Linguistic Validation and Reliability of the Croatian Version of the TOPICOP Questionnaire.

Background and Objectives: This study demonstrates the factor structure and reliability of the Croatian version of the TOPICOP (Topical Corticosteroid Phobia) questionnaire, thereby contributing to further validation and standardization of the measurement of topical corticophobia with dermatological patients or their parents, which directly affects patient or parent compliance, as well as the final therapeutic effect. Materials and Methods: The cross-sectional, observational study was conducted at the University Hospital Centre Split, Department of Dermatovenerology. The research involved inviting 120 participants (age 12-68) who attended the University Hospital Centre Split's Atopy School, patients examined in the Dermatology Outpatient Clinic of the University Hospital Centre Split and diagnosed with atopic dermatitis (AD) or allergic contact dermatitis (ACD), and parents or legal representatives of patients younger than 12 years old. The TOPICOP questionnaire consists of 12 items assessing the three different components of topical corticophobia (worries, beliefs, and behaviour). Respondents evaluated their perception of the correctness of each statement within 10 min of filling out the questionnaire on a four-point Likert scale. Results: The response rate was 94%, resulting in a sample of 113 respondents (109 adults and 4 children). Factor analysis yielded one common factor of relatively high reliability (Cronbach α = 0.85, 95% CI 0.81 to 0.89). No differences were found in questionnaire scores between male and female participants, nor between the parents/legal representatives of dermatological patients and other patients. Conclusions: This research contributes to further development of the appropriate measuring instrument, its practical application, and thus, the better recognition, resolution, and prevention of topical corticophobia as part of the better overall healthcare and treatment of chronic dermatological patients.

The reflective measurement model of adherence to non-pharmaceutical interventions (NPIs) in accordance with normalization process theory (NPT) in coherent and convenient social subgroups: PLS-SEM analysis.

BACKGROUND: Non-pharmaceutical interventions (NPIs) decrease COVID-19 transmission. Reliability and validity of adherence to NPIs in accordance with normalization process theory (NPT) in coherent and convenient social subgroups using reflective measurement model assessment has not been evaluated. METHODS: In February 2021, a sample of medical students and people with substance use disorders in treatment as coherent (based on continuous probability distribution) vs. convenient groups (based on convenience, not equal probability) composed of travellers and COVID-19 suspected persons from Split-Dalmatia County (SDC) (n = 656) in the Mediterranean completed self-administered surveys. Partial least squares structural equation modelling (PLS-SEM) was used to measure reflective model assessment of adherence to NPIs according to NPT. RESULTS: PLS-SEM reflective model assessment provided two-group specific factors in inverse relationships which determined adherence to NPIs with excellent goodness-of-fit [χ2 = 1.292, df = 1; P = 0.297, CFI = 1, TLI = 0.997, RMSEA = 0.011 (90% CI 0-0.105), RMSEA P = 0.604, SRMR = 0.008, Hoelter CN (α = 0.05) = 2322.757]. Significant negative factors covariance estimate (-0.716) revealed an inverse relationship between first (adherence to NPIs and internal locus of control (LoC) (0.640)) and second factor; young adulthood age (≤25) and highest level of education (1362). As the first factor increased the second tended to decrease. LoC is expected potential mechanism by which sex (MLsex = -0.017, SE = 0.007, P < 0.016) and belonging to coherent subgroups (MLgroup = -0.008, SE = 0.003, P = 0.015) can produce indirect effect of adherence to NPIs. CONCLUSIONS: Coherent subgroups had a more pronounced tendency toward integration of NPIs in everyday life. Group factors that facilitate the normalization were higher educated younger adults with a tendency toward external LoC.

Analysis of the quality, accuracy, and readability of patient information on polycystic ovarian syndrome (PCOS) on the internet available in English: a cross-sectional study.

BACKGROUND: Online information about PCOS lacks reliability for patients seeking information about the disease. Thus, we aimed to perform an updated analysis of the quality, accuracy, and readability of patient information on PCOS available online. METHODS: We conducted a cross-sectional study using the top five Google Trends search terms in English associated with PCOS, including "symptoms," "treatment," "test," "pregnancy," and "causes." Five separate searches in Bing, Yahoo, and Google were performed to obtain the first 10 unique webpages for each term that was categorized as commercial, non-profit organization, scientific resources, or private foundation. We used the 16-item DISCERN with Likert-responses (minimum 1, maximum 5) where the total is 80 and lowest is 16, clarity with the 32-item EQIP, where responses of no = 0 and yes = 1 (minimum 0, maximum 32), and accuracy scores with 1 denoting poor and 5 completely accurate information; low scores of each corresponded to poorly reported information. We assessed readability with Flesch-Kincaid reading ease index, where higher scores correspond to reading ease, and lower grades correspond to easier readability with Flesch-Kincaid grade level, Gunning-Fog, Coleman-Liau index, automated readability index, New Dale-Chall Readability, and simple measure of gobbledygook. We additionally assessed word and sentence characteristics. We used Kruskal-Wallis test to compare scores according to webpage categories. RESULTS: Out of 150 webpages, most were commercial (n = 85, 57%), followed by non-profit organizations (n = 44, 29%), scientific resources (n = 13, 9%) and private foundations (n = 6, 4%). Google webpages had higher median DISCERN score ([Md] = 47.0) than Bing ([Md] = 42.0) and Yahoo ([Md] = 43.0) webpages; P = 0.023. No difference in EQIP scores according to search engine was found (P = 0.524). Predominantly, webpages from private foundations had higher DISCERN and EQIP scores, although comparisons were not statistically significant (P = 0.456) and P = 0.653.). Accuracy and readability were similar across search engines and webpage categories (P = 0.915, range 5.0-5.0) and (P = 0.208, range 4.0-5.0). CONCLUSIONS: Quality and clarity of the data were fair according to search engine and category. Accuracy of information was high, showing that the public may encounter accurate information about PCOS. However, the readability of the information was high, reflecting a need for more readable resources about PCOS.

Protocol of a scoping review of systematic reviews and meta-analyses about COVID-19 vaccines and associated adverse events from vaccination.

The continuous dissemination of coronavirus disease of 2019 (COVID-19) literature can inform decision-makers and the public. Since the widespread use of COVID-19 vaccines, more systematic reviews have summarized the effectiveness and reported adverse events associated with vaccination. Previous systematic and scoping reviews on COVID-19 summarized various aspects surrounding COVID-19, however, a scoping review is needed to summarize the characteristics of COVID-19 vaccines and associated adverse events reported in systematic reviews and meta-analyses to provide comprehensive evidence for informed medical decision-making. We will conduct a scoping review concerning COVID-19 vaccines and adverse events from vaccines. We will search from December 2019 to present in Epistemonikos, Campbell Library, CINAHL (Ovid), MEDLINE (Ovid), Scopus, CENTRAL (Ovid), Web of Science, WHO COVID-19 database, Joanna Briggs Institute of Excellence, and COVID-19 Evidence Reviews resource. We will include systematic reviews, meta-analyses, or both of randomized controlled trials and observational studies and exclude individual randomized controlled trials and observational studies. Abstracts and full-texts will be screened prior to selection. Investigators will independently use a calibrated quantitative and qualitative data extraction sheet and rate the quality of articles with AMSTAR, resolving disagreements to aim for good agreement (≥80%). An updated scoping review of the characteristics and safety of COVID-19 vaccines would highlight the accuracy of the evidence to inform decision-making concerning COVID-19 vaccination.

Reporting of the safety from allergic rhinitis trials registered on ClinicalTrials.gov and in publications: An observational study.

BACKGROUND: Incomplete and inconsistent reporting of adverse events (AEs) through multiple sources can distort impressions of the overall safety of the medical interventions examined as well as the benefit-risk relationship. We aimed to assess completed allergic rhinitis (AR) trials registered in ClinicalTrials.gov for completeness and consistency of AEs reporting comparing ClinicalTrials.gov and corresponding publications. METHODS: We retrospectively examined completed randomised controlled trials on AR registered in ClinicalTrials.gov on or after 9/27/2009 to trials updated with results on or before 12/31/2021 along with any corresponding publications. Complete reporting of AEs in ClinicalTrials.gov were summarised in tables describing AE information, and complete reporting in publications was an explicit statement of serious AE, death or other AE. Difference in completeness, number, or description of AEs between ClinicalTrials.gov and publication was classified as inconsistent reporting of AEs. RESULTS: There were 99 registered trials with 45 (45.5%) available publications. All published trials completely reported AEs in ClinicalTrials.gov, and 21 (46.7%) in publications (P < .001). In 43 (95.6%) publications, there was at least one inconsistency in the reporting of AEs (P < .001). 8 (17.8%) publications had different number of serious AEs (P = .003), 36 (80.0%) of other AEs (P < .001) while deaths reporting was inconsistent in 8 (57.1%) publications (P = .127). CONCLUSION: The reporting of AEs from AR trials is complete in ClinicalTrials.gov and incomplete and inconsistent in corresponding publications. There is a need to improve the reporting of AEs from AR trials in corresponding publications, and thus to improve patient safety.

Impact of Neonatal Body (Dis)Proportionality Determined by the Cephalization Index (CI) on Gross Motor Development in Children with Down Syndrome: A Prospective Cohort Study.

Background: Children with Down syndrome (DS) lag behind typical children in the acquisition of developmental milestones, which could differ depending on body proportionality. We aimed to determine the difference in the acquisition of developmental milestones in children with DS with a disproportionate cephalization index (CI) compared to a proportionate CI. We created a motor development model that predicted milestone acquisition times. Methods: In this 20-year prospective cohort study, 47 children with DS aged 3 months to 5 years, followed up to 2020, were grouped according to the ratio of head circumference to birth weight (HC/BW) or CI into proportionate (CI < 1.1) and disproportionate (CI ≥ 1.1). We used a modified Munich Functional Developmental Diagnostic Scale that was assessed for reliability and content validity (Levene's test and discriminant analysis) to determine 28 motor milestones. Linear regression was used to predict time to milestone acquisition, controlling for sex, maternal age, and birth weight. Results: Compared to proportionate CI, children with disproportionate CI were delayed in the milestone acquisition of a prone position by 2.81 months, standing before walking by 1.29 months, and a supine position by 1.61 months. Both groups required more time to reach standing after the acquisition of independent walking, but children with disproportionate CI reached those milestones later (4.50 vs. 4.09 months, p < 0.001). Conclusion: Children with disproportionate CI acquired milestones in a predictable order but slower than those with a proportionate CI. Our findings support the need to classify the degree of motor developmental delay in children with DS into unique functional groups rather than rely on clinicians' arbitrary descriptions of the timing of developmental delays in children with DS.

Unaided general practitioners' clinical diagnosis in evaluation of depressive patients: a pilot study.

BACKGROUND: In this study we wished to determine the diagnostic accuracy of unaided general practitioners' (GPs') clinical diagnosis in the evaluation of depression in depressed patients under their care compared with the Beck Depression Inventory II (BDI-II). SUBJECTS AND METHODS: From 17,000 patients in 10 GPs' offices as representative sample in the city of Zagreb, 5100 patients from three GPs' offices were selected. The sample consisted of 53 out of 76 depressed patients with a diagnosis of Depressive episode (F32) or Recurrent depressive disorder (F33) classified according to ICD-10 and assessed by review of the GP's standardized medical records. Cross-sectional investigation was performed during February 2008. GPs classified depressed patients as either nondepressed without therapy, nondepressed with therapy or depressed with therapy. Within a two-week period, the unaided GPs' diagnosis was compared with BDI-II performed by psychologists unfamiliar with the GPs' assessment. Based on the GP vs. BDI-II comparison, patients were classified as either positive, false positive, false negative or negative. Sensitivity, specificity, PPV, and NPV associated with physician identification of depression were calculated by standard methods. RESULTS: Depressiveness was found by BD-II in the group 'depressed with therapy' (24.39±10.91). ANOVA found a significant difference in BDI-II means between the outcome groups (P<0.001). Scheffe's procedure found a significant difference in BDI-II in patients with therapy (nondepressed vs. depressed) (P<0.001) and nondepressed without therapy vs. depressed with therapy (P<0.001). There were 16 depressed patients, 27 nondepressed, 2 false positive, and 8 false negative. Unaided GPs' clinical diagnosis showed 66% sensitivity, 93%, specificity, 88% PPV, and 77% NPV. CONCLUSION: Unaided GPs' clinical diagnosis with 88% PPV outperforms other measures of patient depression and is easier to implement when compared to the psychiatric model of caseness, which is based on screening instruments.