Benchmarking of abdominal surgery: a study evaluating the HARM score in a European national cohort.

BACKGROUND: Reliable, easily accessible metrics of surgical quality are currently lacking. The HARM (HospitAl length of stay, Readmission and Mortality) score is a composite measure that has been validated across diverse surgical cohorts. The aim of this study was to validate the HARM score in a national population of patients undergoing abdominal surgery. METHODS: Data on all abdominal surgery in Norwegian hospitals from 2011 to 2017 were obtained from the Norwegian Patient Registry. Readmissions and 30-day postoperative complications as well as deaths in and out of hospital were evaluated. The HARM scoring algorithm was tested after adjustment by establishing a newly proposed length of stay score. The correlation between the HARM score and complications, as well as the ability of aggregated HARM scores to discriminate between hospitals, were analysed. Risk adjustment models were developed for nationwide hospital comparisons. RESULTS: The data consisted of 407 113 primary operations on 295 999 patients in 85 hospitals. The HARM score was associated with complications and complication severity (Goodman-Kruskal γ value 0·59). Surgical specialty was the dominating variable for risk adjustment. Based on 1-year data, the risk-adjusted score classified 16 hospitals as low HARM score and 16 as high HARM score of the 53 hospitals that had at least 30 operations. CONCLUSION: The HARM score correlates with major outcomes and is associated with the presence and severity of complications. After risk adjustment, the HARM score discriminated strongly between hospitals in a European population of abdominal surgery.

ANTECEDENTES: En la actualidad no se dispone de un sistema de cuantificación numérica confiable y accesible para evaluar la calidad quirúrgica. La puntuación HARM es una medida compuesta basada en la duración de la estancia hospitalaria, los reingresos y la mortalidad postoperatoria que se ha validado en varias cohortes quirúrgicas. El objetivo de este estudio fue validar la puntuación HARM en una población nacional de pacientes sometidos a cirugía abdominal. MÉTODOS: Se obtuvieron los datos de todas las cirugías abdominales realizadas en hospitales noruegos entre 2011 y 2017 a través del registro noruego de pacientes. Se evaluaron los reingresos y las complicaciones postoperatorias a los 30 días, así como la mortalidad intra- y extra-hospitalaria. Se utilizó el algoritmo de puntuación HARM tras el ajuste con la nueva propuesta de puntuación para la duración de la estancia hospitalaria. Se analizó la correlación entre HARM y complicaciones, así como la capacidad de las puntuaciones HARM agregadas para discriminar entre hospitales. Se desarrollaron modelos de ajuste de riesgo para las comparar hospitales en todo el país. RESULTADOS: Se incluyeron 407.113 intervenciones primarias llevadas a cabo en 295.999 pacientes en 85 hospitales. La puntuación HARM se asoció con las complicaciones y la gravedad de la complicación (Goodman-Kruskal γ de 0,59). La especialidad quirúrgica fue la variable dominante para el ajuste del riesgo. Utilizando los datos de un período anual, la puntuación ajustada al riesgo clasificó a 16 hospitales como de baja puntuación y a 16 de alta puntuación de los 53 hospitales en los que se habían realizado al menos 30 intervenciones. CONCLUSIÓN: La puntuación HARM se correlaciona con los resultados principales y con la presencia y la gravedad de las complicaciones. La puntuación HARM, después del ajuste de riesgo, discrimina de forma sólida entre hospitales en una población europea de cirugía abdominal. This article is protected by copyright. All rights reserved.

Integrated Health Care for People with Chronic Conditions: a policy brief

Clinical research has led to spectacular developments in health care. It has provided us with knowledge about how to prevent diseases, like heart disease, how to reduce the consequences of disease, such as complications of diabetes, and to alleviate symptoms, such as those of lung disease, and how to rehabilitate people who have suffered a disabling event, such as a stroke. Healthcare systems have the potential to deliver interventions that save lives and improve the quality of life. We know this from well designed research and systematic reviews of that research. Unfortunately, we also know that patients often do not receive effective care when they should, that they sometimes receive care that is not effective or safe, and that not all of the money we spend on health care is well spent. This comes from a different type of research ­ health services research. In the same way that clinical research is essential for informing how best to care for patients clinically, health services research is essential to inform decisions about how best to organise, finance and govern our healthcare system. This policy brief is a good example of both the potential for health services research to inform healthcare policies and management, and an example of the limitations of health services research to inform decisions.

Beneficial effects of 1-year optimal medical treatment with and without additional PTA on inflammatory markers of atherosclerosis in patients with PAD. Results from the Oslo Balloon Angioplasty versus Conservative Treatment (OBACT) study.

The influence of optimal medical treatment (OMT) with or without additional percutaneous transluminal angioplasty (PTA) on vascular inflammation in peripheral arterial occlusive disease (PAD) patients was investigated. Patients with intermittent claudication (IC) and angiographically verified PAD were randomized to OMT (n = 28) or OMT + PTA (n = 28) and followed for 12 months. Ankle-brachial index (ABI), treadmill walking distances (WD), visual analogue scale (VAS), and blood sampling for the determination of selected soluble biomarkers were undertaken at baseline and after 3 and 12 months. After both 3 and 12 months, ABI, WD and VAS were highly significantly improved in favour of OMT + PTA (p < 0.05 for all). Significant improvements were recorded in both groups in serum lipids (p < 0.01 for all), except for triglycerides, and in the inflammatory markers P-selectin, interleukin-6, interleukin-10, monocyte chemoattractant protein-1 and fibrinogen (p < 0.05 for all). There were, however, no differences in the changes from baseline between the groups in any variable. Intervention with OMT alone or in combination with PTA did not differ with regard to the effects on serum lipids and markers of inflammation in our population of PAD patients. The combined treatment was, however, better for the treadmill walking distance.

The Oslo balloon angioplasty versus conservative treatment study (OBACT)--the 2-years results of a single centre, prospective, randomised study in patients with intermittent claudication.

OBJECTIVES: To compare the effect of optimal medical treatment only (OMT) with OMT combined with percutaneous transluminal angioplasty (OMT+PTA) in patients with intermittent claudication (IC). DESIGN: A single centre prospective, randomised study. Quality of life (QoL) was the primary outcome measure. Secondary measures were ankle-brachial-index (ABI), treadmill walking distances and mortality. METHODS: From a total of 434 patients considered for inclusion into the trial, only 56 patients with disabling IC fulfilled the inclusion criteria. The patients were randomised into treatment groups consisting of 28 patients each and followed for 2 years. ABI and treadmill walking distances were measured in addition to the visual analogue scale (VAS) for pain evaluation, and QoL assessment using the Short Form (SF-36 and Claudication Scale (CLAU-S). RESULTS: The demographic data in the 2 groups were almost identical. After 2 years of follow-up the ABI, the treadmill walking distances and the VAS were significant improved in the group treated with OMT+PTA, compared to the group treated with OMT only (p<0.01 for all). Furthermore, some variables from the QoL assessment also showed a significant improvement in favour of the OMT+PTA group (p<0.05 for all). CONCLUSION: The advantage of conducting a single centre study and adhering to very strict inclusion criteria was illustrated by the homogenous demographic data of the two groups. This partly outweighed the disadvantage of having included a relatively small number of patients. Early intervention with PTA in addition to OMT seems to have a generally more positive effect compared to OMT only, on haemodynamic, functional as well as QoL aspects during the first 2 years in patients with IC.

Undiagnosed dysglycaemia and inflammation in cardiovascular disease.

BACKGROUND: Cardiovascular (CV) disease is associated with increased levels of glucose, but the prevalence of dysglycaemia in CV diseases is not fully known. The study examined the prevalence of unknown dysglycaemia and its association with inflammation in Caucasian patients with ischaemic vascular complications, i.e. coronary artery disease (CAD), cerebrovascular disease (CVD) and peripheral artery disease (PAD). MATERIALS AND METHODS: This case-controlled study involved 149 patients (mean age 68 years) hospitalized for CAD, PAD or CVD and 59 control-subjects (CTR) free from CV-disease. The prevalence of dysglycaemia according to WHO/ADA criteria (impaired fasting glycaemia, impaired glucose tolerance or diabetes mellitus) was assessed by a 75-g oral glucose tolerance test. Inflammatory parameters were analyzed in fasting samples. RESULTS: Dysglycaemia was found in 49%, 55% and 57% of patients with CAD, CVD and PAD, respectively; all were significantly higher than among the controls (29%). The odds ratio (95% CI) for being dysglycaemic were 1.7 (1.04-2.77), 1.9 (1.19-3.06) and 2.0 (1.25-3.19) for CAD, CVD and PAD, respectively. Inflammatory markers (the total leucocyte count, soluble tumour necrosis factor-receptor type I, C-reactive protein) were elevated in patient groups and tended to increase with increasing blood glucose levels in all groups. The levels of the anti-inflammatory cytokine transforming growth factor-beta1 and insulin-like growth factor binding protein 3 were lowered in patients with CAD and, in patients with PAD, the former was inversely related to the levels of the blood glucose. CONCLUSIONS: Undiagnosed dysglycaemia was common in patients with ischaemic CV manifestations regardless of vascular bed involved. Inflammation was associated in a dosage-related manner to glucose levels.

Markers of vascular inflammation are associated with the extent of atherosclerosis assessed as angiographic score and treadmill walking distances in patients with peripheral arterial occlusive disease.

The importance of inflammation in atherosclerosis is well established in cardiovascular disease. However, limited data exist on the relationship between vascular inflammation and the severity of peripheral arterial occlusive disease (PAD). We investigated the relationship between biochemical markers of vascular inflammation and the diagnostic measures of PAD: ankle-brachial pressure index (ABI), maximum treadmill walking distance and angiographic score. In 127 patients (mean age 66 years; 64% males) with angiographically verified PAD, fasting blood samples were drawn for determination of selected soluble cell adhesion molecules, cytokines and chemokines. Tumor necrosis factor-alpha (TNFalpha), interleukin-6 (IL-6), monocyte chemoattractant protein-1 (MCP-1) and CD40 ligand (CD40L) were all significantly correlated with the angiographic score (p < 0.05 for all). After adjustment for relevant co-variates, MCP-1 and CD40L remained statistically significant (p < 0.01 for both). IL-6 was, independent of other risk factors, inversely correlated with the maximum treadmill walking distance (p < 0.01). Our cross-sectional study in PAD patients showed that the vascular inflammatory markers MCP-1, CD40L and IL-6 were significantly associated with the extent of atherosclerosis, assessed by angiographic score and maximum treadmill walking distance. These findings indicate that vascular inflammation is implicated in PAD, which might be of importance in future diagnosis and treatment of the disease.

Elevated TFPI in malignant disease: relation to cancer type and hypercoagulation.

We have previously reported high levels of the coagulation inhibitor TFPI in the blood of patients with gastrointestinal cancer. TFPI is not an acute-phase reactant, but high levels have also been reported in patients with septicaemia and disseminated intravascular coagulation (DIC). To study its relationship with other types of malignancy, TFPI activity was first determined in plasma samples from 214 patients with various malignancies. In a second cohort of 83 patients, total and free TFPI antigen, protein C, antithrombin, fibrin monomer and D-dimer were also measured. Elevated TFPI activity and antigens were found in about half of the patients with solid tumours. In contrast, elevated TFPI was rare in haematological malignancies (12%). In the 18 patients with acute nonlymphocytic leukaemia (ANLL), elevated free TFPI was found only in patients who also had DIC. No correlation was found between TFPI levels and fibrin monomer or D-dimer levels. Only four out of 20 patients with solid tumours had normal levels of fibrin monomer and D-dimer, yet three out of these four had elevated TFPI. In conclusion, elevated TFPI in ANLL is related to the coexistence of DIC. In solid tumour disease increased TFPI may reduce protective fibrin formation, but the pathogenic mechanism is as yet unknown.

Tissue factor pathway inhibitor in health and disease.

The knowledge of tissue factor pathway inhibitor (TFPI) has greatly expanded during the last few years, and TFPI is now established as a coagulation inhibitor of great importance. Its main role seems to be inhibition of small amounts of tissue factor, which probably is essential for maintaining a normal hemostatic balance. The acceleration of TFPI's inhibitory effect by heparin, the TFPI release caused by heparin injection, and TFPI's heparin affinity may greatly contribute to the anticoagulant properties of the endothelium, and may be particularly important for the outcome of vascular injury. The information provided by one single measurement of plasma TFPI in a patient is difficult to interpret, but serial measurements during the course of a disease may signal the prognosis. Recombinant TFPI has proved effective in the treatment of experimental disseminated intravascular coagulation, sepsis, and thrombosis. Whether TFPI or TFPI derivatives will be as effective in the treatment of patients remains to be determined.

Tissue factor pathway inhibitor: a potent inhibitor of in-vitro coagulation and in-vivo thrombus formation.

Tissue factor pathway inhibitor is established as an important coagulation inhibitor. The knowledge of the relationship between the structure and function of the tissue factor pathway inhibitor molecule has been widely expanded, especially with regard to its interaction with heparin. Perhaps the most important and promising new studies have investigated the possibility, of using tissue factor pathway inhibitor as a potent drug in the treatment of experimental septic shock and arterial and venous thrombosis.

Tissue factor pathway inhibitor prevents thrombus formation on procoagulant subendothelial matrix.

The effect of recombinant tissue factor pathway inhibitor (rTFPI) on extracellular matrix procoagulant activity was studied in a human ex vivo model of thrombogenesis. Extracellular matrix of endotoxin stimulated endothelial cells perfused with human non-anticoagulated blood at a wall shear rate of 100/s induced pronounced fibrin deposition, which covered 82 +/- 11% of the matrix surface within 5 min. Preincubating the matrix with the combination of rTFPI, factor VIIa (FVIIa) and factor Xa (FXa) reduced fibrin deposition to levels observed with matrix from non-stimulated endothelial cells (7 +/- 6% fibrin coverage, P < 0.001). Preincubation with rTFPI plus FXa also reduced fibrin deposition significantly, but to a lesser extent (41 +/- 6% fibrin coverage, P < 0.001). Preincubation with rTFPI alone, or with rTFPI plus FVIIa, did not affect fibrin deposition. The inhibition of thrombus formation on procoagulant extracellular matrix by rTFPI seemed to be FXa-dependent, and a result of TFPI's ability to bind and inhibit both TF activity as well as FXa. The results from this study suggest a future role for rTFPI as an agent for prevention of TF-induced vascular thrombosis.

Plasma thrombomodulin level in malignancy varies according to the tumor type.

Plasma thrombomodulin (TM) level was measured by ELISA in patients with either digestive tract cancers or malignant melanomas. A striking difference was seen between tumor types with an increase in the TM level of the former and a decrease in the latter. This finding is in agreement with the classification of tumors previously proposed by Zacharski et al.