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1.
BMJ Open ; 8(10): e023609, 2018 10 18.
Article in English | MEDLINE | ID: mdl-30341135

ABSTRACT

INTRODUCTION: Hip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on patient-centred outcomes after hip fracture surgery is sparse. METHODS AND ANALYSIS: The iHOPE study is a pragmatic national, multicentre, randomised controlled, open-label clinical trial with a two-arm parallel group design. In total, 1032 patients with hip fracture (>65 years) will be randomised in an intended 1:1 allocation ratio to receive spinal anaesthesia (n=516) or general anaesthesia (n=516). Outcome assessment will occur in a blinded manner after hospital discharge and inhospital. The primary endpoint will be assessed by telephone interview and comprises the time to the first occurring event of the binary composite outcome of all-cause mortality or new-onset serious cardiac and pulmonary complications within 30 postoperative days. In-hospital secondary endpoints, assessed via in-person interviews and medical record review, include mortality, perioperative adverse events, delirium, satisfaction, walking independently, length of hospital stay and discharge destination. Telephone interviews will be performed for long-term endpoints (all-cause mortality, independence in walking, chronic pain, ability to return home cognitive function and overall health and disability) at postoperative day 30±3, 180±45 and 365±60. ETHICS AND DISSEMINATION: iHOPE has been approved by the leading Ethics Committee of the Medical Faculty of the RWTH Aachen University on 14 March 2018 (EK 022/18). Approval from all other involved local Ethical Committees was subsequently requested and obtained. Study started in April 2018 with a total recruitment period of 24 months. iHOPE will be disseminated via presentations at national and international scientific meetings or conferences and publication in peer-reviewed international scientific journals. TRIAL REGISTRATION NUMBER: DRKS00013644; Pre-results.


Subject(s)
Anesthesia, General/methods , Anesthesia, Spinal/methods , Clinical Trial Protocols as Topic , Hip Fractures/surgery , Postoperative Complications/prevention & control , Aged , Arthroplasty, Replacement, Hip , Female , Humans , Male , Middle Aged , Multicenter Studies as Topic , Pain, Postoperative/prevention & control , Pragmatic Clinical Trials as Topic , Randomized Controlled Trials as Topic , Research Design
2.
Z Evid Fortbild Qual Gesundhwes ; 109(9-10): 725-35, 2015.
Article in German | MEDLINE | ID: mdl-26699261

ABSTRACT

BACKGROUND: The use and organisation of medical technology has an important role to play for patient and user safety in anaesthesia. OBJECTIVES: Specification of the recommendations of the German Coalition for Patient Safety (APS) for users and operators of anaesthesia equipment, explore opportunities and challenges for the safe use and organisation of anaesthesia devices. METHODS: We conducted a literature search in Medline/PubMed for studies dealing with the APS recommendations for the prevention of medical device-related risks in the context of anaesthesia. In addition, we performed an internet search for reports and recommendations focusing on the use and organisation of medical devices in anaesthesia. Identified studies were grouped and assigned to the recommendations. The division into users and operators was maintained. RESULTS: Instruction and training in anaesthesia machines is sometimes of minor importance. Failure to perform functional testing seems to be a common cause of critical incidents in anaesthesia. There is a potential for reporting to the federal authority. Starting points for the safe operation of anaesthetic devices can be identified, in particular, at the interface of staff, organisation, and (anaesthesia) technology. CONCLUSIONS: The APS recommendations provide valuable information on promoting the safe use of medical devices and organisation in anaesthesia. The focus will be on risks relating to the application as well as on principles and materials for the safe operation of anaesthesia equipment.


Subject(s)
Anesthesia Department, Hospital/organization & administration , Anesthesia Department, Hospital/standards , Equipment Safety/standards , Equipment and Supplies, Hospital/adverse effects , Equipment and Supplies, Hospital/standards , Equipment and Supplies/adverse effects , Equipment and Supplies/standards , Health Care Coalitions , Medical Errors/prevention & control , Patient Safety , Germany , Humans , Quality Improvement/organization & administration , Quality Improvement/standards
3.
Z Evid Fortbild Qual Gesundhwes ; 109(4-5): 384-93, 2015.
Article in German | MEDLINE | ID: mdl-26354140

ABSTRACT

In the autumn of 2014, more than 3,000 surgeons completed an online questionnaire asking for the prevalence and efficiency of instruments to prevent adverse events within surgical departments in Germany. About 90 % of the respondents stated that perioperative checklists, preoperative marking of the surgical site and the documentation of hospital infections had been implemented in their institution; and 75 % of the institutions had introduced critical incident reporting systems (CIRS), morbidity and mortality conferences and identification bracelets for patients. The surgeons were asked to rank the different instruments for the prevention of adverse events. According to the respondents, preoperative marking of the surgical site and the use of checklists were at the top of the efficacy ranking, followed by an introductory course for surgeons starting work in a hospital or when new devices became available. Only 50 % of the responding surgeons perceived CIRS as being efficient. Overall, the answers showed that instruments to increase patient safety were commonly available in surgical departments. On the other hand, there is still room for improvement in daily practice.


Subject(s)
Health Plan Implementation/organization & administration , Internet , Medical Errors/prevention & control , Surgicenters/organization & administration , Surveys and Questionnaires , Austria , Checklist , Outcome and Process Assessment, Health Care , Patient Identification Systems/organization & administration , Quality Assurance, Health Care/organization & administration , Risk Management/organization & administration , Surgical Wound Infection/prevention & control
5.
Injury ; 45 Suppl 3: S89-92, 2014 Oct.
Article in English | MEDLINE | ID: mdl-25284242

ABSTRACT

PURPOSE: Caring for severely injured trauma patients is challenging for all medical professionals involved both in the preclinical and in the clinical course of treatment. While the overall quality of care in Germany is high there still are significant regional differences remaining. Reasons are geographical and infrastructural differences as well as variations in personnel and equipment of the hospitals. METHODS: To improve state-wide trauma care the German Trauma Society (DGU) initiated the TraumaNetzwerk DGU(®) (TNW) project. The TNW is based on five major components: (a) Whitebook for the treatment of severely injured patients; (b) evidence-based guidelines for the medical care of severe injury; (c) local auditing of participating hospitals; (d) contract of interhospital cooperation; (d) TraumaRegister DGU(®) documentation. RESULTS: By the end of 2013, 644 German Trauma Centres (TC) had successfully passed the audit. To that date 44 regional TNWs with a mean of 13.5 TCs had been established and certified. The TNWs cover approximately 90% of the country's surface. Of those hospitals, 2.3 were acknowledged as Supraregional TC, 5.4 as Regional TC and 6.7 as Lokal TC. Moreover, cross border TNW in cooperation with hospitals in The Netherlands, Luxembourg, Switzerland and Austria have been established. Preparing for the audit 66% of the hospitals implemented organizational changes (e.g. TraumaRegister DGU(®) documentation and interdisciplinary guidelines), while 60% introduced personnel and 21% structural (e.g. X-ray in the ER) changes. CONCLUSIONS: The TraumaNetzwerk DGU(®) project combines the control of common defined standards of care for all participating hospitals (top down) and the possibility of integrating regional cooperation by forming a regional TNW (bottom up). Based on the joint approach of healthcare professionals, it is possible to structure and influence the care of severely injured patients within a nationwide trauma system.


Subject(s)
Critical Care/organization & administration , Guideline Adherence , Length of Stay/statistics & numerical data , Multiple Trauma , Registries/statistics & numerical data , Trauma Centers/organization & administration , Combined Modality Therapy , Cooperative Behavior , Critical Care/trends , Documentation/standards , Evidence-Based Emergency Medicine , Female , Germany/epidemiology , Hospital Mortality/trends , Humans , Injury Severity Score , Interdisciplinary Communication , Length of Stay/trends , Male , Multiple Trauma/mortality , Multiple Trauma/therapy , Trauma Centers/statistics & numerical data
6.
J Trauma Acute Care Surg ; 76(6): 1456-61, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24854315

ABSTRACT

BACKGROUND: Regional differences in the care of severely injured patients remain problematic in industrial countries. METHODS: In 2006, the German Society for Trauma Surgery initiated the foundation of regional networks between trauma centers in a TraumaNetwork (TNW). The TNW consisted of five major elements as follows: (a) a whitebook on the treatment of severely injured patients; (b) evidence-based guidelines (S3); (c) local audits; (d) contracts of interhospital cooperation among all participating hospitals; and (e) TraumaRegister documentation. TNW hospitals are classified according to local audit results as supraregional (STC), regional (RTC), or local (LTC) trauma centers by criteria concerning staff, equipment, admission capacity, and responsibility. RESULTS: Five hundred four German trauma centers (TCs) were certified by the end of December 2012. By then, 37 regional TNWs, with a mean of 13.6 TCs, were established, covering approximately 80% of the country's territory. Of the hospitals, 92 were acknowledged as STCs, 210 as RTCs, and 202 as LTCs.In 2012, 19,124 patients were documented by the certified TCs. Fifty-seven percent of the patients were treated in STCs, 34% in RTCs, and 9% in LTCs. The mean (SD) Injury Severity Score (ISS) was highest in STCs (21 [13]), compared with 18 (12) in RTCs and 16 (10) in LTCs. There were differences in expected mortality (based on Revised Injury Severity Classification) according to the differences in the severity of trauma among the different categories, but in all types, the expected mortality was significantly higher than the observed mortality (differences in STCs, 1.8%; RTCs, 1.4%; LTCs, 2.0%). CONCLUSION: According to our findings, it is possible to successfully structure and standardize the care of severely injured patients in a nationwide trauma system. Better outcomes than expected were observed in all categories of TNW hospitals. LEVEL OF EVIDENCE: Epidemiologic study, level III. Therapeutic/care management study, level IV.


Subject(s)
Documentation/standards , Multiple Trauma/therapy , Registries/standards , Societies, Medical , Trauma Centers/standards , Combined Modality Therapy/standards , Female , Germany , Guideline Adherence , Humans , Injury Severity Score , Interdisciplinary Communication , Licensure, Hospital/standards , Male , Middle Aged , Multiple Trauma/diagnosis , Retrospective Studies
7.
Arch Orthop Trauma Surg ; 130(9): 1117-27, 2010 Sep.
Article in English | MEDLINE | ID: mdl-19921227

ABSTRACT

INTRODUCTION: To investigate whether operative treatment leads to earlier return to previous activity level, 94 patients with the same number of isolated, acute, complete, stable and non-displaced fractures of the scaphoid mid-third were involved in a prospective, multicenter cohort study. METHOD: Fractures were either fixed with a cannulated screw or immobilized with a short arm cast, and followed for 6 months. RESULTS: By 15 weeks, patients receiving surgical treatment returned significantly earlier to their full time work and home activities, as well as achieved significantly better results for functional status, pain, and overall satisfaction. However, complication rates concerning union and secondary operative management were higher. CONCLUSION: Operative treatment therefore primarily facilitates earlier return to previous activity level, as well as better functional status, less pain and higher patient satisfaction, yet conservative treatment seems to be safer and associated with a lower complication rate.


Subject(s)
Bone Screws , Fracture Fixation, Internal/instrumentation , Fractures, Bone/rehabilitation , Fractures, Bone/surgery , Scaphoid Bone/injuries , Acute Disease , Adolescent , Adult , Analysis of Variance , Casts, Surgical , Female , Follow-Up Studies , Fracture Fixation, Internal/methods , Fracture Healing/physiology , Humans , Injury Severity Score , Male , Middle Aged , Pain Measurement , Recovery of Function , Risk Assessment , Treatment Outcome , Young Adult
8.
BMC Musculoskelet Disord ; 7: 41, 2006 May 11.
Article in English | MEDLINE | ID: mdl-16689987

ABSTRACT

BACKGROUND: Acute scaphoid fractures are common in active adults and do lead to reasonable time lost to work. One important goal of treatment is early return to work or sport. On this background, the adequate treatment of non-displaced acute scaphoid fractures is still under discussion. The aim of this study is to compare time to return to previous activity level comparing surgical versus non-surgical treatment of non-displaced acute scaphoid fractures. METHODS/DESIGN: The study is designed as a non-randomized multiple center cohort study including 12 sites in Germany and Austria. The inclusion period is planned to be 12 months with a follow up of 6 months. Allocation to operative or non-operative treatment is chosen by the patient together with his treating surgeon. The primary outcome is time to return to previous activity level adapted for loading of the wrist in daily life as measured by a newly developed questionnaire (PLDL-wrist). Factors identified a priori to be associated with the outcome, e.g., poverty status, age, education, smoking status, gender, and occupation, are measured to ensure adequate control for their potential confounding effects. DISCUSSION: The rationale and the design of a multiple center cohort study are presented. As it is not considered feasible to randomize patients in this study, potential confounding effects need to be controlled adequately.


Subject(s)
Fracture Fixation, Internal , Fractures, Bone/therapy , Immobilization , Scaphoid Bone/injuries , Absenteeism , Acute Disease , Adult , Austria , Bone Screws , Casts, Surgical , Cohort Studies , Confounding Factors, Epidemiologic , Fracture Fixation, Internal/statistics & numerical data , Fracture Healing , Fractures, Bone/rehabilitation , Fractures, Bone/surgery , Germany , Hand Strength , Humans , Immobilization/statistics & numerical data , Internal Fixators , Pain Measurement , Patient Satisfaction , Physical Therapy Modalities , Prospective Studies , Range of Motion, Articular , Recovery of Function , Research Design , Sample Size , Scaphoid Bone/surgery , Socioeconomic Factors , Surveys and Questionnaires , Treatment Outcome
9.
Article in Chinese | WPRIM (Western Pacific) | ID: wpr-402102

ABSTRACT

Evidence is lacking from these trials concerning the optimal procedure for treatment of displaced intraarticular calcaneal fractures. Clinical trials comparing different treatment , especially as they relate to potential risk fractors such as fracture classification, should be explored.

10.
Solid State Nucl Magn Reson ; 22(2-3): 311-26, 2002.
Article in English | MEDLINE | ID: mdl-12469817

ABSTRACT

The flow behavior of nematic liquid crystalline polysiloxanes of the side-chain type is studied by in situ 2H NMR spectroscopy on samples under shear in a cone-and-plate cell. The director orientation as a function of applied shear rate is determined from the quadrupole splitting of the spectra. The data analysis yields the two Leslie viscosity coefficients alpha2 and alpha3 and the flow-alignment parameter lambda = -(alpha3 + alpha2)/(alpha3 - alpha2). The values of lambda were determined for several homopolymers with only one type of side chain and random copolymers containing two different side chains. The results show that the flow behavior is related to the phase structure of the polymers, which varies with their composition. Only polymers with large amounts of smectic clusters in the nematic state show the tumbling instability (absolute value(lambda) < 1); other polymers are flow aligning (absolute value(lambda) > or = 1). For some polymers, a transition from tumbling at low temperature to flow aligning at high temperatures was observed.


Subject(s)
Computer Simulation , Magnetic Resonance Spectroscopy/instrumentation , Models, Theoretical , Polymers/chemistry , Rheology/instrumentation , Deuterium , Equipment Design , Magnetic Resonance Spectroscopy/methods , Reproducibility of Results , Rheology/methods , Sensitivity and Specificity , Stress, Mechanical , Viscosity
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