Abstract Background Frailty syndrome is highly prevalent among elderly surgical patients, increasing their risk of experiencing perioperative complications and developing long-term disability. Prehabilitation may reduce these risks by optimising patients’ physiological reserves prior to surgery. The PRAEP-GO trial, a multicentre randomised controlled outcome assessor-blinded trial conducted in Germany, evaluated the (cost-)effectiveness of prehabilitation for older (pre-)frail patients undergoing elective surgery compared to standard care. Methods The economic evaluation comprised (i) a cost-utility analysis with the quality-adjusted life year (QALY) as the outcome and (ii) a cost-effectiveness analysis. The latter used the change in level of care dependency from baseline to 12 months postoperatively (deterioration versus no deterioration) as the primary effect measure and the WHO Disability Assessment Schedule (WHODAS 2.0) at 12 months as secondary effect measure. We calculated incremental cost-effectiveness ratios (ICERs) and determined the probability of cost-effectiveness at arbitrary willingness-to-pay thresholds. The main analysis was an intention-to-treat analysis. Additionally, we performed complete case, per-protocol and sensitivity analyses as well as subgroup analyses. Results The cost-utility analysis yielded an ICER of 45,547 EUR per QALY gained, indicating a 52% probability of cost-effectiveness at a willingness-to-pay of 50,000 EUR. The cost-effectiveness analysis yielded an ICER of 27,197 EUR per patient with a deterioration in care dependency level prevented, with a 69% probability of being cost-effective at 50,000 EUR. Regarding the QALY, the probabilities were higher in the per-protocol analyses, which included patients who received at least 15 sessions of prehabilitation and those who additionally underwent the planned surgery. The cost-effectiveness analysis based on the WHODAS 2.0 yielded an ICER of 1,241 EUR per point gained. Subgroup analyses revealed that the intervention is cost-effective for patients who received prehabilitation in an outpatient setting compared to a propensity-score matched control. Conclusions The intervention was found to be more effective, but also more costly than standard preoperative care. Cost-utility was higher when the intervention was completed as intended. It may be cost-effective in patients who received prehabilitation in an outpatient setting. Future efforts should therefore prioritise optimising adherence and ensuring effective outpatient delivery. Trial registration Economic evaluation: OSF Registries (osf.io/ecm74), PRAEP-GO trial: ClinicalTrials.gov (NCT04418271).

Patients with frailty syndrome have limited functional resources and an increased risk of postoperative complications. Prehabilitation may reduce adverse events and improve postoperative recovery. This study aimed to investigate the facilitators and barriers to participation in prehabilitation prior to elective surgery from the perspective of elderly (pre-)frail patients. This qualitative study was nested within the PRAEP-GO trial, a multicentre randomised controlled trial currently investigating the (cost-)effectiveness of multimodal prehabilitation for elderly (pre-)frail patients in Germany. From February to April 2023, semi-structured face-to-face interviews were conducted with patients allocated to the intervention group of the PRAEP-GO trial. After verbatim transcription of the interviews, data were analysed using content-structuring qualitative content analysis. Results were synthesised using the capability, opportunity, motivation and behaviour (COM-B) model. Eight patients with a mean age of 78.5 ± 3 years were interviewed in their homes. All interviewees had an indication for an orthopaedic surgery and had participated in the prehabilitation programme offered within the PRAEP-GO trial. In total, 32 facilitators and 25 barriers to participation were identified. These could be assigned to the entire spectrum of the COM-B model. The focus on individual needs, personalised advice from healthcare professionals and a well-organised prehabilitation programme facilitated participation in prehabilitation. Gaps in knowledge, limited physical functioning, (co-)morbidities and an inflexible attitude were identified as barriers. These insights from the elderly (pre-)frail patient’s perspective are an essential addition to the quantitative data generated in prehabilitation trials. The identified facilitators and barriers should be considered in the future implementation of prehabilitation programmes for this population. PRAEP-GO trial: ClinicalTrials.gov (NCT04418271; June 1, 2020), Qualitative study: Open Science Framework Registries (osf.io/xnbqc; February 18, 2023).

Frailty is expressed by a reduction in physical capacity, mobility, muscle strength, and endurance. (Pre-)frailty is present in up to 42% of the older surgical population, with an increased risk for peri- and postoperative complications. Consequently, these patients often suffer from a delayed or limited recovery, loss of autonomy and quality of life, and a decrease in functional and cognitive capacities. Since frailty is modifiable, prehabilitation may improve the physiological reserves of patients and reduce the care dependency 12 months after surgery. Patients ≥ 70 years old scheduled for elective surgery or intervention will be recruited in this multicenter, randomized controlled study, with a target of 1400 participants with an allocation ratio of 1:1. The intervention consists of (1) a shared decision-making process with the patient, relatives, and an interdisciplinary and interprofessional team and (2) a 3-week multimodal, individualized prehabilitation program including exercise therapy, nutritional intervention, mobility or balance training, and psychosocial interventions and medical assessment. The frequency of the supervised prehabilitation is 5 times/week for 3 weeks. The primary endpoint is defined as the level of care dependency 12 months after surgery or intervention. Prehabilitation has been proven to be effective for different populations, including colorectal, transplant, and cardiac surgery patients. In contrast, evidence for prehabilitation in older, frail patients has not been clearly established. To the best of our knowledge, this is currently the largest prehabilitation study on older people with frailty undergoing general elective surgery. ClinicalTrials.gov NCT04418271 . Registered on 5 June 2020. Universal Trial Number (UTN): U1111-1253-4820

Ältere Menschen, die sich operieren lassen müssen, sind besonders gefährdet, von diesem Eingriff nicht zu profitieren. Komplikationen während und nach der Operation, längere Liegezeiten und eine damit einhergehende eingeschränkte Rehabilitationsfähigkeit führen zu einem Verlust an Selbstständigkeit und Lebensqualität. Eine Prähabilitation vor der Operation kann diesem Verlauf entgegenwirken.

Older people demonstrate a higher risk for the occurrence of peri- and postsurgical complications. A frequent risk factor for this is the prevalence of a status called "frailty ". In general, this status can be reversed by adequate therapeutic and medical interventions. More, current evidence suggests that these measures, as part of a so-called prehabilitation, can reduce the risk for experiencing peri- and postsurgical complications and thus assist the rehabilitation process, increase quality of life, and avoid care dependency and a loss of autonomy of these patients. In this article, we describe the concept of prehabilitation, its options to adapt and design this new form of intervention, as well as presenting current evidence. An actual project and a case example on prehabilitation provide an example and outlook.

In den letzten Jahren ist das Frailty-Syndrom (Gebrechlichkeits-Syndrom) zunehmend in den Fokus des perioperativen Settings gerückt und aus dem Kontext der Altersmedizin herausgewachsen. Die Prävalenz bei operativen Patienten liegt bei bis zu 50%. Perioperativ haben diese Patienten eine deutlich erhöhte Morbidität und Mortalität und sind postoperativ häufiger von Immobilität, einer Erhöhung des Pflegegrades und langfristigen kognitiven Störungen betroffen.

Older people demonstrate a higher risk for the occurrence of peri- and postsurgical complications. A frequent risk factor for this is the prevalence of a status called "frailty ". In general, this status can be reversed by adequate therapeutic and medical interventions. More, current evidence suggests that these measures, as part of a so-called prehabilitation, can reduce the risk for experiencing peri- and postsurgical complications and thus assist the rehabilitation process, increase quality of life, and avoid care dependency and a loss of autonomy of these patients. In this article, we describe the concept of prehabilitation, its options to adapt and design this new form of intervention, as well as presenting current evidence. An actual project and a case example on prehabilitation provide an example and outlook.

Abstract Background A peripheral venous catheter (PVC) is the most widely used device for obtaining vascular access, allowing the administration of fluids and medication. Up to 25% of adult patients, and 50% of pediatric patients experience a first-attempt cannulation failure. In addition to patient and clinician characteristics, device features might affect the handling and success rates. The objective of the study was to compare the first-attempt cannulation success rate between PVCs with wings and a port access (Vasofix® Safety, B. Braun, abbreviated hereon in as VS) with those without (Introcan® Safety, B. Braun, abbreviated hereon in as IS) in an anesthesiological cohort. Methods An open label, multi-center, randomized trial was performed. First-attempt cannulation success rates were examined, along with relevant patient, clinician, and device characteristics with univariate and multivariate analyses. Information on handling and adherence to use instructions was gathered, and available catheters were assessed for damage. Results Two thousand three hundred four patients were included in the intention to treat analysis. First-attempt success rate was significantly higher with winged and ported catheters (VS) than with the non-winged, non-ported design (IS) (87.5% with VS vs. 78.2% with IS; P Chi < .001). Operators rated the handling of VS as superior (rating of “good” or “very good: 86.1% VS vs. 20.8% IS, P Chi < .001). Reinsertion of the needle into the catheter after partial withdrawal—prior or during the catheterization attempt—was associated with an increased risk of cannulation failure (7.909, CI 5.989–10.443, P < .001 and 23.023, CI 10.372–51.105, P < .001, respectively) and a twofold risk of catheter damage (OR 1.999, CI 1.347–2.967, P = .001). Conclusions First-attempt cannulation success of peripheral, ported, winged catheters was higher compared to non-ported, non-winged devices. The handling of the winged and ported design was better rated by the clinicians. Needle reinsertions are related to an increase in rates of catheter damage and cannulation failure. Trial registration ClinicalTrials.gov, Identifier: NCT02213965 , Date: 12/08/2014.

In den letzten Jahren ist das Frailty-Syndrom (Gebrechlichkeits-Syndrom) zunehmend in den Fokus des perioperativen Settings geruckt und aus dem Kontext der Altersmedizin herausgewachsen. Die Pravalenz bei operativen Patienten liegt bei bis zu 50%. Perioperativ haben diese Patienten eine deutlich erhohte Morbiditat und Mortalitat und sind postoperativ haufiger von Immobilitat, einer Erhohung des Pflegegrades und langfristigen kognitiven Storungen betroffen.

In Europe, intravenous fosfomycin (IV) is used particularly in difficult-to-treat or complex infections, caused by both Gram-positive and Gram-negative pathogens including multidrug-resistant strains. Here, we investigated the efficacy and safety of intravenous fosfomycin under real-life conditions. Prospective, multi-center, and non-interventional study in patients with bacterial infections from 20 intensive care units (ICU) in Germany and Austria (NCT01173575). Overall, 209 patients were included (77 females, 132 males, mean age: 59 ± 16 years), 194 of which were treated in intensive care (APACHE II score at the beginning of fosfomycin therapy: 23 ± 8). Main indications (± bacteremia or sepsis) were infections of the CNS (21.5%), community- (CAP) and hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP, 15.3%), bone and joint infections (BJI, 11%), abdominal infections (11%), and bacteremia (10.5%). Most frequently identified pathogens were S. aureus (22.3%), S. epidermidis (14.2%), Enterococcus spp. (10.8%), E. coli (12.3%) and Klebsiella spp. (7.7%). At least one multidrug-resistant (MDR) pathogen was isolated from 51 patients (24.4%). Fosfomycin was administered with an average daily dose of 13.7 ± 3.5 g over 12.4 ± 8.6 days, almost exclusively (99%) in combination with other antibiotics. The overall clinical success was favorable in 81.3% (148/182) of cases, and in 84.8% (39/46) of patients with ≥ 1 MDR pathogen. Noteworthy, 16.3% (34/209) of patients developed at least one, in the majority of cases non-serious, adverse drug reaction during fosfomycin therapy. Our data suggest that IV fosfomycin is an effective and safe combination partner for the treatment of a broad spectrum of severe bacterial infections in critically ill patients.

BACKGROUNDApixaban is a direct oral anticoagulant (DOAC) with a specific inhibition of activated factor X (FXa). In case of bleeding or need of urgent surgery a direct antidote is not yet available. Off-label application of non-specific haemostatic agents, such as prothrombin complex concentrate (PCC) and recombinant FVIIa (rFVIIa), has been reported to reverse the effects of apixaban in in vitro and animal studies. The aim of this study is to measure the reversal potential of PCC and rFVIIa in patients with prophylactic apixaban concentrations.MATERIAL AND METHODSWhole blood from patients under prophylactic therapy with apixaban was spiked with two doses of PCC or rFVIIa. Thromboelastometry (ROTEM®), prothrombin time (PT), and activated partial prothrombin time (aPTT) were performed.RESULTSProlongations in PT and aPTT were corrected by the different concentrates with variable efficacies (PCC<rFVIIa) for all time points after medication. Compared with baseline, the reversal effects ranged from partial correction (PCC) to overcorrection of the CT-ExTEM, PT and aPTT by rFVIIa.DISCUSSIONPCC partially reverses the effect of apixaban as measured by point-of-care coagulation testing and standard coagulation tests. Only rFVIIa reliably reverses apixaban anticoagulation.

Apixaban has been recently permitted for medication and the clinics lack an antidote for overturning the drug's effect. We present the first report of the safe dose management of Apixaban in the risk of bleeding connected with the specific agent in replacement surgery. For this study, an unprecedented technique of "Quartz Crystal Microbalance with Dissipation" (QCM-D) has been utilized, while the QCM-D-assays of "activated Partial Thromboplastin Time" (aPTT) and "Thrombin Time" (TT) have been evaluated in parallel with the standard assays. Here, the acoustic signals are substantial for an evaluation of visco-elasticity of the clot, while the "clinical standard" does not yield important information related to the anticoagulant. The two equipment have been subjected to 370 samples, including 220 plasma specimens of patients under medication with Apixaban (during knee or hip replacement surgery). In testing, the coagulation times of the QCM-D-assays demonstrated an attractive co-relation with those of the standard assays within analytical limits of deviations. Conclusively, the QCM-D-aPTT is the "standard assay" for a dosage management of Apixaban, where the (frequency shifts / dissipation shifts) Delta f/Delta Gamma ratio of the QCM-D-assay reveals that Apixiban with FVII 90 combination could offer a secure medication to control Apixaban-induced bleeding in clinics.

The study focuses the dose administration of dabigatran to avoid the deaths due to hemorrhagic complications and thromboembolic stroke in clinics worldwide. To target the issue, a novel emerging acoustic technology, namely ''Quartz Crystal Microbalance with Dissipation'' (QCM-D) has been applied, while the acoustic assays namely ''activated Partial Thromboplastin Time'' (aPTT) and ''Prothrombinase complex-induced Clotting Test'' (PiCT) have been compared with the standard methods in parallel. Both techniques have been applied to 300 samples, including 220 plasma samples of patients suffering coagulation disorders and 80 plasma samples of non-patients. In comparison, the coagulation times of the acoustic aPTT and PiCT yielded an excellent correlation with the standard methods with in analytical standard deviation limits. Finally, the acoustic aPTT assay is the ''gold standard'' for a dose administration of the new oral anticoagulant, where the Δf/ΔΓ ratio of the acoustic assay demonstrates that dabigatran with FEIBA 50 combination could be a safe remedy to avoid the deaths in clinics.

BACKGROUND:One-third of injured patients treated in the emergency department (ED) have an alcohol use disorder (AUD). Few are screened and receive counseling because ED staff have little time for additional tasks. We hypothesized that computer technology can screen and provide an intervention that reduces at-risk drinking (British Medical Association criteria) in injured ED patients. METHODS:In all, 3,026 subcritically injured patients admitted to an ED were screened for an AUD using a laptop computer that administered the AUD Identification Test (AUDIT) and assessed motivation to reduce drinking. Patients with a positive AUDIT (n = 1,139) were randomized to an intervention (n = 563) or control (n = 576) condition. The computer generated a customized printout based on the patient's own alcohol use pattern, level of motivation, and personal factors, which was provided in the form of feedback and advice. RESULTS:Most patients (85%) used the computer with minimal assistance. At study entry, a similar proportion in each group met criteria for at-risk drinking (49.6% versus 46.8%, p = 0.355). At 6 months, 21.7% of intervention and 30.4% of control patients met criteria for at-risk drinking (p = 0.008). Intervention patients also had a 35.7% decrease in alcohol intake, compared with a 20.5% decrease in controls (p = 0.006). At 12 months, alcohol intake decreased by 22.8% in the intervention group versus 10.9% in controls (p = 0.023), but the proportion of at-risk drinkers did not significantly differ (37.3% versus 42.6%, p = 0.168). CONCLUSIONS:The computer-generated intervention was associated with a significant decrease in alcohol use and at-risk drinking. Research is needed to further evaluate and adapt information technology to provide preventive clinical services in the ED.