Digital Outpatient Services for Adults: Development of an Intervention and Protocol for a Multicenter Non-Randomized Controlled Trial.

BACKGROUND: Health care services are being challenged by an increasing number of patients and limited resources. Hence, research investigating options to reduce costs and increase effectiveness is warranted. Digital outpatient services can provide flexible and tailored follow-up, improve patients' health literacy, and facilitate the identification of adverse courses of disease. However, previous research largely focused on disease-specific contexts and outcomes. Therefore, research on digital services investigating generic outcomes such as health literacy is warranted. OBJECTIVE: This article aims to describe the "digital outpatient service" intervention and present the protocol for an ongoing multicenter, nonrandomized trial evaluating this intervention. METHODS: Based on previous experiences and evidence-based knowledge, we developed this intervention through patient-journey maps in collaboration with each clinical specialty. The patients gain access to a mobile app for self-monitoring and patient-reported outcomes and a chat for contact between the patients and health care workers. The health care workers' dashboard includes a traffic light system to draw attention to the most urgent patient reports. In this multicenter, non-randomized controlled trial, patients are allocated to the control group receiving standard care or the 6-month intervention. Eligible patients are aged 18 years or older who receive outpatient care at the neurology, lung, pain, or cancer departments at 2 university hospitals in Norway. Our evaluation will include patient-reported outcomes, qualitative interviews, and clinical measures. The primary outcome will be health literacy using the Health Literacy Questionnaire. A sample size of 165 participants is split into a 1:2 ratio in favor of the intervention. We will analyze quantitative data in SPSS (IBM Corp) using descriptive statistics and logistic regression, and qualitative data using thematic analysis. RESULTS: This trial started in September 2021, and the intervention started in January 2022. Recruitment has ended, with 55 patients in the control group and 107 patients in the intervention group. Follow-up is expected to end in July 2023, with results expected to be obtained in December 2023. CONCLUSIONS: This study will evaluate an intervention facilitated by an already certified digital multicomponent solution, with intervention content based on patient-reported outcomes, health literacy, and self-monitoring. The intervention is specifically tailored to each participating center and the needs of their patients using patient journey maps. The comprehensive and generic evaluation of this digital outpatient service intervention is a strength as it targets a heterogeneous sample of patients. Thus, this study will provide important knowledge about the applicability and effects of digital health care services. As a result, patients and health care workers will gain a new, evidence-based understanding of whether and how digital tools may be used in clinical care. TRIAL REGISTRATION: ClinicalTrials.gov NCT05068869; https://clinicaltrials.gov/ct2/show/NCT05068869. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46649.

Exploring the impact of indication on variation in rates of intrapartum caesarean section in six Palestinian hospitals: a prospective cohort study.

BACKGROUND: Caesarean section rates are rising globally. No specific caesarian section rate at either country-level or hospital-level was recommended. In Palestinian government hospitals, nearly one-fourth of all births were caesarean sections, ranging from 14.5 to 35.6%. Our aim was to assess whether variation in odds for intrapartum caesarean section in six Palestinian government hospitals can be explained by differences in indications. METHODS: Data on maternal and fetal health were collected prospectively for all women scheduled for vaginal delivery during the period from 1st March 2015 to 30th November 2016 in six government hospitals in Palestine. Comparisons of proportions in sociodemographic, antenatal obstetric characteristics and indications by the hospital were tested by χ2 test and differences in means by one-way ANOVA analysis. The odds for intrapartum caesarean section were estimated by logistic regression. The amount of explained variance was estimated by Nagelkerke R square. RESULTS: Out of 51,041 women, 4724 (9.3%) underwent intrapartum caesarean section. The prevalence of intrapartum caesarean section varied across hospitals; from 7.6 to 22.1% in nulliparous, and from 5.8 to 14.1% among parous women. The most common indications were fetal distress and failure to progress in nulliparous, and previous caesarean section with an additional obstetric indication among parous women. Adjusted ORs for intrapartum caesarean section among nulliparous women ranged from 0.42 (95% CI 0.31 to 0.57) to 2.41 (95% CI 1.70 to 3.40) compared to the reference hospital, and from 0.50 (95% CI 0.40-0.63) to 2.07 (95% CI 1.61 to 2.67) among parous women. Indications explained 58 and 66% of the variation in intrapartum caesarean section among nulliparous and parous women, respectively. CONCLUSION: The differences in odds for intrapartum caesarean section among hospitals could not be fully explained by differences in indications. Further investigations on provider related factors as well as maternal and fetal outcomes in different hospitals are necessary.

Improved Detection Of Thromboembolic Complications In Left Ventricular Assist Device By Novel Accelerometer-Based Analysis.

We have previously demonstrated that accelerometer-based vibration analysis detects thromboembolism and pump thrombosis in HeartWare Left Ventricular Assist Device (HVAD) using the third harmonic frequency (pump_speedx3). Thromboembolism also affected the amplitude of the nonharmonic frequencies. The aim of this study was to determine whether nonharmonic-amplitude (NHA) analysis can improve the diagnosis of thromboembolic complications. An accelerometer was attached to HVAD in three in vitro and seven in vivo experiments. Control interventions, including load and pump speed alternations (n = 107), were followed by thromboembolic events (n = 60). A sliding fast-Fourier-transform was analyzed, and changes in NHAs were quantified in the acute phase and in a steady state. Receiver operating characteristic curves were constructed with cutoff values of NHA to detect thromboembolic events. Positive predictive values were calculated on the basis of a specificity of 1. In the acute phase, NHA change was 6.5 times higher under thromboembolism than under control interventions (p < 0.001). Most thromboembolic events lead to concomitant changes in both NHA and third-harmonic amplitude. Combining the two methods improved the PPV by 8.3%. At steady state, signal changes predominantly demonstrated either NHA or third-harmonic changes. Combined signal analysis improved the PPV by 36%. This method enhanced the detection of thromboembolism and pump thrombosis in the HVAD.

Robot-assisted magnetic capsule endoscopy; navigating colorectal inclinations.

Purpose: To investigate the interaction of a robot assisted magnetically driven wireless capsule endoscope (WCE) with colonic tissue, as it traverses the colorectal bends in the dorsal and ventral directions, relying only on the feedback from a 3D accelerometer. We also investigate the impact of shell geometry and water insufflation on WCE locomotion.Methods: A 3D printed incline phantom, lined with porcine colon, was used as the experimental platform, for controlled and repeatable results. The tilt angle of WCE was controlled to observe its influence on WCE locomotion. The phantom was placed underwater to observe the effects of water insufflation. The experiments were repeated using the two capsule shell geometries to observe the effect of shell geometry on WCE locomotion.Results: Friction between WCE and intestinal tissue increased when the tilt angle of the WCE was lower than the angle of the incline of the phantom. Increasing the WCE tilt angle to match the angle of the incline reduced this friction. Water insufflation and elliptical capsule shell geometry reduced the friction further.Conclusion: Tilting of the WCE equal to, or more than the angle of the incline improved the WCE locomotion. WCE locomotion was also improved by using elliptical capsule shell geometry and water insufflation.Abbreviations: CRC: colorectal cancer; GI: gastrointestinal; MRI: magnetic resonance imaging; WCE: wireless capsule endoscope.

A Drone Logistic Model for Transporting the Complete Analytic Volume of a Large-Scale University Laboratory.

We present a model for drone transport of the complete annual analytic volume of 6.5 million analyses-(routine and emergency) between two inner-city university laboratories at Oslo University Hospital located 1.8 km apart and with a time restriction for the analyses of no more than 60 min. The total laboratory activity was analyzed per min for the complete year of 2018. The time from the clinical ordering of tests to the loading of the drone, drone transport time, and analysis time after the sample arrived at the analyzing laboratory were assessed using the lead time of emergency analyses of C-reactive protein, troponin, and the international normalized ratio. The activity had characteristic diurnal patterns, with the most intensive traffic between 8 and 12 a.m. on weekdays and there being considerably less traffic for the rest of the day, at night and on weekends. Drone schedules with departures 15-60 min apart were simulated. A maximum of 15 min between flights was required to meet the emergency demand for the analyses being completed within 60 min. The required drone weight capacity was below 3.5 kg at all times. In multiple simulations, the drone times were appropriate, whereas variations in the clinic- and laboratory-related time intervals caused violations of the allowed time 50% of the time. Drone transport with regular schedules may potentially improve the transport time compared with traditional ground transport and allow the merging of large laboratories, even when the demand for emergency analyses restricts the maximum transport time. Comprehensive economic evaluations and robust drone technology are needed before such solutions can be ready for implementation.

Open chest and pericardium facilitate transpulmonary passage of venous air emboli.

BACKGROUND: Transpulmonary passage of air emboli can lead to fatal brain- and myocardial infarctions. We studied whether pigs with open chest and pericardium had a greater transpulmonary passage of venous air emboli than pigs with closed thorax. METHODS: We allocated pigs with verified closed foramen ovale to venous air infusion with either open chest with sternotomy and opening of the pleura and pericardium (n = 8) or closed thorax (n = 16). All pigs received a five-hour intravenous infusion of ambient air, starting at 4-6 mL/kg/h and increased by 2 mL/kg/h each hour. We assessed transpulmonary air passage by transesophageal M-mode echocardiography and present the results as median with inter-quartile range (IQR). RESULTS: Transpulmonary air passage occurred in all pigs with open chest and pericardium and in nine pigs with closed thorax (56%). Compared to pigs with closed thorax, pigs with open chest and pericardium had a shorter to air passage (10 minutes (5-16) vs. 120 minutes (44-212), P < .0001), a smaller volume of infused air at the time of transpulmonary passage (12 mL (10-23) vs.170 mL (107-494), P < .0001), shorter time to death (122 minutes (48-185) vs 263 minutes (248-300, P = .0005) and a smaller volume of infused air at the time of death (264 mL (53-466) vs 727 mL (564-968), P = .001). In pigs with open chest and, infused air and time to death correlated strongly (r = 0.95, P = .001). CONCLUSION: Open chest and pericardium facilitated the transpulmonary passage of intravenously infused air in pigs.

Pathologic Blood Samples Tolerate Exposure to Vibration and High Turbulence in Simulated Drone Flights, but Plasma Samples Should be Centrifuged After Flight.

OBJECTIVE: Most of the previous studies of drone transport of blood samples examined normal blood samples transported under tranquil air conditions. We studied the effects of 1- and 2-hour drone flights using random vibration and turbulence simulation (10-30 g-force) on blood samples from 16 healthy volunteers and 74 patients with varying diseased. METHODS: Thirty-two of the most common analytes were tested. For biochemical analytes, we used plasma collected in lithium heparin tubes with and without separator gel. Gel samples were analyzed for the effect of separation by centrifugation before or after turbulence. Turbulence was simulated in an LDS V8900 high-force shaker using random vibration (range, 5-200 Hz), with samples randomly allocated to 1- or 2-hour flights with 25 or 50 episodes of turbulence from 10 to 30 G. RESULTS: For all hematologic and most biochemical analytes, test results before and after turbulence exposure were similar (bias < 12%, intercepts < 10%). However, aspartate aminotransferase, folate, lactate dehydrogenase and lipid index increased significantly in samples separated by gel and centrifugation prior to vibration and turbulence test. These changes increased form 10 G to 30 G, but were not observed when the samples were separated after vibration and turbulence. CONCLUSIONS: Whole blood showed little vulnerability to turbulence, whereas plasma samples separated from blood cells by gel may be significantly influenced by turbulence when separated by spinning before the exposure. Centrifugation of plasma samples collected in tubes with separator gel should be avoided before drone flights that could be subject to turbulence.

Continuous Estimation of Acute Changes in Preload Using Epicardially Attached Accelerometers.

OBJECTIVE: A miniaturized accelerometer can be incorporated in temporary pacemaker leads which are routinely attached to the epicardium during cardiac surgery and provide continuous monitoring of cardiac motion during and following surgery. We tested if such a sensor could be used to assess volume status, which is essential in hemodynamically unstable patients. METHODS: An accelerometer was attached to the epicardium of 9 pigs and recordings performed during baseline, fluid loading, and phlebotomy in a closed chest condition. Alterations in left ventricular (LV) preload alter myocardial tension which affects the frequency of myocardial acceleration associated with the first heart sound ( fS1). The accuracy of fS1 as an estimate of preload was evaluated using sonomicrometry measured end-diastolic volume (EDV[Formula: see text]). Standard clinical estimates of global end-diastolic volume using pulse index continuous cardiac output (PiCCO) measurements (GEDV[Formula: see text]) and pulmonary artery occlusion pressure (PAOP) were obtained for comparison. The diagnostic accuracy of identifying fluid responsiveness was analyzed for fS1, stroke volume variation (SVV[Formula: see text]), pulse pressure variation (PPV[Formula: see text]), GEDV[Formula: see text], and PAOP. RESULTS: Changes in fS1 correlated well to changes in EDV[Formula: see text] ( r2=0.81, 95%CI: [0.68, 0.89]), as did GEDV[Formula: see text] ( r2=0.59, 95%CI: [0.36, 0.76]) and PAOP ( r2=0.36, 95%CI: [0.01, 0.73]). The diagnostic accuracy [95%CI] in identifying fluid responsiveness was 0.79 [0.66, 0.94] for fS1, 0.72 [0.57, 0.86] for SVV[Formula: see text], and 0.63 (0.44, 0.82) for PAOP. CONCLUSION: An epicardially placed accelerometer can assess changes in preload in real-time. SIGNIFICANCE: This novel method can facilitate continuous monitoring of the volemic status in open-heart surgery patients and help guiding fluid resuscitation.

Evaluation of Image Quality for 7 Iterative Reconstruction Algorithms in Chest Computed Tomography Imaging: A Phantom Study.

OBJECTIVES: This study aimed to evaluate the image quality of 7 iterative reconstruction (IR) algorithms in comparison to filtered back-projection (FBP) algorithm. METHODS: An anthropomorphic chest phantom was scanned on 4 computed tomography scanners and reconstructed with FBP and IR algorithms. Image quality of anatomical details-large/medium-sized pulmonary vessels, small pulmonary vessels, thoracic wall, and small and large lesions-was scored. Furthermore, general impression of noise, image contrast, and artifacts were evaluated. Visual grading regression was used to analyze the data. Standard deviations were measured, and the noise power spectrum was calculated. RESULTS: Iterative reconstruction algorithms showed significantly better results when compared with FBP for these criteria (regression coefficients/P values in parentheses): vessels (FIRST: -1.8/0.05, AIDR Enhanced: <-2.3/0.01, Veo: <-0.1/0.03, ADMIRE: <-2.1/0.04), lesions (FIRST: <-2.6/0.01, AIDR Enhanced: <-1.9/0.03, IMR1: <-2.7/0.01, Veo: <-2.4/0.02, ADMIRE: -2.3/0.02), image noise (FIRST: <-3.2/0.004, AIDR Enhanced: <-3.5/0.002, IMR1: <-6.1/0.001, iDose: <-2.3/0.02, Veo: <-3.4/0.002, ADMIRE: <-3.5/0.02), image contrast (FIRST: -2.3/0.01, AIDR Enhanced: -2.5/0.01, IMR1: -3.7/0.001, iDose: -2.1/0.02), and artifacts (FIRST: <-3.8/0.004, AIDR Enhanced: <-2.7/0.02, IMR1: <-2.6/0.02, iDose: -2.1/0.04, Veo: -2.6/0.02). The iDose algorithm was the only IR algorithm that maintained the noise frequencies. CONCLUSIONS: Iterative reconstruction algorithms performed differently on all evaluated criteria, showing the importance of careful implementation of algorithms for diagnostic purposes.

Medicine and interest politics a study of decision-making processes in the area of vascular surgery in Norway.

PURPOSE: The purpose of this paper is to increase the understanding of organizational challenges when decision-makers try to comply with technological developments and increasing demands for a more rational distribution of health care services. This paper explores two decision-making processes from 2007-2019 in the area of vascular surgery at a regional and a local level in Norway. DESIGN/METHODOLOGY/APPROACH: The study draws upon extensive document analyses, semi-structured interviews and field conversations. The empirical material was analyzed in several steps through an inductive approach and described and explained through a theoretical framework based on rational choice (i.e. bounded rationality), political behavior and institutionalism. These perspectives were used in a complementary way. FINDINGS: Both decision-making processes were resource-intensive, long-lasting and produced few organizational changes for the provision of vascular services. Stakeholders at both levels outmaneuvered the health care planners, though by different means. Regionally, the decision-making ended up in a political process, while locally the decision-making proceeded as a strategic game between different departments and professional fields. PRACTICAL IMPLICATIONS: Decision-makers need to prepare thoroughly for convincing others of the benefits of new ways of organizing clinical care. By providing meaningful opportunities for public involvement, by identifying and anticipating political agendas and by building alliances between stakeholders with divergent values and aims decision-makers may extend the realm of feasible solutions. ORIGINALITY/VALUE: This paper contributes to the understanding of why decision-making processes can be particularly challenging in a field characterized by rapid technological development, new treatment options and increasing demands for more rational distribution of services.

Prediction of survival and progression in glioblastoma patients using temporal perfusion changes during radiochemotherapy.

BACKGROUND: The aim of this study was to investigate changes in structural magnetic resonance imaging (MRI) according to the RANO criteria and perfusion- and permeability related metrics derived from dynamic contrast-enhanced MRI (DCE) and dynamic susceptibility contrast MRI (DSC) during radiochemotherapy for prediction of progression and survival in glioblastoma. METHODS: Twenty-three glioblastoma patients underwent biweekly structural and perfusion MRI before, during, and two weeks after a six weeks course of radiochemotherapy. Temporal trends of tumor volume and the perfusion-derived parameters cerebral blood volume (CBV) and blood flow (CBF) from DSC and DCE, in addition to contrast agent capillary transfer constant (Ktrans) from DCE, were assessed. The patients were separated in two groups by median survival and differences between the two groups explored. Clinical- and MRI metrics were investigated using univariate and multivariate survival analysis and a predictive survival index was generated. RESULTS: Median survival was 19.2 months. A significant decrease in contrast-enhancing tumor size and CBV and CBF in both DCE- and DSC-derived parameters was seen during and two weeks past radiochemotherapy (p < 0.05). A 10%/30% increase in Ktrans/CBF two weeks after finishing radiochemotherapy resulted in significant shorter survival (13.9/16.8 vs. 31.5/33.1 months; p < 0.05). Multivariate analysis revealed an index using change in Ktrans and relative CBV from DSC significantly corresponding with survival time in months (r2 = 0.843; p < 0.001). CONCLUSIONS: Significant temporal changes are evident during radiochemotherapy in tumor size (after two weeks) and perfusion-weighted MRI-derived parameters (after four weeks) in glioblastoma patients. While DCE-based metrics showed most promise for early survival prediction, a multiparametric combination of both DCE- and DSC-derived metrics gave additional information.

Detection of Thromboembolic Events and Pump Thrombosis in HeartWare HVAD Using Accelerometer in a Porcine Model.

We have recently demonstrated that accelerometer-based pump thrombosis and thromboembolic events detection is feasible in vitro. This article focuses on detection of these conditions in vivo. In an open-chest porcine model (n = 7), an accelerometer was attached to the pump casing of an implanted HeartWare HVAD. Pump vibration was analyzed by Fast Fourier Transform of the accelerometer signals, and the spectrogram third harmonic amplitude quantified and compared with pump power. Interventions included injection of thrombi into the left atrium (sized 0.3-0.4 ml, total n = 35) and control interventions; pump speed change, graft obstruction, and saline bolus injections (total n = 47). Graft flow to cardiac output ratio was used to estimate the expected number of thrombi passing through the pump. Sensitivity/specificity was assessed by receiver operating characteristic curve. Graft flow to cardiac output ratio averaged 66%. Twenty-six of 35 (74%) thrombi caused notable accelerometer signal change. Accelerometer third harmonic amplitude was significantly increased in thromboembolic interventions compared with control interventions, 64.5 (interquartile range [IQR]: 18.8-107.1) and 5.45 (IQR: 4.2-6.6), respectively (p < 0.01). The corresponding difference in pump power was 3 W (IQR: 2.9-3.3) and 2.8 W (IQR: 2.4-2.9), respectively (p < 0.01). Sensitivity/specificity of the accelerometer and pump power to detect thromboembolic events was 0.74/1.00 (area under the curve [AUC]: 0.956) and 0.40/1.00 (AUC: 0.759), respectively. Persistent high third harmonic amplitude was evident at end of all experiments, and pump thrombosis was confirmed by visual inspection. The findings demonstrate that accelerometer-based detection of thromboembolic events and pump thrombosis is feasible in vivo and that the method is superior to detection based on pump power.

Induction Of Labor Among Singleton Pregnancies In Six Palestinian Governmental Hospitals: A Population-Based Cohort Study.

OBJECTIVE: To explore rates and review practices regarding induction of labor (IOL) among singleton pregnancies in Palestine. DESIGN: A prospective population-based cohort study. SETTING: Six secondary and tertiary governmental hospitals located in the two regions of Palestine: West Bank and Gaza. PARTICIPANTS: Singleton pregnancies who had IOL in participating units during the study period were included (n=8290). Women having multiple gestations (1004), planned cesarean births (703), those admitted with cervical dilation >6cm (11228), and pregnancies with no record of cervical dilation and/or gestational age on admission (219) were excluded. PRIMARY OUTCOME MEASURE: Rates of IOL in participating units and regions. RESULTS: There were a total of 33,402 singleton births during the study period with an IOL rate of 24.8%. Rates of IOL significantly varied between units, ranging from 12.9% to 45.6% (P-value <0.05). The majority of women with no previous uterine scar were induced at gestational ages ≤40 weeks where 43.8% were induced at 39-40 gestational weeks (29.9% multiparous; 13.9% nulliparous) and 17.7% were induced between 37 and 38 gestational weeks (11.9% multiparous; 5.8% nulliparous). CONCLUSION: Significant variations in IOL practices between Palestinian hospitals and regions suggest overuse of IOL among singleton pregnancies in some units with the majority of these being performed before 40 weeks' gestation. These findings indicate a gap between implementation of best evidence and current clinical practice.

Women's satisfaction with midwife-led continuity of care: an observational study in Palestine.

OBJECTIVES: A midwife-led continuity model of care had been implemented in the Palestinian governmental health system to improve maternal services in several rural areas. This study investigated if the model influenced women's satisfaction with care, during antenatal, intrapartum and postnatal period. DESIGN: An observational case-control design was used to compare the midwife-led continuity model of care with regular maternity care. PARTICIPANTS AND SETTING: Women with singleton pregnancies, who had registered for antenatal care at a rural governmental clinic in the West Bank, were between 1 to 6 months after birth invited to answer a questionnaire rating satisfaction with care in 7-point Likert scales. PRIMARY OUTCOME: The mean sum-score of satisfaction with care through the continuum of antenatal, intrapartum and postnatal period, where mean sum-scores range from 1 (lowest) to 7 (highest). SECONDARY OUTCOME: Exclusive breastfeeding. RESULTS: Two hundred women answered the questionnaire, 100 who received the midwife-led model and 100 who received regular care. The median time point of interview were 16 weeks postpartum in both groups. The midwife-led model was associated with a statistically significant higher satisfaction with care during antenatal, intrapartum and postnatal period, with a mean sum-score of 5.2 versus 4.8 in the group receiving regular care. The adjusted mean difference between the groups' sum-score of satisfaction with care was 0.6 (95% CI 0.35 to 0.85), p<0.0001. A statistically significant higher proportion of women who received the midwife-led continuity model of care were still exclusively breastfeeding at the time point of interview, 67% versus 46% in the group receiving regular care, an adjusted OR of 2.56 (1.35 to 4.88) p=0.004. CONCLUSIONS: There is an association between receiving midwife-led continuity of care and increased satisfaction with care through the continuum of pregnancy, intrapartum and postpartum period, and an increased duration of exclusive breastfeeding. TRIAL REGISTRATION NUMBER: NCT03863600.

Sepsis causes right ventricular myocardial inflammation independent of pulmonary hypertension in a porcine sepsis model.

INTRODUCTION: Right ventricular (RV) myocardial dysfunction is a common feature in septic shock. It can worsen outcome, but the etiology is poorly understood. Pulmonary artery hypertension (PAH) plays a part in the pathogenesis of the right heart dysfunction in sepsis but its importance is unknown. In pigs, PAH in sepsis is substantial and the translational value of porcine sepsis models therefore questioned. We hypothesized that porcine sepsis causes a myocardial inflammatory response which leads to myocardial dysfunction independent of PAH. MATERIALS AND METHODS: Sepsis was induced by Escherichia coli-infusion in 10 pigs resulting in PAH and increased right ventricular pressure (RVP). The same degree of RVP was achieved by external pulmonary artery banding (PAB) in a consecutive series of 6 animals. RESULTS: Sepsis, but not PAB, led to increase in endothelial damage marker PAI-1 and cytokines TNF and IL-6 (all p<0.05) in plasma. In myocardium, TNF and IL-6 were significantly elevated in sepsis, TNF in both ventricles and IL-6 mostly in RV, while IL-1ß, IL-18 and C5a were significantly higher in RV compared to LV after PAB (all p<0.05). Myocardial mRNA levels of IL-1ß, IL-6, IL-18, IP-10, E-selectin and PAI-1 were significantly elevated in RV and LV during sepsis compared to PAB, while Caspase-1 was decreased in septic compared to PAB animals (all p<0.05). Cathepsin L activity was increased in RV by PAB, while sepsis inhibited this response. Escherichia coli-induced sepsis caused myocardial inflammation independent of PAH. CONCLUSION: Prominent PAH should therefore not exclude porcine sepsis models to further our understanding of human sepsis.

Improving Maternal and Neonatal Health by a Midwife-led Continuity Model of Care - An Observational Study in One Governmental Hospital in Palestine.

BACKGROUND: From 2013 a midwife-led continuity model of care was implemented in the Nablus region in occupied Palestine, involving a governmental hospital and ten rural villages. This study analysed the relation between the midwife-led model and maternal and neonatal health outcomes. METHOD: A register-based, retrospective cohort design was used, involving 2201 singleton births between January 2016 and June 2017 at Nablus governmental hospital. Data from rural women, with singleton pregnancies and mixed risk status, who either lived in villages that offered the midwife-led continuity model and had registered at the governmental clinic, or who lived in villages without the midwife-led model and received regular care, were compared. Primary outcome was unplanned caesarean section. Secondary outcomes were other modes of birth, postpartum anaemia, preterm birth, birth weight, and admission to neonatal intensive care unit. FINDINGS: Statistically significant less women receiving the midwife-led model had unplanned caesarean sections, 12·8% vs 15·9%, adjusted risk ratio (aRR) 0·80 (95% CI 0·64-0·99) and postpartum anaemia,19·8% vs 28·6%, aRR 0·72 (0·60-0·85). There was also a statistically significant lower rate of preterm births within the exposed group, 13·1% vs 16·8, aRR 0·79 (0·63-0·98), admission to neonatal intensive care unit, 7·0% vs 9·9%, aRR 0·71 (0·52-0·98) and newborn with birth weight 1500 g and less, 0·1% vs 1·1%, aRR 0·13 (0·02-0·97). INTERPRETATION: Receiving the midwife-led continuity model of care in Palestine was associated with several improved maternal and neonatal health outcomes. The findings support further implementation of the model. Implementation research, including randomised studies, would be useful to further investigate the effect and feasibility of the model in a low resource setting. FUNDING: This study was partly funded by the Research Council of Norway through the Global Health and Vaccination Program (GLOBVAC), project number 243706. The implementation received public funding through Norwegian Aid Committee (NORWAC).

Impact of animated instruction on tablets and hands-on training in applying bimanual perineal support on episiotomy rates: an intervention study.

INTRODUCTION AND HYPOTHESIS: In Palestine, episiotomy is frequently used among primiparous women.This study assesses the effect of training birth attendants in applying bimanual perineal support during delivery by either animated instruction on tablets or hands-on training on episiotomy rates among primiparous women. METHODS: An interventional cohort study was performed from 15 October 2015 to 31 January 2017, including all primiparous women with singletons and noninstrumental vaginal deliveries at six Palestinian hospitals. Intervention 1 (animated instructions on tablets) was conducted in Hospitals 1, 2, 3, and 4. Intervention 2 (bedside hands-on training) was applied in Hospitals 1 and 2 only. Hospitals 5 and 6 did not receive interventions. Differences in episiotomy rates in intervention and nonintervention hospitals were assessed before and after the interventions and presented as p values using chi-square test, and odds ratios (OR) with 95% confidence intervals (CI). Differences in the demographic and obstetric characteristics were presented as p values using the Kruskal-Wallis test. RESULTS: Of 46,709 women, 12,841 were included. The overall episiotomy rate in the intervention hospitals did not change significantly after intervention 1, from 63.1 to 62.1% (OR = 0.96, 95% CI 0.84-1.08), but did so after intervention 2, from 61.1 to 38.1% (OR = 0.39, 95% CI 0.33-0.47). Rates after Intervention 2 changed from 65.0 to 47.3% (OR = 0.52, 95% CI 0.40-0.67) in Hospital 1 and from 39.4 to 25.1% (OR = 0.49, 95% CI 0.35-0.68) in Hospital 2. CONCLUSIONS: Hands-on training of bimanual perineal support during delivery of primiparous women was significantly more effective in reducing episiotomy rates than animated instruction videos alone.

Evaluation of Accuracy of Episiotomy Incision in a Governmental Maternity Unit in Palestine: An Observational Study.

Episiotomy should be cut at certain internationally set criteria to minimize risk of obstetric anal sphincter injuries (OASIS) and anal incontinence. The aim of this study was to assess the accuracy of cutting right mediolateral episiotomy (RMLE). An institution-based prospective cohort study was undertaken in a Palestinian maternity unit from February 1, to December 31, 2016. Women having vaginal birth at gestational weeks ≥24 or birthweight ≥1000 g and with intended RMLE were eligible (n=240). Transparent plastic films were used to trace sutured episiotomy in relation to the midline within 24-hour postpartum. These were used to measure incisions' distance from midline, and suture angles were used to classify the incisions into RMLE, lateral, and midline episiotomy groups. Clinical characteristics and association with OASIS were compared between episiotomy groups. A subanalysis by profession (midwife or trainee doctor) was done. Less than 30% were RMLE of which 59% had a suture angle of <40° (equivalent to an incision angle of <60°). There was a trend of higher OASIS rate, but not statistically significant, in the midline (16%, OR: 1.7, CI: 0.61-4.5) and unclassified groups (16.5%, OR: 1.8, CI: 0.8-4.3) than RMLE and lateral groups (10%). No significant differences were observed between episiotomies cut by doctors and midwives. Most of the assessed episiotomies lacked the agreed criteria for RMLE and had less than optimal incision angle which increases risk of severe complications. A well-structured training program on how to cut episiotomy is recommended.

Impact of electronic and blended learning programs for manual perineal support on incidence of obstetric anal sphincter injuries: a prospective interventional study.

BACKGROUND: Obstetric anal sphincter injuries (OASIS) are associated with anal incontinence, dyspareunia and perineal pain. Bimanual perineal support technique (bPST) prevents OASIS. The aim of this study was to assess the effect of two different bPST training-methods on OASIS incidence. METHODS: This is a prospective-interventional quality improvement study conducted in two Palestinian maternity units between June 1 2015 and December 31 2016. Women having spontaneous or operative vaginal-delivery at ≥24 gestational-weeks or a birthweight of ≥1000 g (n = 1694) were recruited and examined vaginally and rectally immediately after vaginal birth by a trained assessor. Data on baseline OASIS incidence were collected during Phase-1 of the study. Subsequently, birth attendants in both maternity units were trained in bPST using two training modalities. A self-directed electronic-learning (e-learning) using an animated video was launched in phase-2 followed by a blended learning method (the animated e-learning video+ structured face-to-face training) in phase-3. OASIS incidence was monitored during phases-2 and 3. Variations in OASIS incidence between the three phases were assessed using Pearson-χ2-test (or Fisher's-Exact-test). The impact of each training-method on OASIS incidence was assessed using logistic-regression analysis. RESULTS: A total of 1694 women were included; 376 in phase-1, 626 in phase-2 and 692 in phase-3. Compared to Phase-1, OASIS incidence was reduced by 45% (12.2 to 6.7%, aOR: 0.56, CI; 0.35-0.91, p = 0.018) and 74% (12.2 to 3.2%, aOR, 0.29, CI; 0.17-0.50, p < 0.001) in phases-2 and 3, respectively. There was also a significant reduction in OASIS incidence by 52% from phase-2 to phase-3 (6.7% (42/626) to 3.2% (22/692), p = 0.003). These reductions reached statistical significance among parous-women only (aOR: 0.18, CI; 0.07-0.49, p = 0.001) after the first training method tested in phase-2. However, the reduction was significant among both primiparous (aOR: 0.39, CI; 0.21-0.74, p = 0.004) and parous-women (aOR: 0.11, CI; 0.04-0.32, p < 0.001) after implementing the blended learning method in phase-3. CONCLUSION: The animated e-learning video had a positive impact on reducing OASIS incidence. However, this reduction was enhanced by the use of a blended learning program combining both e- learning and face-to-face training modalities. STUDY REGISTRATION NUMBER: ClinicalTrialo.gov identifier: NCT02427854 , date: 28 April 2015.