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A Protocol for the Development and Validation of the Postpartum Specific Anxiety Scale—Preterm Birth [PSAS‐PTB] and the Postpartum Specific Anxiety Scale—Neonatal Intensive Care Unit [PSAS‐NICU]
Get PDFObjectives
To describe the development and the methodology for validation of a new scale for postpartum anxiety for mothers of preterm infants, and a ‘Velcro’ sub‐scale of the Postpartum Specific Anxiety Scale for use with mothers who have had infants admitted to the Neonatal Intensive Care Unit.
Methods
We undertook three forms of iterative psychometric development: (1) Patient and public involvement and engagement discussions with key clinical, academic, and lay stakeholders to understand the needs for modifying the Postpartum Specific Anxiety Scale—Research Short Form for use in this population; (2) Expert panel ratings with clinical and academic stakeholders; and (3) Cognitive interviews with mothers to ensure items were relevant, comprehensive, and understandable. Planned studies must ensure the psychometric properties of these two new scales.
Results
Patient and Public Involvement and Engagement discussions identified clear avenues for modification of the PSAS‐RSF, but the need for an additional NICU‐specific scale was clear. Experts rated the new items highly on their relevance. Cognitive interviews further ensured that items were well understood and that meaning was being interpreted in the intended manner. Only minor changes to the scales were implemented after each change.
Conclusions
This is the first study to describe the process of developing and the subsequent proposed validation of postpartum‐specific tools for use with mothers of preterm infants and those with infants in the Neonatal Intensive Care Unit. Clear avenues have been identified for the validation and implementation of both measures
Antihypertensive therapy for pregnancy hypertension and implications for fetal and neonatal heart rate monitoring: A systematic review of randomized trials and observational studies
Get PDFIntroduction
Our objective was to evaluate whether antihypertensives affect fetal (FHR) or neonatal (neoHR) heart rate.
Material and methods
Electronic databases and clinical trial registers were searched to August 31, 2024. Eligibility included randomized (RCTs) or observational studies evaluating antihypertensives for pregnancy hypertension. Two reviewers independently assessed studies for inclusion and extracted data. Random effects meta‐analysis was used to determine risk ratios (RRs) and 95% confidence intervals (CIs). Network meta‐analysis was undertaken in a sensitivity analysis.
Results
Fifty‐four RCTs (n = 5736 pregnancies) and 28 observational studies (n = 2 283 855) reported FHR (usually visually‐interpreted) or neoHR (usually clinically‐assessed).
FHR: Non‐Severe Hypertension
Antihypertensives did not increase adverse FHR effects in RCTs of antihypertensives versus placebo/no therapy (RR = 1.08, 95% CI [0.62–1.89]; I2 = 43%; N = 10, n = 1567 pregnancies), antihypertensives versus methyldopa (RR = 1.40 [0.97–2.04]; I2 = 0%; N = 6, n = 515), or labetalol or pure beta‐blockers versus other antihypertensives (RR = 1.70 [0.96–2.99]; I2 = 30%; N = 5, n = 501). In observational studies, adverse FHR effects were more common with: labetalol versus methyldopa, nifedipine or Chinese herbal medication (RR = 2.17 [1.15–4.08]; I2 = 47%; N = 4, n = 664), and bendroflumethiazide versus metoprolol (but not hydralazine), but 95% CIs were wide.
FHR: Severe Hypertension
Antihypertensives had no FHR effects in RCTs of antihypertensives versus either: placebo/no therapy (RR = 0.43 [0.16–1.20]; I2 = 0%; N = 3, n = 242), hydralazine (RR = 0.71 [0.29–1.72]; I2 = 13%; N = 11, n = 727), or CCBs (RR = 0.52 [0.12–2.16]; I2 = 0%, N = 9, n = 1675). In observational studies, there was no difference for labetalol versus other antihypertensives (RR = 0.34 [0.10–1.14], I2 = 87%; N = 4, n = 590), with heterogeneity due to a lower‐quality labetalol versus hydralazine study. There were fewer adverse FHR effects for nifedipine versus hydralazine study (RR = 0.09 [0.01–0.68]; n = 49).
NeoHR: Severe Hypertension
RCTs of antihypertensives versus placebo/no therapy were not associated with adverse neoHR effects (RR = 1.26 [0.31–5.19]; I2 = 66%; N = 4, n = 406), with heterogeneity attributed to more neoHR effects with continuously monitored neoHR. Observational studies revealed no effect on neoHR of antihypertensives versus no therapy (RR = 1.06 [0.67–1.67]; I2 = 54%; N = 4, n = 37 359), but labetalol was associated with more adverse effects and metoprolol with fewer. In RCTs of antihypertensives versus other antihypertensives, there was no difference in adverse neoHR (RR = 3.0 [0.13–71.74]; N = 3, n = 162). Observational studies showed adverse neoHR effects in labetalol versus pure beta‐blockers (RR = 1.99 [1.36–2.91]; I2 = 0%; N = 3, n = 16 204). No severe hypertension RCTs reported neoHR. Observational studies were limited. Network meta‐analysis showed no significant relationships between antihypertensives and FHR or neoHR; 95% CIs were very wide.
Conclusions
Evidence is inadequate to draw reliable conclusions about the impact of antihypertensives on FHR or neoHR. At present, adverse FHR or neoHR effects should be attributed to evolving placental dysfunction
Advanced therapy screening in inflammatory bowel disease and the impact of clinical nurse specialists: A retrospective analysis of electronic patient records
Get PDFAdvanced therapies (AT), encompassing biologics and small molecules, are a common and important treatment for inflammatory bowel disease (IBD). However, these treatments pose a risk of reactivating latent infections and therefore require pre-treatment infection screening, but compliance with this screening has previously been reported to be poor. Clinical nurse specialists (CNS) and pharmacists play a key role in facilitating this screening and safely initiating AT, but are understaffed compared to national standards. Through retrospective review of electronic patient records at St George's University Hospital, a tertiary IBD centre in London, UK, we evaluated the impact of staffing on rates of compliance with screening and time from prescription to administration of AT (TAT). 1,035 patients with IBD treated with an AT were identified, and we found a significant correlation between increased CNS staffing and improved screening compliance, as well as a numerical reduction in the TAT. Incidental findings were relatively low, with 8% of patients presenting positive results, all of whom had clinical risk factors. The study advocates for increased staffing and resources in IBD services to enhance patient safety and treatment efficacy
Modification and validation of the Bluebelle Wound Healing Questionnaire (WHQ) for assessing surgical site infection in wounds healing by secondary intention
Get PDFBackground
Surgical wounds healing by secondary intention are common. Healing is often complicated by surgical site infection (SSI). SSI assessment is important to guide treatment but existing methods generally require in-person assessment, making them resource intensive. A validated patient-reported SSI outcome measure may be useful to overcome this limitation.
Aim
To modify and validate the Bluebelle Wound Healing Questionnaire (WHQ) for wounds healing by secondary intention.
Methods
The 18-item Bluebelle WHQ developed for wounds healing by primary intention was modified to make it applicable to secondary healing wounds. Testing was performed as part of the SWHSI-2 randomised trial assessing negative pressure wound dressings versus standard care. Participants completed the WHQ at five timepoints; in-person (baseline, post-healing) and by post (3, 6, 12 months). A reference SSI assessment was performed by a research nurse at the time of wound healing. Acceptability and criterion validity (ability of the Bluebelle WHQ to discriminate between SSI/no SSI) were explored by examining questionnaire return rates, levels of missing data and total score sensitivity/specificity values (receiver operating characteristic curve (ROC)).
Results
Baseline in-person questionnaire return rates were highest (672/686; 98 %), with postal return rates of 428/615 (68.5 %), 274/416 (65.9 %) and 186/296 (62.8 %) at follow up points. Overall, low levels of item-missing data were observed with few problems completing the questionnaire reported. Ability to discriminate between SSI/no SSI was good (Area under ROC = 0.796).
Conclusion
The modified Bluebelle WHQ is a valuable tool for post-discharge assessment of wounds healing by secondary intention. It is recommended for use in research and clinical practice
Distribution of age at natural menopause, age at menarche, menstrual cycle length, height and BMI in BRCA1 and BRCA2 pathogenic variant carriers and non-carriers: results from EMBRACE
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Carriers of germline pathogenic variants (PVs) in the BRCA1 and BRCA2 genes are at higher risk of developing breast and ovarian cancer than the general population. It is unclear if these PVs influence other breast or ovarian cancer risk factors, including age at menopause (ANM), age at menarche (AAM), menstrual cycle length, BMI or height. There is a biological rationale for associations between BRCA1 and BRCA2 PVs and reproductive traits, for example involving DNA damage and repair mechanisms. The evidence for or against such associations is limited.
Methods
We used data on 3,046 BRCA1 and 3,264 BRCA2 PV carriers, and 2,857 non-carrier female relatives of PV carriers from the Epidemiological Study of Familial Breast Cancer (EMBRACE). Associations between ANM and PV carrier status was evaluated using linear regression models allowing for censoring. AAM, menstrual cycle length, BMI, and height in carriers and non-carriers were compared using linear and multinomial logistic regression. Analyses were adjusted for potential confounders, and weighted analyses carried out to account for non-random sampling with respect to cancer status.
Results
No statistically significant difference in ANM between carriers and non-carriers was observed in analyses accounting for censoring. Linear regression effect sizes for ANM were -0.002 (95%CI: -0.401, 0.397) and -0.172 (95%CI: -0.531, 0.188), for BRCA1 and BRCA2 PV carriers respectively, compared with non-carrier women. The distributions of AAM, menstrual cycle length and BMI were similar between PV carriers and non-carriers, but BRCA1 PV carriers were slightly taller on average than non-carriers (0.5 cm difference, p = 0.003).
Conclusion
Information on the distribution of cancer risk factors in PV carriers is needed for incorporating these factors into multifactorial cancer risk prediction algorithms. Contrary to previous reports, we found no evidence that BRCA1 or BRCA2 PV are associated with hormonal or anthropometric factors, except for a weak association with height. We highlight methodological considerations and data limitations inherent in studies aiming to address this question
Impact of Blood Pressure Self-Management on Vascular Remodeling After Hypertensive Pregnancy
Get PDFBACKGROUND:
Hypertensive pregnancy disorders are associated with long-term adverse cardiac and vascular remodeling postindex pregnancy. The POP-HT trial (Physician Optimised Postpartum Hypertension Treatment) demonstrated that improved puerperal blood pressure control leads to reduced blood pressure and beneficial cardiac remodeling during the first year postpartum. This study describes the impact on postpartum vascular remodeling.
METHODS:
A prospective, randomized, open-label, blinded end point trial in a single UK hospital where 220 women were assigned 1:1 to intervention (self-management via physician-guided antihypertensive titration) or control (usual postnatal care via primary care doctor±midwife). Eligible participants were ≥18 years, with preeclampsia or gestational hypertension and requiring antihypertensives on discharge. Prespecified secondary vascular outcomes included aortic blood pressure and pulse wave velocity measured by Vicorder at baseline and 9 months postpartum, and additional cardiovascular magnetic resonance measures of aortic distensibility were performed.
RESULTS:
There were no baseline differences in aortic blood pressure or pulse wave velocity but by 9 months postpartum, aortic diastolic blood pressure was −5.2 mm Hg lower ([95% CI, −8.0 to −2.2]; P<0.001), and pulse wave velocity was −0.71 m/s lower ([95% CI, −1.42 to −0.006];P=0.048) in the intervention arm compared with the control arm, which corresponded with greater aortic distensibility by 0.78×10 −3mm Hg−1[95% CI, −0.01 to 1.55]; P=0.046).
CONCLUSIONS:
Postpartum blood pressure self-monitoring combined with physician-guided medication titration is associated with reduced central arterial stiffness during the first year after a hypertensive pregnancy, in addition to the previously demonstrated effects on blood pressure and cardiac remodeling.
REGISTRATION:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04273854
Exploring the relationship between learning approaches and problem-based learning: insights from a longitudinal study in medical students
Get PDFBACKGROUND: Problem-based learning (PBL) is expected to encourage a deep learning approach. Whether this is realised in practice remains uncertain. We investigated the relationships between learning approaches, academic achievement and student satisfaction in an integrated PBL curriculum, among students with diverse characteristics. METHODS: All Year 1 students of an undergraduate UK medical programme, delivered concurrently at City St George's, University of London and the University of Nicosia, were invited to participate in 2019-2020 and 2020-2021. Students completed the validated Study Process Questionnaire (SPQ) at the beginning and end of Year 1. We explored changes in learning approaches and the associations of the learning approach with academic performance (in written and clinical examinations) and student satisfaction. RESULTS: 129 students participated. Deep motivation decreased significantly over the year [Baseline: 11.03 ± 2.29; End of Year 1: 10.21 ± 2.26; p < 0.05). Graphical representations and tertile analysis further showed changes in individual learning approaches. Lower deep motivation scores were observed among male students, and those who were older, white, held biomedical sciences degrees, undergraduate degrees, or were native English speakers. Conversely, higher surface motivation was seen among female students, and those who were younger or held undergraduate degrees. Nicosia students became less strategic by the end of the year. No association was found between learning approach, or its change within the year, and examination performance. However, surface learning was negatively correlated with satisfaction regarding aspects of pharmacology learning in PBL and prescribing confidence. Strategic learners preferred lectures and had mixed perceptions about learning pharmacology in PBL, although they found student diversity facilitated their learning. CONCLUSIONS: While PBL is expected to promote deep learning, our findings show that in a real-world context, these benefits are not consistently realised. Learners adopted less favourable learning approaches over the year, with increasing reliance on surface learning and less deep motivation. Such shifts may be due to excessive workload, assessment burden or curriculum uncertainty. We have identified student groups that may be more vulnerable to the stresses of a PBL setting, which may represent targets for intervention. Future studies may also investigate curriculum adaptations to enhance deep learning in a PBL curriculum
Antibiotic treatment of pediatric infections in primary healthcare setting: evaluation and comparison of 80 national treatment guidelines with the WHO AWaRe book recommendations
Get PDFBACKGROUND: Antibiotic recommendations for pediatric infections in national standard treatment guidelines (STGs) vary widely, particularly for Access and Watch antibiotics. The WHO AWaRe book recommends Access antibiotics as first-line treatment for over 80% of common infections managed in primary healthcare. This study aims to evaluate the agreement between first and second-line antibiotics in national STGs with AWaRe book recommendations and the inclusion of these antibiotics in Essential Medicine Lists (EMLs). METHODS: National STGs of 80 countries were systematically collected from databases and grey literature (up to May 2025). Antibiotic recommendations for the ten most common primary healthcare infections in children were compared with the WHO AWaRe book (2022), the WHO Essential Medicines List for children (EMLc) and national Essential Medicines Lists (nEMLs) where available. FINDINGS: A median of eight STGs per country were collected, with higher numbers in LMICs due to guidelines for cholera and enteric fever. A total of 1124 first-line and 841 second-line antibiotic recommendations were identified. Over 70% of first-line recommended treatments were Access antibiotics, while Watch antibiotics accounted for more than 50% of second-line recommended treatments. First-line recommendations showed strong agreement with WHO guidance, whereas second-line treatments exhibited lower agreement and greater variability across regions. More than 80% of first-line antibiotics were included in the EMLc and nEMLs, although some high-income countries lacked nEMLs. INTERPRETATION: First-line antibiotic recommendations in national pediatric STGs largely align with the WHO AWaRe book guidance focusing on Access antibiotic use. In contrast, second-line treatments vary considerably, commonly recommending Watch antibiotics. Strengthening the evidence base of national STGs and aligning second-line recommendations with the WHO AWaRe book could help meet the 79th UNGA High-Level Meeting on AMR target, which aims for 70% of all human antibiotic use to come from the Access group. FUNDING: PRIN 2022 "A Cluster randomized clinical trial to change Antibiotic Prescribing behavior in Outpatient pediatric primary care setting in Italy (CAPO project)", funded in the framework of the National Recovery and Resilience Plan (NRRP), Mission 4, Component 2, Investment 1.1, funded by the European Union-Next Generation EU, Project 2022A7LA2W, CUP C53D23006050006
Prediction of small‐for‐gestational age and fetal growth restriction at routine ultrasound examination at 35–37 weeks' gestation
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To evaluate the performance of sonographic fetal biometry and Doppler parameters assessed at routine third‐trimester ultrasound examination for predicting small‐for‐gestational age (SGA) and fetal growth restriction (FGR).
Methods
This was a retrospective cohort study of low‐risk singleton pregnancies undergoing routine ultrasound examination between 35 + 0 and 37 + 6 weeks' gestation and delivered at St George's University Hospital, London, UK, between December 2019 and February 2024. The study outcomes were SGA (birth weight < 5th centile) and FGR (birth weight < 3rd centile or birth weight < 10th centile with composite adverse perinatal outcome). Composite adverse perinatal outcome comprised intrauterine death, neonatal death or admission to the neonatal intensive care unit. Demographic characteristics, estimated fetal weight (EFW) and abdominal circumference centiles, as well as Doppler indices, including pulsatility indices (PI) of the umbilical artery (UA), middle cerebral artery (MCA) and uterine artery (UtA) were evaluated. The cerebroplacental ratio (CPR) was calculated, and all indices were converted to multiples of the median (MoM). Multivariable logistic regression analysis was performed to identify and adjust for confounders. The area under the receiver‐operating‐characteristics curve (AUC) was used to evaluate the model's performance for predicting small neonates.
Results
A total of 14 161 pregnancies were included in the study. The prevalence of SGA and FGR neonates was 3.1% and 1.5%, respectively. Independent predictors of SGA and FGR, respectively, were: EFW centile (adjusted odds ratio (aOR) 0.91 (95% CI, 0.90–0.92); P < 0.001 and aOR 0.90 (95% CI, 0.89–0.91); P < 0.001); AC centile (aOR 0.91 (95% CI, 0.90–0.92); P < 0.001 and aOR 0.91 (95% CI, 0.90–0.92); P <0.001); UA‐PI MoM (aOR 4.60 (95% CI, 2.19–9.64); P < 0.001 and aOR 2.53 (95% CI, 1.05–6.10); P = 0.038); MCA‐PI MoM (aOR 0.37 (95% CI, 0.20–0.70); P = 0.002 and aOR 0.26 (95% CI, 0.12–0.59); P = 0.001); CPR MoM (aOR 0.23 (95% CI, 0.13–0.42); P < 0.001 and aOR 0.25 (95% CI, 0.12–0.53); P < 0.001); and UtA‐PI MoM (aOR 2.54 (95% CI, 1.68–3.83); P < 0.001 and aOR 2.16 (95% CI, 1.31–3.58); P = 0.003). The EFW centile alone was associated with an AUC of 0.917 (95% CI, 0.907–0.929) for the prediction of SGA and 0.925 (95% CI, 0.908–0.939) for the prediction of FGR. This was similar to AUCs of around 0.92 for the prediction of SGA and AUCs of around 0.93 for the prediction of FGR when the EFW centile was combined with any Doppler parameters.
Conclusions
Sonographic fetal biometry evaluation in the late third trimester can predict delivery of a neonate affected by SGA or FGR, including those at risk for adverse perinatal outcomes. In an unselected population, fetal arterial Doppler parameters were independent predictors of SGA and FGR, but the addition of Doppler parameters to fetal biometry did not improve prediction of the incidence of small neonates
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