Empowering nurses and midwives: the evidence-base for the Nurses and Midwives Certification Programme of ESHRE†.

STUDY QUESTION: How were the logbook and curriculum for the Nurses and Midwives Certification Programme of ESHRE developed? SUMMARY ANSWER: The logbook and corresponding curriculum for the ESHRE Nurses and Midwives Certification Programme were based on an extensive literature review, an international expert panel, and a survey of Belgian and Dutch nurses and midwives (N&M) working in reproductive medicine (RM). WHAT IS KNOWN ALREADY: ESHRE has been running a certification programme for N&M working in RM since 2015. To the best of our knowledge, clinical practice guidelines for nursing/midwifery care within RM are lacking as is consensus on role descriptors of N&M working in RM. STUDY DESIGN, SIZE, DURATION: The Nurses and Midwives Certification Committee (NMCC), established by the ESHRE Executive Committee in 2012, decided to gather background information by: (i) systematically reviewing the literature on the tasks of N&M working in RM, (ii) consulting and surveying an expert panel of international senior N&M, and (iii) surveying Belgian and Dutch N&M working in RM across different clinics. Finally, the NMCC developed a logbook and curriculum fostering a more expanded theoretic background. PARTICIPANTS/MATERIALS, SETTING, METHODS: The NMCC comprised four N&M, one clinical embryologist, and one gynaecologist (both in an advisory capacity). The Medline database was searched for papers relating to the tasks of N&M working in RM, by entering a search string in PubMed. In an attempt to capture insight into the tasks and roles of N&M working in RM, the NMCC subsequently surveyed N&M experts across nine countries (Denmark, Finland, France, Norway, Slovenia, Sweden, Turkey, Ukraine, and the UK), and 48 Belgian and Dutch N&M working in RM. MAIN RESULTS AND THE ROLE OF CHANCE: There were 36 papers on the tasks of N&M working in RM originating from 13 countries (in Asia, Oceania, Europe, and North America), identified. Initially, 43 tasks in which N&M working in RM participated, were identified by literature only (n = 5), the international expert panel only (n = 4), Belgian and Dutch N&M working in RM only (n = 5), or a combination of two (n = 13) or three (n = 16) of these sources. The number and composition of tasks included in the logbook were adapted yearly based on novel insights by the NMCC. In response to the annual review, the extended role of N&M working in RM is now reflected in the 2024 version by 73 tasks. Seven specialist tasks (i.e. embryo transfer) were performed independently by N&M working in RM in some countries, while in other countries N&M merely had an 'assisting' role. Candidates are also expected to submit a mature ethical reflection on one clinical case. To support applicants throughout the certification process, the NMCC developed a curriculum in line with all tasks of N&M working in RM. LIMITATIONS, REASONS FOR CAUTION: The literature review was not completed prior to consulting the international expert panel or surveying the Belgian and Dutch N&M working in RM. WIDER IMPLICATIONS OF THE FINDINGS: The differences in tasks and roles of N&M working in RM across and within countries, clinics and individuals illustrated by the literature review, the international expert panel, and the surveyed Belgian and Dutch N&M working in RM suggest an opportunity for structured professional development. Further research is required to elicit the post-certification experience of N&M working in RM and its impact on their professional development. STUDY FUNDING/COMPETING INTEREST(S): The expert panel meeting was funded by ESHRE and the literature review and surveys were supported by Leuven University (Belgium) and the postdoctoral fellowship of the Research Foundation Flanders of E.A.F.D. H.K. received consulting fees and honoraria from Gedeon Richter, Finox and MEDEA, and travel support from Gedeon Richter and Finox. The other authors declare no conflict of interest. TRIAL REGISTRATION NUMBER: N/A.

The temporal association of hyperhidrosis and its comorbidities - a nationwide hospital-based cohort study.

BACKGROUND: Research on hyperhidrosis comorbidities has documented the co-occurrence of diseases but has not provided information about temporal disease associations. OBJECTIVE: To investigate the temporal disease trajectories of individuals with hospital-diagnosed hyperhidrosis. METHODS: This is a hospital-based nationwide cohort study including all patients with a hospital contact in Denmark between 1994 and 2018. International Classification of Diseases version-10 diagnoses assigned to inpatients, outpatients and emergency department patients were collected from the Danish National Patient Register. The main outcome was the temporal disease associations occurring in individuals with hyperhidrosis, which was assessed by identifying morbidities significantly associated with hyperhidrosis and then examining whether there was a significant order of these diagnoses using binomial tests. RESULTS: Overall, 7 191 519 patients were included. Of these, 8758 (0.12%) patients had localized hyperhidrosis (5674 female sex [64.8%]; median age at first diagnosis 26.9 [interquartile range 21.3-36.1]) and 1102 (0.015%) generalized hyperhidrosis (606 female sex [59.9%]; median age at first diagnosis 40.9 [interquartile range 26.4-60.7]). The disease trajectories comprised pain complaints, stress, epilepsy, respiratory and psychiatric diseases. The most diagnosed morbidities for localized hyperhidrosis were abdominal pain (relative risk [RR] = 121.75; 95% Confidence Interval [CI] 121.14-122.35; P < 0.001), soft tissue disorders (RR = 151.19; 95% CI 149.58-152.80; P < 0.001) and dorsalgia (RR = 160.15; 95% CI 158.92-161.38; P < 0.001). The most diagnosed morbidities for generalized hyperhidrosis were dorsalgia (RR = 306.59; 95% CI 302.17-311.02; P < 0.001), angina pectoris (RR = 411.69; 95% CI 402.23-421.16; P < 0.001) and depression (RR = 207.92; 95% CI 202.21-213.62; P < 0.001). All these morbidities were diagnosed before hyperhidrosis. CONCLUSIONS: This paper ascertains which hospital-diagnosed morbidities precede hospital-diagnosed hyperhidrosis. As hyperhidrosis mainly is treated in the primary health care sector, the trajectories suggests that these morbidities may lead to a worse disease course of hyperhidrosis that necessitates treatment in hospitals. Treating these morbidities may improve the disease course of hyperhidrosis.

High sodium intake is associated with short leukocyte telomere length in overweight and obese adolescents.

BACKGROUND/OBJECTIVES: Telomere shortening has an important role in cellular aging. However, the impact of high sodium intake, an important risk factor of age-related diseases, on telomere shortening remains unknown. Therefore, we examined the relationship between high dietary sodium intake and leukocyte telomere length (LTL), particularly in the context of obesity, as obesity increases salt sensitivity. SUBJECTS/METHODS: LTL was determined by a quantitative polymerase chain reaction method in 766 adolescents aged 14-18 years (50% females, 49% African Americans). Dietary sodium intake was assessed by seven independent 24-h dietary recalls. We divided the sample into low sodium (mean 2388±522 mg per day) or high sodium groups (mean 4142±882 mg per day) based on the median value (3280.9 mg per day). RESULTS: In the entire cohort, there was no significant association between sodium intake and LTL (r=-0.05, P=0.24). However, there was a significant interaction between sodium intake and obesity status (P=0.049). Further multiple linear regression analyses revealed that higher dietary sodium intake was associated with shorter LTL in the overweight/obese group (body mass index ⩾85th percentile, ß=-0.37, P=0.04), but not in the normal-weight group (ß=0.01, P=0.93) after adjusting for multiple confounding factors. In the overweight/obese group, LTL was significantly shorter in the high sodium intake subjects vs low sodium intake subjects (1.24±0.22 vs. 1.32±0.20, P=0.02), but not the normal-weight group (1.29±0.24 vs 1.30±0.24, P=0.69). CONCLUSIONS: Higher dietary sodium intake is associated with shorter telomere length in overweight and obese adolescents.

Increased telomerase activity and vitamin D supplementation in overweight African Americans.

OBJECTIVE: We aimed to investigate whether vitamin D supplementation modulates peripheral blood mononuclear cell (PBMC) telomerase activity in overweight African Americans. DESIGN: A double blind, randomized and placebo-controlled clinical trial (#NCT01141192) was recently conducted. SUBJECTS AND METHODS: African-American adults were randomly assigned to either the placebo, or the vitamin D group (60,000 IU per month (equivalent to ~2000 IU per day) oral vitamin D3 supplementation). Fresh PBMCs were collected from 37 subjects (18 in the placebo group and 19 in the vitamin D group), both at baseline and 16 weeks. PBMC telomerase activity was measured by the telomeric repeat amplification protocol. RESULTS: Serum 25 hydroxyvitamin D levels increased from 40.7±15.7 at baseline to 48.1±17.5 nmol l(-1) at posttest (P=0.004) in the placebo group, and from 35.4±11.3 at baseline to 103.7±31.5 nmol l(-1) at posttests (P<0.0001) in the vitamin D group. In the vitamin D group, PBMC telomerase activity increased by 19.2% from baseline (1.56±0.29 absorbance reading unit (AU)) to posttest (1.86±0.42 AU, P<0.0001). The significance persisted after controlling for age, sex and body mass index (P=0.039). PBMC telomerase activity in the placebo group did not change from baseline (1.43±0.26 AU) to posttest (1.46±0.27 AU, P=0.157). CONCLUSION: Vitamin D supplementation significantly increased PBMC telomerase activity in overweight African Americans. Our data suggest that vitamin D may improve telomere maintenance and prevent cell senescence and counteract obesity-induced acceleration of cellular aging.

Challenges in conducting paediatric trials with off-patent drugs.

INTRODUCTION: For more than two decades several initiatives have emerged to increase recruitment of paediatric patients in drug trials. While trials of newly approved drugs have successfully included paediatric patients in their drug development plan, the collection of safety and efficacy data in paediatric patients treated with off-patent drugs poses a major challenge. AIM: This paper aims to draw attention to problems and solutions across countries in investigator-initiated trials with off-patent drugs and recommendations for improvement. DISCUSSION: Off-patent drugs represent a particular challenge when they are included in a paediatric trial; these trials are frequently investigator-initiated and have limited resources, off-patent drugs are used in clinical settings and the trial protocol must accommodate e.g. flexible dosing and specimen sampling schedules, off-patent drugs typically exist in few formulations and concentrations which necessitates special or imported formulations. Paediatric trials are in some countries confined by e.g. consent from both parents, regardless of whether the Investigational Medicinal Product (IMP) is a well-known drug or a new experimental drug. CONCLUSION: Facilitation of research in off-patent drugs can improve evidence-based and safe treatment for the paediatric population. The following supportive initiatives are recommended: Harmonised regulatory change that improves the consent process in low risk trials to prevent inadequate recruitment. Pharmaceutical expertise should be prioritized to secure the best choice of IMP and supply. Constant focus on flexibility in design to accommodate a multifaceted paediatric population and ensure that trial protocols fit in well with routine clinical care and family life.

Reversal of benzodiazepine intoxication by flumazenil.

In order to firstly evaluate the efficacy of flumazenil in reversing benzodiazepine-induced sedation because of drug overdose and secondly to register adverse events, 13 patients admitted to the intensive care unit because of drug intoxication, were given flumazenil intravenously to a maximum of 1.0 mg. Sedation state was scored on a modified Glasgow Coma Scale and arterial blood pressure, heart rate and arterial blood gases were recorded before and after flumazenil was given, and every 30 min for 2 h. Results showed that flumazenil reversed the sedation due to benzodiazepines effectively increasing the coma score significantly (P less than 0.005). We found no change in arterial blood pressure (apart from one patient), heart rate or arterial blood gases. Two patients gave further information about drug intake after flumazenil was given. Six patients became resedated, only one needed additional flumazenil. One patient developed a hypertensive crisis after flumazenil was given as a result of the unmasking of an untreated hypertension. Another patient aspirated gastric content to the trachea during resedation and needed respiratory support.

Aortic dissection: natural course of disease? Report of two cases representing the extremes of the condition.

OBJECTIVE: In a time when diagnostic methods and above all, surgical as well as interventional radiological treatment for aortic aneurysms and aortic dissections have reached a point nobody could think of a few years back, the present authors feel that it is worth while to remind oneself of the natural course of disease in these conditions. Taking into consideration the high morbidity and mortality rate in surgically treated patients with aortic dissection, and the high complication rate per- and postoperatively, it also seems right to ask if a more expectative and conservative approach to the condition sometimes perhaps may be justified. METHODS AND MATERIAL: Two case reports are given. One was a 15-year-old boy with Stanford (Daily) type B dissection who statistically ought to have a good prognosis, but who died within 2 h after onset of symptoms. The other patient, a middle-aged woman with Stanford type A dissection, survived for 25 years without operation. CONCLUSION: These two cases, though not unique viewed separately, we consider to represent the extremes of the condition and also a natural course of disease, while none of them was operated on.

Effect of age on liver function.

Serum concentrations of bilirubin, alkaline phosphatase, and GOT as well as the retention of BSP and 131I-rose bengal were determined in 43 normal subjects over 50 years old for the purpose of evaluating age-dependent variations. The normalcy of the liver in all subjects was confirmed by biopsy. The values of serum bilirubin, alkaline phosphatase, and GOT were unaltered with increasing age. Age also had no effect on the retention of BSP and 131I-rose bengal, in contrast to some previous studies in which the normalcy of the liver was not satisfactorily established. No variations between the sexes were seen in our study. The median of the 45 minute BSP retention test was 4.2 percent, with a ninth decile of 7.5 percent. The median of the retention of 131I-rose bengal was 32 percent, with a ninth decile of 39.4 percent.

The parameters of care for cleft lip and palate patients in Aarhus, Denmark.

Aarhus Cleft Palate Institute receives approximately 75 new cleft patients a year. Due to statuary notification of all newborn cleft patients to the Institute, the treatment protocol can be offered to the family from right after birth, and a coordinated team approach can be established. The individually planned primary surgery, speech and growth of the maxillo-facial skeleton is followed by regular team examinations. Speech development is followed from the child is one year old in order to be able to provide speech assessment as soon as problems of hypernasality and articulation disorders or language delay is evident. One of the goals of speech assessment is to achieve acceptable speech as early as possible and at best before school start. Orthodontic treatment is usually started at 8 years of age, in UCLP and BCLP patients in combination with bonegrafting at 9-11 years of age. In patients with impaired growth of the maxilla, attention is paid to identify candidates for orthognathic surgical treatment as early as possible. All secondary surgical treatment on jaws, lips and nose are coordinated and usually the treatment can be finished by the late teens. The described team approach towards the parameters of care for cleft lip and palate patients has basically been used for more than 50 years. A systematic follow-up and data collection on all patients provide a scientific base for evaluation of treatment results. Based on long-term investigations the protocol has gradually been modified during time to improve the quality of patient care.

[Sudden death in children with gastrointestinal diseases. 24 forensic cases]. / Uventet død hos børn med gastrointestinal sygdom. 24 mediko-legale tilfaelde.

During the period 1963-1986, 24 fatal cases of gastrointestinal disease in children aged 0-14 years were referred to the Institute of Forensic Medicine, Aarhus, Denmark, for autopsy. We have retrospectively, reviewed the cases and asked the medical officers of health, whether complaints against doctors or hospitals for negligence had been raised. The material consists of 19 boys and 5 girls with 9 different gastrointestinal diagnoses, predominantly small intestinal obstructive diseases such as intussuception, volvolus and adhesions. Five children with gastroenteritis were included who were treated and died at home. Reported prodromal symptoms were present in 23 of 24 cases. Nineteen had contacted a doctor in the week preceding death. The number of consultations ranged from 1 to 3 and involved general practitioners predominantly. Among 14 of 19 cases where death occurred at home, a doctor had been called prior to the death of the child. In 12 cases the clinical diagnoses were different from the autopsy results. The most frequent wrong clinical diagnosis was gastroenteritis. After the autopsies, five cases were reported to the National Board of Health for further consideration. In four cases the National Board of Health stated that negligence had existed. From our investigations and research from elsewhere it appeared that the National Board of Health defines negligence as considerable error of judgement, or where examination or history raking, had been insufficient. The main purpose is to prevent these gastrointestinal deaths. Attention has been drawn, in particular, to the small intestinal obstructive diseases and dehydration following gastroenteritis.

[Latex allergy]. / Latexallergi.

Latex allergy has been described with increasing frequency throughout the last years. The prevalence in Denmark is not yet known. The growing frequency is partly explained by the extensive use of latex-containing products (especially gloves), which has followed the appearance of the HIV-epidemic. The symptoms of latex allergy are usually those produced by type-I hypersensitivity. Type-IV allergy (contact dermatitis) to rubber chemicals is well described but is not directly associated with the latex proteins. The allergens in latex have nearly been identified; diagnostic tools are known but are not yet satisfactory. Cross-reacting antigens are found in banana, kiwi, avocado, chestnut and other plants. It is concluded, that attention to latex allergy has to be intensified and the risk factors reduced, especially concerning the health care units.

[Latex allergy in children]. / Latexallergi hos børn.

More than a thousand cases of type-1 latex allergy have been presented. In children the condition is most often described in patients with spina bifida. Six cases of latex allergy in atopic children are presented. Five of these had food allergies, especially to banana. The allergy was verified with prick-test, LHR-test and measurement of specific IgE. It is concluded that attention to latex allergy in atopic children has to be intensified. Prick-test with standardised latex extracts is the preferred method for diagnosis of the allergy. Latex dummies, latex toys, balloons etc, have to be avoided.

[Landfill gas]. / Lossepladsgas.

In a landfill mixture of gases, consisting principally of methane and carbon dioxide, may be produced by microbial degradation of organic waste under anaerobic conditions. Methane is explosive at concentrations between 5 and 15% by volume. Other gases, for instance hydrogensulphide, mercury and ethane, may be emitted at low concentrations, but usually do not represent a health hazard following normal atmospheric dilution. Indoor climate may be affected, though, in cases of accumulation in closed spaces. A case is presented where two persons died following an explosion caused by lighting a cigarette in their house which was surrounded on three sides by a landfill. The explosion occurred after heavy precipitation on a day with low atmospheric pressure. Methane measurements showed values consistent with risk of explosion.

General and visceral adiposity in black and white adolescents and their relation with reported physical activity and diet.

BACKGROUND: Excess body fat accumulation may begin in youth and is linked with increased risk of cardiovascular disease. Examination of physical activity (PA) and diet behaviours predictive of adiposity may help target efforts to reduce chronic disease risk. OBJECTIVE: We hypothesized that energy intake (EI) from fat, vigorous PA (VPA), and their interaction would predict body fat percentage (%BF) and visceral adipose tissue (VAT) in youth and that sedentary behaviours and intake of dairy, fruit, vegetable and whole grain foods would be related to adiposity. DESIGN: A cross-sectional, observational study of reported PA and diet behaviours and objective adiposity measures. SUBJECTS: Six-hundred sixty-one healthy black and white adolescents aged 14-18 years. MEASUREMENTS: Diet by 24-h recalls using Nutrition Data Systems for Research (Minneapolis, MN, USA), VPA by previous day physical activity recalls (PAR), and %BF with dual-energy X-ray absorptiometry. VAT by magnetic resonance imaging for 434 subjects. RESULTS: Reported EI and VPA were positively correlated with each other and were negative predictors of %BF. Time spent watching television or movies and %EI from protein were positive predictors of %BF. Adjusted for EI, none of the independent variables predictive of %BF retained their significance. %BF and VAT were highly correlated (r=0.73, P<0.0001). EI was the sole and negative predictor of VAT. CONCLUSIONS: Higher energy 'throughput', not energy restriction, characterize leaner youths. Youths should be advised to engage in VPA so that they can eat sufficient calories to obtain the nutrients required for optimal health while remaining lean.

The epidemiology of fatal unintentional child injuries in Denmark.

The main object of this historical follow-up study in a dynamic population was to examine the extent of fatal unintentional child injuries in Denmark. Particular attention was paid to identifying risks and risk groups as targets for prophylactic measures. All 1,202 fatal injuries which occurred during 1976-85 and were reported to the police were included in the study. Death certificate information was supplemented by data from medical files, post-mortem medical examinations and police reports. The average mortality rate (MR) was 14.43 per 100,000 person-years in the group of boys, and 8.21 per 100,000 person years among girls. The cumulative mortality proportion was 2.18 per thousand for boys and 1.25 per thousand for girls. The mortality for boys fell during the period, but remained constant for girls. In the last years of the study the mortality rate for both sexes approached the same level. Boys had an overall mortality rate twice that of girls (RR 1.75 (CI 1.56-1.97)). Mortality was highest in the first five years of children's lives, i.e. the period of motor development and increasing curiosity regarding their surroundings. An overmortality in the rural areas as compared with the urban areas was identified (RR 1.47 (CI 1.31-1.64)). One reason for this may be that children living in rural areas are exposed to greater risks in everyday life and that they must venture into the traffic for purposes of social contact. Traffic-related deaths comprised 58% of all unintentional injury deaths. In around 50% of all cases the cause of death was head injury.(ABSTRACT TRUNCATED AT 250 WORDS)

Fatal unintentional child injuries in Denmark.

The purpose of this study was to estimate the risk of death from unintentional injury among children living in Danish counties and to identify high-risk counties of residence for different categories of external causes of injuries. All Danish children aged 0-14 who died from unintentional injuries (1202) between January 1, 1976 and December 31, 1985 were registered. The study was designed as a historical follow-up study in a dynamic population with particular emphasis on mortality rate (MR), cumulative mortality proportion (CMP) and standardized rate ratio (SRR). Considerable variation in mortality was observed. The analyses showed that, for boys, the risk of unintentional injury death was 32-48% greater in three of the rural counties than in Denmark as a whole. For girls the risk was 40% higher in one of the rural counties. For both sexes the risk in the area around the capital was around 50% lower than the national average. The mortality for the different categories of external causes varied according to county. In the vast majority of counties traffic injuries were the most common category. Pedestrian injuries and bicycle injuries predominated. With the purpose of identifying serious local problems as a basis for injury control/accident prevention, the distribution of the external causes of injuries within each county was stated. The method seems to be an effective tool in mapping county health conditions. One of the prime objectives in injury stategy is the collection of locally relevant information.

Evaluation of unilateral cleft lip and palate treatment: long term results.

Fifty-seven consecutive complete unilateral cleft lip and palate patients were followed longitudinally from birth to 21 years of age. All patients were operated with the same primary surgical procedures. Reevaluation at age 21 with respect to speech, dental condition, need for secondary surgery, and skeletal and soft tissue facial growth was completed. Speech results indicated that 13 patients (23 percent) had required a pharyngeal flap, and that at age 21 only one patient still had unacceptable speech. The majority of patients had slight speech disturbances related to articulation and voice quality. Fifty-one patients had acceptable occlusion following orthodontic treatment, twenty-two patients (39 percent) without need for prosthodontic treatment of the cleft area. Secondary surgery for correction of nasal deformities was required for fifty-two patients. Growth analysis demonstrated deficiency in growth; however, normal and acceptable profiles were obtained in 50/57 of the patients.