Challenges and practices arising during public health emergencies: A qualitative survey on ethics committees.

The particular dynamics of public health emergencies urge scientists and Ethics Committee (EC) members to change and adapt their operating procedures to function effectively. Despite having previous pandemic experiences, ethics committees were unprepared to adapt to COVID-19 pandemic challenges. This survey aims to learn and thoroughly discuss the most salient issues for ECs during the COVID-19 pandemic. The results indicate that the main problems faced by ECs were lack of/insufficient regulations, lack of data/experience/knowledge, sloppy review, poor research design, and poor adaptation to quarantine measures. Coping with factors that threaten the autonomy and independence of ECs, the ethical dilemma regarding maximizing common good versus protecting the rights and well-being of study participants, comprehending the change in the context of vulnerable populations, and redefining the role of ECs to strengthen trust in science and vaccine confidence were outstanding issues.

Comparison of COVID-19 studies registered in the clinical trial platforms: A research ethics analysis perspective.

BACKGROUND: The coronavirus disease (COVID-19) treatment must be based on scientific methods such as clinical trials. Trials involving human subjects and those requiring a risk-benefit analysis may occasionally face challenges owing to the time limitations in the pandemic. METHODOLOGY: This study analyses the WHO's International Clinical Trials Registry Platform and clinicaltrials.gov, where most COVID-19 clinical trials are registered, according to ethical criteria including study design, conflicts of interest, enrollment of healthcare workers, study locations, site-, design-, and participant-related issues. The discussion is based on three aspects: the quality of the information to be produced, the relevance to significant health problems, and the creation or evaluation of interventions, policies, or practices that promote individual or public health. RESULTS: There were significant differences between the two platforms regarding the investigational medicinal product (IMP), the comparator, ethics committee/institutional review board approval, plan to share individual participant data, study phase, site, IMP, and design-related issues. Conflict of interest, sponsor information, and management of vulnerable groups were the main areas wherein both platforms lacked sufficient information. CONCLUSION: With this analysis, we aimed to define a minimum set of ethical criteria for clinical trial platforms to obtain standardization between these two platforms.

Evaluation of Ethical Analyses in Seven Reports from the European Network for Health Technology Assessment.

OBJECTIVES: Ethics has been considered among the core domains of health technology assessment (HTA), but there are still disputes regarding ethical analysis. This study aimed to examine full final reports of the European Network for Health Technology Assessment (EUnetHTA) in terms of their compliance with the ethical methodology and ethical perspective of the HTA Core Model®. METHODS: The study examines seven full final HTA reports of EUnetHTA written based on the methodology proposed in the HTA Core Model®. The reports were analyzed using the following parameters: competency of the person/group who conducted ethical analysis, assessment elements, and the methodology of ethical analysis. RESULTS: The results show that, although the HTA Core Model® helped to standardize the final reports of the assessment, there are still concerns regarding the competency of the ethical analysis team, the perspectives on the purpose of ethical analysis, data sources and viewpoints of various stakeholders, use of ethical analysis methodology, and the evaluation of the ethical appropriateness of the entire HTA process. CONCLUSIONS: The HTA Core Model® helped to standardize the final reports on the HTA; however, not all issues with the content and outcomes were solved. The lack of expertise in ethics and insufficiency of the teams regarding ethical analysis are other existing problems. This study also demonstrated that stakeholder viewpoints in general and patient perspectives, in particular, have been overlooked in the HTA process.

Evaluation of the synergistic effect of a combination of colistin and tigecycline against multidrug-resistant Acinetobacterbaumannii.

OBJECTIVE: Acinetobacter baumannii species cause nosocomial infections and can subsequently develop multidrug resistance (MDR). The objective of this study was to evaluate the susceptibility of A. baumannii to a novel combination of colistin and tigecycline, which may provide a faster and more efficacious treatment via a synergistic effect. METHODS: We included 50 MDR A. baumannii samples that were isolated in our clinics between 2009 and 2014. We used broth microdilution (BMD) and the E-test to evaluate the effects of colistin and tigecycline, and the E-test to assess the interaction of the colistin-tigecycline combination. The interaction between the two antibiotics was evaluated using the fractional inhibition concentration (FIC) index and was classified as follows: FIC≤0.5, synergistic; 0.5

Variability of Pharmacogenomics Information in Drug Labels Approved by Different Agencies and its Ethical Implications.

AIMS: The aim of this study was to determine if there are discrepancies among various agency-approved labels for the same active ingredient and where the labels approved by the Turkish Medicines and Medical Devices Agency (TMMDA) stand regarding the inclusion of PGx and discuss these ethical implications. BACKGROUND: The efficacy and safety of drugs can be improved by rational prescription and personalization of medicine for each patient. Pharmacogenomics information (PGx) in Drug Labels (DL) is one of the important tools for the personalization of medications because genetic differences may affect both drug efficacy and safety. Providing adequate PGx to patients has ethical implications. OBJECTIVE: The study aims to evaluate PGx in the DLs approved by TMMDA and other national agencies provided by the Pharmacogenomics Knowledgebase. METHODS: DL annotations from the Pharmacogenomics Knowledgebase and DLs approved by the TMMDA were analyzed according to information and action levels, which are "testing required", "testing recommended", "actionable", and "informative". RESULTS: There are 381 drugs listed in PharmGKB drug label annotations with pharmacogenomics information, and 278 of these have biomarkers. A total of 242 (63.5%) drugs are approved and available in Turkey. Of these, 207 (85.5%) contain the same information as in or similar to that in the labels approved by the other agencies. The presence and level of information varied among the DLs approved by different agencies. The inconsistencies may have an important effect on the efficacy and the safety of drugs. CONCLUSION: These findings suggest a need for the standardization of PGx information globally because it may not only affect the efficacy and safety of medications but also essential ethical rules regarding patient rights by violating not sufficiently sharing all available information.

Ethical evaluation of informed consent forms used in cardiology clinics and the importance of institutional standardized approach.

OBJECTIVE: This study aimed to evaluate the content of informed consent forms (ICFs) used during cardiology interventions by the university, research and training (R-T), and private hospitals with regard to ethical standards and compare them with the Turkish Society of Cardiology (TSC) templates and among various institutions. METHODS: A total of 185 forms from the university, R-T, and private hospitals and 19 TSC templates were selected and analyzed for 26 criteria. Compliance with TSC templates was also evaluated. Data were presented as the percentage of ICFs satisfying the criteria and compared using the Fisher exact test, and 95% confidence intervals were calculated. RESULTS: TSC templates were more compatible and included more information to comply with ethical standards than ICFs of all 3 types of healthcare institutions. The areas of improvement for these templates were prospects of treatment and alternative treatments, quality of life, explanation for third-party consent, duration of hospitalization, and time to return to normal life. Among the 3 types of hospitals, R-T-ICFs were more compatible with templates. Private hospital ICFs had the poorest compliance with TSC templates. Separate anesthesia ICFs and detailed information about exposure to radioactivity were lacking. CONCLUSION: The current ICFs for cardiology interventions have major ethical deficiencies and need urgent improvement. Professional societies such as TSC are essential institutions to develop and provide guidance and templates for ICFs to meet the ethical standards during the informed consent process and standardization of the process among various institutions.

Does content of informed consent forms make surgeons vulnerable to lawsuits?

BACKGROUND: Written informed consent forms (ICFs) are important for ensuring that physicians disclose core information to patients to help them autonomously decide about treatment and for providing substantial evidence for the surgeon in case of a legal dispute. This paper aims to assess the legal and ethical appropriateness and sufficiency of the contents of ICFs designed for several elective surgical procedures currently in use in Turkish hospitals. METHODS: One hundred and twenty-six forms were randomly selected and were analyzed for 22 criteria. The results were compared using the Fisher' exact test, and 95% confidence intervals were calculated. RESULTS: More than 80% of ICFs contained information about the risks of the proposed treatment, the diagnosis of the patient, and the patient's voluntariness/willingness, as well as a designated space for the signatures of the patient and the physician and a description of the proposed treatment. Some ICFs were designed for obtaining blanket consent for using patients' specimens. CONCLUSIONS: The ICFs for general elective surgery contain many deficiencies regarding disclosure of information, and there is significant variation among primary healthcare providers. Unrealistic expectations regarding the surgery or the post-operative recovery period due to insufficient information disclosure may lead patients, who experience post-surgical inconveniences, to file lawsuits against their surgeons. Although all ICFs, regardless of their institution, are generally insufficient for defending hospital administrations or surgeons during a lawsuit, ICFs of private hospitals might be considered better equipped for the situation than those of state or university hospitals. However, further research is needed to show if private hospitals have lower lawsuit rates or better lawsuit outcomes than state or university hospitals in Turkey.

A Survey Study Evaluating and Comparing the Health Literacy Knowledge and Communication Skills Used by Nurses and Physicians.

Health literacy (HL) is considered as an interaction between the demands of health systems and the skills of individuals. The current global approach demands health professionals to be more accountable for universal precautions approach and improve communication skills, and employ strategies to confirm patients' understanding. The aim of this study is to assess the knowledge and attitude of health care professionals (HCPs) about HL and their communication skills, and its effect on their practices, and to compare the findings among subgroups of HCPs. An online cross-sectional survey involving 29 items was developed for sociodemographic and professional characteristics and knowledge, attitude, and practices evaluation. Health care professionals reached by occupational organizations and social media platforms. Among the 277 participants that answered the questions, 184 were physicians and 78 were nurses, and 37.99% of physicians and 18.42% nurses heard about the term "HL" through this survey. Most of the participants stated their willingness to receive information/training on the subject and that knowing HL level would change their approach to and outcomes of the patients. Nurses were using a variety of methods that improve communication with patients and considered HCPs' lack of knowledge of the concept of "HL" and their neglect of HL as obstacles to its evaluation more than physicians. These results emphasize the urgent need of initiatives to be taken to improve the awareness of HCPs of HL and the subsequent incorporation of these initiatives into the daily health care services they provide. Nurses' awareness of HL is higher and they are already better at incorporating HL-sensitive items into their practices. Both graduate and continuing education programs need to be modified to improve HL knowledge of all HCPs and its positive effects on health care. The current structure of the roles and responsibilities of these professions needs to be improved to make it more HL sensitive.

Healthcare professionals' pharmacovigilance knowledge and adverse drug reaction reporting behavior and factors determining the reporting rates.

Background: Spontaneous adverse drug reaction (ADR) reports prepared by healthcare professionals (HCPs) are the backbone of collecting post-marketing safety data. However, underreporting is a global problem creating health, economic, and ethical burden. Objectives: To determine the factors limiting ADR reporting rates from the HCPs' point of view. Methods: A questionnaire containing 43 questions evaluating sociodemographic characteristics, pharmacovigilance knowledge and activities, and prescription behaviors was prepared on "surveymonkey.com." The link was distributed mainly by professional organizations. Results: Although this survey aimed to reach all HCPs, most of the respondents were physicians and nurses. Of the 259 (69.6%) participants who encountered ADR at least once, only 105 (40.5%) reported ADR. The term "pharmacovigilance" was heard for the first time in this survey by 35.5% (n = 132) of the participants. Only 34.7% (n = 129) of the participants knew where to find the ADR reporting form, and 25.5% (n = 95) had previously filled the form and/or read it. Only 28.5% (n = 106) of the participants were aware of the ADR reporting and monitoring system of their institutions and related professionals. Almost all the participants agreed that pharmacovigilance and ADR reporting training are necessary. Conclusion: The main reason for underreporting is limited pharmacovigilance knowledge of HCPs. Training activities based on the needs and preferences of HCPs and close follow-up by authorities are the main steps to improve pharmacovigilance activities.

Health Literacy Level of Casting Factory Workers and Its Relationship With Occupational Health and Safety Training.

Health literacy (HL) is a stronger predictor of an individual's health status than income, employment status, education level, and race or ethnicity. Lower levels of HL may contribute to low uptake or less adherence to occupational health and safety (OHS) training. This study was conducted among casting factory workers who received OHS training routinely. Data on sociodemographic characteristics, OHS training, and scores of the Health Literacy Survey-European Union (HLS-EU) were collected. Of the 282 of the 600 (47%) workers surveyed, 13.5% had inadequate, 47.5% problematic, 30.9% sufficient, and 8.2% excellent HL scores. There were no statistically significant differences between workers with limited and proficient HL with respect to age group or educational level. Workers with limited HL were less satisfied with OHS training content and were less likely to identify one-on-one health and safety training sessions as training. Limited HL is a universal problem both in the general and working populations, and it may be restricting the workers understanding of OHS training. Occupational health nurses should be aware of the detrimental effects of limited HL and modify their OHS training where needed for purposes of increasing the successful adoption of safe work practices.

Two cases with HSS/DRESS syndrome developing after prosthetic joint surgery: does vancomycin-laden bone cement play a role in this syndrome?

We report two cases of hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms (HSS/DRESS) syndrome following systemic and local (via antibiotic laden bone cement (ALBC)) exposures to vancomycin. Both cases developed symptoms 2-4 weeks after the initiation of treatment. They responded to systemic corticosteroid treatment and were cured completely. Various drug groups may cause HSS/DRESS syndrome, and vancomycin-related cases do not exceed 2-5% of the reported cases. Almost all of these cases developed the syndrome following systemic exposure to vancomycin. ALBC seems to be the safer antibiotic administration method, as systemic antibiotic levels did not reach a toxic threshold level. However, local administration may not always be sufficient for bone-related/joint-related infections; these infections may require systemic antibiotics as well. As HSS/DRESS syndrome can mimic infectious diseases, it must be considered during differential diagnosis before suspecting failure of treatment and initiation of a different antibiotic course.