Background: Two billion peripheral intravenous catheters (PIVC) are inserted into inpatients worldwide year. Almost 1 in 2 PIVC failed for various reasons before completion of intravenous therapy. We aimed to determine the efficacy and costs of a multimodal intervention to reduce PIVC failure rates among hospitalised patients. Methods:We conducted a cluster-randomised controlled trial at seven public hospitals in Spain. Clusters had at least 70% of permanent staff, being enrolled and randomly assigned (1:1) to the multimodal intervention or control arms. We concealed randomisation to allocation, without masking patients and professionals to the intervention arm. The protocol-prespecified primary outcomes were PIVC failure at 12 months (phlebitis, extravasation, obstruction or infections). Subsequently, we included dislodgment as part of PIVC failure, being a post-hoc modification. We registered this trial with the ISRCTN Registry, number ISRCTN10438530. Findings: Between Jan 1, 2019, and March 1, 2020, we randomly assigned 22 eligible clusters to receive the multimodal intervention (n=11 clusters; 2196 patients; 2235 PIVCs, and 131 nurses) or usual practice in control group (n=11; 2282 patients, 2330 PIVCs, and 138 nurses). The intervention arm reduced the percentage of PIVC failure rates compared to the control group (37•10 [SD 1•32; HR = 0•81] vs 46•49 [SD 2•59; HR = 1•23]; mean difference -9•39 [95% CI -11•22 to -7•57; p<0•001]), as incurred less costs (€21•39 [SD 191•05] vs €40•89 [SD 389•55]) with a reduction of €-19•50 per PIVC (95% CI -37•20 to -1•80]; p=0.033) at 12 months. Per protocol-prespecified analysis of the primary outcome showed the intervention significantly reduced PIVC failure compared to the control group at 12 months. The median PIVC dwell time was 85 hours (IQR 55-110). Interpretation: A multimodal intervention reduced PIVC failure, potentially serious complications for hospitalised patients, improved adherence to the best available evidence and savings for the National Health System. Funding: This study is funded by The College of Nurses of the Balearic Islands under award number PI2017/0192.
Background: The global prevalence of postpartum depression is about 20%. This disease has serious consequences for women, their infants, and their families. The aim of this randomized clinical trial was to analyze the effectiveness and safety of a moderate-intensity aerobic water exercise program on postpartum depression, sleep problems, and quality of life in women at one month after delivery. Methods: This was a multi-center, parallel, randomized, evaluator blinded, controlled trial in a primary care setting. Pregnant women (14–20 weeks gestational age) who had low risk of complications and were from five primary care centers in the area covered by the obstetrics unit of Son Llatzer Hospital (Mallorca, Spain) were invited to participate. A total of 320 pregnant women were randomly assigned to two groups, an intervention group (moderate aquatic aerobic exercise) and a control group (usual prenatal care). One month after birth, sleep quality (MOS sleep), quality of life (EQ-5D), and presence of anxiety or depression (EPDS) were recorded. Findings: Women in the intervention group were less likely to report anxiety or depression on the EQ5D (11.5% vs. 22.7%; p < 0.05) and had a lower mean EPDS score (6.1 ± 1.9 vs. 6.8 ± 2.4, p < 0.010). The two groups had no significant differences in other outcomes, maternal adverse events, and indicators of the newborn status. Conclusion: Moderate-intensity aquatic exercise during pregnancy decreased postpartum anxiety and depressive symptoms in mothers and was safe for mothers and their newborns.
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