accrual of clinical benefits and long-term durability. OBJECTIVE: Evaluation of three-year effectiveness and safety in patients with refractory, disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. MATERIALS AND METHODS: Prospective, observational follow-up of the 204 implanted trial participants. Low back pain visual analog scale (VAS), Oswestry Disability Index (ODI), EuroQol quality of life survey, and opioid intake were assessed at baseline, six months, and one, two, and three years after activation. The mixed-effects model repeated measures approach was used to provide implicit imputations of missing data for continuous outcomes and multiple imputation for proportion estimates. RESULTS: Data were collected from 133 participants, and 16 patients missed their three-year follow-up because of coronavirus disease restrictions but remain available for future follow-up. A total of 62% of participants had a ≥ 70% VAS reduction, and 67% reported CLBP resolution (VAS ≤ 2.5cm); 63% had a reduction in ODI of ≥ 20 points; 83% had improvements of ≥ 50% in VAS and/or ≥ 20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 71% (36/51) participants on opioids at baseline had voluntarily discontinued (49%) or reduced (22%) opioid intake. The attenuation of effectiveness in the imputed (N = 204) analyses was relatively small and did not affect the statistical significance and clinical relevance of these results. The safety profile remains favorable, and no lead migrations have been observed to date. CONCLUSION: At three years, 83% of participants experienced clinically substantial improvements in pain, disability, or both. The results confirm the long-term effectiveness, durability, and safety of restorative neurostimulation in patients with disabling CLBP associated with multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT02577354.

Corticosteroids as risk factor for COVID-19-associated pulmonary aspergillosis in intensive care patients.

PURPOSE: Corticosteroids, in particular dexamethasone, are one of the primary treatment options for critically ill COVID-19 patients. However, there are a growing number of cases that involve COVID-19-associated pulmonary aspergillosis (CAPA), and it is unclear whether dexamethasone represents a risk factor for CAPA. Our aim was to investigate a possible association of the recommended dexamethasone therapy with a risk of CAPA. METHODS: We performed a study based on a cohort of COVID-19 patients treated in 2020 in our 13 intensive care units at Charité Universitätsmedizin Berlin. We used ECMM/ISHM criteria for the CAPA diagnosis and performed univariate and multivariable analyses of clinical parameters to identify risk factors that could result in a diagnosis of CAPA. RESULTS: Altogether, among the n = 522 intensive care patients analyzed, n = 47 (9%) patients developed CAPA. CAPA patients had a higher simplified acute physiology score (SAPS) (64 vs. 53, p < 0.001) and higher levels of IL-6 (1,005 vs. 461, p < 0.008). They more often had severe acute respiratory distress syndrome (ARDS) (60% vs. 41%, p = 0.024), renal replacement therapy (60% vs. 41%, p = 0.024), and they were more likely to die (64% vs. 48%, p = 0.049). The multivariable analysis showed dexamethasone (OR 3.110, CI95 1.112-8.697) and SAPS (OR 1.063, CI95 1.028-1.098) to be independent risk factors for CAPA. CONCLUSION: In our study, dexamethasone therapy as recommended for COVID-19 was associated with a significant three times increase in the risk of CAPA. TRIAL REGISTRATION: Registration number DRKS00024578, Date of registration March 3rd, 2021.

The impact of lumbar alignment targets on mechanical complications after adult lumbar scoliosis surgery.

PURPOSE: The purpose of this study was to determine the discriminatory ability of age-adjusted alignment offset and the global alignment and proportion (GAP) score parameters to predict postoperative mechanical complications. METHODS: Surgical patients from the Adult Symptomatic Lumbar Scoliosis cohort were reviewed at 2 year follow up. Age-adjusted alignment offsets and GAP parameters were calculated for each patient. A series of nonlinear logistic regression models were fit, and the odds of mechanical complications were calculated. The discriminatory ability of the GAP score, GAP score parameters, and age-adjusted alignment offsets were determined plotting receiver operative characteristic (ROC) with the C statistic (AUC). RESULTS: A total of 165 patients were included. A total of 49 mechanical complications occurred in 41 patients (21 proximal junctional kyphosis and 28 pseudoarthrosis). The GAP score had no discriminatory ability in this cohort. Relative lumbar lordosis 15 degrees greater than ideal lumbar lordosis was associated with greater mechanical complications. A lumbar distribution index of 90% was associated with fewer mechanical complications compared to a lumbar distribution index of 65%. Age-adjusted offset alignment targets had no discriminatory ability to predict mechanical complications. CONCLUSION: Radiographic alignment targets using either age-adjusted alignment target offset or GAP score parameters had minimal ability to predict mechanical complications in isolation. Mechanical complications following adult spinal deformity surgery are complex, and patient factors play a critical role. Clinical trial registeration This study was registered at ClinicalTrials.gov (number NCT00854828) in March 2009.

Berlin survey on obstetric anal sphincter injury (OASI).

PURPOSE: Obstetric anal sphincter injuries (OASIs) complicate about 5% of vaginal births. The risk of anal incontinence is increased. OASI detection rates improve with knowledge and experience. This study describes Berlin's medical care 10 years after starting training focusing on standards set at the German speaking country guideline on third degree tears. METHODS: In 2018, women experiencing OASIs in Berlin's obstetric departments were informed about the study, including standardized after-care. Descriptive analysis in respect to anal sphincter function and risk factor analysis was performed. RESULTS: 207 OASIs occurred in Berlin. 189 women participated. In 148 cases guideline according terminology was applied (n = 57 IIIa, n = 58 IIIb, n = 23 IIIc, n = 10 IV). Minor tears predominated. Minor and major tears differed in respect to birthweight (p = 0.047). N = 75 reported no sphincter function affection. Macrosomia compromised sphincter function (p = 0.008). Univariate analysis showed age (p < 0.001), male infants (p = 0.017) and higher parity (p = 0.013) to be risk factors. Symptomatic women had weaker pelvic floor muscle (p = 0.009) and suffered from urinary incontinence (p < 0.001). Multiple regression analysis showed an association of St. Mark's Scores ≥ 5 with parity (CI 0.191-0.847, p = 0.016) and ≥ 10 with maternal age (CI 1.077-1.396, p = 0.002) and for urinary incontinence with birthweight (CI 1.000-1.002, p = 0.032 and St. Mark's categories ((0-4, 5-9, > 10) CI 2.657-10.904, p = 0.005)). CONCLUSION: Overall, Berlin's medical care of OASI is based on guideline standards. Anal and urinary incontinence correlate. Parity and higher age are risk factors in developing severe anal symptoms.

The impact of non-antimicrobial drug agents on the acquisition of ESBL-producing Enterobacterales in non-critical care wards in a German university hospital: an exploratory, matched case-control study.

OBJECTIVES: To investigate therapeutical drugs other than antimicrobials as risk factors for the acquisition of ESBL-producing Enterobacterales (ESBL-E). METHODS: This matched case-control study is based on rectal surveillance screening data obtained during a larger trial between 2014 and 2016 upon patients' admission and at least once before discharge in eight non-ICU wards. Patients with ward-acquired ESBL-E (cases) were matched 1:1 to non-ESBL-E carriers (controls) based on ward, number of screening samples, days at risk and Charlson comorbidity index (CCI). Daily medication data were documented according to the Anatomical Therapeutic Chemical classification system. Multivariable conditional logistic regression models were used to calculate risk factors for ESBL-E acquisition. RESULTS: Of the 232 cases and 232 controls analysed, baseline characteristics such as gender (male 56.9%), median age (65 years old, IQR 52-74), number of screening samples (N = 3, IQR 2-4), days to first sample (2, IQR 1-2), days at risk (8, IQR 6-11) and CCI (4, IQR 2-6) were similar. Multivariable analysis showed that glucocorticoids, opium alkaloids and selective ß-2-adrenoreceptor agonists increased the chance to detect ESBL-E (OR 1.07, 95% CI 1.001-1.13, P = 0.047; OR 1.06, 95% CI 1.007-1.12, P = 0.027; and OR 1.31, 95% CI 1.105-1.55, P = 0.001, respectively), while antihistamines decreased it (OR 0.61, 95% CI 0.39-0.97, P = 0.034). In a sensitivity analysis, including drugs prescribed to at least 50 patients, proton pump inhibitors remained as risk factors (OR 1.049, 95% CI 1.001-1.100, P = 0.047). CONCLUSIONS: In a non-ICU setting, drugs other than antimicrobials were determined as potential independent risk factors for ESBL-E acquisition.

Epidemiology and infection control of carbapenem resistant Acinetobacter baumannii and Klebsiella pneumoniae at a German university hospital: a retrospective study of 5 years (2015-2019).

BACKGROUND: Carbapenem resistant (CR) Klebsiella pneumoniae (Kp) and Acinetobacter baumannii (Ab) are emerging multidrug resistant bacteria with very limited treatment options in case of infection. Both are well-known causes of nosocomial infections and outbreaks in healthcare facilities. METHODS: A retrospective study was conducted to investigate the epidemiology of inpatients with CR Kp and CR Ab in a 1500-bed German university hospital from 2015 to 2019. We present our infection control concept including a weekly microbiologic screening for patients who shared the ward with a CR Kp or CR Ab index patient. RESULTS: Within 5 years, 141 CR Kp and 60 CR Ab cases were hospitalized corresponding to 118 unique patients (74 patients with CR Kp, 39 patients with CR Ab and 5 patients with both CR Ab and CR Kp). The mean incidence was 0.045 (CR Kp) and 0.019 (CR Ab) per 100 inpatient cases, respectively. Nosocomial acquisition occurred in 53 cases (37.6%) of the CR Kp group and in 12 cases (20.0%) of the CR Ab group. Clinical infection occurred in 24 cases (17.0%) of the CR Kp group and in 21 cases (35.0%) of the CR Ab group. 14 cases (9.9%) of the CR Kp group and 29 cases (48.3%) of the CR Ab group had a history of a hospital stay abroad within 12 months prior to admission to our hospital. The weekly microbiologic screening revealed 4 CR Kp cases caused by nosocomial transmission that would have been missed without repetitive screening. CONCLUSIONS: CR Kp and CR Ab cases occurred infrequently. A history of a hospital stay abroad, particularly in the CR Ab group, warrants pre-emptive infection control measures. The weekly microbiologic screening needs further evaluation in terms of its efficiency.