A four-years retrospective study: Clinical outcomes of XEN45 in patients with glaucoma.

INTRODUCTION: To evaluate the long-term effectiveness and safety of XEN45 implant, either alone or in combination with cataract surgery, in patients with glaucoma. METHODS: Retrospective and single center study conducted on consecutive patients who underwent a XEN45 implant, either alone or in combination with cataract surgery, between November 2016 and October 2021. The primary endpoint was the mean IOP lowering from preoperative values. RESULTS: Among the 230 screened patients, 206 eyes (176 patients) were included. Fifty-three (25.7%) eyes had undergone XEN-alone and 153 (74.3%) eyes had undergone a combined procedure (XEN+Phacoemulsification). The mean preoperative intraocular pressure (IOP) was significantly higher in the XEN-alone (22.2±5.9 mmHg) than in the XEN+Phaco (19.8±4.5 mmHg) group (p=0.0035). In the overall study population, the mean preoperative IOP was significantly lowered from 20.5±5.0 mmHg to 15.8±4.4 at year-4, p<0.0001. The mean preoperative (95% CI) IOP was significantly lowered from 22.2 (20.6 to 23.8) mmHg and 19.8 (19.1 to 20.6) mmHg to 15.6 (12.2 to 16.9) mmHg and 15.9 (15.2 to 16.5) mmHg at year-4 in the XEN-alone and XEN+Phaco groups, respectively (p<0.0001 each, respectively). The number of ocular hypotensive medications was significant reduced from 2.6±1.0 drugs to 1.3±1.3 drugs, with no significant differences between XEN-alone and XEN+Phaco groups (p=0.1671). On the first postoperative day, 62 (30.1%) eyes presented some type of complication. Fifteen (7.3%) eyes underwent a needling procedure. CONCLUSION: XEN45, either alone or in combination with phacoemulsification, significantly lowered the IOP and reduce the need of ocular hypotensive medication in the long-term.

Validation of a Reduced Set of High-Performance Triggers for Identifying Patient Safety Incidents with Harm in Primary Care: TriggerPrim Project.

OBJECTIVE: The aim of the study was to construct and validate a reduced set of high-performance triggers for identifying adverse events (AEs) via electronic medical records (EMRs) review in primary care (PC). METHODS: This was a cross-sectional descriptive study for validating a diagnostic test. The study included all 262 PC centers of Madrid region (Spain). Patients were older than 18 years who attended their PC center over the last quarter of 2018. The randomized sample was n = 1797. Main measurements were as follows: ( a ) presence of each of 19 specific computer-identified triggers in the EMR and ( b ) occurrence of an AE. To collect data, EMR review was conducted by 3 doctor-nurse teams. Triggers with statistically significant odds ratios for identifying AEs were selected for the final set after adjusting for age and sex using logistic regression. RESULTS: The sensitivity (SS) and specificity (SP) for the selected triggers were: ≥3 appointments in a week at the PC center (SS = 32.3% [95% confidence interval {CI}, 22.8%-41.8%]; SP = 92.8% [95% CI, 91.6%-94.0%]); hospital admission (SS = 19.4% [95% CI, 11.4%-27.4%]; SP = 97.2% [95% CI, 96.4%-98.0%]); hospital emergency department visit (SS = 31.2% [95% CI, 21.8%-40.6%]; SP = 90.8% [95% CI, 89.4%-92.2%]); major opioids prescription (SS = 2.2% [95% CI, 0.0%-5.2%]; SP = 99.8% [95% CI, 99.6%-100%]); and chronic benzodiazepine treatment in patients 75 years or older (SS = 14.0% [95% CI, 6.9%-21.1%]; SP = 95.5% [95% CI, 94.5%-96.5%]).The following values were obtained in the validation of this trigger set (the occurrence of at least one of these triggers in the EMR): SS = 60.2% (95% CI, 50.2%-70.1%), SP = 80.8% (95% CI, 78.8%-82.6%), positive predictive value = 14.6% (95% CI, 11.0%-18.1%), negative predictive value = 97.4% (95% CI, 96.5%-98.2%), positive likelihood ratio = 3.13 (95% CI, 2.3-4.2), and negative likelihood ratio = 0.49 (95% CI, 0.3-0.7). CONCLUSIONS: The set containing the 5 selected triggers almost triples the efficiency of EMR review in detecting AEs. This suggests that this set is easily implementable and of great utility in risk-management practice.

Is primary care a patient-safe setting? Prevalence, severity, nature, and causes of adverse events: numerous and mostly avoidable.

Knowing the frequency and characteristics of adverse events (AEs) is key to implementing actions that can prevent their occurrence. However, reporting systems are insufficient for this purpose and epidemiological studies are also required. Currently, the reviewing of clinical records is the gold standard method for knowing the frequency and characteristics of AEs. Research on AEs in a primary care setting has been limited and primarily focuses on specific types of events (medication errors, etc.) or patients. Large studies that search for any kind of AE in all patients are scarce. This study aimed to estimate the prevalence of AEs in the primary care setting and their characteristics. SETTING: all 262 primary health-care centres in the Madrid region (Spain) during the last quarter of 2018. DESIGN: cross-sectional descriptive study. Eligible population: subjects over 18 years of age who attended medical consultation over the last year (N = 2 743 719); a randomized sample stratified by age. MAIN OUTCOMES: age, sex, occurrence of an AE, number of consultations in the study period, avoidability, severity, place of occurrence, type of event, and contributory factors. The clinical records were reviewed by three teams, each composed of one doctor and one nurse trained and with expertise in patient safety. The SPSS software package (version 26) was used for the statistical analyses. The evaluators reviewed 1797 clinical records. The prevalence of AEs over the study period was 5.0% [95% confidence interval (CI): 4.0%‒6.0%], with higher values in women (5.7%; 95% CI: 4.6%‒6.8%;P = 0.10) and patients over 75 years of age (10.3%; 95% CI: 8.9%‒11.7%; P < 0.001). The overall occurrence per hundred consultations was estimated to be 1.58% (95% CI: 1.28%‒1.94%). Of the detected AEs, 71.3% (95% CI: 62.1%‒80.5%) were avoidable. Additionally, 60.6% (95% CI: 50.7%‒70.5%) were categorized as mild, 31.9% (95% CI: 22.4%‒41.4%) as moderate, and 7.4% (95% CI: 2.1%‒12.7%) as severe. Primary care was the occurrence setting in 76.6% (95% CI: 68.0%‒85.2%) of cases. The overall incidence of AEs related to medication was 53.2% (95% CI: 50.9%‒55.5%). The most frequent types of AEs were prescription errors (28.7%; 95% CI: 19.5%‒37.9%), followed by drug administration errors by patients (17.0%; 95% CI: 9.4%‒24.6%), and clinical assessment errors (11.7%; 95% CI: 5.2%‒18.2%). The most common contributory factors were those related to the patient (80.6%; 95% CI: 71.1%‒90.1%) and tasks (59.7%; 95% CI: 48.0%‒71.4%). A high prevalence of AEs (1 in 66 consultations) was observed, which was slightly higher than that reported in similar studies. About 3 out of 4 such events were considered to be avoidable and 1 out of 13 was severe. Prescription errors, drug administration errors by patients, and clinical assessment errors were the most frequent types of AEs. Graphical Abstract.

Objective Diagnosis of Fibromyalgia Using Neuroretinal Evaluation and Artificial Intelligence / Diagnóstico objetivo de fibromialgia analizando la neurorretina con inteligencia artificial

ResumenAntecedentes/Objetivo: Identificar biomarcadores objetivos de fibromialgia (FM) apli-cando inteligencia artificial a datos estructurales de retina obtenidos mediante tomogra-fía de coherencia óptica Swept Source (TCO-SS). Método: Se evaluó una cohorte de 29 pacientes con FM y otra de 32 sujetos control, registrando los espesores de la retina completa, de varias capas de la retina [capa de células ganglionares (CCG+), CCG amplia-da (CCG++, entre la membrana limitante interna y los límites de la capa nuclear interna) y capa de fibras nerviosas (CFNR)] y de la coroides, mediante TCO-SS. La capacidad dis-criminante se evaluó mediante el área bajo la curva ROC (AROC) y el algoritmo Relief. Se implementó un sistema de ayuda al diagnóstico con clasificador automático. Resultados: No se observó diferencia significativa (p ≥ 0,660) en la coroides, pero sí en el sector in-ferior del anillo interno de la CFNR (p = 0,010) y en los cuatro sectores del anillo interno en las capas CCG+, CCG++ y retina completa. Utilizando un árbol de decisión ensemble RUSBoosted como clasificador de las características con mayor capacidad discriminante, se obtuvo una predicción alta (AROC = 0,820). Conclusiones: Se identifica un potencial biomarcador objetivo y no invasivo para el diagnóstico de FM basado en el análisis de la neurorretina mediante TCO-SS.

AbstractBackground/Objective: This study aims to identify objective biomarkers of fibromyalgia (FM) by applying artificial intelligence algorithms to structural data on the neuroretina obtained using swept-source optical coherence tomography (SS-OCT). Method: The study cohort comprised 29 FM patients and 32 control subjects. The thicknesses of complete retina, 3 retinal layers [ganglion cell layer (GCL+), GCL++ (between the inner limiting membrane and the inner nuclear layer boundaries) and retinal nerve fiber layer (RNFL)] and choroid in 9 areas around the macula were obtained using SS-OCT. Discriminant capacity was evaluated using the area under the curve (AUC) and the Relief algorithm. A diagnostic aid system with an automatic classifier was implemented. Results: No significant difference (p ≥ .660) was found anywhere in the choroid. In the RNFL, a significant difference was found in the inner inferior region (p = .010). In the GCL+, GCL++ layers and complete retina, a significant difference was found in the 4 regions defining the inner ring: temporal, superior, nasal and inferior. Applying an ensemble RUSBoosted tree classifier to the features with greatest discriminant capacity achieved accuracy = .82 and AUC = .82. Conclusions: This study identifies a potential novel objective and non-invasive biomarker of FM based on retina analysis using SS-OCT.

Evaluation of Progressive Retinal Degeneration in Bipolar Disorder Patients over a Period of 5 Years.

PURPOSE: To quantify visual and retinal changes in patients with bipolar disorder (BD) over 5 years, compared with controls. METHODS: Thirty-eight patients with BD and 122 healthy subjects underwent visual acuity (VA) evaluation, contrast sensitivity vision testing (CSV) with the Pelli Robson and CSV 1000E tests, and retinal thicknesses measurement [ganglion cell layer (GCL) and retinal nerve fiber layer (RNFL)] using Spectralis Optical Coherence Tomography (OCT). All subjects were re-evaluated after 5 years. The relationship between progressive structural changes and disease duration was analyzed. RESULTS: Visual function parameters in BD patients remained unchanged during the follow-up period. A progressive decrease affecting macular and peripapillary RNFL thickness (p < 0.050) was observed in patients. Progressive changes in BD were more pronounced when compared with healthy controls (p < 0.050). A significant correlation between GCL thickness changes and disease duration was found (GCL outer temporal, r = -0.680, p = 0.016; GCL central, r = -0.540, p = 0.038). CONCLUSIONS: Progressive axonal loss was detected in BD patients. Visual function parameters were not affected after the 5-year follow-up. Despite observed changes in the neuroretina of patients with BD, axonal degeneration in these patients seemed to be mild and might be slowed down by other factors, such as BD treatments.

Objective Diagnosis of Fibromyalgia Using Neuroretinal Evaluation and Artificial Intelligence.

Background/Objective: This study aims to identify objective biomarkers of fibromyalgia (FM) by applying artificial intelligence algorithms to structural data on the neuroretina obtained using swept-source optical coherence tomography (SS-OCT). Method: The study cohort comprised 29 FM patients and 32 control subjects. The thicknesses of complete retina, 3 retinal layers [ganglion cell layer (GCL+), GCL++ (between the inner limiting membrane and the inner nuclear layer boundaries) and retinal nerve fiber layer (RNFL)] and choroid in 9 areas around the macula were obtained using SS-OCT. Discriminant capacity was evaluated using the area under the curve (AUC) and the Relief algorithm. A diagnostic aid system with an automatic classifier was implemented. Results: No significant difference (p ≥ .660) was found anywhere in the choroid. In the RNFL, a significant difference was found in the inner inferior region (p = .010). In the GCL+, GCL++ layers and complete retina, a significant difference was found in the 4 regions defining the inner ring: temporal, superior, nasal and inferior. Applying an ensemble RUSBoosted tree classifier to the features with greatest discriminant capacity achieved accuracy = .82 and AUC = .82. Conclusions: This study identifies a potential novel objective and non-invasive biomarker of FM based on retina analysis using SS-OCT.

Antecedentes/Objetivo: Identificar biomarcadores objetivos de fibromialgia (FM) aplicando inteligencia artificial a datos estructurales de retina obtenidos mediante tomografía de coherencia óptica Swept Source (TCO-SS). Método: Se evaluó una cohorte de 29 pacientes con FM y otra de 32 sujetos control, registrando los espesores de la retina completa, de varias capas de la retina [capa de células ganglionares (CCG+), CCG ampliada (CCG++, entre la membrana limitante interna y los límites de la capa nuclear interna) y capa de fibras nerviosas (CFNR)] y de la coroides, mediante TCO-SS. La capacidad discriminante se evaluó mediante el área bajo la curva ROC (AROC) y el algoritmo Relief. Se implementó un sistema de ayuda al diagnóstico con clasificador automático. Resultados: No se observó diferencia significativa (p ≥ .660) en la coroides, pero sí en el sector inferior del anillo interno de la CFNR (p = .010) y en los cuatro sectores del anillo interno en las capas CCG+, CCG++ y retina completa. Utilizando un árbol de decisión ensemble RUSBoosted como clasificador de las características con mayor capacidad discriminante, se obtuvo una predicción alta (AROC=.820). Conclusiones: Se identifica un potencial biomarcador objetivo y no invasivo para el diagnóstico de FM basado en el análisis de la neurorretina mediante TCO-SS.

Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action.

BACKGROUND: There is increased recognition that incorporating patients' perspectives and insights into the medicines development process results in better health outcomes and benefits for all involved stakeholders. Despite the increased interest and the existence of frameworks and practical recommendations, patient engagement (PE) is not yet considered standard practice. The objective of this work was to provide a roadmap to support systematic change in all stakeholder organisations involved in medicines development across Europe, patients and patient organisations, medicines developers, academia, regulatory authorities, Health Technology Assessment bodies, payers, policy-makers and public research funders, to sustain PE practices. METHODS: A mixed-methods approach was used by the EU-funded Innovative Medicines Initiative PARADIGM Consortium to co-develop the sustainability roadmap including background work to identify success factors and scenarios for sustainable PE. The roadmap development was based on the Theory of Change concept and populated with findings from (1) interviews with national/ and international institutions with the potential to increase PE uptake by other stakeholders; (2) multi-stakeholder workshops and webinars; and (3) consultations with specific stakeholder groups, Consortium members and a consultative body formed by international PE initiatives. RESULTS: This roadmap sets strategic goals for the PE community to achieve meaningful and systematic PE through changes in the culture, processes and resources of stakeholder organisations. It brings in key PARADIGM outputs to work in a coordinated fashion with existing frameworks and mechanisms to achieve system-wide sustained PE. CONCLUSIONS: The roadmap provides a framework for all stakeholders to take collective action within their organisations and across Europe to implement PE in a sustainable manner.

Eficacia de las perfusiones de lidocaína en la fibromialgia / Efficacy of lidocaine perfusions in fibromyalgia: a prospective cohort study

INTRODUCCIÓN: La fibromialgia se define como un síndrome de dolor crónico benigno caracterizado por dolor generalizado, fatiga, alteración del sueño, ansiedad y depresión, y en muchas ocasiones una respuesta al tratamiento insuficiente y frustrante que obliga a la comunidad médica a un esfuerzo continuo en la búsqueda de un tratamiento óptimo. Hemos evaluado el efecto de la lidocaína intravenosa en perfusión sobre las diferentes características de la fibromialgia. MÉTODOS: Después de la aprobación del comité de ética de nuestro hospital y el consentimiento informado de cada paciente, se incluyeron 62 pacientes con criterio de fibromialgia según la American College of Rheumatology. Se realizaron perfusión de lidocaína a dosis creciente desde 2 mg/kg hasta 5 mg/kg durante 10 días. En todos los casos se rellenaron los siguientes cuestionarios en el día 0 (pretratamiento), día 10 (postratamiento) día 30 y día 90: Health Survey SF-12 (SF-12), Fibromyalgia Impact Questionnaire (FIQ), Brief Pain Inventory (BPI), Big Five Inventory (BFI), Beck Depression Inventory II (BDI-II), Medical Outcomes Sleep Scale (MOS), Patient Improvement Expectations (EXPEC). RESULTADOS: De los 62 pacientes, 9 abandonaron el estudio por efectos adversos intolerables y 5 se perdieron o no completaron los cuestionarios en los siguientes meses. Finalmente completaron el estudio 48 pacientes, 46 mujeres y 2 hombres con una edad media de 55 (36-70) años. Encontramos una mejoría en los cuestionarios BPI, BFI y BDI-II en el día 10 que no se mantienen a los 30 días. DISCUSIÓN: En nuestro estudio el tratamiento con perfusiones de lidocaína en pacientes con fibromialgia objetivó una buena eficacia inicial que no se mantuvo con el paso del tiempo

INTRODUCTION: Fibromyalgia is defined as a pain syndrome characterized by generalized chronic pain, fatigue, sleep disturbances, anxiety and depression and, at times, an insufficient and frustrating treatment response. It is a benign condition chronically suffered by many patients, which forces the medical community on an ongoing search for an optimal treatment. We evaluated the effect of intravenous lidocaine on the different characteristics of fibromyalgia. METHOD: This is a prospective, longitudinal study. We recorded data for 48 patients diagnosed with fibromyalgia syndrome according with the American College of Rheumatology criteria (ACR 1990). Patients with abnormal electrocardiogram or abnormal blood electrolytes were excluded. Included cases received an increasing dose of 2 mg/kg up until 5 mg/kg of an intravenous lidocaine perfusion during 10 days. All included cases filled the following questionnaires at day 0 (pre-treatment), day 10 (post-treatment) day 30 and day 90: Health Survey SF-12 (SF-12), Fibromyalgia Impact Questionnaire (FIQ), Brief Pain Inventory (BPI), Big Five Inventory (BFI), Beck Depression Inventory II (BDI-II), Medical Outcomes Sleep Scale (MOS), Patient Improvement Expectations (EXPEC). RESULTS: 48 cases were recorded, 46 were female and 2 were male, the median age was 55 (36-70). We found improvement in pain, fatigue and psychological attitude at 10 days that disappears at 30 days. DISCUSSION: The treatment with infusion of intravenous lidocaine at these doses on this set of patients did not modify the clinical characteristics of fibromyalgia as a sustained manner