Factores psicosociales, estrés psicológico y burnout en enfermería: un modelo de trayectorias / Psychosocial factors, psychological stress, and burnout in nursing: a model of trajectories / Fatores psicossociais, estresse psicológico e burnout em enfermagem: um modelo de trajetórias

Resumen Introducción: El personal de enfermería se enfrenta cotidianamente a diferentes eventos asociados al estrés, factores psicosociales y otros mecanismos que afectan su salud mental. Objetivo: Evaluar la correlación entre la demanda psicológica, el control laboral, el apoyo social, el estrés psicológico, y las dimensiones del Síndrome de Burnout (ilusión por el trabajo, desgaste psíquico, indolencia y culpa), en un modelo de trayectorias en enfermeras mexicanas. Metodología: Estudio transversal, observacional, analítico, conducido en 357 profesionales de enfermería de Morelos, México, seleccionados por conveniencia. Los datos fueron colectados empleando tres cuestionarios, la Escala de Estrés Percibido, el Cuestionario del Contenido del Trabajo y el Cuestionario para la Evaluación del Síndrome de Quemarse por el Trabajo. Los programas SPSS 19 y LISREL 8.3 fueron empleados para el procesamiento y modelaje de los datos. Resultados: En el modelo de trayectorias, se especificó como variable mediadora de los factores psicosociales y de las dimensiones del Síndrome de Quemarse por el Trabajo (SQT), al estrés psicológico. Los índices de ajuste fueron aceptables. Se encontraron altos niveles de apoyo social, control laboral e ilusión por el trabajo; grados moderados de demanda psicológica y estrés psicológico; y bajos niveles de desgaste psíquico, indolencia y culpa. Conclusión: Implicaciones para la disciplina, se propone implementar estrategias de intervención efectivas para mantener en el personal de enfermería bajos niveles de demandas psicológicas, altos niveles de control laboral, altos niveles de apoyo social, y niveles moderados de estrés, para prevenir, el SQT.

Abstract Introduction: Nurses frequently face different events associated with stress, psychosocial factors, and other issues which have impacts on their mental health. Objective: To assess the correlation between psychological demand, work control, social support, psychological stress, and burnout dimensions (illusion for the activity, psychic wear, indolence, guilt), within a model of trajectories among Mexican nurses. Methodology: This is a transversal, observational, and analytical study conducted on a convenience sample of 357 nursing professionals from the state of Morelos, Mexico. Data were gathered using three questionnaires, the Perceived Stress Scale, the Job Content Questionnaire, y el Maslach Burnout Inventory. SPSS 19 and LISREL 8.3 were used to process and model the data. Results: Psychological Stress was specified as the mediating variable of the psychosocial factors and dimensions of burnout within the model of trajectories. Adjustment indexes were acceptable. High levels of social support, work control, and illusion for the activity were found. Moderate degrees of psychological demand and psychological stress were found. Low levels of psychic wear, indolence, and guilt were found. Conclusion: It is recommended to implement effective intervention strategies to maintain nursing personnel within low levels of psychological demand, high levels of work control, high levels of social support, and moderate levels of stress, all these in order to prevent the Syndrome of Burnout.

Resumo Introdução: O pessoal de enfermagem se enfrenta cotidianamente a diferentes eventos associados ao estresse, fatores psicossociais e outros mecanismos que afetam sua saúde mental. Objetivo: Avaliar a correlação entre a demanda psicológica, o controle laboral, o apoio social, o estresse psicológico, e as dimensões e da Síndrome de Burnout (ilusão pelo trabalho, desgaste psíquico, indolência e culpa), em um modelo de trajetórias em enfermeiras mexicanas. Metodologia: Estudo transversal, observacional, analítico, conduzido em 357 profissionais de enfermagem de Morelos, México, selecionados por conveniência. Os dados foram coletados empregando três questionários, a Escala de Estresse Percebido, o Questionário do Conteúdo do Trabalho e o Questionário para a Avaliação da Síndrome de Burnout no Trabalho. Os programas SPSS 19 e LISREL 8.3 foram empregados para o processamento e modelagem dos dados. Resultados: No modelo de trajetórias, especificou-se como variável mediadora dos fatores psicossociais e das dimensões da Síndrome de Burnout no Trabalho (SQT), ao estresse psicológico. Os índices de ajuste foram aceitáveis. Encontraram-se altos níveis de apoio social, controle laboral e ilusão pelo trabalho; graus moderados de demanda psicológica e estresse psicológico; e baixos níveis de desgaste psíquico, indolência e culpa. Conclusão: Implicações para a disciplina, propõe-se implementar estratégias de intervenção efetivas para manter no pessoal de enfermagem baixos níveis de demandas psicológicas, altos níveis de controle laboral, altos níveis de apoio social, e níveis moderados de estresse, para prevenir, o SQT.

Modeling the economic outcomes of immuno-oncology drugs: alternative model frameworks to capture clinical outcomes.

BACKGROUND: Economic models in oncology are commonly based on the three-state partitioned survival model (PSM) distinguishing between progression-free and progressive states. However, the heterogeneity of responses observed in immuno-oncology (I-O) suggests that new approaches may be appropriate to reflect disease dynamics meaningfully. MATERIALS AND METHODS: This study explored the impact of incorporating immune-specific health states into economic models of I-O therapy. Two variants of the PSM and a Markov model were populated with data from one clinical trial in metastatic melanoma patients. Short-term modeled outcomes were benchmarked to the clinical trial data and a lifetime model horizon provided estimates of life years and quality adjusted life years (QALYs). RESULTS: The PSM-based models produced short-term outcomes closely matching the trial outcomes. Adding health states generated increased QALYs while providing a more granular representation of outcomes for decision making. The Markov model gave the greatest level of detail on outcomes but gave short-term results which diverged from those of the trial (overstating year 1 progression-free survival by around 60%). CONCLUSION: Increased sophistication in the representation of disease dynamics in economic models is desirable when attempting to model treatment response in I-O. However, the assumptions underlying different model structures and the availability of data for health state mapping may be important limiting factors.

Methadone and buprenorphine for the management of opioid dependence: a systematic review and economic evaluation.

OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of buprenorphine maintenance therapy (BMT) and methadone maintenance therapy (MMT) for the management of opioid-dependent individuals. DATA SOURCES: Major electronic databases were searched from inception to August 2005. Industry submissions to the National Institute for Health and Clinical Excellence were accessed. REVIEW METHODS: The assessment of clinical effectiveness was based on a review of existing reviews plus an updated search for randomised controlled trials (RCTs). A decision tree with Monte Carlo simulation model was developed to assess the cost-effectiveness of BMT and MMT. Retention in treatment and opiate abuse parameters were sourced from the meta-analysis of RCTs directly comparing flexible MMT with flexible dose BMT. Utilities were derived from a panel representing a societal perspective. RESULTS: Most of the included systematic reviews and RCTs were of moderate to good quality, and focused on short-term (up to 1-year follow-up) outcomes of retention in treatment and the level of opiate use (self-report or urinalysis). Most studies employed a trial design that compared a fixed-dose strategy (i.e. all individuals received a standard dose) of MMT or BMT and were conducted in predominantly young men who fulfilled criteria as opiate-dependent or heroin-dependent users, without significant co-morbidities. RCT meta-analyses have shown that a fixed dose of MMT or BMT has superior levels of retention in treatment and opiate use than placebo or no treatment, with higher fixed doses being more effective than lower fixed doses. There was evidence, primarily from non-randomised observational studies, that fixed-dose MMT reduces mortality, HIV risk behaviour and levels of crime compared with no therapy and one small RCT has shown the level of mortality with fixed-dose BMT to be significantly less than with placebo. Flexible dosing (i.e. individualised doses) of MMT and BMT is more reflective of real-world practice. Retention in treatment was superior for flexible MMT than flexible BMT dosing but there was no significant difference in opiate use. Indirect comparison of data from population cross-sectional studies suggests that mortality with BMT may be lower than that with MMT. A pooled RCT analysis showed no significant difference in serious adverse events with MMT compared with BMT. Although treatment modifier evidence was limited, adjunct psychosocial and contingency interventions (e.g. financial incentives for opiate-free urine samples) appeared to enhance the effects of both MMT and BMT. Also, MMT and BMT appear to be similarly effective whether delivered in a primary care or outpatient clinic setting. Although most of the included economic evaluations were considered to be of high quality, none used all of the appropriate parameters, effectiveness data, perspective and comparators required to make their results generalisable to the NHS context. One company (Schering-Plough) submitted cost-effectiveness evidence based on an economic model that had a 1-year time horizon and sourced data from a single RCT of flexible-dose MMT compared with flexible-dose BMT and utility values obtained from the literature; the results showed that for MMT vs no drug therapy, the incremental cost-effectiveness ratio (ICER) was pound 12,584/quality-adjusted life-year (QALY), for BMT versus no drug therapy, the ICER was pound 30,048/QALY and in a direct comparison, MMT was found to be slightly more effective and less costly than BMT. The assessment group model found for MMT versus no drug therapy that the ICER was pound 13,697/QALY, for BMT versus no drug therapy that the ICER was pound 26,429/QALY and, as with the industry model, in direct comparison, MMT was slightly more effective and less costly than BMT. When considering social costs, both MMT and BMT gave more health gain and were less costly than no drug treatment. These findings were robust to deterministic and probabilistic sensitivity analyses. CONCLUSIONS: Both flexible-dose MMT and BMT are more clinically effective and more cost-effective than no drug therapy in dependent opiate users. In direct comparison, a flexible dosing strategy with MMT was found be somewhat more effective in maintaining individuals in treatment than flexible-dose BMT and therefore associated with a slightly higher health gain and lower costs. However, this needs to be balanced by the more recent experience of clinicians in the use of buprenorphine, the possible risk of higher mortality of MMT and individual opiate-dependent users' preferences. Future research should be directed towards the safety and effectiveness of MMT and BMT; potential safety concerns regarding methadone and buprenorphine, specifically mortality and key drug interactions; efficacy of substitution medications (in particular patient subgroups, such as within the criminal justice system, or within young people); and uncertainties in cost-effectiveness identified by current economic models.

A systematic review of the clinical effectiveness and cost-effectiveness of enzyme replacement therapies for Fabry's disease and mucopolysaccharidosis type 1.

OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of the administration of intravenous enzyme replacement therapy (ERT) to symptomatic patients for the prevention of long-term damage and symptoms in Fabry's disease and in mucopolysaccharidosis type 1 (MPS1). DATA SOURCES: Electronic databases from inception up to mid-2004. Contact with clinical experts. REVIEW METHODS: Relevant studies were identified and assessed using recommended quality criteria. RESULTS: The results suggested beneficial effects of ERT for Fabry's disease on measures of pain, cardiovascular function and some end-points reflecting neurosensory function. Renal function appeared to be stabilised by ERT. At present there are no utility-related health-related quality of life data on which to assess the relative health gain of ERT in MPS1. In order to be able to demonstrate the full extent of health gain from treatment, it was necessary to review the natural history of untreated patients in each disease in order to try to estimate the health loss prevented. The published information for Fabry's disease tallied with descriptions of a multi-system, life-threatening disorder particularly involving kidney, heart and brain with individual patients exhibiting many manifestations. The fragmentary information reviewed in 16 studies relevant to the natural history of MPS1 did not generate a coherent picture of disease progression and could provide little added value to published narrative reviews. For Fabry's disease, the mean cost per patient (50 kg) treated is around pounds sterling 85,000 per annum in England and Wales. The cost per patient varies considerably by dose. No published evidence reporting an economic evaluation of ERT for Fabry's disease was identified by this review. A dynamic decision model was constructed based on a birth cohort of male patients who are followed up until death. Owing to lack of information reported in the literature, many assumptions had to be applied. The key assumptions were that ERT returns patients to full health and a normal life expectancy. As far as possible, all assumptions favoured rather than detracted from the value of ERT. ERT was assumed to restore patients to full health in the base case. The estimated incremental cost-effectiveness ratio (ICER) in the base case was pounds sterling 252,000 per QALY (agalsidase beta). Univariate sensitivity analysis around the key assumptions produced ICERs ranging from pounds sterling 602,000 to pounds sterling 241,000. The base case unit cost of ERT was taken as pounds sterling 65.1/mg based on the cost of agalsidase beta. The unit cost would have had to be reduced to pounds sterling 9 to obtain an ICER of pounds sterling 30,000 per QALY. For MPS1, the mean cost per child patient (20 kg) treated is approximately pounds sterling 95,000 and an adult (70 kg) around pounds sterling 335,000 per annum in England and Wales. The cost per patient varies considerably by dose. There is no published evidence reporting an economic evaluation of ERT for MPS1 and no study was identified that reported the quality of life of MPS1 patients within a utility format. Furthermore, no or minimal information of the severity and rate of change of clinical manifestations of disease or the impact of ERT on these factors was identified. Information on the effect of ERT on mortality is also lacking owing to the relatively short time that the treatment has been available. Given this lack of data, it was not possible to develop a cost-effectiveness model of ERT treatment for MPS1 as the model would consist almost completely of assumptions based on no published evidence, leading to an incremental cost per QALY result that would be meaningless. CONCLUSIONS: Although ERT for treating the 'average' patient with Fabry's disease exceeds the normal upper threshold for cost-effectiveness seen in NHS policy decisions by over sixfold, and the value for MPS1 is likely to be of a similar order of magnitude, clinicians and the manufacturers argue that, as the disease is classified as an orphan disease under European Union legislation, it has special status, and the NHS has no option but to provide ERT. More information is required before the generalisability of the findings can be determined. Although data from the UK have been used wherever possible, this was very thin indeed. Nonetheless, even large errors in assumptions made will not reduce the ICER to anywhere near the upper level of treatments usually considered cost-effective. In order to overcome limited evidence on the natural history of the disease and the clinical effectiveness of the intervention, the establishment of disease-specific data registries is suggested to facilitate the process of technology assessment and improving patient care. These registries should attempt to include all affected patients in the UK, and collect longitudinal patient level data on clinically relevant problems, interventions received and quality of life in a utility format.