Effect of far infrared therapy on arteriovenous fistula maturation, survival and stenosis in hemodialysis patients, a randomized, controlled clinical trial: the FAITH on fistula trial.

BACKGROUND: An arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis treatment. After creation many of the AVFs will never mature or if functioning will need an intervention within 1 year due to an AVF stenosis. Studies investigating possible therapies that improves the AVF maturation and survival are scarce. Far infrared therapy (FIR) has shown promising results. In minor single centre and industry supported trials FIR has shown improved AVF maturation and survival. There is a need of a randomized multicentre controlled trial to examine the effect of FIR on the AVF maturation and survival and to explore the possible AVF protective mechanism induced by the FIR treatment. METHODS: This investigator initiated, randomized, controlled, open-labeled, multicenter clinical trial will examine the effect of FIR on AVF maturation in patients with a newly created AVF (incident) and AVF patency rate after 1 year of treatment in patients with an existing AVF (prevalent) compared to a control group. The intervention group will receive FIR to the skin above their AVF three times a week for 1 year. The control group will be observed without any treatment. The primary outcome for incident AVFs is the time from surgically creation of the AVF to successful cannulation. The primary outcome for the prevalent AVFs is the difference in number of AVFs without intervention and still functioning in the treatment and control group after 12 months. Furthermore, the acute changes in inflammatory and vasodilating factors during FIR will be explored. Arterial stiffness as a marker of long term AVF patency will also be examined. DISCUSSION: FIR is a promising new treatment modality that may potentially lead to improved AVF maturation and survival. This randomized controlled open-labelled trial will investigate the effect of FIR and its possible mechanisms. TRIAL REGISTRATION: Clinicaltrialsgov NCT04011072 (7th of July 2019).

Muscle mitochondrial function in patients with type 2 diabetes mellitus and peripheral arterial disease: implications in vascular surgery.

OBJECTIVES: (1) To review the available information on mitochondrial function in type 2 diabetes mellitus (T2DM) and peripheral arterial disease (PAD) obtained by non-invasive phosphorus magnetic resonance spectroscopy ((31)PMRS), near-infrared spectroscopy (NIRS) in vivo and respirometry on mitochondria isolated from muscle biopsies in vitro (2) to evaluate the usefulness of such data in the diagnosis, treatment and prognosis of these patients. DESIGN: Review. SEARCH STRATEGY: PubMed (http://www.ncbi.nlm.nih.gov/PubMed) and manual literature search. MAIN RESULTS: Fifty-three articles were retrieved, which included (31)PMRS, 15, NIRS, 11, Combined, 1 and Respirometry, 2 and background literature, 24. CONCLUSION: Muscle mitochondrial function is impaired in both T2DM and PAD patients, but differently. Patients suffering from both pathological conditions will display more serious impairment of the mitochondrial function. Mitochondrial function and the degree of ischaemic disease as evaluated by (31)PMRS and NIRS are well correlated. The NIRS technique appears to determine the degree of PAD better than (31)PMRS. It is argued that systematic testing of mitochondrial function may be a useful prognostic tool with PAD and T2DM, but clinical studies are needed.

Unchanged incidence and increased survival in children with neuroblastoma in Denmark 1981-2000: a population-based study.

Treatment results for neuroblastoma in Denmark have been poorer than in other Nordic countries, so we investigated whether a change in incidence, stage distribution and survival had occurred between 1981 and 2000. Clinical data were retrieved from the medical charts of 160 children <15 years of age with extra-cranial neuroblastoma (n=139) or ganglioneuroblastoma (n=21) diagnosed in Denmark between 1981 and 2000. The minimal follow-up time was 52 months. Statistical analyses were performed in STATA. The incidence was 8.55 per million children below 15 years of age (world standard 9.6) and 42.6 per million children below 12 months of age, and it has remained unchanged since 1970. The median age at diagnosis was 27 months. In all, 32% of the children were aged below 12 months at diagnosis, 53% had metastatic disease and in 12% the diagnosis was made incidentally. Prognostic factors such as age, stage and site of primary tumour were the same as in other studies and did not change. During the study period, the mortality rate decreased steadily, and the 5-year survival rate increased from 38% in 1981-1985 to 59% in 1996-2000, corresponding to the level found in other Western countries. Increased survival was also seen in children with metastatic disease. Participation in international studies, better supportive care and possibly postoperative autologous stem cell transplantation may have contributed to the increased survival.

Intramuscular adrenaline does not reduce the incidence of respiratory distress and hypoglycaemia in neonates delivered by elective caesarean section at term.

AIM: To test whether intramuscular injection of 30 microg adrenaline decreased the incidence of respiratory distress and hypoglycaemia in term infants delivered by elective caesarean section before active labour. METHOD: The study was randomised and double-blinded. A total of 270 neonates were assigned to intramuscular treatment with saline (0.30 ml) or 30 microg adrenaline (0.30 ml) immediately after birth. The primary endpoint was referral to the neonatal ward because of respiratory distress or a blood glucose level <1.8 mmol/l measured 2 h after birth. The first 50 infants were monitored with pulse oximetry to disclose potential side effects. RESULTS: Pulse-oximetry recordings revealed a modest systemic effect by intramuscular adrenaline as the heart rate and the haemoglobin oxygen saturation were significantly higher in infants who received adrenaline. In contrast, the incidence of respiratory distress and hypoglycaemia was 14% among infants treated with adrenaline compared with 7% in those who received saline injection (p = 0.048). CONCLUSION: Intramuscular injection of 30 microg adrenaline does not reduce the incidence of respiratory distress or hypoglycaemia after elective caesarean section.

[Risk management by reporting critical incidents. Vitamin K and ephedrine mix-up at a birthing unit]. / Risikostyring med rapportering af kritiske situationer. Forveksling af K-vitamin og ephedrin på en fødegang.

INTRODUCTION: Errors of medication are frequent causes of hazards to patients. It has been suggested that containers that look alike constitute a risk of such errors. In this article, we present an example of how reporting incidents of potential risks, can be applied in their clinical management. MATERIAL AND METHODS: As part of a medical technology assessment project on risk management in a delivery department, the staff were encouraged to report incidents that could create a potential risk to patients. The incidents were assessed by a project group as either a general problem to patient safety or a solitary incident. If considered a general problem, procedures should be changed and implemented in the department. RESULTS: Two incidents were reported, where ephedrine and adrenaline were found in a box supposed to contain vitamin K for new-born babies. These were considered a general problem by the project group, and the procedure for storing and managing ephedrine and adrenaline in the delivery department was changed to prevent new cases. DISCUSSION: Near misses occur more often than actual errors, and we argue that, as they are easier to discover, it is important to learn from them and thus prevent further incidents. A forum should be set up to exchange experiences of acknowledged risks, hazards, analytical results and preventive solutions.

[Incidence of adverse events in hospitals. A retrospective study of medical records]. / Forekomsten af utilsigtede haendelser på sygehuse. En retrospektiv gennemgang af journaler.

INTRODUCTION: Over the past decade a number of studies on the incidence and preventability of adverse events in the health care have been published in the US, Australia and the UK. So far no similar study has been performed in Denmark. In order to determine whether foreign findings could be generalised to Danish health care, a pilot study on adverse events was carried out in Danish acute care hospitals. METHOD: Chart reviews were carried out on 1.097 acute care hospital admissions, sampled from the central Danish National Patient Register. The sample was truly proportional with no over-sampling of high-risks groups. Chart reviews was done in 17 different acute care hospitals, reviewing between 20 and 204 admissions per hospital. Adverse events was identified using a three-step procedure: 1) Nurse screening by 18 criteria identifying high-risk groups. 2) Independent reviews by pairs of consultants. 3) In case of disagreement between second step consultants, two additional independent reviews was performed by new consultants (internist and surgeon) followed by conference. All chart reviews were performed independent of medical specialty. All nurses and doctors were senior and experienced clinicians. RESULTS: In 114 admissions 176 Adverse Events (AEs) were identified. The prevalence of admissions with adverse events were 9.0% of all admissions. Preventability of adverse events was found in 46 of admissions (40.4% of AEs). The adverse events caused on average a 7.0 days prolonged hospital stay. Most adverse events resulted in minor, transient disabilities. Permanent disability or death in relation to adverse event were recorded in 30 admissions. DISCUSSION: The findings from the Danish Adverse Event Study are similar to the results found in Australia, United Kingdom and the United States. It is therefore recommended that further Danish research, is directed towards high-risk groups focussing on narratives and intervention and towards research in primary health care.

Human papilloma virus and p53 expression in carcinomas associated with sinonasal papillomas: a Danish Epidemiological study 1980-1998.

OBJECTIVES: To determine a putative role and relation between human papilloma virus (HPV) and p53 in the etiology of sinonasal carcinomas associated with papillomas. STUDY DESIGN: The study group consists of all patients with sinonasal carcinomas associated with papillomas diagnosed in Denmark from 1980 to 1998. After reviewing our national pathological files, tumor tissues from 36 patients were collected, comprising 15% of the total cases of sinonasal carcinomas. In 35 cases a squamous cell carcinoma was demonstrated and in one case an adenocarcinoma was evident. Inverted papilloma was associated with carcinoma in 31 cases and exophytic papillomas in 5 cases. The material was investigated for HPV using polymerase chain reaction analyses with two sets of consensus primers (GP5+/GP6+ and MY09/MY11). The HPV-positive cases were submitted to dot-blot hybridization to establish the HPV type. Using immunohistochemistry, the p53 expression was determined. A p53 overexpression is defined as positive staining in 10% or more of the tumor cells. RESULTS: Among 30 examined cases of carcinomas associated with inverted papillomas, 4 cases were HPV-positive (13%). P53 overexpression was not shown among the HPV-positive cases, whereas p53 overexpression was seen in 21 of the 24 (88%) examined HPV-negative cases. Among the 5 carcinomas associated with exophytic papillomas, HPV was demonstrated together with p53 overexpression in 3 cases (60%). In addition, one case more was with p53 overexpression. CONCLUSION: An inverse relation between HPV and p53 overexpression in sinonasal carcinomas associated with inverted papillomas appears to have been demonstrated. HPV and p53 might also have an etiological role among the carcinomas associated with exophytic papillomas.

Differences between users and non-users of emergency contraception after a recognized unprotected intercourse.

Knowledge of emergency contraception is crucial but might not transform into use. Factors influencing decision-making related to use of emergency contraception after an unprotected intercourse and the characteristics of users of emergency contraception (EC) were assessed. In an abortion clinic setting, 217 women referred for termination of pregnancy were asked to fill in a questionnaire. Of the 217 women, 139 (64%) were aware of pregnancy risk but only 9 (4%) had used EC after the unprotected intercourse. 42% were estimated to have sufficient knowledge to use hormonal emergency contraception. In a larger background population, a calculated 29% used EC after a recognized unprotected intercourse. EC users were older, better educated, more often in stable relationships, had experienced more abortions, and gestation age was less. However, younger women were in general better informed of EC. Knowledge of EC does not necessarily transform into action. Neglect of risk after an unprotected intercourse is frequent in younger well-informed women and information has to be better targeted.

Dissolution of hydrocortisone in human and simulated intestinal fluids.

PURPOSE: To compare solubility and dissolution rate of hydrocortisone in aspirated human intestinal fluids (HIFs) with simulated intestinal fluids (SIFs) and buffer. METHODS: Solubility and flux from a rotating disk of hydrocortisone were measured. The bile salt content, pH and osmotic pressure were determined in HIFs. RESULTS: In fasted state the solubility of hydrocortisone was higher in HIFs than in the buffer and SIFs. The flux of hydrocortisone in HIFs was similar to the flux in the buffer but lower than the flux in SIFs at fasted state. Addition of intestinal surfactants in SIFs increased solubility and flux at both fasted and fed state. The increase in solubility was caused by micelle formation in SIFs. The increase in flux may partly be explained by increased solubility. The bile salt content of the HIFs did not correlate with the solubility or the flux but pH in the HIFs seems to have some effect on the components of the HIFs resulting in increased solubility. CONCLUSIONS: It is possible to perform comparable dissolution tests in HIFs and SIFs. The lack of correlation between the results in HIFs and the bile salt content may be explained by the relatively low lipophilicity of the model drug.

Stratified rates of cesarean sections and spontaneous vaginal deliveries. Data from five labor wards in Denmark--1996.

BACKGROUND: A fundamental point when auditing labor management is to ensure present and stratified process data. METHOD: Stratification of deliveries into ten mutually exclusive groups enabled comparisons of rates of cesarean sections and rates of spontaneous vaginal deliveries between labor wards. RESULTS: Data from five labor wards in Denmark in 1996 were included in the study comprising a total of 11,287 women. The overall cesarean section rates were between 13.2 and 15.2% which was not a significant difference, whereas cesarean section rates in several of the ten groups and the rates of spontaneous vaginal delivery in group 1 and 3 were significantly different between the labor wards. DISCUSSION: The method presented here is simple and can be used as an integrated part of the daily work and quality assurance. We advocate that stratification of the delivering women into ten groups should take place in every labor ward with focus on both the cesarean section rate and the rate of spontaneous vaginal delivery. Stratification provides data for periodical evaluation of the outcome within a department and for comparison between departments with different populations and policy.

[Breech delivery. Selection by X-ray pelvimetry]. / Forløsningsmåde ved underkropspraesentation. Selektion ved røntgenologisk baekkenmåling.

An attempt was made to evaluate the possible benefit of selecting women for vaginal breech delivery at term by radiological pelvimetry. Information from medical records on 276 singleton breech deliveries were analysed. A total of 188 breech presentations were diagnosed before the onset of labour, pelvimetry was performed in 74 women, where pelvic dimensions too small for recommendation of vaginal breech delivery were found in 30 cases. The overall rate of caesarean section was 78%, among diagnosed patients it was 84% and 64% among undiagnosed breech presentations. Rates of morbidity (low Apgar score and admission to the neonatal care unit) did not differ significantly between infants delivered vaginally or by elective caesarean section. The material, however, is too small for valid conclusions regarding safety of vaginal delivery of term breech in women selected by criteria including estimate of pelvic size.

Vaginismus--iatrogenic precipitation and maintenance.

Four cases of vaginismus are presented. Two of them illustrate an iatrogenic precipitation of vaginismus, one misdiagnosis of vaginismus, and one shows the use of unnecessary hymenectomy as the first choice of treatment of vaginismus. The etiology of vaginismus and the indications of first pelvic examinations are discussed.