| 1. |
- Bauhofer, A., et al.
(författare)
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Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol for a controlled clinical trial developed by consensus of an international study group : Part two
- 2001
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Ingår i: Inflammation Research. - : Springer Science and Business Media LLC. - 1023-3830 .- 1420-908X. ; 50:4, s. 187-205
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Forskningsöversikt (refereegranskat)abstract
- General design: Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4) This part describes the design of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). Objective: The trial design includes the following elements for a prototype protocol: - The study population is restricted to patients with colorectal cancer, including a left sided resection and an increased perioperative risk (ASA 3 and 4). - Patients are allocated by random to the control or treatment group. - The double blinding strategy of the trial is assessed by psychometric indices - An endpoint construct with quality of life (EORTC QLQ-C30) and a recovery index (modified Mc Peek index) are used as primary endpoints Qualitative analysis of clinical relevance of the endpoints is performed by both patients and doctors. - Statistical analysis uses an area under the curve (AUC) model for improvement of quality of life on leaving hospital and two and six months after operation. A confirmatory statistical model with quality of life as the first primary endpoint in the hierarchic test procedure is used. Expectations of patients and surgeons and the negative affect are analysed by social psychological scales. Conclusion: This study design differs from other trials on preoperative prophylaxis and postoperative recovery, and has been developed to try a new concept and avoid previous failures.
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| 2. |
- Törn, Carina, et al.
(författare)
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Combinations of beta cell specific autoantibodies at diagnosis of diabetes in young adults reflects different courses of beta cell damage
- 2001
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Ingår i: Autoimmunity. - 0891-6934. ; 33:2, s. 115-120
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Tidskriftsartikel (refereegranskat)abstract
- To explore the natural course of beta cell function in recent onset diabetes, a subgroup (n = 157) of all incident cases (n = 879) 15-34 years old. 1992-1993 in Sweden. and with positivity for at least one autoantibody of islet cell antibodies (ICA), glutamic acid decarboxylase antibodies (GADA) or tyrosine phosphatase antibodies (1A-2A) were followed prospectively thr the first four years with annual analysis of C-peptide. The aim was to relate the course of beta cell function, measured as C-peptide, in early diabetes with the presence of different islet autoantibodies at diagnosis. We found that patients positive for ICA alone (n = 11 ) had significantly higher C-peptide levels both at diagnosis and during the first three years compared with the other patients (n = 146; p = 0.022, p < 0.001, p = 0.004 and p = 0.0022). Patients positive for GADA alone or in combination with other antibodies (n = 125) had significantly lower C-peptide during the first three years after diagnosis compared with the other patients (n = 32. p < 0.001, p = 0.0011 and p = 0.0136). Patients with two or three autoantibodies had C-peptide levels similar to levels found in patients positive only for GADA. However. after four years, there were no significant differences between any of the groups of different autoantibody combinations. At diagnosis. 55% (86/157) of the patients had C-peptide: levels above the lower normal range of 0.25 nmol/l, but the frequency of patients with beta cell Function above this level decreased after two years to 41% (65/157; p = 0.035) and after four years to 22% (35/157; p = 0.0041).
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| 3. |
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| 4. |
- Östman, Jan, et al.
(författare)
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Ketoacidosis in young adults is not related to the islet antibodies at the diagnosis of Type 1 diabetes mellitus - A nationwide study
- 2000
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Ingår i: Diabetic Medicine. - : Wiley. - 0742-3071 .- 1464-5491. ; 17, s. 269-
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Tidskriftsartikel (refereegranskat)abstract
- Aims: To test the hypothesis that there is lower prevalence of islet antibodies in subjects with newly diagnosed Type 1 diabetes mellitus in young adulthood than in children is associated with less severe diabetes at time of diagnosis. Methods: This investigation was based on a nationwide study (Diabetes Incidence Study in Sweden) of 15-34-year-old newly diagnosed diabetic subjects. During 1992-1993, all diabetic subjects (excluding secondary and gestational diabetes) were reported on standardized forms, with information about clinical characteristics at diagnosis. The study examined islet cell antibodies (ICA) by indirect immunofluorescence, and autoantibodies to glutamic acid decarboxylase (GADA), tyrosine phosphatase- like antigen (IA-2A) and insulin (IAA) as well as C-peptide by radioimmunoassay. Results: Blood samples were available from 78 patients with diabetic ketoacidosis (DKA) and 517 non-acidotic patients. The prevalence of ICA (63% vs. 57%), GADA (63% vs. 66%), IA-2A (35% vs. 44%) and IAA (20% vs. 15%) were very similar in patients with or without DKA. The median levels of the four autoantibodies did not differ between the two groups. High blood glucose (P < 0.001) and low C-peptide levels (P < 0.001) were the only parameters found to be related to DKA. Conclusions: The similarities in findings of newly diagnosed diabetic patients with or without DKA regarding ICA, GADA, IA-2A and IAA suggest that there is no relationship between the expression of antigenicity and the severity of β-cell dysfunction. The lower prevalence of the four autoantibodies in 15-34-year-old diabetic subjects compared with previous findings in children is not explained by misclassification of diabetes type.
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| 5. |
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| 6. |
- Littorin, Bengt, et al.
(författare)
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Increasing body mass index at diagnosis of diabetes in young adult people during 1983-1999 in the Diabetes Incidence Study in Sweden (DISS)
- 2003
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Ingår i: Journal of Internal Medicine. - : Wiley. - 0954-6820 .- 1365-2796. ; 254:3, s. 251-256
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Tidskriftsartikel (refereegranskat)abstract
- Objective. To study trends in body mass index (BMI) at diagnosis of diabetes in all young Swedish adults in the age range of 15-34 years registered in a nation-based registry. Design. The BMI was assessed at diagnosis in diabetic patients 15-34 years of age at diagnosis, for a period of 17 years (1983-1999). Islet cell antibodies (ICA) were measured during three periods (1987-1988, 1992-1993 and 1998-1999). Setting. A nationwide study (Diabetes Incidence Study in Sweden). Subjects. A total of 4727 type 1 and 1083 type 2 diabetic patients. Main outcome measures. Incidence-year specific BMI adjusted for age, gender and time of diagnosis (month). Results. Body mass index at diagnosis increased significantly both in type 1 (21.4 ▒ 3.6 to 22.5 ▒ 4.0: P < 0.0001) and in type 2 (27.4 ▒ 6.8 to 32.0 ▒ 6.0, P < 0.0001) diabetic patients, also when adjusted for age, gender and month of diagnosis. A similar significant increase in BMI was found in type 1 diabetic patients and in type 2 diabetic patients in the periods 1987-1988, 1992-1993 and 1998-1999, years when ICA were assessed and considered in the classification of diabetes. Despite this increase in BMI, there was no increase in the incidence of diabetes in young-adult people in Sweden. Conclusion. Body mass index at diagnosis of diabetes in subjects 15-34 years of age has substantially increased during 1983-1999 in Sweden when adjusted for age, gender and month of diagnosis.
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| 7. |
- Lorenz, W., et al.
(författare)
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Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4) : Part one
- 2001
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Ingår i: Inflammation Research. - : Springer Science and Business Media LLC. - 1023-3830 .- 1420-908X. ; 50:3, s. 115-122
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Forskningsöversikt (refereegranskat)abstract
- General design: Presentation of a novel study protocol to evalue the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). The rationale and hypothesis are presented in this part of the protocol of the randomised, placebo controlled, double-blinded, single-centre study performed at an - university hospital (n = 40 patients for each group). Objective: Part one of this protocol describes the concepts of three major sections of the study: - Definition of optimum and sub-optimal recovery after operation. Recovery, as an outcome, is not a simple univariate endpoint, but a complex construction of mechanistic variables (i. e. death, complications and health status assessed by the surgeon), quality of life expressed by the patient, and finally a weighted outcome judgement by both the patient and the surgeon (true endpoint). Its conventional early assessment within 14-28 days is artificial: longer periods (such as 6 months) are needed for the patient to state: "I am now as well as I was before". Identification of suitable target patients: - the use of biological response modifiers (immune modulators) in addition to traditional prophylaxes (i. e. antibiotics, heparin, volume substitutes) may improve postoperative outcome in appropriate selected patients with reduced host defence and increased immunological stress response, but these have to be defined. Patients classified as ASA 3 and 4 (American Society for Anaesthesiologists) and with colorectal cancer will be studied to prove this hypothesis. Choice of biological response modifier: - Filgrastim has been chosen as an example of a biological response modifier because it was effective in a new study type, clinic-modelling randomised trials in rodents, and has shown promise in some clinical trials for indications other than preoperative prophylaxis. It has also enhanced host defence and has been anti-inflammatory in basic research. Conclusion: The following hypothesis will be tested in patients with operations for colorectal cancer and increased preoperative risk (ASA 3 and 4): is the outcome as evaluated by the hermeneutic endpoint (quality of life expressed by the patient) and mechanistic endpoints (mortality rate, complication rate, relative hospital stay, assessed by the doctor) improved in the group receiving filgrastim prophylaxis in comparison with the placebo group? Quality of life will be the first primary endpoint in the hierarchical, statistical testing of confirmatory analysis.
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| 8. |
- Nyström, A-M, et al.
(författare)
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A novel nonsense mutation of the mineralocorticoid receptor gene in a Swedish family with pseudohypoaldosteronism type I (PHA1).
- 2004
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Ingår i: J Clin Endocrinol Metab. - 0021-972X. ; 89:1, s. 227-31
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Tidskriftsartikel (refereegranskat)abstract
- Pseudohypoaldosteronism type I (PHA1) is a condition associated with salt wasting leading to dehydration, hypotension, hyperkalemia, and metabolic acidosis. Sporadic cases and two familial forms, one autosomal dominant and one autosomal recessive form, have been described. The autosomal dominant or sporadic form manifests milder salt wasting that remits with age. Mutations in the gene encoding the mineralocorticoid receptor (MR) have been identified in patients with the autosomal dominant inheritance. However, recent studies suggest that the autosomal dominant and sporadic forms are genetically heterogeneous and that additional genes might be involved. We report on the study of 15 members of a Swedish five-generation family with the autosomal dominant form of PHA1. Interestingly, neuropathy was found in two of five affected individuals. A novel heterozygous nonsense mutation C436X in exon 2 was identified in the index patient by linkage analysis, PCR, and direct sequencing of the MR gene. Analysis of the family demonstrated that the mutation segregated with PHA1 in the family. It is unclear whether the neuropathy is associated with the mutation found. Our results together with previously published data suggest that loss-of-function mutations of the MR gene located at 4q31.1, commonly are associated with the autosomal dominant form of PHA1.
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| 9. |
- Nyström, I., et al.
(författare)
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Area of and volume enclosed by digital and triangulated surfaces
- 2002
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Ingår i: Medical Imaging 2002: Visualization, Image-Guided Procedures, and Display. ; , s. 669-680
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Konferensbidrag (refereegranskat)abstract
- We demonstrate that the volume enclosed by triangulated surfaces can be computed efficiently in the same elegant way the volume enclosed by digital surfaces is computed by digital surface integration.
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| 10. |
- Nyström, P, et al.
(författare)
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Accumulated means analysis : a novel method to determine reliability of behavioral studies using continuous focal sampling.
- 2001
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Ingår i: In Vivo. - 0258-851X .- 1791-7549. ; 15:1
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Tidskriftsartikel (refereegranskat)abstract
- During the past decade, the behavioral needs, and especially the social needs, of laboratory animals have received increasing attention. New captive care guidelines have been developed, and these advocate group housing of laboratory animals whenever possible and appropriate. Analyses of behavioral observations are commonly used to assess the effects of experimental manipulations on behavioral responses. In studies of animal welfare, stress levels and effects on well being can be measured in this manner. Collecting the proper amount of data both to allow statistical analyses and to optimize time investment in data collection is a practical concern in behavioral research. The aim of the present study was to develop a simple method to estimate how much behavioral data should be collected in order to achieve a preset level of reliability across observations. This paper examines the behavior of 12 rhesus monkeys (Macaca mulatta) housed in two small social groups. Each monkey was observed for a total of two hours in 10 minute observation periods spread over 12 days. Accumulated Means Analysis, in which the accumulated mean for a behavior across successive observation sessions must meet several criteria, is proposed as a method to assess reliability across observations, thereby providing information concerning the optimum number of observational data sessions that need to be collected. The data in this study indicate that this optimum number of observations varies with the behavior being measured and with the group observed, as does the value of the Accumulated Means Analysis technique. Six hours of observation of rhesus macaques may be sufficient to provide the type of simple, yet reliable time budget (for a specific window of time) needed by those managing groups of primates. Accumulated Means Analysis should be applicable to behavioral data collected during multiple time periods on other non-human primate species, both in captivity and in the field.
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