Understanding literature and AI: how to choose and conduct the right assessment for your research question.

This masterclass was presented on the 30th October 2023 at the 2023 ESCP Aberdeen symposium. Building on previous successful editions, this Masterclass provided an overview of each of the different types of literature review, narrative, scoping and systematic, and help design research question and stepwise protocol relevant to researchers own interests while also spending some time to critically reflect on the future use of AI in the scientific writing process. Summarising, evaluating and critically analysing the vast body of available scientific literature to further their research and practice, poses numerous challenges for healthcare researchers, professionals, and early career researchers. For example, a vast range of scientific literature exists on each topic using different research designs, underpinning theory, sampling strategies and sampling sizes. In addition, several different types of literature reviews exist (narrative, scoping and systematic), so choosing the correct approach to answer research question can be challenging. In addition, we are now seeing the advent of artificial intelligence (AI) tools that can achieve a literature review in a fraction of the time, seemingly short-circuiting this laborious process

Nursing and adverse drug reactions: a dawning role

Trabajo fin de grado en EnfermeríaObjetivo: El presente trabajo pretende explorar y definir el rol de la enfermera en la detección y notificación de las reacciones adversas a medicamentos. Metodología: Se realizó una revisión narrativa mediante la búsqueda bibliográfica en las bases de datos PubMed, Cinahl y Scielo; en el repositorio Cochrane Library, y en el metabuscador Google Académico. Resultados: Se seleccionaron 29 artículos que se organizaron en tres subapartados: la notificación de RAM en los profesionales sanitarios, herramientas e instrumentos utilizados por enfermeras, y características y otros datos relacionados. Se examinaron resultados como el porcentaje de notificación de las enfermeras, la calidad de dichas notificaciones y el conocimiento de las enfermeras en cuanto a los sistemas de farmacovigilancia en distintos países. Asimismo, se recogieron otros datos como las herramientas desarrolladas para el uso por enfermeras, su validez y los resultados derivados de su uso; los sentimientos reportados por enfermeras en cuanto al desarrollo de su rol como notificadoras; sus conductas y las barreras referidas por ellas mismas para cumplir sus nuevas responsabilidades, y estudios con una intervención educativa con distintos fines. Discusión: Las enfermeras ostentan una posición privilegiada para la detección y notificación de RAM. No obstante, existen déficits de conocimiento relacionados con el ámbito de la farmacovigilancia y la farmacología general, que deben solventarse si las enfermeras quieren afianzar su rol en los equipos clínicos de farmacovigilancia en el ámbito hospitalario. Los estudios parecen apoyar la idea de que la formación continua es clave para ello.Aim: Explore and define the nurses’ role in detection and reporting of adverse drug reactions (ADR). Method: A narrative review was carried out through a bibliographic research in the following databases: PubMed, Cinahl and Scielo; in the Cochrane Library repository, and in the metasearcher Google Scholar. Outcomes: 29 articles were selected, which were divided into three subparts: ADR reporting by healthcare professionals, tools and instruments used by nurses, and characteristics and other data related to the aim of the study. Results were examined, such as nurses’ reporting percentage, the quality of these reports and the nurses’ self-reported knowledge on the pharmacovigilance system in different countries. In addition, other data were collected, such as the tools developed for nurses’ usage, their validity and the outcomes of their implementation; the feelings reported by nurses related to the development of their role as reporters; their conducts and self-reported barriers to accomplish their new responsibilities, and studies with educational interventions involved. Discussion: Nurses are a in a privileged position to detect and report ADR. Nevertheless, there is a lack of knowledge on pharmacovigilance and general pharmacology that must be dealt with if nurses are to secure their role in the pharmacovigilance clinical team at hospitals. Studies seem to support the idea that continuous training is the key to do so

Adverse drug reaction profile at psychiatry outpatient department of a tertiary care centre

Background: Monitoring adverse drug reactions (ADRs) helps in alerting physicians and developing strategies to prevent and minimize the risk of developing ADRs. Data regarding pattern of ADRs due to psychotropic medications is scanty. Hence, the study was planned to assess ADRs among psychiatry outpatients of a tertiary care hospital in Maharashtra.Methods: A prospective, observational study was conducted in psychiatry outpatient department of a tertiary care centre for 3 months. Cases were enrolled by active and passive surveillance after obtaining informed consent. Demographic details, adverse event details, history of medications were recorded. Pattern of ADRs was studied according to demographic parameters, drug class, organ system affected, causality (WHO - Uppsala Monitoring Centre Scale) and severity (modified Hartwig and Siegel Scale).Results: Out of total 1200 patients screened, 77 qualified the inclusion and exclusion criteria and 92 ADRs were reported; overall incidence rate of 6.41%. Maximum ADRs were reported in the age group of 31- 40 years. 63.63% subjects received more than 2 psychotropic drugs. Among 24 types of ADRs observed, tremor (13.04%) was the commonest, closely followed by somnolence. Antipsychotics (45.65%) were most frequently incriminated and central nervous system (46.73%) the most often affected. Trifluoperazine (11.96%) was the commonest drug, followed by olanzapine and haloperidol (10.53% each). Causality analysis yielded 66 ADRs as “probable” and on severity analysis 80.43% were mild.Conclusions: The study provides an insight into pattern of ADRs in psychiatry outpatients. It is prudent to communicate this to treating physicians as well as counsel patients (and caregivers). Initiatives and concerted efforts involving all stakeholders in healthcare can go a long way in decreasing drug-related morbidity and health costs

Impacto da pandemia COVID-19 nas notificações de eventos adversos de medicamentos às autoridades de saúde: protocolo de revisão sistemática

The aim was to outline the protocol for carrying out the systematic review, which will have the objective of evaluating the impact of the COVID-19 pandemic on notifications of adverse drug events to health authorities worldwide. This is a systematic review protocol consistent with PRISMA 2020 regulations and checklist, will be conducted in accordance with the recommendations of the Cochrane Manual, will include original observational studies, letters to editors and editorials containing summary information on adverse drug events before and during the COVID-19 pandemic. The search strategy was developed for the MEDLINE, Embase, CINALH, SciELO and gray literature databases, using the Health Sciences Descriptors (DECs) and the Medical Subject Heading (MeSH). Two independent reviewers will investigate the eligibility of the articles, extract the data and assess the risk of bias. The results of this review will contribute to identifying the impact of COVID-19 on adverse drug event reporting, this will be a significant step in informing and preventing such events and will provide an essential evidence base for the development of strategies and improvements that will contribute to patient safety worldwide.Objetivou-se delinear o protocolo da realização da revisão sistemática que terá o objetivo de avaliar o impacto da pandemia COVID-19 nas notificações de eventos adversos a medicamentos às autoridades sanitárias em todo o mundo.  Trata-se de um protocolo de revisão sistemática consistente com as normativas e checklist PRISMA 2020, será conduzido de acordo com as recomendações do Manual Cochrane, incluirá estudos observacionais originais, cartas aos editores e editoriais contendo informações resumidas sobre os eventos adversos a medicamentos antes e durante a pandemia COVID-19. A estratégia de busca foi desenvolvida para as bases de dados MEDLINE, Embase, CINALH, SciELO e literatura cinzenta, utilizando os Descritores em Ciências da Saúde (DECs) e no Medical Subject Heading (MeSH). Dois revisores independentes investigarão a elegibilidade dos artigos, extrairão os dados e avaliarão o risco de viés. Os resultados desta revisão contribuirão para identificar o impacto da COVID-19 nas notificações de eventos adversos a medicamentos, este será um passo significativo para informar e prevenir tais eventos e fornecerá uma base de evidências essenciais para o desenvolvimento de estratégias e melhorias que contribuirão para a segurança do paciente em nível mundial

Impacto da pandemia COVID-19 nas notificações de eventos adversos de medicamentos às autoridades de saúde: protocolo de revisão sistemática

The aim was to outline the protocol for carrying out the systematic review, which will have the objective of evaluating the impact of the COVID-19 pandemic on notifications of adverse drug events to health authorities worldwide. This is a systematic review protocol consistent with PRISMA 2020 regulations and checklist, will be conducted in accordance with the recommendations of the Cochrane Manual, will include original observational studies, letters to editors and editorials containing summary information on adverse drug events before and during the COVID-19 pandemic. The search strategy was developed for the MEDLINE, Embase, CINALH, SciELO and gray literature databases, using the Health Sciences Descriptors (DECs) and the Medical Subject Heading (MeSH). Two independent reviewers will investigate the eligibility of the articles, extract the data and assess the risk of bias. The results of this review will contribute to identifying the impact of COVID-19 on adverse drug event reporting, this will be a significant step in informing and preventing such events and will provide an essential evidence base for the development of strategies and improvements that will contribute to patient safety worldwide.Objetivou-se delinear o protocolo da realização da revisão sistemática que terá o objetivo de avaliar o impacto da pandemia COVID-19 nas notificações de eventos adversos a medicamentos às autoridades sanitárias em todo o mundo.  Trata-se de um protocolo de revisão sistemática consistente com as normativas e checklist PRISMA 2020, será conduzido de acordo com as recomendações do Manual Cochrane, incluirá estudos observacionais originais, cartas aos editores e editoriais contendo informações resumidas sobre os eventos adversos a medicamentos antes e durante a pandemia COVID-19. A estratégia de busca foi desenvolvida para as bases de dados MEDLINE, Embase, CINALH, SciELO e literatura cinzenta, utilizando os Descritores em Ciências da Saúde (DECs) e no Medical Subject Heading (MeSH). Dois revisores independentes investigarão a elegibilidade dos artigos, extrairão os dados e avaliarão o risco de viés. Os resultados desta revisão contribuirão para identificar o impacto da COVID-19 nas notificações de eventos adversos a medicamentos, este será um passo significativo para informar e prevenir tais eventos e fornecerá uma base de evidências essenciais para o desenvolvimento de estratégias e melhorias que contribuirão para a segurança do paciente em nível mundial

Post-vaccination Symptoms with Second Dose of AstraZeneca in a Sample of Immunized Population of Ecuadorian Public Servants

Since AstraZeneca is a new vaccine against SARSCOV2, it should be monitored worldwide. This study presents the adverse reactions caused by the second dose of the AstraZeneca vaccine. Thequantitative, descriptive, cross-sectional research used a validated survey conducted on 428 public staff who were vaccinated with the second dose of the ChAdOx1-S vaccine at the Escuela Superior Politécnica de Chimborazo, the results were processed in Jamovi. 289 respondents reported having symptoms after inoculation, women (13.15%) presented more symptoms than men (7.27%). Most of the symptoms, both local and systemic, were mild and subsided with the administration of oral analgesics and lasted up to three days in 50% of the cases. AstraZeneca’s vaccine proves to be a safe biologic vaccine to generate antibodies against SARSCOV” in the adult population, and its use is therefore recommended. Keywords: drug-related side effects and adverse reactions, coronavirus infections, pharmacovigilance Resumen Introducción: Dado que se trata de una nueva vacuna contra el SARSCOV2, debe ser monitoreada a nivel mundial, el presente estudio presenta las reacciones adversas presentadas con la segunda dosis de la vacuna AstraZeneca. Materiales y Métodos: La presente investigación cuantitativa, descriptiva, transversal, utilizó una encuesta validada aplicada a 428 funcionarios públicos que fueron vacunados con la segunda dosis de la vacuna ChAdOx1- S en la Escuela Superior Politécnica de Chimborazo, los resultados fueron procesados en Jamovi . Resultados: 289 encuestados informaron tener síntomas después de la inoculación, las mujeres (13,15%) presentaron más síntomas que los hombres (7,27%). La mayoría de los síntomas, tanto locales como sistémicos, fueron leves y cedieron con la administración de analgésicos orales y duraron hasta tres días en el 50% de los casos. Conclusiones: La vacuna de AstraZeneca demuestra ser una vacuna biológica segura para generar anticuerpos frente al SARSCOV” en la población adulta, por lo que se recomienda su uso. Palabras Clave: kwd2

Systematic review of adverse drug reactions of ofloxacin

Adverse drug reactions (ADRs) are a major cause of morbidity and mortality in countries having limited healthcare resources. Of all the Adverse Drug Reactions, antimicrobials contribute 28% which is highest compared to the other drugs. Ofloxacin is an antimicrobial used for treating several bacterial infections. Incidence rate of adverse drug reactions (ADRs) to ofloxacin is 4.27%. Although these figures appear to be small, it is consumed for gastrointestinal infections along with ornidazole in India contributing significant burden of ADRs. However, there is no research done in past many years focusing on the adverse drug reactions of ofloxacin. This article bridges the gap of such a need. The objective of the present study was to review the adverse drug reactions related to ofloxacin in human and animal studies. Authors conducted Pubmed and Cochrane library search to review all the articles related to the adverse drug reaction of ofloxacin from 1980 to 2016. Authors got 84 articles pertaining to the adverse drug reactions of ofloxacin. Authors conclude that ofloxacin should be judiciously used as the side effect profile is increasing.

A study on the management of corticosteroid side effects in cancer patients

Background Systemic corticosteroids lead to many adverse effects especially in cancer patients. Preventive measures and treatment options are essential to minimise such side effects. Objectives The aims of the study included the evaluation of the prescribers’ management of corticosteroid induced hyperglycaemia, dyspepsia, oral candidiasis and proximal myopathy, the discussion of possible reasons for non-adherence to guidelines, and the recommendation of interventions to reduce their risk of occurrence. Method A retrospective review of the medical records for 156 consecutive patients at oncology out-patients and in oncology wards of Boffa Hospital between the 1st and the 14th September 2014 was performed. Only patients who were on long term corticosteroids (>2 weeks’ duration) were considered. Patients younger than 12 years of age or those that were prescribed corticosteroids for antiemetic purposes were excluded from the study. For each of the sampled patients, any management aimed at reducing corticosteroid side effects was compared to the guidelines as stated in an article published in a prominent international journal. Results From 156 cancer patients, 55 patients satisfied the inclusion criteria. The mostly addressed side effect was dyspepsia (n=35; 63.6%) followed by proximal myopathy (n=27; 49%), hyperglycaemia (n=24; 43.6%) and lastly oral candidiasis (n=20; 36%). Adherence to guidelines was as follows: hyperglycaemia – haemo-glucose test (HGT) and glycated haemoglobin (HbA1c) (36%); dyspepsia - prescribing of omeprazole (51%) and ranitidine (5%); oral candidiasis - orophargyngeal exam (29%); and proximal myopathy (40% compliance; of which 35% complying with resistance and endurance exercise and 5% complying with steroid dose reduction). Conclusion Improvement is required with regards to the management of corticosteroid side effects especially for hyperglycaemia and oral candidiasis. Possible actions that may be taken include strategies to improve guideline awareness, the prescribing of the lowest effective dose, adequate patient education and the implementation of a steroid card.peer-reviewe

Patient-based benefit-risk assessment of medicines: development, refinement, and validation of a content search strategy to retrieve relevant studies

INTRODUCTION: Poor indexing and inconsistent use of terms and keywords may prevent efficient retrieval of studies on the patient-based benefit-risk assessment (BRA) of medicines. We aimed to develop and validate an objectively derived content search strategy containing generic search terms that can be adapted for any search for evidence on patient-based BRA of medicines for any therapeutic area. METHODS: We used a robust multistep process to develop and validate the content search strategy: (1) we developed a bank of search terms derived from screening studies on patient-based BRA of medicines in various therapeutic areas, (2) we refined the proposed content search strategy through an iterative process of testing sensitivity and precision of search terms, and (3) we validated the final search strategy in PubMed by firstly using multiple sclerosis as a case condition and secondly computing its relative performance versus a published systematic review on patient-based BRA of medicines in rheumatoid arthritis. RESULTS: We conceptualized a final search strategy to retrieve studies on patient-based BRA containing generic search terms grouped into two domains, namely the patient and the BRA of medicines (sensitivity 84%, specificity 99.4%, precision 20.7%). The relative performance of the content search strategy was 85.7% compared with a search from a published systematic review of patient preferences in the treatment of rheumatoid arthritis. We also developed a more extended filter, with a relative performance of 93.3% when compared with a search from a published systematic review of patient preferences in lung cancer

Enhanced Safety Surveillance of Influenza Vaccines in General Practice, Winter 2015-16: Feasibility Study

BACKGROUND: The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced real-time surveillance of seasonal influenza vaccination. The EMA has specified a list of adverse events of interest to be monitored. The EMA sets out 3 different ways to conduct such surveillance: (1) active surveillance, (2) enhanced passive surveillance, or (3) electronic health record data mining (EHR-DM). English general practice (GP) is a suitable setting to implement enhanced passive surveillance and EHR-DM. OBJECTIVE: This study aimed to test the feasibility of conducting enhanced passive surveillance in GP using the yellow card scheme (adverse events of interest reporting cards) to determine if it has any advantages over EHR-DM alone. METHODS: A total of 9 GPs in England participated, of which 3 tested the feasibility of enhanced passive surveillance and the other 6 EHR-DM alone. The 3 that tested EPS provided patients with yellow (adverse events) cards for patients to report any adverse events. Data were extracted from all 9 GPs' EHRs between weeks 35 and 49 (08/24/2015 to 12/06/2015), the main period of influenza vaccination. We conducted weekly analysis and end-of-study analyses. RESULTS: Our GPs were largely distributed across England with a registered population of 81,040. In the week 49 report, 15,863/81,040 people (19.57% of the registered practice population) were vaccinated. In the EPS practices, staff managed to hand out the cards to 61.25% (4150/6776) of the vaccinees, and of these cards, 1.98% (82/4150) were returned to the GP offices. Adverse events of interests were reported by 113 /7223 people (1.56%) in the enhanced passive surveillance practices, compared with 322/8640 people (3.73%) in the EHR-DM practices. CONCLUSIONS: Overall, we demonstrated that GPs EHR-DM was an appropriate method of enhanced surveillance. However, the use of yellow cards, in enhanced passive surveillance practices, did not enhance the collection of adverse events of interests as demonstrated in this study. Their return rate was poor, data entry from them was not straightforward, and there were issues with data reconciliation. We concluded that customized cards prespecifying the EMA's adverse events of interests, combined with EHR-DM, were needed to maximize data collection. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2016-015469