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Radiographic measurement | tooth | CREST | The CBCT images were collected using the Planmeca 3D Imaging System (field-of-view of 8 cm (D) × 8 cm (H), resolution 0.16 mm, Planmeca, Finland). After being exported as digital imaging and communications in medicine (DICOM) files, the data were analyzed using planning software (Nobel Clinician, Nobel Biocare, Sweden) for GV measurement (Fig. Data import. The measurement point of GV. Schematic diagram of the identification of measurement point for GV. The GV measurement baseline is on the alveolar ridge’s crest. Following the long axis of the tooth, the red dot is a point for measuring bone density underneath 3 mm of baseline. The center part of the biopsy is the same as the GV-measured point of the CBCT image | PMC10579201 |
Histomorphological examination | Tissue biopsies were immersed in 10% neutral formalin solution for 24 h with the trephines.Thereafter, samples were dehydrated with alcohol gradients after flushing, and embedded with polymethyl methacrylate. The samples were sectioned opposite to the long axis of the biopsy, and five tissue sections of 600 µm thicknesses (1 mm spacing) were collected for each piece, polished to a final thickness of 50–100 µm, and stained with McNeal’s tetrachrome staining. The Image Pro Plus program (version 6.0, Media Cybernetics) was used to calculate the area of new bone, the residual material, and the unmineralized tissue at the center slice of the biopsy (Fig. Light micrographs of biopsy slice (diameter 1.1 mm) in the natural healing group ( | PMC10579201 | ||
Statistical analysis | ± | Categorical data are expressed as frequencies and percentages, and continuous data as mean (± standard deviation, SD) or median and interquartile range (IQR) (25th–75th percentile). Analysis was performed in the per-protocol (PP) dataset, that is, all patients who were randomized, received the intervention, and completed the study procedures. A single-factor analysis of variance (ANOVA) was used to compare CVs changes among the three study groups. The Mann–Whitney | PMC10579201 | |
Results | Of the 40 patients recruited for the study, 4 (10%) were excluded due to protocol violations (prohibited medication history, significantly exceeding the follow-up time-point limit, and severely defective bone), 2 of them from the natural healing group, and 1 patient each from the rhBMP-2/BioCaP/β-TCP and β-TCP groups, respectively. Therefore, the study population included 14 patients in the rhBMP-2/BioCaP/β-TCP group, 14 in the β-TCP, and 8 in the control group. | PMC10579201 | ||
GV changes on CBCT images | In the first CBCT scan (baseline), there were no statistically significant differences in GVs between the rhBMP-2/BioCaP/β-TCP and β-TCP groups (Table Initial GV in β-TCP and rhBMP-2/BioCaP/β-TCP groupComparison of CBCT data of the GV change in three groupsComparison of CBCT data of the GV change in β-TCP group and RhBMP-2/BioCaP/β-TCPgroup | PMC10579201 | ||
Histomorphological results | The percentage of new bone area at the 3 mm point was statistically significant different in the three study groups, with higher values in the rhBMP-2/BioCaP/β-TCP group (21.18% ± 7.62% in the rhBMP-2/BioCaP/β-TCP group, 13.44% ± 6.03% in the β-TCP group, and 9.49% ± 0.08% in controls). Also, the median (min, max) values were 20.93% (10.62%, 39.08%) in the rhBMP-2/BioCaP/β-TCP group, 13.48% (3.78%, 23.42%) in the β-TCP group, and 12.21% (0.28%, 18.58%) in the controls (Table Comparison of histological data of the biopsies-PPS in three groupsPairwise comparison of histological data of the new bone area %1: rhBMP-2/BioCaP/β-TCP group; 2: β-TCP group; 3: natural healing groupIn the rhBMP-2/BioCaP/β-TCP group, the percentage of residual materials area was 10.04% ± 4.57%, the median (min, max) was 10.47% (2.58%, 16.80%), which was significantly lower than that observed in the β-TCP group, 20.60% ± 9.54%, median (min, max) was 18.24% (9.38%, 42.22%) (Table There were statistically significant differences in the percentage of unmineralized tissue area among the three groups (the rhBMP-2/BioCaP/β-TCP group: 68.78% ± 7.67%; the β-TCP group: 65.96% ± 12.64%; and the natural healing group: 90.38% ± 7.5%) (Pairwise comparison of histological data of the unmineralized tissue area %1: rhBMP-2/BioCaP/β-TCP group; 2: β-TCP group; 3: natural healing group | PMC10579201 | ||
Discussion | bone loss, tooth | ADHESION, BONE LOSS | This study used CBCT scanning and histological examination to evaluate degradation and new bone formation associated with the use of rhBMP-2/BioCaP/β-TCP and β-TCP as filling materials in socket preservation. CBCT scanning showed that there was a greater GV decrease in the rhBMP 2/BioCaP/β-TCP group than in the β-TCP group, which suggest a faster degradation rate of this material. In addition, less residual material and more new bone formation were identified in rhBMP-2/BioCaP/β-TCP group based on histomorphometric examination.In both CBCT and biopsy tissue samples, the center of the filled area was selected to assess bone density, the volume of residual material, and new bone, as there were fewer interference factors (soft tissue and old bone tissue) around the target sites. Since the biopsies were 6 mm high, 3 mm under the reference of the alveolar ridge and alongside the tooth-long axis was included for GV change measurement, and CBCT results revealed that rhBMP-2/BioCaP/β-TCP group has more GV decrease in CBCT images, which indicated faster degradation than β-TCP group, and this assumption was confirmed in histomorphometric evaluations. Despite the CBCT results were consistent with those from histomorphometric assays. GV from CBCT alone cannot precisely reflect bone density, as GV quantifies the amount of X-ray attenuation of bone tissue and filled materials. Therefore, CBCT cannot independently determine the occurrence of new bone development.The faster degradation of rhBMP-2/BioCaP/β-TCP may be attributed to more cell adhesion. In biomaterial-induced bone regeneration, biomaterials act as scaffolds where bone cells and osteoclasts can adhere and grow [Multislice computed tomography (MSCT) and micro-CT have been widely used to evaluate bone density, using the Hounsfield unit (HU) values, in orthopedics and laboratory studies [Alveolar ridge preservation can provide adequate alveolar bone for dental implants [In this study, patients with extraction defect assessment (EDS) class 1 (EDS-1) or 2 (EDS-2), having less bone loss than those with EDS-3 or EDS-4, were included after tooth extraction, and they were in a better condition for bone healing. The rhBMP-2/BioCaP/β-TCP group was superior to β-TCP and natural healing (control) groups in bone formation. However, to assess the efficiency of rhBMP-2/BioCaP/β-TCP in adverse conditions for bone regeneration (e.g., EDS-3 and EDS-4), more studies are warranted. | PMC10579201 |
Acknowledgements | We thank Frederieke Monchen and Isa Massee for collecting CBCT data, Dr. Naichuan Su for statistical data analysis, and Marta Pulido, MD, for editing the manuscript. | PMC10579201 | ||
Author contributions | YS: writing—original draft and visualization; CX and MW: writing—review and editing; HP: performed in trial design and management; YW and LW: writing—review; YL: conceptualization; supervision; writing—review and editing. | PMC10579201 | ||
Funding | This work was supported by the NWO grant (No. 729001041) and the Dutch ZonMW grant LSH2TREAT (No. 436001004). | PMC10579201 | ||
Data availability | The datasets used and/or analysed during the current study are available from the corresponding author upon reasonable request. | PMC10579201 | ||
Declarations | PMC10579201 | |||
Ethical approval and consent to participate | The study was approved by the Clinical Research Ethics Committees of the Academic Center for Dentistry Amsterdam (code ACTA 202061), Vrije Universiteit Amsterdam, the Netherlands and Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University, School of Medicine (code SH9H-2019-T231-4), China. | PMC10579201 | ||
Consent for publication | Written informed consent was obtained from all participants. | PMC10579201 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10579201 | ||
References | PMC10579201 | |||
Keywords | PMC10208731 | |||
Palavras-chave | PMC10208731 | |||
Introduction | PTB, sPTB | PRETERM BIRTH, PRETERM DELIVERY |
Multiple gestations are at higher risk for preterm birth (PTB), and neonatal morbidity and mortality, and their incidence has been in a rising trend since many of them are associated with assisted reproduction treatments.
The use of risk factors to identify women at higher risk of preterm delivery is part of the prevention strategies.
Studies involving singleton pregnancies have considered 25 mm as the most accepted cutoff to define a short cervix,
To correctly identify the CL that is associated to sPTB, specific populational distribution curves are necessary to describe the range of CL and to suggest what should be considered a short cervix in Brazilian twins' pregnancies. Moreover, it is important to know if it is possible to use CL as a predictor for sPTB in twin gestations. The main objective of this study was to describe a reference curve for CL in mid-trimester twin gestations using TVU and to identify the association between CL and gestational age at birth, and whether mid-pregnancy CL is a good predictor for PTB. | PMC10208731 |
Methods | fetal malformation, PTB, cholestasis, sPTB | VAGINAL BLEEDING, CONTRACTIONS, LIVER DISEASE, PREGNANCY COMPLICATIONS, CHOLESTASIS, PLACENTA PREVIA, THROMBOEMBOLISM, REGRESSION, DILATION, PRETERM BIRTH |
We performed an ancillary analysis using a cohort strategy analysis of all twin pregnancies included in the P5 Trial (Pessary Plus Progesterone to Prevent Preterm Birth Study – Trial registration RBR-3t8prz, approved by the Brazilian National Review Board/CONEP – number 1.055.555) to describe Brazilian populational curves.
The P5 Trial was a multicenter, randomized, controlled trial involving 17 institutions (nine states in three regions: South, Southeast, and Northeast of Brazil) that compared the effectiveness of vaginal progesterone alone versus progesterone plus cervical pessary in women with short cervix. The study was coordinated by the University of Campinas from July 2015 to March 2019. A TVU screening program using a GE Logiq C5 (GE HealthCare. Chicago, IL, EUA) equipment or similar with a 5 to 9MHz transvaginal probe was offered as part of standard care for all women attending the ultrasound department during routine second trimester ultrasonographic examinations between 18 0/7 and 22 6/7 weeks. Women received information about the TVU technique and P5 study and all provided written informed consent. Sociodemographic characteristics, obstetric history, and current pregnancy information were previously collected.Exclusion criteria for CL measurement were related to symptoms or pregnancy complications: painful contractions, vaginal bleeding, cerclage during current pregnancy before the screening, ruptured membranes diagnosed before screening, severe liver disease, cholestasis during this pregnancy, previous or current thromboembolism, placenta previa, cervical dilation greater than 1 cm, monoamniotic twin pregnancy, higher order multiple pregnancies (triplets or higher), major fetal malformation in at least one fetus, and stillbirth. For this analysis, we also excluded singleton gestations. The information on pregnancies was accessed using an online database from the screening phase of the P5 trial. Considering P5 trial interventions, 80 women had CL ≤ 30mm and 71 accepted to participate in the RCT, where 71 of the patients received progesterone and 43 also received a cervical pessary.All participating sonographers received previous training in CL measurement according to the Fetal Medicine Foundation program, as well as additional training regarding the volume measurement developed by the University of Campinas's ultrasound department.Describing the TVU technique briefly, after emptying the bladder, the woman was placed in the dorsal lithotomy position. The TVU probe was introduced until the anterior fornix region, avoiding extra pressure on the cervix, which can artificially increase the CL. A sagittal view of the cervix, showing the endocervical mucosa, was used to properly identify the internal and external ostium (os). Sludge and funneling were also evaluated and described, if present.
Descriptive statistical analysis was performed for demographic characteristics, expressed as means and percentages. Logistic regression was used to estimate odds ratio (OR) for baseline characteristics, gestational age, and CL measurements. Mean, median, and percentiles of CL (P5, P10, P25, P50, P75, P90, and P95) were obtained for the descriptive analysis. The receiver operating characteristics (ROC) curve analysis was performed to identify the most effective cutoff point to predict a sPTB (< 37 weeks). We also used the ROC curve analysis to identify the most effective cutoff points to predict overall PTB (< 37) and sPTB at different gestational ages (< 37 and > 34 weeks – later PTB; < 34–PTB; and < 28 weeks – extreme PTB). We calculated sensitivity, specificity, negative (NPV) and positive predictive values (PPV), and likelihood ratios (LR). The Kaplan-Meyer survival curves were used to analyze time to delivery, considering CL intervals (≤ 10 mm, 10–15 mm, 15–20 mm, 20–25 mm, 25–30 mm, 30–35 mm, 35–40 mm, and > 40 mm). A
| PMC10208731 |
Results | PTB, sPTB, abortion | OBESE |
A total of 253 from 8,168 women were included in this analysis. We excluded 71 women due to missing information, and 7844 singleton women (
Patient enrolment flowchart.
The incidence of twin pregnancy in the P5 screening phase was 3.5%, with 157 dichorionic diamniotic twins (62%), and 96 monochorionic diamniotic twins (38%). Approximately 70.8% (179/253) of the women were between 20 and 34 years old, and 86.9% (220/253) had studied less than 11 years. Most of the women, 53.4% (135/253), were non-white, and 32.8% (83/253) were obese (body mass index, BMI > 30). Considering obstetrical history, 58.5% (148/253) had at least one previous pregnancy, 7.5% (19/253) had at least one previous PTB, and 24.9% (63/253) had a previous abortion. Funneling was present in 10.7% (27/253), and 13.4% (34/253) presented sludge at measurement. The rate of PTB was 73.9% (187/253), with 33.6% of sPTB < 37 weeks (85/253), and 15% (38/253) of sPTB < 34 weeks (
| PMC10208731 |
Values of percentile 5, 10, 25, 50, 75, 90, and 95 for the cervical length according to gestational age at measurement | sPTB |
As a presumable consequence, considering two gestational ages intervals at measurement (18–20 vs. 21–22 weeks), we identified an increase in sensitivity to predict sPTB < 37 during 21 to 22 weeks (
| PMC10208731 | |
Discussion | PTB, sPTB |
Our study provides Brazilian CL distribution curves from 18 to 22 + 6 weeks in asymptomatic twin gestations. The CL 10
The mean CL identified in our study and the PTB rate are very similar to previous Brazilian studies focused on twin gestations. A prospective cohort involving 341 patients with CL measurement between 18 and 21 weeks, described CL mean (31.95–33.46 mm) with 68.2% of PTB < 37 weeks.
Thus, before defining what is a short cervix (and its association with sPTB) in a Brazilian twin population it is crucial to know the CL distribution curve in this specific subset of women. If we consider short cervix as CL under P10, we demonstrated that in the Brazilian population CL ≤ 25 mm is not the best cutoff value for twin gestations. This way, a more interesting cutoff point would be CL ≤ 20 mm, since it is very close to P10 and demonstrated a clear association with early sPTB in the Kaplan-Meier curves.
Differently from a singleton gestation, where the maternal sociodemographic characteristics may influence the incidence of sPTB,
Implementing a screening test for prediction is the first step for prevention, offering possible therapies when risk factors are present. However, treatments such as progesterone and cerclage used for preventing sPTB in singleton with short cervix do not demonstrate promising results in twins.
A strength of our study is that our sample was composed by women from 17 different settings in Brazil, involving diverse population characteristics that can be found in a country with a continental territory.
One limitation is that almost all women with CL ≤ 30 mm received progesterone 200 mg/day and part of them also received a cervical pessary, which could have influenced the PTB's final result or even postponed PTB. However, the last studies did not show these two interventions as capable of causing a significant reduction in PTB for twins.
Finally, as CL does not show a good performance to predict PTB, and the available treatments for PTB in twins do not show a clear benefit, we believe that a universal screening program for twin gestation in Brazil, considering a panel with limited resources, would not be helpful or economically viable. When treatments for these high-risk populations show good efficacy, maybe a screening and treatment strategy could be justified. | PMC10208731 | |
Conclusion | PTB | A cutoff point of CL ≤ 20 mm can be interesting to identify short cervix in Brazilian twin pregnancies. However, in Brazilian asymptomatic twin pregnancies, CL does not show a good performance to predict PTB. Furthermore, the available treatments for PTB in twins do not support a CL screening program in Brazil. | PMC10208731 | |
Contributions | JP | TV Silva: design, investigation, data collection, data analysis, data curation, methodology, writing, and review & editing. AB Pinheiro: review & editing. MS França: investigation, data collection, and data analysis. KF Marquart: investigation, data collection, and data analysis. JP Argenton: statistics and data analysis. BW Mol: funding acquisition, writing, and review & editing. RC Pacagnella: conceptualization, design, data curation, funding acquisition, methodology, writing, and review & editing. | PMC10208731 | |
References | PMC10208731 | |||
Background | The authors have declared that no competing interests exist.The World Health Organization recommends that primaquine should be given once weekly for 8-weeks to patients with | PMC10482257 | ||
Methods | Within the context of a multicentre, randomised clinical trial of two primaquine regimens in | PMC10482257 | ||
Results | G6PD DEFICIENCY | Between July 2014 and November 2017, 42 male and 8 female patients were enrolled in Afghanistan (6), Ethiopia (5), Indonesia (19), and Vietnam (20). G6PD deficiency was confirmed by genotyping in 31 patients: Viangchan (14), Mediterranean (4), 357A-G (3), Canton (2), Kaiping (2), and one each for A | PMC10482257 | |
Conclusions | PQ8W was highly effective in preventing | PMC10482257 | ||
Trial registration | This trial is registered at ClinicalTrials.gov ( | PMC10482257 | ||
Author summary | Fifty patients with | PMC10482257 | ||
Data Availability | All data are in the manuscript and/or | PMC10482257 | ||
Materials and methods | PMC10482257 | |||
Ethics statement | Ethics approval was obtained from the following national and local committees and authorities: The Human Research Ethics Committee of the Northern Territory Department of Health (HREC), Australia, the Islamic Republic of Afghanistan, Ministry of Public Health, Institutional Review Board, Afghanistan, the National Research Ethics Review Committee (NRERC), Ethiopia, the Scientific & Ethical Review Committee (SERC), Ethiopian Public Health Institute, Ethiopia, the Food Medicine and Health Care Administration and Control Authority (FMHACA), Ethiopia, the Health Research Ethics Committee of the Faculty of Medicine University of Indonesia, Indonesia, the Indonesian Food and Drug Agency (BPOM), Indonesia, the Oxford Tropical Research Ethics Committee (OxTREC), UK, and the Ministry of Health Evaluation Committee on Ethics in Biomedical Research, Vietnam. | PMC10482257 | ||
Trial design, study site, conduct and ethics | gastrointestinal symptoms, parasitaemia, abdominal pain, nausea, vomiting | INFECTIOUS DISEASES, ALLERGY, ADVERSE EVENTS, DRUG WITHDRAWAL, EVENTS, SEVERE ANEMIA, BLOOD | The clinical trial design and methodology have been described previously [G6PDd patients were treated with supervised primaquine (blister-packed 7.5 & 15 mg tablets, Centurion Laboratories, Vadodara, India), at a target dose of 0.75mg base/kg per week (At enrolment, a medical history was taken, a physical examination was performed, and antimalarial treatment initiated. Patients were reviewed weekly for the first 8 weeks and then monthly for one year. At each visit, blood was taken and Giemsa stained for microscopic examination for peripheral parasitaemia, and Hb concentration (HemoCue AB, Ängelholm, Sweden). Blood films were declared negative if no parasites were detected after examining 200 high power fields (1,000× magnification) on the thick film.The primary efficacy outcome was the incidence rate of all recurrent vivax parasitaemia over 12 months of follow up, i.e. the total number of detected Haematological safety outcome measures included: the incidence risk of severe anemia (Hb <7g/dL) and/or blood transfusion, and an acute drop in Hb >5g/dL over the first 56 days of follow up, the median fall in Hb concentration from baseline to D3 and D7, the nadir Hb concentration (defined as minimum Hb concentration recorded over 56 days), the median time to nadir Hb, the maximal fractional change of Hb concentration (calculated from the difference in Hb at nadir from baseline), and the proportion of patients who achieved complete Hb recovery (D90 Hb > baseline Hb concentration).Adverse events (AE) were graded using the National Institute of Allergy and Infectious Diseases Table for grading the severity of Adult and Pediatric adverse events. Solicited gastrointestinal symptoms in routine questionnaires included nausea, vomiting and abdominal pain between D0 and D13. Any AE leading to study drug withdrawal, and serious AEs over 12 months were also recorded, irrespective of their relationship to study drugs.Ethics approvals were obtained from the relevant national and local committees and authorities, the Oxford University Tropical Ethics Committee and the Human Research Ethics Committee of the Northern Territory Department of Health, Australia ( | PMC10482257 |
G6PD deficiency assessment and genotyping | G6PD deficiency | G6PD DEFICIENCY | At the two Indonesian sites, patients with an FST result indicating G6PD deficiency had their enzyme activities quantified by spectrophotometry (Trinity Biotech, Ireland), processed within 7 days of sampling [Patient’s G6PDd status was confirmed by genotyping for local variants known to be associated with reduced enzyme activity. DNA from these Indonesian samples was extracted using QIAamp DNA mini kit (Qiagen, Germany) and genotyped first by PCR/RFLP for regional variants including Viangchan, Chatham, Mahidol, Vanua Lava, Orissa, Kaiping, Union, and Coimbra. If these variants were not detected, samples were sequenced from exons 3−13, as described previously [ | PMC10482257 |
Statistical methods & data management | parasitaemia | REGRESSION, RECURRENCE, G6PD DEFICIENCY | Data were entered from standardised case record forms and analysed using Stata v16.0 (StataCorp, College Station, TX). Negative binomial regression adjusted for follow up time was used to estimate the incidence rate of recurrence outcomes and Kaplan Meier survival estimates were used to assess the incidence risk of recurrent parasitaemia. Descriptive statistics are presented for haematological outcomes. All patients who received at least one dose of study drug were included in the efficacy and safety analyses. Estimates of safety and efficacy outcomes are provided with 95% confidence intervals but no statistical comparison is made between these estimates in the patients treated with weekly primaquine and those in main randomised trial. Since only eligible patients agreeing to be enrolled into the IMPROV study were tested for G6PD deficiency, reliable estimates of the background prevalence of G6PD at each of the sites were not available. Handling of missing data and adjudication of outcomes are described in detail in the | PMC10482257 |
Results | Between July 20, 2014, and November 25, 2017, 50 patients (42 [84%] males) with G6PDd and microscopy confirmed | PMC10482257 | ||
Trial profile. | PMC10482257 | |||
Baseline characteristics of patients enrolled into the study. | The baseline characteristics of patients enrolled at each site are presented in | PMC10482257 | ||
G6PD activity and genotyping | G6PD deficiency | G6PD DEFICIENCY | Genotyping of G6PD variants was conducted on all but one patient from Afghanistan who had a missing blood sample. Seventeen patients were wild type at the loci tested (See In South Sumatra, the G6PD activity of the six patients diagnosed with G6PD deficiency by FST ranged from 1.4 to 52% (Of the 31 patients enrolled in Ethiopia, Afghanistan and Vietnam, a G6PD variant was identified in 22 hemizygous males and 3 heterozygous females ( | PMC10482257 |
G6PD variants identified in patients enrolled into the study. | 202G | *1 male in Ethiopia genotyped as AF2 (202G>A) and was categorized as A+ and not confirmed as deficient. Enzyme activities are presented in | PMC10482257 | |
Efficacy | parasitaemia, aparasitaemic | The initial response to treatment was rapid in all patients. After 24 hours, 88% (44/50) were aparasitaemic and 92% (45/49) were afebrile. By 48 hours, all patients had cleared their peripheral parasitaemia and were afebrile. Two Vietnamese patients had recurrent symptomatic The incidence rate of | PMC10482257 | |
Efficacy endpoints. | PMC10482257 | |||
Haematological profile | Overall, the median Hb concentration fell after starting treatment with the lowest concentration reported on D7 (12.2 g/dL, range 8.3–16.6). The Hb concentration rose thereafter to exceed the median baseline Hb on D28 ( | PMC10482257 | ||
Changes in haemoglobin concentrations (g/dL) over time in all patients identified as G6PD deficient by the fluorescent spot test. | Footnote: Purple dotted lines show individual patient Hb profiles.The Hb concentrations over time by G6PD status are shown in | PMC10482257 | ||
Distribution of haemoglobin concentrations (g/dL) over time during follow up by G6PD status. | Footnote: Boxes represent 25 | PMC10482257 | ||
Hemoglobin Profile by Treatment Arm. | Two patients had falls in Hb exceeding 5 g/dL ( | PMC10482257 | ||
Relationship between haemoglobin at baseline and day 7 as A) fractional change and B) absolute change, by G6PD status. | PMC10482257 | |||
Tolerability | No patient vomited their medication within 1 hour of administration. During the first week ( | PMC10482257 | ||
Symptoms elicited from symptom questionnaires. | diarrheal, abdominal pain, anorexia, nausea, vomiting | ANOREXIA | * Composite of any of the following: nausea, vomiting, anorexia, diarrheal or abdominal pain | PMC10482257 |
Discussion | anemia, acute disease, parasitaemia, G6PD deficiency, hemolysis, anorexia | EVENT, RECRUITMENT, ANEMIA, ACUTE DISEASE, G6PD DEFICIENCY, HEMOLYSIS, ANOREXIA | Our study represents the largest study to date on the use of the 8-week primaquine regimen for the radical cure of Defining antirelapse efficacy of primaquine and tafenoquine is confounded by the frequency and timing of hypnozoite reactivation and recurrent parasitaemia, which vary with hypnozoite load, and parasite strains in a geographical region [Few studies have estimated the efficacy of weekly primaquine. In the 1960s, 10% (2/11) of patients experimentally challenged with the Chesson strain of The current WHO guidelines recommend a daily dose of PQ in adults of 15 mg (0.25 mg/kg) or 30 mg (0.5 mg/kg) for the 14 day regimen and weekly 45 mg (0.75mg/kg) in the 8 week regimen. The weekly dose of PQ in our study was weight adjusted to provide a total mg/kg dose of approximately 7mg/kg (The primary safety concern for primaquine relates to its ability to cause severe hemolysis in patients with G6PD deficiency [Weekly spacing of PQ administration allows some haematological recovery between drug exposures. Two male patients with Mediterranean and Kaiping variants had a fall in Hb >5g/dL, but both started with high baseline Hb concentrations, neither had a fall in Hb below 10g/dL or reported concomitant symptoms, and both recovered quickly while completing their course of primaquine. By contrast, a 16-year old male with the Kaiping variant had a 33% fall in Hb to 9.0 g/dL, associated with general malaise, anorexia and reduced oral intake requiring intravenous fluid administration in hospital. A similar event occurred in a Cambodian trial, in which a male with the Viangchan variant was treated with PQ8W and had a fractional fall of 25% (from 10 to 7.5 g/dL) resulting in symptomatic anemia necessitating a blood transfusion [Our study has several limitations. We were unable to measure the enzyme activity by spectrophotometry at all sites and thus relied on screening with the FST. This qualitative assay only detects G6PD deficiency in patients with less than 30% enzyme activity and is vulnerable to subjective visual discrimination [Another limitation of our analysis is the relatively low patient recruitment into the study. Despite being the largest study of primaquine in patients with G6PDd, the sample size is relatively small for an antimalarial clinical trial conducted over multiple sites. This limitation has confounded previous clinical trials seeking to enrol intermediate or severely G6PD deficient patients and likely reflects the protective effect of G6PDd against acute disease [In conclusion, our study provides important new evidence on the tolerability, safety and efficacy of PQ8W in Asian and African patients with G6PDd. PQ8W was highly effective in preventing | PMC10482257 |
Supporting information | PMC10482257 | |||
Statistical analysis plan. | (PDF)Click here for additional data file. | PMC10482257 | ||
Literature review of clinical trials treating patients with weekly primaquine regimens. | (DOCX)Click here for additional data file. | PMC10482257 | ||
Information about study sites. | (DOCX)Click here for additional data file. | PMC10482257 | ||
List of Ethics Review Boards and Regulatory Agencies. | (DOCX)Click here for additional data file. | PMC10482257 | ||
Weekly primaquine dosing. | (DOCX)Click here for additional data file. | PMC10482257 | ||
Dosing table for dihydroartemisinin piperaquine used in Indonesia. | (DOCX)Click here for additional data file. | PMC10482257 | ||
Baseline Characteristics of all patients stratified by site. | (DOCX)Click here for additional data file. | PMC10482257 | ||
Study data. | (XLSX)Click here for additional data file.We wish to express our sincere gratitude to the patients for volunteering to join this study and to the nurses and laboratory staff. For the purpose of open access, the author has applied a CC BY public copyright license to any Author Accepted Manuscript version arising from this submission. | PMC10482257 | ||
References | PMC10482257 | |||
Background | CARDIOPULMONARY | Cardiopulmonary resuscitation skill have a direct impact on its success rate. Choosing the right method to acquire this skill can lead to effective performance. This investigation was conducted to compare the effect of Real-time feedback and debriefing by video recording on basic life support skill in nursing students. | PMC9878936 | |
Methods | This quasi-experimental study was performed on 67 first year nursing students. First, a theoretical basic life support (BLS) training session was held for the all participants, at the end of session the pre-test was taken. Students were randomly assigned to two groups. A 4-hour practical BLS training session was conducted in the real - time feedback group as well as the debriefing by video recording group, and at the end of the training, a post-test was taken from each group. Each group received a post-test. Data were analyzed using SPSS 25 software. | PMC9878936 | ||
Results | Results showed a significant difference between mean (SD) of debriefing by video recording group in pre-test and post-test ( | PMC9878936 | ||
Conclusions | Both real-time feedback and debriefing by video recording were effective on basic life support skill. | PMC9878936 | ||
Keywords | PMC9878936 | |||
Introduction | cardiovascular disease, cardiac arrest | CARDIOVASCULAR DISEASE, CARDIAC ARREST | The burden of cardiovascular disease and the sudden increase in the number of cardiac arrests is one of the most important health problems in the world, which imposes high costs on the health care system of countries every year [Resuscitation education is a necessary element of skills training for nurses who are likely to be first-line rescuer because they spend significant time alongside patients who are experiencing in-hospital cardiac arrest [Lack of feedback to rescuers is one of the barriers to high-quality CPR [The necessity of continuous and up-to-date training is increasingly felt in the survival of victims. In this regard, finding a training method with the highest effect which can also retain the learning of rescuers is of particular importance.Therefore, researchers performed the present study aiming to compare of real-time feedback and Debriefing by Video Recording on basic life support skill in nursing students. | PMC9878936 |
Methods | This study was quasi-experimental (pretest-posttest). Research sample in this study included 67 first year nursing students studying in Mashhad School of Nursing and Midwifery in the academic year 2019–2020 who were selected by convenience sampling method. Inclusion criteria were: no clinical work experience, no participation in CPR training courses and willingness to participate in the study. Exclusion criteria were Persons who attended a training session or similar study at the same time and those who did not want to continue working from the study. In this study, the sample size was calculated ( | PMC9878936 | ||
Measurement and instrument | HEART | The instruments used in the research were demographic information questionnaire, Kolb learning style inventory and BLS checklist with 18 items. This researcher-made checklist was prepared after reviewing samples of similar foreign and domestic checklists and based on the latest changes in the clinical guidelines of the American Heart Association and European Resuscitation Council (2020–2021). Scoring consisted of not doing at all (zero) and doing completely and correctly (one), and the score range considered for this observation checklist was from 0 to 14 with four items for CPR meter 2 laerdal (including: accuracy percentage of chest compression depth, accuracy percentage of chest compression rate, accuracy percentage of complete chest recoil and accuracy percentage of chest compression fraction) were evaluated to assess the performed chest compression. Content validity was assessed for tool validity so that the study tool was provided to 9 faculty members of Mashhad School of Nursing and Midwifery and it was confirmed by coefficient of variation ratio (CVR): 0.99 and content validity index (CVI): 1. The reliability of the basic life support skill checklist of rescuers was approved using Richardson’s Koder method with a coefficient of 0.804. The reliability of the Kolb Learning Style Inventory was confirmed with a Cronbach’s alpha coefficient of 0.92. | PMC9878936 | |
Intervention | After obtaining permission from the ethics committee of Mashhad University of Medical Sciences (MUMS) and approval of the Nursing and Midwifery Education Department, students’ informed written consent was obtained. The participants were included in the study in an accessible manner according to the inclusion criteria. First, a theoretical BLS training session (by the second author) was held for all students for 4 hours and pre-test was taken at the end of the session. Participants were assigned to two groups of real-time feedback and debriefing by video recording using a random sequence generated using SPSS software, with 37 participants in each group. For the practical BLS training session, each group was divided into smaller groups of 5–6 persons. In the group of real-time feedback and debriefing by video recording, the students’ practical BLS training session was held for 4 hours as a training using a manikin. In the real-time feedback group, the resuscitation steps and how to provide feedback of the device were practically taught. Next, cardiopulmonary resuscitation was performed and the performance of rescuer was corrected using the feedback of the device. In the Debriefing by Video Recording group, first the practical BLS training of resuscitation steps was provided and the students performed resuscitation operations on the manikin and their performance was filmed. The recorded videos were then reviewed so that students could improve their BLS skill again. At the end of the session, students in both groups were retested (Fig. Study Method Diagram | PMC9878936 | ||
Data analysis | The collected data were analyzed using SPSS software version 25. Kolmogorov-Smirnov and Shapiro Wilk tests were used to determine the normal distribution of data. Mann-Whitney test was used to compare the mean basic life support skill between the two groups of real-time feedback and debriefing by video recording before and after the intervention. Paired t-test was also used to compare the means in both groups before and after the intervention. | PMC9878936 | ||
Discussion | Findings of the study showed that basic life support skill significantly increased due to the application of both real-time feedback training and Debriefing by Video Recording methods, while there was no significant difference between the two training methods.Regarding the effect of real-time feedback method, our study findings were in line with the findings of Tanaka et al. study, which examined the effect of real-time auditory feedback device on the skill of non-professionals trained in Japan. Their results showed that the use of feedback devices in cardiopulmonary resuscitation has been able to significantly improve quality of CPR [Based on the findings of the present study, in both groups, the evaluation factors by CPRmeter 2 feedback device increased significantly after the intervention, but the rate of increase of these criteria was higher in the real-time feedback group than Debriefing by Video Recording group in the post-test. Intergroup comparison of real-time feedback method compared to Debriefing by Video Recording method in chest compression depth parameters ( | PMC9878936 | ||
Acknowledgements | This paper is extracted from a master’s thesis in Medical Surgical Nursing approved by the School of Nursing and Midwifery, Mashhad University of Medical Sciences. The authors would like to thank all the undergraduate nursing students who participated in the study. | PMC9878936 | ||
Authors’ contributions | MG, JM, SR. M, and TP conceptualized and designed the study. MG acquired the data. MG and SR. M analyzed the data. MG and SR. M interpreted analyzed data. MG and TP drafted the manuscript and tables. MG, JM, SR. M, and TP revised the manuscript. All authors have reviewed and approved the manuscript. | PMC9878936 | ||
Funding | The Mashhad medical university of medical sciences (MUMS) (grant number 980568, to Tayebe pourghaznein). | PMC9878936 | ||
Availability of data and materials | All data generated or analyzed during this study are included in this published article. | PMC9878936 | ||
Declarations | PMC9878936 | |||
Ethics approval and consent to participate | The study has been performed in full accordance with the Declaration of Helsinki and was approved of the ethics committee of School of Nursing And Midwifery - Mashhad University of Medical Sciences, code of ethics (IR.MUMS.NURSE.REC.1398.062). The researcher explained the purpose of the study and the method of work to the participants. After signing the informed consent form, they were told that it was possible for them to withdraw from participating in the study at any stage of the research. Participants were assured regarding the confidentiality of the data and videos collected. | PMC9878936 | ||
Consent for publication | Not applicable. | PMC9878936 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9878936 | ||
References | PMC9878936 | |||
Subject terms | papillary thyroid microcarcinoma, tumour, PTMC | REGRESSION, TUMOUR, DELAYED HEALING | In order to provide clinical references for the RFA procedure and to study the pivotal factors affecting the recovery time of radiofrequency ablation (RFA) in patients with papillary thyroid microcarcinoma (PTMC), 176 patients with low-risk intrathyroidal PTMC were included in this research. We randomly divided the whole cohort into training and test groups at a ratio of 7:3. The two-sample t-test was used to detect differences between the two groups. Least absolute shrinkage and selection operator (LASSO) regression was used to select the best predictor variables for predicting the status of RFA zone. Multiple test methods were used to ensure the scientific nature and accuracy of the Cox proportional hazards model. We tested the performance for the parameters and revealed the best cut-off value of each variable by the ROC curve and log-rank tests. The results showed patients aged above 49 years old, with RFA energy above 2800 J, the average diameter of the original tumour above 0.6 cm, or the average diameter of ablation zone at 1 month after RFA above 1.1 cm are risk factors for RFA zone delayed healing. | PMC10439129 |
Introduction | primary thyroid cancer, PTC, Papillary thyroid microcarcinoma, PTMC | THYROID, PAPILLARY THYROID CANCER | Papillary thyroid microcarcinoma (PTMC) is a form of papillary thyroid cancer (PTC) with a maximum diameter of 1 cmAs an ultrasound-guided interventional technique, RFA is a less invasive alternative to surgeryUltrasound images of PTMC locoregional lymph nodes status in different treatment stages. (The 2017 RFA guideline of the Korean Society of Thyroid Radiology acknowledged RFA as a therapeutic option for patients with primary thyroid cancer who refuse surgery or who are unable to undergo surgeryDespite the widespread acceptance of RFA among physicians and patients, the standardization of the procedure remains relatively empirical. There exist variations in the energy and time parameters employed for ablating PTMC, underscoring the need for quantification and improved precisionMany postoperative follow-up patients are deeply concerned about the complete absorption time of the RFA zone. To provide more accurate answers to patients, we reviewed our previous clinical work and research findings | PMC10439129 |
Results | PMC10439129 | |||
Patient cohort baseline | PTMC | RECRUITMENT | In this study, we obtained the medical records of patients with low-risk intrathyroidal PTMC from the Second Affiliated Hospital Zhejiang University School of Medicine. There were 208 patients meeting the above inclusion criteria and were all pathologically diagnosed with PTMC by fine-needle aspiration samples and underwent RFA. There were 32 patients without a proper follow-up ultrasound examination or enough clinical information were excluded. A total of 176 patients finally included in this study were randomly divided into training and test groups at a ratio of 7:3. The participants selection process is depicted in Fig. Flowchart of the patient recruitment pathway. RFA, radiofrequency ablation; CEUS, contrast-enhanced ultrasonography.Baseline characteristics of patients with low-risk intrathyroidal PTMC from The Second Affiliated Hospital Zhejiang University School of Medicine. | PMC10439129 |
LASSO regression and feature selection | REGRESSION | Least absolute shrinkage and selection operator (LASSO) regression analysis prevents overfitting and has very good performance in selecting variablesThe prognostic factors of RFA focus absorption time were selected by the least absolute shrinkage and selection operator (LASSO) regression model. ( | PMC10439129 | |
Construction and diagnosis of absorption time nomogram | PTMC | REGRESSION | By using the aforementioned four variables, we constructed the PTMC RFA absorption model by Cox regression, and a nomogram prediction model is shown in Fig. The construction and diagnosis t-test of the absorption time nomogram. ( | PMC10439129 |
Accuracy of the nomogram | To evaluate the accuracy of the nomogram, we used the “Survival ROC” package to draw the ROC curve of the training (Fig. Test of the accuracy of the nomogram. ( | PMC10439129 | ||
Decision curve analysis | Decision curve analysis (DCA) was used to evaluate the clinical net benefit of the predictive model | PMC10439129 | ||
RFA zone absorption time analysis | In our data, the patient’s RFA zone absorption time ranged from 3 to 48 months, with an average absorption time of 12.8 months. We defined that patients whose RFA absorption time was greater than 12 months as the “high-risk group”, and the rest were defined as the “low-risk group”. Nextly, we applied the log-rank test to find the optimal cut-off points for each selected prognostic factor. The calculation results are displayed in Fig. The optimal cut-off points for each selected prognostic factor ( | PMC10439129 | ||
Discussion | skin burns, dysphonia, infection, tumour, endocrine malignancy, injury to vital neck organs, PTMC, gastric cancer | RECURRENCE, DISEASE, INFECTION, TUMOUR, NECK HEMATOMA, REGRESSION, GASTRIC CANCER | Many studies have shown that RFA has a good therapeutic effect in patients with PTMC. However, the description of the RFA treatment process in patients with PTMC in clinical guidelines is relatively empirical. The RFA power used for PTMC patients are varied from several watts to dozens watts among different medical institutions, so did the RFA time, for example. Although a large number of studies have shown that RFA can significantly benefit PTMC patients in terms of efficacy and quality of life, more energy is not always better in RFA surgeryPTMC is the most common endocrine malignancy worldwide, and its morbidity rate has increased significantly. The disease is usually asymptomatic, well-differentiated, less invasive, and unlikely to spread regionally. Although surgery remains the most common treatment for PTMC, many influential studies have shown that ultrasound-guided RFA is highly effective and safe for treating PTMCBy assessing the predictor–outcome correlation and decreasing the regression coefficients with the LASSO approach, six prospective clinical features were reduced to four viable predictors for the prediction model. This strategy outperformed the method of selecting predictors based on the strength of their univariable connection with the outcome, allowing a nomogram to be constructed from a panel of selected characteristics. Recent studies have incorporated multimarker analyses that combine individual markers into marker panels. Such as RNA sequencing and the clinical data of patients with gastric cancer revealed that the interaction of m6A alterations and lncRNAs may play a key role in predicting gastric cancer prognosis, shaping the tumour immune milieu, and predicting immune checkpoint inhibitor therapeutic responsesGiven that the RFA zone recovery time was comparable in the patient cohorts, the improved discrimination implies that the complex signature was robust for prediction and could be applied directly in the test cohort. In this study, we used our data to build a clinical model and provide a reference for clinical practice. The data of 176 patients with low-risk intrathyroidal PTMC were collected and randomly divided into the training and test groups. No instances of neck hematoma, skin burns, dysphonia, local infection, or injury to vital neck organs were observed in the whole corhort. Using LASSO regression analysis and Cox regression, we built a clinical model that can predict foci absorption time after RFA. By applying the log-rank test, we noted that the age of the patient, RFA energy, the average diameter of original tumour, and the average diameter of RFA zone at 1 month after ablation were prognostic variables for the RFA zone absorption time. In addition, the patient’s age above 49 years old, an ablation energy above 2800 J, an average diameter of original tumour above 0.6 cm, or the the average diameter of RFA zone above 1.1 cm at 1 month after ablation are risk factors for ablation foci healing within 12 months. These findings tell us that when a patient has the aforementioned risk factors, his/her expected RFA absorption time should be prolonged. In particular, we should note that there may be the best cut-off points for total energy during RFA in patients with low-risk intrathyroidal PTMC.The energy used in RFA surgery is very important. The RFA range need to be greater than the tumour edge to prevent marginal residue and recurrence. When all portions of the target ablation area had changed to transient hyperechoic zones, the ablation was terminatedStudy limitations include the fact that the nomogram was developed using retrospectively collected data from a cohort of patients at a single centre, and the sample size of the study was relatively small. Therefore, confounding bias, admission bias (Berkson bias), current case-new case bias (Nyman shift) are unavoidable in this study. Further research is needed to validate the performance of the nomogram in a larger external validation cohort.Taken together, our results highlight the vital factors that influence RFA zone absorption time. As a retrospective study, we developed a nomogram based on the clinical data. It can help doctors in risk assessment of patients and in careful planning of RFA procedure. The result of this study may provide a new view of RFA procedure. | PMC10439129 |
Methods | PMC10439129 | |||
Study population | thyroid lesions, dysphagia, voice, hoarseness, intraoperative or postoperative reactions, extrathy, hematoma, PTMC | DYSPHAGIA, NEUROLOGICAL COMPLICATION, HYPOPARATHYROIDISM, RECRUITMENT, LYMPH NODE METASTASIS, LEAKAGE, HEMATOMA, LYMPHATIC CYSTS | This retrospective study was approved by the Institutional Review Board (IRB) of the Second Affiliated Hospital Zhejiang University School of Medicine (SAHZU). The requirement for the informed consent from the patients was waived by the IRB of SAHZU, and all experiments were performed in accordance with relevant guidelines and regulations. The inclusion criteria were as follows: (1) patients with a definitive biopsy-proven pathological diagnosis of PTMC; (2) patients who underwent RFA of thyroid lesions, without extrathy roidal invasion and no lymph node metastasis in former imaging studies; (3) patients who had undergone CEUS examinations before and after radiofrequency ablation; and (4) patients with complete 5-year clinical data. The exclusion criteria were as follows: (1) patients with a follow-up time less than 1 month or (2) patients with missing detailed case information. A total of 176 patients with cytopathologically confirmed PTMC were enrolled in the study between July 2015 and July 2017.Among the patients who underwent RFA surgery between 2015 and 2017, there were no cases of dysphagia, permanent hoarseness, hematoma, lymphatic cysts, chylous leakage, or neurological complications. One patient experienced temporary hypoparathyroidism, while two other patients had transient voice changes. Among the cases included in the study cohort based on the aforementioned inclusion and exclusion criteria, no adverse intraoperative or postoperative reactions were observed. The patient recruitment pathway is presented in Fig. | PMC10439129 |
Protocol of CEUS | CEUS examinations were conducted utilizing a Resona 7 machine (Mindray Company, China) equipped with UWN | PMC10439129 | ||
Protocol of RFA | tumor | INTRAOPERATIVE COMPLICATIONS, TUMOR, TUMOR RECURRENCE, RESIDUAL TUMOR | Radiofrequency energy was generated using a VIVA radiofrequency generator (STARmed, Goyang, Korea) and an 18-gauge monopolar internally cooled electrode (VIVA; STARmed). Continuous cooling with distilled water circulation prevented overheating of the electrode shaft. The patient was positioned supine with a slightly extended neck. Local anesthesia with 1% lidocaine was administered, and fluid was injected between the tumor and surrounding tissues to create a distance from the tumor, thereby mitigating the risk of heat-related injury. Ablation was performed under ultrasound guidance with an energy output of 20–40 W until complete tumor coverage. Immediately following the ablation, CEUS was conducted to assess the ablation zone. If residual tumor tissue was suspected based on CEUS findings, repeat RFA was performed to achieve comprehensive tumor eradication. Neck compression was applied for a duration of 30 min. The duration of the procedure, as well as any intraoperative complications, were diligently documented. Following the ablation, each patient remained under observation at the hospital for a period of 1–2 h. Postoperative follow-up examinations were conducted at 1, 3, and 6 months using neck ultrasound and CEUS. Subsequently, every 6 months, the ablation zone and tumor recurrence were evaluated using two dimensional ultrasounds (2D-US). At 3 months post-RFA, an ultrasound-guided fine needle aspiration biopsy (FNAB) would performed on the RFA zone to confirm the therapeutic efficacy. | PMC10439129 |
US image acquisition | TUMOR RECURRENCE | Before RFA, the ultrasound features of PTMC typically included a hypoechoic nodule with well-defined margins, a taller-than-wide shape, and intranodular vascularity on Doppler ultrasound. After RFA, the ultrasound features of the treated area would vary based on the degree of ablation. Ideally, the treated area should show non-enhancement in the entire ablation zone, indicating complete ablation. However, in cases of incomplete ablation or tumor recurrence, there may be areas of enhancement within the ablation zone. It is important to monitor these ultrasound features during follow-up to evaluate the effectiveness of the RFA treatment | PMC10439129 | |
Construction of the clinical predictive model | tumour | TUMOUR | We collected the following clinical data of the cohorts as potential variables for the predictive model: patient age, sex, the energy of RFA, the average diameter of the original tumour, and RFA range at different time points (1 day after RFA and 1 month after RFA). In addition, the RFA focus absorbtion time of each patient were also documented and gathered as endpoint of our research. Based on these clinical data from The Second Affiliated Hospital Zhejiang University School of Medicine, the training set of our predictive model had a size of 123 people, and the test set had a size of 53 people. The construction of the model was based on R software. | PMC10439129 |
Acknowledgements | We are very grateful to professor Pintong Huang, who is the cheif of Radiology Department of Zhejiang University School of Medicine, designing the study. And we are also very grateful to the Department of Ultrasound in Medicine, The Second Affiliated Hospital Zhejiang University for accumulating and collecting the clinical data for the study. | PMC10439129 |
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