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Introduction | PMC10131812 | |||
Background | The COVID-19 “infodemic” [However, it is also important not to oversimplify such concepts (eg, “trust the science”) [Scientists often share cognitive claims (eg, the results of their work) In further support of investigating differences between cognitive and normative claims, and their impact on perceptions of science ... | PMC10131812 | ||
Study Objectives and Hypotheses | This study is designed to better understand the degree to which the use of cognitive and normative language by scientists influences perceptions of trust and credibility. Specifically, this paper reports the results from a highly granular, causal assessment of the effect of a single exposure to normative language from ... | PMC10131812 | ||
Methods | PMC10131812 | |||
Study Design and Participants | Participants were a nationally representative US sample by cross sections of age, sex, and race/ethnicity obtained using the online research and data collection platform Prolific (Prolific Academic Ltd). Prolific maintains a panel of around 130,000 research participants and verifies the identity of all accounts using a... | PMC10131812 | ||
Randomization, Masking, and Enrollment | LGA | Participants who passed all quality control checks were randomized to 1 of the 2 study arms. The intervention arm (arm 1) contained an image of a social media post about face masks for reducing COVID-19 transmission that included both cognitive and normative claims. The control arm (arm 2) contained the same image exce... | PMC10131812 | |
Procedures | As previously described, participants who began the study in Qualtrics completed sociodemographic questions intermixed with quality control checks (see our rationale for the importance of such checks in [Intervention image.Control image.Once participants advanced, they were shown a smaller copy of the image they had ju... | PMC10131812 | ||
Outcomes | There were 5 primary outcome variables, each of which corresponded to a hypothesis as well as a prespecified reanalysis of that hypothesis (in which arm × political orientation was added as an interaction term). The variables were collected as prespecified, so we directly copied the text from our protocol here [The ove... | PMC10131812 | ||
Covariates | RTI | As with the outcome variables, the covariates were collected as prespecified, so we directly copy the text from our protocol here [Familiarity with science was measured by 1 item asking, “How often do you read science papers or science in the news?” (1=never to 5=always); this item was suggested in Song et al [Level of... | PMC10131812 | |
Statistical Analysis | We planned to recruit 1500 participants, which would allow the detection of small effects at α=.05 (Cohen For hypotheses 1 through 5, we used analysis of covariance, with the study arm (intervention or control) as the independent variable and each of the outcome variables set as the dependent variable (1 per hypothesis... | PMC10131812 | ||
Ethics Approval and Consent to Participate | All participants digitally provided informed consent prior to beginning the study (Indiana University Institutional Review Board, approval number 16141). | PMC10131812 | ||
Results | PMC10131812 | |||
Overview | Additional details from the study, including raw data, data cleaning syntax, and analytic code, are available in | PMC10131812 | ||
Sample Characteristics | A total of 1635 unique individuals accepted the survey in their Prolific account and accessed the study between September 4, 2022, and September 6, 2022, when 1500 surveys were verified for payment. Prior to randomization, cases were removed from the data set and resampled if they declined to participate after reading ... | PMC10131812 | ||
Hypothesis 1 | We hypothesized that overall trust in science and scientists [Main effects (arm, trust in science/scientists). | PMC10131812 | ||
Hypotheses 2 Through 5 | μMain | We hypothesized that each of the 4 single-item measures of trust and credibility specific to the featured post and the scientist who conducted the study would be significantly lower in the intervention arm (cognitive plus normative language) than in the control arm (cognitive language alone) [Credibility of the scienti... | PMC10131812 | |
Additional Preregistered Analyses | We preregistered additional analyses for this study focused on interactions between arm assignment and political orientation [ | PMC10131812 | ||
Study Arm | In 4 of the 5 additional analyses, the study arm remained nonsignificant, including for overall trust in science and scientists (β=0.01, 95% CI –0.10 to 0.11; | PMC10131812 | ||
Arm × Political Orientation Interaction | INTERACTION | The interaction between study arm and political orientation was nonsignificant for overall trust in science and scientists (β=0.00, 95% CI –0.02 to 0.02; Interaction (arm × political orientation, trust in science/scientists).Interaction (arm × political orientation, credibility of the scientist).Interaction (arm × poli... | PMC10131812 | |
Political Orientation | Political orientation was strongly associated with each variable (more conservative orientation was associated with lower scores). This was true for overall trust in science and scientists (β=–0.13, 95% CI –0.15 to –0.12; | PMC10131812 | ||
Exploratory Results | This study was not intended to study the covariates in detail, but we would be remiss in failing to mention an interesting feature of both the basic models and the models with the arm × political interaction (all outcome tables are available in | PMC10131812 | ||
Discussion | PMC10131812 | |||
Principal Findings | We conducted a large, preregistered, randomized controlled trial to test whether the addition of normative language to cognitive language about face masks in otherwise identical social media posts influenced 5 different measures of trust and credibility of science and scientists. As we outlined in our “Introduction” se... | PMC10131812 | ||
Interpretation | This study examined the effects of normative language using very specific parameters: a single exposure to normative plus cognitive language from a study in comparison to cognitive language alone, at a dose of at least 30 seconds. Further, the exposure specifically pertained to a topic that is highly politicized in US ... | PMC10131812 | ||
Limitations and Conclusions | LGA | In addition to the caveats addressed throughout our manuscript, we note several additional considerations that are important when interpreting this work. First, although the study sample was nationally representative by cross sections of age, gender, and race/ethnicity, the Prolific service is an online program, which ... | PMC10131812 | |
1. Introduction | Background: Cognitive functions decline with age. Declined cognitive functions negatively affect daily behaviors. Previous studies showed the positive effect of spices and herbs on cognition. In this study, we investigated the positive impact of wasabi, which is a traditional Japanese spice, on cognitive functions. The... | PMC10648564 | ||
2. Materials and Methods | PMC10648564 | |||
2.1. Setting of Trial | This RCT was conducted in Sendai from October 2018 to March 2019. The study was approved by the Tohoku University Hospital Ethical Committee. This study was registered at the University Hospital Medical Information Network (UMIN) Clinical Trial Registry (UMIN 000032694).We investigated the positive effects of 6-MSITC o... | PMC10648564 | ||
2.2. Participants | FOOD ALLERGIES | To recruit participants, we posted advertisements in the local town paper in Sendai. The exclusion and inclusion criteria were written in the advertisements. Firstly, researchers checked whether the interested participants met eligibility based on the criteria, such as their basic information, medical history, and food... | PMC10648564 | |
2.3. Inclusion and Exclusion Criteria | Based on previous studies [ | PMC10648564 | ||
2.4. Sample Size Estimation | The sample size was calculated by G power [ | PMC10648564 | ||
2.5. Randomization | We used a randomization program using the Graphpad (version 9) tool. We stratified participants based on sex with 1:1 [ | PMC10648564 | ||
2.6. General Procedure of the Intervention | Participants in both groups were asked to take one tablet (6-MSITC or the placebo supplements) before going to bed every day for 12 weeks. Cognitive functions in all participants were assessed at the pre- and post-intervention period. Participants were also required to record their supplement intakes in the diary. Afte... | PMC10648564 | ||
2.7. 6-MSITC and Placebo Supplements | The 6-MSITC group took one 6-MSITC capsule that contained 100 mg wasabi extract powder containing 6-MSITC (0.8 mg) absorbed on α cyclodextrin and a 100 mg vehicle (calcium stearate, starch, and silicon dioxide) per day. The placebo group took one placebo capsule containing α 100 mg cyclodextrin and the vehicle per day.... | PMC10648564 | ||
2.8. Cognitive Functions | We performed the screening tests at the baseline using the Japanese version of MMSE [To measure several cognitive domains (processing speed, attention, short-term memory, working memory, episodic memory, executive functions, and visual–spatial abilities), we used standardized cognitive assessments for healthy older adu... | PMC10648564 | ||
2.9. Analysis | In this study, we used the intention to treat (ITT) principle. We calculated the change scores in each cognitive function (post–pre difference score). R (ver. 4.10) was used to conduct all analyses. A multiple imputation method with predictive mean matching was used to impute data (m = 20). All variables were included ... | PMC10648564 | ||
3. Results | We did not find any significant difference between the two groups at the baseline (We performed ANCOVAs for the change scores ( | PMC10648564 | ||
4. Discussion | chronic fatigue | This study aimed to test whether 12 weeks’ 6-MSITC intervention has positive effects on cognitive performances in healthy older adults. We found two main findings. First, the 6-MSITC intervention improved working memory capacity as measured by DS-B compared to the placebo group. Second, the 6-MSITC intervention improve... | PMC10648564 | |
5. Conclusions | 6-MSITC is the main bioactive compound of wasabi. We investigated the benefits of 6-MSITC intake on cognitive health in older adults. The current RCT revealed that an intake of 0.8 mg of 6-MSITC for 12 weeks significantly improved memory functioning, including episodic and working memory, compared to the placebo group,... | PMC10648564 | ||
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10648564 | ||
Author Contributions | H.N. | Conceptualization, R.N.; project administration, R.N.; methodology, R.N.; formal analysis, R.N.; investigation, R.N., N.Y.S.K., T.S., and H.N.; data curation, R.N. and H.N.; writing—original draft preparation, R.N.; writing—review and editing, R.N., N.Y.S.K., T.S., H.N., and R.K.; funding acquisition, R.N.; visualizati... | PMC10648564 | |
Institutional Review Board Statement | This study was conducted in accordance with the Declaration of Helsinki and was approved by the Institutional Review Board of the Tohoku University Graduate School of Medicine (ref. 2017-2-348-1 and 19 July 2017). | PMC10648564 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in this study. | PMC10648564 | ||
Data Availability Statement | The datasets used and analyzed in this study are available from the corresponding author on reasonable request. | PMC10648564 | ||
Conflicts of Interest | This study was supported by KINJIRUSHI Co., Ltd. The funding body had no role in the design of the study, collection, analyses, or interpretation of the data, writing of the manuscript, or the decision to publish the results. | PMC10648564 | ||
Trial Registration | MAY | This trial was registered at The University Hospital Medical Information Network Clinical Trials Registry (UMIN 000032694). Registered 24 May 2018, | PMC10648564 | |
References | Depression | CONSORT diagram.Baseline data in both groups.Note: 6-MSITC, 6 mthylsulfinyl hexyl isothiocyanate; MMSE, Mini-Mental State examination; FAB, Frontal Assessment Battery at bedside; JART, Japanese Reading Ability Test; GDS, Geriatric Depression Scale; d, Cohen’s d (effect size).Compositions in each capsule.Note: 6-MSITC, ... | PMC10648564 | |
Background | micropapillary bladder cancer | The present study aimed to construct and validate nomograms that can be used to predict cancer-specific survival (CSS) and overall survival (OS) in patients with micropapillary bladder cancer.
| PMC9926703 | |
Methods | micropapillary bladder cancer, bladder cancer | REGRESSION, BLADDER CANCER | The data of 627 patients diagnosed with micropapillary bladder cancer between 2000 and 2018 were obtained from the surveillance, epidemiology, and end results database. Patients were randomly divided into the training and internal validation sets (7:3). The Cox proportional hazards regression model was applied to evalu... | PMC9926703 |
Results | tumor | TUMOR | Several independent risk factors were taken into the two nomograms (CSS and OS), including age, marital status, AJCC TMN stage, surgical approach, lymph node ratio, and tumor size while the OS nomogram additionally contained race. The concordance index of the training set, internal validation set, and external verifica... | PMC9926703 |
Conclusions | micropapillary bladder cancer | The nomograms predicting the survival outcome of patients with micropapillary bladder cancer would provide a valuable tool to help clinicians to evaluate the risk of patients and make individual treatment strategies. | PMC9926703 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12894-023-01183-z. | PMC9926703 | ||
Keywords | PMC9926703 | |||
Background | micropapillary bladder cancer, cancer prognosis [, MPBC, Micropapillary bladder cancer, AJCC, Cancer | CANCER | Micropapillary bladder cancer (MPBC) was first recognized in 1994 by Amin et al. [At present, the prognosis evaluation of the micropapillary bladder cancer patients mainly depends on American Joint Committee for Cancer (AJCC) tumor-node-metastasis (TNM) staging system [Nomograms can simplify the statistical prediction ... | PMC9926703 |
Methods | PMC9926703 | |||
Data sources | Data were extracted from SEER using SEER*Stat software version 8.4.0 ( | PMC9926703 | ||
Patient selection | cancer, micropapillary bladder cancer, Tumor | CANCER, DISEASES, TUMOR | We searched the SEER database including 17 cancer registries and covering 26.5% of the US population. The inclusion site code was C67.0-C67.9, and the histological code was 8131/2, 8131/3, according to the International Classification of Tumor Diseases, Third Edition (ICD-O-3). The exclusion criteria were (1) incomplet... | PMC9926703 |
Variables | AJCC T stage, tumor, AJCC N stage, Cancer | TUMOR, CANCER | The information collected included age, sex, race, annual income, marital status, histologic type, grade, American Joint Committee on Cancer stage I-IV, AJCC T stage, AJCC N stage, AJCC M stage, surgery of primary site, lymph node examined and positive lymph node, radiotherapy, chemotherapy, tumor size, survival months... | PMC9926703 |
Outcomes | death, micropapillary bladder cancer | SECONDARY | The primary outcome was CSS, defined as the time from the first diagnosis of micropapillary bladder cancer to cancer-specific death, and the secondary outcome was OS, defined as the time from the first diagnosis to death from any cause. | PMC9926703 |
Construction and validation of the nomogram | micropapillary bladder cancer, Micropapillary bladder cancer | REGRESSION | Eligible micropapillary bladder cancer patients from the SEER database were randomly divided into a training set and an internal validation set using a ratio of 7:3. Micropapillary bladder cancer patients from the tertiary center were designated as the external validation set. External validation was performed to furth... | PMC9926703 |
Results | PMC9926703 | |||
Patients baseline characters | micropapillary bladder cancer | According to the inclusion criteria, a total of 668 micropapillary patients were retrospectively enrolled from SEER (n = 627) and tertiary centers (n = 41). By the end of follow-up, a total of 360 of the 627 people enrolled from SEER database had died, of which 280 died from micropapillary bladder cancer and the remain... | PMC9926703 | |
Univariable and multivariable cox regression in the training set | tumor, AJCC TMN stage | REGRESSION, TUMOR | In univariable Cox regression analysis for CSS, eleven factors (age, sex, histologic grade, marital status, T stage, N stage, M stage, AJCC TMN stage, surgical approach, radiotherapy, lymph node ratio, and tumor size) reached statistical significance. Then, above eleven factors were included in the multivariate Cox ana... | PMC9926703 |
Nomogram construction | tumor, micropapillary bladder cancer | TUMOR, LYMPH NODE METASTASIS | Nomograms were established based on the above independent prognostic factors for predicting the 1-, 3-, 5-year CSS and OS (Fig. Nomograms predicting the 1-, 3-, 5-year CSS of micropapillary bladder cancer. I Each of the independent prognostic factors was given a point according to HR. The scores corresponding to indepe... | PMC9926703 |
Nomogram validation | PMC9926703 | |||
Internal validation | micropapillary bladder cancer | Nomograms were validated internally in the training set and the internal validation set.In the training set, C-indices of the nomogram were 0.766 (95% CI 0.735–0.797), 0.742 (95% CI 0.726–0.758) for CSS and OS respectively, which were both higher than 0.7, suggesting that these two nomograms were relatively accurate an... | PMC9926703 | |
External validation | In the external validation set, C-indices of the nomograms were 0.813, 0.828 for CSS and OS respectively. The AUC values were 0.741, 0.929, and 0.968 for the 1-, 3-, and 5-year CSS (F | PMC9926703 | ||
Discussion | papillary tumor, tumor, comorbidity, micropapillary breast cancer, cancer, urothelial carcinoma, micropapillary bladder cancer, bladder cancer, muscle-invasive bladder cancer, tumors, Micropapillary bladder cancer, AJCC | TUMOR, MICROPAPILLARY CARCINOMA, CANCER, UROTHELIAL CARCINOMA, BLADDER CANCER, INFILTRATING, TUMORS, METASTASES | Micropapillary carcinoma, a rare variant, is composed of infiltrating slender delicate filiform processes or small tight papillary tumor cell clusters that lie within lacunae [Although AJCC TNM staging system is popular for cancer prognosis, the rationality of its application in micropapillary bladder cancer has been m... | PMC9926703 |
Conclusion | micropapillary bladder cancer | We established the visible nomograms to predict individual CSS and OS of micropapillary bladder cancer patients using demographic information, clinicopathological factors and treatment-related factors. The internal validation and external validation of the model proved its significant performance. The nomograms can be ... | PMC9926703 | |
Acknowledgements | Not applicable. | PMC9926703 | ||
Author contributions | PL: Conceptualization, Data Analysis, Investigation, Methodology, Project administration, Visualization, Writing; LX: Data Analysis, Investigation, Methodology, Visualization, Writing; GC: Data curation, Supervision, Writing; BS: Data curation, Supervision, Writing; QZ: Data curation, Supervision, Writing; SC: Conceptu... | PMC9926703 | ||
Funding | This work was supported by the Shandong Medical and Health Science and Technology Development Plan Project (2018WS333), the National Natural Science Foundation of China (Grant No. 81970661; 81900637) and the Tai Shan Scholar Foundation to Benkang Shi (ts201511092). | PMC9926703 | ||
Availability of data and materials | The dataset supporting the conclusions of this article is available in the SEER*Stat software version 8.4.0 repository ( | PMC9926703 | ||
Declarations | PMC9926703 | |||
Ethics approval and consent to participate | Data were extracted from SEER using SEER*Stat software version 8.4.0 ( | PMC9926703 | ||
Consent for publication | Not applicable. | PMC9926703 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9926703 | ||
References | PMC9926703 | |||
Background | COMPLICATIONS, VASOVAGAL REACTION | Vasovagal reactions (VVRs) are the most common acute complications of blood donation. Responsible for substantial morbidity, they also reduce the likelihood of repeated donations and are disruptive and costly for blood services. Although blood establishments worldwide have adopted different strategies to prevent VVRs (... | PMC10413586 | |
Methods | BLOOD | STRIDES is a cluster-randomised cross-over/stepped-wedge factorial trial of four interventions to reduce VVRs involving about 1.4 million whole blood donors enrolled from all 73 blood donation sites (mobile teams and donor centres) of National Health Service Blood and Transplant (NHSBT) in England. Each site (“cluster”... | PMC10413586 | |
Discussion | The STRIDES trial should yield novel information about interventions, singly and in combination, for the prevention of VVRs, with the aim of generating policy-shaping evidence to help inform blood services to improve donor health, donor experience, and service efficiency. | PMC10413586 | ||
Trial registration | ISRCTN: 10412338. Registration date: October 24, 2019. | PMC10413586 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07473-z. | PMC10413586 | ||
Keywords | PMC10413586 | |||
Introduction | PMC10413586 | |||
Background and rationale | hypovolaemic, fractures, pain | RECRUITMENT, COMPLICATIONS, COMPLICATION, BLOOD, VASOVAGAL REACTION | Vasovagal reactions (VVRs), the most common acute complication related to blood donation, are responsible for substantial morbidity, especially when accompanied by complications such as fall and fractures [Operating at different stages of blood donation, the principal mechanisms believed to underlie donation-related VV... | PMC10413586 |
Objectives {7} | SECONDARY | The primary objective of STRIDES is to determine the optimum intervention(s) or combination of interventions to prevent VVRs in whole blood donors. A secondary objective is to advance understanding of the determinants of VVRs and to help develop prevention strategies for VVRs tailored to specific donor sub-populations ... | PMC10413586 | |
Hypothesis | We will test the hypothesis that the implementation of one or more interventions, singly or in combination, will reduce VVRs when compared to current practice in NHSBT. | PMC10413586 | ||
Trial design {8} | PMC10413586 | |||
Feasibility study | Prior to the initiation of STRIDES, a feasibility study was conducted in five blood donation sites (comprising 3 donor centres and 2 mobile teams) over a period of 15 weeks (25 March 2019 to 26 June 2019) to establish if the protocol for a cluster-randomised trial could be implemented successfully without disrupting ro... | PMC10413586 | ||
Main trial design | STRIDES is a cluster-randomised cross-over/stepped-wedge factorial trial of four interventions to reduce VVRs involving randomisation of all 73 blood donation sites (mobile teams and donor centres) of NHSBT in England. Four interventions were compared to current practice in NHSBT (i.e. | PMC10413586 | ||
Methods: participants, interventions and outcomes | PMC10413586 | |||
Study setting {9} | RECRUITMENT | NHSBT collects whole blood from donors at both static donation centres and mobile teams. Recruitment in STRIDES has been taking place in all 73 blood donation sites of NHSBT located across England (Fig. A map showing the locations of the blood donation sites. Mobile team points relate to the centre where the team is ba... | PMC10413586 | |
Eligibility criteria {10} | All blood donors who were eligible to donate and attended a donation site during the study period (2 | PMC10413586 | ||
Who will take informed consent? {26a} | fainting | We have followed the guidance of the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trial [To avoid biases that could undermine the interpretation of study results (e.g. greater awareness of fainting that could result in “social contagion” or other group triggers that lead to increasing fainti... | PMC10413586 | |
Additional consent provisions for collection and use of participant data and biological specimens {26b} | As noted above, the need for individual consent into the trial has been waived by the ethics committee. For the STRIDES BioResource sub-study, however, donors have needed to provide their individual and informed consent if they agree to join the NIHR BioResource and provide their surplus blood (taken from the satellite... | PMC10413586 | ||
Interventions | PMC10413586 | |||
Explanation for the choice of comparators {6b} | Interventions are tested versus current NHSBT practice (i.e. the standard of care). | PMC10413586 | ||
Intervention description {11a} | orthostatic stress, hypovolemic, anxiety, pain | CONTRACTIONS | As noted above, our trial is evaluating different interventions: (1) 500ml of isotonic drink before donation; (2) 3-min rest on donation chair after donation; (3) modified applied muscle tension (AMT); and (4) a psychosocial intervention using preparatory materials. Table Details of the proposed interventions
Physical ... | PMC10413586 |
Criteria for discontinuing or modifying allocated interventions {11b} | MINOR | As this pragmatic trial was embedded into routine donation services, the study has been open to the following minor amendments. First, if a participant has not wished to receive the trial’s interventions, they have been able to receive NHSBT’s standard interventions (e.g. water loading rather than the isotonic drink ev... | PMC10413586 |
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