Living on the Edge of Being Overstretched—A Norwegian Qualitative Study of Employed Pregnant Women

In this study, our aim was to explore female employees’ experiences of work during pregnancy and their expectations of becoming a mother for the first time. We conducted 10 interviews and analyzed the data using qualitative content analysis. The main finding, living on the edge of being overstretched, contained two themes: being exhausted by adapting to professional life and being prepared for becoming a mother. In order to increase the well-being of pregnant employees, women should be provided with information from their supervisors and health care services about pregnancy-related life changes.     

Can Parent Training Alter Parent Practice and Reduce Conduct Problems in Ethnic Minority Children? A Randomized Controlled Trial

A randomized prevention study for ethnic minority mothers assessed the intervention effects of Parent Management Training—Oregon Model (PMTO) on maternal parent practices and child behavior. Ninety-six mothers from Somalia and Pakistan and their children aged 3 to 9 years were randomized to PMTO or a wait-list condition (WLC). Assessments were carried out at the baseline and post-intervention, using standardized measures and a multi-agent approach. All analyses were based on the intention-to-treat principle. Analysis of covariance (ANCOVA) showed that PMTO was effective in enhancing parent practices, with a decrease in harsh discipline and an increase in positive parenting. Moreover, PMTO produced reductions in motherreported child conduct problems. The largest effect sizes were found among mothers who attended more than 50 % of the PMTO group sessions. Teacher reports showed, however, that there were no significant intervention effects on conduct problems and social competence in kindergarten or school. The results emphasize the importance and feasibility of offering PMTO to ethnic minority families.     

C‐reactive protein and tumor necrosis factor‐alpha in relation to insulin‐mediated glucose uptake,smoking and atherosclerosis

Objectives. To examine the hypothesis that serum concentration of C‐reactive protein (CRP) is inversely associated with insulin sensitivity and obesity, and that this may by mediated by tumor necrosis factor‐α (TNFα) and interleukin‐6 (IL‐6). Material and methods. Cross‐sectional, one‐center study of a population‐based sample of 58‐year‐old Swedish men (n = 98). Exclusion criteria were cardiovascular disease, clinical diabetes mellitus and/or continuous cardiovascular medication. Glucose infusion‐rate (euglycemic hyperinsulinemic clamp), adjusted for fat‐free mass, which together with total body fat was measured by dual‐energy X‐ray absorptiometry. Serum concentrations of CRP, TNFα, soluble TNFα receptor 2 (sTNFAR2), IL‐6 determined by ELISA. Ultrasound was used to measure intima‐media thickness (IMT) in both common carotid arteries, carotid bulbs and in the right femoral artery. Results. CRP was inversely associated with insulin sensitivity (r = ?0.28, p<0.01) and with total body fat (r = 0.31, p<0.01), but not independently of the TNFα and sTNFAR2 product. Serum CRP, TNFα, sTNFAR2, but not IL‐6, were associated with low insulin sensitivity, total body fat, abdominal obesity, hyperinsulinemia, hypertriglyceridemia, low HDL cholesterol and small LDL particles, i.e. the metabolic syndrome. These associations were independent of smoking and carotid and femoral artery IMT. Conclusions. Serum concentrations of CRP were related to insulin sensitivity and accompanying factors constituting the metabolic syndrome. The results indicate that this association may be mediated by adipose tissue and TNFα effects, the latter measured as the product of TNFα and sTNFAR2. This was a cross‐sectional study and causality cannot be proven.     

Impaired Anticoagulant Effect of Heparin in the Artificial Kidney: An Experimental Study

Bjo?rnson, J. &; Godal, H. C. Impaired Anticoagulant Effect of Heparin in the Artificial Kidney. An Experimental Study. Scand. J. clin. Lab. Invest. 36, 581–589, 1976.

Dialysis of blood and plasma was performed in vitro, in a ‘mini-Kiil’ dialyser as well as in dialysis bags. A marked shortening of the thrombin-clotting time was observed, indicating fall in heparin anticoagulant effect. The concentration of heparin, however, as measured by polybrene titration, was substantially less reduced. Fibrin formation, as evidenced by the ethanol gelation test, occurred more often in the dialysed than in the control plasma. In conclusion, the discrepancy between concentration and anticoagulant effect of heparin could be partly explained by influx from the dialysate of calcium, magnesium, and acetate ions. The fibrin-polymerizing effect of these ions was confirmed by a shortening of the clotting time with Reptilase, a proteolytic enzyme not influenced by thrombin inhibitors such as heparin. In addition, liberation of platelet factor 4 may be responsible for some reduction in antithrombin activity of heparin. No evidence of heparin being dialysed or adhering to the dialysis membrane was found.     

Pragmatic clinical trials in the context of regulation of medicines

Abstract

The pragmatic clinical trial addresses scientific questions in a setting close to routine clinical practice and sometimes using routinely collected data. From a regulatory perspective, when evaluating a new medicine before approving marketing authorization, there will never be enough patients studied in all subgroups that may potentially be at higher risk for adverse outcomes, or sufficient patients to detect rare adverse events, or sufficient follow-up time to detect late adverse events that require long exposure times to develop. It may therefore be relevant that post-marketing trials sometimes have more pragmatic characteristics, if there is a need for further efficacy and safety information. A pragmatic study design may reflect a situation close to clinical practice, but may also have greater potential methodological concerns, e.g. regarding the validity and completeness of data when using routinely collected information from registries and health records, the handling of intercurrent events, and misclassification of outcomes. In a regulatory evaluation it is important to be able to isolate the effect of a specific product or substance, and to have a defined population that the results can be referred to. A study feature such as having a wide and permissive inclusion of patients might therefore actually hamper the utility of the results for regulatory purposes. Randomization in a registry-based setting addresses confounding that could otherwise complicate a corresponding non-interventional design, but not any other methodological issues. Attention to methodological basics can help generate reliable study results, and is more important than labelling studies as ‘pragmatic’.     

The prevalence of gastrointestinal symptoms in patients with chronic renal failure is increased and associated with impaired psychological general well-being.

BACKGROUND: Malnutrition occurs frequently in patients with end-stage renal disease (ESRD). Gastrointestinal (GI) symptoms may lead to reduced food intake, resulting in malnutrition and impaired well-being in these patients. The prevalence of GI symptoms in various chronic renal failure (CRF) groups is unexplored. We assessed the prevalence of GI complaints in patients on either haemodialysis (HD), peritoneal dialysis (PD), or in the pre-dialysis stage. Patients with and without diabetic nephropathy were also compared. METHODS: A total of 233 patients with CRF (128 HD, 55 PD, and 50 pre-dialytic patients) completed two self-administered questionnaires: the Psychological General Well-Being (PGWB) index and the Gastrointestinal Symptom Rating Scale (GSRS), which measures GI symptoms. The values were compared with reference values obtained from the general population. The association between GI symptoms and serum (s-)albumin was also studied. RESULTS: The total GSRS score in patients with CRF was significantly higher than the reference values (HD 2.14 (1.97-2.31), PD 2.24 (2.00-2.48), and pre-dialytic patients 2.03 (1.82-2.25) vs controls 1.53 (1.50-1.55; P<0.001). When comparing CRF subgroups there was no overall difference between the groups, but PD patients had more severe reflux and eating dysfunction. In patients with diabetic nephropathy, only eating dysfunction was significantly more common than in the non-diabetic patients. There was a negative correlation between GI symptoms and psychological general well-being in CRF patients (Rho=-0.46, P<0.001) indicating that patients with a high GI symptom profile have impaired psychological general well-being. A negative correlation was found between eating dysfunction and s-albumin (Rho=-0.33, P<0.01). CONCLUSION: The prevalence of GI symptoms is high in patients with CRF and is associated with impairment in psychological general well-being. Presence of dialysis or not, type of dialysis, and presence or absence of diabetes mellitus seem to have limited impact on GI symptoms.     

The long-term significance of microscopic dural invasion in 354 patients with pituitary adenomas treated with transsphenoidal surgery

OBJECT: Pituitary adenomas are considered benign tumors; however, they may infiltrate surrounding tissues including the dura mater. In this paper the authors analyze the clinical significance of microscopically confirmed dural invasion by comparing a range of variables (age and sex of patients, adenoma type, adenoma size on magnetic resonance [MR] images, remission, residual pituitary disease, recurrence, survival, and disease-free interval after surgery) between patients with noninvasive adenomas and those with invasive ones. METHODS: Between 1992 and 1997 dural specimens were obtained in 354 patients with pituitary adenomas who underwent transsphenoidal surgery performed by the senior author (E.R.L.). Dural specimens were examined using routine histological methods and assessed for invasion by pituitary adenoma tissue. The dura was invaded by the pituitary adenoma in 161 patients (45.5%), and in 192 patients (54.5%) no evidence of dural invasion was found. Dural invasion was present significantly more frequently in the repeated surgery group (69%, 55 patients) than in the primary transsphenoidal surgery group (41%, 291 patients). The mean age of patients undergoing primary transsphenoidal surgery was significantly older in cases of invasive adenomas (50 years) compared with cases of noninvasive adenomas (43 years), and these age differences also correlated with adenoma size. Women tend to develop clinically evident, smaller adenomas at a younger age than men. Of the patients with pituitary adenomas that were 20 mm or smaller, 117 (76%) of 154 were women, whereas of the patients with adenomas that were larger than 20 mm, 74 (54%) of 137 were men. The frequency of dural invasion increased with increasing size of the pituitary adenoma as measured on MR images. In 291 patients who underwent primary pituitary surgery, the frequency of dural invasion according to adenoma size was 24% (< or = 10 mm), 35% (> 10 to < or = 20 mm), 55% (> 20 to < or = 40 mm), and 70% (> 40 mm). In patients who underwent primary transsphenoidal surgery, dural invasion was present in more than 50% of those with nonfunctioning adenomas and in 30 to 35% of patients with endocrinologically active adenomas. The mean diameter of the gonadotrophic adenomas and null-cell adenomas was significantly larger than that of each of the endocrinologically active adenomas. In 58 (20%) of 291 patients who underwent primary pituitary surgery there was residual pituitary disease postsurgery, and 20% of this subset of patients showed clinical improvement to such an extent that no further management was recommended. After pituitary surgery, residual tumor tissue was demonstrable significantly more frequently in patients with invasive adenomas than in those with noninvasive adenomas. Recurrences after initial remission (cure) of pituitary disease occurred in 18 (8.8%) of 205 patients between 2 and 79 months after primary pituitary surgery (median 25 months). The recurrence rate was not related to dural invasion in a consistent or significant fashion. Seven patients died between 14 and 79 months after pituitary surgery and all had invasive adenomas identified on gross observation at surgery and on microscopy. The survival rate was slightly but significantly decreased for patients with invasive adenomas (91%) compared with patients with noninvasive adenomas (100%) at 6 years postsurgery. CONCLUSIONS: The principal significance of dural invasion by pituitary adenoma is the persistence of tumor tissue after transsphenoidal surgery (incomplete adenomectomy; 20% in primary pituitary tumor resections). The increase in adenoma size with time and the concurrent development of dural invasion are the major factors that determine an incomplete adenomectomy. When the adenoma remains restricted to the sellar compartment or shows only moderate suprasellar extension, dural invasion may not yet have developed and conditions for complete selective adenomectomy are improved.     

Hepatic reticuloendothelial function during parenteral nutrition including an MCT/LCT or LCT emulsion after liver transplantation – a double-blind study

It has been demonstrated that total parenteral nutrition (TPN) modulates the function of the hepatic reticuloendothelial system (RES). The objective of this study was to evaluate the impact of two different TPN lipid emulsions on the recovery of allograft RES function after orthotopic liver transplantation (OLTx). In a prospective, double-blind study, OLTx patients were randomly assigned to two treatment groups. Group I ( n=13) received a TPN regimen that included long-chain triglycerides (LCT). Group II ( n=9) received a TPN regimen that included a fat emulsion consisting of both medium-chain triglycerides (MCT) and LCT. At baseline, i.e., on days 2 or 3 after OLTx ( t1), before lipids for TPN were started, hepatic RES function was determined using the human serum albumin millimicrosphere technique (K-value, 1/min). A second measurement ( t2) was obtained after 7 days of TPN, including one of the study's two fat emulsions. The mean (+/- SD) K-value (1/min) was 0.48+/-0.16 in the LCT group and 0.55+/-0.28 in the MCT/LCT group at t1, and it improved to 0.62+/-0.21 in the LCT group and to 0.86+/-0.32 in the MCT/LCT group at t2. RES function recovery was significantly better in the MCT/LCT group ( P< or = 0.05). MCT/LCT emulsion appears to be the TPN fat emulsion of choice after OLTx as it seems to have less impact on hepatic RES recovery.