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Biology of Blood and Marrow... Jul 2020The American Society for Transplantation and Cellular Therapy (ASTCT) published its first white paper on indications for autologous and allogeneic hematopoietic cell...
The American Society for Transplantation and Cellular Therapy (ASTCT) published its first white paper on indications for autologous and allogeneic hematopoietic cell transplantation (HCT) in 2015. It was identified at the time that periodic updates of indications would be required to stay abreast with state of the art and emerging indications and therapy. In recent years the field has not only seen an improvement in transplantation technology, thus widening the therapeutic scope of HCT, but additionally a whole new treatment strategy using modified immune effector cells, including chimeric antigen receptor T cells and engineered T-cell receptors, has emerged. The guidelines review committee of the ASTCT deemed it optimal to update the ASTCT recommendations for indications for HCT to include new data and to incorporate indications for immune effector cell therapy (IECT) where appropriate. The guidelines committee established a multiple stakeholder task force consisting of transplant experts, payer representatives, and a patient advocate to provide guidance on indications for HCT and IECT. This article presents the updated recommendations from the ASTCT on indications for HCT and IECT. Indications for HCT/IECT were categorized as (1) Standard of care, where indication is well defined and supported by evidence; (2) Standard of care, clinical evidence available, where large clinical trials and observational studies are not available but have been shown to be effective therapy; (3) Standard of care, rare indication, for rare diseases where demonstrated effectiveness exists but large clinical trials and observational studies are not feasible; (4) Developmental, for diseases where preclinical and/or early-phase clinical studies show HCT/IECT to be a promising treatment option; and (5) Not generally recommended, where available evidence does not support the routine use of HCT/IECT. The ASTCT will continue to periodically review these guidelines and update them as new evidence becomes available.
Topics: Hematopoietic Stem Cell Transplantation; Humans; Lymphocytes; Receptors, Antigen, T-Cell; Transplantation, Autologous; Transplantation, Homologous; United States
PubMed: 32165328
DOI: 10.1016/j.bbmt.2020.03.002 -
Revue Medicale de LiegeCoronarography consists in selective angiography of the coronary arteries obtained invasively. It represents the gold standard for the anatomical exploration of the...
Coronarography consists in selective angiography of the coronary arteries obtained invasively. It represents the gold standard for the anatomical exploration of the coronary arteries and establishes the first step for the indication of possible percutaneous or surgical revascularisation. According to substantial progress, it represents an essential diagnostic tool frequently used with, despite its invasive characteristic, a very low complication's rate. The present article describes the patient's preparation for this procedure, technical modalities, major indications, contraindications and possible complications.
Topics: Contraindications; Coronary Angiography; Heart Diseases; Humans
PubMed: 31070311
DOI: No ID Found -
Frontiers in Artificial Intelligence 2021Drug labeling contains an 'INDICATIONS AND USAGE' that provides vital information to support clinical decision making and regulatory management. Effective extraction of...
Drug labeling contains an 'INDICATIONS AND USAGE' that provides vital information to support clinical decision making and regulatory management. Effective extraction of drug indication information from free-text based resources could facilitate drug repositioning projects and help collect real-world evidence in support of secondary use of approved medicines. To enable AI-powered language models for the extraction of drug indication information, we used manual reading and curation to develop a rug ndication lassification and ncyclopedia (DICE) based on FDA approved human prescription drug labeling. A DICE scheme with 7,231 sentences categorized into five classes (indications, contradictions, side effects, usage instructions, and clinical observations) was developed. To further elucidate the utility of the DICE, we developed nine different AI-based classifiers for the prediction of indications based on the developed DICE to comprehensively assess their performance. We found that the transformer-based language models yielded an average MCC of 0.887, outperforming the word embedding-based Bidirectional long short-term memory (BiLSTM) models (0.862) with a 2.82% improvement on the test set. The best classifiers were also used to extract drug indication information in DrugBank and achieved a high enrichment rate (>0.930) for this task. We found that domain-specific training could provide more explainable models without performance sacrifices and better generalization for external validation datasets. Altogether, the proposed DICE could be a standard resource for the development and evaluation of task-specific AI-powered, natural language processing (NLP) models.
PubMed: 34409286
DOI: 10.3389/frai.2021.711467 -
Journal of Intensive Medicine Jan 2022The indications and contraindications of parenteral nutrition (PN) are discussed in view of recent clinical findings. For decades, PN has been restricted to patients... (Review)
Review
The indications and contraindications of parenteral nutrition (PN) are discussed in view of recent clinical findings. For decades, PN has been restricted to patients unable to tolerate enteral nutrition (EN) intake owing to the perceived risk of severe side-effects. The evolution of the PN substrate composition and delivery of nutrition via all-in-one bags has dramatically improved the application prospects of PN. Recent studies show similar complication rates of nutrition therapy administered through enteral and intravenous routes. Therefore, indications of PN have, based on evidence, extended beyond complete gastrointestinal (GI) failure to include conditions such as insufficient EN generating persistent negative energy balance and insufficient protein intakes, malabsorption, or specific needs that are impossible to cover with EN feeds.
PubMed: 36789227
DOI: 10.1016/j.jointm.2021.11.006 -
Journal of the American Medical... Nov 2015Medication-indication information is a key part of the information needed for providing decision support for and promoting appropriate use of medications. However, this... (Comparative Study)
Comparative Study Review
OBJECTIVE
Medication-indication information is a key part of the information needed for providing decision support for and promoting appropriate use of medications. However, this information is not readily available to end users, and a lot of the resources only contain this information in unstructured form (free text). A number of public knowledge bases (KBs) containing structured medication-indication information have been developed over the years, but a direct comparison of these resources has not yet been conducted.
MATERIAL AND METHODS
We conducted a systematic review of the literature to identify all medication-indication KBs and critically appraised these resources in terms of their scope as well as their support for complex indication information.
RESULTS
We identified 7 KBs containing medication-indication data. They notably differed from each other in terms of their scope, coverage for on- or off-label indications, source of information, and choice of terminologies for representing the knowledge. The majority of KBs had issues with granularity of the indications as well as with representing duration of therapy, primary choice of treatment, and comedications or comorbidities.
DISCUSSION AND CONCLUSION
This is the first study directly comparing public KBs of medication indications. We identified several gaps in the existing resources, which can motivate future research.
Topics: Drug Therapy, Computer-Assisted; Humans; Knowledge Bases; Off-Label Use; Systematized Nomenclature of Medicine
PubMed: 26335981
DOI: 10.1093/jamia/ocv129 -
Acta Bio-medica : Atenei Parmensis May 2020The medial patellofemoral ligament (MPFL) is the most important structure commonly injured during lateral patellar dislocation and its rupture accounts for 3% of total... (Review)
Review
BACKGROUND AND AIM
The medial patellofemoral ligament (MPFL) is the most important structure commonly injured during lateral patellar dislocation and its rupture accounts for 3% of total knee injuries. MPFL reconstruction (MPFLR) is a reliable procedure with good results but variable rates of recurrent instability. The aim of this study is to underline the proper indications for the MPFLR reconstruction and to explain all the pearls and pitfalls regarding the MPFLR both in our experience and found in the latest literature.
METHODS
A comprehensive search in the latest literature using various combinations of the keywords MPFL, MPFLR, dislocation, treatment was performed. The following data were extracted: diagnosis methods, indications and contraindications for isolated MPFLR, type of management, recurrence of instability, outcomes and complications.
RESULTS
History of multiple patellar dislocations is the most relevant indication for ligament reconstruction especially after a failed course of conservative treatment in presence of persistent patello-femoral instability. Gold standard technique for MPFLR has not been clearly defined yet.
CONCLUSIONS
There is still poor literature about outcome comparisons, therefore it is challenging to decide which technique is the most appropriate as surgical procedures are continuously developing. The ideal candidates for MPFLR have to be decided after a throughout evaluation and careful planning and, with nowadays knowledge, it is possible to put indication for a reconstruction exposing the patient to minimal risks.
Topics: Humans; Joint Instability; Ligaments, Articular; Orthopedic Procedures; Patellofemoral Joint; Treatment Outcome
PubMed: 32555079
DOI: 10.23750/abm.v91i4-S.9669 -
Journal of Minimally Invasive Surgery Sep 2022Laparoscopic cholecystectomy has become a basic procedure for cholecystectomy due to rapid recovery and cosmetic satisfaction after surgery, and it is currently the...
Laparoscopic cholecystectomy has become a basic procedure for cholecystectomy due to rapid recovery and cosmetic satisfaction after surgery, and it is currently the primary treatment for most benign gallbladder diseases. Thanks to advances in laparoscopic equipment and techniques, single-incision laparoscopic cholecystectomy (SILC) was introduced. Initially, SILC was performed only on highly selected patients due to the high proficiency required and the potential collision of surgical instruments due to the narrow operating space. However, as surgeons gradually accumulated experience with it and various surgical equipment was introduced, the indications were gradually expanded. Nevertheless, clear indications for SILC have not yet been established. If continuous technological development and large-scale SILC clinical results are accumulated, the indications for SILC will be clearer and can be expanded in the future.
PubMed: 36177376
DOI: 10.7602/jmis.2022.25.3.87 -
Investigational New Drugs Aug 2022Previous research focused on the clinical evidence supporting new cancer drugs' initial US Food and Drug Administration (FDA) approval. However, targeted drugs are...
BACKGROUND
Previous research focused on the clinical evidence supporting new cancer drugs' initial US Food and Drug Administration (FDA) approval. However, targeted drugs are increasingly approved for supplementary indications of unknown evidence and benefit.
OBJECTIVES
To examine the clinical trial evidence supporting new targeted cancer drugs' initial and supplementary indication approval in the US, EU, Canada, and Australia.
DATA AND METHODS
25 cancer drugs across 100 indications were identified with FDA approval between 2009-2019. Data on regulatory approval and clinical trials were extracted from the FDA, European Medicines Agency (EMA), Health Canada (HC), Australian Therapeutic Goods Administration (TGA), and clinicaltrials.gov. Regional variations were compared with χ-tests. Multivariate logistic regressions compared characteristics of initial and supplementary indication approvals, reporting adjusted odds ratios (AOR) with 95% confidence intervals (CI).
RESULTS
Out of 100 considered cancer indications, the FDA approved 96, the EMA 92, HC 86, and the TGA 83 (83%, p < 0.05). The FDA more frequently granted priority review, conditional approval, and orphan designations than other agencies. Initial approvals were more likely to receive conditional / accelerated approval (AOR: 2.69, 95%CI [1.07-6.77], p < 0.05), an orphan designation (AOR: 3.32, 95%CI [1.38-8.00], p < 0.01), be under priority review (AOR: 2.60, 95%CI [1.17-5.78], p < 0.05), and be monotherapies (AOR: 5.91, 95%CI [1.14-30.65], p < 0.05) than supplementary indications. Initial indications' pivotal trials tended to be shorter (AOR per month: 0.96, 95%CI [0.93-0.99], p < 0.05), of lower phase design (AOR per clinical phase: 0.28, 95%CI [0.09-0.85], p < 0.05), and enroll more patients (AOR per 100 patients: 1.19, 95%CI [1.01-1.39], p < 0.05).
CONCLUSIONS
Targeted cancer drugs are increasingly approved for multiple indications of varying clinical benefit. Drugs are first approved as monotherapies in rare diseases with a high unmet need. Whilst expedited regulatory review incentivizes this prioritization, indication-specific safety, efficacy, and pricing policies are necessary to reflect each indication's differential clinical and economic value.
Topics: Antineoplastic Agents; Australia; Drug Approval; Humans; Neoplasms; United States; United States Food and Drug Administration
PubMed: 35389145
DOI: 10.1007/s10637-022-01227-5 -
Deutsches Arzteblatt International Aug 2020Diverticular disease is one of the more common abdominal disorders. In 2016, approximately 130 000 patients received inpatient treatment for diverticular disease in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Diverticular disease is one of the more common abdominal disorders. In 2016, approximately 130 000 patients received inpatient treatment for diverticular disease in Germany. The disease has a number of subtypes, each of which has an appropriate treatment. In this article, we present the current surgical indications and optimal timing of surgery for diverticular disease.
METHODS
This review is based on publications that were retrieved by an extensive, selective search in Medline and the Cochrane Library (1998-2018) for studies and guidelines with information on the indications for surgery in diverticular disease.
RESULTS
Studies of evidence grades 2 to 4 were available. Patients receiving a diagnosis of freely perforated diverticulitis and peritonitis (Classification of Diverticular Disease [CDD] type 2c) should be operated on at once. Covered perforated diverticulitis with a macroabscess (>1 cm, CDD type 2b) may be an indication for elective surgery after successful conservative treatment. New evidence from a randomized, controlled trial suggests that elective surgery should also be considered for patients with chronic recurrent diverticulitis (CDD type 3b). The decisive factor in such cases is the impairment of the quality of life for the individual patient. Elective surgery is indicated in chronic recurrent diverticulitis with complications (fistulae, stenoses). Asymptomatic diverticulosis (CDD type 0) and uncomplicated diverticulitis (CDD type 1) are not surgical indications. Likewise, in diverticular hemorrhage (CDD type 4), surgery is only indicated in exceptional cases, when conservative treatment fails.
CONCLUSION
The surgical indication and the proper timing of surgery depend on the type of disease that is present. Future studies should more thoroughly investigate the effect of surgery on the quality of life in patients with the various types of diverticular disease.
Topics: Adult; Aged; Aged, 80 and over; Diverticulitis; Elective Surgical Procedures; Germany; Humans; Middle Aged; Quality of Life; Retrospective Studies
PubMed: 33161943
DOI: 10.3238/arztebl.2020.0591