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Results | Calcium excretion (mmol/24 h) was − 1.2877 + 0.646*[Ca] | PMC10227114 | ||
Conclusion | DEMINERALIZATION | During citrate CVVH, calcium balance was negative in most patients, despite supplementation of calcium based on plasma ionized calcium levels. This may contribute to demineralization of the skeleton. We propose that calcium supplementation should be based on both plasma ionized calcium and a simple calculation of calci... | PMC10227114 | |
Graphical abstract | PMC10227114 | |||
Supplementary Information | The online version contains supplementary material available at 10.1007/s40620-022-01482-y. | PMC10227114 | ||
Keywords | PMC10227114 | |||
Introduction | bleeding | BLEEDING, COMPLICATIONS | Systemic anticoagulation during continuous venovenous hemofiltration (CVVH) is associated with bleeding complications. Citrate-based regional anticoagulation has a lower risk of bleeding [An alternative for guiding calcium supplementation by blood ionized calcium concentrations is monitoring the daily loss of calcium b... | PMC10227114 |
Methods | BLOOD, CLOT | This study consisted of two parts. First a model was developed to calculate calcium excretion by CVVH and, second, this model was used to retrospectively study calcium balance in CVVH patients during a 7-years period. The development and validation of a model to calculate calcium excretion by CVVH was performed as a re... | PMC10227114 | |
Statistical analysis | Statistical analyses were made in SPSS version 25.0. For the development of the equation to calculate calcium loss by CVVH ultrafiltrate, the population of patients treated with CVVH in 2021 was randomly divided into a development and a validation set, both containing all measurements of a subset of 50% of patients. A ... | PMC10227114 | ||
Results | HF1400, 127,897 | From January 1st, 2021 until December 31st, 2021, 765 daily measurements of calcium excretion in CVVH ultrafiltrate in 84 patients were analyzed for this study. Characteristics of patients and the CVVH episodes are shown in Table Characteristics of analyzed CVVH episodes (days) and patients used for developing the mode... | PMC10227114 | |
Discussion | fits, trauma | In this study we present a simple mathematical equation to calculate calcium-excretion in the ultrafiltrate during CVVH with citrate anticoagulation using routinely available parameters. Using this equation, we found that in a population of ICU patients treated with citrate anticoagulated CVVH, cumulative CVVH calcium ... | PMC10227114 | |
Conclusion | HYPERCALCEMIA | During citrate anticoagulated CVVH, and following recommendations for calcium supplementation from the literature, a negative calcium balance was commonly found. Adhering to higher target levels for plasma ionized calcium will lower this risk, but can not prevent negative calcium balances in patients who have some degr... | PMC10227114 | |
Author contributions | MP | EJ, FR and CEK set up the study design. MV and MP collected the data. All authors contributed to the interpretation of the data and the writing of the manuscript. All authors read and approved the final manuscript. | PMC10227114 | |
Funding | For this study there was no external funding. | PMC10227114 | ||
Availability of data and materials | The datasets analyzed during the current study are available from the corresponding author on reasonable request. | PMC10227114 | ||
Declarations | PMC10227114 | |||
Conflict of interest | On behalf of all authors, the corresponding author states that there is no conflict of interest. | PMC10227114 | ||
Ethical approval | The medical ethics committee (MEC) of the Leiden University Medical Center was informed and had no objection to this study. According to Dutch legislation, there was no need for informed patient consent, since this concerned a retrospective study on anonymized, routinely collected data (MEC waiver G21.169 and G21.191). | PMC10227114 | ||
References | PMC10227114 | |||
Background | Anatomy is a crucial part of medical education, and there have been attempts to improve this field by utilizing various methods. With the advancement of technology, three-dimensional (3D) materials have gained popularity and become a matter of debate about their effectiveness compared to two-dimensional (2D) sources. T... | PMC10722710 | ||
Methods | This study is a randomized controlled trial involving 87 Year-1 and Year-2 medical students at Gazi University Faculty of Medicine, Turkey. The study was conducted in two steps. In Step-1, students were randomized to watch lecture videos on liver anatomy and male genitalia anatomy supplemented with either a 3D PDF (int... | PMC10722710 | ||
Results | In the immediate test, while there was no significant difference between the groups for the liver test ( | PMC10722710 | ||
Conclusion | 3D PDF is more effective than 2D atlases in teaching anatomy, especially to initial learners. It is particularly useful for teaching complex anatomical structures, such as male genitalia, compared to the liver. Hence, it may be a valuable tool for medical teachers to utilize during lectures. | PMC10722710 | ||
Keywords | PMC10722710 | |||
Introduction | cadaver dissections | Medical education requires a holistic approach to the human body. Learning anatomy is one of the most essential elements in the preclinical education process of medical students [Throughout the years, various methods have been utilized for anatomy education. Traditional approaches included cadaver dissections and physi... | PMC10722710 | |
Methods | PMC10722710 | |||
Trial design | LIVER | We followed the CONSORT statement [We evaluated the effectiveness of 3D PDFs and traditional 2D atlases in teaching two topics: Liver anatomy and male genitalia anatomy. These structures were specifically selected based on their different levels of anatomical complexity, with male genitalia anatomy being considered mor... | PMC10722710 | |
Participants | RECRUITMENT | The study included Year-1 and Year-2 medical students in 2022–2023 term at Gazi University Faculty of Medicine, Ankara, Turkey. All Year-1 (n = 571) and Year-2 (n = 488) medical students were invited to the study through messaging groups covered the entire population. They had not yet taken anatomy classes on liver ana... | PMC10722710 | |
Materials | EXTERNAL GENITALIA | Educational materials included lecture videos on liver anatomy and male genitalia anatomy. The liver anatomy videos covered liver topography, gallbladder, and biliary system. The male genitalia anatomy videos covered male internal and external genitalia.Four videos (two for each topic) using the same written transcript... | PMC10722710 | |
Trial process | cognitive overload | The participants were randomly assigned to two groups (3D PDF and 2D atlas). Simple randomization was performed using SPSS v22.0 for Windows, ensuring that each participant had an equal chance of being assigned to either group.The trial took place at Gazi University Faculty of Medicine. The videos were displayed to the... | PMC10722710 | |
Statistical analysis | Statistical analyses were carried out using SPSS v22.0 for Windows. A In order to ensure that randomization worked well, the group characteristics in terms of gender, year, and repeating Year-2 were compared between the intervention group and the control group by using Chi-squared test.The Step-1 liver anatomy and male... | PMC10722710 | ||
Results | PMC10722710 | |||
Participants | A total of 87 participants volunteered for the experiment. They were randomized into two groups: 3D PDF and 2D atlas. Group characteristics are shown in Table The 3D PDF (intervention) group had a female majority (65.9%) and the 2D atlas (control) group had again a female majority (58.1%). The two groups did not signif... | PMC10722710 | ||
Immediate test | There was no significant difference between the performances of the 3D PDF group (Median = 15.00) and the 2D atlas group (Median = 17.00) in the liver test, U = 900.00, Z = -0.39, Among Year-2 medical students, neither in the liver test (
Statistical analysis of immediate and delayed tests*Mann-Whitney U test | PMC10722710 | ||
Delayed test | In the liver test, there was no significant difference between the performances of the 3D PDF group (Median = 12.00) and the 2D atlas group (Median = 9.50), U = 479.00, Z = -0.64, Year-1 students’ liver test performances did not differ significantly between the 2D atlas group (Median = 9.00) and the 3D PDF group (Media... | PMC10722710 | ||
Item analysis | Item analysis was performed on both the immediate and delayed tests by calculating item difficulty and discrimination indices. In the immediate test, the mean difficulty and discrimination indices of 10 items in the liver test were 0.72 and 0.52, respectively, while they were 0.56 and 0.47 in the genitalia test. In the... | PMC10722710 | ||
Discussion | a reduced number | Our study aimed to compare the effects of 3D PDF (intervention) and 2D atlas (control) on teaching anatomic structures with different levels of complexity in video lectures to initial learners. Their effects on short-term and long-term retention were assessed.While there were non-significant differences with little eff... | PMC10722710 | |
Acknowledgements | We would like to express our gratitude to the students in Gazi University Faculty of Medicine who participated in this study. We are grateful to Korea Institute of Science and Technology Information (KISTI) for granting permission to use 3D PDFs for research purposes. | PMC10722710 | ||
Author contributions | Conceptualization: SK, FSE, YSK; Methodology: YSK, FSE, BE, SK; Data Collection: FSE, BE, SBK, ZRK, FEÇ, MÜ, MA, YSK; Analysis: BE, FSE, YSK; Interpretation: FSE, BE, SBK, ZRK, FEÇ, MÜ, MET, MA, YSK ; First Draft: FSE, BE, SBK, ZRK, FEÇ, MÜ, MET, MA ; Review and Editing: YSK, SK, IİB, ÖC ; All authors have read and app... | PMC10722710 | ||
Funding | The authors received no financial support for the research, authorship, and publication of this article. | PMC10722710 | ||
Data availability | The dataset supporting the conclusions of this article is available in the Zenodo repository, accessible from 10.5281/zenodo.7830028. | PMC10722710 | ||
Declarations | PMC10722710 | |||
Ethics approval and consent to participate | All methods were carried out in accordance with relevant guidelines and regulations. All experimental protocols were approved by Gazi University Institutional Review Board (code: 2022 − 1073). Written informed consent was obtained from all subjects. | PMC10722710 | ||
Consent for publication | All participants gave written informed consent for publication. | PMC10722710 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10722710 | ||
Previous presentations | Preliminary results of this study titled ‘3D PDF: A Promising Learning Tool for Anatomy Education’ has been presented at the AMEE 2023 Conference, August 26–30, 2023, in Glasgow, UK. | PMC10722710 | ||
References | PMC10722710 | |||
INTRODUCTION | RSV, pneumonia, human illness, bronchiolitis, RSV-associated lower respiratory tract disease | VACCINE VIRUS SHEDDING, RESPIRATORY DISEASE, VIRUS, PNEUMONIA, RESPIRATORY SYNCYTIAL VIRUS (RSV), CARDIOPULMONARY DISEASE, ADVERSE EVENTS, DISEASE, KENNEL COUGH, BRONCHIOLITIS | Respiratory syncytial virus (RSV) can lead to serious disease in infants, and no approved RSV vaccine is available for infants. This first in-human clinical trial evaluated a single dose of BLB201, a PIV5-vectored RSV vaccine administrated via intranasal route, for safety and immunogenicity in RSV-seropositive healthy ... | PMC10599610 |
RESULTS | PMC10599610 | |||
Participants and study conduct | A total of 30 subjects were enrolled in this phase 1 trial, and all received a single intranasal dose of BLB201 at 10 | PMC10599610 | ||
Trial cohort demographics. | *One participant dropped out of the study on day 8 (lost to follow-up). | PMC10599610 | ||
Safety | RSV infection | ADVERSE EVENTS, EVENTS, RSV INFECTION | After intranasal immunization with Teleflex MAD300, the safety and tolerability of BLB201 were monitored for 6 months. Participants recorded information of local and systemic adverse events (AEs) for 7 days after vaccination (solicited local and systematic events) and unsolicited AEs for 28 days using a memory aid. No ... | PMC10599610 |
Summary of local and systemic reactogenicity and AEs. | nausea/vomiting, myalgia, fatigue, fever, headache, chills | ADVERSE EVENT | Grading scale: Grade 1 = mild (awareness of a symptom but the symptom is easily tolerated); grade 2 = moderate (discomfort enough to cause interference with usual activity); grade 3 = severe (incapacitating; unable to perform usual activities; requires absenteeism from work or bed rest). AE, adverse event.In group 1, a... | PMC10599610 |
Vaccine virus shedding and genetic stability | VIRUS | At day 1 before participants were immunized, no vaccine virus genomic RNA was detected as expected [i.e., below the lower limit of detection (LOD) by reverse transcription quantitative polymerase chain reaction (RT-qPCR)] in the nasal swabs of any participant ( | PMC10599610 | |
Vaccine-virus shedding. PIV5 viral genomic RNA detection by RTqPCR in individual BLB201 recipients at days 8 and 15. | The dotted line indicates the LOD at 4.6 log | PMC10599610 | ||
Immunogenicity | PMC10599610 | |||
Serum Ab titers
| All participants were seropositive for RSV nAbs at baseline, and the titer changes are presented in | PMC10599610 | ||
Serum RSV-specific Ab titers before and after vaccination. | ( | PMC10599610 | ||
Summary of RSV Ab and CMI response rates. | A positive seroresponse was defined as ≥1.5-fold rise from baseline for RSV F IgG and IgG. A positive nasal IgA Ab response was defined as ≥2-fold rise over baseline. CMI response was defined as >0.1% rise of sum of individual T cell secreting >1 cytokine after subtraction of baseline (before vaccination). CTL response... | PMC10599610 | ||
Serum PIV5 Ab titers before and after vaccination. | ( | PMC10599610 | ||
RSV F–specific IgA Ab titers in nasal swabs
| At baseline, RSV F–specific IgA Ab titers in nasal swabs were variable ranging from below the LOD to 514 (9.0 log | PMC10599610 | ||
Nasal IgA Ab titers before and after vaccination. | RSV IgA Abs | F-specific RSV IgA Abs by ELISA. Individual logOverall, the results suggested that BLB201 boosted RSV-specific nasal IgA levels in adults and elderly but to a lesser degree in elderly. Similar to results seen with systemic Ab responses, the fold increases in F-specific nasal IgA titers in both groups inversely correlat... | PMC10599610 | |
Cell mediated immunity
| At baseline, RSV F–specific CD4 | PMC10599610 | ||
RSV F–specific CD4 | (In both groups 1 and 2, T cells expressing a single T | PMC10599610 | ||
DISCUSSION | RSV infection, upper respiratory tract, nasal F-specific IgA Ab, RSV-specific nasal IgA, infection, human disease | INFECTION, VIRUS, RSV INFECTION | This clinical study of the PIV5-vectored RSV vaccine candidate BLB201 was the first in-human study for this vaccine and for the replicating PIV5 vector. The study showed that BLB201 administered as a single intranasal dose had an acceptable safety profile. Solicited local and systemic AEs were generally mild and only r... | PMC10599610 |
MATERIALS AND METHODS | PMC10599610 | |||
Study design and vaccination | The phase 1 clinical trial of PIV5-RSV vaccine (BLB201; Primary outcome measures included (i) solicited AEs (days 1 to 8) and (ii) unsolicited AEs (days 1 to 29). Secondary outcome measures included (i) serum IgG titers to RSV protein (days 15 and 29), (ii) SAEs (days 1 to 181), and (iii) AEs of special interest (AESIs... | PMC10599610 | ||
Safety assessments | SAEs, Toxicity | EVENTS | The safety and tolerability of PIV5-RSV intranasal vaccine were assessed over the period of 6 months after vaccination. Participants recorded the information of local and systemic AEs for 7 days after vaccination (solicited local and systematic events) and unsolicited AEs for 28 days using a memory aid. SAEs and AESIs ... | PMC10599610 |
Vaccine shedding and genetic stability | VIRUS SHEDDING | Vaccine-virus shedding was analyzed by RT-qPCR of nasal swabs collected on days 1 (before vaccination) and days 8, 15, and 29 after vaccination. A regular sized flocked nylon swab was used to collect nasal secretion from one nostril, placed in 1-ml universal transport medium (VTM, Copan), and stored at −80°C until samp... | PMC10599610 | |
Immunogenicity assessment | BLOOD, VIRUS, APC | Blood and nasal samples were collected at baseline (day 1, before vaccination), day 15, and day 29 before vaccination. To reduce sample variation, samples from the same participant were run on the same plate in a blinded fashion in all the assays. Serum RSV nAb levels were determined by a qualified RSV A2 microneutrali... | PMC10599610 | |
Statistical analysis | Statistical analysis was performed using GraphPad Prism software (Version 9). Given the small sample size, statistical analysis was mostly descriptive and summative. | PMC10599610 | ||
Supplementary Materials | PMC10599610 | |||
This PDF file includes: | Figs. S1 and S2Click here for additional data file. | PMC10599610 | ||
REFERENCES AND NOTES | PMC10599610 | |||
Key Points | PMC10220519 | |||
Question | What is the effect of parent-led, infant-directed singing—initiated in the neonatal intensive care unit with support from a music therapist and extending 6 months after discharge—on parent-infant bonding at 6 and 12 months’ infant-corrected age? | PMC10220519 | ||
Findings | In this randomized clinical trial involving 213 families, mothers engaging in parent-led, infant-directed singing reported similar parent-infant bonding at 6 and 12 months’ corrected age as mothers receiving standard care only. | PMC10220519 | ||
Meaning | These results suggest that, although safe and accepted by parents, parent-led, infant-directed singing was no more effective at improving mother-infant bonding than standard care.This randomized clinical trial conducted in 5 countries examines the effect of parent-led, infant-directed singing on parent-infant bonding a... | PMC10220519 | ||
Importance | PRETERM BIRTH | Parent-infant bonding contributes to long-term infant health but may be disrupted by preterm birth. | PMC10220519 | |
Objective | To determine if parent-led, infant-directed singing, supported by a music therapist and initiated in the neonatal intensive care unit (NICU), improves parent-infant bonding at 6 and 12 months. | PMC10220519 | ||
Design, Setting, and Participants | This randomized clinical trial was conducted in level III and IV NICUs in 5 countries between 2018 and 2022. Eligible participants were preterm infants (under 35 weeks’ gestation) and their parents. Follow-up was conducted across 12 months (as part of the LongSTEP study) at home or in clinics. Final follow-up was condu... | PMC10220519 | ||
Intervention | Participants randomized to music therapy (MT) plus standard care or standard care alone during NICU admission, or to MT plus standard care or standard care alone postdischarge, using computer-generated randomization (ratio 1:1, block sizes of 2 or 4 varying randomly), stratified by site (51 allocated to MT NICU, 53 to ... | PMC10220519 | ||
Main Outcome and Measure | Primary outcome was mother-infant bonding at 6 months’ corrected age, measured by the Postpartum Bonding Questionnaire (PBQ), with follow-up at 12 months’ corrected age, and analyzed intention-to-treat as group differences. | PMC10220519 | ||
Results | Of 206 enrolled infants with 206 mothers (mean [SD] age, 33 [6] years) and 194 fathers (mean [SD] age, 36 [6] years) randomized at discharge, 196 (95.1%) completed assessments at 6 months and were analyzed. Estimated group effects for PBQ at 6 months’ corrected age were 0.55 (95% CI, −2.20 to 3.30; | PMC10220519 | ||
Conclusions and Relevance | In this randomized clinical trial, parent-led, infant-directed singing did not have clinically important effects on mother-infant bonding, but was safe and well-accepted. | PMC10220519 | ||
Trial Registration | ClinicalTrials.gov Identifier: | PMC10220519 | ||
Introduction | Prematurity | PREMATURITY | Parent-infant bonding, an important contributor to quality of early parent-infant relationship and long-term infant health,Prematurity is associated with poorer cognitive development, mental health, and quality of life for the child, | PMC10220519 |
Methods | PMC10220519 | |||
Study Design | PREMATURE | Longitudinal Study of Music Therapy’s Effectiveness for Premature Infants and Their Caregivers (LongSTEP) was designed as a 2 × 2 factorial, multinational, pragmatic randomized clinical trial (RCT) evaluating longer-term effects of music therapy (MT) in neonatal intensive care unit (NICU) and after discharge on preterm... | PMC10220519 | |
Participants | POLAND | We recruited participants from 8 NICUs (7 level III and 1 level IV) in Argentina, Colombia, Israel, Norway, and Poland, countries where social systems enable continual parental presence during infant hospitalization. Preterm infants that were born at less than 35 weeks’ gestational age, were likely to be hospitalized a... | PMC10220519 | |
Randomization and Masking | Following completion of written informed consent and baseline assessments, participants were randomized to MT plus standard care or standard care alone during NICU using a computer-generated randomization list with ratio 1:1, in block sizes of 2 or 4 varying randomly, stratified by site, using an online system (Sealed ... | PMC10220519 | ||
Intervention | Infants and parents in the NICU MT group received 3 individual MT sessions per week throughout hospitalization, with maximum 27 sessions, lasting approximately 30 minutes each (with time in active music making depending upon infant tolerance). MT consisted of parent-led, infant-directed singing; our use of the concept ... | PMC10220519 | ||
Outcomes | Our primary outcome was mother-infant bonding measured by the Postpartum Bonding Questionnaire (PBQ) | PMC10220519 | ||
Statistical Analysis | In the absence of a generally agreed minimal clinically important difference for the PBQ, we designed the trial to have 80% power to detect a difference of 4 points (corresponding to Descriptive statistics characterizing the sample have been published elsewhere. | PMC10220519 | ||
Results | Of 213 infants randomized in NICU from August 2018 to April 2020, | PMC10220519 | ||
Study Flow Diagram | The second randomization forms the basis for all numbers thereafter. | PMC10220519 | ||
Baseline Characteristics Across 4 Study Arms | Abbreviation: MT, music therapy.For 206 participants who were randomized twice. | PMC10220519 | ||
Analysis of Covariance and Regression Results | depression, Depression, Anxiety, anxiety | DISORDER, REGRESSION | Abbreviations: ASQ-3, Ages and Stages Questionnaire, third edition; ASQ:SE-2, Ages and Stages Questionnaire: Social-Emotional, second edition; EPDS, Edinburgh Postnatal Depression Scale; GAD-7, Generalized Anxiety Disorder Assessment; PBQ, Postpartum Bonding Questionnaire; PSS, Parental Stress Scale.Based on a linear m... | PMC10220519 |
Mean Observed Values for Postpartum Bonding Questionnaire (PBQ) and Secondary Outcomes | Depression, Anxiety | DISORDER | ASQ-3 indicates Ages and Stages Questionnaire, third edition; ASQ:SE-2, Ages and Stages Questionnaire: Social-Emotional, second edition; EPDS, Edinburgh Postnatal Depression Scale; GAD-7, Generalized Anxiety Disorder Assessment; MT, music therapy; PSS, Parental Stress Scale. | PMC10220519 |
Observed Group Means and Mean Differences for All Outcomes | Depression, Anxiety | DISORDER | Abbreviations: ASQ-3, Ages and Stages Questionnaire, third edition; ASQ:SE-2, Ages and Stages Questionnaire: Social-Emotional, second edition; EPDS, Edinburgh Postnatal Depression Scale; GAD-7, Generalized Anxiety Disorder Assessment; MT, music therapy; NA, not applicable; PBQ, Postpartum Bonding Questionnaire; PSS, Pa... | PMC10220519 |
Discussion | depression, anxiety | PREMATURE BIRTH | We used a multinational, pragmatic RCT to examine longer-term effects of parent-led, infant-directed singing supported by a music therapist on mother-infant bonding, parental well-being, and infant development from NICU hospitalization to 12 months’ corrected age. Parents had lower than anticipated levels of impaired b... | PMC10220519 |
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