Image Guided Intraoperative Radiation Therapy After Surgical Resection of Brain Metastases: A First In-Human Feasibility Report.

Purpose: A correct placement of the applicator during intraoperative radiation therapy for brain metastasis is of paramount importance, to deliver a precise and safe treatment. The applicator-to-surface contact assessment cannot be performed under direct observation because the applicator itself limits the visual range. No image guided verification is currently performed intracranially. We hypothesize that image guided intraoperative radiation therapy would assure a more precise delivery in the target area. We describe our workflow in a first in-human experience. Methods and Materials: Phantom-based measurements were performed to reach the best cone beam computed tomography imaging quality possible. Once defined, a clinical feasibility study was initiated. An in-room cone beam computed tomography device is used to acquire intraoperative images after placing the applicator. Repositioning the applicator is thereafter discussed with the surgeon, according to the imaging outcomes, if required. Results: An optimal image quality was achieved with 120-kV voltage, 20-mA current, and a tube current time product of 150 mAs. An additional 0.51 mSv patient exposure was calculated for the entire procedure. The wide dynamic range (-600 HU to +600 HU) of cone beam computed tomography and a 27 HU mean computed tomography values difference between brain tissue and spherical applicator allows distinguishing both structures. In this first in-human experience, the applicator was repositioned after evidencing air gaps, assuring full applicator-to-surface contact. Conclusions: This first in-human procedure confirmed the feasibility of kilovoltage image guided intraoperative radiation therapy in a neurosurgical setting. A prospective study has been initiated and will provide further dosimetric details.

Easy-to-implement educational interventions to bring climate-smart actions to daily anesthesiologic practice: a cross-sectional before and after study.

BACKGROUND: Anesthesia contributes significantly to a hospital's carbon footprint. Climate-smart actions have the potential to reduce greenhouse gas emissions. Prerequisites for sustainable behavior of providers are knowledge and awareness. We aimed to assess the change in anesthesiologists' climate-friendly behavior before and after educational interventions in three areas that every anesthesiologist can address in their daily clinical routine: 1) energy use; 2) recycling opportunities; 3) consumption of volatile anesthetics. METHODS: We performed a cross-sectional before-and-after single center sub-study within the multicenter "Provider Education and Evaluation Project" at the Department of Anesthesiology, RWTH Aachen University hospital from May3 2021 to May 1 2022. Educational interventions consisted of stickers, posters and a presentation on climate-smart actions in anesthesiologists' work routine between the first and the second assessment. For each cross-sectional assessment, all central 28 ORs were observed for one week. During the before-and-after comparison we analyzed: 1) energy wasted in unoccupied ORs because of running computers and turned-on lights at 9 p.m.; 2) feasibility of recycling preoperative anesthesia plastic packaging by determining the difference between calculated weight of unseparated preoperative plastic waste in the first assessment and the weight of actual separated waste in the second assessment; 3) fresh gas flow in balanced anesthesia cases in steady state at 9 a.m., and purchased hypnotics converted to bottles/1000 general anesthesia cases in 2018-2022. RESULTS: We observed a reduction of wasted energy by 44% in unoccupied ORs. Usage of low fresh gas flow settings increased from 55% to 75%. The average of purchased desflurane in 2018-2020 decreased by 72% in 2022. We calculated 10.33 kg of preoperative plastic waste per week but were unable to implement waste separation for infrastructural and logistical reasons. CONCLUSIONS: We found that environment-friendly working behaviors increased after the implementation of educational interventions. The causality between the interventions and the observed improvements remains to be proven.

The association between frailty and ageing: Results from an observational study including 9497 elderly patients.

BACKGROUND: Elderly surgical patients have a high risk of postoperative complications. However, patients exhibit considerable diversity in health and functional status; thus, identifying the fragile may be necessary when selecting surgical candidates. We aimed to compare the prevalence of frailty in patients ≥90 years with patients aged 80-89. Second, we assessed the association between frailty and all-cause 30-day mortality. METHODS: We performed a planned secondary analysis of the peri-interventional outcome study in the elderly (POSE), including 9497 patients (≥80 years) undergoing any surgical and nonsurgical procedures in 177 European centres from October 2017 to December 2018. The primary outcome assessment included frailty as a binary variable, and data were analysed using Fisher's exact test/Chi-squared test. The association between frailty and all-cause 30-day mortality was analysed using a multivariate logistic regression model adjusted for age, sex, surgical urgency, orthopaedic urgency, and surgical severity. RESULTS: In total, 999 of 9497 (10.5%) patients were 90 years or above. Among patients ≥90 years, 274 (27.4%) were frail compared to 1062 (12.5%) of patients aged 80-89 (odds ratio (OR): 2.6; 95% CI 2.3-3.1). Frailty was associated with increased 30-day mortality in both the unadjusted (crude OR 6.3; 5.1-7.7) and adjusted analysis (OR 4.5; 3.6-5.7). In the adjusted analysis, age ≥90 was not associated with 30-day mortality. CONCLUSION: We found a high frequency of frailty in patients aged 90 years or above compared with patients aged 80-89. In addition, frailty was associated with an increased risk of 30-day mortality. Surprisingly, age was not a significant risk factor in the adjusted mortality analysis.

Preoperative Midazolam and Patient-Centered Outcomes of Older Patients: The I-PROMOTE Randomized Clinical Trial.

Importance: The effect of oral midazolam premedication on patient satisfaction in older patients undergoing surgery is unclear, despite its widespread use. Objective: To determine the differences in global perioperative satisfaction in patients with preoperative administration of oral midazolam compared with placebo. Design, Setting, and Participants: This double-blind, parallel-group, placebo-controlled randomized clinical trial was conducted in 9 German hospitals between October 2017 and May 2019 (last follow-up, June 24, 2019). Eligible patients aged 65 to 80 years who were scheduled for elective inpatient surgery for at least 30 minutes under general anesthesia and with planned extubation were enrolled. Data were analyzed from November 2019 to December 2020. Interventions: Patients were randomized to receive oral midazolam, 3.75 mg (n = 309), or placebo (n = 307) 30 to 45 minutes prior to anesthesia induction. Main Outcomes and Measures: The primary outcome was global patient satisfaction evaluated using the self-reported Evaluation du Vécu de l'Anesthésie Generale (EVAN-G) questionnaire on the first postoperative day. Key secondary outcomes included sensitivity and subgroup analyses of the primary outcome, perioperative patient vital data, adverse events, serious complications, and cognitive and functional recovery up to 30 days postoperatively. Results: Among 616 randomized patients, 607 were included in the primary analysis. Of these, 377 (62.1%) were male, and the mean (SD) age was 71.9 (4.4) years. The mean (SD) global index of patient satisfaction did not differ between the midazolam and placebo groups (69.5 [10.7] vs 69.6 [10.8], respectively; mean difference, -0.2; 95% CI, -1.9 to 1.6; P = .85). Sensitivity (per-protocol population, multiple imputation) and subgroup analyses (anxiety, frailty, sex, and previous surgical experience) did not alter the primary results. Secondary outcomes did not differ, except for a higher proportion of patients with hypertension (systolic blood pressure ≥160 mm Hg) at anesthesia induction in the placebo group. Conclusion and Relevance: A single low dose of oral midazolam premedication did not alter the global perioperative patient satisfaction of older patients undergoing surgery or that of patients with anxiety. These results may be affected by the low dose of oral midazolam. Further trials-including a wider population with commonplace low-dose intravenous midazolam and plasma level measurements-are needed. Trial Registration: ClinicalTrials.gov Identifier: NCT03052660.

Pre-Interventional Risk Assessment in The Elderly (PIRATE): Development of a scoring system to predict 30-day mortality using data of the Peri-Interventional Outcome Study in the Elderly.

Risk assessment before interventions in elderly patients becomes more and more vital due to an increasing number of elderly patients requiring surgery. Existing risk scores are often not tailored to marginalized groups such as patients aged 80 years or older. We aimed to develop an easy-to-use and readily applicable risk assessment tool that implements pre-interventional predictors of 30-day mortality in elderly patients (≥80 years) undergoing interventions under anesthesia. Using Cox regression analysis, we compared different sets of predictors by taking into account their ease of availability and by evaluating predictive accuracy. Coefficient estimates were utilized to set up a scoring system that was internally validated. Model building and evaluation were based on data from the Peri-Interventional Outcome Study in the Elderly (POSE), which was conducted as a European multicenter, observational prospective cohort study. Our risk assessment tool, named PIRATE, contains three predictors assessable at admission (urgency, severity and living conditions). Discriminatory power, as measured by the concordance index, was 0.75. The estimated prediction error, as measured by the Brier score, was 0.036 (covariate-free reference model: 0.043). PIRATE is an easy-to-use risk assessment tool that helps stratifying elderly patients undergoing interventions with anesthesia at increased risk of mortality. PIRATE is readily available and applies to a wide variety of settings. In particular, it covers patients needing elective or emergency surgery and undergoing in-hospital or day-case surgery. Also, it applies to all types of interventions, from minor to major. It may serve as a basis for multidisciplinary and informed shared decision-making.

Poor reporting quality of randomized controlled trials comparing treatments of COVID-19-A retrospective cross-sectional study on the first year of publications.

INTRODUCTION: Transparent and complete reporting of randomized controlled trials (RCTs) is essential for critical scientific appraisal of the results. It has been argued whether publications during the COVID-19 pandemic have met reporting standards. In this study, we assessed reporting adherence of RCTs on treatment interventions in COVID-19 patients to the CONSORT checklist and discuss which lessons can be learned to improve reporting in the future. METHODS: This was a retrospective, cross-sectional study performed at the University Hospital RWTH Aachen, Germany. We conducted a pragmatic systematic literature search in the PubMed database to identify RCTs on treatment interventions in COVID-19 patients in the first year of publications on the topic (March 2020-February 2021). We investigated the adherence of each publication to the CONSORT checklist and assessed the association between specific predictors and percentage adherence in an exploratory multivariable regression model. RESULTS: We analyzed 127 RCTs and found that the median percentage adherence to the CONSORT checklist was 54.3% [IQR 38.9 to 65.7]. In the exploratory multivariable regression model, the impact factor (highest tertile of impact factor compared to lowest tertile ß = 21.77, 95% CI 13.89 to 29.66, p<0.001; middle tertile compared lowest tertile ß = 11.79, 95% CI 5.74 to 17.84, p<0.001)) and authors' referral to the CONSORT statement (ß = 9.29, 95% CI 2.98 to 15.60, p = 0.004) were associated with a higher percentage adherence to the CONSORT checklist. CONCLUSION: The reporting quality of RCTs on treatment interventions in COVID-19 patients during the first year of publications was poor. Measures to improve reporting quality are urgently needed.

Telemedical support for prehospital emergency medical service in severe emergencies: an open-label randomised non-inferiority clinical trial.

BACKGROUND: A tele-emergency medical service with a remote emergency physician for severe prehospital emergencies may overcome the increasing number of emergency calls and shortage of emergency medical service providers. We analysed whether routine use of a tele-emergency medical service is non-inferior to a conventional physician-based one in the occurrence of intervention-related adverse events. METHODS: This open-label, randomised, controlled, parallel-group, non-inferiority trial included all routine severe emergency patients aged ≥ 18 years within the ground-based ambulance service of Aachen, Germany. Patients were randomised in a 1:1 allocation ratio to receive either tele-emergency medical service (n = 1764) or conventional physician-based emergency medical service (n = 1767). The primary outcome was the occurrence of intervention-related adverse events with suspected causality to the group assignment. The trial was registered with ClinicalTrials.gov (NCT02617875) on 30 November 2015 and is reported in accordance with the CONSORT statement for non-inferiority trials. RESULTS: Among 3531 randomised patients, 3220 were included in the primary analysis (mean age, 61.3 years; 53.8% female); 1676 were randomised to the conventional physician-based emergency medical service (control) group and 1544 to the tele-emergency medical service group. A physician was not deemed necessary in 108 of 1676 cases (6.4%) and 893 of 1544 cases (57.8%) in the control and tele-emergency medical service groups, respectively. The primary endpoint occurred only once in the tele-emergency medical service group. The Newcombe hybrid score method confirmed the non-inferiority of the tele-emergency medical service, as the non-inferiority margin of - 0.015 was not covered by the 97.5% confidence interval of - 0.0046 to 0.0025. CONCLUSIONS: Among severe emergency cases, tele-emergency medical service was non-inferior to conventional physician-based emergency medical service in terms of the occurrence of adverse events.

Pupillary Pain Index Predicts Postoperative Pain but Not the Effect of Peripheral Regional Anaesthesia in Patients Undergoing Total Hip or Total Knee Arthroplasty: An Observational Study.

Background and Objectives: The pupillary pain index (PPI) allows the evaluation of intraoperative nociception by measuring pupillary reaction after a localized electrical stimulus. It was the objective of this observational cohort study to investigate the pupillary pain index (PPI) as a method to evaluate the fascia iliaca block (FIB) or adductor canal block (ACB) sensory areas during general anaesthesia in orthopaedic patients with lower-extremity joint replacement surgery. Materials and Methods: Orthopaedic patients undergoing hip or knee arthroplasty were included. After anaesthesia induction, patients received an ultrasound-guided single-shot FIB or ACB with 30 mL and 20 mL of 0.375% ropivacaine, respectively. Anaesthesia was maintained with isoflurane or propofol/remifentanil. The first PPI measurements were performed after anaesthesia induction and before block insertion, the second at the end of surgery. Pupillometry scores were evaluated in the area of the femoral or saphenous nerve (target) and C3 dermatome (control). Primary outcomes were differences between PPIs before and after peripheral block insertion as well as the relationship between PPIs and postoperative pain scores; secondary outcomes were the relationship between PPIs and opioid requirements after surgery. Results: PPI decreased significantly from the first to the second measurement (4.17 ± 2.7 vs. 1.6 ± 1.2, p < 0.001 for target; 4.46 ± 2.7 vs. 2.17 ± 2.1, p < 0.001 for control). Control and target measurements did not show significant differences. A linear regression analysis showed that early postoperative pain scores could be predicted with intraoperative piritramide with improved prediction after adding PPI scores, PCA opioids and surgery type. Forty-eight-hour pain scores at rest and in movement were correlated with intraoperative piritramide and control PPI after the PNB in movement and with second-postoperative-day opioids and target PPI scores before block insertion, respectively. Conclusions: While the effect of an FIB and ACB could not be shown with PPI postoperative pain scores due to a large effect of opioids, perioperative PPI was shown to be associated with postoperative pain. These results suggest that preoperative PPI may be used to predict postoperative pain.

Relationship between Heart Rate Variability and Postoperative Cognitive Dysfunction in Elderly Patients.

Objectives: Postoperative cognitive dysfunction (POCD) is objectively measurable after anesthesia and surgery. Lower heart rate variability (HRV) is associated with poorer cognitive performance, but the relationship between HRV and POCD remains unclear. Methods: Elderly patients who underwent total hip replacement under general anesthesia from the Department of Bone and Joint Surgery, Affiliated Hospital of Southwest Medical University were enrolled. Neuropsychological tests, standard deviation of the interbeat interval (SDNN, a parameter of HRV), and plasma concentrations of glial cell line-derived neurotrophic factors (GDNF) were performed one day before (T-1) and 7 days after (T7) surgery. Results: POCD occurred in 35% of patients on 7 days after surgery. Lower SDNN(T7) (OR=.91) and longer surgery time (OR=1.33) were associated with POCD. Compared with patients without POCD, there was higher variation SDNN (Δ SDNN) and plasma GDNF (ΔGDNF) in those with POCD from T-1 to T7 period. ΔGDNF is positively correlated with ΔSDNN (r = .61, p<.001). Conclusions: Lower SDNN (T7) was associated with POCD and might be used as a warning indicator for the risk of POCD.

Intra-operative blood transfusion in elderly patients on antithrombotic therapy.

BACKGROUND: Many elderly patients are receiving antithrombotics, which may increase intra-operative blood loss. We aimed to assess whether chronic antithrombotic therapy was associated with intra-operative transfusion of packed red blood cells in patients at least 80 years of age undergoing elective procedures. METHODS: We performed a secondary analysis of the prospective, observational European multicentre study entitled POSE (peri-interventional outcome study in the elderly) including 9497 surgical patients aged 80 years and older in 177 centres from October 2017 to December 2018. In this secondary analysis we included POSE patients who underwent elective procedures and with available data on chronic antithrombotic therapy. The primary outcome was intra-operative transfusion of packed red blood cells and results were analysed using multiple logistic regression model. We adjusted for the following predetermined explanatory variables: Age, sex, body mass index, American Society of Anaesthesiologists Physical Status Classification System, baseline haemoglobin concentration, disseminated cancer, and type and severity of surgery. RESULTS: A total of 7174 patients were included of whom 4073 (56.8%) were on antithrombotic therapy. Among patients on antithrombotic therapy 191 (4.7%) received intra-operative blood transfusion compared with 98 (3.2%) of patients not on chronic antithrombotic therapy (crude odds ratio: 1.51, 95% CI 1.18-1.94). Following multiple logistic regression analysis, the adjusted odds ratio was 0.98; 0.73-1.32. We found that chronic antithrombotic therapy was associated with intra-operative transfusion of packed red blood cells in elderly patients undergoing elective procedures in an unadjusted analysis, but not in a multivariate adjusted model.

Connected consciousness after tracheal intubation in young adults: an international multicentre cohort study.

BACKGROUND: Connected consciousness, assessed by response to command, occurs in at least 5% of general anaesthetic procedures and perhaps more often in young people. Our primary objective was to establish the incidence of connected consciousness after tracheal intubation in young people aged 18-40 yr. The secondary objectives were to assess the nature of these responses, identify relevant risk factors, and determine their relationship to postoperative outcomes. METHODS: This was an international, multicentre prospective cohort study using the isolated forearm technique to assess connected consciousness shortly after tracheal intubation. RESULTS: Of 344 enrolled subjects, 338 completed the study (mean age, 30 [standard deviation, 6.3] yr; 232 [69%] female). Responses after intubation occurred in 37/338 subjects (11%). Females (13%, 31/232) responded more often than males (6%, 6/106). In logistic regression, the risk of responsiveness was increased with female sex (odds ratio [ORadjusted]=2.7; 95% confidence interval [CI], 1.1-7.6; P=0.022) and was decreased with continuous anaesthesia before laryngoscopy (ORadjusted=0.43; 95% CI, 0.20-0.96; P=0.041). Responses were more likely to occur after a command to respond (and not to nonsense, 13 subjects) than after a nonsense statement (and not to command, four subjects, P=0.049). CONCLUSIONS: Connected consciousness occured after intubation in 11% of young adults, with females at increased risk. Continuous exposure to anaesthesia between induction of anaesthesia and tracheal intubation should be considered to reduce the incidence of connected consciousness. Further research is required to understand sex-related differences in the risk of connected consciousness.

The effect of warm and humidified gas insufflation in gynecological laparoscopy on maintenance of body temperature: a prospective randomized controlled multi-arm trial.

BACKGROUND: Hypothermia is defined as a decrease in body core temperature to below 36 °C. If intraoperative heat-preserving measures are omitted, a patient's temperature will fall by 1 - 2 °C. Even mild forms of intraoperative hypothermia can lead to a marked increase in morbidity and mortality. Using warm and humidified gas insufflation in laparoscopy may help in the maintenance of intraoperative body temperature. METHODS: In this prospective randomized controlled study, we investigated effects of temperature and humidity of the insufflation gas on intra- and postoperative temperature management. 150 patients undergoing gynecologic laparoscopic surgery were randomly assigned to either insufflation with non-warmed, non-humidified CO2 with forced air warming blanket (AIR), humidified warm gas without forced air warming blanket (HUMI) or humidified warm gas combined with forced air warming blanket (HUMI+). We hypothesized that the use of warmed laparoscopic gas would have benefits in the maintenance of body temperature and reduce the occurrence of hypothermia. RESULTS: The use of warm and humidified gas insufflation alone led to more hypothermia episodes with longer duration and longer recovery times as well as significantly lower core body temperature compared to the other two groups. In the comparison of the AIR group and HUMI + group, HUMI + patients had a significantly higher body temperature at arrival at the PACU (Post Anaesthesia Care Unit), had the least occurrence of hypothermia and suffered from less shivering. CONCLUSION: The use of warm and humidified gas insufflation alone does not sufficiently warm the patients. The optimal temperature management is achieved in the combination of external forced air warming and insufflation of warm and humidified laparoscopy gas.

Intraoperative transfusion practices and perioperative outcome in the European elderly: A secondary analysis of the observational ETPOS study.

The demographic development suggests a dramatic growth in the number of elderly patients undergoing surgery in Europe. Most red blood cell transfusions (RBCT) are administered to older people, but little is known about perioperative transfusion practices in this population. In this secondary analysis of the prospective observational multicentre European Transfusion Practice and Outcome Study (ETPOS), we specifically evaluated intraoperative transfusion practices and the related outcomes of 3149 patients aged 65 years and older. Enrolled patients underwent elective surgery in 123 European hospitals, received at least one RBCT intraoperatively and were followed up for 30 days maximum. The mean haemoglobin value at the beginning of surgery was 108 (21) g/l, 84 (15) g/l before transfusion and 101 (16) g/l at the end of surgery. A median of 2 [1-2] units of RBCT were administered. Mostly, more than one transfusion trigger was present, with physiological triggers being preeminent. We revealed a descriptive association between each intraoperatively administered RBCT and mortality and discharge respectively, within the first 10 postoperative days but not thereafter. In our unadjusted model the hazard ratio (HR) for mortality was 1.11 (95% CI: 1.08-1.15) and the HR for discharge was 0.78 (95% CI: 0.74-0.83). After adjustment for several variables, such as age, preoperative haemoglobin and blood loss, the HR for mortality was 1.10 (95% CI: 1.05-1.15) and HR for discharge was 0.82 (95% CI: 0.78-0.87). Pre-operative anaemia in European elderly surgical patients is undertreated. Various triggers seem to support the decision for RBCT. A closer monitoring of elderly patients receiving intraoperative RBCT for the first 10 postoperative days might be justifiable. Further research on the causal relationship between RBCT and outcomes and on optimal transfusion strategies in the elderly population is warranted. A thorough analysis of different time periods within the first 30 postoperative days is recommended.

Poor reporting quality of observational clinical studies comparing treatments of COVID-19 - a retrospective cross-sectional study.

BACKGROUND: During the COVID-19 pandemic, the scientific world is in urgent need for new evidence on the treatment of COVID patients. The reporting quality is crucial for transparent scientific publication. Concerns of data integrity, methodology and transparency were raised. Here, we assessed the adherence of observational studies comparing treatments of COVID 19 to the STROBE checklist in 2020. METHODS: Design: We performed a retrospective, cross-sectional study. SETTING: We conducted a systematic literature search in the Medline database. This study was performed at the RWTH Aachen University Hospital, Department of Anaesthesiology Participants: We extracted all observational studies on the treatment of COVID-19 patients from the year 2020. MAIN OUTCOME MEASURES: The adherence of each publication to the STROBE checklist items was analysed. The journals' impact factor (IF), the country of origin, the kind of investigated treatment and the month of publication were assessed. RESULTS: We analysed 147 observational studies and found a mean adherence of 45.6% to the STROBE checklist items. The percentage adherence per publication correlated significantly with the journals' IF (point estimate for the difference between 1st and 4th quartile 11.07%, 95% CI 5.12 to 17.02, p < 0.001). U.S. American authors gained significantly higher adherence to the checklist than Chinese authors, mean difference 9.10% (SD 2.85%, p = 0.023). CONCLUSIONS: We conclude a poor reporting quality of observational studies on the treatment of COVID-19 throughout the year 2020. A considerable improvement is mandatory.

Association between benzodiazepine premedication and 30-day mortality rate: A propensity-score weighted analysis of the Peri-interventional Outcome Study in the Elderly (POSE).

BACKGROUND: Recent guidelines suggest that benzodiazepine premedication should be avoided in elderly patients, though with limited supporting evidence. OBJECTIVE: We conducted a secondary analysis of the POSE data to explore the association of premedication in patients aged 80 years or older with 30-day mortality. DESIGN: We used propensity score methods to perform a confounder-adjusted time-to-event analysis of the association between benzodiazepine premedication and 30-day mortality of the POSE study. SETTING: POSE was conducted as a European multicentre prospective cohort study. PATIENTS: Adults aged 80 years or older scheduled for surgical or nonsurgical intervention under anaesthesia. RESULTS: A total of 9497 patients were analysed. One thousand five hundred and twenty-one patients received benzodiazepine premedication, 7936 patients received no benzodiazepine premedication, 30 received clonidine and 10 had missing premedication data. Inverse propensity-score-weighted log-rank analysis did not provide unambiguous evidence for an association between benzodiazepine premedication and 30-day mortality; median [range] P = 0.048 [0.044 to 0.078], estimated 30-day mortality rates 3.21% and 4.45% in benzodiazepine-premedicated and nonbenzodiazepine-premedicated patients, respectively. Inverse propensity-score-weighted Cox regression resulted in a hazard ratio of 0.71 (95% CI 0.49 to 1.04), pointing at a possible reduction of 30-day mortality in the benzodiazepine premedication group. Sensitivity analyses, which constituted subgroup, matched-pairs, and subclassification analyses, resulted in similar findings. CONCLUSION: This secondary analysis of the POSE data did not find evidence for an unambiguous association between benzodiazepine premedication and 30-day mortality. Point estimates indicated a reduction of 30-day mortality in benzodiazepine-premedicated patients. The results presented here might be affected by unmeasured confounding factors, which could be addressed in a randomised trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03152734.

Warm and humidified insufflation gas during gynecologic laparoscopic surgery reduces postoperative pain in predisposed patients-a randomized, controlled multi-arm trial.

BACKGROUND: Postoperative pain remains a common problem in gynecologic laparoscopy, especially in head zone-related regions, triggered by intra-abdominal pressure during capnoperitoneum. Humidified and prewarmed insufflation gas may ameliorate pain and be beneficial. METHODS: This prospective randomized controlled parallel group multi-arm single-center study investigated the effects of temperature and humidity of insufflation gas on postoperative pain during gynecologic laparoscopy with a duration ≥ 60 min. Female participants (18-70 years) were blinded and randomly assigned-computer generated-to either insufflation with dry cold CO2 with forced air warming blanket ("AIR"), humidified warm gas without forced air warming blanket ("HUMI"), or humidified warm gas with forced air warming blanket ("HUMI +"). We hypothesized that using humidified warm gas resulted in lower pain scores and less analgesic consumption. The primary endpoint postoperative pain was assessed for different pain localizations every 12 h during 7 days after surgery. Secondary endpoints were demand for painkillers and epidural anesthetics, length of stay in recovery room, and hospital stay. (Registration: ClinicalTrials.gov NCT02781194-completed). RESULTS: 150 participants were randomized. Compared to group "AIR" (n = 48), there was significantly less pain in group "HUMI +" (n = 48) in the recovery room (- 1.068; 95% CI - 2.08 to - 0.061), as well as significantly less ibuprofen use at day two (- 0.5871 g ± 0.258; p-value = 0.0471). Other variables did not change significantly. Stratification for presence of endometriosis or non-previous abdominal surgery in patient history revealed significantly less pain in both groups "HUMI" (n = 50) and "HUMI +" versus group "AIR." Related side effects were not noted. CONCLUSION: In the overall population, the use of warm, humidified insufflation gas did not yield clinically relevant effects; however, in predisposed patients with endometriosis and who could otherwise expect high pain levels, warm and humidified gas may be beneficial.

A Retrospective Analysis of Randomized Controlled Trials on Traumatic Brain Injury: Evaluation of CONSORT Item Adherence.

Traumatic brain injury (TBI) contributes to death and disability, resulting in an enormous individual and socio-economic challenges. Despite huge efforts, there are still controversies on treatment strategies and early outcome estimation. We evaluate current randomized controlled trials (RCTs) on TBI according to their fulfillment of the CONSORT (Consolidated Statement of Reporting Trials) statement's criteria as a marker of transparency and the quality of study planning and realization. A PubMed search for RCTs on TBI (January 2014-December 2019) was carried out. After screening of the abstracts (n = 1.926), the suitable full text manuscripts (n = 72) were assessed for the fulfillment of the CONSORT criteria. The mean ratio of consort statement fulfillment was 59% (±13%), 31% of the included studies (n = 22) complied with less than 50% of the CONSORT criteria. Citation frequency was moderately related to ratio of CONSORT item fulfillment (r = 0.4877; p < 0.0001) and citation frequency per year (r = 0.5249; p < 0.0001). The ratio of CONSORT criteria fulfillment was associated with the impact factor of the publishing journal (r = 0.6428; p < 0.0001). Essential data for study interpretation, such as sample size determination (item 7a), participant flow (item 13a) as well as losses and exclusions (item 13b), were only reported in 53%, 60% and 63%, respectively. Reporting and methodological aspects in RCTs on TBI still may be improved. Thus, the interpretation of study results may be hampered due to methodological weaknesses.

Pain drawing as a screening tool for anxiety, depression and reduced health-related quality of life in back pain patients: A cohort study.

BACKGROUND: Back pain patients are more likely to suffer from depression, anxiety and reduced quality of life. Pain drawing is a simple, frequently used anamnesis tool that facilitates communication between physicians and patients. This study analysed pain drawings to examine whether pain drawing is suitable as a screening tool for signs of anxiety, depression or reduced quality of life, as the detection of these symptoms is essential for successful treatment. METHODS: Pain drawings of 219 patients with lower back pain were evaluated retrospectively. Pain drawings are a schematic drawing of a human being. Six variables of the pain drawing were analysed. Subscales of the Hospital Anxiety and Depression Scale (HADS) and the Mental Component Summary (MCS) of the Short Form 12 (SF-12) were used to measure anxiety, depression and quality of life, respectively. Descriptive statistics, uni- and multivariate linear regression analyses and analysis of variance were performed. Logistic regression analyses were conducted for suitable variables. RESULTS: We revealed significant positive correlations between the variables "filled body surface" and "number of pain sites" and the anxiety (HADS-A) and depression subscales (HADS-D) of the HADS (p<0.01). The same predictors had significant negative correlations with the MCS (p<0.01). However, the sensitivity and specificity of the variable "number of pain sites" were too low compared to those for existing screening tests to consider it as a screening tool for anxiety, depression and quality of life (HADS-A: sensitivity: 45.2%, specificity: 83.3%; HADS-D: sensitivity: 61.1%, specificity: 51%; MCS: sensitivity: 21.2%, specificity: 85.7%). CONCLUSIONS: There were significant correlations between the amount of filled body surface and the number of pain sites in the pain drawing and anxiety, depression and quality of life. Although useful in routine clinical practice, pain drawing cannot be used as a screening tool based on our results.