Antihistamine use during breastfeeding with focus on breast milk transfer and safety in humans - a systematic literature review.

Current data on use of antihistamines during breastfeeding and risks to the breastfed infant are insufficient. The aim of this systematic review was to provide an overview of studies measuring the levels of antihistamines in human breast milk, estimating the exposure for breastfed infants, and/or reporting possible adverse effects on the breastfed infant. An additional aim was to review the antihistamine product labels available in EU and the US. We searched seven online databases and identified seven human lactation studies that included 25 mother-infant pairs covering cetirizine, clemastine, ebastine, epinastine, loratadine, terfenadine and triprolidine. In addition, one study investigated the impact of chlorpheniramine or promethazine on prolactin levels among 17 women, and one study investigated possible adverse drug reactions in 85 breastfed infants exposed to various antihistamines. The relative infant dose was below 5% for all antihistamines, ranging from 0.3% for terfenadine to 4.5% for clemastine. Most product labels of the ten antihistamines with available information in both EU and the US, reported lack of evidence and recommended to avoid use during breastfeeding. The knowledge gap on antihistamines and lactation is extensive, and further human studies are warranted to ensure optimal treatment of breastfeeding women with allergy

Robust estimation of bacterial cell count from optical density

Optical density (OD) is widely used to estimate the density of cells in liquid culture, but cannot be compared between instruments without a standardized calibration protocol and is challenging to relate to actual cell count. We address this with an interlaboratory study comparing three simple, low-cost, and highly accessible OD calibration protocols across 244 laboratories, applied to eight strains of constitutive GFP-expressing E. coli. Based on our results, we recommend calibrating OD to estimated cell count using serial dilution of silica microspheres, which produces highly precise calibration (95.5% of residuals <1.2-fold), is easily assessed for quality control, also assesses instrument effective linear range, and can be combined with fluorescence calibration to obtain units of Molecules of Equivalent Fluorescein (MEFL) per cell, allowing direct comparison and data fusion with flow cytometry measurements: in our study, fluorescence per cell measurements showed only a 1.07-fold mean difference between plate reader and flow cytometry data

Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study

Funder: European Society of Intensive Care Medicine; doi: http://dx.doi.org/10.13039/501100013347Funder: Flemish Society for Critical Care NursesAbstract: Purpose: Intensive care unit (ICU) patients are particularly susceptible to developing pressure injuries. Epidemiologic data is however unavailable. We aimed to provide an international picture of the extent of pressure injuries and factors associated with ICU-acquired pressure injuries in adult ICU patients. Methods: International 1-day point-prevalence study; follow-up for outcome assessment until hospital discharge (maximum 12 weeks). Factors associated with ICU-acquired pressure injury and hospital mortality were assessed by generalised linear mixed-effects regression analysis. Results: Data from 13,254 patients in 1117 ICUs (90 countries) revealed 6747 pressure injuries; 3997 (59.2%) were ICU-acquired. Overall prevalence was 26.6% (95% confidence interval [CI] 25.9–27.3). ICU-acquired prevalence was 16.2% (95% CI 15.6–16.8). Sacrum (37%) and heels (19.5%) were most affected. Factors independently associated with ICU-acquired pressure injuries were older age, male sex, being underweight, emergency surgery, higher Simplified Acute Physiology Score II, Braden score 3 days, comorbidities (chronic obstructive pulmonary disease, immunodeficiency), organ support (renal replacement, mechanical ventilation on ICU admission), and being in a low or lower-middle income-economy. Gradually increasing associations with mortality were identified for increasing severity of pressure injury: stage I (odds ratio [OR] 1.5; 95% CI 1.2–1.8), stage II (OR 1.6; 95% CI 1.4–1.9), and stage III or worse (OR 2.8; 95% CI 2.3–3.3). Conclusion: Pressure injuries are common in adult ICU patients. ICU-acquired pressure injuries are associated with mainly intrinsic factors and mortality. Optimal care standards, increased awareness, appropriate resource allocation, and further research into optimal prevention are pivotal to tackle this important patient safety threat

Correction to: Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study

The original version of this article unfortunately contained a mistake

Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study

Funder: European Society of Intensive Care Medicine; doi: http://dx.doi.org/10.13039/501100013347Funder: Flemish Society for Critical Care NursesAbstract: Purpose: Intensive care unit (ICU) patients are particularly susceptible to developing pressure injuries. Epidemiologic data is however unavailable. We aimed to provide an international picture of the extent of pressure injuries and factors associated with ICU-acquired pressure injuries in adult ICU patients. Methods: International 1-day point-prevalence study; follow-up for outcome assessment until hospital discharge (maximum 12 weeks). Factors associated with ICU-acquired pressure injury and hospital mortality were assessed by generalised linear mixed-effects regression analysis. Results: Data from 13,254 patients in 1117 ICUs (90 countries) revealed 6747 pressure injuries; 3997 (59.2%) were ICU-acquired. Overall prevalence was 26.6% (95% confidence interval [CI] 25.9–27.3). ICU-acquired prevalence was 16.2% (95% CI 15.6–16.8). Sacrum (37%) and heels (19.5%) were most affected. Factors independently associated with ICU-acquired pressure injuries were older age, male sex, being underweight, emergency surgery, higher Simplified Acute Physiology Score II, Braden score 3 days, comorbidities (chronic obstructive pulmonary disease, immunodeficiency), organ support (renal replacement, mechanical ventilation on ICU admission), and being in a low or lower-middle income-economy. Gradually increasing associations with mortality were identified for increasing severity of pressure injury: stage I (odds ratio [OR] 1.5; 95% CI 1.2–1.8), stage II (OR 1.6; 95% CI 1.4–1.9), and stage III or worse (OR 2.8; 95% CI 2.3–3.3). Conclusion: Pressure injuries are common in adult ICU patients. ICU-acquired pressure injuries are associated with mainly intrinsic factors and mortality. Optimal care standards, increased awareness, appropriate resource allocation, and further research into optimal prevention are pivotal to tackle this important patient safety threat

Use of Decision Support Tools to Empower Pregnant Women: Systematic Review

Background Women face many health-related decisions during pregnancy. Digitalization, new technology, and a greater focus on empowering patients have driven the development of patient-centered decision support tools. Objective This systematic review provides an overview of studies investigating the effect of patient-centered decision support tools for pregnant women. Methods We searched 5 online databases, MEDLINE, EMBASE, Web of Science, PsycINFO, and Scopus, from inception to December 1, 2019. Two independent researchers screened titles, abstracts, and full-texts against the inclusion criteria. All studies investigating the effect of patient-centered decision support tools for health-related issues among pregnant women were included. Study characteristics and results were extracted using the review management tool Rayyan and analyzed according to topic, type of decision support tools, control group, outcome measurements, and results. Results The 25 eligible studies covered a range of health topics, including prenatal screening (n=10), gestational diabetes and weight gain (n=7), lifestyle (n=3), blood pressure and preeclampsia (n=2), depression (n=1), asthma (n=1), and psychological well-being (n=1). In general, the use of decision support tools increased women's knowledge, and recording symptoms enhanced satisfaction with maternity care. Conclusions The opportunities created by digitalization and technology should be used to develop innovative patient-centered decision support tools tailored to support pregnant women. Effect on clinical outcomes should be documented

The effect of a pharmacist consultation on pregnant women’s quality of life with a special focus on nausea and vomiting: an intervention study

Background Maternal wellbeing and quality of life (QOL) are increasingly being recognized as important for healthy pregnancies. The aim of this study was to investigate the impact of a pharmacist consultation on pregnant women’s QOL focusing on nausea and vomiting in pregnancy (NVP), and patient satisfaction. Methods For this intervention study in 14 community pharmacies, women in early pregnancy were recruited and assigned to a pharmacist consultation (intervention) or standard care (control). The consultation aimed to address each woman’s concerns regarding medications and pregnancy-related ailments. Data were collected through online questionnaires at baseline (Q1) and during the second trimester (Q2). The intervention group completed an additional satisfaction questionnaire after the consultation was completed. The primary outcome was the impact of the intervention on the Quality of Life Scale (QOLS) scores between the first and second trimesters. The impact of the intervention was assessed by linear regression, and secondary analyses were performed to assess effect modification by NVP. Results Of the 340 women enrolled in the study, we analyzed data for 245. Half (170/340) of the original participants were allocated to the intervention group, of whom 131 received the pharmacist consultation. Most women (75%, 78/96) reported that the consultation was useful to a large/very large extent. The consultation had no overall impact on QOLS scores between the first and the second trimesters compared with standard care (adjusted β: 0.7, 95% CI: -2.1, 3.4). The impact of the intervention on QOLS was greater amongst women with moderate/severe NVP (adjusted β: 3.6, 95% CI: -0.6, 7.7) compared to those with no/mild NVP (adjusted β: -1.4, 95% CI: -5.1, 2.2) (interaction term study group*NVP severity, p = 0.048). Conclusions The pregnant women highly appreciated the pharmacist consultation, but the intervention did not affect their QOL scores compared with standard care. Future studies should further explore the effect of a pharmacist consultation specifically for NVP and on other outcomes such as use of health care services and medication use in pregnancy. Trial registration Retrospectively registered in ClinicalTrials.gov (identifier: NCT04182750, registration date: December 2, 2019)

Impact of a Mobile Application for Tracking Nausea and Vomiting During Pregnancy (NVP) on NVP Symptoms, Quality of Life, and Decisional Conflict Regarding NVP Treatments: MinSafeStart Randomized Controlled Trial

Background: Pregnant women are active users of mobile apps for health purposes. These apps may improve self-management of health-related conditions. Up to 70% of pregnant women experience nausea and vomiting (NVP). Even mild NVP can significantly reduce quality of life (QoL), and it can become an economic burden for both the woman and society. NVP often occurs before the first maternal care visit; therefore, apps can potentially play an important role in empowering pregnant women to recognize, manage, and seek appropriate treatment for NVP, when required. Objective: This study investigated whether the MinSafeStart (MSS) mobile app could impact NVP-related symptoms, QoL, and decisional conflict regarding NVP treatment. Methods: This randomized controlled trial enrolled 268 pregnant women with NVP in Norway from 2019 to 2020. The intervention group had access to the MSS app, which could be used to track NVP symptoms and access tailored advice. NVP severity was rated with the Pregnancy Unique Quantification of Emesis (PUQE) score. The control group followed standard maternal care. We collected data on maternal baseline characteristics, NVP severity, QoL, and decisional conflict using 2 sets of online questionnaires. One set of questionnaires was completed at enrollment, and the other was completed after 2 weeks. We performed linear regression analyses to explore whether the use of the MSS app was associated with NVP severity, QoL, or decisional conflict. Results: Among the 268 women enrolled in the study, 192 (86.5%) completed the baseline questionnaires and were randomized to either the intervention (n=89) or control group (n=103). In the intervention group, 88 women downloaded the app, and 468 logs were recorded. In both groups, women were enrolled at a median of 8 gestational weeks. At baseline, the average PUQE scores were 4.9 and 4.7; the average QoL scores were 146 and 149; and the average DCS scores were 40 and 43 in the intervention and control groups, respectively. The app had no impact on NVP severity (aβ 0.6, 95% Cl −0.1 to 1.2), QoL (aβ −5.3, 95% Cl −12.5 to 1.9), or decisional conflict regarding NVP treatment (aβ −1.1, 95% Cl −6.2 to 4.2), compared with standard care. Conclusions: Tracking NVP symptoms with the MSS app was not associated with improvements in NVP symptoms, QoL, or decisional conflict after 2 weeks, compared with standard care. Future studies should include a process evaluation to improve our understanding of how pregnant women use the app and how to optimize its utility within maternity care. Specifically, studies should focus on how digital tools might facilitate counseling and communication between pregnant women and health care providers regarding NVP management during pregnancy.publishedVersio

Community pharmacist counseling in early pregnancy—Results from the SafeStart feasibility study

Background: Community pharmacists are available to counsel women in early pregnancy, but no studies have assessed the feasibility of such a service. Objective: To test the feasibility of a pharmacist consultation in early pregnancy and to inform the design of a definitive trial. Setting: Six community pharmacies in Norway from Oct. to Dec. 2017. Method: We evaluated recruitment approaches and an automatic data preprocessing system (ADPS) to enroll, assign participants, and distribute questionnaires. Women (≥18 years) in early pregnancy were eligible for inclusion. Participants were assigned to a pharmacist consultation (intervention group) or standard care (control group). The intervention aimed to address each woman’s concerns and needs regarding medications and ailments in pregnancy, and was documented on a standard form. The women’s acceptability of the intervention was measured by a questionnaire. Main outcome measures: Appropriate recruitment approaches, workflow of the ADPS, and women’s acceptability of the intervention. Results: Of the 35 participants recruited, 19 were recruited through Facebook. The ADPS worked well. Treatment of nausea and vomiting (NVP) (10/11) and general information about medications (8/11) were frequently discussed during the consultations (n=11). The women reported high satisfaction with the consultation. Having the option of telephone and follow-up consultations was important to the women. Conclusion: It is feasible to provide community pharmacist consultations in early pregnancy. In a definitive study, the consultations should focus on NVP and general medication use and further explore social media as a recruiting tool. Both in-pharmacy and telephone consultations should be offered to deliver the intervention

Community pharmacist counseling in early pregnancy—Results from the SafeStart feasibility study

Background: Community pharmacists are available to counsel women in early pregnancy, but no studies have assessed the feasibility of such a service. Objective: To test the feasibility of a pharmacist consultation in early pregnancy and to inform the design of a definitive trial. Setting: Six community pharmacies in Norway from Oct. to Dec. 2017. Method: We evaluated recruitment approaches and an automatic data preprocessing system (ADPS) to enroll, assign participants, and distribute questionnaires. Women (≥18 years) in early pregnancy were eligible for inclusion. Participants were assigned to a pharmacist consultation (intervention group) or standard care (control group). The intervention aimed to address each woman’s concerns and needs regarding medications and ailments in pregnancy, and was documented on a standard form. The women’s acceptability of the intervention was measured by a questionnaire. Main outcome measures: Appropriate recruitment approaches, workflow of the ADPS, and women’s acceptability of the intervention. Results: Of the 35 participants recruited, 19 were recruited through Facebook. The ADPS worked well. Treatment of nausea and vomiting (NVP) (10/11) and general information about medications (8/11) were frequently discussed during the consultations (n=11). The women reported high satisfaction with the consultation. Having the option of telephone and follow-up consultations was important to the women. Conclusion: It is feasible to provide community pharmacist consultations in early pregnancy. In a definitive study, the consultations should focus on NVP and general medication use and further explore social media as a recruiting tool. Both in-pharmacy and telephone consultations should be offered to deliver the intervention