Browsing by Subject "Consensus"

Now showing 1 - 20 of 33

Open Access
A novel classification system for spinal instability in neoplastic disease: an evidence-based approach and expert consensus from the Spine Oncology Study Group.
(Spine, 2010-10) Fisher, Charles G; DiPaola, Christian P; Ryken, Timothy C; Bilsky, Mark H; Shaffrey, Christopher I; Berven, Sigurd H; Harrop, James S; Fehlings, Michael G; Boriani, Stefano; Chou, Dean; Schmidt, Meic H; Polly, David W; Biagini, Roberto; Burch, Shane; Dekutoski, Mark B; Ganju, Aruna; Gerszten, Peter C; Gokaslan, Ziya L; Groff, Michael W; Liebsch, Norbert J; Mendel, Ehud; Okuno, Scott H; Patel, Shreyaskumar; Rhines, Laurence D; Rose, Peter S; Sciubba, Daniel M; Sundaresan, Narayan; Tomita, Katsuro; Varga, Peter P; Vialle, Luiz R; Vrionis, Frank D; Yamada, Yoshiya; Fourney, Daryl R
Study design
Systematic review and modified Delphi technique.
Objective
To use an evidence-based medicine process using the best available literature and expert opinion consensus to develop a comprehensive classification system to diagnose neoplastic spinal instability.
Summary of background data
Spinal instability is poorly defined in the literature and presently there is a lack of guidelines available to aid in defining the degree of spinal instability in the setting of neoplastic spinal disease. The concept of spinal instability remains important in the clinical decision-making process for patients with spine tumors.
Methods
We have integrated the evidence provided by systematic reviews through a modified Delphi technique to generate a consensus of best evidence and expert opinion to develop a classification system to define neoplastic spinal instability.
Results
A comprehensive classification system based on patient symptoms and radiographic criteria of the spine was developed to aid in predicting spine stability of neoplastic lesions. The classification system includes global spinal location of the tumor, type and presence of pain, bone lesion quality, spinal alignment, extent of vertebral body collapse, and posterolateral spinal element involvement. Qualitative scores were assigned based on relative importance of particular factors gleaned from the literature and refined by expert consensus.
Conclusion
The Spine Instability Neoplastic Score is a comprehensive classification system with content validity that can guide clinicians in identifying when patients with neoplastic disease of the spine may benefit from surgical consultation. It can also aid surgeons in assessing the key components of spinal instability due to neoplasia and may become a prognostic tool for surgical decision-making when put in context with other key elements such as neurologic symptoms, extent of disease, prognosis, patient health factors, oncologic subtype, and radiosensitivity of the tumor.
Open Access
A standardized nomenclature for cervical spine soft-tissue release and osteotomy for deformity correction: clinical article.
(Journal of neurosurgery. Spine, 2013-09) Ames, Christopher P; Smith, Justin S; Scheer, Justin K; Shaffrey, Christopher I; Lafage, Virginie; Deviren, Vedat; Moal, Bertrand; Protopsaltis, Themistocles; Mummaneni, Praveen V; Mundis, Gregory M; Hostin, Richard; Klineberg, Eric; Burton, Douglas C; Hart, Robert; Bess, Shay; Schwab, Frank J; International Spine Study Group
Object
Cervical spine osteotomies are powerful techniques to correct rigid cervical spine deformity. Many variations exist, however, and there is no current standardized system with which to describe and classify cervical osteotomies. This complicates the ability to compare outcomes across procedures and studies. The authors' objective was to establish a universal nomenclature for cervical spine osteotomies to provide a common language among spine surgeons.
Methods
A proposed nomenclature with 7 anatomical grades of increasing extent of bone/soft tissue resection and destabilization was designed. The highest grade of resection is termed the major osteotomy, and an approach modifier is used to denote the surgical approach(es), including anterior (A), posterior (P), anterior-posterior (AP), posterior-anterior (PA), anterior-posterior-anterior (APA), and posterior-anterior-posterior (PAP). For cases in which multiple grades of osteotomies were performed, the highest grade is termed the major osteotomy, and lower-grade osteotomies are termed minor osteotomies. The nomenclature was evaluated by 11 reviewers through 25 different radiographic clinical cases. The review was performed twice, separated by a minimum 1-week interval. Reliability was assessed using Fleiss kappa coefficients.
Results
The average intrarater reliability was classified as "almost perfect agreement" for the major osteotomy (0.89 [range 0.60-1.00]) and approach modifier (0.99 [0.95-1.00]); it was classified as "moderate agreement" for the minor osteotomy (0.73 [range 0.41-1.00]). The average interrater reliability for the 2 readings was the following: major osteotomy, 0.87 ("almost perfect agreement"); approach modifier, 0.99 ("almost perfect agreement"); and minor osteotomy, 0.55 ("moderate agreement"). Analysis of only major osteotomy plus approach modifier yielded a classification that was "almost perfect" with an average intrarater reliability of 0.90 (0.63-1.00) and an interrater reliability of 0.88 and 0.86 for the two reviews.
Conclusions
The proposed cervical spine osteotomy nomenclature provides the surgeon with a simple, standard description of the various cervical osteotomies. The reliability analysis demonstrated that this system is consistent and directly applicable. Future work will evaluate the relationship between this system and health-related quality of life metrics.
Open Access
A Unified Framework for Evidence-Based Diagnostic Criteria Programs in Movement Disorders.
(Movement disorders : official journal of the Movement Disorder Society, 2023-07) Mestre, Tiago A; Fabbri, Margherita; Luo, Sheng; Stebbins, Glenn T; Goetz, Christopher G; Sampaio, Cristina
Open Access
Acquisition, Analysis, and Sharing of Data in 2015 and Beyond: A Survey of the Landscape: A Conference Report From the American Heart Association Data Summit 2015.
(J Am Heart Assoc, 2015-11-05) Antman, Elliott M; Benjamin, Emelia J; Harrington, Robert A; Houser, Steven R; Peterson, Eric D; Bauman, Mary Ann; Brown, Nancy; Bufalino, Vincent; Califf, Robert M; Creager, Mark A; Daugherty, Alan; Demets, David L; Dennis, Bernard P; Ebadollahi, Shahram; Jessup, Mariell; Lauer, Michael S; Lo, Bernard; MacRae, Calum A; McConnell, Michael V; McCray, Alexa T; Mello, Michelle M; Mueller, Eric; Newburger, Jane W; Okun, Sally; Packer, Milton; Philippakis, Anthony; Ping, Peipei; Prasoon, Prad; Roger, Véronique L; Singer, Steve; Temple, Robert; Turner, Melanie B; Vigilante, Kevin; Warner, John; Wayte, Patrick; American Heart Association Data Sharing Summit Attendees
BACKGROUND: A 1.5-day interactive forum was convened to discuss critical issues in the acquisition, analysis, and sharing of data in the field of cardiovascular and stroke science. The discussion will serve as the foundation for the American Heart Association's (AHA's) near-term and future strategies in the Big Data area. The concepts evolving from this forum may also inform other fields of medicine and science. METHODS AND RESULTS: A total of 47 participants representing stakeholders from 7 domains (patients, basic scientists, clinical investigators, population researchers, clinicians and healthcare system administrators, industry, and regulatory authorities) participated in the conference. Presentation topics included updates on data as viewed from conventional medical and nonmedical sources, building and using Big Data repositories, articulation of the goals of data sharing, and principles of responsible data sharing. Facilitated breakout sessions were conducted to examine what each of the 7 stakeholder domains wants from Big Data under ideal circumstances and the possible roles that the AHA might play in meeting their needs. Important areas that are high priorities for further study regarding Big Data include a description of the methodology of how to acquire and analyze findings, validation of the veracity of discoveries from such research, and integration into investigative and clinical care aspects of future cardiovascular and stroke medicine. Potential roles that the AHA might consider include facilitating a standards discussion (eg, tools, methodology, and appropriate data use), providing education (eg, healthcare providers, patients, investigators), and helping build an interoperable digital ecosystem in cardiovascular and stroke science. CONCLUSION: There was a consensus across stakeholder domains that Big Data holds great promise for revolutionizing the way cardiovascular and stroke research is conducted and clinical care is delivered; however, there is a clear need for the creation of a vision of how to use it to achieve the desired goals. Potential roles for the AHA center around facilitating a discussion of standards, providing education, and helping establish a cardiovascular digital ecosystem. This ecosystem should be interoperable and needs to interface with the rapidly growing digital object environment of the modern-day healthcare system.
Open Access
Assessment of Surgical Treatment Strategies for Moderate to Severe Cervical Spinal Deformity Reveals Marked Variation in Approaches, Osteotomies, and Fusion Levels.
(World neurosurgery, 2016-07) Smith, Justin S; Klineberg, Eric; Shaffrey, Christopher I; Lafage, Virginie; Schwab, Frank J; Protopsaltis, Themistocles; Scheer, Justin K; Ailon, Tamir; Ramachandran, Subaraman; Daniels, Alan; Mundis, Gregory; Gupta, Munish; Hostin, Richard; Deviren, Vedat; Eastlack, Robert; Passias, Peter; Hamilton, D Kojo; Hart, Robert; Burton, Douglas C; Bess, Shay; Ames, Christopher P; International Spine Study Group
Objective
Although previous reports suggest that surgery can improve the pain and disability of cervical spinal deformity (CSD), techniques are not standardized. Our objective was to assess for consensus on recommended surgical plans for CSD treatment.
Methods
Eighteen CSD cases were assembled, including a clinical vignette, cervical imaging (radiography, computed tomography/magnetic resonance imaging), and full-length standing radiography. Fourteen deformity surgeons (10 orthopedic, 4 neurosurgery) were queried regarding recommended surgical plans.
Results
There was marked variation in treatment plans across all deformity types. Even for the least complex deformities (moderate midcervical apex kyphosis), there was lack of agreement on approach (50% combined anterior-posterior, 25% anterior only, 25% posterior only), number of anterior (range, 2-6) and posterior (range, 4-16) fusion levels, and types of osteotomies. As the kyphosis apex moved caudally (cervical-thoracic junction/upper thoracic spine) and for cases with chin-on-chest kyphosis, >80% of surgeons agreed on a posterior-only approach and >70% recommended a pedicle subtraction osteotomy or vertebral column resection, but the range in number of anterior (4-8) and posterior (4-27) fusion levels was exceptionally broad. Cases of cervical/cervical-thoracic scoliosis had the least agreement for approach (48% posterior only, 33% combined anterior-posterior, 17% anterior-posterior-anterior or posterior-anterior-posterior, 2% anterior only) and had broad variation in the number of anterior (2-5) and posterior (6-19) fusion levels, and recommended osteotomies (41% pedicle subtraction osteotomy/vertebral column resection).
Conclusions
Among a panel of deformity surgeons, there was marked lack of consensus on recommended surgical approach, osteotomies, and fusion levels for CSD. Further study is warranted to assess whether specific surgical treatment approaches are associated with better outcomes.
Open Access
Bumps and bridges on the road to responsible sharing of clinical trial data.
(Clin Trials, 2014-02) Berlin, Jesse A; Morris, Sandra; Rockhold, Frank; Askie, Lisa; Ghersi, Davina; Waldstreicher, Joanne
BACKGROUND: Sharing data from clinical trials could assist with the advancement of science and medicine, potentially providing a better understanding of both the benefits and risks of medicines and other treatments. Sharing data also allows for questions to be addressed at the meta-analysis level that cannot be addressed within individual studies. PURPOSE: In this article, we offer some practical recommendations that will allow researchers to readily combine datasets from different studies and sources, thereby enabling meta-analyses that could have significant impact on advancing medicine. METHODS: The authors relied on their collective experience in the conduct and reporting of clinical trials to define the areas of potential concern related to responsible sharing of clinical trial data. We conducted a review of the literature and engaged in an iterative consensus-building process. RESULTS: To further the goal of responsible sharing of clinical trial data, collaboration on a consistent set of data standards and methods across both industry and academia is sorely needed. Protection of participant privacy is a paramount principle. The additional questions of who maintains, funds, and oversees databases of participant-level data will be important to resolve. Requiring researchers to register their requests for participant-level data and to provide details of their intended research would allow others to evaluate the proposed research plan, consistent with the principles of science and transparency. LIMITATIONS: The recommendations represent the views of the individual authors. We recognize that other approaches to data sharing that have been advocated are also based on sound ethical and scientific principles.
Open Access
Commentary: Shunted single-ventricle neonatal ventricular-assist device support: Are we nearing a consensus strategy?
(The Journal of thoracic and cardiovascular surgery, 2019-08) Andersen, Nicholas D; Kirmani, Sonya; Turek, Joseph W
Open Access
Consensus development of a pediatric emergency medicine clerkship curriculum.
(West J Emerg Med, 2014-09) Askew, Kim L; Weiner, Debra; Murphy, Charles; Duong, Myto; Fox, James; Fox, Sean; O'Neill, James C; Nadkarni, Milan
INTRODUCTION: As emergency medicine (EM) has become a more prominent feature in the clinical years of medical school training, national EM clerkship curricula have been published to address the need to standardize students' experiences in the field. However, current national student curricula in EM do not include core pediatric emergency medicine (PEM) concepts. METHODS: A workgroup was formed by the Clerkship Directors in Emergency Medicine and the Pediatric Interest Group of the Society of Academic Emergency Medicine to develop a consensus on the content to be covered in EM and PEM student courses. RESULTS: The consensus is presented with the goal of outlining principles of pediatric emergency care and prioritizing students' exposure to the most common and life-threatening illnesses and injuries. CONCLUSION: This consensus curriculum can serve as a guide to directors of PEM and EM courses to optimize PEM knowledge and skills education.
Open Access
Consensus guidelines for newborn screening, diagnosis and treatment of infantile Krabbe disease.
(Orphanet journal of rare diseases, 2018-02) Kwon, Jennifer M; Matern, Dietrich; Kurtzberg, Joanne; Wrabetz, Lawrence; Gelb, Michael H; Wenger, David A; Ficicioglu, Can; Waldman, Amy T; Burton, Barbara K; Hopkins, Patrick V; Orsini, Joseph J
BACKGROUND:Krabbe disease is a rare neurodegenerative genetic disorder caused by deficiency of galactocerebrosidase. Patients with the infantile form of Krabbe disease can be treated at a presymptomatic stage with human stem cell transplantation which improves survival and clinical outcomes. However, without a family history, most cases of infantile Krabbe disease present after onset of symptoms and are ineligible for transplantation. In 2006, New York began screening newborns for Krabbe disease to identify presymptomatic cases. To ensure that those identified with infantile disease received timely treatment, New York public health and medical systems took steps to accurately diagnose and rapidly refer infants for human stem cell transplantation within the first few weeks of life. After 11 years of active screening in New York and the introduction of Krabbe disease newborn screening in other states, new information has been gained which can inform the design of newborn screening programs to improve infantile Krabbe disease outcomes. FINDINGS:Recent information relevant to Krabbe disease screening, diagnosis, and treatment were assessed by a diverse group of public health, medical, and advocacy professionals. Outcomes after newborn screening may improve if treatment for infantile disease is initiated before 30 days of life. Newer laboratory screening and diagnostic tools can improve the speed and specificity of diagnosis and help facilitate this early referral. Given the rarity of Krabbe disease, most recommendations were based on case series or expert opinion. CONCLUSION:This report updates recommendations for Krabbe disease newborn screening to improve the timeliness of diagnosis and treatment of infantile Krabbe disease. In the United States, several states have begun or are considering Krabbe disease newborn screening. These recommendations can guide public health laboratories on methodologies for screening and inform clinicians about the need to promptly diagnose and treat infantile Krabbe disease. The timing of the initial referral after newborn screening, the speed of diagnostic confirmation of infantile disease, and the transplantation center's experience and ability to rapidly respond to a suspected patient with newly diagnosed infantile Krabbe disease are critical for optimal outcomes.
Open Access
Consensus opinion on immune-mediated cytopenias after hematopoietic cell transplant for inherited metabolic disorders.
(Bone marrow transplantation, 2021-06) Gupta, Ashish O; Jan Boelens, Jaap; Ebens, Christen L; Kurtzberg, Joanne; Lund, Troy C; Smith, Angela R; Wagner, John E; Wynn, Robert; Blazar, Bruce R; Orchard, Paul J
Hematopoietic stem cell transplantation (HCT) has been increasingly used for patients with inherited metabolic disorders (IMD). Immune mediated cytopenias (IMCs) after HCT, manifesting as hemolytic anemia, thrombocytopenia, and/or neutropenia, are recognized as a significant complication in this patient population, yet our understanding of the incidence, risk factors, and pathophysiology is currently limited. Review of the published literature demonstrates a higher incidence in younger patients who undergo HCT for a nonmalignant disease indication. However, a few reports suggest that the incidence is even higher among those with IMD (incidence ranging from 10 to 56%). This review summarizes the literature, provides an approach to better understanding of the possible etiology of IMCs, and proposes a diagnostic and management plan for patients with IMD who develop single or multi-lineage cytopenias after HCT.
Open Access
Consensus recommendations for the classification and long-term follow up of infants who screen positive for Krabbe Disease.
(Molecular genetics and metabolism, 2021-09) Thompson-Stone, Robert; Ream, Margie A; Gelb, Michael; Matern, Dietrich; Orsini, Joseph J; Levy, Paul A; Rubin, Jennifer P; Wenger, David A; Burton, Barbara K; Escolar, Maria L; Kurtzberg, Joanne
Objective
To provide updated evidence and consensus-based recommendations for the classification of individuals who screen positive for Krabbe Disease (KD) and recommendations for long-term follow-up for those who are at risk for late onset Krabbe Disease (LOKD).
Methods
KD experts (KD NBS Council) met between July 2017 and June 2020 to develop consensus-based classification and follow-up recommendations. The resulting newly proposed recommendations were assessed in a historical cohort of 47 newborns from New York State who were originally classified at moderate or high risk for LOKD.
Results
Infants identified by newborn screening with possible KD should enter one of three clinical follow-up pathways (Early infantile KD, at-risk for LOKD, or unaffected), based on galactocerebrosidase (GALC) activity, psychosine concentration, and GALC genotype. Patients considered at-risk for LOKD based on low GALC activity and an intermediate psychosine concentration are further split into a high-risk or low-risk follow-up pathway based on genotype. Review of the historical New York State cohort found that the updated follow-up recommendations would reduce follow up testing by 88%.
Conclusion
The KD NBS Council has presented updated consensus recommendations for efficient and effective classification and follow-up of NBS positive patients with a focus on long-term follow-up of those at-risk for LOKD.
Open Access
Core outcomes set for research on the treatment of opioid use disorder (COS-OUD): the National Institute on Drug Abuse Clinical Trials Network protocol for an e-Delphi consensus study.
(Trials, 2021-01-28) Karnik, Niranjan S; Campbell, Cynthia I; Curtis, Megan E; Fiellin, David A; Ghitza, Udi; Hefner, Kathryn; Hser, Yih-Ing; McHugh, R Kathryn; Murphy, Sean M; McPherson, Sterling M; Moran, Landhing; Mooney, Larissa J; Wu, Li-Tzy; Shmueli-Blumberg, Dikla; Shulman, Matisyahu; Schwartz, Robert P; Stephens, Kari A; Watkins, Katherine E; Marsden, John
Background
A lack of consensus on the optimal outcome measures to assess the efficacy and effectiveness of interventions for the treatment of opioid use disorder (OUD) has hampered the pooling of research data for evidence synthesis and clinical guidelines. A core outcome set (COS) is a minimum set of outcome measures that are recommended for all studies of a particular condition. The National Drug Abuse Treatment Clinical Trials Network (CTN) Core Outcome Set for OUD (COS-OUD) is a development study to identify core constructs, meaningful outcomes, and their optimal measurement for all efficacy and effectiveness studies of OUD treatment and service delivery.
Methods/design
Overseen by an expert workgroup, a modified, stepwise, e-Delphi methodology will be used to gain consensus among a panel of clinical practitioners and researchers involved in the treatment of OUD, who are members of the CTN. Sequential rounds of anonymous, online questionnaires will be used to identify, rate the importance of, and refine a core outcome set. A consensus threshold will be achieved if at least 70% of the panel rate the measure as critical for inclusion in the COS-OUD. Where consensus is not reached or there are suggestions for new measures, these will be brought forward to a further round of review prior to a consensus meeting. Products from this study will be communicated via peer-reviewed scientific journals and conferences.
Discussion
This initiative will develop a COS for OUD intervention trials, treatment studies, and service delivery and will support the pooling of research and clinical practice data and efforts to develop measurement-based care within the OUD treatment cascade.
Trial registration
http://www.comet-initiative.org/Studies/Details/1579.
Open Access
Diagnostic criteria for temporomandibular disorders (DC/TMD) for children and adolescents: An international Delphi study-Part 1-Development of Axis I.
(Journal of oral rehabilitation, 2021-07) Rongo, Roberto; Ekberg, EwaCarin; Nilsson, Ing-Marie; Al-Khotani, Amal; Alstergren, Per; Conti, Paulo Cesar Rodrigues; Durham, Justin; Goulet, Jean-Paul; Hirsch, Christian; Kalaykova, Stanimira I; Kapos, Flavia P; Komiyama, Osamu; Koutris, Michail; List, Thomas; Lobbezoo, Frank; Ohrbach, Richard; Peck, Christopher C; Restrepo, Claudia; Rodrigues, Maria Joao; Sharma, Sonia; Svensson, Peter; Visscher, Corine M; Wahlund, Kerstin; Michelotti, Ambra
Background
Since in children and adolescence prevalence is assessed mainly on self-reported or proxy-reported signs and symptoms; there is a need to develop a more comprehensive standardised process for the collection of clinical information and the diagnosis of TMD in these populations.
Objective
To develop new instruments and to adapt the diagnostic criteria for temporomandibular disorders (DC/TMD) for the evaluation of TMD in children and adolescents.
Method
A modified Delphi method was used to seek international consensus among TMD experts. Fourteen clinicians and researchers in the field of oro-facial pain and TMD worldwide were invited to participate in a workshop initiated by the International Network for Orofacial Pain and Related Disorders Methodology (INfORM scientific network) at the General Session of the International Association for Dental Research (IADR, London 2018), as the first step in the Delphi process. Participants discussed the protocols required to make physical diagnoses included in the Axis I of the DC/TMD. Thereafter, nine experts in the field were added, and the first Delphi round was created. This survey included 60 statements for Axis I, and the experts were asked to respond to each statement on a five-item Likert scale ranging from 'Strongly disagree' to 'Strongly agree'. Consensus level was set at 80% agreement for the first round, and at 70% for the next.
Results
After three rounds of the Delphi process, a consensus among TMD experts was achieved and two adapted DC/TMD protocols for Axis I physical diagnoses for children and adolescents were developed.
Conclusion
Through international consensus among TMD experts, this study adapted the Axis I of the DC/TMD for use in evaluating TMD in children and adolescents.
Open Access
Elusive consensus: Polarization in elite communication on the COVID-19 pandemic.
(Science advances, 2020-07) Green, Jon; Edgerton, Jared; Naftel, Daniel; Shoub, Kelsey; Cranmer, Skyler J
Cues sent by political elites are known to influence public attitudes and behavior. Polarization in elite rhetoric may hinder effective responses to public health crises, when accurate information and rapid behavioral change can save lives. We examine polarization in cues sent to the public by current members of the U.S. House and Senate during the onset of the COVID-19 pandemic, measuring polarization as the ability to correctly classify the partisanship of tweets' authors based solely on the text and the dates they were sent. We find that Democrats discussed the crisis more frequently-emphasizing threats to public health and American workers-while Republicans placed greater emphasis on China and businesses. Polarization in elite discussion of the COVID-19 pandemic peaked in mid-February-weeks after the first confirmed case in the United States-and continued into March. These divergent cues correspond with a partisan divide in the public's early reaction to the crisis.
Open Access
Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: consensus statement for anaesthesia practice.
(Acta anaesthesiologica Scandinavica, 2016-03) Feldheiser, A; Aziz, O; Baldini, G; Cox, BPBW; Fearon, KCH; Feldman, LS; Gan, TJ; Kennedy, RH; Ljungqvist, O; Lobo, DN; Miller, T; Radtke, FF; Ruiz Garces, T; Schricker, T; Scott, MJ; Thacker, JK; Ytrebø, LM; Carli, F
The present interdisciplinary consensus review proposes clinical considerations and recommendations for anaesthetic practice in patients undergoing gastrointestinal surgery with an Enhanced Recovery after Surgery (ERAS) programme.Studies were selected with particular attention being paid to meta-analyses, randomized controlled trials and large prospective cohort studies. For each item of the perioperative treatment pathway, available English-language literature was examined and reviewed. The group reached a consensus recommendation after critical appraisal of the literature.This consensus statement demonstrates that anaesthesiologists control several preoperative, intraoperative and postoperative ERAS elements. Further research is needed to verify the strength of these recommendations.Based on the evidence available for each element of perioperative care pathways, the Enhanced Recovery After Surgery (ERAS®) Society presents a comprehensive consensus review, clinical considerations and recommendations for anaesthesia care in patients undergoing gastrointestinal surgery within an ERAS programme. This unified protocol facilitates involvement of anaesthesiologists in the implementation of the ERAS programmes and allows for comparison between centres and it eventually might facilitate the design of multi-institutional prospective and adequately powered randomized trials.
Open Access
ERAS/STS 2024 Expert Consensus Statement on Perioperative Care in Cardiac Surgery: Continuing the Evolution of Optimized Patient Care and Recovery.
(Journal of cardiothoracic and vascular anesthesia, 2024-10) Gregory, Alexander; Ender, Joerg; Shaw, Andrew D; Denault, André; Ibekwe, Stephanie; Stoppe, Christian; Alli, Ahmad; Manning, Michael W; Brodt, Jessica L; Galhardo, Carlos; Sander, Michael; Zarbock, Alexander; Fletcher, Nick; Ghadimi, Kamrouz; Grant, Michael C
Open Access
Global guideline for the diagnosis and management of the endemic mycoses: an initiative of the European Confederation of Medical Mycology in cooperation with the International Society for Human and Animal Mycology.
(The Lancet. Infectious diseases, 2021-12) Thompson, George R; Le, Thuy; Chindamporn, Ariya; Kauffman, Carol A; Alastruey-Izquierdo, Ana; Ampel, Neil M; Andes, David R; Armstrong-James, Darius; Ayanlowo, Olusola; Baddley, John W; Barker, Bridget M; Lopes Bezerra, Leila; Buitrago, Maria J; Chamani-Tabriz, Leili; Chan, Jasper FW; Chayakulkeeree, Methee; Cornely, Oliver A; Cunwei, Cao; Gangneux, Jean-Pierre; Govender, Nelesh P; Hagen, Ferry; Hedayati, Mohammad T; Hohl, Tobias M; Jouvion, Grégory; Kenyon, Chris; Kibbler, Christopher C; Klimko, Nikolai; Kong, David CM; Krause, Robert; Lee Lee, Low; Meintjes, Graeme; Miceli, Marisa H; Rath, Peter-Michael; Spec, Andrej; Queiroz-Telles, Flavio; Variava, Ebrahim; Verweij, Paul E; Schwartz, Ilan S; Pasqualotto, Alessandro C
The global burden of the endemic mycoses (blastomycosis, coccidioidomycosis, emergomycosis, histoplasmosis, paracoccidioidomycosis, sporotrichosis, and talaromycosis) continues to rise yearly and these infectious diseases remain a leading cause of patient morbidity and mortality worldwide. Management of the associated pathogens requires a thorough understanding of the epidemiology, risk factors, diagnostic methods and performance characteristics in different patient populations, and treatment options unique to each infection. Guidance on the management of these infections has the potential to improve prognosis. The recommendations outlined in this Review are part of the "One World, One Guideline" initiative of the European Confederation of Medical Mycology. Experts from 23 countries contributed to the development of these guidelines. The aim of this Review is to provide an up-to-date consensus and practical guidance in clinical decision making, by engaging physicians and scientists involved in various aspects of clinical management.
Open Access
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021.
(Nature reviews. Rheumatology, 2022-08) Coates, Laura C; Soriano, Enrique R; Corp, Nadia; Bertheussen, Heidi; Callis Duffin, Kristina; Campanholo, Cristiano B; Chau, Jeffrey; Eder, Lihi; Fernández-Ávila, Daniel G; FitzGerald, Oliver; Garg, Amit; Gladman, Dafna D; Goel, Niti; Helliwell, Philip S; Husni, M Elaine; Jadon, Deepak R; Katz, Arnon; Laheru, Dhruvkumar; Latella, John; Leung, Ying-Ying; Lindsay, Christine; Lubrano, Ennio; Mazzuoccolo, Luis Daniel; Mease, Philip J; O'Sullivan, Denis; Ogdie, Alexis; Olsder, Wendy; Palominos, Penelope Esther; Schick, Lori; Steinkoenig, Ingrid; de Wit, Maarten; van der Windt, DA; Kavanaugh, Arthur; GRAPPA Treatment Recommendations domain subcommittees
Since the second version of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) treatment recommendations were published in 2015, therapeutic options for psoriatic arthritis (PsA) have advanced considerably. This work reviews the literature since the previous recommendations (data published 2013-2020, including conference presentations between 2017 and 2020) and reports high-quality, evidence-based, domain-focused recommendations for medication selection in PsA developed by GRAPPA clinicians and patient research partners. The overarching principles for the management of adults with PsA were updated by consensus. Principles considering biosimilars and tapering of therapy were added, and the research agenda was revised. Literature searches covered treatments for the key domains of PsA: peripheral arthritis, axial disease, enthesitis, dactylitis, and skin and nail psoriasis; additional searches were performed for PsA-related conditions (uveitis and inflammatory bowel disease) and comorbidities. Individual subcommittees used a GRADE-informed approach, taking into account the quality of evidence for therapies, to generate recommendations for each of these domains, which were incorporated into an overall schema. Choice of therapy for an individual should ideally address all disease domains active in that patient, supporting shared decision-making. As safety issues often affect potential therapeutic choices, additional consideration was given to relevant comorbidities. These GRAPPA treatment recommendations provide up-to-date, evidence-based guidance on PsA management for clinicians and people with PsA.
Open Access
Guidance for switching from off-label antipsychotics to pimavanserin for Parkinson's disease psychosis: an expert consensus.
(CNS spectrums, 2018-12) Black, Kevin J; Nasrallah, Henry; Isaacson, Stuart; Stacy, Mark; Pahwa, Rajesh; Adler, Charles H; Alva, Gustavo; Cooney, Jeffrey W; Kremens, Daniel; Menza, Matthew A; Meyer, Jonathan M; Patkar, Ashwin A; Simuni, Tanya; Morrissette, Debbi A; Stahl, Stephen M
Patients with Parkinson's disease psychosis (PDP) are often treated with an atypical antipsychotic, especially quetiapine or clozapine, but side effects, lack of sufficient efficacy, or both may motivate a switch to pimavanserin, the first medication approved for management of PDP. How best to implement a switch to pimavanserin has not been clear, as there are no controlled trials or case series in the literature to provide guidance. An abrupt switch may interrupt partially effective treatment or potentially trigger rebound effects from antipsychotic withdrawal, whereas cross-taper involves potential drug interactions. A panel of experts drew from published data, their experience treating PDP, lessons from switching antipsychotic drugs in other populations, and the pharmacology of the relevant drugs, to establish consensus recommendations. The panel concluded that patients with PDP can be safely and effectively switched from atypical antipsychotics used off label in PDP to the recently approved pimavanserin by considering each agent's pharmacokinetics and pharmacodynamics, receptor interactions, and the clinical reason for switching (efficacy or adverse events). Final recommendations are that such a switch should aim to maintain adequate 5-HT2A antagonism during the switch, thus providing a stable transition so that efficacy is maintained. Specifically, the consensus recommendation is to add pimavanserin at the full recommended daily dose (34 mg) for 2-6 weeks in most patients before beginning to taper and discontinue quetiapine or clozapine over several days to weeks. Further details are provided for this recommendation, as well as for special clinical circumstances where switching may need to proceed more rapidly.
Open Access
Introduction to a Special Issue of the Journal of Immunological Methods: Building global resource programs to support HIV/AIDS clinical trial studies.
(J Immunol Methods, 2014-07) Sanchez, Ana M; Denny, Thomas N; O'Gorman, Maurice
This Special Issue of the Journal of Immunological Methods includes 16 manuscripts describing quality assurance activities related to virologic and immunologic monitoring of six global laboratory resource programs that support international HIV/AIDS clinical trial studies: Collaboration for AIDS Vaccine Discovery (CAVD); Center for HIV/AIDS Vaccine Immunology (CHAVI); External Quality Assurance Program Oversight Laboratory (EQAPOL); HIV Vaccine Trial Network (HVTN); International AIDS Vaccine Initiative (IAVI); and Immunology Quality Assessment (IQA). The reports from these programs address the many components required to develop comprehensive quality control activities and subsequent quality assurance programs for immune monitoring in global clinical trials including: all aspects of processing, storing, and quality assessment of PBMC preparations used ubiquitously in HIV clinical trials, the development and optimization of assays for CD8 HIV responses and HIV neutralization, a comprehensive global HIV virus repository, and reports on the development and execution of novel external proficiency testing programs for immunophenotyping, intracellular cytokine staining, ELISPOT and luminex based cytokine measurements. In addition, there are articles describing the implementation of Good Clinical Laboratory Practices (GCLP) in a large quality assurance laboratory, the development of statistical methods specific for external proficiency testing assessment, a discussion on the ability to set objective thresholds for measuring rare events by flow cytometry, and finally, a manuscript which addresses a framework for the structured reporting of T cell immune function based assays. It is anticipated that this series of manuscripts covering a wide range of quality assurance activities associated with the conduct of global clinical trials will provide a resource for individuals and programs involved in improving the harmonization, standardization, accuracy, and sensitivity of virologic and immunologic testing.

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