The ISTH-BAT score and outcomes after endometrial ablation in women with heavy menstrual bleeding

BACKGROUND: The International Society on Thrombosis and Haemostasis bleeding assessment tool (ISTH-BAT), is used during the diagnostic workup of bleeding disorders. Data on ISTH-BAT scores in women with heavy menstrual bleeding (HMB) undergoing endometrial ablation (EA) could be essential in optimizing HMB counselling. OBJECTIVE: To investigate the postsurgical incidence of amenorrhea, dysmenorrhea, quality of life, re-intervention after EA, and ISTH-BAT score. METHODS: This study included women who have undergone EA because of HMB. During a follow-up of 2 to 5 years, ISTH-BAT, pictorial blood assessment chart (PBAC), and Short Form-36 survey (SF-36) were administered. At 10 years of follow-up surgical re-interventions were evaluated. RESULTS: Seventy-one women were included of whom 77% (n = 55) had an ISTH-BAT score < 6, versus 23% (n = 16) ISTH-BAT score =6 (mean age 46.3 versus 42.3, p = 0.004). In the ISTH-BAT =6 group versus < 6 group, amenorrhea occurred in 63% (10/16) versus 82% (45/55) (p = 0.111), dysmenorrhea in 38% (6/16) versus 18% (10/55) (p = 0.111), and surgical re-intervention in 19% (3/16) versus 25% (14/55) (p = 0.582). SF-36 item (Bodily) pain was lower in the ISTH-BAT =6 group versus < 6 (median score 58.7 vs. 80.0, p = 0.104). CONCLUSIONS: An ISTH-BAT score =6 may be related to a lower amenorrhea incidence and higher dysmenorrhea rate after EA

Reliability of IMU-Based Gait Assessment in Clinical Stroke Rehabilitation

Background: Gait is often impaired in people after stroke, restricting personal independence and affecting quality of life. During stroke rehabilitation, walking capacity is conventionally assessed by measuring walking distance and speed. Gait features, such as asymmetry and variability, are not routinely determined, but may provide more specific insights into the patient’s walking capacity. Inertial measurement units offer a feasible and promising tool to determine these gait features. Objective: We examined the test–retest reliability of inertial measurement units-based gait features measured in a two-minute walking assessment in people after stroke and while in clinical rehabilitation. Method: Thirty-one people after stroke performed two assessments with a test–retest interval of 24 h. Each assessment consisted of a two-minute walking test on a 14-m walking path. Participants were equipped with three inertial measurement units, placed at both feet and at the low back. In total, 166 gait features were calculated for each assessment, consisting of spatio-temporal (56), frequency (26), complexity (63), and asymmetry (14) features. The reliability was determined using the intraclass correlation coefficient. Additionally, the minimal detectable change and the relative minimal detectable change were computed. Results: Overall, 107 gait features had good–excellent reliability, consisting of 50 spatio-temporal, 8 frequency, 36 complexity, and 13 symmetry features. The relative minimal detectable change of these features ranged between 0.5 and 1.5 standard deviations. Conclusion: Gait can reliably be assessed in people after stroke in clinical stroke rehabilitation using three inertial measurement units

Reliability and Feasibility of the Self-Administered ISTH-Bleeding Assessment Tool

Introduction  Standardized bleeding assessment tools (BATs), such as the International Society for Thrombosis and Hemostasis (ISTH)-BAT, are screening instruments used during the diagnostic workup of suspected bleeding disorders. A self-administered ISTH-BAT (self-BAT) would enhance screening and save time during an outpatient clinic visit. Aim  This study was aimed to investigate the reliability and feasibility of the self-BAT. Methods  The electronic self-BAT was created from the ISTH-BAT and paper-version of self-BAT and optimized by patients and physicians. Patients with a (suspected) congenital platelet defect (CPD), who had previously undergone physician-administered ISTH-BAT assessment, were invited to complete the self-BAT. Optimal self-BAT cut-off values to detect a bleeding tendency, as defined by the ISTH-BAT, were evaluated by receiver operator characteristic (ROC) curve analysis to reach a sensitivity ≥95%. Reliability was tested by assessing sensitivity, specificity, and intraclass correlation (ICC). Feasibility was evaluated on comprehension and length of self-BAT. Results  Both versions of the BAT were completed by 156 patients. Optimal cut-off values for self-BAT to define a bleeding tendency were found to be identical to those of the ISTH-BAT. Normal/abnormal scores of the ISTH-BAT and self-BAT were agreed in 88.5% (138/156, 95% confidence interval [CI]: 0.83-0.93) of patients. The sensitivity and specificity of the self-BAT to detect a bleeding tendency were 96.9 and 48.1%, respectively. The ICC was 0.73. Self-BAT questions were graded by 96.8% (151/156) as "very easy," "easy," and "satisfactory" and questionnaire length as "exactly right" by 91% (142/156) of patients. Conclusion  In patients with a (suspected) CPD, the self-BAT is sufficiently reliable and feasible to detect a bleeding tendency, which supports its use as a screening tool

Strategies for intrapartum foetal surveillance in low- and middle-income countries : A systematic review

METHODS AND FINDINGS: The review was registered with Prospero (CRD42016038679). Five databases were searched up to May 1st, 2016 for studies related to intrapartum foetal monitoring strategies and neonatal outcomes in low-resource settings. Two authors extracted data and assessed the risk of bias for each study. The outcomes were narratively synthesised. Strengths, weaknesses, opportunities and threats analysis (SWOT) was conducted for each monitoring technique to analyse their implementation. There were 37 studies included: five intervention and 32 observational studies. Use of the partograph improved perinatal outcomes. Intermittent auscultation with Pinard was associated with lowest rates of caesarean sections (10-15%) but with comparable perinatal outcomes to hand-held Doppler and Cardiotocography (CTG). CTG was associated with the highest rates of caesarean sections (28-34%) without proven benefits for perinatal outcome. Several tests on admission (admission tests) and adjunctive tests including foetal stimulation tests improved the accuracy of foetal heart rate monitoring in predicting adverse perinatal outcomes. CONCLUSIONS: From the available evidence, the partograph is associated with improved perinatal outcomes and is recommended for use with intermittent auscultation for intrapartum monitoring in low resource settings. CTG is associated with higher caesarean section rates without proven benefits for perinatal outcomes, and should not be recommended in low-resource settings. High-quality evidence considering implementation barriers and enablers is needed to determine the optimal foetal monitoring strategy in low-resource settings. BACKGROUND: The majority of the five million perinatal deaths worldwide take place in low-resource settings. In contrast to high-resource settings, almost 50% of stillbirths occur intrapartum. The aim of this study was to synthesise available evidence of strategies for foetal surveillance in low-resource settings and associated neonatal and maternal outcomes, including barriers to their implementation

Strategies for intrapartum foetal surveillance in low- and middle-income countries : A systematic review

METHODS AND FINDINGS: The review was registered with Prospero (CRD42016038679). Five databases were searched up to May 1st, 2016 for studies related to intrapartum foetal monitoring strategies and neonatal outcomes in low-resource settings. Two authors extracted data and assessed the risk of bias for each study. The outcomes were narratively synthesised. Strengths, weaknesses, opportunities and threats analysis (SWOT) was conducted for each monitoring technique to analyse their implementation. There were 37 studies included: five intervention and 32 observational studies. Use of the partograph improved perinatal outcomes. Intermittent auscultation with Pinard was associated with lowest rates of caesarean sections (10-15%) but with comparable perinatal outcomes to hand-held Doppler and Cardiotocography (CTG). CTG was associated with the highest rates of caesarean sections (28-34%) without proven benefits for perinatal outcome. Several tests on admission (admission tests) and adjunctive tests including foetal stimulation tests improved the accuracy of foetal heart rate monitoring in predicting adverse perinatal outcomes. CONCLUSIONS: From the available evidence, the partograph is associated with improved perinatal outcomes and is recommended for use with intermittent auscultation for intrapartum monitoring in low resource settings. CTG is associated with higher caesarean section rates without proven benefits for perinatal outcomes, and should not be recommended in low-resource settings. High-quality evidence considering implementation barriers and enablers is needed to determine the optimal foetal monitoring strategy in low-resource settings. BACKGROUND: The majority of the five million perinatal deaths worldwide take place in low-resource settings. In contrast to high-resource settings, almost 50% of stillbirths occur intrapartum. The aim of this study was to synthesise available evidence of strategies for foetal surveillance in low-resource settings and associated neonatal and maternal outcomes, including barriers to their implementation

Voriconazole exposure is influenced by inflammation: A population pharmacokinetic model.

BackgroundVoriconazole is an antifungal drug used for the treatment of invasive fungal infections. Due to highly variable drug exposure, therapeutic drug monitoring (TDM) has been recommended. TDM may be helpful to predict exposure accurately, but covariates, such as severe inflammation, that influence the metabolism of voriconazole have not been included in the population pharmacokinetic (popPK) models suitable for routine TDM.ObjectivesTo investigate whether the effect of inflammation, reflected by C-reactive protein (CRP), could improve a popPK model that can be applied in clinical care.Patients and methodsData from two previous studies were included in the popPK modelling. PopPK modelling was performed using Edsim++. Different popPK models were compared using Akaike Information Criterion and goodness-of-fit plots.ResultsIn total, 1060 voriconazole serum concentrations from 54 patients were included in this study. The final model was a one-compartment model with non-linear elimination. Only CRP was a significant covariate, and was included in the final model and found to affect the maximum rate of enzyme activity (Vmax). For the final popPK model, the mean volume of distribution was 145 L [coefficient of variation percentage (CV%)=61%], mean Michaelis-Menten constant was 5.7 mg/L (CV%=119%), mean Vmax was 86.4 mg/h (CV%=99%) and mean bioavailability was 0.83 (CV%=143%). Internal validation using bootstrapping resulted in median values close to the population parameter estimates.ConclusionsThis one-compartment model with non-linear elimination and CRP as a covariate described the pharmacokinetics of voriconazole adequately

A qualitative study on the experiences of haemophilia carriers before, during and after pregnancy

Introduction: Haemophilia carriers (HCs) face considerable haemostatic and psychological challenges during reproduction. Aim: To explore the perspectives of HCs on healthcare in the current standard of haemophilia treatment during all reproductive phases: preconception, pregnancy, childbirth and the postpartum period. In addition, we examined the psychological impact of haemophilia during these phases. Material and methods: Focus group discussions (FGDs) and semi-structured interviews were conducted with HCs in January/February 2020 until data saturation was reached. All sessions were recorded, transcribed verbatim and analysed by two independent researchers through thematic content analysis using MAXQDA® software. The results were then discussed within the research team until consensus was reached. The constructed themes were shared with and reviewed by the HCs. Results: Fifteen HCs were included in three FGDs and four interviews. Five central themes were constructed: (1) communication by healthcare professionals, (2) lack of knowledge, (3) feeling insecure, (4) autonomy and (5) family experiences with haemophilia. Desired improvements in care mainly concerned counselling during preconception and pregnancy. This included timely access to comprehensive information during each consecutive phase, acceptance of HCs’ choices by healthcare providers and healthcare tailored to the HC's family experience with haemophilia. Conclusions: In recent years, haemophilia treatment has seen major advances, which could impact general and reproductive care for HCs. HCs indicated that reproductive care would benefit from a more personal and informative approach. Healthcare professionals could use these insights to adapt their consultations to meet the needs of these women when they are preparing for having children

Delphi consensus statement on intrapartum fetal monitoring in low-resource settings

OBJECTIVE: To determine acceptable and achievable strategies of intrapartum fetal monitoring in busy low-resource settings. METHODS: Three rounds of online Delphi surveys were conducted between January 1 and October 31, 2017. International experts with experience in low-resource settings scored the importance of intrapartum fetal monitoring methods. RESULTS: 71 experts completed all three rounds (28 midwives, 43 obstetricians). Consensus was reached on (1) need for an admission test, (2) handheld Doppler for intrapartum fetal monitoring, (3) intermittent auscultation (IA) every 30 minutes for low-risk pregnancies during the first stage of labor and after every contraction for high-risk pregnancies in the second stage, (4) contraction monitoring hourly for low-risk pregnancies in the first stage, and (5) adjunctive tests. Consensus was not reached on frequency of IA or contraction monitoring for high-risk women in the first stage or low-risk women in the second stage of labor. CONCLUSION: There is a gap between international recommendations and what is physically possible in many labor wards in low-resource settings. Research on how to effectively implement the consensus on fetal assessment at admission and use of handheld Doppler during labor and delivery is crucial to support staff in achieving the best possible care in low-resource settings

Population Pharmacokinetic Modelling and Limited Sampling Strategies for Therapeutic Drug Monitoring of Pyrazinamide in Patients with Tuberculosis

Pyrazinamide is one of the first-line antituberculosis drugs. The efficacy of pyrazinamide is associated with the ratio of 24-h area under the concentration–time curve (AUC24) to MIC. The objective of this study was to develop and validate a limited sampling strategy (LSS) based on a population pharmacokinetic (popPK) model to predict AUC24. A popPK model was developed using an iterative two-stage Bayesian procedure and was externally validated. Using data from 20 treatment-naive adult tuberculosis (TB) patients, a one compartment model with transit absorption and first-order elimination best described pyrazinamide pharmacokinetics and fed state was the only significant covariate for absorption rate constant (ka). External validation, using data from 26 TB patients, showed that the popPK model predicted AUC24 with a slight underestimation of 2.1%. LSS were calculated using Monte Carlo simulation (n = 10,000). External validation showed LSS with time points 0 h, 2 h, and 6 h performed best with RMSE of 9.90% and bias of 0.06%. Food slowed absorption of pyrazinamide, but did not affect bioavailability, which may be advantageous in case of nausea or vomiting in which food can be used to diminish these effects. In this study, we successfully developed and validated a popPK model and LSS, using 0 h, 2 h, and 6 h postdose samples, that could be used to perform therapeutic drug monitoring (TDM) of pyrazinamide in TB patients