Ethical procedures and patient consent differ in Europe

BACKGROUND: Research ethics approvals, procedures and requirements for institutional research ethics committees vary considerably by country and by type of organisation. OBJECTIVE: To evaluate the requirements and procedures of research ethics committees, details of patient information and informed consent based on a multicentre European trial. DESIGN: Survey of European hospitals participating in the prospective observational study on chronic postsurgical pain (euCPSP) using electronic questionnaires. SETTING: Twenty-four hospitals in 11 European countries. PARTICIPANTS: From the 24 hospitals, 23 local investigators responded; 23 answers were analysed. OUTCOME MEASURES: Comparison of research ethics procedures and committee requirements from the perspective of clinical researchers. Comparison of the institutions' procedures regarding patient information and consent. Description of further details such as costs and the duration of the approval process. RESULTS: The approval process lasted from less than 2 weeks up to more than 2 months with financial fees varying between 0 and 575 €. In 20 hospitals, a patient information sheet of variable length (half page up to two pages) was provided. Requirements for patients' informed consent differed. Written informed consent was mandatory at 12, oral at 10 and no form of consent at one hospital. Details such as enough time for consideration, possibility for withdrawal and risks/benefits of participation were provided in 25 to 30% of the institutions. CONCLUSION: There is a considerable variation in the administrative requirements for approval procedures by research ethics committees in Europe. This results in variation of the extent of information and consent procedures for the patients involved

The EFSUMB Guidelines and Recommendations for Musculoskeletal Ultrasound - Part I: Extraarticular Pathologies

The first part of the guidelines and recommendations for musculoskeletal ultrasound, produced under the auspices of the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB), provides information about the use of musculoskeletal ultrasound for assessing extraarticular structures (muscles, tendons, entheses, ligaments, bones, bursae, fasciae, nerves, skin, subcutaneous tissues, and nails) and their pathologies. Clinical applications, practical points, limitations, and artifacts are described and discussed for every structure. After an extensive literature review, the recommendations have been developed according to the Oxford Centre for Evidence-based Medicine and GRADE criteria and the consensus level was established through a Delphi process. The document is intended to guide clinical users in their daily practice

Systematic review of dexketoprofen in acute and chronic pain

which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background: Dexketoprofen, an NSAID used in the management of acute and chronic pains, is licensed in several countries but has not previously been the subjected of a systematic review. We used published and unpublished information from randomised clinical trials (RCTs) of dexketoprofen in painful conditions to assess evidence on efficacy and harm. Methods: PubMed and Cochrane Central were searched for RCTs of dexketoprofen for pain of any aetiology. Reference lists of retrieved articles and reviews were also searched. Menarini Group produced copies of published and unpublished studies (clinical trial reports). Data were abstracted into a standard form. For studies reporting results of single dose administration, the number of patients with at least 50 % pain relief was derived and used to calculate the relative benefit (RB) and number-needed-to-treat (NNT) for one patient to achieve at least 50 % pain relief compared with placebo. Results: Thirty-five trials were found in acute pain and chronic pain; 6,380 patients were included, 3,381 receiving dexketoprofen. Information from 16 trials (almost half the total patients) wa

Recommendations for effective documentation in regional anesthesia: an expert panel Delphi consensus project

Background and objectives: Documentation is important for quality improvement, education, and research. There is currently a lack of recommendations regarding key aspects of documentation in regional anesthesia. The aim of this study was to establish recommendations for documentation in regional anesthesia. Methods: Following the formation of the executive committee and a directed literature review, a long list of potential documentation components was created. A modified Delphi process was then employed to achieve consensus amongst a group of international experts in regional anesthesia. This consisted of 2 rounds of anonymous electronic voting and a final virtual round table discussion with live polling on items not yet excluded or accepted from previous rounds. Progression or exclusion of potential components through the rounds was based on the achievement of strong consensus. Strong consensus was defined as ≥75% agreement and weak consensus as 50%-74% agreement. Results: Seventy-seven collaborators participated in both rounds 1 and 2, while 50 collaborators took part in round 3. In total, experts voted on 83 items and achieved a strong consensus on 51 items, weak consensus on 3 and rejected 29. Conclusion: By means of a modified Delphi process, we have established expert consensus on documentation in regional anesthesia

Long-term evaluation of motor function following intraneural injection of ropivacaine using walking track analysis in rats

Background. There is a paucity of data regarding neurologic function following nerve injury. Our objective was the long-term evaluation of motor function following intraneural injection of ropivacaine in rats using the sciatic function index (SFI), derived from walking track analysis. Methods. Rats were randomly assigned to one of four groups of 13 animals each. A needle was inserted under magnification into the left sciatic nerve and 0.2 ml of normal saline, formalin 15%, ropivacaine 0.2 or 0.75% were injected intraneurally. The right side was sham operated. Walking track analysis was performed the day before and on days 1, 4, 7, 11, 15, 18, 21, and 67 following intraneural injection. At the end of the experiment (day 67) a semi-quantitative evaluation of neuropathologic changes was performed by three independent observers. Results. Animals treated with saline and ropivacaine (0.2 and 0.75%) had no detectable impairment of motor function at any time point. In contrast, rats treated with formalin had a complete loss of motor function immediately after the intraneural injection, which persisted until day 21 and returned to normal by day 67. Important histopathologic changes (score=2) with excellent inter-observer agreement were seen only in the group treated with formalin. This applied to both axonal degeneration and Schwann cell density evaluations. Conclusions. These findings suggest that intraneural injections of ropivacaine at concentrations routinely used in clinical practice appear to have no deleterious effect on sciatic nerve motor function in this experimental rat model

A year in review in Minerva Anestesiologica 2013

PubMed: 24500141Background. We organized a training program for oral fiber optic intubation (FOI) under conscious sedation. The efficacy of the program was evaluated by comparing the performances of experts and novices. Methods. The training procedure was divided into two sessions: a theoretical session on difficult airways, the fiber optic bronchoscope (FOB), remifentanil, topical anesthesia and patient interactions; and a session involving simulations of the FOI technique on dummies. For in vivo FOI, we enrolled patients requiring orotracheal intubation for elective surgery. Electrocardiograms, mean arterial pressurewas railroaded over the fiberscope, and tracheal intubati6 and 7) FOIs, respectively, joined the study. To reach±23 bpm, P=0.02), and RR was decreased (from 16±3 to 12±4 bpm, P<0.05). No differences were recorded between the experts and less-experienced anesthesiologists. The average duration of FOI was 3.3±2.0 min for experts and 4.2±2.4 min for novices (P=0.03). Procedures were successful in both groups, with patients in each group being equally satisfied with the procedures. Conclusion. This study highlights the importance of a structured FOI training program, demonstrating that it is possible to learn to perform FOI proficiently by practicing on dummies