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Sökning: WFRF:(Engström Lars)

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  • Engström, Gunnar, et al. (författare)
  • The Swedish CArdioPulmonary BioImage Study : objectives and design
  • 2015
  • Ingår i: Journal of Internal Medicine. - : Wiley. - 0954-6820 .- 1365-2796. ; 278:6, s. 645-659
  • Tidskriftsartikel (refereegranskat)abstract
    • Cardiopulmonary diseases are major causes of death worldwide, but currently recommended strategies for diagnosis and prevention may be outdated because of recent changes in risk factor patterns. The Swedish CArdioPulmonarybioImage Study (SCAPIS) combines the use of new imaging technologies, advances in large-scale 'omics' and epidemiological analyses to extensively characterize a Swedish cohort of 30 000 men and women aged between 50 and 64 years. The information obtained will be used to improve risk prediction of cardiopulmonary diseases and optimize the ability to study disease mechanisms. A comprehensive pilot study in 1111 individuals, which was completed in 2012, demonstrated the feasibility and financial and ethical consequences of SCAPIS. Recruitment to the national, multicentre study has recently started.
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  • Alzuhairi, Karam Sadoon, et al. (författare)
  • Sub-acute cardiac magnetic resonance to predict irreversible reduction in left ventricular ejection fraction after ST-segment elevation myocardial infarction : A DANAMI-3 sub-study
  • 2020
  • Ingår i: International Journal of Cardiology. - : Elsevier BV. - 0167-5273. ; 301, s. 215-219
  • Tidskriftsartikel (refereegranskat)abstract
    • Aims: To predict irreversible reduction in left ventricular ejection fraction (LVEF) during admission for ST-segment elevation myocardial infarction (STEMI) using cardiac magnetic resonance (CMR) in addition to classical clinical parameters. Irreversible reduction in LVEF is an important prognostic factor after STEMI which necessitates medical therapy and implantation of prophylactic implantable cardioverter defibrillator (ICD). Methods and results: A post-hoc analysis of DANAMI-3 trial program (Third DANish Study of Optimal Acute Treatment of Patients With ST-elevation Myocardial Infarction) which recruited 649 patients who had CMR performed during index hospitalization and after 3 months. Patients were divided into two groups according to CMR-LVEF at 3 months: Group 1 with LVEF≤35% and Group 2 with LVEF>35%. Group 1 included 15 patients (2.3%) while Group 2 included 634 patients (97.7%). A multivariate analysis showed that: Killip class >1 (OR 7.39; CI:1.47–36.21, P = 0.01), symptom onset-to-wire ≥6 h (OR 7.19; CI 1.07–50.91, P = 0.04), LVEF≤35% using index echocardiography (OR 7.11; CI: 1.27–47.43, P = 0.03), and infarct size ≥40% of LV on index CMR (OR 42.62; CI:7.83–328.29, P < 0.001) independently correlated with a final LVEF≤35%. Clinical models consisted of these parameters could identify 7 out of 15 patients in Group 1 with 100% positive predictive value. Conclusion: Together with other clinical measurements, the assessment of infarct size using late Gadolinium enhancement by CMR during hospitalization is a strong predictor of irreversible reduction in CMR_LVEF ≤35. That could potentially, after validation with future research, aids the selection and treatment of high-risk patients after STEMI, including implantation of prophylactic ICD during index hospitalization.
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  • Engström, Gunnar, et al. (författare)
  • Blood pressure increase and incidence of hypertension in relation to inflammation-sensitive plasma proteins.
  • 2002
  • Ingår i: Arteriosclerosis, Thrombosis and Vascular Biology. - 1524-4636. ; 22:12, s. 2054-2058
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective— The reasons for the relationship between inflammation-sensitive plasma proteins (ISPs) and incidence of cardiovascular diseases are poorly understood. This study explored the hypothesis that ISPs are associated with future hypertension and age-related blood pressure increase. Method and Results— Blood pressure and plasma levels of fibrinogen, {alpha}1-antitrypsin, haptoglobin, ceruloplasmin, and orosomucoid were determined in 2262 healthy men aged 35 to 50 years, initially without treatment for hypertension. The cohort was re-examined after 15.7 (±2.2) years. Incidence of hypertension and blood pressure increase was studied in relation to number of elevated proteins (ie, in the top quartile) at baseline. Among men without treatment for hypertension at follow-up, mean (±SD) increase in systolic blood pressure was 18.8±17, 19.2±17, 19.3±17, and 22.1±18 mm Hg, respectively, for men with 0, 1, 2, and >=3 elevated proteins (P for trend=0.02, adjusted for confounders). The corresponding values for pulse pressure increase was 15.5±14, 15.8±14, 17.4±14, and 17.8±15 mm Hg, respectively (P=0.02). Incidence of hypertension (>=160/95 mm Hg or treatment) and future blood pressure treatment showed similar associations with ISPs. Increase in diastolic blood pressure showed no association with ISPs. Conclusions— Plasma levels of ISPs are associated with a future increase in blood pressure. This could contribute to the relationship between ISP levels and cardiovascular disease.
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  • Engström, Gunnar, et al. (författare)
  • Inflammation-sensitive plasma proteins and incidence of myocardial infarction in men with low cardiovascular risk.
  • 2003
  • Ingår i: Arteriosclerosis, Thrombosis and Vascular Biology. - 1524-4636. ; 23:12, s. 2247-2251
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective— Myocardial infarction (MI) is sometimes experienced by individuals without any traditional risk factor. This prospective study explored whether incidence of MI in nonsmoking, nondiabetic men with normal blood pressure and serum lipids is related to inflammation-sensitive plasma proteins (ISPs). Methods and Results— Five ISPs ({alpha}1-antitrypsin, haptoglobin, ceruloplasmin, fibrinogen, orosomucoid) were analyzed in 6075 men, 47±3.6 years old. A low-risk group (no traditional risk factor, n=1108) and a high-risk group (>=2 major risk factors, n=1011) were defined. Incidence of MI (n=227) was monitored over 18.1±4.3 years of follow-up. In the low-risk group, the age-adjusted relative risks (RRs) were 1.00 (reference), 1.9 (95% CI, 0.8 to 4.2), 1.8 (95% CI, 0.6 to 5.4), and 2.9 (95% CI, 1.05 to 8.1), respectively, for men with 0, 1, 2 and >=3 ISPs in the top quartile (trend: P=0.03). In this group, the increased risk was observed only after >=10 years of follow-up. In the high-risk group, the age-adjusted RRs were 1.00, 1.4 (95% CI, 0.9 to 2.2), 1.9 (95% CI, 1.2 to 3.1), and 2.0 (95% CI, 1.3 to 3.1), respectively, for men with 0, 1, 2, and >=3 ISPs in the top quartile (trend: P=0.0004). Conclusion— Incidence of MI in nonsmoking, nondiabetic men with normal blood pressure and lipids was related to ISPs. The causes for this relationship remain to be explored.
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  • Engström, Gunnar, et al. (författare)
  • Inflammation-sensitive plasma proteins are associated with future weight gain.
  • 2003
  • Ingår i: Diabetes. - : American Diabetes Association. - 1939-327X .- 0012-1797. ; 52:8, s. 2097-2101
  • Tidskriftsartikel (refereegranskat)abstract
    • Cross-sectional studies have associated obesity and other components of the so-called metabolic syndrome with low-grade inflammation. The temporal and causal relations of this association have not been fully explored. This study explored whether elevated levels of inflammation-sensitive plasma proteins (ISPs) (fibrinogen, orosomucoid, {alpha}1-antitrypsin, haptoglobin, and ceruloplasmin) are associated with future weight gain. Five ISPs were measured in 2,821 nondiabetic healthy men (38–50 years of age) who were reexamined after a mean follow-up of 6.1 years. Future weight gain was studied in relation to the number of elevated ISPs (i.e., in the top quartile). The proportion with a large weight gain (75th percentile >=3.8 kg) was 21.0, 25.9, 26.8, and 28.3%, respectively, among men with none, one, two, and three or more ISPs in the top quartile (P for trend 0.0005). This relation remained significant after adjustments for weight at baseline, follow-up time, height (at baseline and follow-up), physical inactivity (at baseline and follow-up), smoking (at baseline and follow-up), high alcohol consumption, and insulin resistance. The relations were largely similar for all individual ISPs. Elevated ISP levels predict a large weight gain in middle-aged men. This relation could contribute to the relation between inflammation, the metabolic syndrome, and cardiovascular disease. Several cross-sectional studies have reported positive correlations between body fatness and inflammation-sensitive plasma proteins (ISPs) and other inflammatory markers (1–4). Weight reduction in obese subjects has been associated with reduced inflammation (5–7). It has been proposed that proinflammatory cytokines formed in the adipose tissue, e.g., interleukin (IL)-6 and tumor necrosis factor-{alpha} (TNF-{alpha}), increase the hepatic synthesis of ISPs (4,8–10). However, the temporal and causal relations between obesity and elevated ISPs are incompletely understood. Even though inflammation is mainly considered an effect of obesity or weight increase, it also has been suggested that there could be a reverse relation, i.e., that inflammation could promote weight gain (11). A 3-year follow-up of the Atherosclerosis Risk in Communities (ARIC) study reported that a large weight gain was more common in subjects with elevated fibrinogen, white blood cells, von Willebrand factor, or factor VIII, i.e., four putative markers of inflammation (12). The Malmö Preventive Study cohort includes ~6,000 men with data on five ISPs (fibrinogen, haptoglobin, {alpha}1-antitrypsin, orosomucoid, and ceruloplasmin). Previous studies from this cohort have shown cross-sectional relations between ISP levels and BMI, blood pressure, and insulin resistance (1,13,14). Follow-up studies have shown that these proteins are associated with an increased incidence of cardiovascular diseases and an increased incidence of high blood pressure (15,16). The present study sought to explore whether these proteins predicted weight gain over a mean follow-up of 6 years.
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  • Engström, Gunnar, et al. (författare)
  • Inflammation-sensitive plasma proteins, diabetes, and mortality and incidence of myocardial infarction and stroke: a population-based study.
  • 2003
  • Ingår i: Diabetes. - : American Diabetes Association. - 1939-327X .- 0012-1797. ; 52:2, s. 442-447
  • Tidskriftsartikel (refereegranskat)abstract
    • This study explores the relationship of inflammation-sensitive plasma proteins (ISPs) with the prevalence of diabetes and the interrelationships between ISPs and diabetes in the prediction of death and incidence of myocardial infarction and stroke. Plasma levels of fibrinogen, α1-antitrypsin, haptoglobin, ceruloplasmin, and orosomucoid were assessed in 6,050 men, aged 28–61 years. All-cause and cardiovascular mortality and incidence of myocardial infarction and stroke were monitored over 18.7 ± 3.7 years. Prevalence of diabetes (n = 321) was significantly associated with ISP levels among overweight and obese men but not among men with BMI &lt;25 kg/m2. The association was similar for insulin resistance according to homeostasis model assessment. High ISP levels (two or more ISPs in the top quartile) increased the cardiovascular risk among diabetic men. The risk factor-adjusted relative risks for cardiovascular mortality, myocardial infarction, and stroke were 2.8 (CI 1.8–4.5), 2.2 (1.5–3.2), and 2.5 (1.4–4.6), respectively, for diabetic men with high ISP levels (reference: nondiabetic men with low ISP levels). The corresponding risks for diabetic men with low ISP levels were 1.8 (1.1–3.0), 1.3 (0.8–2.1), and 1.2 (0.6–2.5), respectively. In conclusion, in this population-based cohort, diabetes was associated with increased ISP levels among overweight and obese men but not among men with normal weight. High ISP levels increased the cardiovascular risk similarly in diabetic as compared with nondiabetic men.
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  • Engström, Gabriella (författare)
  • Lower Urinary Tract Symptoms in Swedish Male Population : Prevalence, Distress and Quality of Life
  • 2006
  • Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
    • The aim the thesis was to investigate, the prevalence of Lower Urinary Tract Symptoms (LUTS). Moreover, we examine symptom severity and different levels of distress and describe how different symptoms from the lower urinary tract affect the self-assessed health, sadness, happiness and the quality of life in men. The studies are based on two data collections. In the first data collection, all men aged 40 – 80 years (n=2571) living in the Swedish community received a postal questionnaire. Twelve months later, 504 men who had earlier reported LUTS and 504 who had not reported symptoms were asked to complete the DAN-PSS and the SF-36 questionnaires. The overall prevalence of LUTS was 24%. Post-micturition dribbling (21%) was the most frequent symptom, and stress incontinence (2%) was the least frequent symptom. Urge incontinence, stress incontinence and “other” incontinence cause a high level of distress, even if the symptoms do not occur very often. Men experiencing mild, moderate or severe urge, stress or “other incontinence” had lower mean scores for all of the eight dimensions measured by the SF-36 than men without the same symptoms. Men experiencing a moderate/severe degree of weak stream or nocturia reported a poorer quality of life in all dimensions compared to men with a mild level of the same symptoms. The total burden of moderate/severe LUTS is related to self-assessed health, sadness and happiness. For each of the 12 specific LUTS, men with mild, moderate or severe symptoms had lower scores for self-assessed health and happiness, and higher scores for self-assessed sadness, than men without the same symptoms. In conclusions, one of every four men reports LUTS. Urinary incontinence causes high level of distress even to men who experience this symptom rarely. LUTS have a negative impact on quality of life, health, sadness and happiness.
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  • Engström, Gabriella, 1965-, et al. (författare)
  • Prevalence of Three Lower Urinary Tract Symptoms in Men –a Population-Based Study.
  • 2003
  • Ingår i: Family Practice. - : Oxford University Press (OUP). - 0263-2136 .- 1460-2229. ; 20:1, s. 7-10
  • Tidskriftsartikel (refereegranskat)abstract
    • Background. Lower urinary tract symptoms are a common and costly public health issue. In earlier studies, the prevalence of urinary symptoms can be seen to fluctuate because there is no consensus about how to define and categorize the severity of the symptoms. Objectives. The study was undertaken in order to investigate the prevalence of three common lower urinary tract symptoms (urgency, stress incontinence and post-micturition dribbling) and analyse health care-seeking behaviour. Methods. A self-administered questionnaire was developed to investigate all men aged 40-80 years residing in the community of Surahammar, Sweden. The questionnaire included items on three specific urinary symptoms: urgency, stress incontinence and post-micturition dribbling, and one question about health care-seeking behaviour. Results. A response rate of 86% was obtained in the questionnaire study. The overall prevalence of the lower urinary tract symptoms was 24%. The prevalence increased from 20% in the group aged 40-49 years to 28% in the group aged 70-80 years (P < 0.01). Post-micturition dribbling (21%) was the most frequent symptom, and stress incontinence (2.4%) was the least frequent symptom. The number of participants who sought health care was low (4%) and increased significantly with age (P < 0.001). Conclusions. The present study showed that 24% of the Swedish cohort of men of 40-80 years of age reported at least one of the following symptoms: urgency, stress incontinence or postmicturition dribbling. This study is consistent with other research regarding the low consultation frequency for these symptoms. Moreover, the study is also in accord with those findings indicating that for the majority of men with urinary symptoms, their health care providers are not aware of their problem.
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  • Engström, Gabriella, et al. (författare)
  • The impact on quality of life of different symptoms from the lower urinary tract in men measured by the SF-36 questionnaire
  • 2006
  • Ingår i: Scandinavian Journal of Urology and Nephrology. - : Informa UK Limited. - 0036-5599 .- 1651-2065. ; 40:6, s. 485-494
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective. To describe how different lower urinary tract symptoms (LUTS) affect the quality of life (QOL) in men. Material and methods. The study included 1008 men aged 40-80 years living in the community of Surahammar, Sweden who had answered a questionnaire concerning stress incontinence, urgency and post-micturition dribbling 12 months earlier. The occurrence and severity/frequency of 12 specific LUTS were assessed using the Danish Prostatic Symptom Score questionnaire. QOL was evaluated using the Short Form 36 (SF-36) questionnaire. Results. Post-micturition dribbling was the most frequently reported symptom (71%) and stress incontinence the least common (11%). Men who experienced urge, stress or "other incontinence'' had lower mean scores for all of the eight dimensions measured by the SF-36 than men without such symptoms. Furthermore, men who experienced a moderate/severe degree of weak stream or nocturia reported a poorer QOL for all dimensions compared to men with a mild level of the same symptoms. QOL was found to decrease with increasing age. Men aged 66-80 years with "other incontinence'' reported lower mean SF-36 scores for physical functioning, role physical, role emotional, social functioning and body pain than 40-65-year-old men. Conclusions. LUTS in men affect QOL dimensions differently. Storage symptoms appear to reduce QOL more than voiding and post-micturition symptoms. Urinary incontinence affected all eight of the dimensions evaluated. Elderly men with LUTS reported a lower QOL than younger men.
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  • Engström, Ingemar, 1952-, et al. (författare)
  • Relational continuity may give better clinical outcomes in patients with serious mental illness - a systematic review
  • 2023
  • Ingår i: BMC Psychiatry. - : BioMed Central (BMC). - 1471-244X. ; 23:1
  • Forskningsöversikt (refereegranskat)abstract
    • BackgroundContinuity of care is considered important for results of treatment of serious mental illness (SMI). Yet, evidence of associations between relational continuity and different medical and social outcomes is sparse. Research approaches differ considerably regarding how to best assess continuity as well as which outcome to study. It has hitherto been difficult to evaluate the importance of relational continuity of care. The aim of this systematic review was to investigate treatment outcomes, including effects on resource use and costs associated with receiving higher relational continuity of care for patients with SMI.MethodsEleven databases were searched between January 2000 and February 2021 for studies investigating associations between some measure of relational continuity and health outcomes and costs. All eligible studies were assessed for study relevance and risk of bias by at least two independent reviewers. Only studies with acceptable risk of bias were included. Due to study heterogeneity the synthesis was made narratively, without meta-analysis. The certainty of the summarized result was assessed using GRADE. Study registration number in PROSPERO: CRD42020196518.ResultsWe identified 8 916 unique references and included 17 studies comprising around 300 000 patients in the review. The results were described with regard to seven outcomes. The results indicated that higher relational continuity of care for patients with serious mental illness may prevent premature deaths and suicide, may lower the number of emergency department (ED) visits and may contribute to a better quality of life compared to patients receiving lower levels of relational continuity of care. The certainty of the evidence was assessed as low or very low for all outcomes. The certainty of results for the outcomes hospitalization, costs, symptoms and functioning, and adherence to drug treatment was very low with the result that no reliable conclusions could be drawn in these areas.ConclusionsThe results of this systematic review indicate that having higher relational continuity of care may have beneficial effects for patients with severe mental illness, and no results have indicated the opposite relationship. There is a need for better studies using clear and distinctive measures of exposure for relational continuity of care.
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  • Engström, Jon (författare)
  • Co-creation in Healthcare Service Development : A Diary-based approach
  • 2012
  • Licentiatavhandling (övrigt vetenskapligt/konstnärligt)abstract
    • The patient is the only person who experiences the complete course of a healthcare problem, from first symptom to any contacts with the healthcare system to examination, treatment, follow-up activities and rehabilitation. The aim of this thesis is to explore how caregivers, together with patients, can draw on the knowledge patients acquire from their experiences in healthcare service development. This represents a break with the traditional role of the patient, which has been one of a passive receiver of care, following a supplier-centered view on value creation, which has increasingly been challenged both in the healthcare management discourse and in service research. Instead it is argued that value can only be co-created with customers, or patients in the case of healthcare. This means that the patients’ value-creating processes and contexts need to be emphasized and that patients are seen as a possible resource in their own care but also in the development of services and products. Despite this change in discourse, practical methods and empirical studies concerning patient involvement are scarce. This thesis adds to the field through an empirical exploration of co-creation in the development of healthcare. Through an action research approach, researchers and healthcare personnel have collaborated to develop a model for involving patients in service development, by inviting patients to share ideas and experiences through diaries.A workable, three-phase (preparation, execution and learning) model for patient involvement through diaries has been developed, and applied in three clinics (orthopedic, rehabilitation, gastro). A total of 53 patients from the different care processes have contributed ideas and experiences using paper and pen diaries or blogs, or by calling an answering machine. By doing so for a period of 14 days, the patients have submitted a total of 360 ideas.Three ways are proposed for utilizing the rich data submitted by the patients in service development. First, ideas from diaries can be used as input for service development. Second, a larger sample of diaries can be used to create a report of patient experiences, in which problem areas in the care process can be identified, and combined with other statistics. Third, individual patients’ stories can be highlighted and serve as a basis for discussion in the organization to shift the focus to the patient’s experience, serving as a motivator for change within the caregiving organization.The study shows that patients can share ideas and experiences regarding a range of topics, including clinical, organizational, social, informational, and practical issues and attitudes among healthcare staff. The contexts to which these ideas and experiences applied were caregiver, home, extended caregiver, and work, and often concerned topics and aspects of the patient’s care process that are invisible to the caregiver.Although healthcare organizations should be aware of the limitations to participation an illness may imply among some patients, patient co-creation in service development provides several important benefits. Acquiring knowledge regarding the parts of the patient’s care process that are invisible to the caregiver is key to improving care and supporting patients’ work of healing and managing life. Patients’ insights and creativity are an untapped resource for development of many aspects of the healthcare process.
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  • Engström, Mats, et al. (författare)
  • Serial gadolinium-enhanced magnetic resonance imaging and assessment of facial nerve function in Bell's palsy
  • 1997
  • Ingår i: Otolaryngology and head and neck surgery. - 0194-5998 .- 1097-6817. ; 117:5, s. 559-566
  • Tidskriftsartikel (refereegranskat)abstract
    • Eleven patients with mild or moderate acute idiopathic peripheral facial palsy, so-called Bell's palsy, were serially examined by gadolinium-DTPA-enhanced MRI on mean days 11, 40, and 97 (third examination, n = 10) after the onset of palsy. Results of the clinical and neurophysiologic assessment of facial nerve function were compared with the gadolinium-enhanced MRI findings. Eight of the 11 patients demonstrated contrast enhancement of the facial nerve at the initial examination, but in 7 of them, the enhancement had disappeared by the time of the serial follow-up gadolinium-enhanced MRI scans. The disappearance of facial nerve enhancement was found to be related to clinical and neurophysiologic improvements in facial nerve function during recovery from Bell's palsy. The three patients whose scans were negative at the initial gadolinium-enhanced MRI examination had the same clinical severity of palsy, but initially they had milder neurophysiologic involvement than those who demonstrated enhancement; these three patients did not exhibit enhancement at serial follow-up scans. These findings indicate that the presence of enhancement at the initial MRI scan is not necessarily indicative of a poor prognosis for recovery.
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21.
  • Engström, Sevek, et al. (författare)
  • Can costs of screening for hypertension and diabetes in dental care and follow-up in primary health care be predicted?
  • 2013
  • Ingår i: Upsala Journal of Medical Sciences. - : Informa Healthcare / Upsala Medical Society. - 0300-9734 .- 2000-1967. ; 118:4, s. 256-262
  • Tidskriftsartikel (refereegranskat)abstract
    • Aim. The purpose was to assess the direct costs of screening for high blood pressure and blood glucose in dental care and of follow-up in primary health care and, based on these data, arrive at a prediction function. less thanbrgreater than less thanbrgreater thanStudy population. All subjects coming for routine check-ups at three dental health clinics were invited to have blood pressure or blood glucose measurements; 1,623 agreed to participate. Subjects screening positive were referred to their primary health care centres for follow-up. less thanbrgreater than less thanbrgreater thanMethods. Information on individual screening time was registered during the screening process, and information on accountable time, costs for the screening staff, overhead costs, and analysis costs for the screening was obtained from the participating dental clinics. The corresponding items in primary care, i.e. consultation time, number of follow-up appointments, accountable time, costs for the follow-up staff, overhead costs, and analysis costs during follow-up were obtained from the primary health care centres. less thanbrgreater than less thanbrgreater thanResults. The total screening costs per screened subject ranged from (sic)7.4 to (sic)9.2 depending on subgroups, corresponding to 16.7-42.7 staff minutes. The corresponding follow-up costs were (sic)57-(sic)91. The total resource used for screening and follow-up per diagnosis was 563-3,137 staff minutes. There was a strong relationship between resource use and numbers needed to screen (NNS) to find one diagnosis (P andlt; 0.0001, degree of explanation 99%). less thanbrgreater than less thanbrgreater thanConclusions. Screening and follow-up costs were moderate and appear to be lower for combined screening of blood pressure and blood glucose than for separate screening. There was a strong relationship between resource use and NNS.
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  • Engstrøm, Thomas, et al. (författare)
  • Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients : A phase 2 randomised clinical trial
  • 2018
  • Ingår i: Heart. - : BMJ. - 1355-6037 .- 1468-201X. ; 104:19, s. 1593-1599
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives: Reperfusion immediately after reopening of the infarct-related artery in ST-segment elevation myocardial infarction (STEMI) may cause myocardial damage in addition to the ischaemic insult (reperfusion injury). The gap junction modulating peptide danegaptide has in animal models reduced this injury. We evaluated the effect of danegaptide on myocardial salvage in patients with STEMI. Methods: In addition to primary percutaneous coronary intervention in STEMI patients with thrombolysis in myocardial infarction flow 0-1, single vessel disease and ischaemia time less than 6 hours, we tested, in a clinical proof-of-concept study, the therapeutic potential of danegaptide at two-dose levels. Primary outcome was myocardial salvage evaluated by cardiac MRI after 3 months. Results: From November 2013 to August 2015, a total of 585 patients were randomly enrolled in the trial. Imaging criteria were fulfilled for 79 (high dose), 80 (low dose) and 84 (placebo) patients eligible for the per-protocol analysis. Danegaptide did not affect the myocardial salvage index (danegaptide high (63.9±14.9), danegaptide low (65.6±15.6) and control (66.7±11.7), P=0.40), final infarct size (danegaptide high (19.6±11.4 g), danegaptide low (18.6±9.6 g) and control (21.4±15.0 g), P=0.88) or left ventricular ejection fraction (danegaptide high (53.9%±9.5%), danegaptide low (52.7%±10.3%) and control (52.1%±10.9%), P=0.64). There was no difference between groups with regard to clinical outcome. Conclusions: Administration of danegaptide to patients with STEMI did not improve myocardial salvage. Trial registration number: NCT01977755; Pre-results.
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