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Ivana Vuka,1 Tihana Marciuš,1 Damir Kovačić,2 Antonio Šarolić,3 Livia Puljak,4,* Damir Sapunar1,* 1Laboratory for Pain Research, University of Split School of Medicine, Split, Croatia; 2Laboratory for Biophysics and Medical Neuroelectronics, University of Split Faculty of Science, Split, Croatia; 3Laboratory for Applied Electromagnetics (EMLab), FESB, University of Split, Split, Croatia; 4Centre for Evidence-Based Medicine and Health Care, Catholic University of Croatia, Zagreb, Croatia*These authors contributed equally to this workCorrespondence: Damir SapunarLaboratory for Pain Research, University of Split School of Medicine, Šoltanska 2, Split, 21000, CroatiaTel +385 21-557-809Email ds@mefst.hrObjective: This was a proof of concept study, based on systematic reviews of the efficacy and safety of the dorsal root ganglion (DRG) stimulation. The main objective was to develop an implantable, programmable, and wireless device for electrical stimulation of DRG and a methodology that can be used in translational research, especially to understand the mechanism of neuromodulation and to test new treatment modalities in animal models of pain.Methods: We developed and tested a stimulator that uses a battery-powered microelectronic circuit, to generate constant current square biphasic or monophasic pulsed waveform of variable amplitudes and duration. It is controlled by software and an external controller that allows radio frequency communication with the stimulator. The stimulator was implanted in Sprague–Dawley (SD) rats. The lead was positioned at the L5 DRG level, while the stimulator was placed in the skin pocket at the ipsilateral side. Forty-five animals were used and divided into six groups: spinal nerve ligation (SNL), chronic compression injury of the DRG (CCD), SNL + active DRG stimulation, intact control group, group with the implanted sham stimulator, and sham lead. Behavioral testing was performed on the day preceding surgery and three times postoperatively (1st, 3rd, and 7th day).Results: In animals with SNL, neurostimulation reduced pain-related behavior, tested with pinprick hyperalgesia, pinprick withdrawal test, and cold test, while the leads per se did not cause DRG compression. The rats well tolerated the stimulator. It did not hinder animal movement, and it enabled the animals to be housed under regular conditions.Conclusion: A proof-of-concept experiment with our stimulator verified the usability of the device. The stimulator enables a wide range of research applications from adjusting stimulation parameters for different pain conditions, studying new stimulation methods with different frequencies and waveforms to obtain knowledge about analgesic mechanisms of DRG stimulation.Keywords: neurostimulation, implantable stimulator, DRG, SNL, pain-related behavior

Ivana Vuka,1 Tihana Marciuš,1 Svjetlana Došenović,2 Lejla Ferhatović Hamzić,3 Katarina Vučić,4 Damir Sapunar,1,5,* Livia Puljak5,* 1Laboratory for Pain Research, University of Split School of Medicine, 21000 Split, Croatia; 2Department of Anesthesiology, Reanimatology and Intensive Care, University Hospital Split, 21000 Split, Croatia; 3Department for Proteomics, Center for Translational and Clinical Research, University of Zagreb School of Medicine, 10000 Zagreb, Croatia; 4Department for Safety and Efficacy Assessment of Medicinal Products, Agency for Medicinal Products and Medical Devices, 10000 Zagreb, Croatia; 5Center for Evidence-Based Medicine and Health Care, Catholic University of Croatia, 10000 Zagreb, Croatia *These authors contributed equally to this work Objective: We conducted a systematic review about patient selection, efficacy, and safety of neuromodulation with electrical field stimulation (EFS) of dorsal root ganglion (DRG) in various painful conditions. We also analyzed conclusion statements as well as conflict of interest and financing of the included studies.Methods: All study designs were eligible for inclusion. We searched MEDLINE, CINAHL, Embase, PsycINFO, and clinical trial registries until September 7, 2018. We assessed risk of bias by using Cochrane tool for randomized controlled trials (RCTs).Results: Among the 29 included studies, only one was RCT, majority being case series and case reports. The evidence is based on studies with small number of participants (median: 6, range 1–152) with various painful conditions. Neuromodulation with EFS of DRG was mostly performed in participants who have failed other treatment modalities. Most of the authors of the included studies reported positive, but inconclusive, evidence regarding efficacy of neuromodulation with EFS of DRG. Meta-analysis was not possible since only one RCT was included.Conclusion: Available evidence suggest that neuromodulation with EFS of DRG may help highly selected participants with various pain syndromes, who have failed to achieve adequate pain relief with other pharmacological and nonpharmacological interventions. However, these findings should be confirmed in high-quality RCTs with sufficient numbers of participants. Keywords: DRG, pain, neuropathic pain, chronic pain, neurostimulation, electrical stimulation

Livia Puljak1,2 1Laboratory for Pain Research, University of Split School of Medicine, Split, Croatia; 2Department for Development, Research and Health Technology Assessment, Agency for Quality and Accreditation in Health Care and Social Welfare, Zagreb, CroatiaOn October 16, 2017 in the Journal of Pain Research, a randomized controlled trial (RCT) comparing efficacy and safety of flupirtine versus piroxicam in postoperative pain in patients undergoing lower limb surgery was published.1 However, this paper fails to report important information. Author’s reply Sowmya Chinnaiyan,1 Narayana Sarala,1 Heddur Shanthappa Arun21Department of Pharmacology, 2Department of Orthopedics, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Kolar, Karnataka, India We thank Livia Puljak for the valuable insights on the article titled “A comparative study of efficacy and safety of flupirtine versus piroxicam in postoperative pain in patients undergoing lower limb surgery” published in the Journal of Pain Research. The concerns highlighted in the Letter to the Editor have been answered.View the original paper by Chinnaiyan and colleagues.

Marina Biocic,1 Dijana Vidosevic,2 Matija Boric,1,3 Teo Boric,4 Lovel Giunio,2 Damir Fabijanic,2 Livia Puljak1,5 1Laboratory for Pain Research, University of Split School of Medicine, 2Department of Cardiology, 3Department of Abdominal Surgery, 4Department of Vascular Surgery, University Hospital Split, Split, 5Department for Development, Research and Health Technology Assessment, Agency for Quality and Accreditation in Health Care and Social Welfare, Zagreb, Croatia Background: The degree of pain caused by the implantation of cardiac electronic devices (CEDs) and the type of anesthesia or perioperative pain management used with the procedure have been insufficiently studied. The aim of this study was to analyze perioperative pain management, as well as intensity and location of pain among patients undergoing implantation of CED, and to compare the practice with published guidelines. Patients and methods: This was a combined retrospective and prospective study conducted at the tertiary hospital, University Hospital Split, Croatia. The sample included 372 patients who underwent CED implantation. Perioperative pain management was analyzed retrospectively in 321 patients who underwent CED implantation during 2014. In a prospective study, intensity and location of pain before, during, and after the procedure were measured by using a numerical rating scale (NRS) ranging from 0 to 10 in 51 patients at the same institution from November 2014 to August 2015. Results: A quarter of patients received analgesia or sedation before surgery. All the patients received local lidocaine anesthesia. After surgery, 31% of patients received pain medication or sedation. The highest pain intensity was observed during CED implantation with the highest NRS pain score being 8. Some patients reported severe pain (NRS >5) also at 1, 3, 6, 8, and 24 hours after surgery. The most common pain locations were surgical site, shoulder, and chest. Adherence to guidelines for acute perioperative pain management was insufficient. Conclusion: Patients may experience severe pain during and after CED implantation. Perioperative pain management was suboptimal, and higher doses of sedation and intensive analgesia are required. Guidelines for acute perioperative pain management and anesthesia during CED implantation should be developed. Keywords: cardiac electronic devices, perioperative pain management, postoperative pain, analgesics, pain intensity, guidelines

Filipa Markotic,1 Davorka Vrdoljak,2 Marijana Puljiz,3 Livia Puljak,4 1Centre for Clinical Pharmacology, University Clinical Hospital Mostar, Mostar, Bosnia and Herzegovina; 2Department of Family Medicine, University of Split School of Medicine, Split, 3Family Medicine Clinic, Health Centre Imotski, Kamenmost, 4Laboratory for Pain Research, University of Split School of Medicine, Split, Croatia Background: One form of self-medication is sharing of medications, defined as borrowing or lending medications in situations where the receiver of these drugs is not the individual to whom the medications were allocated. Objective: To explore experiences and opinions of patients about sharing prescription analgesics, reasons for sharing prescription analgesics, the way in which patients choose to share those medications, their awareness of risk regarding sharing prescription analgesics, and how they estimated the potential risk.Methods: This qualitative study was conducted by focus group discussions with 40 participants led by a moderator trained in focus group methodology using a semi-structured moderator guide. Adults aged ≥18 years who had received a prescription for an analgesic at least once in a lifetime were included. Six separate focus groups were conducted to discuss participants’ perception of risks associated with sharing of prescription analgesics among patients. Additionally, participants filled out two questionnaires on demographic data, their own behavior regarding sharing analgesics, and their attitudes about risks associated with sharing prescription analgesics.Results: In a questionnaire, 55% of the participants indicated that they personally shared prescription analgesics, while subsequently in the focus group discussions, 76% confessed to such behavior. Participants recognized certain risks related to sharing of prescription analgesics, mentioned a number of reasons for engaging in such behavior, and indicated certain positive aspects of such behavior. Forty-five percent of the participants indicated that sharing prescription analgesics is riskier than sharing nonprescription analgesics.Conclusion: There is a prevalent attitude among participants that sharing prescription analgesics is a positive behavior, where potential benefits outweigh risks. Keywords: pain, self-medication, drugs, risk awareness, risk estimation

Krste Boric,1 Matija Boric,1,2 Teo Boric,3 Livia Puljak1 1Laboratory for Pain Research, University of Split School of Medicine, Split, Croatia; 2Department of Abdominal Surgery, 3Department of Vascular Surgery, University Hospital Split, Split, Croatia Background: Inadequate treatment of pain related to surgery may be associated with complications and prolonged recovery time and increased morbidity and mortality rates. We investigated perioperative pain management in vascular surgery and compared it with the relevant guidelines for the treatment of perioperative pain. Methods: We conducted a retrospective study on 501 patients who underwent vascular surgery at the University Hospital Split, Croatia. We collected the following data from patients’ charts: age, gender, premedication, preoperative patient’s physical status, type of surgery, duration of surgery and anesthesia, type of anesthesia, postoperative analgesia, and need for intensive care. We examined departmental procedures to assess adherence to guidelines for perioperative pain management. Results: None of the 501 patients’ charts recorded information about perioperative pain intensity, 28% of patients did not receive any medication the night before their elective surgical procedures, and 17% of patients did not receive premedication immediately before the procedure. Most patients (66%) did not receive any pain medication in the operating room after surgery. Following surgery, 36% of patients were monitored in the intensive care units, while the rest were released to the ward. Some patients (17%) did not receive any analgesia after surgery. Procedures at the department did not adhere to the current recommendations for perioperative pain management. Conclusion: The study indicates that management of surgery-related pain in complex vascular procedures at this hospital did not follow guidelines for the management of acute perioperative pain. Our finding that most patients did not receive appropriate analgesia after vascular surgery leads to the conclusion that the institution would benefit from developing guidelines for the management of acute perioperative pain, which should be applied in all cases. Keywords: perioperative pain, postoperative pain, vascular surgery, pain management, anesthesia, analgesia

Filipa Markotic,1 Livia Puljak2 1Centre for Clinical Pharmacology, University Clinical Hospital Mostar, Mostar, Bosnia and Herzegovina; 2Laboratory for Pain Research, University of Split School of Medicine, Split, Croatia Background: Understanding and improving patient safety is a key issue in medicine. One of the potential threats to patient safety is the sharing of medication among patients, which is a form of self-medication. This study analyzed experiences and attitudes of pain management physicians (PMPs) about sharing prescription analgesics among patients.Methods: This qualitative study was conducted by semi-structured interviews among PMPs employed in Croatian pain clinics. The study involved two researchers and 15 PMPs.Results: Among PMPs, 80% have seen patients who share their prescription analgesics with other patients for whom prescription is not intended. Most PMPs consider prescription analgesics sharing a risky and negative behavior. Some of them, however, found certain positive aspects associated to it, such as being a benevolent behavior, helping patients to get medications when they need them, and helping them cope with pain.Conclusion: The majority of physicians specialized in pain management encountered patients sharing prescription analgesics. Most of them considered this as risky behavior with a number of potential consequences. It has been noted that this problem is neglected and that physicians should inquire about medication sharing. Direct-to-consumers advertising was perceived as a factor contributing to such behavior. Patient education and more involvement of physicians in identifying this behavior were cited as potential remedies for preventing sharing of prescription analgesics. Keywords: analgesics, sharing, lending, borrowing, risks

Tonci Brkovic,1 Eliana Burilovic,2 Livia Puljak3 1Department of Internal Medicine, Division of Nephrology, 2Department of Psychiatry, University Hospital Split, 3Department of Anatomy, Histology and Embryology, Laboratory for Pain Research, University of Split School of Medicine, Split, Croatia Objectives: Understanding the epidemiology of pain in patients on hemodialysis (HD) is crucial for further improvement in managing pain. The aim of this study was to systematically review available evidence on the prevalence and severity of pain in adult end-stage renal disease patients on chronic intermittent HD. Materials and methods: We carried out a systematic review of the literature and developed a comprehensive search strategy based on search terms on pain and HD. We searched the databases MEDLINE, Scopus, PsycINFO, and CINAHL from the earliest date of each database to July 24, 2014. Manuscripts in all languages were taken into consideration. Two authors performed each step independently, and all disagreements were resolved after discussion with the third author. The quality of studies was estimated using the STROBE checklist and Cochrane risk-of-bias tool.Results: We included 52 studies with 6,917 participants. The prevalence of acute and chronic pain in HD patients was up to 82% and 92%, respectively. A considerable number of patients suffered from severe pain. Various locations and causes of pain were described, with most of the studies reporting pain in general, pain related to arteriovenous access, headache, and musculoskeletal pain.Conclusion: The findings of this systematic review indicate high prevalence of pain in HD patients and considerable gaps and limitations in the available evidence. Pain in this population should be recognized as a considerable health concern, and the nephrology community should promote pain management in HD patients as a clinical and research priority to improve patients’ quality of life and pain-related disability. Keywords: pain, hemodialysis, prevalence, intensity, epidemiology

Mladen Lesin,1,* Mirna Dzaja Lozo,1,* Zeljka Duplancic-Sundov,1 Ivana Dzaja,1 Nikolina Davidovic,2 Adriana Banozic,3 Livia Puljak3 1Department of Ophthalmology, 2Department of Psychiatry, University Hospital Split, 3Laboratory for Pain Research, University of Split School of Medicine, Split, Croatia *These authors contributed equally to this work Background: Risk factors associated with postoperative pain intensity and duration, as well as consumption of analgesics after ophthalmic surgery are poorly understood. Methods: A prospective study was conducted among adults (N=226) who underwent eye surgery at the University Hospital Split, Croatia. A day before the surgery, the patients filled out questionnaires assessing personality, anxiety, pain catastrophizing, sociodemographics were given and details about the procedure, anesthesia, and analgesia for each postoperative day. All scales were previously used for the Croatian population. The intensity of pain was measured using a numerical rating scale from 0 to 10, where 0 was no pain and 10 was the worst imaginable pain. The intensity of pain was measured before the surgery and then 1 hour, 3 hours, 6 hours, and 24 hours after surgery, and then once a day until discharge from the hospital. Univariate and multivariate analyses were performed. Results: A multivariate analysis indicated that independent predictors of average pain intensity after the surgery were: absence of premedication before surgery, surgery in general anesthesia, higher pain intensity before surgery and pain catastrophizing level. Independent predictors of postoperative pain duration were intensity of pain before surgery, type of anesthesia, and self-assessment of health. Independent predictors of pain intensity ≥5 during the first 6 hours after the procedure were the type of procedure, self-assessment of health, premedication, and the level of pain catastrophizing. Conclusion: Awareness about independent predictors associated with average postoperative pain intensity, postoperative pain duration, and occurrence of intensive pain after surgery may help health workers to improve postoperative pain management in ophthalmic surgery. Keywords: postoperative pain, factors, personality, psychology, affect, pain catastrophizing, sociodemographics

Darko Krnic,1 Andrea Anic-Matic,2 Svjetlana Dosenovic,2 Pero Draganic,1 Sasa Zezelic,1 Livia Puljak2 1Agency for Medicinal Products and Medical Devices, Zagreb, 2Laboratory for Pain Research, School of Medicine, University of Split, Split, Croatia Background: The increased consumption of analgesics has been documented worldwide during the last 2 decades. The aim of the study was to examine the trends in opioid and nonopioid analgesic consumption in Croatia between 2007 and 2013. Methods: Data on opioid consumption were extracted from the database of the national authority. All opioid and nonopioid analgesics were included in the analysis. Data were presented as defined daily doses per 1,000 inhabitants per day. Adequacy of opioid consumption was calculated using adequacy of consumption measure. Results: During the examined 7-year period, the total consumption and total cost of all analgesics in Croatia showed continuous increase. In the M01A group (anti-inflammatory and antirheumatic products, nonsteroids), ibuprofen had an exponential increasing trend, and in 2011, it overtook diclofenac consumption. Ibuprofen and diclofenac had the highest consumption also in the M02A group of topical products for joint and muscular pain. Tramadol was by far the most consumed type of opioids (N02A group) and paracetamol in the group of other analgesics and antipyretics (N02B). The adequacy of consumption measure value was 0.19, indicating that Croatia is a country with a low opioid consumption. Conclusion: Between 2007 and 2013, both consumption of analgesics and their cost in Croatia had an increasing trend. Comparisons with data from other countries, based on the published literature, indicate that analgesic consumption in Croatia is still relatively low. Calculation of the adequacy of opioid consumption indicated that Croatia is a country with low opioid consumption. Further studies are necessary for establishing whether current analgesic consumption in Croatia corresponds to patient needs. Keywords: pain, analgesic agents, prescription opioids, drug utilization, adequacy

Eliana Brković,1 Katarina Novak,2,3 Livia Puljak3 1Department of Psychiatry, 2Department of Internal Medicine, Division of Cardiology, 3Laboratory for Pain Research, University of Split School of Medicine, Split, Croatia Background: The aim of the study was to analyze the most recent trends in myocardial infarction (MI) care, the number of patients treated for MI and their outcomes, cardiovascular disease risk factors, and pain-to-hospital times in MI patients. Subjects and methods: For 778 patients treated for acute MI at the Coronary Care Unit (CCU) of University Hospital Split, Croatia the following data were acquired: outcome during hospitalization (survived, deceased), cardiovascular risk factors (hypertension, diabetes, dyslipidemia, previous MI, smoking), and pain-to-CCU time. Results: Among 778 patients treated for acute MI, there were 291 (37%) women and 487 (63%) men. Forty-five patients (6%) died during hospitalization, mostly due to cardiogenic shock. An association was found between early intrahospital mortality and the following risk factors: age >70 years, female sex, previous MI, and smoking. Median pain-to-call time was 2 hours, and median time from the onset of pain to arrival into the CCU was 4 hours. There were 59 (7.6%) patients admitted to the CCU within recommended 90 minutes. Diabetic comorbidity was not associated with early death or with longer time from pain to emergency calls. Conclusion: Some of the risk factors associated with adverse outcomes in MI are modifiable. Prehospital delay of 4 hours observed in patients who suffered an MI is too long, and more effort should be devoted to investments in health care and education of the general public regarding chest pain symptoms. Keywords: prehospital delay, ischemic heart disease

Anka Coric,1 Adriana Banozic,2 Miro Klaric,3 Katarina Vukojevic,4 Livia Puljak5 1School of Medicine, University of Mostar, Health Center Mostar, Mostar, Bosnia and Herzegovina; 2Laboratory for Pain Research, University of Split School of Medicine, Split, Croatia; 3Department of Psychiatry, School of Medicine, University of Mostar, Mostar, Bosnia and Herzegovina; 4Department of Anatomy, University of Split School of Medicine, Split, Croatia; 5Laboratory for Pain Research, University of Split School of Medicine, Split, Croatia Abstract: An association between dental fear and anxiety (DFA) has been confirmed for children younger than 8 years, but this association in older children is less clear. The aim of this study was to fill this knowledge gap by studying DFA in older children and their parents with validated measures. This cross-sectional study, conducted at Community Health Centre Mostar, Bosnia and Herzegovina, included 114 children and their parents. DFA, coping, and sociodemographic variables were studied using Corah Dental Anxiety Questionnaire (CDAS), Dental Subscale of the Children's Fear Survey Schedule (CFSS-DS), Dental Cope Questionnaire, and sociodemographic questionnaire. Maternal CDAS scores had significant positive correlation with child DFA measured with CFSS-DS (r=0.35, P

Damir Sapunar, Sandra Kostic, Adriana Banozic, Livia PuljakDepartment of Anatomy, Histology, and Embryology, University of Split Medical School, Soltanska 2, 21000 Split, CroatiaAbstract: A regional approach can protect our patients from often unacceptable adverse effects produced by systematically applied drugs. Regional therapeutic approaches, as well as interventions at the level of the peripheral nervous system and particularly the dorsal root ganglion (DRG), represent an alternative to the systemic application of therapeutic agents. This article provides an overview of DRG anatomical peculiarities, explains why the DRG is an important therapeutic target, and how animal models of targeted drug delivery can help us in the translation of basic research into clinical practice.Keywords: dorsal root ganglion, neuropathic pain, pain therapy, targeted drug delivery

Background: Conference abstracts are a potential source of new and relevant information about randomized controlled trials (RCTs). However, their dependability is questionable. The objectives of this study were to quantify the agreement between results of RCTs reported in abstracts presented at the four most recent World Congresses on Pain (WCP) and their corresponding full publications, and to analyse the completeness of reporting in those abstracts.Methods: To identify RCTs, we screened all abstracts presented at four WCPs from 2008 to 2014. Two independent authors identified corresponding full-text reports published through August 2016. Data about the main outcomes in each abstract and full publication were extracted, including the outcome domains and numerical results reported. We reported discordance between abstracts and full texts. We evaluated abstracts against the CONSORT for Abstracts checklist.Results: Approximately half of the 614 included abstracts had been fully published. Among the 306 abstract/publication pairs, eight pairs were not evaluable, and in the remaining 298 we found some form of discordance in 31% of the cases; the majority of discordances were quantitative, i.e. numerical results were different in the two locations, but with the same direction of effect. In the abstract-publication pairs where the abstract presented only preliminary/interim results, 79% had some form of discordance, mostly quantitative.Conclusions: The reporting quality of the 614 abstracts was suboptimal; the median adherence across all domains for all abstracts was 26%. In conclusion, conference abstracts of pain research are often not necessarily dependable information. Authors should be required to report abstracts according to reporting guidelines.Significance: Abstracts of RCTs addressing pain are not often dependable information sources; half of them are not published, their reporting quality is suboptimal. When published, 30% of abstracts-full text pairs have discordant results, with 78% discordance when abstracts present preliminary results. [ABSTRACT FROM AUTHOR]

Objective: To analyse the frequency of nonrecreational prescription analgesic sharing, associated factors and differences between lenders and borrowers.Methods: A cross-sectional study was conducted in 10 outpatient family medicine practices in Croatia amongst 1000 patients to whom their physicians have prescribed analgesics at least once in their lives. A questionnaire was used to collect data about patients' pain intensity, prescription analgesic sharing habits, factors associated with this behaviour, perception of risks associated with the conduct and demographic data. Logistic regression was conducted to analyse independent factors associated with lending and borrowing prescription analgesics.Results: We found that 61% of patients in family medicine practices engage in sharing prescription analgesics, whether it was lending (42%) and/or borrowing (54%). Independent predictors of lending prescription analgesics were as follows: history of sharing prescription medication other than analgesics, providing information regarding the medication alongside the prescription medication itself, not reading package insert that accompanies medication, subjective perception of personal health and decreased awareness of personal harm associated with prescription analgesic sharing. Independent predictors of prescription analgesic borrowing were as follows: younger age, communicating details regarding the medication that was given, scanning of package insert accompanying the medication, biased subjective perception of personal health and perceiving alternative medicine as a safer option over conventional medicine.Conclusions: Sharing prescription analgesics is highly prevalent amongst patients in family medicine. Healthcare providers should remain alert by routinely questioning patients regarding such behaviours. Preventive interventions should be conceived and established.Significance: Sharing of prescription analgesics is a highly prevalent behaviour amongst pain patients, and there exist independent factors associated with such conduct. This information can be useful in the design of interventions aimed at mitigating analgesic sharing behaviour in the future. [ABSTRACT FROM AUTHOR]

Background: Women are underrepresented in the higher levels of appointment in academic medicine, despite the so-called feminization of medicine. Purpose: A 27-year (1979-2006) retrospective study was conducted regarding the success and advancement of women and men at the University of Split School of Medicine in Croatia. Methods: Data were collected from the school's archive, including number of women and men among applicants, enrollees, graduates, teachers, department chairs and the school management: high school grade averages and admission tests scores by applicant gender and gender-based graduation grade averages. The number and gender patterns of all employed and unemployed physicians in the Split-Dalmatia county were also collected. Results: Men represent the minority among applicants, enrollees, and graduates, whereas women were in the minority among faculty, department chairs, and the school management across all 27 years. Graduation grades from high school and medical school showed that women were statistically better students, although the difference was slight. In the same geographic area, women are more often unemployed and less likely to specialize. Conclusions: More women are applying, enrolling and graduating from the University of Split School of Medicine. Women also perform statistically better on entrance exam and have better graduation grades, yet they remain a minority in faculty and leadership positions. A review of county-wise employment statistics revealed that women were more frequently unemployed and less likely to specialize in this study. [ABSTRACT FROM AUTHOR]

Background: Clinical practice guidelines (CPGs) are designed to assist health care professionals in medical decision-making, but they often lack effective integration of shared decision-making (SDM) principles to reflect patient values and preferences, particularly in the context of preference-sensitive CPG recommendations. To address this shortcoming and foster SDM through CPGs, the integration of patient decision aids (PDAs) into CPGs has been proposed as an important strategy. However, methods for systematically identifying and prioritizing CPG recommendations relevant to SDM and related decision support tools are currently lacking., Objective: The aim of the project is to develop (1) a tool for systematically identifying and prioritizing CPG recommendations for which SDM is considered particularly relevant and (2) a platform for PDAs to support practical SDM implementation., Methods: The project consists of 6 work packages (WPs). It is embedded in the German health care context but has an international focus. In WP 1, we will conduct a scoping review in bibliographic databases and gray literature sources to identify methods used to foster SDM via PDAs in the context of CPGs. In WP 2, we will conduct semistructured interviews with CPG experts to better understand the concepts of preference sensitivity and identify strategies for fostering SDM through CPGs. WP 3, a modified Delphi study including surveys and focus groups with SDM experts, aims to define and operationalize preference sensitivity. Based on the results of the Delphi study, we will develop a methodology for prioritizing key questions in CPGs. In WP 4, the tool will be developed. A list of relevant items to identify CPG recommendations for which SDM is most relevant will be created, tested, and iteratively refined, accompanied by the development of a user manual. In WP 5, a platform for creating and digitizing German-language PDAs will be developed to support the practical application of SDM during clinical encounters. WP 6 will conclude the project by testing the tool with newly developed and revised CPGs., Results: The Brandenburg Medical School Ethics Committee approved the project (165122023-ANF). An international multidisciplinary advisory board is involved to guide the tool development on CPGs and SDM. Patient partners are involved throughout the project, considering the essential role of the patient perspective in SDM. As of February 20, 2024, we are currently assessing literature references to determine eligibility for inclusion in the scoping review (WP 1). We expect the project to be completed by December 31, 2026., Conclusions: The tool will enable CPG developers to systematically incorporate aspects of SDM into CPG development, thereby providing guideline-based support for the patient-practitioner interaction. Together, the tool for CPGs and the platform for PDAs will create a systematic link between CPGs, SDM, and PDAs, which may facilitate SDM in clinical practice., International Registered Report Identifier (irrid): DERR1-10.2196/57611., (©Lena Fischer, Fülöp Scheibler, Corinna Schaefer, Torsten Karge, Thomas Langer, Leon Vincent Schewe, Ivan D Florez, Andrew Hutchinson, Sheyu Li, Marta Maes-Carballo, Zachary Munn, Lilisbeth Perestelo-Perez, Livia Puljak, Anne Stiggelbout, Dawid Pieper. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 04.11.2024.)

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., (© 2024. The Author(s).)

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., (© 2024. The Author(s).)

Introduction: There is unmet need in the treatment of ovarian and testicular germ cell tumors (GCTs). This study analyzed registered trials of interventions for GCTs., Materials and Methods: We included trials of interventions for GCTs registered on ClinicalTrials.gov by July 29, 2022. We analyzed their interventions, outcome measures and study design., Results: We included 142 trials registrations; 42 (30 %) for ovarian GCTs, 50 (35 %) for testicular GCTs, and 50 (35 %) trials for both. The majority of the trials were completed (56 %) and did not have results available (75 %). Most trials were in Phase 2. Information about the study design were not reported for many analyzed trials. Most trials had a single-group assignment (44 %) and were open-label (68 %). The median planned number of enrolled participants was 43. Most registrations used medicine(s) (87 %), either as a single type of intervention or in combination. The most commonly used type of medicine was chemotherapy (54 %). Primary outcome was not reported in 23 % of registrations, and secondary outcomes were not reported in 35 % of registrations. Overall survival was used in 6 % of registrations as a primary outcome and in 31 % of registrations as a secondary outcome., Conclusions: Few trials on GCTs were registered on ClinicalTrials.gov, and their number was declining in recent times. Most registrations did not report relevant information about the study design, or results if completed. More effort is needed to foster trials on GCTs, as well as to optimize the management of the registrations and foster the publication of research results., Competing Interests: Declaration of competing interest The authors declare they do not have any conflict of interest., (Copyright © 2024 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)

Although reproducibility is central to the scientific method, its understanding within the research community remains insufficient. We aimed to explore the perceptions of research reproducibility among stakeholders within academia, learn about possible barriers and facilitators to reproducibility-related practices, and gather their suggestions for the Croatian Reproducibility Network website. We conducted four focus groups with researchers, teachers, editors, research managers, and policymakers from Croatia ( n  = 23). The participants observed a lack of consensus on the core definitions of reproducibility, both generally and between disciplines. They noted that incentivization and recognition of reproducibility-related practices from publishers and institutions, alongside comprehensive education adapted to the researchers' career stage, could help with implementing reproducibility. Education was considered essential to these efforts, as it could help create a research culture based on good reproducibility-related practices and behavior rather than one driven by mandates or career advancement. This was particularly found to be relevant for growing reproducibility efforts globally. Regarding the Croatian Reproducibility Network website, the participants suggested we adapt the content to users from different disciplines or career stages and offer guidance and tools for reproducibility through which we should present core reproducibility concepts. Our findings could inform other initiatives focused on improving research reproducibility.