Daratumumab infusion reaction rates pre- and post-addition of montelukast to pre-medications

2022 ◽  
pp. 107815522110728
Author(s):  
Kelsey Coffman ◽  
Coby Carstens ◽  
Susan Fajardo
Keyword(s):  
Multiple Myeloma ◽  
Allergic Rhinitis ◽  
Reaction Rates ◽  
Infusion Reaction ◽  
Outpatient Setting ◽  
Published Data ◽  
Rapid Rate ◽  
International Classification Of Disease ◽  
Icd 10 ◽  
Leukotriene Receptors

Daratumumab, a CD38-directed monoclonal antibody indicated for multiple myeloma treatment in adult patients, is associated with a high incidence of infusion-related reactions (IRRs). Due to CD38 receptor presence in the lungs, many reactions present similarly to asthma or allergic rhinitis. Montelukast, a leukotriene receptor antagonist, has been hypothesized to reduce daratumumab IRRs due to its efficacy in treating allergic rhinitis and asthma and the presence of leukotriene receptors in the lungs. Recently published data reported daratumumab can be safely administered via rapid rate protocol that reduces infusion time from 195 min to 90 min after completion of two doses. This retrospective, observational cohort study examined 73 patients who received daratumumab in the outpatient setting between December 2015 and April 2020. Patients were included if they were 18 years or older, had an International Classification of Disease (ICD)-10 diagnosis code for multiple myeloma, and received daratumumab intravenously. The primary outcome was a comparison of IRRs between those who did and did not receive montelukast. Secondary outcomes included IRR symptoms, rescue medications utilized for IRRs, and rapid rate administration outcomes. Montelukast use was associated with a lower rate of IRRs (44.4% vs. 65.2%, p = 0.044). Pulmonary IRR symptoms were more common in those who did not receive montelukast. Rapid rate administration of daratumumab did not lead to any IRRs. Adding montelukast as a pre-medication for daratumumab infusions led to a reduction in IRRs, and rapid rate administration was found to be safe after completion of two full doses of daratumumab.

scholarly journals Neue Terminologie für Sprachentwicklungsstörungen?

2021 ◽  
Author(s):  
K. Neumann ◽  
B. Arnold ◽  
A. Baumann ◽  
C. Bohr ◽  
H. A. Euler ◽  
...  
Keyword(s):  
International Classification Of Diseases ◽  
International Classification ◽  
International Classification Of Disease ◽  
Diagnostik Und Therapie ◽  
Classification Of Diseases ◽  
Icd 10

Zusammenfassung Hintergrund Sprachtherapeutisch-linguistische Fachkreise empfehlen die Anpassung einer von einem internationalen Konsortium empfohlenen Änderung der Nomenklatur für Sprachstörungen im Kindesalter, insbesondere für Sprachentwicklungsstörungen (SES), auch für den deutschsprachigen Raum. Fragestellung Ist eine solche Änderung in der Terminologie aus ärztlicher und psychologischer Sicht sinnvoll? Material und Methode Kritische Abwägung der Argumente für und gegen eine Nomenklaturänderung aus medizinischer und psychologischer Sicht eines Fachgesellschaften- und Leitliniengremiums. Ergebnisse Die ICD-10-GM (Internationale statistische Klassifikation der Krankheiten und verwandter Gesundheitsprobleme, 10. Revision, German Modification) und eine S2k-Leitlinie unterteilen SES in umschriebene SES (USES) und SES assoziiert mit anderen Erkrankungen (Komorbiditäten). Die USES- wie auch die künftige SES-Definition der ICD-11 (International Classification of Diseases 11th Revision) fordern den Ausschluss von Sinnesbehinderungen, neurologischen Erkrankungen und einer bedeutsamen intellektuellen Einschränkung. Diese Definition erscheint weit genug, um leichtere nonverbale Einschränkungen einzuschließen, birgt nicht die Gefahr, Kindern Sprach- und weitere Therapien vorzuenthalten und erkennt das ICD(International Classification of Disease)-Kriterium, nach dem der Sprachentwicklungsstand eines Kindes bedeutsam unter der Altersnorm und unterhalb des seinem Intelligenzalter angemessenen Niveaus liegen soll, an. Die intendierte Ersetzung des Komorbiditäten-Begriffs durch verursachende Faktoren, Risikofaktoren und Begleiterscheinungen könnte die Unterlassung einer dezidierten medizinischen Differenzialdiagnostik bedeuten. Schlussfolgerungen Die vorgeschlagene Terminologie birgt die Gefahr, ätiologisch bedeutsame Klassifikationen und differenzialdiagnostische Grenzen zu verwischen und auf wertvolles ärztliches und psychologisches Fachwissen in Diagnostik und Therapie sprachlicher Störungen im Kindesalter zu verzichten.

Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group.

1998 ◽  
Vol 16 (12) ◽  
pp. 3832-3842 ◽  
Keyword(s):  
Multiple Myeloma ◽  
Combination Chemotherapy ◽  
Randomized Trials ◽  
Outcome Measure ◽  
Individual Patient Data ◽  
Collaborative Group ◽  
Published Data ◽  
Recurrence Rates ◽  
Subgroup Analyses ◽  
Risk Patients

PURPOSE To compare combination chemotherapy (CCT) versus melphalan plus prednisone (MP) as treatment for multiple myeloma. PATIENTS AND METHODS In a collaborative worldwide overview of randomized trials of CCT versus MP, individual patient data on 4,930 patients from 20 trials were analyzed, with the addition of published data on a further 1,703 patients from seven trials. The main outcome measure was mortality, with response and recurrence rates being subsidiary end points. RESULTS Taking all of the trials together, response rates were significantly higher with CCT than with MP (60.0% v 53.2%; P < .00001, two-tailed). There was no evidence of any difference in mortality between CCT and MP, with a nonsignificant 1.5% reduction in death rate in favor of CCT (P = .6, two-tailed). There is heterogeneity of design between the trials, but subgroup analyses by type of CCT or by dose-intensities of CCT, of melphalan, or of prednisone did not identify any particular forms of therapy that were either clearly beneficial or clearly adverse. Similarly, analysis of the presentation features of the patients did not find any categories in which CCT differed significantly from MP in its effects on mortality; in particular, there was no evidence that poor-risk patients benefited more from CCT. CONCLUSION This overview found no difference, either overall or within any subgroup, in mortality between CCT and MP. In terms of survival, these therapeutic options, as tested in the trials considered, are approximately equivalent.

Poverty transitions in severe mental illness: longitudinal analysis of social drift in China, 1994–2015

2021 ◽  
pp. 1-9
Author(s):  
Yue-Hui Yu ◽  
Wei Luo ◽  
Bo Liu ◽  
Wei-Hong Kuang ◽  
Larry Davidson ◽  
...  
Keyword(s):  
Mental Illness ◽  
Severe Mental Illness ◽  
Poverty Rate ◽  
International Classification Of Disease ◽  
Fast Change ◽  
The Social ◽  
Poverty Transitions ◽  
Icd 10 ◽  
Persistent Poverty

Abstract Background Although poverty associated with severe mental illness (SMI) has been documented in many studies, little long-term evidence of social drift exists. This study aimed to unravel the poverty transitions among persons with SMI in a fast change community in China. Methods Two mental health surveys, using the International Classification of Disease (ICD-10), were conducted in the same six townships of Xinjin county, Chengdu, China in 1994 and 2015. A total of 308 persons with SMI identified in 1994 were followed up in 2015. The profiles of poverty transitions were identified and regression modelling methods were applied to determine the predictive factors of poverty transitions. Results The poverty rate of persons with SMI increased from 39.9% to 49.4% in 1994 and 2015. A larger proportion of them had fallen into poverty (27.3%) rather than moved out of it (17.8%). Those persons with SMI who had lost work ability, had physical illness and more severe mental disabilities in 1994, as well as those who had experienced negative changes on these factors were more likely to live in persistent poverty or fall into poverty. Higher education level and medical treatment were major protective factors of falling into poverty. Conclusions This study shows long-term evidence on the social drift of persons with SMI during the period of rapid social development in China. Further targeted poverty alleviation interventions should be crucial for improving treatment and mental recovery and alleviating poverty related to SMI.

scholarly journals Validating International Classification of Disease 10th revision algorithms for identifying influenza and respiratory syncytial virus hospitalizations

2021 ◽  
Vol 2 (2) ◽  
Author(s):  
Mackenzie A Hamilton ◽  
Andrew Calzavara ◽  
Scott D Emerson ◽  
Jeffrey C Kwong
Keyword(s):  
Respiratory Syncytial Virus ◽  
Administrative Data ◽  
Predictive Value ◽  
Hospitalized Patients ◽  
International Classification ◽  
Health Administrative Data ◽  
International Classification Of Disease ◽  
Icd 10 ◽  
Syncytial Virus

Objective: Routinely collected health administrative data can be used to efficiently assess disease burden in large populations, but it is important to evaluate the validity of these data. The objective of this study was to develop and validate International Classification of Disease 10PthP revision (ICD -10) algorithms that identify laboratory-confirmed influenza or laboratory-confirmed respiratory syncytial virus (RSV) hospitalizations using population-based health administrative data from Ontario, Canada. Study Design and Setting: Influenza and RSV laboratory data from the 2014-15 through to 2017-18 respiratory virus seasons were obtained from the Ontario Laboratories Information System (OLIS) and were linked to hospital discharge abstract data to generate influenza and RSV reference cohorts. These reference cohorts were used to assess the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the ICD-10 algorithms. To minimize misclassification in future studies, we prioritized specificity and PPV in selecting top-performing algorithms. Results: 83,638 and 61,117 hospitalized patients were included in the influenza and RSV reference cohorts, respectively. The best influenza algorithm had a sensitivity of 73% (95% CI 72% to 74%), specificity of 99% (95% CI 99% to 99%), PPV of 94% (95% CI 94% to 95%), and NPV of 94% (95% CI 94% to 95%). The best RSV algorithm had a sensitivity of 69% (95% CI 68% to 70%), specificity of 99% (95% CI 99% to 99%), PPV of 91% (95% CI 90% to 91%) and NPV of 97% (95% CI 97% to 97%). Conclusion: We identified two highly specific algorithms that best ascertain patients hospitalized with influenza or RSV. These algorithms may be applied to hospitalized patients if data on laboratory tests are not available, and will thereby improve the power of future epidemiologic studies of influenza, RSV, and potentially other severe acute respiratory infections.

scholarly journals Strategies to upgrade safety for at-home autologous stem cell transplantation in multiple myeloma patients.

2020 ◽  
Author(s):  
Luis Gerardo Rodríguez-Lobato ◽  
Alexandra Martínez-Roca ◽  
Sandra Castaño-Díez ◽  
Alicia Palomino-Mosquera ◽  
Gonzalo Gutiérrez-García ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Stem Cell ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Hospital Readmissions ◽  
Primary Prophylaxis ◽  
Outpatient Setting ◽  
The Impact ◽  
At Home

Abstract Background. Autologous stem cell transplantation (ASCT) remains the standard of care for young multiple myeloma (MM) patients; indeed, at-home ASCT has been positioned as an appropriate therapeutic strategy. However, despite the use of prophylactic antibiotics, neutropenic fever (NF) and hospital readmissions continue to pose as the most important limitations in the outpatient setting. It is possible that the febrile episodes may have a non-infectious etiology, and engraftment syndrome could play a more significant role. The aim of this study was to analyze the impact of both G-CSF withdrawal and the addition of primary prophylaxis with corticosteroids after ASCT.Methods. Between January 2002 and August 2018, 111 MM patients conditioned with melphalan were managed at-home beginning + 1 day after ASCT. Three groups were established: Group A (n = 33) received standard G-CSF post-ASCT; group B (n = 32) avoided G-CSF post-ASCT; group C (n = 46) avoided G-CSF yet added corticosteroid prophylaxis post-ASCT.Results. The incidence of NF among the groups was reduced (64%, 44%, and 24%; P < 0.001), with a non-significant decrease in hospital readmissions as well (12%, 6%, and 2%; P = 0.07). The most important variables identified for NF were: HCT-CI > 2 (OR 6.1; P = 0.002) and G-CSF avoidance plus corticosteroids (OR 0.1; P < 0.001); and for hospital readmission: age ≥ 60 years (OR 14.6; P = 0.04) and G-CSF avoidance plus corticosteroids (OR 0.07; P = 0.05).Conclusions. G-CSF avoidance and corticosteroid prophylaxis post ASCT minimize the incidence of NF in MM patients undergoing at-home ASCT.

Patient preferences for interferon alfa in multiple myeloma.

1997 ◽  
Vol 15 (4) ◽  
pp. 1672-1679 ◽  
Author(s):  
H Ludwig ◽  
E Fritz ◽  
J Neuda ◽  
B G Durie
Keyword(s):  
United States ◽  
Multiple Myeloma ◽  
Overall Survival ◽  
Patient Preferences ◽  
Maintenance Treatment ◽  
The United States ◽  
Interferon Alfa ◽  
Medical Decision ◽  
Published Data ◽  
Financial Cost

PURPOSE Interferon alfa treatment in multiple myeloma marginally improves relapse-free and overall survival. Often it does so at the expense of toxicity and financial cost. If patients are unwilling or unable to participate in the decision of whether to initiate such treatment, known patient preferences can serve as guidelines for the physician. We interviewed myeloma patients in the United States to obtain information that might facilitate medical decision-making. PATIENTS AND METHODS Three hundred fifty-five myeloma patients throughout the United States were interviewed by telephone. Without identifying interferon alfa as the treatment agent, interviewers described potential adverse effects, financial cost, and self-injection procedures. The potential benefits of four treatment choices, derived from a meta-analysis of published data, were presented as gains in remission rate (+10%), remission duration (an additional 4 and 7 months, respectively, for induction and maintenance treatment), and overall survival (an additional 3 and 6 months, respectively, for induction and maintenance treatment). Patients' choices for or against use of the unidentified substance were recorded, and interferon was subsequently disclosed as the treatment. The profiles of patients making different choices were determined using multivariate regression techniques. RESULTS Approximately half of the patients accepted the unidentified treatment if remission and/or survival improved by at least 6 months. Accepters were younger and more likely to have used interferon. Of patients who rejected the unidentified treatment, 25% to 50% would have been willing to accept it if the benefits were > or = 12 months. Test/retest reliability of all choices, determined in 36 cancer patients, was 0.896. CONCLUSION In multiple myeloma, interferon therapy and, by inference, other treatments with comparable features are acceptable to approximately half of the patients if a 6-month gain in relapse-free or overall survival can be expected.

scholarly journals Insomnia in Schizophrenia Patients: Prevalence and Quality of Life

2020 ◽  
Vol 17 (4) ◽  
pp. 1350 ◽  
Author(s):  
David Batalla-Martín ◽  
Angel Belzunegui-Eraso ◽  
Eva Miralles Garijo ◽  
Elena Martínez Martín ◽  
Rosanna Romaní Garcia ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Severity Index ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Probabilistic Sampling ◽  
International Classification Of Disease ◽  
Important Health ◽  
Icd 10 ◽  
Schizophrenic Patients

Sleep disorders are often not regarded as an important health problem, despite their impact on heath. Insomnia is the most frequent sleep disorder in mental health. The aim is to quantify the prevalence of insomnia in a population with schizophrenic disorder and assess its influence on quality of life. This is a descriptive, analytical and cross-sectional study conducted in a sample of 267 schizophrenic patients over 18 years of age using consecutive non-probabilistic sampling. The variables of interest were collected by means of the "Cuestionario Oviedo de Sueño," "Insomnia Severity Index" and EuqoQol-5D. The estimation of insomnia in our schizophrenic population according to the International Classification of Disease (ICD-10) criteria was 23.2%. The likelihood of insomnia when there are problems in the quality of life is significant in all its dimensions: mobility OR: 3.54 (95% CI 1.88– 6.65), self-care OR: 2.69 (95% CI 1.36–5.32), usual activities OR: 3.56 (95% CI 1.97–6.44), pain/discomfort OR: 4.29 (95% CI 2.37–7.74) and anxiety/depression OR: 3.01 (95% CI 1.61–5.65). The prevalence of insomnia fluctuates depending on the diagnostic criteria; however, the schizophrenic population shows high prevalence in some clinical characteristics. People with insomnia have a lower quality of life.

Molecular Classification of Multiple Myeloma: A Distinct Transcriptional Profile Characterizes Patients Expressing CCND1 and Negative for 14q32 Translocations

2005 ◽  
Vol 23 (29) ◽  
pp. 7296-7306 ◽  
Author(s):  
Luca Agnelli ◽  
Silvio Bicciato ◽  
Michela Mattioli ◽  
Sonia Fabris ◽  
Daniela Intini ◽  
...  
Keyword(s):  
Gene Expression ◽  
Multiple Myeloma ◽  
Expression Profiles ◽  
Quantitative Polymerase Chain Reaction ◽  
Gene Expression Pattern ◽  
Marker Genes ◽  
Published Data ◽  
Cyclin D ◽  
Chromosome 13Q ◽  
13Q Deletion

Purpose The deregulation of CCND1, CCND2 and CCND3 genes represents a common event in multiple myeloma (MM). A recently proposed classification grouped MM patients into five classes on the basis of their cyclin D expression profiles and the presence of the main translocations involving the immunoglobulin heavy chain locus (IGH) at 14q32. In this study, we provide a molecular characterization of the identified translocations/cyclins (TC) groups. Materials and Methods The gene expression profiles of purified plasma cells from 50 MM cases were used to stratify the samples into the five TC classes and identify their transcriptional fingerprints. The cyclin D expression data were validated by means of real-time quantitative polymerase chain reaction analysis; fluorescence in situ hybridization was used to investigate the cyclin D loci arrangements, and to detect the main IGH translocations and the chromosome 13q deletion. Results Class-prediction analysis identified 112 probe sets as characterizing the TC1, TC2, TC4 and TC5 groups, whereas the TC3 samples showed heterogeneous phenotypes and no marker genes. The TC2 group, which showed extra copies of the CCND1 locus and no IGH translocations or the chromosome 13q deletion, was characterized by the overexpression of genes involved in protein biosynthesis at the translational level. A meta-analysis of published data sets validated the identified gene expression signatures. Conclusion Our data contribute to the understanding of the molecular and biologic features of distinct MM subtypes. The identification of a distinctive gene expression pattern in TC2 patients may improve risk stratification and indicate novel therapeutic targets.

Interfacility Transfers for Isolated Craniomaxillofacial Trauma: Perspectives of the Facial Trauma Surgeon

2020 ◽  
pp. 194338752096227
Author(s):  
Matthew Pontell ◽  
Delora Mount ◽  
Jordan P. Steinberg ◽  
Donald Mackay ◽  
Michael Golinko ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Outpatient Setting ◽  
Facial Trauma ◽  
Published Data ◽  
The North ◽  
Facial Plastic ◽  
Craniomaxillofacial Trauma ◽  
American Society ◽  
Transfer Services ◽  
Trauma Surgeons

Study Design: Secondary overtriage is a burden to the medical system. Unnecessary transfers overload trauma centers, occupy emergency transfer resources, and delay definitive patient care. Craniomaxillofacial (CMF) trauma, especially in isolation, is a frequent culprit. Objective: The aim of this study is to assess the perspectives of facial trauma surgeons regarding the interfacility transfer of patients with isolated CMF trauma. Methods: A 31-item survey was developed using Likert-type scale and open-ended response systems. Internal consistency testing among facial trauma surgeons yielded a Cronbach’s α calculation of .75. The survey was distributed anonymously to the American Society of Maxillofacial Surgeons, the North American Division of AO Craniomaxillofacial, and the American Academy of Facial Plastic and Reconstructive Surgery. Statistical significance in response plurality was determined by nonoverlapping 99.9% confidence intervals ( P < .001). Sum totals were reported as means with standard deviations and z scores with P values of less than .05 considered significant. Results: The survey yielded 196 responses. Seventy-seven percent of respondents did not believe that most isolated CMF transfers required emergency surgery and roughly half (49%) thought that most emergency transfers were unnecessary. Fifty-four percent of respondents agreed that most patients transferred could have been referred for outpatient management and 87% thought that transfer guidelines could help decrease unnecessary transfers. Twenty-seven percent of respondents had no pre-transfer communication with the referring facility. Perspectives on the transfer of specific fracture patterns and their presentations were also collected. Conclusion: Most facial trauma surgeons in this study believe that emergent transfer for isolated CMF trauma is frequently unnecessary. Such injuries rarely require emergent surgery and can frequently be managed in the outpatient setting without activating emergency transfer services. The fracture-specific data collected are a representation of the national, multidisciplinary opinion of facial trauma surgeons and correlate with previously published data on which specific types of facial fractures are most often transferred unnecessarily. The results of this study can serve as the foundation for interfacility transfer guidelines, which may provide a valuable resource in triaging transfers and decreasing associated health-care costs.

scholarly journals Conducting Retrospective Ontological Clinical Trials in ICD-9-CM in the Age of ICD-10-CM

2014 ◽  
Vol 13s3 ◽  
pp. CIN.S14032 ◽  
Author(s):  
Neeta K. Venepalli ◽  
Ardaman Shergill ◽  
Parvaneh Dorestani ◽  
Andrew D. Boyd
Keyword(s):  
Clinical Trials ◽  
Financial Risk ◽  
Web Portal ◽  
International Classification Of Disease ◽  
Incomplete Coverage ◽  
Icd 10 ◽  
Backward Mapping ◽  
Medicare Database ◽  
Conversion Tool ◽  
The Impact

Objective To quantify the impact of International Classification of Disease 10th Revision Clinical Modification (ICD-10-CM) transition in cancer clinical trials by comparing coding accuracy and data discontinuity in backward ICD-10-CM to ICD-9-CM mapping via two tools, and to develop a standard ICD-9-CM and ICD-10-CM bridging methodology for retrospective analyses. Background While the transition to ICD-10-CM has been delayed until October 2015, its impact on cancer-related studies utilizing ICD-9-CM diagnoses has been inadequately explored. Materials and Methods Three high impact journals with broad national and international readerships were reviewed for cancer-related studies utilizing ICD-9-CM diagnoses codes in study design, methods, or results. Forward ICD-9-CM to ICD-10-CM mapping was performing using a translational methodology with the Motif web portal ICD-9-CM conversion tool. Backward mapping from ICD-10-CM to ICD-9-CM was performed using both Centers for Medicare and Medicaid Services (CMS) general equivalence mappings (GEMs) files and the Motif web portal tool. Generated ICD-9-CM codes were compared with the original ICD-9-CM codes to assess data accuracy and discontinuity. Results While both methods yielded additional ICD-9-CM codes, the CMS GEMs method provided incomplete coverage with 16 of the original ICD-9-CM codes missing, whereas the Motif web portal method provided complete coverage. Of these 16 codes, 12 ICD-9-CM codes were present in 2010 Illinois Medicaid data, and accounted for 0.52% of patient encounters and 0.35% of total Medicaid reimbursements. Extraneous ICD-9-CM codes from both methods (Centers for Medicare and Medicaid Services general equivalent mapping [CMS GEMs, n = 161; Motif web portal, n = 246]) in excess of original ICD-9-CM codes accounted for 2.1% and 2.3% of total patient encounters and 3.4% and 4.1% of total Medicaid reimbursements from the 2010 Illinois Medicare database. Discussion Longitudinal data analyses post-ICD-10-CM transition will require backward ICD-10-CM to ICD-9-CM coding, and data comparison for accuracy. Researchers must be aware that all methods for backward coding are not comparable in yielding original ICD-9-CM codes. Conclusions The mandated delay is an opportunity for organizations to better understand areas of financial risk with regards to data management via backward coding. Our methodology is relevant for all healthcare-related coding data, and can be replicated by organizations as a strategy to mitigate financial risk.

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