'You're never pregnant in the same way again': prior early pregnancy loss influences need for health care and support in subsequent pregnancy.

STUDY QUESTION: What are couples' needs for health care and support in a subsequent pregnancy after prior early pregnancy loss (PL) and how do needs change across the pregnancy? SUMMARY ANSWER: Couples described unmet needs for pregnancy care in the first 20 weeks of pregnancy and were more satisfied with the care provided during the remainder of the pregnancy. WHAT IS KNOWN ALREADY: Despite early PL being common (∼25% of pregnancies), there is a paucity of research to guide practice to optimize treatment and support future pregnancies. There has been low priority for the issue in research and a pervasive acceptance that couples should 'just try again' after experiencing PL. Women with prior PL report increased anxiety during the first trimester of pregnancy compared to those without previous PL. No longitudinal studies explore what couples' needs are throughout the pregnancy and how these needs shift across time. STUDY DESIGN SIZE DURATION: This was a qualitative longitudinal dyadic (joint) interview study. In total, 15 couples who were pregnant after a prior PL were interviewed four times over their pregnancy. Couples were recruited from the Copenhagen Pregnancy Loss Cohort Research Programme. Interviews were held in person at the hospital or university, or online. Interviews ranged from 20 to 91 min (mean = 54 min). PARTICIPANTS/MATERIALS SETTING METHODS: Inclusion criteria included couples with one to two prior early PL(s) who self-reported a new pregnancy and were willing to be interviewed together and in English. Couples were interviewed four times: after a positive pregnancy test and once in each trimester. Interviews were transcribed and data were analysed using thematic analysis to compare and contrast needs of the couples at each of the four time periods in the pregnancy and across the entire pregnancy. One same-sex couple and 14 heterosexual couples participated. MAIN RESULTS AND THE ROLE OF CHANCE: Couples' needs were categorized into two main longitudinal themes across the pregnancy, divided by the 20-week scan. Within each longitudinal theme, there were two themes to represent each time period. In the longitudinal theme 'The first 20 weeks: a 'scary' gap in care' there were two themes: Positive pregnancy test: 'Tell them it's not the same pregnancy' and First trimester: 'We craved that someone was taking care of us'. The standard pregnancy care offered in the public healthcare system in Denmark includes a scan at 12 and 20 weeks. While all couples wished for additional access to scans and monitoring of the foetus in early pregnancy to provide reassurance and detect problems early, they described considerable variation in the referrals and care they were offered. Both partners expressed a high degree of worry and anxiety about the pregnancy, with pregnant women in particular describing 'surviv[ing] from scan to scan' in the early weeks. Couples took scans wherever offered or paid for comfort scans, but this resulted in fragmented care. Instead, they wished for continuity in care, and acknowledgement and sensitivity that a pregnancy after PL is not the same as a first pregnancy. In the longitudinal theme 'The second 20 weeks: Safety in the care system' there were two themes: Second trimester: 'I think we are in good hands' and Third trimester: 'It's more of a 'nice to know' everything is OK than a 'need to know'. Couples reported their distress was lower and overall needs for care were met during this time. They expressed general satisfaction with regular or extended antenatal support although, as in the first 20 weeks, additional acknowledgement and sensitivity regarding their history of PL was desired. Couples said they felt more secure given that they had access to a 24-hour telephone support by midwife/nurse if they had any concerns or questions. LIMITATIONS REASONS FOR CAUTION: Participants were self-selected from an ongoing cohort study of patients presenting at hospital with PL. Single women were not included in the study. This study was limited to data collection in Denmark; however, other countries with public healthcare systems may have similar offerings with regard to their provision of antenatal care, care provided in recurrent pregnancy loss (RPL) clinics and the availability of private scans. WIDER IMPLICATIONS OF THE FINDINGS: The findings underscore that an early PL creates an increased need for monitoring and care in a subsequent pregnancy. This study highlights a gap in pregnancy care for those with a history of PL given that their need for monitoring and support is high in the early weeks of a new pregnancy before they have access to antenatal care, and before they have had multiple PLs and can be referred to the RPL unit. STUDY FUNDING/COMPETING INTERESTS: This project has received funding from the European Union's Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant agreement No 101028172 for E.K. The Copenhagen Pregnancy Loss Cohort is funded by a grant from the BioInnovation Institute Foundation. H.S.N. has received scientific grants from Freya Biosciences, Ferring Pharmaceuticals, BioInnovation Institute, Ministry of Education, Novo Nordisk Foundation, Augustinus Fonden, Oda og Hans Svenningsens Fond, Demant Fonden, Ole Kirks Fond, and Independent Research Fund Denmark. H.S.N. received personal payment or honoraria for lectures and presentations from Ferring Pharmaceuticals, Merck, Astra Zeneca, Cook Medical, Gedeon Richter, and Ibsa Nordic. All other authors declare no competing interests.

Scale-up of the Internet-based Professional Learning to help teachers promote Activity in Youth (iPLAY) intervention: a hybrid type 3 implementation-effectiveness trial.

BACKGROUND: Whole-of-school programs have demonstrated success in improving student physical activity levels, but few have progressed beyond efficacy testing to implementation at-scale. The purpose of our study was to evaluate the scale-up of the 'Internet-based Professional Learning to help teachers promote Activity in Youth' (iPLAY) intervention in primary schools using the RE-AIM framework. METHODS: We conducted a type 3 hybrid implementation-effectiveness study and collected data between April 2016 and June 2021, in New South Wales (NSW), Australia. RE-AIM was operationalised as: (i) Reach: Number and representativeness of students exposed to iPLAY; (ii) Effectiveness: Impact of iPLAY in a sub-sample of students (n = 5,959); (iii) Adoption: Number and representativeness of schools that received iPLAY; (iv) Implementation: Extent to which the three curricular and three non-curricular components of iPLAY were delivered as intended; (v) Maintenance: Extent to which iPLAY was sustained in schools. We conducted 43 semi-structured interviews with teachers (n = 14), leaders (n = 19), and principals (n = 10) from 18 schools (11 from urban and 7 from rural locations) to determine program maintenance. RESULTS: Reach: iPLAY reached ~ 31,000 students from a variety of socio-economic strata (35% of students were in the bottom quartile, almost half in the middle two quartiles, and 20% in the top quartile). EFFECTIVENESS: We observed small positive intervention effects for enjoyment of PE/sport (0.12 units, 95% CI: 0.05 to 0.20, d = 0.17), perceptions of need support from teachers (0.26 units, 95% CI: 0.16 to 0.53, d = 0.40), physical activity participation (0.28 units, 95% CI: 0.10 to 0.47, d = 0.14), and subjective well-being (0.82 units, 95% CI: 0.32 to 1.32, d = 0.12) at 24-months. Adoption: 115 schools received iPLAY. IMPLEMENTATION: Most schools implemented the curricular (59%) and non-curricular (55%) strategies as intended. Maintenance: Based on our qualitative data, changes in teacher practices and school culture resulting from iPLAY were sustained. CONCLUSIONS: iPLAY had extensive reach and adoption in NSW primary schools. Most of the schools implemented iPLAY as intended and effectiveness data suggest the positive effects observed in our cluster RCT were sustained when the intervention was delivered at-scale. TRIAL REGISTRATION: ACTRN12621001132831.

Early in-hospital course of critically ill nontrauma patients in a resuscitation room of a German emergency department (OBSERvE2 study).

BACKGROUND: Management of critically ill nontrauma (CINT) patients in the resuscitation room of the emergency department (ED) is very challenging. Detailed data describing the patient characteristics and management of this population are lacking. This observational study describes the epidemiology, management and outcome in CINT ED patients in the resuscitation room. METHODS: This prospective, single center observational study included all adult patients who were consecutively admitted to the ED resuscitation room during 2 periods of 1 year (September 2014-August 2015 vs. September 2017- August 2018). Patient characteristics, out-of-hospital/in-hospital treatment, admission-related conditions, time intervals for diagnostics and interventions and outcome were recorded using a self-developed questionnaire. RESULTS: A total of 34,303 patients in the first and 35,039 patients in the second study period were admitted to the ED, of whom 532 and 457 patients, respectively, were admitted to the nontrauma resuscitation room due to acute life-threatening conditions. The patient characteristics did not differ significantly between the study periods (male: 58% vs. 59%, age: 68 ± 17 years vs. 65 ± 17 years). Time intervals for diagnostic and therapeutic interventions were similar. The CINT patients during the second study period were treated faster compared to the first study period (end of ED management: 53 ± 33 min vs. 41 ± 24 min, p < 0.0001). The 30-day all-cause mortality was comparable (34.0% vs. 36.3%). CONCLUSION: Observation of critically ill patient management in the ED resuscitation room showed reliable results between both study periods. Structured ED management guidelines for CINT patients may provide comparable results at one institution.

MRI-guided and CT-guided cervical nerve root infiltration therapy: a cost comparison.

PURPOSE: To evaluate and compare the costs of MRI-guided and CT-guided cervical nerve root infiltration for the minimally invasive treatment of radicular neck pain. MATERIALS AND METHODS: Between September 2009 and April 2012, 22 patients (9 men, 13 women; mean age: 48.2 years) underwent MRI-guided (1.0 Tesla, Panorama HFO, Philips) single-site periradicular cervical nerve root infiltration with 40 mg triamcinolone acetonide. A further 64 patients (34 men, 30 women; mean age: 50.3 years) were treated under CT fluoroscopic guidance (Somatom Definition 64, Siemens). The mean overall costs were calculated as the sum of the prorated costs of equipment use (purchase, depreciation, maintenance, and energy costs), personnel costs and expenditure for disposables that were identified for MRI- and CT-guided procedures. Additionally, the cost of ultrasound guidance was calculated. RESULTS: The mean intervention time was 24.9 min. (range: 12 - 36 min.) for MRI-guided infiltration and 19.7 min. (range: 5 - 54 min.) for CT-guided infiltration. The average total costs per patient were EUR 240 for MRI-guided interventions and EUR 124 for CT-guided interventions. These were (MRI/CT guidance) EUR 150/60 for equipment use, EUR 46/40 for personnel, and EUR 44/25 for disposables. The mean overall cost of ultrasound guidance was EUR 76. CONCLUSION: Cervical nerve root infiltration using MRI guidance is still about twice as expensive as infiltration using CT guidance. However, since it does not involve radiation exposure for patients and personnel, MRI-guided nerve root infiltration may become a promising alternative to the CT-guided procedure, especially since a further price decrease is expected for MRI devices and MR-compatible disposables. In contrast, ultrasound remains the less expensive method for nerve root infiltration guidance.

[Management of critically ill patients in the resuscitation room. Different than for trauma?]. / Schockraummanagement kritisch erkrankter Patienten. Anders als beim Trauma?

The general approach to the initial resuscitation of non-trauma patients does not differ from the ABCDE approach used to evaluate severely injured patients. After initial stabilization of vital functions patients are evaluated based on the symptoms and critical care interventions are initiated as and when necessary. Adequate structural logistics and personnel organization are crucial for the treatment of non-trauma critically ill patients although there is currently a lack of clearly defined requirements. For severely injured patients there are recommendations in the S3 guidelines on treatment of multiple trauma and severely injured patients and these can be modeled according to the white paper of the German Society of Trauma Surgery (DGU). However, structured training programs similar to the advanced trauma life support (ATLS®)/European resuscitation course (ETC®) that go beyond the current scope of advanced cardiac life support training are needed. The development of an advanced critically ill life support (ACILS®) concept for non-trauma critically ill patients in the resuscitation room should be supported.

[Arthroscopic correction of extra-articular subspinal impingement in the hip joint]. / Arthroskopische Korrektur des extraartikulären Subspine-Impingements am Hüftgelenk.

We report the case of symptomatic extra-articular subspinal impingement in the hip joint caused by a pathological contact between the anterior inferior iliac spine (AIIS) and the femoral neck. A 28-year-old patient presented with activity-related inguinal pain on the right side and a positive anterior impingement test in the clinical examination. Radiological examinations revealed a hypertrophic AIIS with caudal extension below the acetabulum. After a positive injection test confirmed the AIIS as the origin of the pain, arthroscopic correction with partial resection of the AIIS was performed resulting in significant pain relief and improved range of motion.

Cost comparison of nerve root infiltration of the lumbar spine under MRI and CT guidance.

OBJECTIVES: To compare the costs of CT- and MR-guided lumbosacral nerve root infiltration for minimally invasive treatment of low back pain and radicular pain. METHODS: Ninety patients (54 men, 36 women; mean age, 45.5 ± 12.8 years) underwent MR-guided single-site periradicular lumbosacral nerve root infiltration with 40 mg of triamcinolone acetonide. A further 91 patients (48 men, 43 women; mean age, 59.1 ± 13.8 years) were treated under CT fluoroscopy guidance. Prorated costs of equipment use (purchase, depreciation and maintenance), staff costs based on involvement times and expenditure for disposables were identified for MR- and CT-guided procedures. RESULTS: Mean intervention time was 20.6 min (14-30 min) for MR-guided and 14.3 min (7-32 min) for CT-guided treatment. The average total costs per patient were €177 for MR-guided and €88 for CT-guided interventions. These consisted of (MR/CT guidance) €93/29 for equipment use, €43/35 for staff and €41/24 for disposables. CONCLUSIONS: Lumbosacral nerve root infiltration using MRI guidance is still about twice as expensive as infiltration using CT guidance. Given the advantages of no radiation exposure and possible future decrease in prices for MRI devices and MR-compatible injection needles, MR-guided nerve root infiltration may become a promising alternative to the CT-guided procedure. KEY POINTS: • MR-guided nerve root infiltration therapy is now technically and clinically established. • Costs using MRI guidance are still about double those for CT guidance. • MR guidance involves no radiation exposure to patients and personnel. • MR-guided nerve root infiltration may become a promising alternative to CT.

MR-guided discography using an open 1 Tesla MRI system.

OBJECTIVE: To evaluate the feasibility of MR-guided discography using an open 1 Tesla MRI system. METHODS: 48 disc segments of 41 patients scheduled for intradiscal thermal treatment, total disc replacement or spondylodesis were examined. A 1.0-T open MRI was used for instrument guidance and imaging. After primary disc puncture under guidance of interactive PDw TSE imaging, 1-2 ml of gadolinium contrast saline mixture was injected into the disc. The occurrence of memory pain during injection was recorded. Axial and sagittal T1w TSE images with and without fat saturation were obtained. All MRI discograms were analysed by two readers, who were blinded to the clinical findings. RESULTS: Overall, the placement of the puncture needle in the targeted disc was accurate under real-time MR guidance. Injections were technically successful in all cases. No major complications occurred. The mean procedure time was 17 min (range 13-34 min). Image quality of contrast-enhanced MR discograms was excellent when using an optimized gadolinium contrast saline mixture of 1:600. Memory pain was detected in 16 out of 48 affected segments. CONCLUSION: MR-guided discography is accurate and safe. Multiplanar dynamic imaging facilitates the puncture of discs and provides high-quality MR discograms.

[Monosegmental anterior lumbar interbody fusion with the SynFix-LR™ device. A prospective 2-year follow-up study]. / Die monosegmentale ventrale Spondylodese mit dem SynFix-LR™. Eine prospektive 2-Jahres-Studie.

BACKGROUND: With anterior lumbar interbody fusion (ALIF) alone, the morbidity associated with a posterior approach can be avoided. In this study we evaluated the use of a PEEK cage with an integrated angle-stable locking plate (SynFix-LR™). MATERIAL AND METHODS: Thirty-two patients with osteochondrosis at L4/5 or L5/S1 were treated with the SynFix-LR™. Follow-up at 0, 3, 6, 9, 12, and 24 months included the Oswestry Disability Index (ODI), visual analog scale (VAS), and questions regarding satisfaction and use of pain medication. The fusion rate was assessed by X-ray and computed tomography (CT) examination. RESULTS: A significant reduction of the ODI and VAS was achieved (p<0.05) with a high rate of patient satisfaction. After 2 years, 79% of the patients were able to dispense with long-term use of analgesics. We observed a fusion rate of 93% (X-ray) and 70% (CT) at final follow-up. CONCLUSION: The SynFix-LR™ device is a suitable option for the treatment of monosegmental osteochondrosis at L4/5 and L5/S1 with comparable or superior results in comparison to posterior or combined fusion techniques.

Biocompatibility of bacterial contaminated prosthetic meshes and porcine dermal collagen used to repair abdominal wall defects.

BACKGROUND AND AIMS: A contaminated or infected surgical site is considered a contraindication for the use of the nonabsorbable alloplastic materials employed to repair abdominal wall defects. Therefore, the biocompatibility of new prosthetic materials was investigated. MATERIALS AND METHODS: Meshes measuring 1.5x1.5 cm made of conventional and titanium-coated polypropylene, polyglycol, or porcine dermal collagen were implanted under the abdominal wall of 96 rats (eight groups of 12 animals each) employing the inlay technique. Implantation of all four materials was performed both under semisterile conditions and bacterial contamination of the mesh. The meshes were explanted after 28 days. RESULTS: All the materials implanted under semisterile conditions were incorporated into the abdominal wall with only few intraabdominal adhesions (mean adhesion scores: 1.0, 1.2, 1.0, 0.8 points, respectively, not significant). With the porcine dermal collagen, proliferation rate and the proportion of inflammatory cells were statistically lower (p<0.01). In the bacterial contamination group, all meshes were associated with a suppurating infection and strong adhesions between the bowel and mesh, which were most prominent in the case of dermal collagen (mean adhesion scores: 1.6, 1.7, 1.7, and 1.9 points, respectively, not significant). In this group, two animals died of peritonitis. In comparison with the other materials, the proliferation rate was significantly elevated (p=0.03). No significant differences were seen between the other materials employed. CONCLUSION: Irrespective of the material employed, implantation of alloplastic meshes in an abdominal wall contaminated with bacteria, is associated with suppurating infections, in particular in the case of the membrane-like porcine dermal collagen. Nonabsorbable alloplastic meshes and dermal skin grafts should therefore not be used to repair infected abdominal wall defects.

[Clinical studies in liver transplantation]. / Klinische Studien in der Lebertransplantation.

Clinical liver transplantation became an established therapy of end-stage liver disease since the first at least medium-term successful liver transplantation in 1967. Clinical studies have played a major part in improving peri- and postoperative therapy in liver transplantation. In this article clinical studies of major impact are presented. Main topics are studies dealing with immunosuppressants, improvements in surgical techniques, viral infections and tumor diseases. Controlled randomized multicentric studies are rare; most of the studies are unicentric. Further studies in the fields of reducing side effects of immunosuppression, the introduction of monoclonal antibodies and improvement of the therapy of viral hepatitis would be helpful. These studies should be controlled, randomized and multicentric.

Augmented baroreflex heart rate gain after moderate-intensity, dynamic exercise.

The occurrence of a sustained vasodilation and hypotension after acute, dynamic exercise suggests that exercise may alter arterial baroreflex mechanisms. Therefore, we assessed systemic hemodynamics, baroreflex regulation of heart rate, and cardiac vagal tone after 60 min of cycling at 60% peak oxygen consumption in 12 healthy, untrained men and women (ages 21-28 yr). We derived sigmoidal carotid-cardiac baroreflex relations by measurement of R-R interval changes induced by ramped, stepwise, R-wave-triggered changes in external neck pressure from 40 to -65 mmHg. We estimated tonic cardiac vagal control with power spectral analysis of R-R interval variability in the respiratory frequency band (0.2-0.3 Hz) during frequency- and tidal volume-controlled breathing. Both mean arterial pressure and total peripheral resistance were reduced postexercise [pressure: from 86 +/- 2 (mean +/- SE) to 81 +/- 2 mmHg; resistance: from 23 +/- 2 to 16 +/- 1 units; both P < 0.05]. Cardiac output was increased postexercise (from 3.9 +/- 0.3 to 5.5 +/- 0.5 l/min, P < 0.05). Both slope and range of the carotid-cardiac baroreflex relation were increased postexercise (slope: from 4.7 +/- 0.7 to 6.1 +/- 0.9 ms/mmHg; range: from 186 +/- 23 to 238 +/- 30 ms, P < 0.05). Respiratory R-R interval variability (cardiac vagal tone) was not changed at any time after exercise, whereas heart rate and plasma norepinephrine levels were elevated. Thus moderate-intensity, dynamic exercise increases heart rate and cardiac output, reduces peripheral vascular resistance, and augments baroreflex responsiveness. Our data suggest that augmented baroreflex heart rate gain restrains rather than contributes to postexercise hypotension, which appears to be mediated predominately by vasodilation.

[Normal findings with duplex sonography of liver blood vessels--experience in the examination of 100 patients with healthy livers]. / Normalbefunde der Duplexsonographie der Lebergefässe--Erfahrungen mit der Untersuchung von 100 lebergesunden Patienten.

100 patients of our kidney transplantation program and uneventful as regards their liver history were indexed by the pulsatile flow (PFI) of the hepatic artery and the damp curve (DI) of the hepatic veins. The average age of the patients was 36 years (20-50y). The pulsatile flow index (PFI) was calculated as 0.4 to 0.7. The damp index (DI) as 0.3 to 0.54. In 10 of these volunteers the measurement was performed 3 times per day for 5 days: there was no difference to be found in comparison to the values of the total group. The presented values of the PFI and DI give the normal range and will be the basis for further investigations in patients after liver transplantation or suffering from liver diseases.

[The value of duplex sonography after orthotopic liver transplantation. Experience with 44 patients]. / Der Wert der Duplexsonographie nach der orthotopen Lebertransplantation. Erfahrungen an 44 Patienten.

In a prospective study, 44 patients (11 women, 33 men) who had received orthotopic liver transplants underwent a total of 196 consecutive duplex Doppler ultrasound examinations. The aim of the study was to evaluate the correlation between the pulsatile flow index (PFI) and the damping index (DI) as far as complications as rejection or cholangitis were concerned. The patients were examined five times each on average. The PFI and DI were measured in the hepatic artery, the portal vein and the hepatic veins. The findings were compared with the clinical course (cholangitis, rejection) and the histomorphological diagnosis as determined in biopsy specimens. In biopsy-proven rejection episodes, the sensitivity of the PFI in the hepatic artery was 69.4%, the specificity 72.2%. The sensitivity of the DI in the hepatic vein was 89.4%, the specificity 89.1%. Combining the two, specificity was more than 90%. PFI and DI in the portal vein bore no apparent relation to clinical course or histomorphological diagnosis. We found duplex Doppler ultrasound extremely beneficial in determining the timing and indication for liver biopsy. In addition, this simple examination, which can be performed as often as desired, accurately shows the transplanted liver's response to measures taken to counter rejection.