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From November 2014 to May 2017, 332 patients homogeneously treated with bortezomib, lenalidomide, and dexamethasone (VRD) induction, autologous stem cell transplant, and VRD consolidation were randomly assigned to receive maintenance therapy with lenalidomide and dexamethasone (RD; 161 patients) vs RD plus ixazomib (IRD; 171 patients). RD consisted of lenalidomide 15 mg/d from days 1 to 21 plus dexamethasone 20 mg/d on days 1 to 4 and 9 to 12 at 4-week intervals, whereas in the IRD arm, oral ixazomib at a dose of 4 mg on days 1, 8, and 15 was added. Therapy for patients with negative measurable residual disease (MRD) after 24 cycles was discontinued, whereas those who tested positive for MRD remained on maintenance with RD for 36 more cycles. After a median follow-up of 69 months from the initiation of maintenance, the progression-free survival (PFS) was similar in both arms, with a 6-year PFS rate of 61.3% and 55.6% for RD and IRD, respectively (hazard ratio, 1.136; 95% confidence interval, 0.809-1.603). After 2 years of maintenance, treatment was discontinued in 163 patients with negative MRD, whereas 63 patients with positive MRD continued with RD therapy. Maintenance discontinuation in patients tested negative for MRD resulted in a low progression rate (17.2% at 4 years), even in patients with high-risk features. In summary, our results show the efficacy of RD maintenance and support the safety of maintenance therapy discontinuation in patients with negative MRD at 2 years. This trial was registered at www.clinicaltrials.gov as #NCT02406144 and at EudraCT as 2014-00055410.
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Mieloma Múltiple , Humanos , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Dexametasona/uso terapéutico , Lenalidomida/uso terapéutico , Mieloma Múltiple/terapiaRESUMEN
Although light-chain amyloidosis (AL) and multiple myeloma (MM) are characterized by tumor plasma cell (PC) expansion in bone marrow (BM), their clinical presentation differs. Previous attempts to identify unique pathogenic mechanisms behind such differences were unsuccessful, and no studies have investigated the differentiation stage of tumor PCs in patients with AL and MM. We sought to define a transcriptional atlas of normal PC development in secondary lymphoid organs (SLOs), peripheral blood (PB), and BM for comparison with the transcriptional programs (TPs) of tumor PCs in AL, MM, and monoclonal gammopathy of undetermined significance (MGUS). Based on bulk and single-cell RNA sequencing, we observed 13 TPs during transition of normal PCs throughout SLOs, PB, and BM. We further noted the following: CD39 outperforms CD19 to discriminate newborn from long-lived BM-PCs; tumor PCs expressed the most advantageous TPs of normal PC differentiation; AL shares greater similarity to SLO-PCs whereas MM is transcriptionally closer to PB-PCs and newborn BM-PCs; patients with AL and MM enriched in immature TPs had inferior survival; and protein N-linked glycosylation-related TPs are upregulated in AL. Collectively, we provide a novel resource to understand normal PC development and the transcriptional reorganization of AL and other monoclonal gammopathies.
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Amiloidosis de Cadenas Ligeras de las Inmunoglobulinas/patología , Mieloma Múltiple/patología , Células Plasmáticas/patología , Transcriptoma , Adulto , Humanos , Amiloidosis de Cadenas Ligeras de las Inmunoglobulinas/genética , Mieloma Múltiple/genética , Células Plasmáticas/metabolismo , Células Tumorales CultivadasRESUMEN
Achieving and maintaining a high-quality response is the treatment goal for patients with newly diagnosed multiple myeloma (NDMM). The phase 3 PETHEMA/GEM2012 study, in 458 patients aged ≤65 years with NDMM, is evaluating bortezomib (subcutaneous) + lenalidomide + dexamethasone (VRD) for 6 cycles followed by autologous stem cell transplant (ASCT) conditioned with IV busulfan + melphalan vs melphalan and posttransplant consolidation with 2 cycles of VRD. We present grouped response analysis of induction, transplant, and consolidation. Responses deepened over time; in patients who initiated cycle 6 of induction (n = 426), the rates of a very good partial response or better were 55.6% by cycle 3, 63.8% by cycle 4, 68.3% by cycle 5, and 70.4% after induction. The complete response rate of 33.4% after induction in the intent-to-treat (ITT) population, which was similar in the 92 patients with high-risk cytogenetics (34.8%), also deepened with further treatment (44.1% after ASCT and 50.2% after consolidation). Rates of undetectable minimal residual disease (median 3 × 10-6 sensitivity) in the ITT population also increased from induction (28.8%) to transplant (42.1%) and consolidation (45.2%). The most common grade ≥3 treatment-emergent adverse events during induction were neutropenia (12.9%) and infection (9.2%). Grade ≥2 peripheral neuropathy (grouped term) during induction was 17.0%, with a low frequency of grade 3 (3.7%) and grade 4 (0.2%) events. VRD is an effective and well-tolerated regimen for induction in NDMM with deepening response throughout induction and over the course of treatment. This trial was registered at www.clinicaltrials.gov as #NCT01916252 and EudraCT as #2012-005683-10.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Quimioterapia de Inducción/métodos , Mieloma Múltiple/tratamiento farmacológico , Terapia Neoadyuvante/métodos , Adulto , Anciano , Bortezomib/administración & dosificación , Bortezomib/efectos adversos , Quimioterapia Adyuvante/métodos , Dexametasona/administración & dosificación , Dexametasona/efectos adversos , Femenino , Trasplante de Células Madre Hematopoyéticas/métodos , Humanos , Lenalidomida/administración & dosificación , Lenalidomida/efectos adversos , Masculino , Persona de Mediana Edad , Acondicionamiento Pretrasplante/métodos , Trasplante AutólogoRESUMEN
AIM: To determine the impact of the Best Practice Spotlight Organization® initiative on nurses' perception of their work environment and their attitudes to evidence-based practice. DESIGN: Quasi-experimental, multicentre study. The intervention is the participation in Best Prectice Spotilight Organizations to implement Best Practice Guidelines. METHODS: The study will include seven centres in the interventional group and 10 in the non-equivalent control group, all of them belonging to the Spanish national health system. The Practice Environment Scale of the Nursing Work Index, and the Health Sciences Evidence-Based Practice Questionnaire will be administered to a sample of 1,572 nurses at the beginning of the programme and at 1 year. This 3-year study started in April 2018 and will continue until December 2021. Statistical analyses will be carried out using the SPSS 25.0. This project was approved by the Drug Research Ethics Committee of the Parc de Salut Mar and registered in Clinical Trials. DISCUSSION: The study findings will show the current state of nurses' perception of their work environment and attitudes to evidence-based practice, and possible changes in these parameters due to the programme. IMPACT: The findings could provide a strong argument for health policymakers to scale up the Best Practice Spotlight Organization® initiative in the Spanish national health system.
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Práctica Clínica Basada en la Evidencia , Enfermeras y Enfermeros , Conocimientos, Actitudes y Práctica en Salud , Humanos , Estudios Multicéntricos como Asunto , Rol de la Enfermera , Encuestas y CuestionariosRESUMEN
AIM: The gap between research and clinical practice leads to inconsistent decision-making and clinical audits are an effective way of improving the implementation of best practice. Our aim is to assess the effectiveness of a model that implements evidence-based recommendations for patient outcomes and healthcare quality. DESIGN: National quasi-experimental, multicentre, before and after study. METHODS: This study focuses on patients attending primary care and hospital care units and associated socio-healthcare services. It uses the Joanna Brigg's Institute Getting Research into Practice model, which improves processes by referring to prior baseline clinical audits. The variables are process and outcome criteria for pain, urinary incontinence, and fall prevention, with data collection at baseline and key points over 12 months drawn from clinical histories and records. Project funding was received from the Spanish Strategic Health Action in November 2014. DISCUSSION: The project results will provide knowledge on the effectiveness of the Getting Research into Practice model, to apply evidence-based recommendations for the detection and management of pain, urinary incontinence, and fall prevention. It will also establish whether using research results, based on clinical audits and situation analysis, is effective for implementing evidence-based recommendations and improving patients' health. IMPACT: This nationwide Spanish project aims to detect and prevent high-prevalence healthcare problems, namely pain in patients at any age and falls and urinary incontinence in people aged 65 and over. Tailoring clinical practice to evidence-based recommendations will reduce unjustified clinical variations in providing healthcare services. Clinical Trial ID: NCT03725774.
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Calidad de la Atención de Salud , Accidentes por Caídas/prevención & control , Anciano , Auditoría Clínica , Toma de Decisiones , Humanos , Manejo del Dolor/normas , España , Incontinencia Urinaria/prevención & controlRESUMEN
AIMS: To determine how prevalent circadian rhythm impairments are in nurses working in medical, surgical and intensive care units in five Spanish hospitals and how the quality of night-time sleeping and sleepiness affect the nurses' morning and evening chronotypes. BACKGROUND: Shift work is a recognized work pattern for nurses in all countries. Given the important role that nurses play in hospital care, it is vital to establish what repercussions this has on the nurses' working schedules and how any disturbance in circadian rhythm affects patient safety. DESIGN: A multicentre, observational, descriptive and cross-sectional study in seven hospitals in the Spanish National Health System. METHOD: A stratified sample of 1,300 nurses is being collected in three types of units: medical, surgical and intensive care. The 3-year study started in January 2012 and will continue until December 2014, with no exclusion criteria. The Kronowise(®) will be used to monitor the nurses' circadian rhythms, by recording their activity, position and wrist temperature. We will also use three questionnaires to evaluate sleep quality, daytime drowsiness and chronotype: (a) Pittsburg Sleep Quality Index; (b) Epworth Daytime Sleepiness Scale; and (c) Morning and Evening Questionnaire. Data will be collected from each hospital and statistical analysis will be carried out using the SPSS 19.0. DISCUSSION: The study findings will show the current state of the nurses' circadian rhythms and how shift work can affect them and their job performance. Funding for this 3-year study was granted in December 2011 by the Spanish Health Research Fund (PI 11/00646, Health Ministry). This project is also funded by the Instituto de Salud Carlos III (RETICEF, RD12/0043/0011, RD12/0043/0006).
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Ritmo Circadiano/fisiología , Personal de Enfermería en Hospital/estadística & datos numéricos , Trastornos del Sueño-Vigilia/etiología , Tolerancia al Trabajo Programado/fisiología , Estudios Transversales , Femenino , Humanos , Masculino , Enfermeras Obstetrices/estadística & datos numéricos , Enfermeras y Enfermeros/estadística & datos numéricos , Trastornos del Sueño-Vigilia/epidemiología , España/epidemiologíaRESUMEN
OBJECTIVE: It is necessary to facilitate the implementation of evidence-based practice in clinical practice to improve patients' health results. Sumamos Excelencia® is an implementation project led by nurses that aims to improve the evidence-based practice uptake. Building on the first edition, we have improved the project design and proposed new intervention topics. The objective is to evaluate the effects of the implementation of evidence-based recommendations through a multifaceted implementation strategy. METHODS: This study is an implementation research with a quasi-experimental, multicentre, before-and-after design and audits for data collection at baseline, 3, 6, and 12 months. It will be developed in hospital units, primary care centres, and nursing homes. Units choose to implement recommendations of one of these topics: assessment and management of pain, conservative management of urinary incontinence, prevention of childhood obesity, or breastfeeding promotion. All units will implement recommendations about hand hygiene. Audits will assess changes in process and patient outcomes, barriers and strategies, and evidence-based practice competencies through specific questionnaires and clinical records data. Analysis will be descriptive and inferential. CONCLUSIONS: Sumamos Excelencia® will aim to improve the use of evidence-based practice in the Spanish National Health System and to advance implementation science. This study will also provide important insight into the barriers that nurses face to implementing evidence-based practice in clinical practice and the strategies that they can use to overcome them. This generated knowledge can be used in other evidence-based practice implementation projects in a similar context to enhance adherence to evidence-based recommendations.
OBJECTIVE: Es necesario facilitar la implantación de la evidencia científica en la práctica clínica para mejorar los resultados de salud de los pacientes. Sumamos Excelencia® es un proyecto de implantación liderado por enfermeras para aumentar el uso de prácticas basadas en la evidencia en la práctica clínica. En base a la primera edición, se ha mejorado el diseño del proyecto y desarrollado nuevos paquetes de intervención clínica. El objetivo es evaluar los efectos de la implantación de recomendaciones basadas en evidencia en la práctica clínica mediante una estrategia de implantación multifacética. METHODS: Investigación en implantación con diseño cuasi-experimental multicéntrico antes-después sin grupo control, auditorías a los 0, 3, 6 y 12 meses. Realizado en unidades hospitalarias, centros de atención primaria y centros sociosanitarios. Las unidades eligen buenas prácticas sobre una intervención clínica: evaluación y manejo del dolor, manejo conservador de la incontinencia urinaria, prevención de la obesidad infantil o promoción de la lactancia materna. Todas implantarán recomendaciones sobre higiene de manos. Las auditorías evaluarán cambios en procesos y resultados, barreras y estrategias, y competencias de práctica basada en evidencia mediante cuestionarios específicos y registros clínicos. Análisis descriptivo e inferencial. CONCLUSIONS: Sumamos Excelencia® pretende mejorar el uso de la práctica basada en evidencia y aportar conocimiento a la ciencia de la implantación. Proporcionará información sobre las barreras para implantar prácticas basadas en evidencia en la práctica clínica y las estrategias para superarlas. El conocimiento generado puede utilizarse en otros proyectos de implantación para mejorar la adherencia a las recomendaciones basadas en evidencia.
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Enfermería Basada en la Evidencia , España , Humanos , Enfermería Basada en la Evidencia/organización & administración , Guías de Práctica Clínica como AsuntoRESUMEN
Radioactive radon gas poses significant threats to human health. Understanding the complexities of radon distribution and the dynamic relationship with atmospheric parameters will help in mitigating its impact. In this study, Multifractal Detrended Fluctuation Analysis (MF-DFA) and chaos analysis were used to examine the fractal structure in radon gas at La Cueva del Viento, Tenerife, between January 2021 and December 2022. The results showed that radon has multifractal properties in 2021, 2022, and 2021-2022, with values of the spectrum with of about 0.43, 0.49 and 0.44 respectively. The multifractality in radon gas was found to be driven by both long-range correlations and fat-tail distribution. Radon gas concentration at La Cueva del Viento was found to be chaotic in nature, hence, long-term prediction is impossible. Meteorological parameters such as relative humidity, air temperature and pressure were found to contribute to the variation in radon gas concentration within the cave. Relative humidity was observed to have the strongest cross-correlation with radon gas in 2021, 2022, and 2021-2022. The results from this study will help in dosimetric control for both workers and visitors to the cave.
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BACKGROUND: Evidence from randomized studies support complete over culprit-only revascularization for patients with acute coronary artery syndrome (ACS) and multivessel coronary artery diseases (MVD). Whether these findings extend to elderly patients, however, has not been thoroughly explored. METHODS: We conducted a systematic review and meta-analysis comparing clinical outcomes of elderly individuals (defined as age ≥75â years) with ACS and MVD submitted to complete vs partial-only percutaneous coronary intervention (PCI). PubMed, Embase, and Cochrane were searched. We computed pooled hazard ratios with 95% confidence intervals (CI) to preserve time time-to-event data. RESULTS: We included 7 studies, of which 2 were RCT and 5 were multivariable adjusted cohorts, comprising a total 10â 147, of whom 43.8% underwent complete revascularization. As compared with partial-only PCI, complete revascularization was associated with a lower all-cause mortality (hazard ratio 0.71; 95% CI 0.60-0.85; Pâ <â 0.01), cardiovascular mortality (hazard ratio 0.64; 95% CI 0.52-0.79; Pâ <â 0.01), and recurrent myocardial infarction (hazard ratio 0.65; 95% CI 0.50-0.85; Pâ <â 0.01). There was no significant difference between groups regarding the risk of revascularizations (hazard ratio 0.80; 95% CI 0.53-1.20; Pâ =â 0.28). CONCLUSION: Among elderly patients with ACS and multivessel CAD, complete revascularization is associated with a lower risk of all-cause mortality, cardiovascular mortality, and recurrent myocardial infarction.
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INTRODUCTION AND OBJECTIVES: Effectiv. e management of post-operative pain improves the condition of patients and reduces their hospital stay. This, in turn, has an impact on caregivers, professionals, and institutions and, as such, is considered a primary indicator of quality. The aim of this project was to improve the assessment and management of post-surgical pain in thoracic surgery patients. METHODS: This implementation project was conducted in a thoracic surgery unit of a tertiary hospital in Spain. The project was guided by the JBI Evidence Implementation Framework, which is grounded in an audit, feedback, and re-audit strategy. A baseline audit was conducted with 44 patients, and barriers to best practice were identified. Strategies were then implemented to improve the assessment and management of post-operative pain. Three follow-up audits were performed using nine audit criteria with 34, 40, and 46 patients, respectively. RESULTS: The baseline audit revealed poor compliance with best practices. After implementing strategies to address areas of non-compliance, health education for patients and caregivers improved up to 80%, while the measurement of pain upon admission and post-surgery rose to 91%. However, patients undergoing pre-operative assessment to guide their post-operative pain management at hospital discharge remained below 50%. CONCLUSIONS: Using a methodology to implement best practices, together with clinical audits, improved compliance with the use of validated scales to assess and manage pain. A multidisciplinary approach improves the quality of care received by patients and contributes to their recovery. SPANISH ABSTRACT: http://links.lww.com/IJEBH/A240.
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OBJECTIVE: The objective of this study is to evaluate the content validity of the Iberian Spanish version of the questionnaire The Practice Environment Scale of the Nursing Work Index (PES-NWI) by using the Content Validity Indexing (CVI). METHODS: A descriptive cross-sectional observational study was conducted. The Spanish version of the questionnaire was translated from the American English instrument through forward and back translation processes. Experts evaluated the translated items through content validity indexing. Once the assessments were completed, CVI indicators were calculated: number of agreements, item Content Validity Index and overall content validity and modified kappa coefficient of the instrument. RESULTS: The overall content validity of the instrument was 0.82. The average modified kappa coefficient of the items was 0.80, with a rating of 'excellent'. Only 4 of the items were rated as weak or poor. CONCLUSIONS: The study demonstrates that the content validity of the Spanish version of the PES-NWI is acceptable. Some results indicate that some items have cross-cultural applicability challenges that need to be addressed in future research studies. Use of the instrument in other Spanish language speaking countries should be taken with caution since some words may not reflect the language of the healthcare systems there.
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Proceso de Enfermería , Traducción , Estudios Transversales , España , Encuestas y CuestionariosRESUMEN
OBJECTIVES: The aim of this project was to improve compliance with evidence-based criteria regarding risk of delirium and the assessment of delirium among older patients in the general hospitalization wards and the emergency department. INTRODUCTION: More than 50% of older hospitalized patients experience delirium. Some studies have highlighted the need to implement an orientation protocol in the emergency department and to continue this in the general wards, with the aim of decreasing the delirium rate among older patients admitted to hospital. METHODS: The project followed the JBI evidence implementation framework. We conducted a baseline audit, a half-way audit, and final audit of 50 patients at risk of delirium admitted to the emergency department and the general wards, respectively. The audits measured compliance with eight criteria informed by the available evidence. RESULTS: In the final audit, three of the eight criteria achieved more than 50% compliance in the general wards: pressure injury screening (96%); monitoring changes (74%); and performing interventions (76%). In the emergency department, worse results were reported because of the service conditions. The exception was the criterion on the training of nurses on the topic, with 98%. The integration of a tool to screen for delirium in older patients in the hospital's electronic clinical history records increased the percentage of compliance with audit criteria regarding the use of the scale and delirium detection (rising from 0% to 32% in the final audit in the general wards). CONCLUSION: Through the implementation of this project, validated and evidence-based evaluation will ensure that nurses are supported through appropriate measures to reduce patient confusion and aggression resulting from delirium.
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Delirio , Habitaciones de Pacientes , Humanos , Anciano , Hospitales , Hospitalización , Delirio/diagnóstico , Delirio/prevención & control , Servicio de Urgencia en HospitalRESUMEN
OBJECTIVES: This project aimed to improve compliance with evidence-based practice in pain assessment and management in a gynecology ward. INTRODUCTION: Effective pain control is important to prevent the negative consequences of pain that is poorly managed. However, it remains undervalued and inadequately treated. Applying evidence-based practices to correctly evaluate and manage pain is essential to improve pain relief. METHODS: This project followed the JBI Evidence Implementation Framework. A baseline audit of 41 women admitted to the gynecology ward was conducted and measured against 5 best practice criteria, along with a patient satisfaction questionnaire. Targeted strategies were then implemented and a follow-up audit was conducted using the same criteria, methods, and sample size as the baseline audit. RESULTS: The baseline audit revealed gaps between current and best practice. Barriers to implementation were identified and strategies to resolve the barriers were designed and implemented (nurse education, informative materials, electronic patient records system improvements). Comprehensive pain assessment, including dynamic and static pain assessment, use of a validated tool, and education provided to patients and carers, improved in the follow-up audit. There was no change in patient satisfaction levels; however, the discrepancy between pain measured by nurses and pain measured by patients was reduced. CONCLUSIONS: The JBI methodology was useful in improving compliance with evidence-based practice criteria. It also facilitated adaptation to new barriers, such as the COVID-19 pandemic. Improving nurses' knowledge of pain assessment can lead to more accurate assessment. Inadequate records systems also made it difficult to record the care that was provided. Subsequent audits will assess sustainability and the project will be escalated to other wards.
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Ginecología , Humanos , Adulto , Femenino , Dimensión del Dolor , Competencia Clínica , Pandemias , DolorRESUMEN
La Cueva del Viento is a volcanic lava tube located in Tenerife Island (Canary Islands, Spain). Its touristic section, 180 m long, receives more than 28,200 visitants each year. According to the European and Spanish legislation, a radon monitoring program is required to minimize the radon exposition of workers, tourists, and cavers. In this work, we studied the radon concentration dynamics in the touristic section of the cave for ca. 1 year, using both passive and active radon detectors. Pluviometry and external air temperature played an important role in the seasonal and daily variations of indoor radon concentrations. Daily fluctuations during the dry season were analyzed using time series (Box-Jenkins methodology) and frequency analysis (Fourier and Wavelet transforms) methods. The experimental radon time-series was well-fitted using a seasonal autoregressive integrated moving average model: Seasonal Auto-Regressive Integrated Moving Average (2,0,1) (2,1,0)24, and its value, in a short-time window (ca. 1 week) was conveniently forecasted. Finally, this work revealed that the annual effective doses received, during the observation period (1 year), by the touristic guides and visitors was ca. 2 mSv/yr and 4 µSv/hr, respectively. We concluded that the touristic exploitation of La Cueva del Viento is safe for both tourists and guides. However, based on our results, La Cueva del Viento had to be classified as a "Monitoring zone" and a regular monitoring program should be implemented.
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PURPOSE: The existence of patients with multiple myeloma (MM) and light-chain (AL) amyloidosis who present with a monoclonal gammopathy of undetermined significance (MGUS)-like phenotype has been hypothesized, but methods to identify this subgroup are not standardized and its clinical significance is not properly validated. PATIENTS AND METHODS: An algorithm to identify patients having MGUS-like phenotype was developed on the basis of the percentages of total bone marrow (BM) plasma cells (PC) and of clonal PC within the BM PC compartment, determined at diagnosis using flow cytometry in 548 patients with MGUS and 2,011 patients with active MM. The clinical significance of the algorithm was tested and validated in 488 patients with smoldering MM, 3,870 patients with active MM and 211 patients with AL amyloidosis. RESULTS: Patients with smoldering MM with MGUS-like phenotype showed significantly lower rates of disease progression (4.5% and 0% at 2 years in two independent series). There were no statistically significant differences in time to progression between treatment versus observation in these patients. In active newly diagnosed MM, MGUS-like phenotype retained independent prognostic value in multivariate analyses of progression-free survival (PFS; hazard ratio [HR], 0.49; P = .001) and overall survival (OS; HR, 0.56; P = .039), together with International Staging System, lactate dehydrogenase, cytogenetic risk, transplant eligibility, and complete remission status. Transplant-eligible patients with active MM with MGUS-like phenotype showed PFS and OS rates at 5 years of 79% and 96%, respectively. In this subgroup, there were no differences in PFS and OS according to complete remission and measurable residual disease status. Application of the algorithm in two independent series of patients with AL predicted for different survival. CONCLUSION: We developed an open-access algorithm for the identification of MGUS-like patients with distinct clinical outcomes. This phenotypic classification could become part of the diagnostic workup of MM and AL amyloidosis.
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Amiloidosis de Cadenas Ligeras de las Inmunoglobulinas , Gammopatía Monoclonal de Relevancia Indeterminada , Mieloma Múltiple , Paraproteinemias , Humanos , Gammopatía Monoclonal de Relevancia Indeterminada/diagnóstico , Gammopatía Monoclonal de Relevancia Indeterminada/terapia , Relevancia Clínica , Progresión de la Enfermedad , Paraproteinemias/diagnóstico , Paraproteinemias/terapia , Mieloma Múltiple/diagnóstico , FenotipoRESUMEN
INTRODUCTION: Response kinetics is a well-established prognostic marker in acute lymphoblastic leukemia. The situation is not clear in multiple myeloma (MM) despite having a biomarker for response monitoring (monoclonal component [MC]). MATERIALS AND METHODS: We developed a mathematical model to assess the prognostic value of serum MC response kinetics during 6 induction cycles, in 373 NDMM transplanted patients treated in the GEM2012Menos65 clinical trial. The model calculated a "resistance" parameter that reflects the stagnation in the response after an initial descent. RESULTS: Two patient subgroups were defined based on low and high resistance, that respectively captured sensitive and refractory kinetics, with progression-free survival (PFS) at 5 years of 72% and 59% (HR 0.64, 95% CI 0.44-0.93; P = .02). Resistance significantly correlated with depth of response measured after consolidation (80.9% CR and 68.4% minimal residual disease negativity in patients with sensitive vs. 31% and 20% in those with refractory kinetics). Furthermore, it modulated the impact of reaching CR after consolidation; thus, within CR patients those with refractory kinetics had significantly shorter PFS than those with sensitive kinetics (median 54 months vs. NR; P = .02). Minimal residual disease negativity abrogated this effect. Our study also questions the benefit of rapid responders compared to late responders (5-year PFS 59.7% vs. 76.5%, respectively [P < .002]). Of note, 85% of patients considered as late responders were classified as having sensitive kinetics. CONCLUSION: This semi-mechanistic modeling of M-component kinetics could be of great value to identify patients at risk of early treatment failure, who may benefit from early rescue intervention strategies.
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Mieloma Múltiple , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Humanos , Mieloma Múltiple/tratamiento farmacológico , Neoplasia Residual/diagnóstico , Paraproteínas , Pronóstico , Resultado del TratamientoRESUMEN
AIMS AND OBJECTIVE: To examine attitudes towards research and perceived barriers and facilitators of research utilisation in clinical practice in a broad cross-section of Spanish nurses. BACKGROUND: Nurses' attitudes towards research are critical in determining whether study findings are used to improve practice. DESIGN: Cross-sectional comparative survey in Hospitals, Primary Care Centres and University-affiliated schools of nursing. METHODS: Surveys were completed by 917 nurses: 69 who received funding from the Spanish national agency (1998-2004) and a nationally representative sample of 848 nurses who did not have the same research experience (the Comparison group). Two instruments (BARRIERS and Attitudes towards nursing research) were translated and culturally adapted for use in Spain. A descriptive analysis of demographic and practice characteristics was performed. Total scale scores, as well as subscale scores, were computed and compared across the two groups using one-way analysis of variance (anova) and multivariate analysis of variance (manova) with post hoc tests. Pearson product-moment correlation coefficients were computed between the total tool scores and subscales measuring barriers and attitudes in both groups. RESULTS: The investigators differed from other nurses on several demographic and work characteristics (more males, older age and more likely to work a fixed day shift schedule). On the whole, investigators showed more favourable attitudes but perceived several elements as posing greater barriers to research utilisation than the Comparison groups. Across all respondents, issues related to the quality of research were rated as the greatest barriers to research utilisation, followed by organisational barriers, barriers involving the communication of findings and finally, those related to nurses' values, awareness and skills. CONCLUSIONS: Very similar profiles of perceptions and attitudes regarding research were found in these samples of Spanish nurses relative to those from other countries in earlier reports. Nurses who had experience conducting research demonstrated more favourable research-related attitudes and perceived barriers differently than those without such experience. RELEVANCE TO CLINICAL PRACTICE: Understanding different organisational and experience perspectives is important to identify challenges and opportunities to ensure research utilisation in clinical practice.
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Actitud del Personal de Salud , Enfermeras y Enfermeros/psicología , Investigación en Enfermería , Adulto , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Investigadores , EspañaRESUMEN
AIM: Personal protective equipment (PPE), including respirators, is essential in a pandemic like COVID-19, which has required, on many occasions, the reuse of material due to its shortage. The aim of this review is to summarize available evidence on the reuse and extended use of filtering facepiece respirator. METHOD: Scoping review. Search through natural language in PUBMED and Centers, Agencies and Organizations for Disease Control. Limited to articles published between 2010-2020 in English and Spanish. RESULTS: 83 articles were located, 14 were selected, plus 5 recommendations. The topics included in this study are classified in 7 sections: expiration, extended use and reuse of masks, handling techniques, sealing, physical-psychological effects and compliance, contamination and decontamination of respirators. CONCLUSIONS: The reuse of masks is not recommended by official organizations or manufacturers, and is only accepted in extraordinary cases, such as pandemics. The studies are characterized by having small samples, using different models of respirators adjusting their recommendation to the model.
Asunto(s)
COVID-19 , Equipo Reutilizado , Descontaminación , Humanos , SARS-CoV-2 , Ventiladores MecánicosRESUMEN
The implementation of Best practice guidelines is effective in improving clinical practice and reducing clinical variability. The Best Practice Guidelines of the Ontario Nurses Association have been implemented in Spain since 2012 following the principles of the Canadian programme of the Best Practice Spotlight Organisations® (BPSO®). The Nursing and Healthcare Research Unit (Investén-isciii) coordinates this programme in Spain, having been nominated BPSO Host by the Ontario Nurses Association. Four strategies were followed: translation of the Best Practice Guidelines, dissemination of same and of the programme, implementation of the Best Practice Guidelines and assessment of the results in competitively selected centres, and, finally, the development of sustainability mechanisms. Implementation is based on the theoretical Knowledge to Action model, which establishes a cycle of 6 phases: identification of the problem and training of selected BPSO®; adaptation to the local context; assessment of facilitators and barriers; adaptation and implementation of interventions; monitoring and evaluation of results, and sustainability. Each of these phases incorporate evidence-based elements that promote the effectiveness of implementation, such as the competitive selection of candidates to participate in the programme, selection by the institution of the guidelines to be implemented, leadership by nurses with a multi-professional approach, planning of the process from work structures that are non-vertical but with the support of the institution, the simultaneous use of multiple strategies, ongoing assessment and feedback of results. All of which is mentored and supported by the BPSO Host. There are currently 27 institutions in Spain of different characteristics that implement a total of 20 clinical guidelines. The scope and structure of the programme has recently been extended with regional BPSO Host coordinating centres, which has brought the number of institutions to 36 and the number of implemented clinical guidelines to 22. The programme has had a positive impact on organisations and the system, on care processes and on patient health. This is evidenced by enriched evidence-based professional practice, the promotion of collaborative networking and by improved patient health outcomes and the quality of care provided.