scholarly journals Finally, an FDA Approval for an Immunization Against COVID-19: Hope on the Horizon

2022 ◽  
pp. 106002802110583
Author(s):  
Jason Powell ◽  
Christopher R. Piszczatoski
Keyword(s):  
Placebo Group ◽  
Vaccine Efficacy ◽  
Data Extraction ◽  
Severe Infection ◽  
Vaccine Group ◽  
Efficacy Rate ◽  
Fda Approval ◽  
Study Selection ◽  
Control And Prevention ◽  
Definition Of

Objective Coronavirus disease 2019 (COVID-19) is a respiratory infection known as severe respiratory acute syndrome coronavirus 2 (SARS-CoV-2). The purpose of this manuscript is to review information leading to the Food and Drug Administration (FDA) approval of the Pfizer-BioNTech COVID-19 Vaccine. Data Sources A literature search was conducted of PubMed and clinicaltrials.gov (August 2018—October 2021) to identify trials related to the FDA approval of Pfizer-BioNTech COVID-19 Vaccine. Study selection and data extraction Trials included are those the FDA deemed significant and accurate enough to be included in the FDA approval process. Information not recognized by the Centers of Disease Control and Prevention (CDC) nor FDA is omitted to not add to further confusion and misinformation. Data synthesis In persons 16 years or older without evidence of prior SARS-CoV-2 infection, a total of 77 COVID-19 cases (0.39%) in the vaccine group from 7 days onward after the second dose vs 833 (4.1%) in the placebo group (Vaccine efficacy 91.1%; 95% confidence interval [CI]: 88.8-93.1). According the CDC definition of severe infection, there were no severe infections in the vaccine group 7 days and onward after the second dose, compared to 31 (0.15%) in the placebo group (Vaccine efficacy 100%; 95% CI: 87.6-100.0). Relevance to Patient Care and Clinical Practice: Reduction of infection by SARS-COV-2 is a top priority in protecting the health of all people and the official approval of the Pfizer-BioNTech vaccination may improve this goal. Conclusions Data available show a high efficacy rate of preventing SARS -CoV-2 with relatively low rates of ADE after full vaccination with Pfizer-BioNTech COVID-19 vaccine.

Evolution of Equations for Estimating Renal Function and Their Application to the Dosing of New Antimicrobials

2019 ◽  
Vol 54 (5) ◽  
pp. 496-503
Author(s):  
Alison K. Lew ◽  
Ryan L. Crass ◽  
Gregory Eschenauer
Keyword(s):  
Dose Adjustment ◽  
English Language ◽  
Antimicrobial Agents ◽  
Data Extraction ◽  
New Era ◽  
Mdrd Equation ◽  
Language Studies ◽  
Fda Approval ◽  
Literature Searches ◽  
Study Selection

Objective: To address the background and rationale for the recent introduction of the Modification of Diet in Renal Disease (MDRD) equation for renal dose adjustment of antimicrobials and to provide recommendations for pharmacists dosing new antimicrobial agents. Data Sources: Comprehensive MEDLINE and EMBASE literature searches (from August 2018 to October 2019) were performed. Search terms included creatinine clearance, Cockcroft-Gault, MDRD, and glomerular filtration rate and a subsequent search included the preceding terms AND antimicrobials OR antibiotics. Study Selection and Data Extraction: Available English-language studies on the derivation and/or use of the Cockcroft-Gault (CG) and MDRD study equation were evaluated as well as those that specifically discussed their use for dosing antimicrobial agents. Data Synthesis: The US Food and Drug Administration (FDA) approval of delafloxacin and meropenem-vaborbactam in 2017 ushered in a new era in renal dosing of antibiotics, in that both agents are recommended to be dosed by the MDRD equation. Studies demonstrate that the CG and MDRD equations can result in discrepant dosing recommendations. Relevance to Patient Care and Clinical Practice: The renal estimation equation recommended in a new antibiotic label should dictate the dosing of that medication. It is noteworthy that these equations are not interchangeable. Conclusion: Recently approved antimicrobials utilizing the MDRD equation for renal dose adjustment will be interspersed with old and new antimicrobials utilizing the CG equation because of lack of singular guidance by the FDA. This requires pharmacists to be vigilant in evaluating drug labels to determine which equation is recommended and to understand the differences, strengths, and limitations of each equation.

scholarly journals Reflective Practice in Physical Therapy: A Scoping Review

2019 ◽  
Vol 99 (8) ◽  
pp. 1056-1068 ◽  
Author(s):  
Christina Ziebart ◽  
Joy C MacDermid
Keyword(s):  
Clinical Practice ◽  
Physical Therapy ◽  
Reflective Practice ◽  
Professional Growth ◽  
Data Extraction ◽  
Publication Type ◽  
Conceptual Approach ◽  
Theoretical Concepts ◽  
Study Selection ◽  
Definition Of

AbstractBackgroundMany practitioners experience complex, uncertain, and unique clinical practice situations that can be navigated with reflection. Little is known about the theoretical and pragmatic perspectives of reflection in physical therapy.PurposeThe purpose of this paper was to examine the literature on reflection in physical therapy and identify gaps in the literature.Data SourceThe Cumulative Index to Nursing and Allied Health Literature (CINAHL), PubMed, EMBASE, Scopus, and PsycINFO were used to identify articles.Study SelectionStudies were selected to describe: (1) theoretical concepts related to reflection, (2) examples of reflection, and (3) the use of reflection in clinical or educational contexts.Data ExtractionAuthors, year of publication, country of origin, publication type or source, methodology, conceptual approach (including terminology used, definition of terminology used), and practical approach (including theoretical underpinning, context of reflection/reflective practice, and target group) guided the data extraction.Data SynthesisA total of 46 articles were reviewed spanning from 1992 to 2017, which included research studies, field articles, editorials, and a review article. Theoretical underpinnings of reflection were based on the thoughts of Donald Schön. Written approaches to reflection were most common, and reflection was used to inform education, clinical practice, and professional growth.LimitationsAs with any review paper, there is a certain level of interpretation required when collating and interpreting data.ConclusionsReflection in physical therapy could be advanced by a thorough conceptualization of reflective practice, a broader and deeper pool of research to inform optimal implementation of reflection across the career span from learners to experts, and a clear definition and linkage of reflection to epistemologies of physical therapy practice.

scholarly journals RV144 Vaccine Imprinting Constrained HIV-1 Evolution Following Breakthrough Infection

2021 ◽  
Author(s):  
Eric Lewitus ◽  
Eric Sanders-Buell ◽  
Meera Bose ◽  
Anne Marie O’Sullivan ◽  
Kultida Poltavee ◽  
...  
Keyword(s):  
Placebo Group ◽  
Vaccine Efficacy ◽  
Vaccine Group ◽  
Efficacy Trial ◽  
Breakthrough Infection ◽  
Diversifying Selection ◽  
Hiv 1 ◽  
Rv144 Vaccine ◽  
Over Time ◽  
Roll Out

Abstract The scale of the HIV-1 epidemic underscores the need for a vaccine. The multitude of circulating HIV-1 strains together with HIV-1’s high evolvability hint that HIV-1 could adapt to a future vaccine. Here we wanted to investigate the effect of vaccination on the evolution of the virus post-breakthrough infection. We analyzed 2,635 HIV-1 env sequences sampled up to a year post-diagnosis from 110 vaccine and placebo participants who became infected in the RV144 vaccine efficacy trial. We showed that the Env signatures sites that were previously identified to distinguish vaccine and placebo participants were maintained over time. In addition, fewer sites were under diversifying selection in the vaccine group than in the placebo group. These results indicate that HIV-1 would possibly adapt to a vaccine upon its roll out.

Use of Fish Oil to Prevent Coronary Angioplasty Restenosis

1992 ◽  
Vol 26 (12) ◽  
pp. 1541-1545 ◽  
Author(s):  
Vincent F. Mauro ◽  
Lawrence A. Frazee
Keyword(s):  
Eicosapentaenoic Acid ◽  
Fish Oil ◽  
English Language ◽  
Data Extraction ◽  
Current Data ◽  
Study Selection ◽  
Number Of Patients ◽  
Bibliographic Search ◽  
Definition Of ◽  
Key Terms

OBJECTIVE: To review the literature investigating the use of fish oil in preventing restenosis postangioplasty (RPA). DATA SOURCES: An Index Medicus and bibliographic search of the English-language literature pertaining to the use of fish oil in preventing RPA. The key terms used were fish oil, angioplasty, and eicosapentaenoic acid. STUDY SELECTION AND DATA EXTRACTION: The results of all trials, including abstracts, that were obtained are reviewed and critiqued. DATA SYNTHESIS: Restenosis of a coronary vessel at the site of angioplasty occurs 30–40 percent of the time. Because fish oil has been theorized to prevent atherosclerosis and because atherosclerotic-like processes are theorized to be involved in RPA restenosis, fish oil has been studied to determine whether it can prevent RPA. Results of such trials have been mixed. Some have observed a reduction in the number of patients with angiographic or clinical evidence of restenosis. Two trials have failed to observe such an effect. Reasons for the differences are unknown. Possible explanations include differences in study design, endpoint parameters, definition of restenosis, and dosing methods of the fish oil. Bleeding was not of significant concern in any of the trials, even when fish oil was combined with antiplatelet therapy. CONCLUSIONS: Fish oil may be considered for use in patients to prevent RPA. It probably should be continued for only six months following the procedure. Current data suggest that at least 3 g/d of eicosapentaenoic acid and 1 g/d of docosahexaenoic acid should be used. If possible, therapy should be started as soon as it is known that angioplasty will be performed or at least as soon as possible following the procedure. Many patients may not be able to tolerate fish oil because of its gastrointestinal effects.

Ervebo (Ebola Zaire Vaccine, Live/rVSVΔG-ZEBOV-GP): The First Licensed Vaccine for the Prevention of Ebola Virus Disease

2020 ◽  
Vol 36 (6) ◽  
pp. 243-250 ◽  
Author(s):  
Christopher R. Piszczatoski ◽  
John G. Gums
Keyword(s):  
English Language ◽  
Ebola Virus ◽  
Virus Disease ◽  
Data Extraction ◽  
Ebola Virus Disease ◽  
Cochrane Library ◽  
Effective Vaccine ◽  
Fda Approval ◽  
Study Selection ◽  
Disease Relevance

Objective: To review the clinical data regarding the safety and efficacy of the Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) vaccine for the prevention of the Ebola virus disease. Data Sources: A literature search through PubMed, MEDLINE, and Cochrane Library was conducted for clinical trials published between January 2014 and June 2020 in the English language using the keywords Ervebo, rVSVΔG-ZEBOV, rVSVΔG-ZEBOV-GP, Ebola Zaire, and vaccine. Study Selection and Data Extraction: Articles were selected if they were related to the Food and Drug Administration (FDA) approval of Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) or provided novel data regarding this entity. Twelve articles noted in the FDA approval were chosen, along with 2 additional articles identified as providing novel information. Data Synthesis: The findings of the review show that Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) is a safe, immunogenic, and likely effective vaccine for the prevention of Ebola virus disease. Relevance to Patient Care and Clinical Practice: Ebola virus disease is highly infectious and often fatal. There have been multiple large outbreaks in the past 5 years, with no licensed treatments or vaccines. An effective vaccine could largely curtail current outbreaks and prevent further ones. Conclusion: The recent FDA approval of Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) offers the first approved vaccine for the prevention of Ebola virus disease. It has been shown to be safe, immunogenic, and likely effective for use in real-world applications for those at risk of contracting the disease.

Assessing the Quality of Pharmaceutical Care I. One Perspective of Quality

1993 ◽  
Vol 27 (1) ◽  
pp. 68-73 ◽  
Author(s):  
Karen B. Farris ◽  
Duane M. Kirking
Keyword(s):  
Pharmaceutical Care ◽  
English Language ◽  
Data Extraction ◽  
Quality Care ◽  
Pharmacy Practice ◽  
Pharmacy Services ◽  
Medline Search ◽  
Study Selection ◽  
International Pharmacy ◽  
Definition Of

OBJECTIVE: To evaluate the concept of pharmaceutical care (PC) as a standard of quality care for ambulatory pharmacy practice. DATA SOURCES: Donabedian's article on the seven pillars or characteristics of quality provides a framework for a discussion of the merits of PC as a definition of quality. A MEDLINE search augmented by a manual review of International Pharmacy Abstracts was also used to identify pertinent English-language pharmacy literature; indexing terms included quality, community pharmacy services, ambulatory, pharmacy services, and pharmacist(s). STUDY SELECTION: Representative articles and studies promoting PC were considered. DATA EXTRACTION: The literature was independently reviewed by the primary author. DATA SYNTHESIS: An interpretation of the principles of Donabedian's article was applied to PC. PC appears to be consistent with the quality characteristics of efficacy and acceptability. The effectiveness, cost-effectiveness, and efficiency of PC should be firmly established by its practitioners as barriers are eliminated and/or overcome. The pillars of optimality, equity, and legitimacy seem to be overlooked under the current definition of PC. This article contends that PC assumes an individualist definition of quality, by definition, because of its covenantal relationship with the patient. CONCLUSIONS: Quality is defined in terms of the values of individuals and society. For now, PC appears to be the appropriate standard for defining quality in pharmacy because of the importance of individual maximal benefits within our society.

Brexanolone (Zulresso): Finally, an FDA-Approved Treatment for Postpartum Depression

2019 ◽  
Vol 54 (2) ◽  
pp. 157-163 ◽  
Author(s):  
Jason G Powell ◽  
Scott Garland ◽  
Kayla Preston ◽  
Chris Piszczatoski
Keyword(s):  
Postpartum Depression ◽  
English Language ◽  
Data Extraction ◽  
Clinical Information ◽  
Rapid Onset ◽  
Depression Symptoms ◽  
Onset Of Action ◽  
Fda Approval ◽  
Study Selection

Objective: To review the safety and efficacy of brexanolone for the treatment of moderate to severe postpartum depression (PPD). Data Sources: A literature search through PubMed was conducted (January 2012 to July 2019) using the keyword brexanolone for clinical trials published in the English language. Study Selection and Data Extraction: Articles were selected if they were related to the Food and Drug Administration (FDA) approval of brexanolone or provided novel clinical information regarding this drug entity. Data Synthesis: The findings of the review show that brexanolone administered via IV infusion is both an effective and a fairly safe option for the treatment of PPD. Relevance to Patient Care and Clinical Practice: There are several antidepressants currently used to treat PPD; however, this is the first with FDA approval for this indication. The rapid onset of action of brexanolone may offer a quicker relief of these symptoms and may possibly lead to improved quality of life for both the mother and the child. Conclusion and Relevance: The recent FDA approval of brexanolone may offer an effective treatment of moderate to severe PPD and has been shown to rapidly decrease depression symptoms.

scholarly journals Incidence of postintubation hemodynamic instability associated with emergent intubations performed outside the operating room: a systematic review

CJEM ◽  
2014 ◽  
Vol 16 (01) ◽  
pp. 69-79 ◽  
Author(s):  
Robert Green ◽  
Brian Hutton ◽  
Jason Lorette ◽  
Dominique Bleskie ◽  
Lauralyn Mclntyre ◽  
...  
Keyword(s):  
Systematic Review ◽  
Data Extraction ◽  
Meta Analysis ◽  
Geographic Location ◽  
Hemodynamic Instability ◽  
Included Study ◽  
Third Party ◽  
Summary Estimate ◽  
Study Selection ◽  
Definition Of

ABSTRACTObjective:Hemodynamic instability following emergent endotracheal intubation (EETI) is a potentially life-threatening adverse event. The objectives of this systematic literature review were to document the incidence of postintubation hemodynamic instability (PIHI), to determine the definitions for PIHI used in the available literature, and to examine factors associated with PIHI in adult patients who require EETI.Data Source:Articles published in Medline (1966–August 2012).Study Selection:This systematic review included adult, inhospital studies of EETIs. Studies with nonemergent or pediatric patient populations were excluded.Data Extraction:Two authors independently performed data abstraction. Disagreements were resolved by a third party. The methodological quality of included studies was assessed with the Newcastle-Ottawa Quality Assessment Scale for Cohort Studies.Data Synthesis:We estimated the pooled prevalence of PIHI across studies using a random effects meta-analysis. Subgroups analyzed included study design, intubation setting, geographic location of the study, physician experience, medications used for sedation, neuromuscular blockade, and definition of PIHI. Eighteen studies were analyzed, with sample sizes from 84 to 2,833 patients. The incidence of PIHI ranged from 5 to 440 cases per 1,000 intubations, with a pooled estimate of 110 cases per 1,000 intubations (95% CI 65–167).Conclusions:PIHI was found to occur in 110 cases per 1,000 in-hospital, emergent intubations. However, heterogeneity among the included studies limits the reliability of this summary estimate. Further investigation is warranted.

scholarly journals Overdiagnosis across medical disciplines: a scoping review

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e018448 ◽  
Author(s):  
Kevin Jenniskens ◽  
Joris A H de Groot ◽  
Johannes B Reitsma ◽  
Karel G M Moons ◽  
Lotty Hooft ◽  
...  
Keyword(s):  
Scoping Review ◽  
Diagnostic Tests ◽  
Data Extraction ◽  
Primary Study ◽  
English Studies ◽  
Extensive Discussion ◽  
Article Type ◽  
Study Selection ◽  
Definition Of ◽  
Medical Disciplines

ObjectiveTo provide insight into how and in what clinical fields overdiagnosis is studied and give directions for further applied and methodological research.DesignScoping review.Data sourcesMedline up to August 2017.Study selectionAll English studies on humans, in which overdiagnosis was discussed as a dominant theme.Data extractionStudies were assessed on clinical field, study aim (ie, methodological or non-methodological), article type (eg, primary study, review), the type and role of diagnostic test(s) studied and the context in which these studies discussed overdiagnosis.ResultsFrom 4896 studies, 1851 were included for analysis. Half of all studies on overdiagnosis were performed in the field of oncology (50%). Other prevalent clinical fields included mental disorders, infectious diseases and cardiovascular diseases accounting for 9%, 8% and 6% of studies, respectively. Overdiagnosis was addressed from a methodological perspective in 20% of studies. Primary studies were the most common article type (58%). The type of diagnostic tests most commonly studied were imaging tests (32%), although these were predominantly seen in oncology and cardiovascular disease (84%). Diagnostic tests were studied in a screening setting in 43% of all studies, but as high as 75% of all oncological studies. The context in which studies addressed overdiagnosis related most frequently to its estimation, accounting for 53%. Methodology on overdiagnosis estimation and definition provided a source for extensive discussion. Other contexts of discussion included definition of disease, overdiagnosis communication, trends in increasing disease prevalence, drivers and consequences of overdiagnosis, incidental findings and genomics.ConclusionsOverdiagnosis is discussed across virtually all clinical fields and in different contexts. The variability in characteristics between studies and lack of consensus on overdiagnosis definition indicate the need for a uniform typology to improve coherence and comparability of studies on overdiagnosis.

High-Dose Inactivated Influenza Vaccine Quadrivalent for Older Adults

2020 ◽  
Vol 55 (1) ◽  
pp. 89-97
Author(s):  
Elias B. Chahine
Keyword(s):  
Older Adults ◽  
Influenza Vaccine ◽  
English Language ◽  
Standard Dose ◽  
Data Extraction ◽  
High Dose ◽  
Efficacy And Safety ◽  
Study Selection ◽  
Control And Prevention ◽  
Age Appropriate

Objective: To review the efficacy and safety of the high-dose inactivated influenza vaccine quadrivalent (HD-IIV4) in the prevention of influenza in older adults. Data Sources: A literature search was performed using PubMed and Google Scholar with the search terms high-dose, influenza vaccine, and quadrivalent. Other resources included the Centers for Disease Control and Prevention (CDC), the prescribing information, and the manufacturer’s website. Study Selection and Data Extraction: All relevant English-language articles of studies assessing the efficacy and safety of HD-IIV4 were included. Data Synthesis: HD-IIV4 is licensed by the Food and Drug Administration for the prevention of influenza in adults aged 65 years and older. The safety and immunogenicity of HD-IIV4 was demonstrated in a phase 3 trial, and the efficacy of the trivalent formulation (HD-IIV3) was demonstrated in a phase 3b-4 trial. HD-IIV4 carries a warning regarding the occurrence of Guillain-Barré syndrome. Adverse reactions, including injection-site pain and myalgia, were reported more frequently with HD-IIV4 than with HD-IIV3. Relevance to Patient Care and Clinical Practice: Although the CDC recommends any age-appropriate influenza vaccine for adults aged 65 years and older, HD-IIV4 was associated with improved immunogenicity against the added B strain and HD-IIV3 provided better protection against influenza than the standard-dose vaccine. Other influenza vaccines have weaker evidence of efficacy in older adults. Therefore, HDIIV4 should be recommended as the vaccine of choice in adults aged 65 years and older. Conclusion: HD-IIV4 has proven immunogenic, safe, and effective in preventing influenza in older adults and should be recommended as the vaccine of choice in this patient population.

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