Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: a qualitative study of parents’ and health professionals’ views and experiences

Background: More effective recruitment strategies like alternative approaches to consent are needed to facilitate adequately powered trials. WithHolding Enteral feeds Around Transfusion (WHEAT) was a multicentre, randomised, pilot trial that compared withholding and continuing feeds around transfusion. The primary clinical outcome was necrotising enterocolitis (NEC). The trial used simplified opt-out consent with concise parent information and no consent form. Objective: To explore the views and experiences of parents and health professionals on the acceptability and feasibility of opt-out consent in randomised comparative effectiveness trials. Methods: A qualitative, descriptive interview-based study nested within a randomised trial. Semi-structured interview transcripts were analysed using inductive thematic analysis. Setting: Eleven neonatal units in England. Participants: Eleven parents and ten health professionals with experience of simplified consent. Results: Five themes emerged: ‘Opt-out consent operationalised as verbal opt-in consent’, ‘Opt-out consent normalises participation while preserving parental choice’, ‘Opt-out consent as an ongoing process of informed choice’, ‘Consent without a consent form’ and ‘Choosing to opt out of a comparative effectiveness trial’, with two subthemes: ‘Wanting “normal care”’ and ‘A belief that feeding is better’. Conclusions: Introducing a novel form of consent proved challenging in practice. The principle of simplified, opt-out approach to consent was generally considered feasible and acceptable by health professionals for a neonatal comparative effectiveness trial. The priority for parents was having the right to decide about trial participation, and they did not see opt-out consent as undermining this. Describing a study as ‘opt-out’ can help to normalise participation and emphasise that parents can withdraw consent

Prevalence and risk factors for postnatal mental health problems in mothers of infants admitted to neonatal care: Analysis of two population-based surveys in England

Background Previous research suggests that mothers whose infants are admitted to neonatal units (NNU) experience higher rates of mental health problems compared to the general perinatal population. This study examined the prevalence and factors associated with postnatal depression, anxiety, post-traumatic stress (PTS), and comorbidity of these mental health problems for mothers of infants admitted to NNU, six months after childbirth. Methods This was a secondary analysis of two cross-sectional, population-based National Maternity Surveys in England in 2018 and 2020. Postnatal depression, anxiety, and PTS were assessed using standardised measures. Associations between sociodemographic, pregnancy- and birth-related factors and postnatal depression, anxiety, PTS, and comorbidity of these mental health problems were explored using modified Poisson regression and multinomial logistic regression. Results Eight thousand five hundred thirty-nine women were included in the analysis, of whom 935 were mothers of infants admitted to NNU. Prevalence of postnatal mental health problems among mothers of infants admitted to NNU was 23.7% (95%CI: 20.6–27.2) for depression, 16.0% (95%CI: 13.4–19.0) for anxiety, 14.6% (95%CI: 12.2–17.5) for PTS, 8.2% (95%CI: 6.5–10.3) for two comorbid mental health problems, and 7.5% (95%CI: 5.7–10.0) for three comorbid mental health problems six months after giving birth. These rates were consistently higher compared to mothers whose infants were not admitted to NNU (19.3% (95%CI: 18.3–20.4) for depression, 14.0% (95%CI: 13.1–15.0) for anxiety, 10.3% (95%CI: 9.5–11.1) for PTS, 8.5% (95%CI: 7.8–9.3) for two comorbid mental health problems, and 4.2% (95%CI: 3.6–4.8) for three comorbid mental health problems six months after giving birth. Among mothers of infants admitted to NNU (N = 935), the strongest risk factors for mental health problems were having a long-term mental health problem and antenatal anxiety, while social support and satisfaction with birth were protective. Conclusions Prevalence of postnatal mental health problems was higher in mothers of infants admitted to NNU, compared to mothers of infants not admitted to NNU six months after giving birth. Experiencing previous mental health problems increased the risk of postnatal depression, anxiety, and PTS whereas social support and satisfaction with birth were protective. The findings highlight the importance of routine and repeated mental health assessments and ongoing support for mothers of infants admitted to NNU

The impact of the Covid-19 pandemic on postnatal anxiety and posttraumatic stress: Analysis of two population-based national maternity surveys in England

Background Few studies have evaluated postnatal anxiety and posttraumatic stress (PTS) before and during the Covid-19 pandemic using comparable data across time. We used data from two national maternity surveys in England to explore the impact of the pandemic on prevalence and risk factors for postnatal anxiety and PTS. Methods Analysis was conducted using population-based surveys carried out in 2018 (n = 4509) and 2020 (n = 4611). Weighted prevalence estimates for postnatal anxiety and PTS were compared across surveys. Adjusted risk ratios (aRR) were estimated for the association between risk factors and postnatal anxiety and PTS. Findings Prevalence of postnatal anxiety increased from 13.7 % in 2018 to 15.1 % in 2020 (+1.4 %(95%CI:-0.4–3.1)). Prevalence of postnatal PTS increased from 9.7 % in 2018 to 11.5 % in 2020 (+1.8 %(95%CI:0.3–3.4)), due to an increase in PTS related to birth trauma from 2.5 % to 4.3 % (+1.8 %(95%CI:0.9–2.6); there was no increase in PTS related to non-birth trauma. Younger age (aRR = 1.31–1.51), being born in the UK (aRR = 1.29–1.59), long-term physical or mental health problem(s) (aRR = 1.27–1.94), and antenatal anxiety (aRR = 1.97–2.22) were associated with increased risk of postnatal anxiety and PTS before and during the pandemic, whereas higher satisfaction with birth (aRR = 0.92–0.94) and social support (aRR = 0.81–0.82) were associated with decreased risk. Interpretation Prevalence of PTS was significantly higher during the pandemic, compared to before the pandemic, due to an increase in PTS related to birth trauma. Prevalence of postnatal anxiety was not significantly higher during the pandemic. Risk factors for anxiety and PTS were similar before and during the pandemic

Prevalence and factors associated with postpartum posttraumatic stress in a population-based maternity survey in England

Background: Studies on prevalence and factors associated with postpartum posttraumatic stress (PTS) typically do not distinguish between PTS related to childbirth (PTS-C) and PTS related to other stressors (PTS-O). This study aimed to describe the prevalence, clinical characteristics, and factors associated with PTS-C and PTS-O in postpartum women. Methods: The study was a cross-sectional population-based survey of 16,000 postpartum women, selected at random from birth registrations in England to receive a postal questionnaire, including the Primary Care Posttraumatic Stress Disorder Screen. Results: Questionnaires were returned by 4,509 women. The median age was 32 years (IQR=29-36), 64% were married, 77% were UK-born, and 76% were White-British. Prevalence of PTS-C was 2.5% (95%CI:2.0-3.0) and prevalence of PTS-O was 6.8% (95%CI:6.0-7.8). Women with PTS-C were significantly more likely to report re-experiencing symptoms (Chi-Square=7.69,p<0.01). Factors associated with PTS-C were: higher level of deprivation, not having a health professional to talk to about sensitive issues during pregnancy, and the baby being admitted for neonatal intensive care. Factors associated with PTS-O were: age ≤24 years, depression during pregnancy, and having a pregnancy affected by long-term health problems. Factors associated with both were: living without a partner, anxiety during pregnancy, pregnancy-specific health problems, and lower birth satisfaction. Conclusions: PTS during the postpartum period is relatively common and, for many women, unrelated to childbirth. Increased awareness among health professionals of prevalence, clinical characteristics and factors associated with postpartum PTS-C and PTS-O will aid the development of appropriate management protocols to identify and support women during the perinatal period

Salt and Water Retention Is Associated with Microinflammation and Endothelial Injury in Chronic Kidney Disease

BACKGROUND: Progressive chronic kidney disease (CKD) inevitably leads to salt and water retention and disturbances in the macro-and microcirculation. OBJECTIVES: We hypothesize that salt and water dysregulation in advanced CKD may be linked to inflammation and microvascular injury pathways. METHODS: We studied 23 CKD stage 5 patients and 11 healthy controls (HC). Tissue sodium concentration was assessed using 23Sodium magnetic resonance (MR) imaging. Hydration status was evaluated using bioimpedance spectroscopy. A panel of inflammatory and endothelial biomarkers was also measured. RESULTS: CKD patients had fluid overload (FO) when compared to HC (overhydration index: CKD = 0.5 ± 1.9 L vs. HC = -0.5 ± 1.0 L; p = 0.03). MR-derived tissue sodium concentrations were predominantly higher in the subcutaneous (SC) compartment (median [interquartile range] CKD = 22.4 mmol/L [19.4-31.3] vs. HC = 18.4 mmol/L [16.6-21.3]; p = 0.03), but not the muscle (CKD = 24.9 ± 5.5 mmol/L vs. HC = 22.8 ± 2.5 mmol/L; p = 0.26). Tissue sodium in both compartments correlated to FO (muscle: r = 0.63, p < 0.01; SC: rs = 0.63, p < 0.01). CKD subjects had elevated levels of vascular cell adhesion molecule (p < 0.05), tumor necrosis factor-alpha (p < 0.01), and interleukin (IL)-6 (p = 0.01) and lower levels of vascular endothelial growth factor-C (p = 0.04). FO in CKD was linked to higher IL-8 (r = 0.51, p < 0.05) and inversely associated to E-selectin (r = -0.52, p = 0.01). Higher SC sodium was linked to higher intracellular adhesion molecule (ICAM; rs = 0.54, p = 0.02). CONCLUSION: Salt and water accumulation in CKD appears to be linked with inflammation and endothelial activation pathways. Specifically IL-8, E-Selectin (in FO), and ICAM (in salt accumulation) may be implicated in the pathophysiology of FO and merit further investigation

Prevalence of anxiety and post-traumatic stress (PTS) among the parents of babies admitted to neonatal units: a systematic review and meta-analysis

Background Parents of babies admitted to neonatal units (NNU) are exposed to a range of potentially distressing experiences, which can lead to mental health symptoms such as increased anxiety and post-traumatic stress (PTS). This review aimed to describe how anxiety and PTS are defined and assessed, and to estimate anxiety and PTS prevalence among parents of babies admitted to NNU. Method Medline, Embase, PsychoINFO, Cumulative Index to Nursing and Allied Health literature were searched to identify studies published prior to April 14, 2021. Included studies were assessed using Hoy risk of bias tool. A random-effects model was used to estimate pooled prevalence with 95% CIs. Potential sources of variation were investigated using subgroup analyses and meta-regression. The review is registered with PROSPERO (CRD42020162935). Findings Fifty six studies involving 6,036 parents met the review criteria; 21 studies assessed anxiety, 35 assessed PTS, and 8 assessed both. The pooled prevalence of anxiety was 41.9% (95%CI:30.9, 53.0) and the pooled prevalence of PTS was 39.9% (95%CI:30.8, 48.9) among parents up to one month after the birth. Anxiety prevalence decreased to 26.3% (95%CI:10.1, 42.5) and PTS prevalence to 24.5% (95%CI:17.4, 31.6) between one month and one year after birth. More than one year after birth PTS prevalence remained high 27.1% (95%CI:20.7, 33.6). Data on anxiety at this time point were limited. There was high heterogeneity between studies and some evidence from subgroup and meta-regression analyses that study characteristics contributed to the variation in prevalence estimates. Interpretation The prevalence of anxiety and PTS was high among parents of babies admitted to NNU. The rates declined over time, although they remained higher than population prevalence estimates for women in the perinatal period. Implementing routine screening would enable early diagnosis and effective intervention. Funding This research is funded by the National Institute for Health Research (NIHR) Policy Research Programme, conducted through the Policy Research Unit in Maternal and Neonatal Health and Care, PR-PRU-1217-21202. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care