Methodology of clinical trials on sodium-glucose cotransporter 2 inhibitors registered on ClinicalTrials.gov: a cross-sectional study.

BACKGROUND/OBJECTIVE: The research on sodium-glucose cotransporter 2 (SGLT2) inhibitors has been increasing rapidly in the last decade, as well as indications for their use. This study aimed to analyze the methodological characteristics of clinical trials on SGLT2 inhibitors registered on ClinicalTrials.gov. DESIGN: We conducted a cross-sectional study of trials on SGLT2 inhibitors registered on ClinicalTrials.gov up to November 11, 2022. We included clinical trials that tested SGLT2 inhibitors for any clinical condition, as a single or combined SGLT2 therapy, compared to any other medication or placebo and mapped their characteristics. RESULTS: We identified 1102 eligible trials on 14 different SGLT2 inhibitors. The first trial registration was in 2005. There were 993 (90%) interventional and 109 (10%) observational trials. Most trials were in Phase 1 (29%), Phase 3 (23%), or Phase 4 (24%). Interventional trials were mostly randomized (85%); almost half of them did not use masking (44%). Trials on empagliflozin, dapagliflozin, and canagliflozin accounted for 75% of all trials. More than 60% of trials included patients with diabetes mellitus, 13% included only healthy subjects, and 12% included patients with heart diseases. Overall, these trials included more than 9.5 million participants (~ 312,000 of which in interventional studies). Almost 65% of all clinical trials were industry-funded. Most trials were completed (60%) and 35% of those reported results. For trials that are obligated to report results by the Food and Drugs Administration (FDA), 88% of them did so. Trials fully or partially funded by industry more frequently published results compared to non-industry funded trials (46.1% vs. 11.2%; p < 0.001). CONCLUSIONS: The number of registered trials on SGLT2 inhibitors is increasing progressively along with expanding indications for its use, shifting from diabetes mellitus to cardiovascular and renal diseases. Public reporting of trial results improved with time but remains suboptimal.

Frequency of exposure incidents in hospital workers before and during the COVID-19 pandemic based on the hospital status and the use of personal protective equipment: a descriptive study with a historical comparison group.

BACKGROUND: An occupational exposure, i.e. exposure incident (EI), is contact with potentially contaminated material that may contain bloodborne pathogens and that occurs during occupational activities inside or outside a health care facility, either during direct work with a patient or during contact with a patient's body fluids and tissues. This study aimed to compare the frequency of EIs in a university hospital before and during the Coronavirus Disease 2019 (COVID-19) pandemic. METHODS: This was a descriptive study with a historical comparison group conducted at the Dubrava University Hospital (DUH) in Zagreb, Croatia. We compared the frequency of EIs among healthcare and non-healthcare workers before (from March 11, 2018, to March 10, 2020) and during (from March 11, 2020, to March 11, 2022) the COVID-19 pandemic, expressed as the number of EIs per number of hospitalized patients and the total number of hospital activities. We analyzed data based on the status of the hospital (a COVID-19 hospital or not) and the use of personal protective equipment (PPE) as recommended by the World Health Organization. RESULTS: During the total analyzed period, 241 EIs were reported in DUH. Before the pandemic, 128 EIs were reported, compared to 113 during the pandemic. Before the pandemic, 91% of EIs were recorded in healthcare workers, while during the pandemic, 96% of EIs were recorded in healthcare workers. Slightly more EIs were recorded during the period of mixed work form and de-escalation of PPE. The rate of EIs relative to the total number of hospital patients was significantly higher during the pandemic (3.9/1000) than in the pre-pandemic period (2.5/1000). The rate of EIs relative to the total number of hospital activities was significantly higher during the pandemic (0.4/1000) than in the pre-pandemic period (0.2/1000). CONCLUSION: The rate of EIs relative to the total number of hospitalized patients and the total number of hospital activities in DUH was significantly higher during the pandemic, and the rate of total EIs increased among healthcare workers during the COVID-19 pandemic. The results of this study show that it is necessary to constantly and effectively work on the prevention of EI.

Levels of depression, anxiety and subjective happiness among health sciences students in Croatia: a multi-centric cross-sectional study.

BACKGROUND: Previous studies have shown that symptoms of depression and anxiety were highly prevalent among health sciences students. This may lead to other professional and personal difficulties and a decrease in individuals' well-being. This study aimed to analyze levels of depression, anxiety and subjective happiness among health sciences students in Croatia. METHODS: We conducted a cross-sectional study in 10 higher education institutions in Croatia during March 2023. Eligible participants were health sciences students. Participants filled out an online survey consisting of sociodemographic questions and validated scales for determining the levels of depression (9-question Patient Health Questionnaire, PHQ-9), anxiety (General Anxiety Disorder 7-item scale, GAD-7), and happiness (Subjective Happiness Scale, SHS). RESULTS: Of 7460 invited students, 2137 students participated in the study (29% response rate). There were 41.4% of students that exhibited at least mild depressive symptoms, with 8% of students exhibiting moderately severe symptoms and 1.8% severe depressive symptoms. Mild anxiety was found in 36.8%, moderate anxiety in 23.9% and severe anxiety in 15.8% of students. The median SHS score was 19 (15.25-22). Women students had significantly higher levels of depression (p < 0.001) and anxiety (p < 0.001) than their men peers. Students in earlier study years showed higher levels of depression, anxiety and lower levels of subjective happiness compared to those in later study years. Students with lower self-assessed financial status had higher levels of depression (p < 0.001) and anxiety (p < 0.001). Students that failed an academic year had higher levels of depression (p < 0.001), but lower levels of anxiety (p = 0.005). CONCLUSION: In this study, we have shown that health sciences students exhibit high levels of depression and anxiety, at rates exceeding those in the general population reported in other studies. Our results may help educational institutions to put greater effort into the battle against mental health stigma, foster acceptance of mental health issues and encourage students to seek help when needed. Adequate mental health services are needed at universities to promote timely diagnosis and treatment of mental health problems.

Perceptions on support, challenges and needs among parents and caregivers of children with developmental disabilities in Croatia, North Macedonia and Serbia: a cross-sectional study.

BACKGROUND: Parents/caregivers of children with developmental disabilities (CDD) have a wide range of support needs and there are various interventions available. Support, challenges, and needs among parents/caregivers of CDD likely vary in different geographical settings. This study aimed to analyze the perceptions of support, challenges, and needs among parents/caregivers of CDD in Croatia, North Macedonia, and Serbia. METHODS: We conducted a cross-sectional study in March-April 2023 within the Erasmus + SynergyEd project. The eligible participants were parents and caregivers of CDD in Croatia, North Macedonia, and Serbia, who filled out a modified Caregiver Needs Survey online. RESULTS: Among 953 participants, 542 (57%) were from Croatia, 205 (21%) were from North Macedonia and 206 (22%) were from Serbia. The most common diagnosis of participants' children was autism spectrum disorder (26%). The child most often received the first diagnosis at the median of 2 years, diagnosed by a team of professionals. More than half (58%) of children attended preschool and public school, while 22% did not attend any schooling. Additional support from the state/city/county was received by 66% of CDD. Most participants declared not participating in association/organization for family support. Participants mostly (68%) used experts who work with the child as a source of information about their child's condition, followed by the Internet (53%). In the last 12 months, 60% of participants had difficulties with the availability of services in their area or problems getting appointments. The biggest problem in getting support was ensuring the child's basic rights were protected. Participants stated that ensuring greater rights for CDD was the greatest need for their families. CONCLUSION: Parents/caregivers of CDD in Croatia, North Macedonia, and Serbia faced multiple challenges, but most of them were satisfied with the services provided to their children. Future efforts to develop policies and services related to CDD should consider the opinions of their parents/caregivers and disparities in access to services.

Secondary traumatic stress in working nurses studying part time in a bachelor or Master's nursing program in Croatia: a cross-sectional study.

BACKGROUND: Nurses are more likely to be exposed to human suffering than other healthcare professionals. Persons exposed to indirect trauma can experience symptoms of posttraumatic stress disorder, symptoms of avoidance, arousal and intrusion. Secondary traumatic stress (STS) occurs when a person hears about the firsthand traumatic experiences of another. This study aimed to explore the prevalence of STS among working nurses enrolled at a university nursing program. METHODS: A cross-sectional study was conducted among nurses working in healthcare enrolled in university bachelor's or Master's nursing studies at the Catholic University of Croatia in November 2017. Data were collected using the Secondary Traumatic Stress Scale (STSS) and two items from the World Health Organization quality of life brief version (WHOQOL-BREF). RESULTS: The study included 151 students; the response rate was 70%. The mean STS score was 38, indicating that the students on average suffered from moderate STS. Half of participating nurses met the criteria for STS. Working nurses enrolled in Master's studies had lower STS scores than those enrolled into bachelor studies (t = 4.14, df = 149, p < 0.01). The level of STS had a negative correlation with participants' quality of life assessment (r=-0.392, p < 0.01) and satisfaction with their health (r=-0.387, p < 0.01). We also found a significant positive correlation between subjective assessment of quality of life and satisfaction with personal health (r = 0.432, p < 0.01). We did not find a significant association between the level of STS and sex (r=-0.094) or years of nursing work experience (r=-0.069). Level of STS varied depending on the participants' workplace, years of experience in that workplace and their work shifts. The highest levels of STS were seen in nurses working in the internal medicine department, those with 10-14 years of work experience in the current workplace, and those who work block shifts (12-hr shift followed by 24-hour shift). CONCLUSION: Over half of working nurses attending university studies had at least moderate STS. Furthermore, STS was negatively associated with participants' perception of quality of life and satisfaction with their health. Prevention and alleviation interventions could reduce the burden of STS among nurses.

Pain associated with psoriasis: a qualitative study.

BACKGROUND: Pain is a major factor in the psychosocial impact of psoriasis. There is a paucity of qualitative reports of dermatologists' views on psoriasis-related pain. OBJECTIVES: The aim of this study was to explore the views of dermatologists on the presence and importance of pain associated with psoriasis. METHODS: This qualitative study, based on semi-structured interviews, included dermatologists from different cities working in the hospital and private sector in Croatia between May and July, 2022. We collected demographic and occupational data on participants and information about their experiences and attitudes toward psoriasis-related pain. Data were analysed by applying interpretative descriptive and thematic analysis using the 4-stage method for systematic text condensation. RESULTS: We included 19 dermatologists, all women, aged 38 (range: 31 to 63 years). Most dermatologists acknowledged the presence of pain in patients with psoriasis. They indicated that they sometimes do not sufficiently address this pain in daily practice. Some indicated that pain was a neglected symptom in psoriasis, while for others it was not crucial. Most indicated that it is necessary to focus more on psoriasis-related pain in clinical practice, to disambiguate between skin pain and joint pain in psoriatic conditions, and to better educate family physicians about psoriasis-related pain. They emphasized the importance of considering pain during psoriatic patient assessment and management. Further research on psoriasis-related pain was suggested. CONCLUSIONS: More emphasis is needed on psoriasis-related pain for effective management of psoriasis, informing decision-making in the context of patient-centric care and improving the quality of life in patients with psoriasis.

Consumption of psychotropic drugs in Croatia before and during the COVID-19 pandemic: a 10-year longitudinal study (2012-2021).

PURPOSE: This longitudinal study aimed to examine the trends in antipsychotics, antidepressants, anxiolytics, and hypnotics/sedatives consumption in Croatia over a 10-year period (2012-2021). The study also assessed whether the COVID-19 pandemic had an impact on the yearly consumption of psychotropic drugs. METHODS: Data were collected from Croatian Agency for Medicinal Products and Medical Devices (HALMED) and presented as defined daily doses per 1000 inhabitants per day (DDD/TID). The consumption before (2012-2019) and during the COVID-19 pandemic (2020-2021) was compared with interrupted time series analysis. RESULTS: There was an increase in total consumption of analyzed psychotropic drugs in Croatia between the years 2012 and 2021, from 115.47 DDD/TID in 2012 to 155.50 DDD/TID in 2021. An increasing trend was observed in the consumption of all 4 analyzed groups of medicines (antipsychotics, anxiolytics, hypnotics and sedatives, and antidepressants). Anxiolytics accounted for 59% (68.29/115.47 DDD/TID), and hypnotics and sedatives for 8.5% (9.76/115.47 DDD/TID) of total consumption in 2012. At the end of a 10-year period, hypnotics and sedatives represented 12% (19.05/155.50 DDD/TID) and anxiolytics 54% (83.53/155.50 DDD/TID) of psychotropic drugs consumption. The total consumption of psychotropic drugs was not significantly different before and during COVID-19 pandemic (estimate ± standard error = 5.029 ± 6.899, t = 0.729, P = 0.490). CONCLUSION: Croatia had a high, continuously increasing consumption of psychotropic drugs. National anxiolytics consumption was one of the highest globally, while consumption of antidepressants was rather low compared to other high-income countries. The COVID-19 pandemic did not seem to influence the yearly utilization of psychotropic drugs in Croatia.

Tendencies towards emigration and their association with introversion and ethnocentrism among final-year medical students from Osijek, Croatia: a cross-sectional study.

BACKGROUND: The migration of healthcare workers is attracting growing attention worldwide. Attitudes towards emigration develop over the years, and it is possible that, in addition to social factors, they are influenced by the characteristics of a person's personality and the sense of belonging to the social environment. This study aimed to determine the tendencies of final-year medical students' from Osijek, Croatia, towards emigration after graduation and after specialization, as well as their specialty preferences and to investigate whether introversion and ethnocentrism have an impact on attitudes toward leaving the country in search of employment elsewhere. METHODS: A cross-sectional study was conducted among final-year (6th year) medical students from Osijek, Croatia, in two consecutive academic years - 2014/2015 and 2015/2016. Students completed a questionnaire about sociodemographic characteristics, academic and scientific performance, preferences about their future medical career, the medical specialty of choice, emigration tendencies after graduation and specialization, ethnocentrism and introversion. RESULTS: There were 124 students who participated in the study (response rate: 96%). A quarter of participants agreed that they are likely or very likely to emigrate after graduation (25.0%) or after specialization (23.39%). Variables associated with the intention to emigrate were specialty preferences (students that prefer endocrinology and psychiatry had the highest emigration tendencies), academic year in which the participants were included (students included in 2014/2015 were more prone to emigrate after specialization, p = 0.060), prior involvement in scientific projects (students with experience in scientific projects expressed higher tendencies to emigrate after graduation, p = 0.023), and ethnocentrism (higher ethnocentrism was associated with a lower tendency towards emigration after specialization, Spearman's rho = -0.191). CONCLUSION: Our finding that a quarter of final-year medical students from the Faculty of Medicine Osijek were considering emigrating from Croatia in search of employment elsewhere after graduation or specialization is not as high as in previous Croatian studies or studies conducted in other European countries. Even though these data may be encouraging, considering the lack of physicians in Croatia, interventions are needed to prevent permanent emigration to protect the future functioning of the Croatian health system. Furthermore, our study did not find significant associations between levels of introversion and ethnocentrism and tendency to emigrate from Croatia. It seems that the phenomenon covering the emigration of students is more complex and influenced by many other factors which were not included in our study.

The knowledge, attitudes and behaviors of hospital nurses on smoking cessation interventions: a cross-sectional study.

BACKGROUND: Smoking is a major public health problem in Croatia. It is unknown to what extent nurses in Croatia use interventions for smoking cessation to help their patients. This study aimed to analyze the knowledge, attitudes and behaviors of hospital nurses on smoking cessation interventions. METHODS: We conducted a cross-sectional study in Zagreb, Croatia, in 2022 on a convenient sample of hospital nurses. We collected data with a questionnaire that included sociodemographic questions and questions about the frequency of implementation of 5 A's (Ask, Advise, Assess, Assist, Arrange) interventions for smoking cessation during their work using the Helping Smokers Quit (HSQ) survey, participants' attitudes and knowledge about smoking cessation skills and the smoking status of the nurses. RESULTS: There were 824 nurses employed in the targeted departments; 258 nurses participated in the study (response rate: 31%). Among them, 43% responded that they always ask patients about their use of tobacco products. Only 2.7% indicated that they always help the patient to stop smoking. Very few (2%) attended any training in the past two years about helping patients to quit smoking, and 82% never had such training. 44% of the included nurses were smokers. Nurses who smoked stated more frequently than nonsmokers they should not be role models for their patients by avoiding smoking (P 0.001). Additionally, patients were less frequently questioned about their inability to stop smoking by nurses who smoked than nurses who did not smoke (P = 0.010). CONCLUSION: Even though smoking cessation interventions delivered by nurses were proven effective, such interventions are used by a small number of surveyed nurses. A small number of nurses have received training to help them support smokers in quitting. The high smoking prevalence among nurses may impact their attitudes and the implementation of workplace smoking cessation efforts.

Heterogeneity of outcomes in randomized controlled trials on implant prosthodontic therapy is hindering comparative effectiveness research: meta-research study.

BACKGROUND: Consistency in outcomes across clinical trials allows for comparing and combining results from different studies. A core outcome set (COS), representing a minimally agreed standardized group of outcomes that should be monitored and measured through research in a specific field of medicine, is not yet available for trials in implant prosthodontic (dental implant) therapy. This meta-research study aimed to analyze outcomes used in clinical trials on implant prosthodontic therapy. METHODS: We searched the Cochrane Oral Health Group (COHG) register to identify systematic reviews of interventions in implant prosthodontic therapy published by October 2023. From the randomized controlled trials (RCTs) included in the relevant reviews, we extracted data on the characteristics of the included trials and the outcomes used. We categorized outcomes into domains. RESULTS: From 182 systematic reviews in the COHG register, we included 11 systematic reviews on dental implant therapy. The reviews included 117 unique RCTs with 4725 participants, published from 1995 to 2020, which analyzed 74 different outcomes. Using different definitions, implant failure was analyzed in 73 RCTs. Seventeen RCTs did not define implant failure. Failure was most often (30 RCTs) followed up for one year. Only one RCT assessed implant failure after five years. Trials used 17 definitions of implant failure, while 17 trials did not report on the criteria of implant failure. Complications were analyzed in 48 RCTs, although they were not clearly defined in 12 RCTs. Failure of prosthodontic supra-structure was analyzed in 74 RCTs, with definitions of failure and criteria not clearly defined in 44 RCTs. Trials considered adverse events, peri-implant tissue health, patient attitudes, and other outcomes, including cost, aesthetics, or procedure duration. These outcomes were often different between trials. Twenty-six outcomes were used only once per study. CONCLUSIONS: Clinical trials in implant prosthodontics used different outcomes, different definitions of outcomes and used different times to monitor them. Standardization of outcomes is necessary to allow comparability and evidence synthesis about the effectiveness of implant prosthodontic therapy.

Adopting AMSTAR 2 critical appraisal tool for systematic reviews: speed of the tool uptake and barriers for its adoption.

BACKGROUND: In 2007, AMSTAR (A MeaSurement Tool to Assess systematic Reviews), a critical appraisal tool for systematic reviews (SRs), was published, and it has since become one of the most widely used instruments for SR appraisal. In September 2017, AMSTAR 2 was published as an updated version of the tool. This mixed-methods study aimed to analyze the extent of the AMSTAR 2 uptake and explore potential barriers to its uptake. METHODS: We analyzed the frequency of AMSTAR or AMSTAR 2 use in articles published in 2018, 2019 and 2020. We surveyed authors who have used AMSTAR but not AMSTAR 2 in the analyzed time frame to identify their reasons and barriers. The inclusion criterion for those authors was that the month of manuscript submission was after September 2017, i.e. after AMSTAR 2 was published. RESULTS: We included 871 studies. The majority (N = 451; 52%) used AMSTAR 2, while 44% (N = 382) used AMSTAR, 4% (N = 31) used R-AMSTAR and others used a combination of tools. In 2018, 81% of the analyzed studies used AMSTAR, while 16% used AMSTAR 2. In 2019, 52% used AMSTAR, while 44% used AMSTAR 2. Among articles published in 2020, 28% used AMSTAR, while AMSTAR 2 was used by 69%. An author survey indicated that the authors did not use AMSTAR 2 mostly because they were not aware of it, their protocol was already established, or data collection completed at the time when the new tool was published. Barriers towards AMSTAR 2 use were lack of quantitative assessment, insufficient awareness, length, difficulties with a specific item. CONCLUSION: In articles published in 2018-2020, that were submitted to a journal after AMSTAR 2 tool was published, almost half of the authors (44%) still used AMSTAR, the old version of the tool. However, the use of AMSTAR has been declining in each subsequent year. Our survey indicated that editors and peer-reviewers did not ask the authors to use the new version of the tool. Few barriers towards using AMSTAR 2 were identified, and thus it is anticipated that the use of the old version of AMSTAR will continue to decline.

Conclusiveness, linguistic characteristics and readability of Cochrane plain language summaries of intervention reviews: a cross-sectional study.

BACKGROUND: One of the most important formats to disseminate the evidence in health to different populations are Cochrane Plain Language Summaries (PLSs). PLSs should be written in a simplified language, easily understandable and providing clear message for the consumer. The aim of this study was to examine the extent to which PLSs are customized for lay persons, specifically by providing conclusive, comprehensible, and readable messages. METHODS: The study analyzed Cochrane PLSs of interventional studies (N = 4360) in the English language published from 1995 to 2019. We categorized the conclusiveness into one of the following categories: "positive", "positive inconclusive", "no evidence", "no opinion", "negative", "negative inconclusive", "unclear", "equal", "equal inconclusive". Language characteristics were analyzed using Linguistic Inquiry and Word Count (LIWC) software. The level of readability was measured by SMOG (Simple Measure of Gobbledygook) index, indicating the number of years of education required to read the text. For each PLS, we also collected the following data: Cochrane Review Network, year of publication and number of authors. RESULTS: Most of the PLSs (80%) did not have a conclusive message. In 53% PLSs there was no concluding opinion about the studied intervention or the conclusion was unclear. The most frequent conclusiveness category was "no opinion" (30%), and its frequency increased over time. The conclusiveness categories were similarly dispersed across Cochrane Networks. PLSs were written in an objective style, with high levels of analytical tone and clout above neutral, but a lower relation to authenticity and tone. The median number of years of non-specific education needed to read the PLSs was 14.9 (IQR 13.8 to 16.1), indicating that the person needs almost 15 years of general education to read the content with ease. CONCLUSION: Most of the Cochrane PLSs provided no concluding opinion or unclear conclusion regarding the effects of analyzed intervention. Analysis of readability indicated that they may be difficult to read for the lay population without medical education. Our results indicate that PLSs may not be so plain, and that the writing of Cochrane PLSs requires more effort. Tools used in this study could improve PLSs and make them better suited for lay audiences.

Standard of care for COVID-19 in randomized clinical trials registered in trial registries and published in preprint servers and scholarly journals: a cross-sectional study.

BACKGROUND: The concept of standard of care (SoC) treatment is commonly utilized in clinical trials. However, in a setting of an emergent disease, such as COVID-19, where there is no established effective treatment, it is unclear what the investigators considered as the SoC in early clinical trials. The aim of this study was to analyze and classify SoC reported in randomized controlled trial (RCT) registrations and RCTs published in scholarly journals and on preprint servers about treatment interventions for COVID-19. METHODS: We conducted a cross-sectional study. We included RCTs registered in a trial registry, and/or published in a scholarly journal, and/or published on preprint servers medRxiv and bioRxiv (any phase; any recruitment status; any language) that aim to compare treatment interventions related to COVID-19 and SoC, available from January 1, 2020, to October 8, 2020. Studies using "standard" treatment were eligible for inclusion if they reported they used standard, usual, conventional, or routine treatment. When we found such multiple reports of an RCT, we treated those multiple sources as one unit of analysis. RESULTS: Among 737 unique trials included in the analysis, 152 (21%) reported that SoC was proposed by the institutional or national authority. There were 129 (18%) trials that reported component(s) of SoC; the remaining trials simply reported that they used SoC, with no further detail. Among those 129 trials, the number of components of SoC ranged from 1 to 10. The most commonly used groups of interventions in the SoC were antiparasitics (62% of the trials), antivirals (57%), antibiotics (31%), oxygen (17%), antithrombotics/anticoagulants (14%), vitamins (13%), immunomodulatory agents (13%), corticosteroids (12%), analgesics/antipyretics (12%). Various combinations of those interventions were used in the SoC, with up to 7 different types of interventions combined. Posology, timing, and method of administration were frequently not reported for SoC components. CONCLUSION: Most RCTs (82%) about treatment for COVID-19 that were registered or published in the first 9 months of the pandemic did not describe the "standard of care" they used. Many of those interventions have, by now, been shown as ineffective or even detrimental.

Comparison of supervised exercise therapy with or without biopsychosocial approach for chronic nonspecific low back pain: a randomized controlled trial.

BACKGROUND: A biopsychosocial rehabilitation is recommended for chronic nonspecific low back pain (CNLBP); however, its effectiveness compared to the traditional supervised exercise therapy of CNLBP treatment is still unclear. METHODS: This was a parallel-group randomized controlled clinical trial. The sample consisted of 180 participants of both sexes, aged ≥18 years, with CNLBP for ≥3 months. Using web randomization and concealed allocation, they were assigned to three groups; graded activity receiving cognitive-behavioral therapy, group-based combined exercise therapy and education (GA; n = 59), supervised group-based combined exercise therapy and education (SET; n = 63), and a control group receiving usual care (n = 58). Interventions were administered for 4 weeks (8 sessions). The primary outcome was pain intensity. Outcome measures were collected baseline, after interventions (4 weeks), and during two follow-up periods (3 and 6 months). RESULTS: After the intervention, GA had a significant large effect on pain reduction compared to the control group (MD of 22.64 points; 95% CI = 16.10 to 29.19; p < 0.0001; Cohen's d = 1.70), as well as SET compared with the control group (MD of 21.08 points; 95% CI = 14.64 to 27.52; p < 0.0001; Cohen's d = 1.39), without significant difference between two intervention groups. At 3 and 6 months of follow-up, GA had a statistically significantly better effect in reducing pain, disability and fear-avoidance beliefs, and improving spinal extensor endurance, range of extension and quality of life compared to SET and the control group. A statistically significantly better effect of SET compared with the control group was found in reducing pain, disability, fear-avoidance beliefs, and improving the physical component of quality of life. Harms were not reported. CONCLUSION: This study suggests that graded activity and group-based supervised exercise therapy have beneficial effects over the control group in the treatment of CNLBP. The graded activity was more beneficial than supervised group-based exercise therapy only during the follow-up. TRIAL REGISTRATION: Clinicaltrials.gov (NCT04023162; registration date: 17/07/2019).

Anticipatory grief and experience of providing at-home palliative care among informal caregivers of spouses in Croatia: a qualitative study.

BACKGROUND: In palliative care, caring for spouses suffering from incurable diseases can provoke a range of reactions in informal caregivers that are part of the grieving process, as well as other reactions and ways of coping with a current role, which is often challenging. Anticipatory grief occurs before death and is often present in people who face the eventual loss of a loved one or their own death. This study aimed to gain insight into the anticipatory grief of informal caregivers who are providing at-home palliative care for their ill spouse. Our research questions focus on investigating the meanings caregivers ascribe to the experience of providing palliative care and the impending loss of a spouse. METHODS: A qualitative study was conducted in Zagreb, Croatia, from April to June of 2021. Eight participants took part in the study. Participants in the study were informal caregivers of a spouse suffering from an incurable, terminal disease that receives at-home palliative care. Data were collected through semi-structured face-to-face interviews. Transcripts were analyzed by interpretive phenomenological analysis. RESULTS: The analysis provided several meanings that represent caregivers' experiences and coping strategies. The caregivers bravely face the challenges of "living with an illness" by maintaining optimism, strong cohesion with their partner and a sense of joint destiny. They tend to repress their own personal needs and feelings while carrying the burden of care. Caregivers tend to stay positive and focus on living in the present by taking an active role in providing care for the ill spouse and family. CONCLUSIONS: Anticipatory grief presents emotional, cognitive, and spiritual challenges to spouse caregivers in palliative care. The contribution of this study was to gain insight into the meaning that caregivers ascribe to the experience and challenges they face while providing everyday care for their ill spouse. Confirming prior results, the experiences are generally similar to all caregivers, pointing to the need for substantial improvement in the quality of the support and help from the healthcare workers and other experts who provide palliative care and support for the patients' family members.

Web-Based Educational Intervention to Improve Knowledge of Systematic Reviews Among Health Science Professionals: Randomized Controlled Trial.

BACKGROUND: Lack of knowledge of systematic reviews (SRs) could prevent individual health care professionals from using SRs as a source of information in their clinical practice or discourage them from participating in such research. OBJECTIVE: In this randomized controlled trial, we evaluated the effect of a short web-based educational intervention on short-term knowledge of SRs. METHODS: Eligible participants were 871 Master's students of university health sciences studies in Croatia; 589 (67.6%) students who agreed to participate in the trial were randomized using a computer program into 2 groups. Intervention group A (294/589, 49.9%) received a short web-based educational intervention about SR methodology, and intervention group B (295/589, 50.1%) was presented with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) checklist. The participants' knowledge of SRs was assessed before and after the intervention. The participants could not be blinded because of the nature of the intervention. The primary outcome was the difference in the percentage of correct answers about SR methodology per participant between the groups after the intervention, expressed as relative risk and 95% CI. RESULTS: Results from 162 and 165 participants in the educational intervention and PRISMA checklist groups, respectively, were available for analysis. Most of them (educational intervention group: 130/162, 80.2%; PRISMA checklist group: 131/165, 79.4%) were employed as health care professionals in addition to being health sciences students. After the intervention, the educational intervention group had 23% (relative risk percentage) more correct answers in the postintervention questionnaire than the PRISMA checklist group (relative risk=1.23, 95% CI 1.17-1.29). CONCLUSIONS: A short web-based educational intervention about SRs is an effective tool for short-term improvement of knowledge of SRs among health care studies students, most of whom were also employed as health care professionals. Further studies are needed to explore the long-term effects of the tested education. TRIAL REGISTRATION: OSF Registries 10.17605/OSF.IO/RYMVC; https://osf.io/rymvc.

Creating an online educational intervention to improve knowledge about systematic reviews among healthcare workers: mixed-methods pilot study.

BACKGROUND: Lack of knowledge about systematic reviews (SRs) could prevent individual healthcare workers (HCWs) from using SRs as a source of information in their clinical practice or discourage them from participating in such research. In this study, we aimed to explore in-depth the opinion of a sample of HCWs about the newly created online educational intervention designed to improve knowledge about SRs. METHODS: We created a brief online educational intervention on SRs, consisting of 11 textual modules. We evaluated it among practicing HCWs who graduated from a university-level health sciences program using a mixed-methods pilot study that consisted of pre- and post-intervention questionnaires and qualitative evaluation via semi-structured interviews. We assessed participants' knowledge about SR methodology before and after the intervention, and compared the responses. We sought their opinions about the characteristics of SRs. Also, the participants were presented with four scientific abstracts, where they were asked to distinguish whether those abstracts presented summaries of a systematic or a non-systematic review. RESULTS: Twelve participants took part in the study. In the pilot study, the participants' knowledge about SRs was improved after the intervention compared to the baseline. Participants provided positive feedback regarding the educational intervention. Suggestions to improve the educational intervention were to provide more details about the forest plot, add more digital content or images, provide more details about the methodological steps of an SR, add descriptions about practical applications of SRs and provide links to additional educational materials. The participants suggested that HCWs could be motivated to take part in such an education if it is offered as continuing medical education (CME) course or credit for academic/career advancement. CONCLUSION: HCWs provided positive feedback about the newly designed online educational intervention on SRs; they considered it an appropriate tool for learning about SRs and resulted in increased knowledge about SRs. In addition, participants gave suggestions for improving education, which can be used to tailor the education for end-users. In future studies, it would be useful to examine the effectiveness of the modified educational intervention on increasing knowledge in a larger sample and in the form of a randomized controlled trial.

Emotional Intelligence and Degree of Education of Healthcare Professionals in Emergency Medicine.

BACKGROUND: Emotional intelligence (EI) includes two major skills: managing oneself and successful cooperation with others. Healthcare workers are exposed to numerous work stressors, such as limited resources, organizational challenges, complex diseases, etc. EI can help healthcare workers to better cope with the demands of their work. This study aimed to analyze whether there is an association between emotional intelligence and the degree of education of healthcare professionals working in emergency medicine. SUBJECTS AND METHODS: The study was conducted among healthcare personnel employed in in-hospital and out-of-hospital emergency departments in Croatia. EI was measured using the Emotional Skills & Competence Questionnaire (ESCQ-45). RESULTS: Of the 137 eligible participants, 97 (71%) accepted to participate. Emotional intelligence was not significantly associated with the respondents' education. Healthcare personnel employed in the in-hospital emergency department and women had higher emotional competence than workers from out-of-hospital emergency departments and men. There was no significant association between EI and the age of respondents. CONCLUSION: EI of employed adults is an individual characteristic that does not depend on the educational level or degree. It would be worthwhile to explore further whether there are significant differences between the EI of healthcare workers in various settings within the health system and invest resources in increasing EI in settings with a lower EI.

FEASIBILITY OF THE MULTIMODAL SMOKING CESSATION INTERVENTION DURING HOSPITALIZATION WITH SIX-MONTH FOLLOW-UP POST-DISCHARGE: A PILOT STUDY.

The main aim of this pilot project was to introduce multimodal smoking cessation intervention in the hospital setting and to analyze users' satisfaction and efficacy of the intervention within six months post-discharge. Multimodal intervention for smoking cessation was used and it consisted of the "5 A's" model (Ask, Advice, Assess, Assist, Arrange) for behavior change, printed self-help materials for smoking cessation, and telephone counseling (one, three and six months after discharge from the hospital). The main outcome of the study was smoking status at six months. A total of 103 participants were included in this pilot project. At six-month follow-up, 49% of participants self-reported continuous non-smoking. Among the remaining participants, 20 reported smoking reduction, 19 were still smoking, and 16 participants were unable to make contact with. In the logistic regression, among all analyzed variables, only two of them were positively associated with smoking cessation after six months: participants' response that they would like to quit smoking within the next six months (B=4.688; p=0.018) and answering that they did not smoke when they were ill and bed-ridden due to illness (B=3.253; p=0.020). Satisfaction with the intervention was very high; 70% of participants rated the intervention as 'excellent'. Therefore, multimodal smoking cessation intervention can be successfully introduced at hospital setting yielding high smoking abstinence rates at six months post-discharge and high level of user satisfaction. Healthcare workers who work in hospitals should be educated so they can provide such intervention on a regular basis.

Replication of 15 loci involved in human plasma protein N-glycosylation in 4802 samples from four cohorts.

Human protein glycosylation is a complex process, and its in vivo regulation is poorly understood. Changes in glycosylation patterns are associated with many human diseases and conditions. Understanding the biological determinants of protein glycome provides a basis for future diagnostic and therapeutic applications. Genome-wide association studies (GWAS) allow to study biology via a hypothesis-free search of loci and genetic variants associated with a trait of interest. Sixteen loci were identified by three previous GWAS of human plasma proteome N-glycosylation. However, the possibility that some of these loci are false positives needs to be eliminated by replication studies, which have been limited so far. Here, we use the largest set of samples so far (4802 individuals) to replicate the previously identified loci. For all but one locus, the expected replication power exceeded 95%. Of the 16 loci reported previously, 15 were replicated in our study. For the remaining locus (near the KREMEN1 gene), the replication power was low, and hence, replication results were inconclusive. The very high replication rate highlights the general robustness of the GWAS findings as well as the high standards adopted by the community that studies genetic regulation of protein glycosylation. The 15 replicated loci present a good target for further functional studies. Among these, eight loci contain genes encoding glycosyltransferases: MGAT5, B3GAT1, FUT8, FUT6, ST6GAL1, B4GALT1, ST3GAL4 and MGAT3. The remaining seven loci offer starting points for further functional follow-up investigation into molecules and mechanisms that regulate human protein N-glycosylation in vivo.