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OBJECTIVES: Although a growing share of the population in many countries has been vaccinated against the SARS-CoV-2 virus to different degrees, social distancing and hygienic non-pharmaceutical interventions still play a substantial role in containing the pandemic. The goal of this study was to investigate which factors are correlated with a higher compliance with these regulations in the context of a cohort study in the city of Munich, southern Germany, during the summer of 2020, i.e. after the first lockdown phase. METHODS: Using self-reported compliance with six regulations and personal hygiene rules (washing hands, avoiding touching face, wearing a mask, keeping distance, avoiding social gatherings, avoiding public spaces) we extracted two compliance factor scores, namely compliance with personal hygiene measures and compliance with social distancing regulations. Using linear and logistic regressions, we estimated the correlation of several socio-demographic and risk perception variables with both compliance scores. RESULTS: Risk aversion proved to be a consistent and significant driver of compliance across all compliance behaviors. Furthermore, being female, being retired and having a migration background were positively associated with compliance with personal hygiene regulations, whereas older age was related with a higher compliance with social distancing regulations. Generally, socioeconomic characteristics were not related with compliance, except for education, which was negatively related with compliance with personal hygiene measures. CONCLUSIONS: Our results suggest that for a targeted approach to improve compliance with measures to prevent SARS-CoV-2 infection, special attention should be given to younger, male and risk-prone individuals.
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COVID-19 , Masculino , Humanos , Femenino , COVID-19/prevención & control , SARS-CoV-2 , Estudios de Cohortes , Control de Enfermedades Transmisibles , Factores SocioeconómicosRESUMEN
BACKGROUND: The COVID-19 pandemic impacts on working routines and workload of palliative care (PC) teams but information is lacking how resource use and associated hospital costs for PC changed at patient-level during the pandemic. We aim to describe differences in patient characteristics, care processes and resource use in specialist PC (PC unit and PC advisory team) in a university hospital before and during the first pandemic year. METHODS: Retrospective, cross-sectional study using routine data of all patients cared for in a PC unit and a PC advisory team during 10-12/2019 and 10-12/2020. Data included patient characteristics (age, sex, cancer/non-cancer, symptom/problem burden using Integrated Palliative Care Outcome Scale (IPOS)), information on care episode, and labour time calculated in care minutes. Cost calculation with combined top-down bottom-up approach with hospital's cost data from 2019. Descriptive statistics and comparisons between groups using parametric and non-parametric tests. RESULTS: Inclusion of 55/76 patient episodes in 2019/2020 from the PC unit and 135/120 episodes from the PC advisory team, respectively. IPOS scores were lower in 2020 (PCU: 2.0 points; PC advisory team: 3.0 points). The number of completed assessments differed considerably between years (PCU: episode beginning 30.9%/54.0% in 2019/2020; PC advisory team: 47.4%/40.0%). Care episodes were by one day shorter in 2020 in the PC advisory team. Only slight non-significant differences were observed regarding total minutes/day and patient (PCU: 150.0/141.1 min., PC advisory team: 54.2/66.9 min.). Staff minutes showed a significant decrease in minutes spent in direct contact with relatives (PCU: 13.9/7.3 min/day in 2019/2020, PC advisory team: 5.0/3.5 min/day). Costs per patient/day decreased significantly in 2020 compared to 2019 on the PCU (1075 Euro/944 Euro for 2019/2020) and increased significantly for the PC advisory team (161 Euro/200 Euro for 2019/2020). Overhead costs accounted for more than two thirds of total costs. Direct patient cost differed only slightly (PCU: 134.7 Euro/131.1 Euro in 2019/2020, PC advisory team: 54.4 Euro/57.3 Euro). CONCLUSIONS: The pandemic partially impacted on daily work routines, especially on time spent with relatives and palliative care problem assessments. Care processes and quality of care might vary and have different outcomes during a crisis such as the COVID-19 pandemic. Direct costs per patient/day were comparable, regardless of the pandemic.
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COVID-19 , Cuidados Paliativos , Humanos , Pandemias , Costos de la Atención en Salud , Estudios Retrospectivos , Estudios Transversales , HospitalizaciónRESUMEN
INTRODUCTION: Primary patella resurfacing (PPR) in primary total knee arthroplasty (TKA) is a topic without clear clinical evidence. Using Patient Reported Outcome Measurements (PROM), previous work found TKA patients without PPR to have more pain postoperatively, but little is known whether this may impede patients from returning to their usual leisure sport. This observational study aimed at evaluating the treatment effect of PPR, with PROMs and return to sport (RTS). MATERIALS AND METHODS: 156 primary TKA patients were retrospectively included from August 2019 to November 2020, from a single hospital in Germany. PROMs were measured with the Western Ontario McMaster University Osteoarthritis Index (WOMAC) and the EuroQoL Visual Analog Scale (EQ-VAS), preoperatively and 1 year postoperatively. Leisure sport with three levels of intensity (never, sometimes, regular) were requested. The treatment effect of PPR was evaluated with a difference-in-difference (DiD) approach, with several confounders. RESULTS: Descriptively, the mean WOMAC total score and the mean WOMAC pain score were postoperatively better with PPR, ( - 4.8 points, - 1.1 points), then without PPR. The mean improvements of the WOMAC total score were better with PPR ( - 7.8 points). Mean improvements for the WOMAC pain score were also better with PPR ( - 1.2 points). Mean EQ-VAS were postoperatively similar, and the mean improvements were better with PPR (3.4 points). Rate of RTS was 93% for patients with PPR and 95% for patients without PPR. The DiD revealed minor differences in PROMs and RTS, not to result in statistically significant treatment effects. CONCLUSIONS: There was no treatment effect for TKA with PPR, regarding PROMs and RTS, and descriptive differences were below published thresholds for clinical relevance. Rate of RTS was high for all patients, regardless of PPR. For the two endpoint categories, there was no measurable advantage of TKA with PPR over TKA without PPR.
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Artroplastia de Reemplazo de Rodilla , Osteoartritis de la Rodilla , Humanos , Calidad de Vida , Estudios Retrospectivos , Volver al Deporte , Rótula/cirugía , Resultado del Tratamiento , Dolor/cirugía , Osteoartritis de la Rodilla/cirugía , Articulación de la Rodilla/cirugíaRESUMEN
BACKGROUND: Total knee arthroplasty are among the most frequently conducted surgeries, due to an aging society. Since hospital costs are subsequently rising, adequate preparation of patients and reimbursement becomes more and more important. Recent literature revealed anemia as a risk factor for enhanced length of stay (LOS) and complications. This study analyzed whether preoperative hemoglobin (Hb) and postoperative Hb were associated with total hospital costs and general ward costs. METHODS: The study comprised 367 patients from a single high-volume hospital in Germany. Hospital costs were calculated with standardized cost accounting methods. Generalized linear models were applied to account for confounders, such as age, comorbidities, body mass index, insurance status, health-related quality of life, implant types, incision-suture-time and tranexamic acid. RESULTS: Preoperative anemic women had 426 Euros higher general ward costs (p < 0.01), due to increased LOS. For men, 1 g/dl less Hb loss between the preoperative value and the value before discharge reduced total costs by 292 Euros (p < 0.001) and 161 Euros fewer general ward costs (p < 0.001). Total hospital costs were reduced by 144 Euros with 1 g/dl higher Hb on day 2 postoperatively for women (p < 0.01). CONCLUSION: Preoperative anemia was associated with increased general ward costs for women and Hb loss with decreasing total hospital costs for men and women. Cost containment, especially reduced utilization of the general ward, may be feasible with the correction of anemia for women. Postoperative Hb values may be a factor for adjustments of reimbursement systems. LEVEL OF EVIDENCE: Retrospective cohort study, III.
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Anemia , Artroplastia de Reemplazo de Rodilla , Masculino , Humanos , Femenino , Costos de Hospital , Estudios Retrospectivos , Calidad de Vida , Anemia/complicaciones , Hemoglobinas , Tiempo de InternaciónRESUMEN
PURPOSE: This study aimed to investigate inequality and heterogeneity in health-related quality of life (HRQoL) and to provide EQ-5D-5L population reference data for Sweden. METHODS: Based on a large Swedish population-based survey, 25,867 respondents aged 30â104 years, HRQoL is described by sex, age, education, income, economic activity, health-related behaviours, self-reported diseases and conditions. Results are presented by EQ-5D-5L dimensions, respondents rating of their overall health on the EQ visual analogue scale (EQ VAS), VAS index value and TTO (time trade-off) index value allowing for calculation of quality-adjusted life years (QALYs). Ordinary Least Squares and multivariable logistic regression analyses were used to study inequalities in observed EQ VAS score between socioeconomic groups and the likelihood to report problems on the dimensions, respectively, adjusted for confounders. RESULTS: In total, 896 different health states were reported; 24.1% did not report any problems. Most problems were reported with pain/discomfort. Women reported worse HRQoL than men, and health deteriorated with age. The strongest association between diseases and conditions and EQ VAS score was seen for depression and mental health problems. There was a socioeconomic gradient in HRQoL; adjusting for health-related behaviours, diseases and conditions slightly reduced the differences between educational groups and income groups, but socioeconomic inequalities largely remained. CONCLUSION: EQ-5D-5L population reference (norms) data are now available for Sweden, including socioeconomic differentials. Results may be used for comparisons with disease-specific populations and in health economic evaluations. The observed socioeconomic inequality in HRQoL should be of great importance for policy makers concerned with equity aspects.
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Estado de Salud , Calidad de Vida , Adulto , Anciano , Anciano de 80 o más Años , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Calidad de Vida/psicología , Encuestas y Cuestionarios , SueciaRESUMEN
INTRODUCTION: Interstitial lung diseases (ILDs) are associated with a high economic burden, yet prospective data of the German healthcare system are sparse. OBJECTIVE: We assessed average ILD-related costs of pharmacological and non-pharmacological (hospitalizations, outpatient, rehabilitation, physiotherapy, and medical aids) interventions in ILD. METHODS: We used data from the multicenter, observational, prospective Exploring Clinical and Epidemiological Characteristics of Interstitial Lung Diseases registry to evaluate adjusted per capita costs and cost drivers for ILD-related healthcare costs over 4 years, using generalized estimating equation regression models. RESULTS: Idiopathic pulmonary fibrosis (IPF) had the highest annual pharmacological costs >EUR 21,000, followed by connective tissue disease-associated ILD (CTD-ILD) averaging EUR 6,000. Other idiopathic interstitial pneumonias and hypersensitivity pneumonitis averaged below EUR 2,400 and sarcoidosis below EUR 400. There were no significant differences in pharmacological costs over time. Trends in non-pharmacological costs were statistically significant. At year 1, CTD-ILD had the highest costs (EUR 7,700), while sarcoidosis had the lowest (EUR 2,547). By year 4, these declined to EUR 3,218 and EUR 232, respectively. Regarding cost drivers, the ILD subtype had the greatest impact with 75 times higher pharmacological costs in IPF and 4 times higher non-pharmacological costs in CTD-ILD, compared to the reference. Pulmonary hypertension (PH) and gastroesophageal reflux disease (GERD) triggered higher pharmacological costs, and higher values of forced vital capacity % predicted were associated with lower pharmacological and non-pharmacological costs. CONCLUSION: Stabilizing lung function and reducing the impact of PH and GERD are crucial in reducing the economic burden of ILD. There is an urgent need for effective treatment options, especially in CTD-ILD.
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Enfermedades del Tejido Conjuntivo , Reflujo Gastroesofágico , Hipertensión Pulmonar , Fibrosis Pulmonar Idiopática , Enfermedades Pulmonares Intersticiales , Sarcoidosis , Humanos , Estudios Prospectivos , Fibrosis Pulmonar Idiopática/tratamiento farmacológico , Enfermedades del Tejido Conjuntivo/complicaciones , Alemania/epidemiología , Sarcoidosis/complicaciones , Hipertensión Pulmonar/complicaciones , Reflujo Gastroesofágico/complicaciones , Reflujo Gastroesofágico/terapiaRESUMEN
BACKGROUND: A casemix classification based on patients' needs can serve to better describe the patient group in palliative care and thus help to develop adequate future care structures and enable national benchmarking and quality control. However, in Germany, there is no such an evidence-based system to differentiate the complexity of patients' needs in palliative care. Therefore, the study aims to develop a patient-oriented, nationally applicable complexity and casemix classification for adult palliative care patients in Germany. METHODS: COMPANION is a mixed-methods study with data derived from three subprojects. Subproject 1: Prospective, cross-sectional multi-centre study collecting data on patients' needs which reflect the complexity of the respective patient situation, as well as data on resources that are required to meet these needs in specialist palliative care units, palliative care advisory teams, and specialist palliative home care. Subproject 2: Qualitative study including the development of a literature-based preliminary list of characteristics, expert interviews, and a focus group to develop a taxonomy for specialist palliative care models. Subproject 3: Multi-centre costing study based on resource data from subproject 1 and data of study centres. Data and results from the three subprojects will inform each other and form the basis for the development of the casemix classification. Ultimately, the casemix classification will be developed by applying Classification and Regression Tree (CART) analyses using patient and complexity data from subproject 1 and patient-related cost data from subproject 3. DISCUSSION: This is the first multi-centre costing study that integrates the structure and process characteristics of different palliative care settings in Germany with individual patient care. The mixed methods design and variety of included data allow for the development of a casemix classification that reflect on the complexity of the research subject. The consecutive inclusion of all patients cared for in participating study centres within the time of data collection allows for a comprehensive description of palliative care patients and their needs. A limiting factor is that data will be collected at least partly during the COVID-19 pandemic and potential impact of the pandemic on health care and the research topic cannot be excluded. TRIAL REGISTRATION: German Register for Clinical Studies trial registration number: DRKS00020517 .
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Cuidados Paliativos , Adulto , COVID-19 , Estudios Transversales , Humanos , Estudios Multicéntricos como Asunto , Pandemias , Estudios ProspectivosRESUMEN
PURPOSE: The purpose of this study was a comparison between osteoarthritis patients with primary hip and knee replacements before, during and after the first COVID-19 lockdown in Germany. Patients' preoperative health status is assumed to decrease, owing to delayed surgeries. Costs for patients with osteoarthritis were assumed to increase, for example, due to higher prices for protective equipment. Hence, a comparison of patients treated before, during and after the first lockdown is conducted. METHODS: In total, 852 patients with primary hip or knee replacement were included from one hospital in Germany. Preoperative health status was measured with the WOMAC Score and the EQ-5D-5L. Hospital unit costs were calculated using a standardised cost calculation. Kruskal-Wallis tests and Chi-squared tests were applied for the statistical analyses. RESULTS: The mean of the preoperative WOMAC Score was slightly higher (p < 0.01) for patients before the first lockdown, compared with patients afterwards. Means of the EQ-5D-5L were not significantly different regarding the lockdown status (NS). Length of stay was significantly reduced by approximately 1 day (p < 0.001). Total inpatient hospital unit costs per patient and per day were significantly higher for patients during and after the first lockdown (p < 0.001). CONCLUSION: Preoperative health, measured with the WOMAC Score, worsened slightly for patients after the first lockdown compared with patients undergoing surgery before COVID-19. Preoperative health, measured using the EQ-5D-5L, was unaffected. Inpatient hospital unit costs increased significantly with the COVID-19 pandemic. LEVEL OF EVIDENCE: Retrospective cohort study, III.
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Artroplastia de Reemplazo de Cadera , COVID-19 , Osteoartritis , COVID-19/epidemiología , Control de Enfermedades Transmisibles , Alemania/epidemiología , Costos de Hospital , Humanos , Pandemias , Calidad de Vida , Estudios RetrospectivosRESUMEN
BACKGROUND: Little is known about how long-term weight gain affects the health perception of COPD patients. OBJECTIVES: The aim is to evaluate the long-term association of BMI change and health-related quality of life (HRQoL) in obese COPD patients. METHODS: Claims and survey data from a COPD disease management program were used to match two groups of COPD patients with BMI ≥ 30 who have differing weight trajectories over a 5-year timespan via propensity score and genetic matching. EQ-5D-5L, including visual analog scale (VAS) and COPD Assessment Test (CAT), were used as outcomes of interest. Sociodemographic and disease-based variables were matched. RESULTS: Out of 1202 obese COPD patients, 126 with a weight increase of four or more BMI points were matched separately with 252 (propensity score matching) and 197 (genetic matching) control subjects who had relatively stable BMI. For the EQ-5D-5L, patients with BMI increase reported significantly worse health perception for VAS and all descriptive dimensions except pain/discomfort. For the CAT, especially the perception of ability to complete daily activities and overall energy results were significantly worse. VAS differences reach the range of minimal important differences. Stopping smoking and already being in obesity class II were the most influential risk factors for BMI increase. CONCLUSION: Obese COPD patients who gain four or more BMI points over 5 years report significantly lower results in different dimensions of generic and disease-specific HRQoL than their peers with stable BMI. To improve real-world outcomes, tracking and preventing specific BMI trajectories could constitute a clinically relevant aspect of managing COPD patients.
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Manejo de la Enfermedad , Obesidad/psicología , Enfermedad Pulmonar Obstructiva Crónica/psicología , Calidad de Vida/psicología , Encuestas y Cuestionarios , Aumento de Peso/fisiología , Actividades Cotidianas/psicología , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Obesidad/epidemiología , Obesidad/terapia , Puntaje de Propensión , Enfermedad Pulmonar Obstructiva Crónica/epidemiología , Enfermedad Pulmonar Obstructiva Crónica/terapia , Factores de Riesgo , Factores de Tiempo , Programas de Reducción de Peso/tendenciasRESUMEN
BACKGROUND: Body mass index (BMI) is an important parameter associated with mortality and health-related quality of life (HRQoL) in chronic obstructive pulmonary disease (COPD). However, informed guidance on stratified weight recommendations for COPD is still lacking. This study aims to determine the association between BMI and HRQoL across different severity grades of COPD to support patient management. METHODS: We use conjunct analysis of claims and survey data based on a German COPD disease management program from 2016 to 2017. The EQ-5D-5L visual analog scale (VAS) and COPD Assessment Test (CAT) are used to measure generic and disease-specific HRQoL. Generalized additive models with smooth functions are implemented to evaluate the relationship between BMI and HRQoL, stratified by COPD severity. RESULTS: 11,577 patients were included in this study. Mean age was 69.4 years and 59% of patients were male. In GOLD grades 1-3, patients with BMI of around 25 had the best generic and disease-specific HRQoL, whereas in GOLD grade 4, obese patients had the best HRQoL using both instruments when controlled for several variables including smoking status, income, COPD severity, comorbidities, emphysema, corticosteroid use, and days spent in hospital. CONCLUSION: This real-world analysis shows the non-linear relationship between BMI and HRQoL in COPD. HRQoL of obese patients with mild to severe COPD might improve following weight reduction. For very severe COPD, a negative association of obesity and HRQoL could not be confirmed. The results hint at the need to stratify COPD patients by disease stage for optimal BMI management.
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Índice de Masa Corporal , Obesidad/diagnóstico , Enfermedad Pulmonar Obstructiva Crónica/diagnóstico , Calidad de Vida , Reclamos Administrativos en el Cuidado de la Salud , Anciano , Anciano de 80 o más Años , Bases de Datos Factuales , Femenino , Alemania/epidemiología , Encuestas de Atención de la Salud , Estado de Salud , Humanos , Masculino , Persona de Mediana Edad , Obesidad/epidemiología , Obesidad/fisiopatología , Obesidad/terapia , Pronóstico , Enfermedad Pulmonar Obstructiva Crónica/epidemiología , Enfermedad Pulmonar Obstructiva Crónica/fisiopatología , Enfermedad Pulmonar Obstructiva Crónica/terapia , Índice de Severidad de la Enfermedad , Factores de TiempoRESUMEN
BACKGROUND: American Society of Anaesthesiologists (ASA) physical status classification system and its association with postoperative outcomes has been studied in different diseases. However, there is a paucity of studies on the relationship between ASA class and postoperative health-related quality of life (HRQoL) outcomes following total hip replacement (THR). The aim of this study was to assess the discriminative abilities of EQ-5D-3L value sets from Sweden, Germany, Denmark and the United Kingdom in relation to ASA classes and these value sets' abilities to show the predictive performance of ASA classes on HRQoL among THR patients in Sweden. METHODS: A longitudinal study was conducted using data of patients in the Swedish Hip Arthroplasty Register who underwent THR between 2008 and 2016. We included 69,290 pre- and 1-year postoperative records and 21,305 6-year postoperative records. The study examined three experience-based EQ-5D-3L value sets (the Swedish VAS and TTO and the German VAS) and five hypothetical value sets (TTO from Germany and VAS and TTO value sets from Denmark and the UK each). Using linear models, the abilities of the value sets to discriminate among ASA classes and to show the predictive performance of ASA classes on HRQoL score were assessed. RESULTS: All value sets differentiated among ASA classes and showed the predictive effect of ASA classes on HRQoL. ASA classes were found to predict HRQoL consistently for all value sets investigated, with small variations in prediction error among the models. CONCLUSION: ASA classes of patients undergoing THR predicted HRQoL scores significantly and consistently, indicating their importance in tailoring care for patients.
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Artroplastia de Reemplazo de Cadera/rehabilitación , Indicadores de Salud , Medición de Resultados Informados por el Paciente , Calidad de Vida , Recuperación de la Función , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Modelos Lineales , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Periodo Posoperatorio , Sociedades Médicas/normas , SueciaRESUMEN
BACKGROUND: Evidence on the economic impact of chronic obstructive pulmonary disease (COPD) for third-party payers and society based on large real world datasets are still scarce. Therefore, the aim of this study was to estimate the economic impact of COPD severity and its comorbidities, stratified by GOLD grade, on direct and indirect costs for an unselected population enrolled in the structured German Disease Management Program (DMP) for COPD. METHODS: All individuals enrolled in the DMP COPD were included in the analysis. Patients were only excluded if they were not insured or not enrolled in the DMP COPD the complete year before the last DMP documentation (at physician visit), had a missing forced expiratory volume in 1 s (FEV1) measurement or other missing values in covariates. The final dataset included 39,307 patients in GOLD grade 1 to 4. We used multiple generalized linear models to analyze the association of COPD severity with direct and indirect costs, while adjusting for sex, age, income, smoking status, body mass index, and comorbidities. RESULTS: More severe COPD was significantly associated with higher healthcare utilization, work absence, and premature retirement. Adjusted annual costs for GOLD grade 1 to 4 amounted to 3809 [3691-3935], 4284 [4176-4394], 5548 [5328-5774], and 8309 [7583-9065] for direct costs, and 11,784 [11,257-12,318], 12,985 [12,531-13,443], 15,805 [15,034-16,584], and 19,402 [17,853-21,017] for indirect costs. Comorbidities had significant additional effects on direct and indirect costs with factors ranging from 1.19 (arthritis) to 1.51 (myocardial infarction) in direct and from 1.16 (myocardial infarction) to 1.27 (cancer) in indirect costs. CONCLUSION: The findings indicate that more severe GOLD grades in an unselected COPD population enrolled in a structured DMP are associated with tremendous additional direct and indirect costs, with comorbidities significantly increase costs. In direct cost category hospitalization and in indirect cost category premature retirement were the main cost driver. From a societal perspective prevention and interventions focusing on disease control, and slowing down disease progression and strengthening the ability to work would be beneficial in order to realize cost savings in COPD.
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Manejo de la Enfermedad , Costos de la Atención en Salud/estadística & datos numéricos , Enfermedad Pulmonar Obstructiva Crónica/economía , Enfermedad Pulmonar Obstructiva Crónica/terapia , Factores de Edad , Anciano , Comorbilidad , Progresión de la Enfermedad , Femenino , Volumen Espiratorio Forzado , Alemania , Hospitalización/economía , Humanos , Renta , Masculino , Aceptación de la Atención de Salud , Enfermedad Pulmonar Obstructiva Crónica/complicaciones , Jubilación/economía , Jubilación/estadística & datos numéricos , Factores Sexuales , Ausencia por Enfermedad/economía , Ausencia por Enfermedad/estadística & datos numéricos , Fumar/efectos adversos , Fumar/economíaRESUMEN
BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a rare disease with a median survival of 3-5 years after diagnosis with limited treatment options. The aim of this study is to assess the psychometric characteristics of the Short Form 36 Health Status Questionnaire (SF-36) in IPF and to provide disease specific minimally important differences (MID). METHODS: Data source was the European IPF Registry (eurIPFreg). The psychometric properties of the SF-36 version 2 were evaluated based on objective clinical measures as well as subjective perception. We analysed acceptance, feasibility, discrimination ability, construct and criterion validity, responsiveness and test-retest-reliability. MIDs were estimated via distribution and anchor-based approaches. RESULTS: The study population included 258 individuals (73.3% male; mean age 67.3 years, SD 10.7). Of them 75.2% (194 individuals) had no missing item. The distribution of several items was skewed, although floor effect was acceptable. Physical component score (PCS) correlated significantly and moderately with several anchors, whereas the correlations of mental component score (MCS) and anchors were only small. The tests showed mainly significant lower HRQL in individuals with long-term oxygen therapy. Analyses in stable individuals did not show significant changes of HRQL except for one dimension and anchor. Individuals with relevant changes of the health status based on the anchors had significant changes in all SF-36 dimensions and summary scales except for the dimension PAIN. PCS and MCS had mean MIDs of five and six, respectively. Mean MIDs of the dimensions ranged from seven to 21. CONCLUSION: It seems that the SF-36 is a valid instrument to measure HRQL in IPF and so can be used in RCTs or individual monitoring of disease. Nevertheless, the additional evaluation of longitudinal aspects and MIDs can be recommended to further analyse these factors. Our findings have a great potential impact on the evaluation of IPF patients. TRIAL REGISTRATION: The eurIPFreg and eurIPFbank are listed in https://clinicaltrials.gov ( NCT02951416 ).
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Estado de Salud , Fibrosis Pulmonar Idiopática/diagnóstico , Fibrosis Pulmonar Idiopática/epidemiología , Encuestas y Cuestionarios/normas , Anciano , Estudios Transversales , Femenino , Estudios de Seguimiento , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Psicometría , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND: Evaluation of variations in pre- and postoperative patient reported outcomes (PRO) and the association between preoperative patient characteristics and health and satisfaction outcomes after total knee arthroplasty (TKA) may support shared decision-making in Germany. Since previous research on TKA health outcomes indicated valuation differences in longitudinal data, experienced-based population weights were used for the first time as an external valuation system to measure discrepancies between patient and average population valuation of HRQoL. METHODS: Baseline data (n = 203) included sociodemographic and clinical characteristics and PROs, measured by the EQ-5D-3 L and WOMAC. Six-month follow-up data (n = 161) included medical changes since hospital discharge, PROs and satisfaction. A multivariate linear regression analysis was performed to evaluate the relationship between preoperative patient characteristics and PRO scores. Patient acceptable symptom state (PASS) was calculated to provide a satisfaction threshold. Patient-reported health-related quality of life (HRQoL) valuations were compared with average experienced-based population values to detect changes in valuation. RESULTS: One hundred thirty-seven subjects met inclusion criteria. All PRO measures improved significantly. Preoperative WOMAC and EQ-5D VAS, housing situation, marital status, age and asthma were found to be predictors of postoperative outcomes. 73% of study participants valued their preoperative HRQoL higher than the general population valuation, indicating response shift. Preoperatively, patient-reported EQ-5D VAS was substantially higher than average experienced-based population values. Postoperatively, this difference declined sharply. Approximately 61% of the patients reported satisfactory postoperative health, being mainly satisfied with results if postoperative WOMAC was ≥82.49 (change ≥20.25) and postoperative EQ-5D VAS was ≥75 (change ≥6). CONCLUSION: On average, patients benefited from TKA. Preoperative WOMAC and EQ-5D VAS were predictors of postoperative outcomes after TKA. Particularly patients with high absolute preoperative PRO scores were more likely to remain unsatisfied. Therefore, outcome prediction can contribute to shared-decision making. Using general population valuations as a reference, this study underlined a discrepancy between population and patient valuation of HRQoL before, but not after surgery, thus indicating a potential temporary response shift before surgery.
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Artroplastia de Reemplazo de Rodilla/psicología , Medición de Resultados Informados por el Paciente , Calidad de Vida , Adulto , Anciano , Femenino , Alemania , Humanos , Modelos Lineales , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Periodo Posoperatorio , Periodo Preoperatorio , Estudios Prospectivos , Encuestas y CuestionariosRESUMEN
BACKGROUND: The concept of complexity is used in palliative care (PC) to describe the nature of patients' situations and the extent of resulting needs and care demands. However, the term or concept is not clearly defined and operationalised with respect to its particular application in PC. As a complex problem, a care situation in PC is characterized by reciprocal, nonlinear relations and uncertainties. Dealing with complex problems necessitates problem-solving methods tailored to specific situations. The theory of complex adaptive systems (CAS) provides a framework for locating problems and solutions. This study aims to describe criteria contributing to complexity of PC situations from the professionals' view and to develop a conceptual framework to improve understanding of the concept of "complexity" and related elements of a PC situation by locating the complex problem "PC situation" in a CAS. METHODS: Qualitative interview study with 42 semi-structured expert (clinical/economical/political) interviews. Data was analysed using the framework method. The thematic framework was developed inductively. Categories were reviewed, subsumed and connected considering CAS theory. RESULTS: The CAS of a PC situation consists of three subsystems: patient, social system, and team. Agents in the "system patient" are allocated to further subsystems on patient level: physical, psycho-spiritual, and socio-cultural. The "social system" and the "system team" are composed of social agents, who affect the CAS as carriers of characteristics, roles, and relationships. Environmental factors interact with the care situation from outside the system. Agents within subsystems and subsystems themselves interact on all hierarchical system levels and shape the system behaviour of a PC situation. CONCLUSIONS: This paper provides a conceptual framework and comprehensive understanding of complexity in PC. The systemic view can help to understand and shape situations and dynamics of individual care situations; on higher hierarchical level, it can support an understanding and framework for the development of care structures and concepts. The framework provides a foundation for the development of a model to differentiate PC situations by complexity of patients and care needs. To enable an operationalisation and classification of complexity, relevant outcome measures mirroring the identified system elements should be identified and implemented in clinical practice.
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Cuidados Paliativos/organización & administración , Cultura , Femenino , Personal de Salud/estadística & datos numéricos , Humanos , Masculino , Evaluación de Necesidades , Cuidados Paliativos/psicología , Investigación Cualitativa , Factores Socioeconómicos , EspiritualidadRESUMEN
BACKGROUND: Machine-learning classifiers mostly offer good predictive performance and are increasingly used to support shared decision-making in clinical practice. Focusing on performance and practicability, this study evaluates prediction of patient-reported outcomes (PROs) by eight supervised classifiers including a linear model, following hip and knee replacement surgery. METHODS: NHS PRO data (130,945 observations) from April 2015 to April 2017 were used to train and test eight classifiers to predict binary postoperative improvement based on minimal important differences. Area under the receiver operating characteristic, J-statistic and several other metrics were calculated. The dependent outcomes were generic and disease-specific improvement based on the EQ-5D-3L visual analogue scale (VAS) as well as the Oxford Hip and Knee Score (Q score). RESULTS: The area under the receiver operating characteristic of the best training models was around 0.87 (VAS) and 0.78 (Q score) for hip replacement, while it was around 0.86 (VAS) and 0.70 (Q score) for knee replacement surgery. Extreme gradient boosting, random forests, multistep elastic net and linear model provided the highest overall J-statistics. Based on variable importance, the most important predictors for post-operative outcomes were preoperative VAS, Q score and single Q score dimensions. Sensitivity analysis for hip replacement VAS evaluated the influence of minimal important difference, patient selection criteria as well as additional data years. Together with a small benchmark of the NHS prediction model, robustness of our results was confirmed. CONCLUSIONS: Supervised machine-learning implementations, like extreme gradient boosting, can provide better performance than linear models and should be considered, when high predictive performance is needed. Preoperative VAS, Q score and specific dimensions like limping are the most important predictors for postoperative hip and knee PROMs.
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Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Modelos Teóricos , Medición de Resultados Informados por el Paciente , Aprendizaje Automático Supervisado , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Adulto JovenRESUMEN
BACKGROUND: Children's interstitial lung diseases (chILD) cover many rare entities, frequently not diagnosed or studied in detail. There is a great need for specialised advice and for internationally agreed subclassification of entities collected in a register.Our objective was to implement an international management platform with independent multidisciplinary review of cases at presentation for long-term follow-up and to test if this would allow for more accurate diagnosis. Also, quality and reproducibility of a diagnostic subclassification system were assessed using a collection of 25 complex chILD cases. METHODS: A web-based chILD management platform with a registry and biobank was successfully designed and implemented. RESULTS: Over a 3-year period, 575 patients were included for observation spanning a wide spectrum of chILD. In 346 patients, multidisciplinary reviews were completed by teams at five international sites (Munich 51%, London 12%, Hannover 31%, Ankara 1% and Paris 5%). In 13%, the diagnosis reached by the referring team was not confirmed by peer review. Among these, the diagnosis initially given was wrong (27%), imprecise (50%) or significant information was added (23%).The ability of nine expert clinicians to subcategorise the final diagnosis into the chILD-EU register classification had an overall exact inter-rater agreement of 59% on first assessment and after training, 64%. Only 10% of the 'wrong' answers resulted in allocation to an incorrect category. Subcategorisation proved useful but training is needed for optimal implementation. CONCLUSIONS: We have shown that chILD-EU has generated a platform to help the clinical assessment of chILD. TRIAL REGISTRATION NUMBER: Results, NCT02852928.
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Enfermedades Pulmonares Intersticiales/diagnóstico , Adolescente , Adulto , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Sistema de Registros , Reproducibilidad de los Resultados , Adulto JovenRESUMEN
BACKGROUND: Patients with interstitial lung diseases (ILD) have impaired health-related quality of life (HRQL). Little is known about the applicability of the disease-specific King's Brief Interstitial Lung Disease questionnaire (K-BILD) and the generic EQ-5D-5L in a German setting. METHODS: We assessed disease-specific (K-BILD) and generic HRQL (EQ-5D experience based value set (EBVS) and Visual Analog Scale (VAS)) in 229 patients with different ILD subtypes in a longitudinal observational study (HILDA). Additionally, we assessed the correlation of the HRQL measures with lung function and comorbidities. In a linear regression model, we investigated predictors (including age, sex, ILD subtype, FVC percentage of predicted value (FVC%pred), DLCO percentage of predicted value, and comorbidities). RESULTS: Among the 229 patients mean age was 63.2 (Standard deviation (SD): 12.9), 67.3% male, 24.0% had idiopathic pulmonary fibrosis, and 22.3% sarcoidosis. Means scores were as follows for EQ-5D EBVS 0.66(SD 0.17), VAS 61.4 (SD 19.1) and K-BILD Total 53.6 (SD 13.8). K-BILD had good construct validity (high correlation with EQ-5D EBVS (0.71)) and good internal consistency (Cronbach's alpha 0.89). Moreover, all HRQL measures were highly accepted by patients including low missing items and there were no ceiling or floor effects. A higher FVC % pred was associated with higher HRQL in all measures meanwhile comorbidities had a negative influence on HRQL. CONCLUSIONS: K-BILD and EQ-5D had similar HRQL trends and were associated similarly to the same disease-related factors in Germany. Our data supports the use of K-BILD in clinical practice in Germany, since it captures disease specific effects of ILD. Additionally, the use of the EQ-5D-5L could provide comparison to different disease areas and give an overview about the position of ILD patients in comparison to general population.
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Enfermedades Pulmonares Intersticiales/diagnóstico , Enfermedades Pulmonares Intersticiales/epidemiología , Calidad de Vida , Índice de Severidad de la Enfermedad , Anciano , Estudios de Cohortes , Femenino , Alemania/epidemiología , Humanos , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND: Specialist palliative care in the hospital addresses a heterogeneous patient population with complex care needs. In Germany, palliative care patients are classified based on their primary diagnosis to determine reimbursement despite findings that other factors describe patient needs better. To facilitate adequate resource allocation in this setting, in Australia and in the UK important steps have been undertaken towards identifying drivers of palliative care resource use and classifying patients accordingly. We aimed to pioneer patient classification based on determinants of resource use relevant to specialist palliative care in Germany first, by calculating the patient-level cost of specialist palliative care from the hospital's perspective, based on the recorded resource use and, subsequently, by analysing influencing factors. METHODS: Cross-sectional study of consecutive patients who had an episode of specialist palliative care in Munich University Hospital between 20 June and 4 August, 2016. To accurately reflect personnel intensity of specialist palliative care, aside from administrative data, we recorded actual use of all involved health professionals' labour time at patient level. Factors influencing episode costs were assessed using generalized linear regression and LASSO variable selection. RESULTS: The study included 144 patients. Mean costs of specialist palliative care per palliative care unit episode were 6542 (median: 5789, SE: 715) and 823 (median: 702, SE: 31) per consultation episode. Based on multivariate models that considered both variables recorded at beginning and at the end of episode, we identified factors explaining episode cost including phase of illness, Karnofsky performance score, and type of discharge. CONCLUSIONS: This study is an important step towards patient classification in specialist palliative care in Germany as it provides a feasible patient-level costing method and identifies possible starting points for classification. Application to a larger sample will allow for meaningful classification of palliative patients.
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BACKGROUND: Population-based value sets are widely used to transform health states into utilities, but may deviate from actual patient experience. Whether this occurs in a systematic way can be analyzed, in a first step, for respondents who do not report problems on the five domains of the EQ-5D-5L instrument in population studies. METHODS: EQ-5D-5L results from three annual cross-sectional surveys (2012, 2013, and 2014) were filtered for participants who reported being problem-free. Continuous visual analog scale (VAS) scores, ranging from 0 (worst imaginable health) to 100 (best imaginable health) were then used to measure their actual health perception and to compare results with the proposed EQ-5D-5L value. A multiple linear regression model was used to identify possible risk factors for low VAS scores. RESULTS: Some 3739 (61.5%) participants reported being problem-free. Their mean age was 41.1 years and mean VAS score was 91.9. Age and BMI were significantly associated with lower VAS scores. Age groups from 50 years onwards reported VAS means of 90.0 and below. Female gender and low education also had small but significant negative effects on patient experience. The presence of BMI class III as well as diabetes had the greatest negative effect on VAS results (- 9.0 and - 8.4) and reached the range of minimally important differences. Heart disease (- 6.2) and musculoskeletal disease (- 3.4) also had strong negative effects. The 25th percentile of VAS scores in our sample was 90.0, and the 50th percentile was 95.0. CONCLUSIONS: For some groups in population studies, especially older people with high BMI and those affected by specific diseases, no problems on all five domains of the EQ-5D-5L fails to reflect the respondents' health perception as measured by the VAS.