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Consensus on biomarkers for neuroendocrine tumour disease.
Oberg K, Modlin IM, De Herder W, Pavel M, Klimstra D, Frilling A, Metz DC, Heaney A, Kwekkeboom D, Strosberg J, Meyer T, Moss SF, Washington K, Wolin E, Liu E, Goldenring J
(2015) Lancet Oncol 16: e435-e446
MeSH Terms: Biomarkers, Tumor, Delphi Technique, Humans, MicroRNAs, National Cancer Institute (U.S.), Neoplastic Cells, Circulating, Neuroendocrine Tumors, Prognosis, United States
Show Abstract · Added April 12, 2016
Management of neuroendocrine neoplasia represents a clinical challenge because of its late presentation, lack of treatment options, and limitations in present imaging modalities and biomarkers to guide management. Monoanalyte biomarkers have poor sensitivity, specificity, and predictive ability. A National Cancer Institute summit, held in 2007, on neuroendocrine tumours noted biomarker limitations to be a crucial unmet need in the management of neuroendocrine tumours. A multinational consensus meeting of multidisciplinary experts in neuroendocrine tumours assessed the use of current biomarkers and defined the perquisites for novel biomarkers via the Delphi method. Consensus (at >75%) was achieved for 88 (82%) of 107 assessment questions. The panel concluded that circulating multianalyte biomarkers provide the highest sensitivity and specificity necessary for minimum disease detection and that this type of biomarker had sufficient information to predict treatment effectiveness and prognosis. The panel also concluded that no monoanalyte biomarker of neuroendocrine tumours has yet fulfilled these criteria and there is insufficient information to support the clinical use of miRNA or circulating tumour cells as useful prognostic markers for this disease. The panel considered that trials measuring multianalytes (eg, neuroendocrine gene transcripts) should also identify how such information can optimise the management of patients with neuroendocrine tumours.
Copyright © 2015 Elsevier Ltd. All rights reserved.
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9 MeSH Terms
Vascular content, tone, integrity, and haemodynamics for guiding fluid therapy: a conceptual approach.
Chawla LS, Ince C, Chappell D, Gan TJ, Kellum JA, Mythen M, Shaw AD, ADQI XII Fluids Workgroup
(2014) Br J Anaesth 113: 748-55
MeSH Terms: Blood Vessels, Delphi Technique, Dialysis, Fluid Therapy, Hemodynamics, Humans, Microcirculation, Perfusion, Regional Blood Flow, Sepsis
Show Abstract · Added October 20, 2015
BACKGROUND - Despite many clinical trials and investigative efforts to determine appropriate therapeutic intervention(s) for shock, this topic remains controversial. The use of i.v. fluid has represented the cornerstone for the treatment of hypoperfusion for two centuries.
METHODS - As a part of International Acute Dialysis Quality Initiative XII Fluids Workgroup meeting, we sought to incorporate recent advances in our understanding of vascular biology into a more comprehensive yet accessible approach to the patient with hypoperfusion. In this workgroup, we attempted to develop a framework that incorporates key aspects of the vasculature into a diagnostic approach.
RESULTS - The four main components of our proposal involve the assessment of the blood flow (BF), vascular content (vC), the vascular barrier (vB), and vascular tone (vT). Any significant perturbation in any of these domains can lead to hypoperfusion at both the macro- and micro-circulatory level. We have termed the BF, vC, vB, and vT diagnostic approach the vascular component (VC) approach.
CONCLUSIONS - The VC approach to hypoperfusion has potential advantages to the current diagnostic system. This approach also has the distinct advantage that it can be used to assess the systemic, regional, and micro-vasculature, thereby harmonizing the approach to clinical vascular diagnostics across these levels. The VC approach will need to be tested prospectively to determine if this system can in fact improve outcomes in patients who suffer from hypoperfusion.
© The Author 2014. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
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10 MeSH Terms
Pharmacological management of fluid overload.
Goldstein S, Bagshaw S, Cecconi M, Okusa M, Wang H, Kellum J, Mythen M, Shaw AD, ADQI XII Investigators Group
(2014) Br J Anaesth 113: 756-63
MeSH Terms: Critical Care, Delphi Technique, Diuretics, Fluid Therapy, Heart Failure, Humans, Perfusion, Resuscitation, Shock, Water-Electrolyte Imbalance
Show Abstract · Added October 20, 2015
BACKGROUND - Standard treatment practice for the hypotensive patient with poor tissue perfusion is rapid volume resuscitation; in some scenarios, such as septic shock, this is performed with targeted goal-directed endpoints within 6 h of presentation. As a result, patients often develop significant positive fluid accumulation, which has been associated with poor outcomes above certain thresholds.
METHODS - The aim of the current paper is to provide guidance for active pharmacological fluid management in the patient with, or at risk for, clinically significant positive fluid balance from either resuscitation for hypovolaemic shock or acute decompensated heart failure.
RESULTS - We develop rationale for pharmacological fluid management targets (prevention of worsening fluid accumulation, achievement of slow vs rapid net negative fluid balance) in the context of phases of critical illness provided in the earlier Acute Dialysis Quality Initiative 12 papers.
© The Author 2014. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
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10 MeSH Terms
Development and testing of the fibromyalgia diagnostic screen for primary care.
Arnold LM, Stanford SB, Welge JA, Crofford LJ
(2012) J Womens Health (Larchmt) 21: 231-9
MeSH Terms: Academic Medical Centers, Adult, Aged, Comorbidity, Delphi Technique, Female, Fibromyalgia, Humans, Logistic Models, Male, Middle Aged, Ohio, Physical Examination, Physicians, Primary Health Care, ROC Curve
Show Abstract · Added September 18, 2013
BACKGROUND - The Fibromyalgia Diagnostic Screen was developed for use by primary care clinicians to assist in the diagnostic evaluation of fibromyalgia, a disorder that predominantly affects women.
METHODS - The screen was designed to have a patient-completed questionnaire and a clinician-completed section, which included a brief physical examination pertinent to the differential diagnosis of fibromyalgia. The items in the questionnaire were based on patient focus groups and clinician and patient Delphi exercises, which resulted in a ranking of the most common and troublesome fibromyalgia symptoms. One hundred new chronic pain patients (pain > 30 days) and their primary care physicians completed the screen. The patients were grouped as fibromyalgia or nonfibromyalgia by an independent fibromyalgia specialist, who was blind to screen responses. Logistic regression was used to model the probability of fibromyalgia as a function of physician-reported and patient-reported variables. Best subset regression was used to identify a subset of symptoms that were summed to form a single measure. Receiver operating characteristic (ROC) analysis was then used to select thresholds for continuous variables. The symptom and clinical variables were combined to create candidate prediction rules that were compared in terms of sensitivity and specificity to select the best criterion.
RESULTS - Two final models were selected based on overall accuracy in predicting fibromyalgia: one used the patient-reported questionnaire only, and the other added a subset of the physical examination items to this patient questionnaire.
CONCLUSION - A patient-reported questionnaire with or without a brief physical examination may improve identification of fibromyalgia patients in primary care settings.
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16 MeSH Terms
Pathology reporting of neuroendocrine tumors: application of the Delphic consensus process to the development of a minimum pathology data set.
Klimstra DS, Modlin IR, Adsay NV, Chetty R, Deshpande V, Gönen M, Jensen RT, Kidd M, Kulke MH, Lloyd RV, Moran C, Moss SF, Oberg K, O'Toole D, Rindi G, Robert ME, Suster S, Tang LH, Tzen CY, Washington MK, Wiedenmann B, Yao J
(2010) Am J Surg Pathol 34: 300-13
MeSH Terms: Biomarkers, Tumor, Cell Differentiation, Cell Proliferation, Checklist, Consensus Development Conferences as Topic, Delphi Technique, Genetic Techniques, Humans, Immunohistochemistry, Neoplasm Staging, Neuroendocrine Tumors, Practice Guidelines as Topic, Predictive Value of Tests, Prognosis, Reproducibility of Results, Terminology as Topic
Show Abstract · Added April 12, 2016
Epithelial neuroendocrine tumors (NETs) have been the subject of much debate regarding their optimal classification. Although multiple systems of nomenclature, grading, and staging have been proposed, none has achieved universal acceptance. To help define the underlying common features of these classification systems and to identify the minimal pathology data that should be reported to ensure consistent clinical management and reproducibility of data from therapeutic trials, a multidisciplinary team of physicians interested in NETs was assembled. At a group meeting, the participants discussed a series of "yes" or "no" questions related to the pathology of NETs and the minimal data to be included in the reports. After discussion, anonymous votes were taken, using the Delphic principle that 80% agreement on a vote of either yes or no would define a consensus. Questions that failed to achieve a consensus were rephrased once or twice and discussed, and additional votes were taken. Of 108 questions, 91 were answerable either yes or no by more than 80% of the participants. There was agreement about the importance of proliferation rate for tumor grading, the landmarks to use for staging, the prognostic factors assessable by routine histology that should be reported, the potential for tumors to progress biologically with metastasis, and the current status of advanced immunohistochemical and molecular testing for treatment-related biomarkers. The lack of utility of a variety of immunohistochemical stains and pathologic findings was also agreed upon. A consensus could not be reached for the remaining 17 questions, which included both minor points related to extent of disease assessment and some major areas such as terminology, routine immunohistochemical staining for general neuroendocrine markers, use of Ki67 staining to assess proliferation, and the relationship of tumor grade to degree of differentiation. On the basis of the results of the Delphic voting, a minimum pathology data set was developed. Although there remains disagreement among experts about the specific classification system that should be used, there is agreement about the fundamental pathology data that should be reported. Examination of the areas of disagreement reveals significant opportunities for collaborative study to resolve unanswered questions.
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16 MeSH Terms
Content and criterion validity of the preliminary core dataset for clinical trials in fibromyalgia syndrome.
Choy EH, Arnold LM, Clauw DJ, Crofford LJ, Glass JM, Simon LS, Martin SA, Strand CV, Williams DA, Mease PJ
(2009) J Rheumatol 36: 2330-4
MeSH Terms: Cognition Disorders, Consensus, Delphi Technique, Fatigue, Fibromyalgia, Humans, International Cooperation, Outcome Assessment (Health Care), Pain, Randomized Controlled Trials as Topic, Reproducibility of Results, Syndrome
Show Abstract · Added September 18, 2013
OBJECTIVE - Increasing research interest and emerging new therapies for treatment of fibromyalgia (FM) have led to a need to develop a consensus on a core set of outcome measures that should be assessed and reported in all clinical trials, to facilitate interpretation of the data and understanding of the disease. This aligns with the key objective of the Outcome Measures in Rheumatology (OMERACT) initiative to improve outcome measurement through a data driven, interactive consensus process.
METHODS - Through patient focus groups and Delphi processes, working groups at previous OMERACT meetings identified potential domains to be included in the core data set. A systematic review has shown that instruments measuring these domains are available and are at least moderately sensitive to change. Most instruments have been validated in multiple languages. This pooled analysis study aims to develop the core data set by analyzing data from 10 randomized controlled trials (RCT) in FM.
RESULTS - Results from this study provide support for the inclusion of the following in the core data set: pain, tenderness, fatigue, sleep, patient global assessment, and multidimensional function/health related quality of life. Construct validity was demonstrated with outcome instruments showing convergent and divergent validity. Content and criterion validity were confirmed by multivariate analysis showing R square values between 0.4 and 0.6. Low R square value is associated with studies in which one or more domains were not assessed.
CONCLUSION - The core data set was supported by high consensus among attendees at OMERACT 9. Establishing an international standard for RCT in FM should facilitate future metaanalyses and indirect comparisons.
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12 MeSH Terms
Fibromyalgia syndrome module at OMERACT 9: domain construct.
Mease P, Arnold LM, Choy EH, Clauw DJ, Crofford LJ, Glass JM, Martin SA, Morea J, Simon L, Strand CV, Williams DA, OMERACT Fibromyalgia Working Group
(2009) J Rheumatol 36: 2318-29
MeSH Terms: Clinical Trials as Topic, Delphi Technique, Fibromyalgia, Humans, International Cooperation, Outcome Assessment (Health Care), Syndrome
Show Abstract · Added September 18, 2013
The objective of the module was to (1) establish a core domain set for fibromyalgia (FM) assessment in clinical trials and practice, (2) review outcome measure performance characteristics, (3) discuss development of a responder index for assessment of FM in clinical trials, (4) review objective markers, (5) review the domain of cognitive dysfunction, and (6) establish a research agenda for outcomes research. Presentations at the module included: (1) Results of univariate and multivariate analysis of 10 FM clinical trials of 4 drugs, mapping key domains identified in previous patient focus group: Delphi exercises and a clinician/researcher Delphi exercise, and breakout discussions to vote on possible essential domains and reliable measures; (2) Updates regarding outcome measure status; (3) Update on objective markers to measure FM disease state; and (4) Review of the issue of cognitive dysfunction (dyscognition) in FM. Consensus was reached as follows: (1) Greater than 70% of OMERACT participants agreed that pain, tenderness, fatigue, patient global, multidimensional function and sleep disturbance domains should be measured in all FM clinical trials; dyscognition and depression should be measured in some trials; and stiffness, anxiety, functional imaging, and cerebrospinal fluid biomarkers were identified as domains of research interest. (2) FM domain outcome measures have generally proven to be reliable, discriminative, and feasible. More sophisticated and comprehensive measures are in development, as is a responder index for FM. (3) Increasing numbers of objective markers are being developed for FM assessment. (4) Cognitive dysfunction assessment by self-assessed and applied outcome measures is being developed. In conclusion, a multidimensional symptom core set is proposed for evaluation of FM in clinical trials. Research on improved measures of single domains and composite measures is ongoing.
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7 MeSH Terms
Identifying the clinical domains of fibromyalgia: contributions from clinician and patient Delphi exercises.
Mease PJ, Arnold LM, Crofford LJ, Williams DA, Russell IJ, Humphrey L, Abetz L, Martin SA
(2008) Arthritis Rheum 59: 952-60
MeSH Terms: Activities of Daily Living, Adult, Delphi Technique, Fatigue, Female, Fibromyalgia, Humans, Male, Middle Aged, Pain, Physicians, Quality of Life, Rheumatology, Severity of Illness Index, Sleep Wake Disorders
Show Abstract · Added September 18, 2013
OBJECTIVE - In evaluating the effectiveness of fibromyalgia (FM) therapies, it is important to assess the impact of those therapies on the full array of domains considered important by both clinicians and patients. The objective of this research was to identify and prioritize the key clinically relevant and important domains impacted by FM that should be evaluated by outcome assessment instruments used in FM clinical trials, and to approach consensus among clinicians and patients on the priority of those domains to be assessed in clinical care and research.
METHODS - Group consensus was achieved using the Delphi method, a structured process of consensus building via questionnaires together with systematic and controlled opinion feedback. The Delphi exercises involved 23 clinicians with expertise in FM and 100 patients with FM as defined by American College of Rheumatology criteria.
RESULTS - The Delphi exercise revealed that the domains ranked most highly by patients were similar to the domain rankings by clinicians. Pain was consistently ranked highest by both panels. Fatigue, impact on sleep, health-related quality of life, comorbid depression, and cognitive difficulty were also ranked highly. Stiffness was ranked highly by patients but not clinicians. In contrast, side effects was important to clinicians but was not identified as important in the patient Delphi exercise.
CONCLUSION - The clinician and patient Delphi exercises identified and ranked key domains that need to be assessed in FM research. Based on these results, a conceptual framework for measuring patient-reported outcomes is proposed.
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15 MeSH Terms
Fibromyalgia syndrome.
Mease PJ, Clauw DJ, Arnold LM, Goldenberg DL, Witter J, Williams DA, Simon LS, Strand CV, Bramson C, Martin S, Wright TM, Littman B, Wernicke JF, Gendreau RM, Crofford LJ
(2005) J Rheumatol 32: 2270-7
MeSH Terms: Delphi Technique, Fibromyalgia, Humans, Quality of Health Care, Rheumatology, Treatment Outcome
Show Abstract · Added September 18, 2013
The objectives of the first OMERACT Fibromyalgia Syndrome (FM) Workshop were to identify and prioritize symptom domains that should be consistently evaluated in FM clinical trials, and to identify aspects of domains and outcome measures that should be part of a concerted research agenda of FM researchers. Such an effort will help standardize and improve the quality of outcomes research in FM. A principal assumption in this workshop has been that there exists a clinical syndrome, generally known as FM, characterized by chronic widespread pain typically associated with fatigue, sleep disturbance, mood disturbance, and other symptoms and signs, and considered to be related to central neuromodulatory dysregulation. FM can be diagnosed using 1990 American College of Rheumatology criteria. In preparation for the workshop a Delphi exercise involving 23 FM researchers was conducted to establish a preliminary prioritization of domains of inquiry. At the OMERACT meeting, the workshop included presentation of the Delphi results; a review of placebo-controlled trials of FM treatment, with a focus on the outcome measures used and their performance; a panel discussion of the key issues in FM trials, from both an investigator and regulatory agency perspective; and a voting process by the workshop attendees. The results of the workshop were presented in the plenary session on the final day of the meeting. A prioritized list of domains of FM to be investigated was thus developed, key issues and controversies in the field were debated, and consensus on a research agenda on outcome measure development was reached.
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6 MeSH Terms