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.

Protocol for a systematic review and meta-analysis on Janus kinase inhibitors in the management of vitiligo.

BACKGROUND: Vitiligo is a disease that affects people of all skin shades and can impact their quality of life. Reliable evidence on the effectiveness and adverse events associated with the recent use of Janus kinase (JAK) inhibitors to treat vitiligo is needed. This protocol for a systematic review and meta-analysis seeks to collect evidence from both randomized controlled trials (RCTs) and observational studies to determine the effectiveness and patient-centered outcomes concerning treatment with JAK inhibitors. METHODS: We will conduct a systematic review of the literature for RCTs and observational studies that used upadacitinib, ritlecitinib, brepocitinib, ifidancitinib, cerdulatinib, deglocitinib, baricitinib, tofacitinib, and ruxolitinib JAK inhibitors as treatments for vitiligo compared to placebo, no treatment, or combination therapies. We will systematically search from inception in Epistemonikos, MEDLINE, Scopus, Cochrane Central Register of Controlled Trials, EMBASE, ClinicalTrials.gov, PsycINFO, Allied and Complementary Medicine Database, Latin American and Caribbean Health Sciences Literature, Web of Science Core Collection, relevant preprint servers, and the gray literature. Ethics approval was not sought as the protocol and systematic review will not involve human participants, but rather summarized and anonymous data from studies. Primary outcomes include quality of life, percentage repigmentation, decreased vitiligo within 1 year or more, lasting repigmentation after a 2-year follow-up, cosmetic acceptability of repigmentation and tolerability or burden of treatment, and adverse events. Secondary outcomes are patient and study characteristics. We will include full-text articles, preprints, and clinical trial data in any language and all geographic regions. For data sources unavailable in English, we will obtain translations from global collaborators via the Cochrane Engage network. We will exclude articles for which sufficient information cannot be obtained from the authors of articles and systematic reviews. At least two investigators will independently assess articles for inclusion and extract data; reliability will be assessed before subsequent selection and data extraction of remaining studies. The risk of bias and certainty of evidence with Grading of Recommendations Assessment, Development, and Evaluation guidelines will be assessed independently by at least two investigators. We will estimate treatment effects by random-effects meta-analyses and assess heterogeneity using I2. Data that cannot be included in the meta-analysis will be reported narratively using themes. DISCUSSION: The proposed systematic review and meta-analysis describe the methods for summarizing and synthesizing the evidence on the effectiveness and patient-centered outcomes concerning the treatment of vitiligo with JAK inhibitors that were recently approved for this indication. To disseminate further the results of our systematic review, we plan to present them at international conferences and meetings. Our findings will provide robust evidence to facilitate decision-making at the policy or practitioner level. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42023383920.

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.

Adverse drug reaction reporting via mobile applications: A narrative review.

INTRODUCTION: Pharmacovigilance importance has increased in the last few decades and it has led to rise in awareness of adverse drug reaction reporting by both patients and health care professionals. Despite this, research shows reporting practice of health care professionals remains inadequate. Several educational and promotional activities were established in order to improve observed underreporting including the introduction of mobile applications that can be used to report adverse drug reactions. OBJECTIVES: We aimed to review literature on adverse drug reaction reporting applications and whether their introduction improved reporting practice in patients and health care professionals. RESULTS: In this review, we have described several mobile application implementations in different countries. Moreover, we have illustrated some of the applications for particular patients, e.g. patients with multiple sclerosis. CONCLUSION: All of the included studies showed positive association between application use and ADR reporting. However, there is a great need for future high quality studies to confirm impact of mobile application on ADR reporting.

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.

Did an introduction of CONSORT for abstracts guidelines improve reporting quality of randomised controlled trials' abstracts on Helicobacter pylori infection? Observational study.

OBJECTIVE: To determine abstracts' adherence to the Consolidated Standards of Reporting Trials for Abstracts (CONSORT-A) statement and to explore the factors associated with reporting quality. DESIGN: An observational study. SETTING: Abstracts of randomised controlled trials published between 2010 and 2019, found searching the MEDLINE database. PARTICIPANTS: A total of 451 abstracts of the clinical trials on Helicobacter pylori infections were included. PRIMARY AND SECONDARY OUTCOME MEASURES: Abstracts' reporting quality was determined by assessing their adherence to 17-item CONSORT-A checklist, with overall score being calculated as the sum of items that were adequately reported for each abstract. Additional factors that might influence the reporting quality of the abstracts were analysed, with univariate and multivariate linear regression used to determine how those factors influenced the overall reporting quality. RESULTS: Included abstracts had an overall median quality score of 8/17 (IQR 7-9). Large proportions of abstracts adequately reported interventions, participants, objectives, numbers randomised and conclusions (97.1, 99.3, 89.1. 94.7 and 98.4% of abstracts, respectively). Trial design, randomisation, blinding and funding were severely under-reported with only 8.0, 2.7, 11.0 and 2.0% of abstracts reporting each item. Overall quality scores for H. pylori abstracts were higher in association with CONSORT-A endorsement (B=5.698; 95% CI 1.781 to 9.615), pharmacological interventions (B=4.063; 95% CI 0.224 to 7.902), multicentre settings (B=5.057; 95% CI 2.370 to 7.743), higher numbers of participants (B=3.607; 95% CI 1.272 to 5.942), hospital settings (B=4.827; 95% CI 1.753 to 7.901) and longer abstracts (B=3.878; 95% CI 0.787 to 6.969 for abstracts with 251-300 words and B=7.404; 95% CI 3.930 to 10.878 for abstracts with more than 300 words). CONCLUSIONS: The overall reporting quality of abstracts was inadequate. The endorsement of CONSORT-A guidelines by more journals might improve the standards of reporting.

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.

Drug-drug interaction trials incompletely described drug interventions in ClinicalTrials.gov and published articles: an observational study.

OBJECTIVES: The aim of the study was to evaluate the completeness of intervention description in ClinicalTrials.gov and corresponding journal articles for registered and published drug-drug interaction (DDI) trials because complete and transparent description of interventions is particularly important for DDI. STUDY DESIGN AND SETTING: Observational study of completed interventional trials on DDIs with up to two drugs within the Intervention registration element in ClinicalTrials.gov until October 2015. We used the Template for Intervention Description and Replication items to assess the quality of intervention description in both ClinicalTrials.gov Descriptive Information section and matching publications. Corresponding articles were identified in March 2019. RESULTS: The description of 1,180 drug interventions registered for 642 DDI trials mostly lacked information on the intervention provider (99.7%), adherence strategies (99.2%), procedure (83.8%), location (71.3%), and dosage form (60.7%). Generic name (82.5%), dose (70.8%), and duration of administration (65.6%) were most frequently reported. Among 51 trials that had data reported both in ClinicalTrials.gov and publication, 60.8% were in phase 1. Less than half of 96 interventions had clear and matching description of dosage form, procedure, and route of administration in both sources. CONCLUSION: DDI trials did not sufficiently report components required for complete intervention description. Further improvements in ClinicalTrials.gov registration requirements, including phase 1 trials, and more stringent publishing requirements for essential data on drug interventions, are needed to prevent patient risk in clinical practice regarding concomitant medication use.

Clinical trials on drug-drug interactions registered in ClinicalTrials.gov reported incongruent safety data in published articles: an observational study.

OBJECTIVE: To assess safety data of trials on drug-drug interactions (DDIs) reported in ClinicalTrials.gov and published in journal articles, since DDIs are a growing concern. STUDY DESIGN AND SETTING: In an observational study of clinical trials retrieved by the search term "drug-drug interaction(s)," we collected the information on registration and on adverse events (AEs) from ClinicalTrials.gov and corresponding publications. Trials were included if they primarily investigated DDIs, had a National Clinical Trial identifier, and were closed and completed by October 16, 2015. Publication data were extracted until March 2017. RESULTS: Among 1,110 eligible trials, most were in phase 1 (76.8%), industry-funded (68.8%), and started before registration (56.9%). Results were not reported in the registry for 86.8% and not published for 68.1% trials. Published AE data were completely identical to the data submitted to ClinicalTrials.gov for only 15.6% trials. Among 64 trials with results reported both in ClinicalTrials.gov and publications, 34.4% published concordant number for other AEs. CONCLUSION: Discrepancies that emerge from incomplete or changed reporting of AEs in publications emphasize the need to amend and enforce regulatory requirements for timely and complete submission of results, clearer AE reporting for trials focusing on DDIs, and regular assessment of the congruence of AE data submitted to ClinicalTrials.gov and scientific journals during the publication process.

Changes to registration elements and results in a cohort of Clinicaltrials.gov trials were not reflected in published articles.

OBJECTIVES: To assess effectiveness of legislative initiatives to stimulate public registration of trial results, we assessed adherence to protocol and results reporting, changes to registry, and publication data for randomized controlled trials (RCTs) after introduction of Food and Drug Administration Amendment Act (FDAAA). STUDY DESIGN AND SETTING: Observational study of a cohort of ClinicalTrials.gov registered FDAAA-covered RCTs found through ClinicalTrials.gov between 2009 and 2012 and data from corresponding publications. WHO Minimum Data Set items were abstracted by one author and verified by the other author. RESULTS: Among 81 eligible trials, most were industry-funded, with a drug intervention in parallel assignment. Secondary outcomes at the initial and last registration were omitted for 17% and 19.7% of RCTs, respectively. RCT registration changes mostly involved scientific title (18.8%). Inclusion criteria omission was most common (88%) in publications. Inferential statistical methods for primary and secondary outcomes matched between registry and publication for 53.4% and 28.6% of RCTs, respectively. Serious and other adverse events (AEs) that were absent for 23.8% and 4.8% of RCTs, respectively, were published as nonoccurring. CONCLUSION: Discrepancies remain relatively high between registered and published outcomes, particularly regarding registered omissions in publications and concomitant reporting, nature of statistical method used, and reporting of AEs. This seriously undermines transparency of clinical trials and needs immediate attention of all stakeholders in health research.

The Epidemiological Characteristics of Hepatitis B in Croatia: The Results of the Prevention.

This study shows epidemiological characteristics and preventive measures implemented for the prevention and control of hepatitis B infections in Croatia. We analyzed the data from obligatory infectious disease reports and notifications of death due to infectious diseases, data on the hepatitis B infections in Croatia, and data collected by survey of the population. The average prevalence of the disease is 3.67 per 100,000 annually. All age groups are affected, but still a higher rate of the disease is found in the age groups from 15-19 and 20-29 years of age. Hepatitis B disease is 1.4 times more likely in men than in women. For the past 18 years, the average rate of mortality was 0.2%. The incidence of HbsAg-positive donors of blood is within the range of 0.65% in 1992 to 0.012% in 2011. The largest part of preventive measures implemented in Croatia against hepatitis B is predicted and required by legislation. The registrations of acute and chronic carriers of the virus are obligatory. High-risk groups have started being vaccinated since 1992. The obligatory vaccination of infants was introduced in the mandatory vaccination program in 2007. Routine testing of blood exclusively from voluntary donors for HbsAg presence is obligatory. The non-governmental organization "Help" created for intravenous drug users, along with the "Harm reduction" program implemented hepatitis B, C, and HIV/AIDS prevention program in 1995. In order to gain a better understanding of epidemiological characteristics of hepatitis B in Croatia, the specifics of its dynamics in small communities are required since the research of Croatian public health officials and researchers have shown that hepatitis B is spread in different ways.

Relationship of back and neck pain with quality of life in the Croatian general population.

OBJECTIVE: The purpose of this study was to determine the prevalence of back pain and neck pain and their relationship with the quality of life in the Croatian general population. METHODS: This was a cross-sectional study using home-based face-to-face interviews of 1030 participants (51.6% females) 15 years or older. Back and neck pain frequencies were assessed using single items and quality of life using the Short Form Survey and Satisfaction with Life Scale. Analysis of covariance was conducted, where back pain or neck pain frequency was used as the categorical predictor; physical component summary or mental component summary, as the dependent variable; and age, body mass index, and physical activity level, as covariates. RESULTS: The prevalence of back pain was 66.3% (95% confidence interval [CI], 62.3%-70.3%) and 62.9% (95% CI, 58.7%-67.2%) in females and males, respectively. The prevalence of neck pain was 58.0% (95% CI, 53.8%-62.2%) for females and 53.6 (95% CI, 49.2%-58.0%) for males. Differences between men and women were not significant (P>.05). Adjusted mean values for physical component summary and mental component summary were substantially lower in participants who reported back or neck pain often/almost always compared with those without pain. Differences ranged from 8.11 to 11.86 points (95% CI, 5.54-13.99) and from 9.61 to 10.99 points (95% CI, 7.35-13.45) in females and males, respectively. CONCLUSIONS: The findings of this study showed that back and neck pain are highly prevalent and negatively related to quality of life in the Croatian general population. These data might raise the awareness of local government health authorities and lead to improvements in health care service for people with back and neck pain.

Blood lactate levels in patients receiving first- or second- generation antipsychotics.

AIM: To compare the blood lactate levels between patients with psychotic disorder receiving first- and those receiving second-generation antipsychotics. METHODS: The study was conducted at the psychiatric inpatient and outpatient clinics of the Split Clinical Hospital from June 6, 2008 to October 10, 2009. Sixty patients with psychotic disorder who were assigned to 6-month treatment were divided in two groups: 30 received haloperidol (first generation antipsychotic) and 30 received olanzapine (second generation antipsychotic). Blood lactate levels, other metabolic parameters, and scores on the extrapyramidal symptom rating scale were assessed. RESULTS: Patients receiving haloperidol had significantly higher blood lactate levels than patients receiving olanzapine (P < 0.001). They also more frequently had parkinsonism, which was significantly correlated with both haloperidol treatment at 1 month (P < 0.001) and 6 months (P = 0.016) and olanzapine treatment at baseline (P = 0.016), 3 months (P = 0.019), and 6 months (P = 0.021). Also, patients receiving haloperidol had significant correlation between blood lactate and dystonia at 1 month (P < 0.001) and 6 months (P = 0.012) and tardive dyskinesia at 1 month (P = 0.032). There was a significant difference between the treatment groups in lactate levels at all points from baseline to month 6 (P < 0.001). CONCLUSION: It is important to be aware of the potential effect of haloperidol treatment on increase in blood lactate levels and occurrence of extrapyramidal side effects. Therefore, alternative antipsychotics should be prescribed with lower risk of adverse side effects.

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.