Which elements were significant in reducing obstetric anal sphincter injury? A prospective follow-up study.

BACKGROUND: To examine which elements of an obstetric anal sphincter injury (OASI) care bundle were protective for OASI. Several interventional trials showed that application of a care bundle involving a hands-on approach to perineal protection may reduce the risk of OASI. Previously, we found that only the element "hand on the fetal head" in itself was protective, although the risk of a type 2 error was calculated to be 50%. METHODS: A prospective follow-up study in an obstetric department in Denmark with 3200 deliveries per year. We included a cohort of 10,383 women giving birth vaginally from gestational week 22 + 0 from 2016 through 2019. We documented on a person-level the five elements of the care bundle together with maternal and obstetrical characteristics. The elements were 1) communication, 2) visible perineum, 3) hand on fetal head, 4) perineal support and 5) certification. Regression analysis was used for analysis of associations. The primary outcome measure was OASI. RESULTS: The total rate of OASI in vaginally delivering women was 1.9%. The incidence was 3.2% in nulliparous women giving birth vaginally. The rate of cesarean section was 16.5% and for episiotomy 2.4%. The reduction in the incidence of OASI was sustained since 2013. Hand on the fetal head and perineal support both were protective factors for OASI. In case of a nulliparous woman with a neonate weighing 3500 g giving birth spontaneously, the relative risk (RR) for OASI was 0.50 (95% CI 0.49- 0.51) with use of hand on the fetal head together with perineal support against no use. Similarly, with a nulliparous woman giving birth to a neonate of 3500 g by vacuum extraction, the RR for OASI was 0.65 (95% CI 0.62-0.68) against no use. CONCLUSIONS: Both hand on the fetal head and perineal support were associated with a reduced risk of OASI.

Injecting without pressing a button: An exploratory study of a shield-triggered injection mechanism.

AIMS: To evaluate the injection success and user perception of a shield-triggered pen-injector mechanism. METHODS: The trial (ClinicalTrials.gov NCT02627287) was an exploratory, two-centre, one-visit, open-label, randomized controlled trial conducted in Germany in 150 injection-experienced individuals with type 1 or type 2 diabetes. Participants self-administered subcutaneous injections of a placebo solution using a prototype shield-triggered pen-injector, DV3316 (Novo Nordisk, Bagsvaerd, Denmark), and FlexPen (Novo Nordisk, Bagsvaerd, Denmark). Injection success was evaluated on a yes/no basis by the investigator. Participant confidence, leakage of fluid and pain were evaluated after each injection. Pain and device experience were assessed after completion of all injections with each pen-injector. Overall preference was assessed after completion of all injections with both pen-injectors. RESULTS: Injection success was high with both pen-injectors (97.0%, DV3316 vs 99.7%, FlexPen). Participant confidence in dose delivery was similar for the two devices (88% of injections with DV3316 vs 81% with FlexPen were scored as "extremely confident"). The median injection pain score on a visual analogue scale (0-100) was 3 with DV3316 vs 4 with FlexPen after each injection, and 4 with DV3316 vs 5 with FlexPen after all injections with each device. After all injections were completed, 55% of participants reported an overall preference for DV3316 vs 21% for FlexPen. CONCLUSION: This study demonstrates that injection-experienced individuals can achieve a high injection success rate with a shield-triggered pen-injector, with similar patient confidence and injection pain compared with FlexPen.

Description of OPRA: A Danish database designed for the analyses of risk factors associated with 30-day hospital readmission of people aged 65+ years.

AIMS: To describe the construction of the Older Person at Risk Assessment (OPRA) database, the ability to link this database with existing data sources obtained from Danish nationwide population-based registries and to discuss its research potential for the analyses of risk factors associated with 30-day hospital readmission. METHODS: We reviewed Danish nationwide registries to obtain information on demographic and social determinants as well as information on health and health care use in a population of hospitalised older people. The sample included all people aged 65+ years discharged from Danish public hospitals in the period from 1 January 2007 to 30 September 2010. We used personal identifiers to link and integrate the data from all events of interest with the outcome measures in the OPRA database. The database contained records of the patients, admissions and variables of interest. RESULTS: The cohort included 1,267,752 admissions for 479,854 unique people. The rate of 30-day all-cause acute readmission was 18.9% ( n=239,077) and the overall 30-day mortality was 5.0% ( n=63,116). CONCLUSIONS: The OPRA database provides the possibility of linking data on health and life events in a population of people moving into retirement and ageing. Construction of the database makes it possible to outline individual life and health trajectories over time, transcending organisational boundaries within health care systems. The OPRA database is multi-component and multi-disciplinary in orientation and has been prepared to be used in a wide range of subgroup analyses, including different outcome measures and statistical methods.

The risk-stratified osteoporosis strategy evaluation study (ROSE): a randomized prospective population-based study. Design and baseline characteristics.

The risk-stratified osteoporosis strategy evaluation study (ROSE) is a randomized prospective population-based study investigating the effectiveness of a two-step screening program for osteoporosis in women. This paper reports the study design and baseline characteristics of the study population. 35,000 women aged 65-80 years were selected at random from the population in the Region of Southern Denmark and-before inclusion-randomized to either a screening group or a control group. As first step, a self-administered questionnaire regarding risk factors for osteoporosis based on FRAX(®) was issued to both groups. As second step, subjects in the screening group with a 10-year probability of major osteoporotic fractures ≥15% were offered a DXA scan. Patients diagnosed with osteoporosis from the DXA scan were advised to see their GP and discuss pharmaceutical treatment according to Danish National guidelines. The primary outcome is incident clinical fractures as evaluated through annual follow-up using the Danish National Patient Registry. The secondary outcomes are cost-effectiveness, participation rate, and patient preferences. 20,904 (60%) women participated and included in the baseline analyses (10,411 in screening and 10,949 in control group). The mean age was 71 years. As expected by randomization, the screening and control groups had similar baseline characteristics. Screening for osteoporosis is at present not evidence based according to the WHO screening criteria. The ROSE study is expected to provide knowledge of the effectiveness of a screening strategy that may be implemented in health care systems to prevent fractures.

Cesarean section after induction of labor compared with expectant management: no added risk from gestational week 39.

OBJECTIVE: To compare induction of labor and expectant management by gestational week with regard to the need for cesarean section (CS) in labor. DESIGN: Cohort study. SETTING: National study based on the Danish Birth Registry. POPULATION: Aggregated data from 230 528 deliveries from 2004 until mid-year 2009. Women with cesarean section before labor, previous cesarean, preterm birth, breech presentation, multiple pregnancy and specified medical illnesses in pregnancy were excluded. METHODS: We compared by gestational week nulliparous and parous women who were either induced or had expectant management until later spontaneous or induced labor. For each of five comparisons, we conducted multivariable logistic regression analysis, controlling for body mass index, age, smoking in pregnancy and use of epidural analgesia during labor. MAIN OUTCOME MEASURE: Rate of CS in labor. RESULTS: From gestational week 39 and thereafter, there was no difference with regard to CS rates in labor among nulliparous and parous women when comparing women with induced labor and those women who waited for a later labor, either induced or spontaneous. The odds ratios (with confidence intervals) for CS in labor in nulliparous women were 0.99 (0.84-1.17), 1.16 (1.04-1.30), 1.04 (0.94-1.15), 1.00 (0.92-1.10) and 0.97 (0.88-1.07) for weeks 37-41, respectively. For parous women the corresponding figures were 1.72 (1.35-2.20), 1.27 (1.04-1.55), 1.15 (0.95-1.39), 1.18 (0.99-1.40) and 1.07 (0.87-1.32), respectively. CONCLUSIONS: Induction of labor provides a sound tool when counseling a woman either going past term or presenting with a problem, even if it is not a severe medical illness.

Night/day ratio as predictor of preeclampsia in normoalbuminuric, diabetic women: early signs of blood pressure disorders.

PURPOSE: Day/night ratio from diurnal ambulatory blood pressure (AMBP) in pregnant women with type 1 diabetes mellitus (T1DM) and in non-diabetic women was evaluated for its association with preeclampsia, retinopathy, HbA1c, and birth weight. METHODS: One hundred and sixty-one women were recruited for AMBP performed with a Spacelab 90207 monitor. The pregnant women were 50 non-diabetic women and 111 T1DM women with normoalbuminuria and no hypertension. ANOVA, regression, and ROC curves analysis were applied. RESULTS: Women with simplex retinopathy had higher night/day ratio and lower birth weight than those without retinopathy. Women who developed preeclampsia had night/day ratio similar to those with simplex retinopathy. In first trimester they had higher blood pressure than those who did not develop preeclampsia. CONCLUSIONS: Simplex retinopathy and preeclampsia are associated with a reduced night/day ratio even with normal blood pressure but night/day ratio provides no better prediction of preeclampsia than the absolute values.

Tissue Thickness Effects on Immunohistochemical Staining Intensity of Markers of Cancer.

High-quality patient samples are required for reliable immunohistochemistry test outcomes that provide a significant benefit for patient care. Among the preanalytic variables in tissue handling, tissue thickness is thought to be easily controlled; however, whether the thickness of the tissue effects the staining intensity for antibody immunohistochemistry has not been quantitatively demonstrated. To investigate, we cut multiblock tissue sections of tonsil, liver, and kidney at 2, 4, 6, and 8 µm thicknesses. Interferometry measurements of the sectioned paraffin showed a <1 µm variation within a preset microtome thickness. Sections were then immunostained with antibodies targeting different cellular localizations; Ki-67 and BCL6 (nuclear), CD7 (membranous), and cytokeratin (cytoplasmic). A pathologist annotated regions of interest for each marker and performed brightfield and whole-slide visual scoring. Then a pixel-wise processing algorithm determined intensity of each pixel in these regions of interest and binned them into predetermined 0, 1+, 2+, or 3+ intensities. Visual scores from brightfield and whole-slide images were highly correlated to the percentage of pixels in each intensity bin. A stepwise increase was observed in pathologist scores and algorithmically defined percentage of pixels in each bin with increasing thickness demonstrating that changes in preset section thickness impacts staining intensity. The use of tissue thickness outside vendors' recommendations might change the intensity including the proportion of positive and negative cells and eventually the overall diagnosis outcome. Therefore, we recommend that tissue be consistently cut within the middle of thickness range specified by the assay manufacturer.

Importance of Individual Elements for Perineal Protection in Childbirth: An Interventional, Prospective Trial.

Objective To analyze the association between each element of a hands-on intervention in childbirth and the incidence of obstetric anal sphincter injuries (OASIS). Study Design We conducted a prospective, interventional quality improvement project and implemented a care bundle with five elements at an obstetric department in Denmark with 3,000 deliveries annually. We aimed at reducing the incidence of OASIS. In the preintervention period, 355 vaginally delivering nulliparous women were included. Similarly, 1,622 nulliparous women were included in the intervention period. The association of each element with the outcome was estimated using a regression analysis. Results The incidence of OASIS went down from 7.0 to 3.4% among nulliparous women delivering vaginally ( p = 0.003; relative risk = 0.48; 95% confidence interval [CI]: 0.30-0.76). Number needed to treat was 28. Logistic regression analysis showed that using hand on the head of the child significantly reduced the risk of OASIS (odds ratio = 0.28; 95% CI: 0.14-0.58). Conclusion Using a quality improvement framework, we documented the individual elements of the intervention. Hand on the infant's head reduced the risk of OASIS.

Telemedicine compared with standard care in type 2 diabetes mellitus: A randomized trial in an outpatient clinic.

INTRODUCTION: Good metabolic control is important in type 2 diabetes mellitus to improve quality of life, work ability and life expectancy, and the use of telemedicine has proved efficient as an add-on to the usual treatment. However, few studies in type 2 diabetes patients have directly compared telemedicine with conventional outpatient treatment, and we wanted to evaluate whether telemedicine, compared with standard care, provides equivalent clinical outcomes. METHODS: Forty patients with type 2 diabetes mellitus allocated from October 2011-July 2012 were randomized to either treatment at home by video conferences only or standard outpatient treatment. Primary outcomes were HbA1c and blood glucose levels and secondary outcomes were 24-hour blood pressure, cholesterol levels and albuminuria. The video-telephone was a broadband solution installed and serviced by the Danish Telephone Company (TDC). RESULTS: The improvements in the two treatments, given as changes in percentage of telemedicine vs standard, showed significant differences in HbA1c (-15 vs -11%), mean blood glucose (-18 vs -13%) and in cholesterol (-7 vs -6%). No differences in LDL (-4 vs -6%), weight (-1 vs 2%), diastolic diurnal blood pressure (-1 vs -7%), and systolic diurnal blood pressure (0 vs -1%) were found. Nine consultations were missed in the standard outpatient group and none in the telemedicine group. CONCLUSIONS: In the direct comparison of home video consultations vs standard outpatient treatment in type 2 diabetes mellitus, telemedicine was a safe and available option with favourable outcomes after six months treatment.

Reducing the incidence of Obstetric Sphincter Injuries using a hands-on technique: an interventional quality improvement project.

A main concern for women giving birth is the risk of obstetric anal sphincter injuries. In our department the incidence of sphincter injuries was around 8 % among vaginally delivering first time mothers. We aimed to halve the incidence to 4 % or less. A prospective interventional program was instituted. We implemented a hands-on technique with four elements in a bundle of care together with a certification process for all staff on the delivery ward. The incidence of episiotomies served as a balancing indicator. The adherence to three of the four elements of the care bundle rose significantly while the all-or-nothing indicator leveled around 80 %. The median number of deliveries between cases with a sphincter injury increased from 9.5 in the baseline period to 20 during the intervention period. This corresponded with a reduction in the incidence from 7.0 % to 3.4 %. The rate of episiotomy remained low at 8.4 % in this group. By implementing the hands-on technique, we halved the risk of obstetric anal sphincter injuries. Our data suggest that further improvement may be anticipated. The study has demonstrated how implementation of a hands-on technique can be carried out within a quality improvement framework with rapid and sustainable results.

Cytogenetic analysis of an asymmetric potato hybrid.

An asymmetric potato hybrid and its parental lines were cytogenetically examined. DAPI (4'-6-diamidino-2-phenylindole) staining was used to count chromosomes in all analysed lines and revealed the presence of minichromosomes in the hybrid genome. Fluorescent in situ hybridization (FISH) with rDNA sequence as a probe helped to determine the ploidy level of analysed lines and revealed that none of the minichromosomes contains rDNA repeats. CMA (chromomycin A3) band occurred to be a new chromosome marker that identifies potato chromosome No.1. It was possible to detect a deletion in one of four chromosomes No. 1 of the asymmetric potato hybrid. On the basis of these analyses a karyotype of the asymmetric hybrid was constructed.

Evidence for electrical remodelling of the atrial myocardium in patients with atrial fibrillation. A study using the monophasic action potential recording technique.

UNLABELLED: Experimental studies have shown that remodelling of the atrial myocardium is linked to the occurrence and perpetuation of atrial fibrillation (AF). Clinical evidence, however, is insufficient. We recorded monophasic action potentials (MAP) during AF from one to three sites in the right atrium in seven patients with chronic AF (CAF) and in 11 patients with paroxysmal AF (PAF). The fibrillatory (FF) interval between two consecutive upstrokes of the MAP was measured using a computer-assisted manual method. The mean, median, 15th, 10th, 5th percentile and shortest FF intervals were calculated in each patient and used as estimates of the local atrial effective refractory period (AERP) during AF. In three patients burst pacing at 400 and 500 beats min(-1) was delivered during the MAP recording. In nine patients, the AERP was also tested using the extra stimulus technique during sinus rhythm. RESULTS: Thirty-eight recordings were obtained. The shortest FF interval was significantly shorter in patients with CAF as compared with that in patients with PAF (50+/-13 vs. 72+/-31 ms, P<005). Similar differences were seen in the mean, median, 15th, 10th, and 5th percentile FF interval. The AERP during sinusrhythm was significantly longer than the estimated AERPs (P<0 05 to P<0.01) in the nine patients. There was no significant difference in FF interval before and after the burst pacing in the three patients. CONCLUSION: The AERP was significantly shortened during AF, as compared with that during sinus rhythm, and the AERP shortening was more marked in patients with CAF than in patients with PAF. These clinical findings support the connection between the electrical remodelling and the occurrence and/ or perpetuation of the AF.

[Sacral nerve stimulation in fecal incontinence]. / Sakralnervestimulation ved analinkontinens.

INTRODUCTION: Sacral nerve stimulation for the treatment of faecal incontinence has gained increasing use in Europe over the last two years. Experience with the first patients treated in Denmark is described here. MATERIAL AND METHODS: Fourteen patients with severe faecal incontinence were given sacral nerve stimulation. The first treatment was temporary, and if this was successful they had a device for permanent stimulation implanted. RESULTS: The result of the test stimulation was good in ten of the 14 patients and a permanent system was implanted. After a median of 4.5 months' stimulation, nine of the ten patients continued to respond to respond well. DISCUSSION: Sacral nerve stimulation in the treatment of faecal incontinence shows promising results. Compared to other more advanced forms of treatment, this method is minimally invasive.

[Fetal and neonatal alloimmune thrombocytopenia]. / Føtal og neonatal alloimmun trombocytopeni er en mulig fatal tilstand.

Fetal and neonatal alloimmune thrombocytopenia (FNAIT) may lead to intracranial haemorrhage (ICH) resulting in neurological damage or death. In FNAIT, transplacental maternal antibodies cause destruction of fetal platelets. Maternal immunisation occurs to fetal human platelet antigens (HPAs) inherited from the father. In the absence of screening the diagnosis often relies on a serious incident in a previous pregnancy or in a newborn sibling. Thus, a future reduction in the risk of ICH depends on prospective large trials to evaluate different diagnostic, treatment, and prevention strategies.