Blinding. Blinding shall be of the same materials as the hardcore be, crushed and graded from 4 mm upwards, free from clay, chemical or other pollution, pests, weed roots and rubbish.
Blinding. Blinding of selected laboratory results is available as an optional service from QLAB. If The Sponsor determines that there is a requirement for blinding of results in this clinical trial, such requirements will be defined in the Scope of Work.
Blinding. This study is single blind. The participant will be blinded to which study vaccine (MVA-NP+M1 or placebo) they are administered. The Investigator and all study staff acting to determine or record safety, as well as all laboratory staff will also remain blinded (“observer blind”). The pharmacist and any study staff administering the study vaccine will not be blinded. The volume and site of vaccination will be the same for both Group 1 and Group 2. Identical syringes and needles will be used for preparation and administration of each study vaccine. Study vaccine will be prepared out of sight of the participant.
Blinding. Each study in the protocol is open label; no blinding to treatment assignment for individual subjects or their care-providers will be performed. However, aggregate study results will be blinded and tightly controlled until the end of each study.
Blinding. Articles will be blinded by removing author names and affiliation lists from every PDF. Each blinded publication has 2 raters, the ratings were conducted independently. From 192 publications, we have 96 articles for the case group and 96 articles for the control group. See Figure 3.1 No sample size calculation has been done. The publications are given by the output of the group in the years 2017 and 2018. The case group are all medical research publications from PubMed between 2017 and 2018 with at least one of the biostatisticians as main or co-author was retrieved on Dec 9, 2019 (cases). The control group are all medical research publications found in PubMed between 2017 and 2018, with affiliation University of Zurich or University Hospital Zurich or any of the affiliated university hospitals for first and / or second author were extracted (denoted as "potential controls") on Dec 16, 2019. This large number of publications will be used in a random but replicable order aiming to remove potential chronological ordering or any other systematic ordering while adhering to high standards of reproducibility. All statistical programming will be performed with R, in combination with dynamic report- ing. Statistical programming included downloading all potential control publications, random reordering, development of a shiny app for categorization of the publications, development of a shiny app for quality rating of the publications, as well as statistical methods for comparison of case and control group, and its graphical display. We agree that Interrater reliability and agreement examinations are needed to estimate the amount of error in the rating or scoring of tests and classification procedures. such that: Reliability is ability of a measurement to differentiate between subjects (here the articles). Agreement is the degree to which scores or ratings are identical. Both concepts are important, because they provide us information about the quality of measurements in this study. For assessing the level of agreement of reporting quality between the two raters, kappas values, ICC will be estimated. Low levels of agreement would indicate that the ratings are complex and that third party arbitration was required in many publications.
Blinding. Describe whether the investigators were blinded to group allocation during data collection and/or analysis. Note: all studies involving animals and/or human research participants must disclose whether blinding and randomization were used.
Blinding. Figure 5. Staged implementation scheme for the 80 participating practices.
Blinding. In this double-blind study all patients, investigators, site personnel, laboratories and central readers with direct involvement in the conduct of the study or their designees will be blinded to treatment assignments. To prevent potential bias, appropriate measures will be taken to ensure the blind is maintained for the patients and personnel mentioned previously. To maintain the blind, investigators will distribute blinded study drug treatment kits to patients as directed by the IWRS system. Investigators and patients will not be blinded to dose level, but will be blinded to treatment assignment (i.e., active study drug vs. placebo). An IWRS system will manage treatment assignments. The only people with direct access to treatment assignments will be those individuals who develop and maintain the randomization code, the DSMB and the statistical group reporting to the DSMB.
Blinding. RCC analysts and other staff at the RCC were blinded to histology results, and pathologists were blinded to imaging results. RCC analysts were blinded to treatment assignment. Subject demographics, laboratory, anthropomorphic measurements, and medical history ACCEP XXX XXXXX CRIP T were collected at each clinical trial site. Statistical analyses were done with SAS (SAS Institute 2011, Base SAS 9·3 Procedures Guide) and Stata (StataCorp 2013, Stata Statistical Software: release 13). A single PDFF value was calculated for each MRI exam as the mean of the PDFF values for the nine anatomical liver segments. Demographic, histologic and imaging information were summarized with categorical variables expressed as numbers and percentages and continuous variables expressed by mean (± standard deviation [SD]). The proportion of subjects who had, vs did not have MRIs at baseline was compared with regard to treatment group, study site, demographics, liver enzymes, lipids, metabolic factors, co-morbidities, concomitant liver medications, and histology findings. Xxxxxxx partial correlation coefficients and 95% confidence intervals were estimated between PDFF and histologic variables (steatosis, lobular inflammation, hepatocellular ballooning, fibrosis, and portal inflammation) at baseline and for changes from baseline to 72 weeks. Diagnostic accuracy of PDFF to classify hepatic steatosis grade at baseline was tested for grades 0-1 vs 2-3, and grades 0-2 vs 3. Diagnostic accuracy of change in PDFF to classify change in hepatic steatosis grade from baseline to EOT was tested for: reduction vs no change/increase and increase vs no change/decrease. Cross-validated area under ROC (AUROC) curves using a jack-knife procedure and 95% CIs were estimated for each of these dichotomizations [26]. Cut-off PDFF values were estimated using the lowest threshold value for which there was ≥ 90% specificity to distinguish between these dichotomized categories. Sensitivity, positive predictive values (PPVs), and negative predictive valves (NPVs) were calculated along with 95% confidence intervals (CIs) fixing specificity at 90%. ACCEP XXX XXXXX CRIP T Of 283 adults enrolled in the FLINT trial from March 16, 2011 to December 3, 2012 at eight participating FLINT clinical trial sites, 113 (40%) had MRI and liver biopsy at baseline, 85 (30%) had MRI and liver biopsy at EOT, and 78 (28%) had MRI and liver biopsy at both time points. One subject with a baseline MRI but without a centrally-read ba...
Blinding. Randomization to either Investigational or control device will only occur at the surgery visit (Visit 2) and therefore the subjects will be blinded to their randomly assigned treatment device prior to surgery and during the follow up period following surgery. While it is not possible to blind investigators and staff members to the treatment device used, Investigators and staff members will not learn of randomized device until immediately prior to use of device, so as to maintain subject blinding prior to the hernia repair. Investigators and staff members will be asked to maintain subject blinding through the course of the follow up visits so as to not bias subject feedback on applicable study assessments. No device assignment information will be included on the source documentation to be completed by the study subjects (e.g. pain and quality of life assessments) and staff members, including the Investigator(s), will be instructed to not disclose this information during each study visit. Subjects will receive the same standard of care prior to, during and following surgery regardless of randomized device assignment, and therefore will not be able to individually determine what device they have been randomized to. Randomization assignment will be revealed to subjects at conclusion of the study after all assessments and study visits are completed. A subject will be informed of their randomization assignment in the event they withdraw consent or are withdrawn from the study for any other reason.
