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Introduction | SARS-CoV-2 infection | SARS-COV-2 INFECTION | As point-of-care tests (POCTs), lateral flow device antigen (LFD-Ag) tests provide rapid results that avoid the delays and costs associated with laboratory testing [There are concerns about the diagnostic accuracy of LFD-Ag devices and in particular LFD-Ag test performance when used by front-line community-based health... | PMC10361479 |
Methods | PMC10361479 | |||
Design | RAPTOR-C19 (RApid community Point-of-care Testing fOR COVID-19) is the community testbed for diagnostic testing for SARS-CoV-2 within the UK’s COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR) [ | PMC10361479 | ||
Ethical approval | OF DISEASE TRANSMISSION | This study was approved by the North West-Liverpool Central Research Ethics Committee (20/NW/0282). Participants were provided with information about the study via electronic participant information accessible online. All participants (or their parent or guardian, where applicable) gave informed consent via an e-consen... | PMC10361479 | |
Recruitment and participant eligibility | infection | INFECTION, RECRUITMENT | The main setting for this study was UK primary care. Nineteen general practices were recruited after email invitation for expressions of interest, following the sharing of Research Information Sheets for GP surgeries to practices identified through the Oxford-Royal College of General Practitioners (RCGP) Research and S... | PMC10361479 |
Baseline and follow-up assessments | ADVERSE EVENTS, RECRUITMENT | In addition to undergoing testing for the index test(s) and reference standard described below, further participant information was collected at the time of recruitment using an electronic case report form (eCRF). Variables included age, sex, ethnicity, presence and duration of specified symptoms within the preceding 1... | PMC10361479 | |
Index tests | ™ Q SARS-CoV-2 | This paper presents results from two POCTs. The SD Biosensor Standard™ Q SARS-CoV-2 Rapid Antigen Test (REF 9901-NCOV-01G, branded and distributed by Roche Diagnostics GmbH, Mannheim, Germany) was used from the start of the study. This test incorporates an internal quality control and is read and interpreted manually b... | PMC10361479 | |
Reference standard | infection | INFECTION, DISEASE | The reference test for active infection was an in-house validated reverse transcription quantitative PCR (RT-PCR) for the detection of ORF1ab and E gene regions of SARS-CoV-2. The assay incorporated ORF1ab primers and probes as published by the Chinese Center for Disease Control and Prevention and E gene primers and pr... | PMC10361479 |
Sample size | The sample size was based on a target of 150 reference standard positive individuals, for each index test. If the true sensitivity of an index test were 90% or higher, a similar number of positive samples (144) would yield a standard error of the estimate of the sensitivity of ≤2.5%, and a 95% confidence interval width... | PMC10361479 | ||
Statistical methods | DISEASE, RECRUITMENT | A Statistical Analysis Plan was written before the analysis was performed and is available in Supplemental Material. We calculated the prevalence of positive RT-PCR results, and the sensitivity, specificity and predictive values for each index test alongside exact 95% confidence intervals. Index test results were prese... | PMC10361479 | |
Patient and public involvement | RAPTOR was supported from inception by the CONDOR steering committee public co-chairs for Patient and Public Involvement and Engagement (PPIE) who co-developed the CONDOR platform and its PPIE strategy. Additional PPIE contributors provided pre-funding feedback on the value of the study, reviewed plain language text, a... | PMC10361479 | ||
Results | PMC10361479 | |||
Recruitment | RECRUITMENT | A total of 763 participants consented to recruitment between 29th October 2020 and 12th October 2021 ( | PMC10361479 | |
Participant characteristics | 42% of participants recruited were male, mean age was 41 years, the majority (81%) were white, and 26% were contacts of a household member who had tested positive for SARS-CoV-2 ( | PMC10361479 | ||
Baseline characteristics (number (%) or mean (standard deviation)). | * Vaccinated with at least one dose (booster doses were not recorded)† Calculated among participants who reported at least one specific symptom within the preceding 14 days‡ For 6% of participants, no specific symptoms were recorded in the eCRF | PMC10361479 | ||
Diagnostic accuracy (primary outcome) | The prevalence of SARS-CoV-2 positive RT-PCR tests among participants included in the primary analysis was 39.2% (260/663, 95% CI 35.5% to 43.0%). The SD Biosensor POCT had a sensitivity of 84.0% (178/212, 95% CI 78.3% to 88.6%) and specificity of 98.5% (328/333, 96.5% to 99.5%), and the BD Veritor POCT had a sensitivi... | PMC10361479 | ||
Summary of results for each POCT compared to the reference test result. | SDB | DISEASE | SDB = SD Biosensor, BDV = BD Veritor.Of the 300 participants who had results for both POCTs and the reference test, 85 had concordant positive results from both POCTs and RT-PCR and 179 had concordant negative results. Patterns of discordance are shown in Pre-specified subgroup analyses found some variation in test per... | PMC10361479 |
Summary of diagnostic performance in relation to RT-PCR cycle threshold. | There was no clear trend in diagnostic performance in relation to the number of days since first reported symptom among those who commenced participation less than a week after symptom onset, but there was some indication of a decrease in the sensitivity of both index tests among the small number of participants with p... | PMC10361479 | ||
Diagnostic accuracy (enhanced reference standard) | A summary of findings using the composite enhanced reference standard among individuals with discordant result between either index test and the RT-PCR reference standard is provided in S1 Table 3 in Results of the statistical adjustment method for imperfect reference standard bias are shown in S1 Fig 6 and S1 Table 4 ... | PMC10361479 | ||
Secondary outcomes | hMPV, NL63 | CORONAVIRUS, ADVERSE EVENTS, RECRUITMENT, INFLUENZA | Of the 403 participants who had a negative RT-PCR for SARS-CoV-2, RSV was detected in 12 participants (7 subtype A, 5 subtype B), hMPV in 1 participant and seasonal coronavirus in 8 participants (4 species #NL63, 3 #OC43, 1 #229E). No participants tested positive for influenza (subtypes A or B). Among the 260 participa... | PMC10361479 |
Sensitivity analysis | SENSITIVITY | Sensitivity analyses allowing for different date mismatching scenarios did not show a large impact on estimated diagnostic accuracy measures (S1 Table 5 in | PMC10361479 | |
Discussion | infection | RECRUITMENT, VIRUS, SARS-COV-2 INFECTION, DISEASE, RECRUITMENT, INFECTION | The results of this prospective diagnostic accuracy evaluation of two POCTs for the detection of SARS-CoV-2 in symptomatic patients in primary care fall within the wide range of previous studies in other settings [The minimum target for acceptable performance in the target product profile of the Medicines and Healthcar... | PMC10361479 |
References | PMC10361479 | |||
1. Introduction | acute infection, pneumonia, chronic kidney disease, cardiovascular diseases, inflammation, long-term sequelae, fibrosis, liver disease, COVID-19-associated pneumonia, MR, coronavirus disease 2019 | ACUTE INFECTION, VIRUS, CORONAVIRUS DISEASE 2019, PNEUMONIA, LUNG FIBROSIS, ISCHEMIC HEART DISEASE, CARDIOVASCULAR DISEASES, COVID-19 PNEUMONIA, DISEASE, INFLAMMATION, FIBROSIS, LIVER DISEASE, SECONDARY, CONGESTIVE HEART FAILURE, HYPERTENSION, PATHOGENESIS | In March 2020, the World Health Organization (WHO) announced a global pandemic of coronavirus disease 2019 (COVID-19) that presented mainly as an acute infection of the lower respiratory tract (pneumonia), with multiple long-term consequences, including lung fibrosis. The aim of this study was to evaluate the influence... | PMC10532011 |
2. Results | PMC10532011 | |||
2.1. Baseline Patient Characteristics | There were no significant differences observed in age, gender, or body mass index between the placebo group and the intervention group. | PMC10532011 | ||
2.2. Basic Laboratory Tests | No statistically significant differences were observed between the groups in the results of basic initial laboratory tests conducted on day 1 or in the levels of serum inflammatory markers, which include C-reactive protein, procalcitonin, and interleukin-6, as detailed in There were no significant differences between t... | PMC10532011 | ||
2.3. Immunophenotype Analysis on Day 1 and Day 7 | There were no significant differences between the groups in day 1 cell cytometry, including CD3+ blood cell or CD4+ lymphocyte percentage, IL-1ß, IL-2, TNF-α-positive cell percentage in general, lymphocytes specifically, or IL-6 level (There were no significant differences between the groups in control day 7 cell cytom... | PMC10532011 | ||
2.4. Intragroup Comparisons between Potassium Canrenoate and Placebo Groups on Day 1 versus Day 7 | Intragroup comparisons using Wilcoxon’s test were performed to specify if the assessment of the dynamics of change between potassium canrenoate and placebo group or intragroup showed significant differences between day 1 and day 7. The results are shown in The CD3% for potassium canrenoate increased significantly betwe... | PMC10532011 | ||
3. Discussion | SARS-CoV-2 infection, pulmonary interstitial edema, hyperkaliemia, inflammation, hyponatremia, infections, infection, acute lung injury, hyperkalemia, lung tissue damage, hypovolemia | VIRUS, SARS-COV-2 INFECTION, ISCHEMIC HEART DISEASE, SIDE EFFECT, ADVERSE EVENTS, COVID-19 PNEUMONIA, DISEASE, INFLAMMATION, INFECTIONS, HYPONATREMIA, INFECTION, COMPLICATIONS, INFLAMMATORY RESPONSE | The increasing number of infections with the SARS-CoV-2 virus has created the need not only to treat the disease itself but also to develop a way to prevent long-term complications of infection deriving from immunological imbalance. In our study, we evaluated the effects of potassium canrenoate on inflammatory markers ... | PMC10532011 |
4. Materials and Methods | PMC10532011 | |||
4.1. Ethics | SECONDARY, POLAND | This secondary analysis stems from a prospective phase IV randomized placebo-controlled clinical trial (RCT) conducted at University Hospital no. 2 of the Pomeranian Medical University in Szczecin, Poland, spanning from December 2020 to August 2021. The study garnered approval from the Ethics Committee Board at the Pom... | PMC10532011 | |
4.2. Study Population | The study enrolled hospitalized patients of all genders, ranging in age from 18 to 90 years, following comprehensive disclosure of study particulars and obtaining their signed informed consent forms. The research adhered to the principles outlined in the Declaration of Helsinki.In this study, a comprehensive assessment... | PMC10532011 | ||
4.3. Inclusion Criteria | COVID-19 infection, diabetes | HYPERTENSION, CARDIOVASCULAR DISEASE, COVID-19 INFECTION, DIABETES | Individuals of all genders, aged between 18 and 90 years.Patients requiring oxygen therapy with a blood oxygen saturation level below 94%.Confirmed diagnosis of COVID-19 infection through rt-PCR testing.Presence of at least one documented risk factor for heightened COVID-19 mortality, as outlined in current scientific ... | PMC10532011 |
4.4. Exclusion Criteria | mental illness, hyponatremia, dementia, emphysema, ARDS, hyperkalemia, Porphyria, trauma | CHRONIC RENAL FAILURE, PORPHYRIA, ADRENAL CRISIS, HYPONATREMIA, CHRONIC BRONCHITIS, HYPERSENSITIVITY, EMPHYSEMA, OTHER VIRAL INFECTION, ANURIA, INTERSTITIAL LUNG DISEASE, ARDS | Patients with a history of chronic bronchitis, emphysema, interstitial lung disease, or any other preexisting lung conditions.Individuals with contraindications for the use of spironolactone.Hypersensitivity to spironolactone or any of its components.Pregnant individuals (with mandatory pregnancy testing for those of r... | PMC10532011 |
4.5. Clinical Experiment Measures | TNF-α | LYSING, EVENTS, APC, FRANKLIN | Consecutive patients in the study were randomly assigned to one of two groups using a computer-generated list of numbers. The first group, referred to as the intervention group, received 200 mg of potassium canrenoate (Aldactone) dissolved in 100 mL of 0.9% sodium chloride intravenously twice daily for a duration of 7 ... | PMC10532011 |
4.6. Outcome Measures | PMC10532011 | |||
4.6.1. Primary Outcome Measures for Primary Analysis | Duration of invasive mechanical ventilation via endotracheal intubation or tracheotomy (observation time 30 days).Duration of passive oxygen therapy (observation time 30 days). | PMC10532011 | ||
4.6.2. Secondary Outcome Measures for Primary Analysis | Intensive care unit length of stay (LOS) (time frame 30 days).Total hospital length of stay (LOS) (time frame 90 days).Assessment of the dynamics of recovery of changes in lung ultrasound at 7 days.Assessment of the dynamics of recovery of changes in lung ultrasound at 30 days.Assessment of the dynamics of recovery of ... | PMC10532011 | ||
4.6.3. Outcome Measures for Secondary Analysis | TNF-α | Assessment of the dynamics of change in T CD4+ lymphocyte count at 7 days.Assessment of the dynamics of change in T CD3+ lymphocytes count at 7 days.Assessment of the dynamics of change in IL-1ß on lymphocytes and total count of IL-1ß at 7 days.Assessment of the dynamics of change in IL-2 on lymphocytes and total count... | PMC10532011 | |
4.7. Statistical Analysis | SECONDARY | For the secondary analysis, we used data from the primary analysis. Categorical variables are presented as proportions and were compared using the chi-square test. In the case of small numbers in groups, the Yates correction was applied. Continuous variables are presented as means with standard deviation and medians an... | PMC10532011 | |
Author Contributions | Conceptualization, I.K., J.S., W.D. and K.K.; methodology, I.K., K.K., K.L. and P.N.-R.; software, I.K.; validation, A.S. and P.N.-R.; formal analysis, I.K., K.K. and P.N.-R.; investigation, R.H. and P.N.-R.; resources, I.K.; data curation, I.K., R.H., K.L. and P.N.-R.; writing—original draft preparation, I.K., K.K., K... | PMC10532011 | ||
Institutional Review Board Statement | POLAND | The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Institutional Review Board of the Pomeranian Medical University in Szczecin, Poland (ICE consent, 0012/100/2020, date 29 June 2020) and was registered at | PMC10532011 | |
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10532011 | ||
Data Availability Statement | The dataset is not available in a public database due to legal reasons. Anonymous data may be provided by the corresponding author upon a reasonable request from a researcher. | PMC10532011 | ||
Conflicts of Interest | The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. | PMC10532011 | ||
References | TUMOR NECROSIS | CD3% for potassium canrenoate vs. placebo between day 1 and day 7; Interleukin-1ß total count [%] for potassium canrenoate vs. placebo between day 1 and day 7; TNF-α total count [%] for potassium canrenoate vs. placebo between day 1 and day 7; Interleukin-6 [pg/mL] for potassium canrenoate vs. placebo between day 1 and... | PMC10532011 | |
Keywords | PMC10570224 | |||
Introduction | anxiety, pain | Many children feel anxious when they need to undergo a medical examination or intervention. In particular, needle related procedures cause anxiety and fear in children [In adults, the use of communication techniques based on hypnosis can be used to reduce pain and anxiety [Children experience medical procedures within ... | PMC10570224 | |
Methods and materials | PMC10570224 | |||
Study design | CMO | After ethical approval (Ethics Committee CMO Arnhem-Nijmegen, Number 2019-5488), this single-blinded intervention study was performed in an outpatient clinic in a tertiary care hospital in Nijmegen, the Netherlands. The study was registered in the Dutch Trial Register (NL8221). Data was collected between January 2020 a... | PMC10570224 | |
Participants | intellectual disabilities | Children who needed to undergo venipuncture at the outpatient clinic were asked to participate in this study. Inclusion criteria were age between 5 and 18 years, use of topical anesthesia on the presumed needle insertion site (EMLA, Aspen, The Netherlands), and the ability to communicate in Dutch language by child and ... | PMC10570224 | |
Procedure | The study consisted of two groups that were subsequently studied: a SC group and a TC group. The SC group was studied in January and February 2020, and the TC group in September and October 2020. For the SC group, blood sampling procedures were performed according to standardized protocol and baseline data were obtaine... | PMC10570224 | ||
Measures | PMC10570224 | |||
Demographic data | Anxiety, ADHD, anxiety, neurodivergent disorders | DISEASE | Demographic data was obtained prior to venipuncture (e.g. age, gender, underlying disease, amount of previous venipunctures and the presence of neurodivergent disorders (e.g. ADHD, ASD). To measure anxiety the child’s trait level of anxiety and the parents’ trait and state level of anxiety were obtained by the Spielber... | PMC10570224 |
Primary outcome measure | PMC10570224 | |||
Self-reported pain | pain | Self-reported pain was measured directly after venipuncture with the Faces Pain Scale-Revised (FPS-R) [ | PMC10570224 | |
Secondary outcome measures | PMC10570224 | |||
Observed pain | NRS, pain | Directly after the venipuncture parents or guardians and medical professionals scored the observed pain of the child on a NRS (Numeric Rating Scale; 0 = no pain, 10 = worst pain ever). | PMC10570224 | |
Anxiety during venipuncture | anxiety | Children 8 years or older reported their anxiety levels during venipuncture on a NRS (0 = no anxiety, 10 = worst anxiety ever). Parents or guardians and medical professionals scored the observed anxiety of the child and anxiety of the parent on the same NRS. | PMC10570224 | |
Satisfaction | Children 8 years or older, their parents or guardians and medical personnel reported their satisfaction about the procedure on a NRS (0 = unsatisfied, 10 = very satisfied). | PMC10570224 | ||
Procedural time | The time the child spent in the room during venipuncture was measured in minutes. | PMC10570224 | ||
Statistical analysis | pain | For data analysis, IBM SPSS Statistics 26 was used. A power analysis was performed to determine the sample size that was needed to provide a 95% probability of detecting differences between groups. One face (i.e., 2 points, translating to an effect size of Baseline group differences for demographic characteristics wer... | PMC10570224 | |
Results | PMC10570224 | |||
Primary outcome measure | PMC10570224 | |||
Self-reported pain by children | pain | There was no difference in self-reported pain by children between the TC group (Child pain outcomes. | PMC10570224 | |
Secondary outcome measures | PMC10570224 | |||
Observed pain | pain | NRS pain scores observed by parents and by medical personnel did not significantly differ between the TC and SC group (Table | PMC10570224 | |
Anxiety during venipuncture | Anxiety, anxiety | For anxiety scores scored by the child, we found that children in the therapeutic communication group reported lower anxiety Anxiety outcomes. | PMC10570224 | |
Satisfaction | There were no group differences in satisfaction for parents and children (Table Satisfaction outcomes. | PMC10570224 | ||
Procedural time | Procedural time in the TC group was shorter (6min0s) than in the SC group (8min36s), Procedural time. | PMC10570224 | ||
Mediation analyses | anxiety, pain | REGRESSION | Two mediation analyses were conducted to test the direct effect (parental procedural anxiety on child pain) and indirect effects (parental procedural anxiety on child pain via child anxiety) for the TC group and the SC group. The regression models were significant for the SC group (Standardized regression coefficients ... | PMC10570224 |
Subgroup analysis neurodivergence | psychiatric, anxiety | DISORDER | Based on the significant outcome of child anxiety, the subgroup analysis was performed with anxiety as outcome. There were no differential effects of TC on anxiety for neurodivergent children versus non-neurodivergent children (i.e., no diagnosis of a psychiatric disorder), | PMC10570224 |
Discussion | ADHD, anxiety, pain | SECONDARY | The objective of this study was to examine whether patient-centric TC positively affects children’s comfort during venipuncture. Comfort is defined as a ''transient and dynamic state characterized by ease from pain, emotional and physical distress and an emerging sense of positivity, safety, strength and acceptance of ... | PMC10570224 |
Supplementary Information | Below is the link to the electronic supplementary material.Supplementary file1 (PDF 127 KB) | PMC10570224 | ||
Authors’ contributions | LAMA and GJvG contributed to the conception and design of the study. Data collection was performed by LAMA and EV. Data analysis was carried out by RMS. The first draft of the manuscript was written by LAMA and RMS and all authors commented on previous versions of the manuscript. All authors read and approved the final... | PMC10570224 | ||
Funding | Author R.M.S. has received research support from the National Health Care Institute (2017045964). | PMC10570224 | ||
Declarations | PMC10570224 | |||
Ethics approval | MAY | This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the medical ethical committee CMO region Arnhem-Nijmegen (May 24, 2019/N0 2019-5488). | PMC10570224 | |
Consent to participate | Informed consent was obtained from all individual participants included in the study | PMC10570224 | ||
Consent to publish | The authors affirm that human research participants provided informed consent for publication | PMC10570224 | ||
Competing interests | The authors have no relevant financial or non-financial interests to disclose. | PMC10570224 | ||
Storage of data | Subject, code and patient identification were saved in an identification log. A key file with password for the identifying personal data, linked to the study code, was saved on a separate file and was only accessible for the researchers. On the Case Report Form and in the database (Castor EDC) only coded data was used,... | PMC10570224 | ||
References | PMC10570224 | |||
Acknowledgments | Dear Editor:We read with interest the study by Xiaoqin Li et al. that evaluated the effectiveness of probiotic supplementation on immune parameters and gut microbiota in healthy adults (a randomized controlled trial).First, as the authors described in the Study design, “Eligible participants were equally and randomly a... | PMC10540646 | ||
Disclosure statement | No potential conflict of interest was reported by the author(s). | PMC10540646 | ||
Authors’ contributions | Conceptualization, Y.L.; Writing-Original draft preparation, Y.L.; Project administration, Y.L.; Writing – Review & Editing, Y.L. | PMC10540646 | ||
Ethics approval and consent to participate | This study is a bioinformatics study, which does not use the information of human or animal tissues or cases, so there is no need for ethical approval. All authors have read and agreed to the published version of the manuscript. | PMC10540646 | ||
References | PMC10540646 | |||
Purpose | death | We aimed to prospectively investigate the association of an overall oxidative balance score (OBS) with all-cause death and cause-specific mortality among participants in the Seguimiento Universidad de Navarra (SUN) Study, a Mediterranean cohort of Spanish graduates. | PMC10195723 | |
Methods | β-carotenes | Using baseline information on 12 a priori selected dietary and non-dietary lifestyle pro- and antioxidants exposures—vitamins C and E, β-carotenes, selenium, zinc, heme iron, polyphenols, total antioxidant capacity, body mass index, alcohol, smoking, and physical activity—we constructed an equally weighted OBS categori... | PMC10195723 | |
Results | cancer, deaths, CVD | CVD, CANCER, CARDIOVASCULAR DISEASE | A total of 18,561 participants (mean [SD] age, 38.5 [12.4] years; 40.8% males) were included in the analysis. During a median follow-up of 12.2 years (interquartile range 8.3–14.9), 421 deaths were identified, including 80 deaths from cardiovascular disease (CVD), 215 from cancer, and 126 from other causes. After adjus... | PMC10195723 |
Conclusion | cancer | CVD, CANCER | Our findings suggest a strong inverse association between the OBS and all-cause, CVD, and cancer mortality. Individuals exposed to both antioxidant dietary and lifestyle factors may potentially experience the lowest mortality risk. | PMC10195723 |
Study registry number | Dynamic Mediterranean Prospective Cohort: the SUN Project; NCT02669602. | PMC10195723 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s00394-023-03099-8. | PMC10195723 | ||
Keywords | Open Access funding provided thanks to the CRUE-CSIC agreement with Springer Nature. | PMC10195723 | ||
Introduction | deaths, death, cancer | CANCER, DISEASES, OXIDATIVE STRESS | Non-communicable diseases (NCDs) are currently the leading causes of death in the world. Approximately 41 million people (71% of all deaths globally) die each year due to NCDs [Oxidative stress—the imbalance between oxidative and anti-oxidative components that leads to oxidative damage [The main objective of this study... | PMC10195723 |
Methods | PMC10195723 | |||
Study population | RECRUITMENT | The SUN Project (From December 1999 until December 2019, a total of 22,894 participants were recruited. The exclusion criteria applied were: participants recruited < 2 years and 9 months since the end of the recruitment in the database (Flowchart of participants in the Seguimiento Universidad de Navarra Project, 1999 t... | PMC10195723 | |
The oxidative balance score (OBS) | The OBS was constructed using baseline dietary information from a semi-quantitative 136-item food-frequency questionnaire (FFQ) repeatedly validated in Spain [This novel OBS was based on 12 a priori selected components including dietary and non-dietary lifestyle factors associated with oxidative balance, as either pro-... | PMC10195723 |
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