OBJECTIVE: This study aimed to examine whether there were differences in maternal factors, including maternal characteristics and breastfeeding attitudes, between those who were eligible versus non-eligible to be included in a randomised trial, as exclusive breastfeeding was the eligibility criteria for the trial. It also aimed to investigate associations between maternal factors and breastfeeding attitudes.
METHOD: Primiparous pregnant mothers (n=88) completed questionnaires on demographic factors including maternity care and breastfeeding attitude using self-administered questionnaire and Iowa Infant Feeding Attitude Scale (IIFAS). Two weeks post-birth, mothers were screened for eligibility to be included in a randomised trial including assessing for exclusive breastfeeding (EBF). Findings were compared between inclusion (all EBF mothers) and exclusion groups (non-EBF).
RESULTS: Inclusion group mothers were significantly younger than those in the exclusion group (26.7±2.8 v 28.5±2.5, p=0.007) and the majority had their husband as the primary maternity care person after birth (X2=12.8, p=0.01). Inclusion group mothers had a more positive perception toward breastfeeding in public and at work on the IIFAS scale (p<0.05). The overall IIFAS score was positively associated with higher breastfeeding confidence (r=0.285, p=0.008), education levels (r=0.31, p=0.003), household income (r=0.32, p=0.003), and age (r=0.28, p=0.008).
CONCLUSION: EBF mothers (inclusion group) tend to be younger, had husband as primary care, and have more positive perception towards breastfeeding outside home. Overall, maternal characteristics and paternal support could influence breastfeeding practices and should be targeted for future intervention. Maternal attitude and perceptions about breastfeeding in public could be improved to encourage exclusive breastfeeding.
METHODS: A randomised controlled trial will be conducted in first-time breastfeeding mothers and their new-born infants. Pregnant mothers will be recruited at antenatal clinics in Selangor, Malaysia, and four home visits will be carried out at 2, 6, 12 and 14 weeks postnatally. Participants will be randomised into a control and an intervention group in the early post-partum period. Mothers from the intervention group will be asked to listen daily to an audio recording with relaxation therapy during breastfeeding. Maternal psychological state, breastfeeding practices and infant behaviour will be assessed using validated questionnaires. Milk volume will be measured using stable isotopes. Breast milk samples will be collected to measure macronutrient content and hormone levels. Anthropometric measurements (weight, length and head circumference) will be performed during all home visits, including body composition at week 14.
DISCUSSION: The main outcomes will be the effect of the intervention on maternal psychological state, milk production, cortisol levels, and infant behaviour and growth. Secondary outcomes will be associations between breast milk composition and infant appetite and growth. This study aims to provide a greater understanding of maternal-infant factors which influence breastfeeding outcomes and which may be useful targets for future interventions.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01971216.
OBJECTIVES: The aim of this study was to investigate physiological and psychological aspects of mother-infant signaling during breastfeeding experimentally, testing the effects of a relaxation intervention on maternal psychological state, breast milk intake, milk cortisol levels, and infant behavior and growth.
METHODS: Primiparous breastfeeding mothers and full-term infants were randomly assigned to receive relaxation therapy [intervention relaxation group; n = 33 (RG)] or to the control group [n = 31 (CG); no relaxation therapy] at 2 wk postpartum. Both groups received standard breastfeeding support. Home visits were conducted at 2 (HV1), 6 (HV2), 12 (HV3) and 14 (HV4) wk to measure maternal stress and anxiety, breast milk intake and milk cortisol, and infant behavior and growth.
RESULTS: RG mothers had lower stress scores postintervention than the CG (HV3 ∆ = -3.13; 95% CI: -5.9, -0.3) and lower hindmilk cortisol at HV1 (∆ = -44.5%; 95% CI: -76.1%, -12.9%) but not at HV2. RG infants had longer sleep duration (∆ = 82 min/d; 95% CI: 16, 149 min/d) at HV2 and higher gains in weight and body mass index standardized deviation score than the CG infants (∆ = 0.76; 95% CI: 0.3, 1.22; and ∆ = 0.59; 95% CI: 0.09, 1.1, respectively). RG infants had a mean milk intake at HV3 that was 227 g/d higher than that of the CG infants (P = 0.031) after controlling for gender and milk intake at HV1.
CONCLUSIONS: The trial shows the effectiveness of a simple relaxation intervention for improving maternal and infant outcomes and identifies some potential signaling mechanisms for investigation in future and larger studies, especially in settings where mothers are more stressed, such as those with preterm or low birth weight infants. This trial was registered at clinicaltrials.gov as NCT01971216.
METHODS AND MATERIALS: This retrospective cohort study identified all phase three RCTs evaluating anticancer therapies published from 2014 to 2017. RCTs were classified according to anticancer modality and country of origin. Descriptive statistics were used to compare key characteristics of radiotherapy RCT studies according to study design characteristics, tumor types evaluated, types of intervention appraised, treatment intent and main funding sources.
RESULTS: The study cohort included 694 RCTs of which 64 were radiotherapy RCTs (9%) compared to 601 (87%) systemic therapy RCTs. 47% of all radiotherapy RCTs focused on two areas of evaluation; combining radiotherapy with systemic agents (25%) and changes in dose fractionation (22%). The most common cancers studied were head and neck (22%), lung (22%) and breast (14%) with cervical cancer trials only representing 3% of the cohort. 33% of radiotherapy RCTs met their primary end point. 62% of radiotherapy RCTs assessed interventions in the curative setting compared to 31% in systemic therapy RCTs. 77% of the radiotherapy RCTs were performed in high-income countries (HIC), 13% in low-and-middle-income countries (LMIC) and 11% in both HIC and LMICs. 17% of radiotherapy RCTs received funding from industry compared to 79% of systemic therapy RCTs.
CONCLUSION: This study has highlighted the need for greater investment in radiotherapy RCTs and the disparities in conduct of RCTs globally. The study emphases the urgent need for more capacity building for cancer clinical trials in LMICs and more sustainable funding sources.
OBJECTIVE: To reach international consensus among psoriasis experts on a uniform dosing regimen for treatment with methotrexate in adult and pediatric patients with psoriasis and identify potential future research topics.
DESIGN, SETTING, AND PARTICIPANTS: Between September 2020 and March 2021, a survey study with a modified eDelphi procedure that was developed and distributed by the Amsterdam University Medical Center and completed by 180 participants worldwide (55 [30.6%] resided in non-Western countries) was conducted in 3 rounds. The proposals on which no consensus was reached were discussed in a conference meeting (June 2021). Participants voted on 21 proposals with a 9-point scale (1-3 disagree, 4-6 neither agree nor disagree, 7-9 agree) and were recruited through the Skin Inflammation and Psoriasis International Network and European Academy of Dermatology and Venereology in June 2020. Apart from being a dermatologist/dermatology resident, there were no specific criteria for participation in the survey. The participants worked mainly at a university hospital (97 [53.9%]) and were experienced in treating patients with psoriasis with methotrexate (163 [91.6%] had more than 10 years of experience).
MAIN OUTCOMES AND MEASURES: In a survey with eDelphi procedure, we tried to reach consensus on 21 proposals. Consensus was defined as less than 15% voting disagree (1-3). For the consensus meeting, consensus was defined as less than 30% voting disagree.
RESULTS: Of 251 participants, 180 (71.7%) completed all 3 survey rounds, and 58 participants (23.1%) joined the conference meeting. Consensus was achieved on 11 proposals in round 1, 3 proposals in round 2, and 2 proposals in round 3. In the consensus meeting, consensus was achieved on 4 proposals. More research is needed, especially for the proposals on folic acid and the dosing of methotrexate for treating subpopulations such as children and vulnerable patients.
CONCLUSIONS AND RELEVANCE: In this eDelphi consensus study, consensus was reached on 20 of 21 proposals involving methotrexate dosing in patients with psoriasis. This consensus may potentially be used to harmonize the treatment with methotrexate in patients with psoriasis.