RESUMEN
BACKGROUND: Perinatal mood disorders such as depression and anxiety are common, with subclinical symptomology manifesting as perinatal mood disturbances being even more prevalent. These could potentially affect breastfeeding practices and infant development. Pregnant and lactating women usually limit their exposure to medications, including those for psychological symptoms. Interestingly, the naturally occurring probiotic Bifidobacterium longum (BL) NCC3001 has been shown to reduce anxious behavior in preclinical models and feelings of low mood in nonpregnant human adults. During the COVID-19 pandemic, mental health issues increased, and conventionally conducted clinical trials were restricted by social distancing regulations. OBJECTIVE: This study, Probiotics on Mothers' Mood and Stress (PROMOTE), aimed to use a decentralized clinical trial design to test whether BL NCC3001 can reduce symptoms of depression, anxiety, and stress over the perinatal period. METHODS: This double-blind, placebo-controlled, randomized, and 3-parallel-arm study aimed to recruit 180 women to evaluate the efficacy of the probiotic taken either during pregnancy and post partum (from 28-32 weeks' gestation until 12 weeks after delivery; n=60, 33.3%) or post partum only (from birth until 12 weeks after delivery; n=60, 33.3%) in comparison with a placebo control group (n=60, 33.3%). Participants consumed the probiotic or matched placebo in a drink once daily. Mood outcomes were measured using the State-Trait Anxiety Inventory and Edinburgh Postnatal Depression Scale questionnaires, captured electronically at baseline (28-32 weeks' gestation) and during e-study sessions over 5 further time points (36 weeks' gestation; 9 days post partum; and 4, 8, and 12 weeks post partum). Saliva and stool samples were collected longitudinally at home to provide mechanistic insights. RESULTS: In total, 520 women registered their interest on our website, of whom 184 (35.4%) were eligible and randomized. Of these 184 participants, 5 (2.7%) withdrew after randomization, leaving 179 (97.3%) who completed the study. Recruitment occurred between November 7, 2020, and August 20, 2021. Advertising on social media brought in 46.9% (244/520) of the prospective participants, followed by parenting-specific websites (116/520, 22.3%). Nationwide recruitment was achieved. Data processing is ongoing, and there are no outcomes to report yet. CONCLUSIONS: Multiple converging factors contributed to speedy recruitment and retention of participants despite COVID-19-related restrictions. This decentralized trial design sets a precedent for similar studies, in addition to potentially providing novel evidence on the impact of BL NCC3001 on symptoms of perinatal mood disturbances. This study was ideal for remote conduct: because of the high digital literacy and public trust in digital security in Singapore, the intervention could be self-administered without regular clinical monitoring, and the eligibility criteria and outcomes were measured using electronic questionnaires and self-collected biological samples. This design was particularly suited for a group considered vulnerable-pregnant women-during the challenging times of COVID-19-related social restrictions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04685252; https://clinicaltrials.gov/ct2/show/NCT04685252. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41751.
RESUMEN
BACKGROUND: 81 million people face impoverishment from surgical costs every year. The majority of this impoverishment is attributable to the non-medical costs of care-for transportation, for food and for lodging. Of these, transportation is the largest, but because it is not viewed as an actual medical cost, it is frequently unaddressed. This paper examines the effect on surgical utilisation of paying for transportation. METHODS: A hierarchical logistic regression was performed on 2692 patients presenting for surgical care to a non-governmental organisation operating in the Republic of the Congo, Guinea and Madagascar. Controlling for distance from the hospital, age, gender, the need for air travel and time between appointments, the effect of payment for transportation on the surgical no-show rate was evaluated. RESULTS: After adjustment for observed confounders, paying for transportation drops the surgical no-show rate by 45% (OR 0.55; 95% CI 0.40 to 0.77; p<0.001). Age, delay between appointments and the number of hours travelled for surgery also predict surgical no-show. For 28% of no-show patients, the cost of transportation from their homes to a nearby predetermined pick-up point remained a barrier, even when transportation from the pick-up point to the hospital was free. CONCLUSION: Transportation costs are a significant barrier to surgical care in low-resource settings, and paying for it halves the no-show rate. This finding highlights that decreasing demand-side barriers to surgical care cannot be limited only to the removal of user fees.