What is the effect of reducing the air change rate on the ventilation effectiveness in ultra-clean operating rooms?

BACKGROUND: The operating room (OR) department is one of the most energy-intensive departments of a hospital. The majority of ORs in the Netherlands have an air-handling installation with an ultra-clean ventilation system. However, not all surgeries require an ultra-clean OR. AIM: To determine the effect of reducing the air change rate on the ventilation effectiveness in ultra-clean ORs. METHODS: Lower air volume ventilation effectiveness (VELv) of conventional ventilation (CV), controlled dilution ventilation (cDV), temperature-controlled airflow (TcAF) and unidirectional airflow (UDAF) systems were evaluated within a 4 × 4 m measuring grid of 1 × 1 m. The VELv was defined as the recovery degree (RD), cleanliness recovery rate (CRR) and air change effectiveness (ACE). FINDINGS: The CV, cDVLv and TcAFLv ventilation systems showed a comparable mixing character in all areas (A, B and AB) when reducing the air change rate to 20/h. Ventilation effectiveness decreased when the air change rate was reduced, with the exception of the ACE. At all points for the UDAF-2Lv and at the centre point (C3) of the TcAFLv, higher RD10Lv and CRRLv were measured when compared with the other examined ventilation systems. CONCLUSIONS: The ventilation effectiveness decreased when an ultra-clean OR with an ultra-clean ventilation air-supply system was switched to an air change rate of 20/h. Reducing the air change rate in the OR from an ultra-clean OR to a generic OR will reduce the recovery degree (RD10) by a factor of 10-100 and the local air change rate (CRR) by between 42% and 81%.

An analysis of the experiences of bereaved relatives and health care providers following palliative sedation: a study protocol for a qualitative international multicenter case study.

BACKGROUND: Patients at the end-of-life may experience refractory symptoms of which pain, delirium, vomiting and dyspnea are the most frequent. Palliative sedation can be considered a last resort option to alleviate one or more refractory symptoms. There are only a limited number of (qualitative) studies exploring the experiences of relatives of sedated patients and their health care professionals (HCPs). The aims of this study protocol are: 1) to elicit the experiences of bereaved relatives and health care professionals of patients treated with palliative sedation and 2) to explore the understanding of the decision-making process to start palliative sedation across care settings in 5 European countries. METHODS: This study protocol is part of the larger HORIZON 2020 Palliative Sedation project. Organisational case study methodology will be used to guide the study design. In total, 50 cases will be conducted in five European countries (10 per country). A case involves a semi-structured interview with a relative and an HCP closely involved in the care of a deceased patient who received some type of palliative sedation at the end-of-life. Relatives and health care professionals of deceased patients participating in a linked observational cohort study of sedated patients cared for in hospital wards, palliative care units and hospices will be recruited. The data will be analyzed using a framework analysis approach. The first full case will be analyzed by all researchers after being translated into English using a pre-prepared code book. Afterwards, bimonthly meetings will be organized to coordinate the data analysis. DISCUSSION: The study aims to have a better understanding of the experiences of relatives and professional caregivers regarding palliative sedation and this within different settings and countries. Some limitations are: 1) the sensitivity of the topic may deter some relatives from participation, 2) since the data collection and analysis will be performed by at least 5 different researchers in 5 countries, some differences may occur which possibly makes it difficult to compare cases, but using a rigorous methodology will minimize this risk.

The European Medicines Agency review of sacituzumab govitecan for the treatment of triple-negative breast cancer.

Sacituzumab govitecan (SG) is an antineoplastic agent which combines a humanized monoclonal antibody binding to trophoblast cell surface antigen-2 (Trop-2)-expressing cancer cells, linked with cytotoxic moiety SN-38 (govitecan) with topoisomerase I inhibitor action. On 22 November 2021, a marketing authorization valid through the European Union (EU) was issued under the European Medicines Agency (EMA)'s accelerated assessment program for SG as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease. The assessment was based on results from an open-label, randomized, phase III trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SG versus treatment of physician's choice (TPC) in patients with mTNBC who received at least two prior treatments including at least one of them for advanced disease. The efficacy results in the overall population, based on mature data, showed a statistically significant improvement of SG over TPC in progression-free survival (PFS) and overall survival (OS). The median PFS was 4.8 months versus 1.7 months [hazard ratio (HR) = 0.43, n = 529; 95% CI 0.35-0.54; P < 0.0001] and the median OS was 11.8 months versus 6.9 months (HR = 0.51, n = 529; 95% CI 0.41-0.62; P < 0.0001). The most common (>30%) side effects of SG were diarrhea, neutropenia, nausea, fatigue, alopecia, anemia, constipation and vomiting. The aim of this manuscript is to summarize the scientific review of the application leading to regulatory approval in the EU.

Operating room ventilation systems: recovery degree, cleanliness recovery rate and air change effectiveness in an ultra-clean area.

BACKGROUND: Entrainment test methods are described in most European standards and guidelines to determine the protected area for ultra-clean ventilation (UCV) systems. New UCV systems, such as temperature-controlled airflow (TcAF) and controlled dilution ventilation (cDV) systems, claim the whole operating room (OR) to be ultra-clean. However, current test standards were not developed to assess ventilation effectiveness outside the standard protected area. AIM: To assess and compare the ventilation effectiveness of four types of OR ventilation systems in the ultra-clean area using a uniform test grid. METHODS: Ventilation effectiveness of four ventilation systems was evaluated for three different ultra-clean (protected) areas: the standard protected area (A); the area outside the standard protected area (B); and a large protected area (AB). Ventilation effectiveness was assessed using recovery degree (RD), cleanliness recovery rate (CRR) and air change effectiveness (ACE). FINDINGS: RD, CRR and ACE were significantly higher for the unidirectional air flow (UDAF) system compared with the other systems in area A. In area B, the UDAF and cDV systems were comparable for RD and CRR, and the UDAF and conventional ventilation (CV) systems were comparable for ACE. In area AB, the UDAF and cDV systems were comparable for CRR and ACE, but significant differences were found in RD. CONCLUSION: In area A, the ventilation effectiveness of the UDAF system outperformed other ventilation systems. In area B, the cDV system was best, followed by the UDAF, TcAF and CV systems. In area AB, the UDAF system was best, followed by the cDV, TcAF and CV systems.

Minimally Invasive Tensiometry: A New Modality for Per-Operative Measurement of Medialization and Tension During Laparoscopic Hernia Surgery.

Background: Newly developed techniques for minimally invasive abdominal wall reconstruction (AWR) for complex ventral hernia are continuously evolving. In order to achieve hernia defect closure, the aponeurotic edges of the hernia defect need to be approximated. Currently, surgeons have no way to objectively measure and quantify the traction required to approximate these edges. This study presents minimally invasive tensiometry (MINT), a novel technology for measuring fascial tension, as well as initial experiences and results using it. Methods: The MINT device was designed using rapid prototyping principles. It was designed as an add-on tool for any existing laparoscopic instrument, enabling objective assessment of abdominal wall tension by the use of a manually operated linear spring. Pre-clinical measurements of medialization at 10 and 20 N of tension during AWR were performed on fresh-frozen Post-Mortem Human Specimens (PMHS). Results: Three specimens were included, and a total number of 36 measurements of medialization at three different levels of the abdominal wall were performed under structured and similar circumstances. Median total medialization with 20 Newton (N) of applied tension was 25 mm (mm) cranially, 37.5 mm at the umbilicus and 27.5 mm at the caudal level. The highest rate of medialization was seen at the umbilical level (2.25 mm/N). Conclusion: MINT is a novel non-invasive technique, which allows surgeons to intraoperatively measure fascial tension when performing AWR. The MINT device is easy to use and reproduce. The next step is to start performing clinical measurements applying MINT during AWR.

[Detection and prevention in later life: risk profiles for physical, psychological, social and environmental frailty.] / Detectie en preventie van kwetsbaarheid: Op zoek naar risicoprofielen voor fysieke, psychische, sociale en omgevingskwetsbaarheid.

In order to provide proactive care and support for older people attention is needed for the prevention of frailty among older adults. Subsequently, accurate case finding of those who are more at risk of becoming frail is crucial to undertake specific preventive actions. This study investigates frailty and risk profiles of frailty among older people in order to support proactive detection. Hereby, frailty is conceived not only as a physical problem, but also refers to emotional, social, and environmental hazards. Using data generated from the Belgian Ageing Studies (N = 21,664 home-dwelling older people), a multinomial logistic regression model was tested which included socio-demographic and socio-economic indicators as well as the four dimensions of frailty (physical, social, psychological and environmental). Findings indicate that for both men and women having moved in the previous 10 years and having a lower household income are risk factors of becoming multidimensional frail. However, studying the different frailty domains, several risk profiles arise (e. g. marital status is important for psychological frailty), and gender-specific risk groups are detected (e. g. non-married men). This paper elaborates on practical implications and formulates a number of future research recommendations to tackle frailty in an ageing society.

'It is Time to Prepare the Next patient' Real-Time Prediction of Procedure Duration in Laparoscopic Cholecystectomies.

Operating Room (OR) scheduling is crucial to allow efficient use of ORs. Currently, the predicted durations of surgical procedures are unreliable and the OR schedulers have to follow the progress of the procedures in order to update the daily planning accordingly. The OR schedulers often acquire the needed information through verbal communication with the OR staff, which causes undesired interruptions of the surgical process. The aim of this study was to develop a system that predicts in real-time the remaining procedure duration and to test this prediction system for reliability and usability in an OR. The prediction system was based on the activation pattern of one single piece of equipment, the electrosurgical device. The prediction system was tested during 21 laparoscopic cholecystectomies, in which the activation of the electrosurgical device was recorded and processed in real-time using pattern recognition methods. The remaining surgical procedure duration was estimated and the optimal timing to prepare the next patient for surgery was communicated to the OR staff. The mean absolute error was smaller for the prediction system (14 min) than for the OR staff (19 min). The OR staff doubted whether the prediction system could take all relevant factors into account but were positive about its potential to shorten waiting times for patients. The prediction system is a promising tool to automatically and objectively predict the remaining procedure duration, and thereby achieve optimal OR scheduling and streamline the patient flow from the nursing department to the OR.

Safety learning from drugs of the same class: room for improvement.

This study was aimed at assessing the extent of safety learning from data pertaining to other drugs of the same class. We studied drug classes for which the first and second drugs were centrally registered in the European Union from 1995 to 2008. We assessed whether adverse drug reactions (ADRs) associated with one of the drugs also appeared in the Summary of Product Characteristics (SPC) of the other drug, either initially or during the postmarketing phase. We identified 977 ADRs from 19 drug pairs, of which 393 ADRs (40.2%) were listed in the SPCs of both drugs of a pair. Of these 393 that were present in both SPCs of a drug pair, 241 (61.3%) were present when the drug entered the market and 152 (30.7%) appeared in the postmarketing phase. The mention of ADRs in the SPCs of both same-class drugs in the postmarketing phase was associated with type A ADRs, marketing in the same regulator country, a longer time interval between entry into the market by the two drugs, and an earlier date of ADR. Although there appears to be some degree of safety learning from same-class drugs, there is still room for improvement, possibly by increasing proactive risk management.

Determinants of outcome in operatively and non-operatively treated Weber-B ankle fractures.

INTRODUCTION: Treatment of ankle fractures is often based on fracture type and surgeon's individual judgment. Literature concerning the treatment options and outcome are dated and frequently contradicting. The aim of this study was to determine the clinical and functional outcome after AO-Weber B-type ankle fractures in operatively and conservatively treated patients and to determine which factors influenced outcome. PATIENTS AND METHODS: A retrospective cohort study in patients with a AO-Weber B-type ankle fracture. Patient, fracture and treatment characteristics were recorded. Clinical and functional outcome was measured using the Olerud-Molander Ankle Score (OMAS), the American Orthopaedic Foot and Ankle Society ankle-hindfoot score (AOFAS) and a Visual Analog Score (VAS) for overall satisfaction (range 0-10). RESULTS: Eighty-two patients were treated conservatively and 103 underwent operative treatment. The majority was female. Most conservatively treated fractures were AO-Weber B1.1 type fractures. Fractures with fibular displacement (mainly AO type B1.2 and Lauge-Hansen type SER-4) were predominantly treated operatively. The outcome scores in the non-operative group were OMAS 93, AOFAS 98, and VAS 8. Outcome in this group was independently negatively affected by age, affected side, BMI, fibular displacement, and duration of plaster immobilization. In the surgically treated group, the OMAS, AOFAS, and VAS scores were 90, 97, and 8, respectively, with outcome negatively influenced by duration of plaster immobilization. CONCLUSION: Treatment selection based upon stability and surgeon's judgment led to overall good clinical outcome in both treatment groups. Reducing the cast immobilization period may further improve outcome.

Increased rates of wound complications with locking plates in distal fibular fractures.

INTRODUCTION: There is a growing use of locking compression plates in fracture surgery. The current study was undertaken to investigate the wound complication rates of locking versus non-locking plates in distal fibular fractures. PATIENTS AND METHODS: During a 6-year study period all consecutive, closed distal fibular fractures treated with either a locking or a non-locking plate were included and retrospectively analysed for complication related to the fibula. RESULTS: A total of 165 patients received a one-third tubular plate and 40 patients were treated with a locking plate. The two groups were comparable with respect to patient characteristics (age, gender, smokers and diabetics), injury characteristics (affected side, fracture dislocations, number of fractured malleoli and classification) and operation characteristics (surgical delay and duration, use of a tourniquet and plate length). The wound complication rate was 5.5% in the conventional plating group, and 17.5% in the locking plate group (p=0.019). This difference was largely due to an increase in major complications, for which removal of the plate was necessary (p=0.008). CONCLUSION: There is a significant increase in wound complications in distal fibular fractures treated with a locking compression plate. In light of the current study, we would caution against the application of the currently used locking compression plates in the treatment of distal fibular fractures.

Demographics and outcome of metatarsal fractures.

INTRODUCTION: Although metatarsal fractures are amongst the most common injuries of the foot, this is the first study on outcome after metatarsal fractures. METHOD: All consecutive patients with metatarsal fractures treated between January 2006 and September 2008 were re-evaluated. Patients aged 16 to 75 were sent a questionnaire consisting of the American Orthopaedic Foot Ankle Society midfoot score and a Visual Analogue Scale (VAS) for patient satisfaction. RESULTS: Four-hundred metatarsal fractures were identified in 322 patients. The fifth metatarsal was involved in more than 50% of patients. Most fractures were caused by an inversion injury or fall from height (75%). Out of 247 patients between 16 and 75 years, a total of 166 patients (67.2%) returned the questionnaire with a median follow-up of 33 months. All patients were treated conservatively. The median AOFAS score was 100 points (P(25)-P(75), 87-100), the median VAS was 9 points (P(25)-P(75), 8-10). The AOFAS and VAS scores correlated negatively with the body mass index (BMI) (R (s) = -0.409 and -0.305; p < 0.001). Patients with diabetes reported lower VAS (p = 0.010) and AOFAS scores (p = 0.020). Females reported a lower AOFAS score (p = 0.034). An increase in dislocation (>2 mm) resulted in a decrease in VAS score (p = 0.017). Multivariable analysis indicated that the VAS score was significantly affected by BMI and dislocation >2 mm (p = 0.013). The AOFAS score was affected by BMI (p = 0.011). CONCLUSION: This is the first investigation using two validated outcome scoring systems to determine functional outcome in metatarsal fractures. Overall outcome in metatarsal fractures is high, as almost all fractures healed without complaints at 33 months. Outcome is dependent on BMI, diabetes, gender, and dislocation at the fracture site.

Implementation of osteoporosis guidelines: a survey of five large fracture liaison services in the Netherlands.

SUMMARY: Implementation of case findings according to guidelines for osteoporosis in fracture patients presenting at a Fracture Liaison Service (FLS) was evaluated. Despite one guideline, all FLSs differed in the performance of patient selection and prevalence of clinical risk factors (CRFs) indicating the need for more concrete and standardised guidelines. INTRODUCTION: The aim of the study was to evaluate the implementation of case findings according to guidelines for osteoporosis in fracture patients presenting at FLSs in the Netherlands. METHODS: Five FLSs were contacted to participate in this prospective study. Patients older than 50 years with a recent clinical fracture who were able and were willing to participate in fracture risk evaluation were included. Performance was evaluated by criteria for patient recruitment, patient characteristics, nurse time, evaluated clinical risk factors (CRFs), bone mineral density (BMD) and laboratory testing and results of CRFs and BMD are presented. Differences between FLSs were analysed for performance (by chi-square and Student's t test) and for prevalence of CRFs (by relative risks (RR)). RESULTS: All FLSs had a dedicated nurse spending 0.9 to 1.7 h per patient. During 39 to 58 months follow-up, 7,199 patients were evaluated (15 to 47 patients/centre/month; mean age, 67 years; 77% women). Major differences were found between FLSs in the performance of patient recruitment, evaluation of CRFs, BMD and laboratory testing, varying between 0% and 100%. The prevalence of CRFs and osteoporosis varied significantly between FLSs (RR between 1.7 and 37.0, depending on the risk factor). CONCLUSION: All five participating FLSs with a dedicated fracture nurse differed in the performance of patient selection, CRFs and in the prevalence of CRFs, indicating the need for more concrete and standardised guidelines to organise evaluation of patients at the time of fracture in daily practice.

Can a structured checklist prevent problems with laparoscopic equipment?

BACKGROUND: A high incidence of problems with the technical equipment is known to occur during routine laparoscopic procedures. Use of a structured checklist of preparatory measures could help to prevent these problems. This study aimed to determine the extent to which a checklist reduced the number of incidents with technical laparoscopic equipment. METHODS: A 28-item checklist was developed based on frequently occurring laparoscopic equipment problems during 30 laparoscopic cholecystectomies (the control group). A further 30 procedures were conducted with the checklist (the checklist group). The number and type of incidents with the technical equipment were compared between the groups. All the procedures were recorded using a special audio-video system (black-box). RESULTS: In the checklist group, the total number of incidents per procedure was 53% lower than in the control group (23/30 versus 49/30). The checklist led to fewer incidents of wrong positioning (9/30 versus 22/30), and wrong settings and connections (7/30 versus 12/30) of the equipment. Defects or malfunctions decreased from 15/30 in the control group to 7/30 in the checklist group. One or more incidents with the equipment occurred in 47% (14/30) of the checklist procedures compared with 87% (26/30) of the control procedures. Median time taken to complete the checklist items was 3.3 min (range 1.0-8.3 min). CONCLUSIONS: Use of a checklist was feasible and helped to reduce problems with the laparoscopic equipment in the operating room. Future research should aim to implement checklists for different procedures and investigate their effects.

Bio-resorbable versus metal implants in wrist fractures: a randomised trial.

BACKGROUND: Distal radius fractures are often surgically treated if insufficient reduction has been achieved or after conservative treatment has failed. Treatment using metal implants often demands a secondary operation to remove the implant. A bio-resorbable implant (in this study the Reunite osteosynthesis plate by Biomet Inc) should obviate the need for a secondary operation with equal functional results. MATERIALS AND METHODS: Thirty-two patients with a distal radius fracture were assigned to treatment with either a bio-resorbable implant (N = 19) or a metal implant (N = 13). Both groups received the same postoperative care and were followed for 52 weeks in the outpatient clinic. The hypothesis of this study was a decrease in re-operation rate in the experimental group with equal functional results. RESULTS: Five out of 19 patients treated with the Reunite plate were re-operated and four out of 13 treated with metal implants needed a secondary operation. In both implants, equal functional results in Range of Motion and DASH scores were found. CONCLUSION: There were no significant differences between the experimental and control group with respect to re-operations, DASH scores and Range of Motion. Because of the higher initial costs and equal results, the use of bio-resorbable implants must be considered carefully.

Problems with technical equipment during laparoscopic surgery. An observational study.

BACKGROUND: This study was designed to investigate the incidence of technical equipment problems during laparoscopic procedures. METHODS: A video-capturing system was used, consisting of an analog video recorder with three camera image inputs and a microphone. Problems with all technical equipment used by the surgical team, such as the insufflator, diathermy apparatus, monitors, light source, camera and camera unit, endoscope, suction devices, and instruments, were registered. RESULTS: In total, 30 procedures were randomly videotaped. In 87% (26/30) of the procedures, one or more incidents with technical equipment (49 incidents) or instruments (9 incidents) occurred. In 22 of those incidents (45%) the technical equipment was not correctly positioned or not present at all; in the other 27 (55%), the equipment malfunctioned as a result of a faulty connection (9), a defect (5), or the wrong setting of the equipment (3). In 10 (20%) cases the exact cause of equipment malfunctioning was unclear. CONCLUSIONS: The incidence of problems with laparoscopic technical equipment is high. To prevent such problems, improvement and standardization of equipment is needed, combined with the incorporation of checklist use before the start of a surgical procedure. Future research should be aimed at development, implementation, and evaluation of these measures into the operating room.

Bioresorbable fixation devices for musculoskeletal injuries in adults.

BACKGROUND: Bioresorbable implants for musculoskeletal injuries involving bone and ligaments in adults might have significant advantages compared to the conventionally used non-resorbable metal implants because they lead to a gradual transfer of the mechanical load from the implant to the healing bone and do not require a secondary removal operation. Tissue reactions may present a problem and bioresorbable screws are mechanically not as strong as their metal counterparts. OBJECTIVES: To compare bioresorbable implants to non-resorbable implants with respect to functional outcome, wound infections, other complications and reoperation rate,in the fixation of bone fractures or re-attachment of soft tissue to bone. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group Specialised Register (March 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2004), MEDLINE (1966 to February 2004), EMBASE (1988 to February 2004), BL Inside (to February 2004), SIGLE (to February 2004), the metaRegister of Controlled Trials at http//:controlled-trials.com/, and reference lists of articles. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-randomised trials, comparing bioresorbable osteosynthesis with metal osteosynthesis (including titanium and stainless steel implants) were included. DATA COLLECTION AND ANALYSIS: Review authors independently assessed trial quality and extracted data. Data were pooled where relevant and possible. Sub-analyses for specific type of fractures and for specific type of tissue reactions were performed. Requests for more information were sent to trialists. MAIN RESULTS: No significant difference between the bioresorbable and other implants could be demonstrated with respect to functional outcome, infections and other complications. Reoperation rates were lower in some of the groups of people treated with bioresorbable implants. AUTHORS' CONCLUSIONS: In a selected group of compliant patients with simple fractures, the use of bioresorbable fixation devices might be advantageous.

[Diagnostic image (152). A man with a swelling in the groin. Malignant eccrine poroma]. / Diagnose in beeld (152). Een man met een gezwel in de lies. Maligne eccrien poroom.

A malignant eccrine poroma (porocarcinoma) was excised from the right groin of a 78-year-old man.

Apomorphine-susceptible and apomorphine-unsusceptible Wistar rats differ in their recovery from stress-induced ulcers.

The aim of the present study was to investigate the effects of restraint-in-water-stress on gastric ulcerations in two fundamentally different types of animals: the apomorphine-susceptible (APO-SUS) and apomorphine-unsusceptible (APO-UNSUS) rats. APO-SUS and APO-UNSUS do not only differ in their susceptibility to the dopamine agonist apomorphine, but also in stress-induced release of mesolimbic dopamine and corticosterone. All three factors are known to either predict or be involved in gastric ulceration. The results showed that immediately after the stressor the ulcerations in APO-SUS and APO-UNSUS rats were not line-specific. On the contrary, the recovery from gastric ulceration varied between both types of rat: APO-SUS rats did not show any sign of recovery after 6 hours whereas APO-UNSUS rats significantly recovered during the period of 0-6 hr after the stressor. It is hypothesised that this difference is due to the fact that APO-UNSUS rats are characterised by a less and shorter-lasting stress-induced increase of corticosterone. This study provides evidence that the pathological effects of exposure to stressors significantly differ between APO-SUS and APO-UNSUS rats and that genetic factors may direct the process of recovering from ulcers.