Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents III: The 2023 Geneva revision

The set of guidelines for good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents was developed following an international consensus conference in Copenhagen in 1996 (Viby-Mogensen et al., Acta Anaesthesiol Scand 1996, 40 , 59–74); the guidelines were later revised and updated following the second consensus conference in Stockholm in 2005 (Fuchs-Buder et al., Acta Anaesthesiol Scand 2007, 51 , 789–808). In view of new devices and further development of monitoring technologies that emerged since then, (e.g., electromyography, three-dimensional acceleromyography, kinemyography) as well as novel compounds (e.g., sugammadex) a review and update of these recommendations became necessary. The intent of these revised guidelines is to continue to help clinical researchers to conduct high-quality work and advance the field by enhancing the standards, consistency, and comparability of clinical studies. There is growing awareness of the importance of consensus-based reporting standards in clinical trials and observational studies. Such global initiatives are necessary in order to minimize heterogeneous and inadequate data reporting and to improve clarity and comparability between different studies and study cohorts. Variations in definitions of endpoints or outcome variables can introduce confusion and difficulties in interpretation of data, but more importantly, it may preclude building of an adequate body of evidence to achieve reliable conclusions and recommendations. Clinical research in neuromuscular pharmacology and physiology is no exception.     

Good Clinical Research Practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents

Based on an international consensus conference held in Copenhagen in the autumn of 1994, a set of guidelines for Good Clinical Research Practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents are presented. The guidelines are intended to be a help for people working in this research field, and it is hoped that the guidelines will assist researchers, editors, and drug companies to enhance the quality of their pharmacodynamic studies of neuromuscular blocking agents.     

Pharmacokinetic studies of neuromuscular blocking agents: good clinical research practice (GCRP)

In September 1997, an international consensus conference on standardization of studies of neuromuscular blocking agents was held in Copenhagen, Denmark. Based on the conference, a set of guidelines for good clinical research practice (GCRP) in pharmacokinetic studies of neuromuscular blocking agents is presented. Guidelines include: design of the study; relevant patient groups to investigate; test drug administration, sampling and analysis; pharmacokinetic analysis; pharmacokinetic/pharmacodynamic modeling; population pharmacokinetics; statistics; and presentation of pharmacokinetic data. The guidelines are intended to aid those working in this research area; it is hoped that they will assist researchers, editors of scientific papers, and pharmaceutical companies in improving the quality of pharmacokinetic studies.     

The Acute Dialysis Quality Initiative II: the Vicenza conference

A large number of patients develop acute renal failure in the intensive care unit and nephrology wards, and mortality remains high. In recent years, there have been considerable advances in our understanding and technical capabilities, but consensus over the optimal way to diagnose and treat acute renal failure does not exist. Consequently, a consensus conference under the auspices of the Acute Dialysis Quality Initiative (ADQI) has been held in Vicenza in the year 2002 after the previous conference held in New York in the year 2000. The ADQI aims at establishing an evidence-based appraisal and set of consensus recommendations to standardize care and direct further research. The first of these conferences held in June 2000 in New York focused on continuous renal replacement therapy (CRRT). The reports from this first consensus conference are now available online at www.ADQI.net and are also published in part in this issue. However, there remains a need for consensus in several other areas of acute renal failure. Acute renal failure has no accepted definition or rather there are over 30 definitions used in the literature and no consensus as to which one should be used. Studies designed to prevent or treat acute renal failure often use clinical and physiologic endpoints that are not comparable to other studies making it difficult to compare the results of one study to another. Finally, the success of multicentered clinical trials in supportive care in the intensive care unit (transfusion thresholds and ventilator management) have intensified and renewed interest in the study of supportive care methods as a major target for future research. These developments have set the stage for the first conference and have now driven the spirit of the second. Once again, the final objectives are the development of evidence-based guidelines and directions for future research.     

Proceedings of the Consensus Conference on the Role of Sentinel Lymph Node Biopsy in Carcinoma of the Breast April 19–22, 2001, Philadelphia, PA, USA

A consensus conference on the role of sentinel node biopsy in breast cancer was held in Philadelphia in April, 2001; the participants included many highly respected American and European investigators in this area. This report summarizes the deliberations of the group and promotes its current guidelines for the integration of this new technique into contemporary clinical practice.     

Proceedings of the consensus conference on the role of sentinel lymph node biopsy in carcinoma of the breast April 19–22, 2001, Philadelphia,PA, USA

A consensus conference on the role of sentinel node biopsy in breast cancer was held in Philadelphia in April, 2001; the participants included many highly respected American and European investigators in this area. This report summarizes the deliberations of the group and promotes its current guidelines for the integration of this new technique into contemporary clinical practice.     

Proceeding of the consensus conference of the role of sentinel lymph node biopsy in carcinoma or the breast April 19-22, 2001, Philadelphia,PA, USA

A consensus conference on the role of sentinel node biopsy in breast cancer was held in Philadelphia in april, 2001; the participants included many highly respected American and European investigators in this area. This report summarizes the deliberations of the group and promotes its current guidelines for the integration of this new technique into contemporary clinical practice.     

Laparoscopic fundoplication for gastro-oesophageal reflux disease – a consensus development conference and the evidence-based benefit

The aim of this paper is to demonstrate an example of evidence-based medicine for a clinically relevant and frequent disease – gastro-oesophageal reflux disease – for which an increasing number of laparoscopic operations is performed. A consensus development conference was performed on this topic in 1996. During the following 3-year period, increase of knowledge shown by the number of publications was monitored and the consecutive changes of the consensus as well as its consequences and impact were analysed. The six published randomised clinical trials revealed important information about the technique of the laparoscopic operation focussing on the gastric fundic mobilisation and the modification of the anti-reflux wrap. Five consecutive consensus conferences were performed and published. Citations of the 1996 consensus conference could not be found in the major surgical journals – not even by participants of the conference. The responsibility of societies to run such conferences continues. Received: 20 August 1999 Accepted: 7 September 1999     

Standards for economic and quality of life studies in transplantation

There are unique requirements in conducting and reporting economic and quality of life investigations in medicine as compared with more traditional studies involving clinical outcomes. In addition, there are several unique characteristics of the discipline of transplantation that also bear attention in economic and quality of life studies. To provide guidelines for future research and reporting of future research, a consensus conference of transplant professionals was convened to discuss these issues. Five different areas were addressed: "Conducting an Economic Analysis," "Reporting an Economic Analysis," "Quality of Life Studies in Transplantation," "Ethical and Conflict of Interest Issues Between Sponsors and Investigators," and "Future Directions for Research." A series of recommendations for each of these areas with reference to relevant literature is presented.     

Are guidelines for non-invasive ventilation during weaning still valid?

Noninvasive ventilation (NIV) has gained increasing acceptance over the years to reduce endotracheal intubation, pneumonia and to prevent or treat respiratory failure in patients with different diagnoses. The international consensus conference, and the British society guidelines on NIV ventilation have analyzed its use during the weaning phase concluding that there were still conflicting results of its use. However, recent clinical trials have shown clear clinical benefits on the use of NIV in several patient populations during the weaning period. Acute respiratory failure (ARF) during the weaning process is the main object of recently published studies. The latest published randomized trials on the application of NIV for acute respiratory failure following extubation failed to demonstrate any favorable outcome. Even so, the use of NIV during the process of weaning in patients experiencing multiple weaning failure or as a preventive therapy in patients at higher risk of respiratory deterioration showed improved clinical outcomes only in chronic obstructive pulmonary disease and in particular in hypercapnic patients. Reduced invasive mechanical ventilation, tracheostomy and lower mortality rate at 90 days were the major advantages.     

Best Practices in Robot-assisted Radical Prostatectomy: Recommendations of the Pasadena Consensus Panel

Context

Radical retropubic prostatectomy (RRP) has long been the most common surgical technique used to treat clinically localized prostate cancer (PCa). More recently, robot-assisted radical prostatectomy (RARP) has been gaining increasing acceptance among patients and urologists, and it has become the dominant technique in the United States despite a paucity of prospective studies or randomized trials supporting its superiority over RRP.

Objective

A 2-d consensus conference of 17 world leaders in prostate cancer and radical prostatectomy was organized in Pasadena, California, and at the City of Hope Cancer Center, Duarte, California, under the auspices of the European Association of Urology Robotic Urology Section to systematically review the currently available data on RARP, to critically assess current surgical techniques, and to generate best practice recommendations to guide clinicians and related medical personnel. No commercial support was obtained for the conference.

Evidence acquisition

A systematic review of the literature was performed in agreement with the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement.

Evidence synthesis

The results of the systematic literature review were reviewed, discussed, and refined over the 2-d conference. Key recommendations were generated using a Delphi consensus approach. RARP is associated with less blood loss and transfusion rates compared with RRP, and there appear to be minimal differences between the two approaches in terms of overall postoperative complications. Positive surgical margin rates are at least equivalent with RARP, but firm conclusions about biochemical recurrence and other oncologic end points are difficult to draw because the follow-up in existing studies is relatively short and the overall experience with RARP in locally advanced PCa is still limited. RARP may offer advantages in postoperative recovery of urinary continence and erectile function, although there are methodological limitations in most studies to date and a need for well-controlled comparative outcomes studies of radical prostatectomy surgery following best practice guidelines. Surgeon experience and institutional volume of procedures strongly predict better outcomes in all relevant domains.

Conclusions

Available evidence suggests that RARP is a valuable therapeutic option for clinically localized PCa. Further research is needed to clarify the actual role of RARP in patients with locally advanced disease.     

The Second International Conference on Sentinel Node Biopsy in Mucosal Head and Neck Cancer

Background The Second International Conference on Sentinel Node Biopsy in Mucosal Head and Neck Cancer was hosted by the Department of Otorhinolaryngology, Head and Neck Surgery of the University Hospital in Zurich, Switzerland, from September 12 to 13, 2003. The aims of this conference were to present the results of validation studies and to achieve a consensus on methodological requirements. Methods More than 80 delegates from 20 countries attended the conference. The presented validation studies were summarized and compared with the literature. Consensus was achieved concerning requirements for lymphatic mapping and histopathologic work-up. Results Twenty centers presented results on 379 patients with cN0 disease. Sentinel nodes were identified in 366 (97%) of 379. Of these 366, 103 (29%) were positive for occult metastasis, and 263 (71%) were negative. Of those 263 patients, 11 patients (4%) showed nodal disease not revealed by the sentinel lymph node biopsy (SNB). The negative predictive value of a negative sentinel node for the remaining neck was 96%. The consensus conference resulted in the use of a radiotracer, lymphoscintigraphy, and a handheld gamma probe for lymphatic mapping as minimal requirements. The use of conventional hematoxylin and eosin staining and immunohistochemistry for cytokeratin is mandatory. Step-sectioning of the entire node at intervals of 150 μm is recommended. Conclusions The conference attracted delegates from all over the world, thus underscoring the high interest in the topic. With regard to the presented data and the data from the literature, SNB for early oral and oropharyngeal cancer is sufficiently validated. The consensus conference resulted in the definition of minimal methodological requirements for accurate SNB.     

Predonation psychosocial evaluation of living kidney and liver donor candidates: a systematic literature review

Evaluating a person's suitability for living organ donation is crucial, consisting not only of a medical but also of a thorough psychosocial screening. We performed a systematic literature review of guidelines, consensus statements, and protocols on the content and process of psychosocial screening of living kidney and liver donor candidates. We searched PubMed, Embase, CINAHL, and PsycINFO until June 22, 2011, following the PRISMA guidelines, complemented by scrutinizing guidelines databases and references of identified publications. Thirty‐four publications were identified, including seven guidelines, six consensus statements, and 21 protocols or programs. Guidelines and consensus statements were inconsistent and lacked concreteness for both their content and process, possibly explaining the observed variability in center‐specific evaluation protocols and programs. Overall, recommended screening criteria are not evidence‐based and an operational definition of the concept “psychosocial” is missing, causing heterogeneity in terminology. Variation also exists on methods used to psychosocially evaluate potential donors. The scientific basis of predonation psychosocial evaluation needs to be strengthened. There is a need for high‐quality prospective psychosocial outcome studies in living donors, a uniform terminology to label psychosocial screening criteria, and validated instruments to identify risk factors.     

Prevention and treatment of bile duct injuries during laparoscopic cholecystectomy: the clinical practice guidelines of the European Association for Endoscopic Surgery (EAES)

Background

Laparoscopic cholecystectomy is one of the most common surgical procedures in Europe (and the world) and has become the standard procedure for the management of symptomatic cholelithiasis or acute cholecystitis in patients without specific contraindications. Bile duct injuries (BDI) are rare but serious complications that can occur during a laparoscopic cholecystectomy. Prevention and management of BDI has given rise to a host of publications but very few recommendations, especially in Europe.

Methods

A systematic research of the literature was performed. An international expert panel was invited to appraise the current literature and to develop evidence-based recommendations. Statements and recommendations were drafted after a consensus development conference in May 2011, followed by presentation and discussion at the annual congress of the EAES held in Torino in June 2011. Finally, full guidelines were consented and adopted by the expert panel via e-mail and web conference.

Results

A total of 1,765 publications were identified through the systematic literature search and additional submission by panellists; 671 publications were selected as potentially relevant. Only 46 publications fulfilled minimal methodological criteria to support Clinical Practice Guidelines recommendations. Because the level of evidence was low for most of the studies, most statements or recommendations had to be based on consensus of opinion among the panel members. A total of 15 statements and recommendations were developed covering the following topics: classification of injuries, epidemiology, prevention, diagnosis, and management of BDI.

Conclusions

Because BDI is a rare event, it is difficult to generate evidence for prevention, diagnosis, or the management of BDI from clinical studies. Nevertheless, the panel has formulated recommendations. Due to the currently limited evidence, a European registry should be considered to collect and analyze more valid data on BDI upon which recommendations can be based.     

ILCOR- Konsensuskonferenz in Dallas, 1.–4.2.2010

The consensus conference for elaboration of the International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations (CoSTR) of the International Liaison Committee on Resuscitation (ILCOR) took place from 1^st–4^th February 2010 in Dallas. The American Heart Association (AHA) and European Resuscitation Council (ERC) presided over the development of this consensus. The new guidelines for resuscitation 2010 are anticipated to be published in October 2010. The official German language translation document, which is ratified by the German Resuscitation Council (GRC), is planned to be published by the end of 2010.     

The Acute Dialysis Quality Initiative: the New York conference

Over 300,000 Americans develop acute renal failure each year, and half die. In recent years, there have been considerable advances in our understanding and technical capabilities, but consensus over the optimal way to deliver care does not exist. Consequently, a conference held in New York in the year 2000 has given birth to the Acute Dialysis Quality Initiative (ADQI). The conference aimed at establishing an evidence-based appraisal and set of consensus recommendations to standardize care and direct further research on the application of continuous renal replacement therapy (CRRT). CRRT is being used at ever-increasing rates in the United States. Today, approximately one quarter of all patients with acute renal failure are treated with CRRT. Despite the increasing use, there are presently no published standards for the application of this therapy, and practice patterns vary widely between individual centers. Results from recent clinical trials on selection of dialysis membranes and dialysis dose provide strong, yet often conflicting, evidence to guide therapy. Other areas of uncertainty have not been sufficiently addressed by clinical studies and directives for future research are needed. Finally, the success of multicentered clinical trials in supportive care in the intensive care unit (transfusion thresholds and ventilator management) have intensified and renewed interest in the study of supportive care methods as a major target for future research. These developments have set the stage for the first ADQI conference; the final objectives are the development of evidence-based practice guidelines and directions for future research.     

Ambulatory diagnosis and therapy of gonarthrosis

AIM OF STUDY: To develop recommendations for appropriate diagnostic procedures and conservative treatment of knee osteoarthritis in outpatients. MATERIAL AND METHODS: Following a consensus conference and expert reviews basic recommendations were developed. RESULTS: While standardized radiographic assessment is mandatory, MRI investigation should be restricted to problems apart from osteoarthritis. Indications for physical therapy, bracing and pharmaco-treatment depend on the severity of the disease. Guidelines for intraarticular injections are presented. CONCLUSION: Effective treatment of knee osteoarthritis must be based on available recommendations and guidelines.     

Adjuvant Consensus: A Breast Cancer Patient Web Tool

The new web tool Adjuvant Consensus gives the user access to the most recent information on how world leading experts suggest to treat a specific breast cancer with systemic therapy. By entering tumor characteristics, age, and menopausal status, the user can find out what experts and national guidelines suggest for this specific tumor. The basis for the suggested treatment options and guidelines are coming from 2 world leading resources: They reflect the reached expert consensus on the implications of evidence for patient treatment selection at the world leading consensus conference on adjuvant therapy held regularly in St. Gallen, and the 'Clinical Practice Guidelines in Oncology' for breast cancer published in the US by the National Cancer Center Network in January 2007. The calculated treatment options include the suggested systemic treatment - chemotherapy, hormonal therapy, and antibody therapy, alone or in combination - and the duration and sequence of therapy. Furthermore, the user can find information on the mode of action and important side effects of the different drugs.