Search

Corticosteroids (CSs) are widely used in oncology, presenting several different indications. They are useful for induction of apoptosis in hematological neoplasms, for management of anaphylaxis and cytokine release/hypersensitivity reaction and for the symptomatic treatment of many tumour- and treatment-related complications. If the employment of CSs in the oncological setting results in several benefits for patients and satisfaction for clinicians, on the other hand, many potential adverse events (AEs), both during treatment and after withdrawal of CSs, as well as the duality of the effects of these compounds in oncology, recommend being cautious in clinical practice. To date, several gray zones remain about indications, contraindications, dose, and duration of treatment. In this article, a panel of experts provides a critical review on CSs therapy in oncology, focusing on mechanisms of action and pharmacological characteristics, current and emerging therapeutic indications/contraindications, AEs related to CSs treatment, and the impact on patient outcome.

Background There is a limited amount of data on the safety profile of the COVID-19 vector vaccine Gam-COVID-Vac (Sputnik V). Previous infodemiology studies showed that social media discourse could be analyzed to assess the most concerning adverse events (AE) caused by drugs. Objective We aimed to investigate mild AEs of Sputnik V based on a participatory trial conducted on Telegram in the Russian language. We compared AEs extracted from Telegram with other limited databases on Sputnik V and other COVID-19 vaccines. We explored symptom co-occurrence patterns and determined how counts of administered doses, age, gender, and sequence of shots could confound the reporting of AEs. Methods We collected a unique dataset consisting of 11,515 self-reported Sputnik V vaccine AEs posted on the Telegram group, and we utilized natural language processing methods to extract AEs. Specifically, we performed multilabel classifications using the deep neural language model Bidirectional Encoder Representations from Transformers (BERT) “DeepPavlov,” which was pretrained on a Russian language corpus and applied to the Telegram messages. The resulting area under the curve score was 0.991. We chose symptom classes that represented the following AEs: fever, pain, chills, fatigue, nausea/vomiting, headache, insomnia, lymph node enlargement, erythema, pruritus, swelling, and diarrhea. Results Telegram users complained mostly about pain (5461/11,515, 47.43%), fever (5363/11,515, 46.57%), fatigue (3862/11,515, 33.54%), and headache (2855/11,515, 24.79%). Women reported more AEs than men (1.2-fold, P Conclusions After the Sputnik V vaccination, Russian Telegram users reported mostly pain, fever, and fatigue. The Sputnik V AE profile was comparable with other vector COVID-19 vaccines. Discussion on social media could provide meaningful information about the AE profile of novel vaccines.

Background: An excess risk of Bell's palsy has been suggested after mRNA vaccines. We examined the association between the BNT162b2 mRNA COVID-19 vaccine and Bell's palsy. Methods: Using the database of the largest healthcare provider in Israel, we retrieved data from different periods in 2018-2021. Observed cases of Bell's palsy occurring within 21-days after the first vaccine dose and within 30-days after the second vaccine dose were compared to the expected cases, based on the experience of the population in 2019. Standardized incidence ratios (SIRs) and attributable risks (ARs) were computed. Findings: Overall, 132 cases of Bell's palsy were reported in 2,594,990 vaccinees with the first dose, and 152 cases in 2,434,674 vaccinees after the second dose. The age and sex weighted SIRs were 1.36(95% CI, 1.14-1.61) and 1.16(0.99-1.36) after the first and second vaccine dose, respectively. SIRs tended to be higher in older age groups after the first and second vaccine doses. The estimates were more pronounced in older females after the first vaccine dose; SIR=1.71(1.10-2.54) at age 45-64, and 2.51(1.65-3.68) at age ≥65 years. The highest AR was 4.46 per 100,000 vaccinees detected in females aged ≥65 years. In patients with previous history of Bell's palsy, only 4 cases of Bell's palsy were reported in 7,567 vaccinees and 10 cases in 7,045 vaccinees after the first and the second dose, respectively. The age and sex weighted SIRs were 1.15(0.36-2.76) and 2.15(1.09-3.83) after the first and second vaccine dose, respectively. Interpretation: This study suggests that the BNT162b2 mRNA COVID-19 vaccine might be associated with increased risk of Bell's palsy. The small estimated attributable risks suggest that the impact on public health is relatively minor. The benefits of vaccinations explicitly outweigh the possible link to Bell's palsy that has high recovery rate if timely treated with corticosteroids. Funding: No external funding was available for this study.

Randomised controlled clinical trials (RCTs) offer a unique opportunity to obtain controlled efficacy and safety data to support clinical decisions. However, most RCT reporting has a stronger focus on efficacy rather than safety. This study aimed to identify the safety profile of both probiotic and drug interventions in irritable bowel syndrome (IBS). In connection to this paper, an accompanying paper was published in which a meta-analysis was conducted to evaluate the efficacy of probiotic interventions compared to that of drug interventions in IBS. Together, these two studies provide a first assessment regarding the feasibility to determine a burden to benefit ratio for both probiotic and drug interventions in IBS. RCTs including participants (>18 years old) with IBS and comparing probiotic or drugs interventions with control groups were identified by a systematic search of MEDLINE (January 2015 - Jan 2021). Reported safety profiles in drug studies were completer and more detailed as compared with studies on probiotics. Several inconsistencies in safety reporting were identified between and within drug and probiotic studies, such as: didn't report on safety; only reported adverse reactions (ARs) or adverse events (AEs) with a certain severity; didn't report the total number of AEs; didn't split in the control- or experimental arm; didn't specify AEs; and used different thresholds for 'common' AEs. Hence, it is difficult to compare safety data from drug and probiotic RCTs across and between different studies. On the current approaches to safety reporting, we could not establish an unambiguous safety profile for neither probiotic and drug interventions in IBS. These shortcomings hamper a critical comparison of the burden to benefit ratio for IBS intervention.

Implementations of potentially transformative eHealth technologies are currently underway internationally, often with significant impact on national expenditure. Such large-scale efforts and expenditures have been justified on the grounds that picture archiving and communication systems (PACS), electronic prescribing (ePrescribing) and associated computerized provider (or physician) order entry systems (CPOE), and computerized decision support systems (CDSS) are supposed to help to address the problems of variable quality and safety in modern health care. However, the scientific basis of such claims, which are repeatedly made, remains to be firmly established. This paper has the objective to contribute to the scientific discourse on the relationship between the digitalization of hospital care and quality and safety of such care by exploring the experience in the Netherlands. The central question of this thesis is: What is the relation between the maturity of hospital EMR systems and the quality of care. The three sub-studies showed little or no association between maturity and quality of care. We found that implementing clinical documentation, especially nursing documentation, ‘Closed Loop Medication Administration’, and intelligent pathways including CDSS, present as a challenge. The interviewed medical specialists prefer digital over the old paper records. The fact that involved health professionals can access the patient data at any time they need it, is considered important. However, in practice, potential quality improvement lags behind as long as decision support cannot be applied by lack of a fully coded patient record. We believe that Dutch hospitals are only at the beginning of a digital transformation. Moreover, a number of preconditions must also be met, such as the active involvement of professionals and management. It is not just a technical transformation but mainly an organizational one.

Implementations of potentially transformative eHealth technologies are currently underway internationally, often with significant impact on national expenditure. Such large-scale efforts and expenditures have been justified on the grounds that picture archiving and communication systems (PACS), electronic prescribing (ePrescribing) and associated computerized provider (or physician) order entry systems (CPOE), and computerized decision support systems (CDSS) are supposed to help to address the problems of variable quality and safety in modern health care. However, the scientific basis of such claims, which are repeatedly made, remains to be firmly established. This paper has the objective to contribute to the scientific discourse on the relationship between the digitalization of hospital care and quality and safety of such care by exploring the experience in the Netherlands. The central question of this thesis is: What is the relation between the maturity of hospital EMR systems and the quality of care. The three sub-studies showed little or no association between maturity and quality of care. We found that implementing clinical documentation, especially nursing documentation, ‘Closed Loop Medication Administration’, and intelligent pathways including CDSS, present as a challenge. The interviewed medical specialists prefer digital over the old paper records. The fact that involved health professionals can access the patient data at any time they need it, is considered important. However, in practice, potential quality improvement lags behind as long as decision support cannot be applied by lack of a fully coded patient record. We believe that Dutch hospitals are only at the beginning of a digital transformation. Moreover, a number of preconditions must also be met, such as the active involvement of professionals and management. It is not just a technical transformation but mainly an organizational one.

The overall aim of the thesis was to describe adverse events for women with planned vaginal births and healthcare professionals’ perceptions of patient safety. Further, to test the reliability and validity of a teamwork questionnaire and to investigate patient safety culture and teamwork among healthcare professionals in intrapartum care. Methods: Paper I had a retrospective design, with 311 birth record reviews. Paper II had a descriptive and qualitative design using a phenomenographic approach, including interviews with 19 healthcare professionals in three labor wards. Paper III and IV had cross-sectional designs. Healthcare professionals’ (n=450) in various wards responded to the TeamSTEPPS® Teamwork Perceptions Questionnaire (T-TPQ) (III). Healthcare professionals’ (n=184) in three labor wards responded to the Swedish version of the Hospital Survey on Patient Safety Culture and the T-TPQ (IV). Confirmatory factor analysis and descriptive and inferential statistics were used. Main results: Adverse events in women occurred in 11% of planned vaginal births (I). Four descriptive categories with nine perceptions described patient safety for women giving birth (II). Confirmatory factor analysis of the T-TPQ indicated a good fit (III). Main and interaction effects of profession and labor ward on patient safety culture and teamwork were found (IV). Conclusions: The results highlight the occurrence of 3rd- or 4th-degree lacerations, distended urinary bladder, and anesthesia-related adverse events. For safe care, it is crucial for healthcare professionals to provide supportive care and to listen to the woman. Using team members’ competences in a tolerant atmosphere, with a reasonable workload, and learning from failure as well as from success are preconditions for patient safety. The Swedish version of the T-TPQ shows acceptable reliability and validity. Differences between labor wards seemed to have a greater impact than differences between professions on patient safety culture and teamwork. Patient safety is a global health priority. Knowledge about patient safety and adverse events for women giving birth is necessary. Patient safety culture and effective teamwork are important for safe care provided by midwives, physicians and nursing assistants. The overall aim of the thesis was to describe adverse events for women with planned vaginal births and healthcare professionals’ perceptions of patient safety. Further, to test the reliability and validity of a teamwork questionnaire and to investigate patient safety culture and teamwork among healthcare professionals in intrapartum care. A birth record review, interviews and two questionnaires were used. Adverse events were identified in 11% of the birth records, but no permanent harm. Listening to the woman and having a tolerant teamwork atmosphere were important. Both profession and labor ward are important for healthcare professionals’ perceptions of patient safety culture and teamwork in intrapartum care. Article 4 which was included in the thesis as a manuscript is now published.

Randomised controlled clinical trials (RCTs) offer a unique opportunity to obtain controlled efficacy and safety data to support clinical decisions. However, most RCT reporting has a stronger focus on efficacy rather than safety. This study aimed to identify the safety profile of both probiotic and drug interventions in irritable bowel syndrome (IBS). In connection to this paper, an accompanying paper was published in which a meta-analysis was conducted to evaluate the efficacy of probiotic interventions compared to that of drug interventions in IBS. Together, these two studies provide a first assessment regarding the feasibility to determine a burden to benefit ratio for both probiotic and drug interventions in IBS. RCTs including participants (>18 years old) with IBS and comparing probiotic or drugs interventions with control groups were identified by a systematic search of MEDLINE (January 2015 – Jan 2021). Reported safety profiles in drug studies were completer and more detailed as compared with studies on probiotics. Several inconsistencies in safety reporting were identified between and within drug and probiotic studies, such as: didn’t report on safety; only reported adverse reactions (ARs) or adverse events (AEs) with a certain severity; didn’t report the total number of AEs; didn’t split in the control- or experimental arm; didn’t specify AEs; and used different thresholds for ‘common’ AEs. Hence, it is difficult to compare safety data from drug and probiotic RCTs across and between different studies. On the current approaches to safety reporting, we could not establish an unambiguous safety profile for neither probiotic and drug interventions in IBS. These shortcomings hamper a critical comparison of the burden to benefit ratio for IBS intervention.

Ovim diplomskim radom definiran je pojam sigurnosti, kibernetičke sigurnosti, sigurnosnih pravila i sigurnosnih sustava te je objašnjen način implementacije sigurnosnih pravila i sustava u malim i srednjim poduzećima. Cilj rada je podići svijest na važnost zaštite i sigurnosti u malim i srednjim poduzećima te utvrditi koja su to sigurnosna pravila i sigurnosni sustavi koji su bitni za poduzeća i hoće li se njihovom implementacijom smanjiti rizici štetnih događaja koji mogu naštetiti poslovanju poduzeća u digitalnom poslovanju. Mala i srednja poduzeća zbog nedostatka resursa i znanja ne ulažu dovoljno napora kako se zaštitili od različitih vrsta rizika po zaposlenike i imovinu poduzeća. Baš zbog činjenice da mala i srednja poduzeća kontinuirano ne primjenjuju i razvijaju sigurnosna pravila i sustave, poduzeća postaju sve zanimljivija meta raznim napadačima i sve češće se događaju štetni događaji u poduzećima. Kroz predmetni rad objasniti će se sigurnosna pravila i sustavi te njihova primjena u poduzećima. Također, provesti će se analiza odabrani štetnih događaja u poduzećima kako bi se utvrdilo jesu li u poduzećima implementirana sigurnosna pravila i sustavi, odnosno bi li se njihovom primjenom smanjio rizik nastalih štetnih događaja., This thesis defines the concept of security, cyber security, security rules and security systems and explains how to implement security rules and systems in small and medium enterprises. The aim of this paper is to raise awareness of the importance of security and safety in small and medium enterprises and to determine which security rules and security systems are important for enterprises and whether their implementation will reduce the risks of adverse events that could harm digital business. Due to the lack of resources and knowledge, small and medium enterprises do not make enough efforts to protect themselves from various types of risks to employees and assets of enterprises. Precisely due to the fact that small and medium-sized enterprises do not continuously apply and develop security rules and systems, enterprises are becoming an increasingly interesting target for various attackers and harmful events are increasingly occurring in enterprises. This paper will explain security rules and systems and their application in companies. Also, an analysis of selected adverse events in companies will be conducted to determine whether safety rules and systems have been implemented in companies, or whether their application would reduce the risk of adverse events.

Hand osteoarthritis is the most common joint condition and is associated with significant morbidity. It is of paramount importance that patients are thoroughly assessed and examined when complaining of hand stiffness, pain, deformity or disability and that the patient's concerns and expectations are addressed by the healthcare professional. In 2019 the American College of Rheumatology and Arthritis Foundation (ACR/AF) produced guidelines which included recommendations for the treatment of hand osteoarthritis. An ESCEO expert working group (including patients) was convened and composed this paper with the aim to assess whether these guidelines were appropriate for the treatment of hand osteoarthritis therapy in Europe and whether they met with the ESCEO patient-centered approach. Indeed, patients are the key stakeholders in healthcare and eliciting the patient's preference is vital in the context of an individual consultation but also for informing research and policy-making. The patients involved in this working group emphasised the often-neglected area of aesthetic changes in hand osteoarthritis, importance of developing pharmacological therapies which can alleviate pain and disability and the need of the freedom to choose which approach (out of pharmacological, surgical or non-pharmacological) they wished to pursue. Following robust appraisal, it was recommended that the ACR/AF guidelines were suitable for a European context (as described within the body of the manuscript) and it was emphasised that patient preferences are key to the success of individual consultations, future research and future policy-making.

The long-term use of psychopharmacology medications in autism spectrum disorder (ASD) hitherto remains controversial due to a lack of evidence about safety and tolerability. In this regard, genotyping the metabolizing enzyme cytochrome P450 (CYP) 2D6, especially its extreme phenotypes, could help to prevent drug-related adverse reactions or adverse events (AEs). There are several medications warranting CYP2D6 screening that are consumed by people with ASD, such as risperidone and aripiprazole to name a few. A naturalistic observational study was carried out in participants with ASD to analyze the influence of the CYP2D6 phenotype in drug tolerability using a local pharmacovigilance system created for this study. In this case, AEs were identified from participants’ electronic health records (EHRs) and paper registries. Other variables were collected: socio-demographic information, comorbidities, and psychopharmacology prescriptions (polypharmacy defined as ≥4 simultaneous prescriptions) and doses. The genetic analysis included allelic discrimination (CYP2D6*1, *2, *3, *4, *5, *6, *10, *17, and *41) and copy number variations. All of these were used to determine theoretical phenotypes of the metabolic profiles: poor (PM); intermediate (IM); normal (NM); and ultra-rapid (UM). Sex differences were analyzed. A total of 71 participants (30 ± 10 years old, 82% male, 45% CYP2D6 NM phenotype (32 participants)) with a median of 3 (IQR 2–4) comorbidities per person, mainly urinary incontinence (32%) and constipation (22%), were included. CYP2D6 UM showed the highest rate of polypharmacy, whilst, IM participants had the highest rates of neurological and psychiatric AEs, even worse if a CYP2D6 inhibitor drug was prescribed simultaneously. CYP2D6 pharmacogenomics and the monitoring of new antipsychotic prescriptions may make a difference in medication safety in adults with ASD. Particularly in those with psychopharmacology polymedication, it can help with AE avoidance and understanding.

In recent years, the U.S. Food and Drug Administration (FDA) has seen an increase in microfluidic medical device submissions, likely stemming from recent advancements in microfluidic technologies. This recent trend has only been enhanced during the COVID-19 pandemic, as microfluidic-based test kits have been used for diagnosis. To better understand the implications of this emerging technology, device submissions to the FDA from 2015 to 2021 containing microfluidic technologies have been systematically reviewed to identify trends in microfluidic medical applications, performance tests, standards used, fabrication techniques, materials, and flow systems. More than 80% of devices with microfluidic platforms were found to be diagnostic in nature, with lateral flow systems accounting for about 35% of all identified microfluidic devices. A targeted analysis of over 40,000 adverse event reports linked to microfluidic technologies revealed that flow, operation, and data output related failures are the most common failure modes for these device types. Lastly, this paper highlights key considerations for developing new protocols for various microfluidic applications that use certain analytes (e.g., blood, urine, nasal-pharyngeal swab), materials, flow, and detection mechanisms. We anticipate that these considerations would help facilitate innovation in microfluidic-based medical devices.

U bolničkoj zdravstvenoj ustanovi uspostavljanje sustava sigurnosti pacijenta ostvaruje se primjenom standarda čiji je cilj sprječavanje neželjenog događaja koji bi mogao nanijeti štetu zdravlju pacijenta. Ovaj rad prikazuje aspekte sigurnosti pacijenta i upravljanja kliničkim rizicima, analizira uspostavljanje sustava sigurnosti pacijenta primjenom međunarodnog akreditacijskog standarda u Općoj bolnici Gospić te prikazuje promjene u smislu poboljšanja procesa za sigurnost pacijenta koje iz toga proizlaze. Analiza je ukazala na pozitivan učinak akreditacije u sustavu sigurnosti pacijenta. Akreditacija je doprinijela poboljšanju postojećih procesa i uspostavljanju novih, uključujući proces utvrđivanja i otkrivanja izbjegnutih neželjenih događaja (near miss) koji potencijalno utječu i mogu ugroziti sigurnost pacijenta, procese temeljene na riziku i uspostavljanju registra rizika, proces praćenja medicinske pogreške u okviru utvrđivanja i otkrivanja prevalencije i ozbiljnosti incidenata koji ugrožavaju sigurnost pacijenta i proces sustavnog provođenja Kirurške kontrolne liste Svjetske zdravstvene organizacije. Akreditacijski je postupak u Općoj bolnici Gospić pridonio osvještavanju važnosti prepoznavanja i prijavljivanja neželjenog događaja te razvoju kulture bez kažnjavanja i učenja iz pogrešaka., The establishment of a patient safety system in a hospital health care institution is accomplished by implementing standards aimed at preventing an adverse event that could harm the patient's health. This paper discusses aspects of patient safety and clinical risk management, analyzes the implementation of a patient safety system at Gospić General Hospital using the international accreditation standard, and discusses the changes in terms of improving the patient safety process that resulted. The study found that accreditation has a positive impact on the patient safety system. Accreditation has contributed to the improvement of existing processes for the identification and detection of adverse events and the establishment of new processes, including the process of detecting avoided adverse events (near miss), the process of monitoring medical errors, risk-based process based on own risk register and the process of surgical checklist World Health Organization. In addition, the accreditation has contributed to raising awareness of the importance of recognizing and reporting an adverse event and developing a culture without punishing and learning from mistakes.

MRNA technology is not new, but with the COVID-19 pandemic, it is the first time it has been utilized on a large-scale basis in humans. Because of this widespread use, novel side effects have been noted in several organ systems. However, there are no publications to date documenting musculoskeletal side effects. This paper presents 4 cases of potential side effects of the mRNA vaccine noted in a busy shoulder practice.

The purpose of this paper is to renew interest and attention to the medical history, prescription, and/or use of drugs during dental practice. The work analyzes the issue of the use of drugs in dentistry from both a clinical and a medical–legal point of view. The laws governing the matter were also taken into consideration, relating them to the roles of prescriber and user that the dentist can acquire. Analysis of various aspects of this matter demonstrates that it is necessary for dentists to know the drugs and medical substances, their characteristics and properties, related effects, and interactions in order to use them appropriately and adequately. Knowledge of interferences, reactions, and adverse events or complications helps to reduce errors and protect patients’ health. Furthermore, knowledge of the national and international reference standards relating to the use of drugs leads to a reduction in medico–legal questions. In conclusion, knowledge and adequate and appropriate use of drugs reduces the possibility of accidents, adverse events, medico–legal consequences, and disputes with patients. Documented and traceable choices allow the analysis and valuation of professional conduct. Authors perceived the topic of informed consent of patients as relevant to the adequate procedure of prescribing drugs related to dentistry practice; therefore, representative conditions of patients at risk should be illustrated in practice. Legal duties related to physician drug prescription and use must be considered and carefully checked.

BackgroundFew studies have assessed participant safety in human challenge trials (HCTs). Key questions regarding HCTs include how risky such trials have been, how often adverse events (AEs) and serious adverse events (SAEs) occur, and whether risk mitigation measures have been effective.MethodsA systematic search of PubMed and PubMed Central for articles reporting on results of HCTs published between 1980 and 2021 was performed and completed by 7 October 2021.ResultsOf 2838 articles screened, 276 were reviewed in full. A total of 15 046 challenged participants were described in 308 studies that met inclusion criteria; 286 (92.9%) of these studies reported mitigation measures used to minimize risk to the challenge population. Among 187 studies that reported on SAEs, 0.2% of participants experienced at least 1 challenge-related SAE. Among 94 studies that graded AEs by severity, challenge-related AEs graded “severe” were reported by between 5.6% and 15.8% of participants. AE data were provided as a range to account for unclear reporting. Eighty percent of studies published after 2010 were registered in a trials database.ConclusionsHCTs are increasingly common and used for an expanding list of diseases. Although AEs occur, severe AEs and SAEs are rare. Reporting has improved over time, though not all papers provide a comprehensive report of relevant health impacts. We found very few severe symptoms or SAEs in studies that reported them, but many HCTs did not report relevant safety data. This study was preregistered on PROSPERO as CRD42021247218.

Dental practice is characterized by the performance of a wide range of clinical procedures that seek to solve people's oral health needs. Dentistry is a discipline in which great importance is given to the methods and techniques used for patient care, this modernization in turn guarantees quality care. Prioritize patient safety by minimizing risks that prevent a benefit for public health and the exercise of dental clinical practice. The creation of protocols such as dental clinical practice guides are an example of the materialization of these quality purposes, in addition, the statistics of reports of adverse events and incidents are a reference for the prevention of said events and thus improving patient safety. The central objective of this academic exercise was focused on compiling information on patient safety in the dental office. In methodological terms, a compilationtype monograph was carried out, which allowed a compilation and review of different articles, studies and research papers on safety in the dental office and Colombian regulations related to patient safety. Regarding final considerations, it can be stated that patient safety is a fundamental element in the provision of dental services to guarantee a good service to the user, through the implementation of strategies that promote safe care, to reduce the risk to which the patient is exposed in each dental care, which becomes an impact indicator that shows the quality of the service provided. 1 INTRODUCCION ...................................................................................................... 9 1.1 OBJETIVO GENERAL ..................................................................................... 13 1.2 OBJETIVOS ESPECIFICOS ............................................................................ 13 2 METODOLÓGIA ..................................................................................................... 14 2.1 TIPO DE ESTUDIO .......................................................................................... 14 2.2 POBLACIÓN .................................................................................................... 14 2.3 MUESTRA ....................................................................................................... 14 2.4 UNIDAD DE ANÁLISIS .................................................................................... 15 2.5 ORGANIZACIÓN DE LA INFORMACIÓN ........................................................ 15 2.6 PRESENTACIÓN DE LA INFORMACIÓN ....................................................... 15 2.7 ASPECTOS ÉTICOS ....................................................................................... 15 2.8 ASPECTOS DE PROPIEDAD INTELECTUAL Y DERECHOS DE AUTOR ..... 16 3 MONOGRAFIA ....................................................................................................... 17 3.1 NORMATIVIDAD COLOMBIANA DE SEGURIDAD DEL PACIENTE ............... 17 3.2 ADHERENCIA DE LOS PROFESIONALES A LAS GUÍAS DE PRÁCTICAS CLÍNICAS ODONTOLÓGICAS. ................................................................................. 21 3.3 IMPORTANCIA DEL ROL DEL AUDITOR EN LA IMPLEMENTACIÓN, SEGUIMIENTO Y CONTROL DEL PROGRAMA DE SEGURIDAD DEL PACIENTE EN ODONTOLOGÍA. ................................................................................................. 28 4 CONSIDERACIONES FINALES ............................................................................. 34 5 CONCLUSIONES ................................................................................................... 37 6 RECOMENDACIONES ........................................................................................... 39 7 BIBLIOGRAFIA....................................................................................................... 40 La práctica odontológica se caracteriza por la realización de un amplio rango de procedimientos clínicos que buscan la solución de necesidades en salud oral de las personas. La odontología es una disciplina en la que se da una gran importancia a los métodos y técnicas utilizadas para la atención de los pacientes; esa tecnificación a su vez garantiza una atención de calidad, priorizar la seguridad del paciente al minimizar riesgos que impidan un beneficio para la salud pública y el ejercicio de la práctica clínica odontológica. La creación de protocolos como las guías de prácticas clínicas odontológicas, son ejemplo de la materialización de esos propósitos de calidad, además, las estadísticas de reportes de eventos adversos e incidentes son un referente para la prevención de dichos eventos y optimizando así la seguridad del paciente. El objetivo central de este ejercicio académico se enfocó en compilar información sobre la seguridad del paciente en la consulta odontológica. En términos metodológico se realizó una monografía de tipo compilación, la cual permitió una recopilación y revisión de diferentes artículos, estudios y trabajos de investigación sobre seguridad en la consulta odontológica y normatividad colombiana relacionada con la seguridad del paciente. En cuanto a consideraciones finales se puede manifestar que la seguridad del paciente es un elemento fundamental en la prestación de los servicios odontológicos para garantizar un buen servicio al usuario, mediante la implementación de estrategias que promuevan una atención segura, para disminuir el riesgo al que se ve expuesto el paciente en cada atención odontológica, lo cual se convierte en un indicador de impacto que evidencia la calidad de la prestación del servicio. Especialización Especialista en Auditoria de la Calidad en Salud Monografías

ICD-11 provides a promising new way to capture healthcare-related harm or injury. In this paper, we elaborate on the framework for describing healthcare-related events where there is a presumed causal link between an event and underlying healthcare-related factors. The three-part model for describing healthcare-related harm or injury in ICD-11 consists of (1) a healthcare-related activity that is the cause of injury or other harm (selected from Chapter 23 of ICD-11); (2) a mode or mechanism of injury or harm, related to the underlying cause (also from Chapter 23 of ICD-11); and (3) the harmful consequences of the event to the patient, selected from any of Chapters 1 through 22 of ICD-11 (most importantly, the injury or harm experienced by the patient). Concepts from these three elements are linked/clustered through postcoordination to reflect the three-part model in a single coded expression. ICD-11 contains many novel features, and the three-part model described here for healthcare-related adverse events is a notable example.

Many clinicians increasingly use dry needling in clinical practice. However, whether patients'' intake of antithrombotic drugs should be considered as a contraindication for dry needling has not been investigated to date. As far as we know, there are no publications in analyzing the intake of antiplatelet or anticoagulant agents in the context of dry needling techniques. A thorough analysis of existing medications and how they may impact various needling approaches may contribute to improved evidence-informed clinical practice. The primary purpose of this paper is to review the current knowledge of antithrombotic therapy in the context of dry needling. In addition, reviewing guidelines of other needling approaches, such as electromyography, acupuncture, botulinum toxin infiltration, and neck ultrasound-guided fine-needle aspiration biopsy, may provide specific insights relevant for dry needling. Based on published data, taking antithrombotic medication should not be considered an absolute contraindication for dry needling techniques. As long as specific dry needling and individual risks are properly considered, it does not change the risk and safety profile of dry needling. Under specific circumstances, the use of ultrasound guidance is recommended when available. © 2022 María Muñoz et al.

Funding Information: This paper was funded by the Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq, Brazil) (404067/2012-3 and 2020/00433-8), the European and Developing Countries Clinical Trials Partnership (EDCTP) (RIA2017T-2018), the Fundação de Amparo *a Pesquisa do Estado de mInas Gerais (FAPEMIG) (CBB-APQ 00952-16) and the Fundação para a Ciência e Tecnologia (FCT, Portugal) (SFRH/BD/142860/2018). Funding Information: L Pernaute-Lau is a recipient of a fellowship from BioSys PhD program PD65‐2012 (Ref SFRH/BD/142860/2018) from Fundação para a Ciência e Tecnologia (FCT, Portugal). JP Gil, M Camara and U Morris were partially supported by the European Developing Countries Clinical Trial Partnership (EDCTP2) programme supported by the European Union (Grant number RIA2017T-2018 – WANECAM 2). T Nóbrega de Sousa is a recipient of a Senior Research Scholarships from Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq, Brazil). Funded by Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPqants number 404,067/2012-3, 2020/00433-8), and the Fundação de Amparo à Pesquisa do Estado de mInas Gerais (FAPEMIG), grant number CBB-APQ 00952-16). MU Ferreira was funded by Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPqants number 404,067/2012-3, 2020/00433-8), and the Fundação de Amparo à Pesquisa do Estado de mInas Gerais (FAPEMIG), grant number CBB-APQ 00952-16). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Publisher Copyright: © 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. Introduction: Artemisinin-based combination therapies (ACTs) are recommended first-line antimalarials for uncomplicated Plasmodium falciparum malaria. Pharmacokinetic/pharmacodynamic variation associated with ACT drugs and their effect is documented. It is accepted to an extent that inter-individual variation is genetically driven, and should be explored for optimized antimalarial use. Areas covered: We provide an update on the pharmacogenetics of ACT antimalarial disposition. Beyond presently used antimalarials, we also refer to information available for the most notable next-generation drugs under development. The bibliographic approach was based on multiple Boolean searches on PubMed covering all recent publications since our previous review. Expert opinion: The last 10 years have witnessed an increase in our knowledge of ACT pharmacogenetics, including the first clear examples of its contribution as an exacerbating factor for drug–drug interactions. This knowledge gap is still large and is likely to widen as a new wave of antimalarial drug is looming, with few studies addressing their pharmacogenetics. Clinically useful pharmacogenetic markers are still not available, in particular, from an individual precision medicine perspective. A better understanding of the genetic makeup of target populations can be valuable for aiding decisions on mass drug administration implementation concerning region-specific antimalarial drug and dosage options. publishersversion published

Disinvestment is the removal or reduction of previously provided practices or services, and has typically been undertaken where a practice or service has been clearly shown to be ineffective, inefficient and/or harmful. However, practices and services that have uncertain evidence of effectiveness, efficiency and safety can also be considered as candidates for disinvestment. Disinvestment from these practices and services is risky as they may yet prove to be beneficial if further evidence becomes available. A novel research approach has previously been described for this situation, allowing disinvestment to take place while simultaneously generating evidence previously missing from consideration. In this paper, we describe how this approach can be expanded to situations where three or more conditions are of relevance, and describe the protocol for a trial examining the reduction and elimination of use of mobilisation alarms on hospital wards to prevent patient falls. Our approach utilises a 3-group, concurrent, non-inferiority, stepped wedge, randomised design with an embedded parallel, cluster randomised design. Eighteen hospital wards with high rates of alarm use (≥3%) will be paired within their health service and randomly allocated to a calendar month when they will transition to a “Reduced” (