Implementing and evaluating group interpersonal therapy for postnatal depression in Lebanon and Kenya-individually randomised superiority trial.

BACKGROUND: Depression ranks as the foremost mental health concern among childbearing women. Within low- and middle-income countries (LMICs), between 20 and 25% of women encounter depression during pregnancy or soon after delivery. This condition impacts not only the mothers but also their offspring. Offspring of women suffering from postnatal depression (PND) exhibit suboptimal cognitive development and increased emotional and behavioural issues throughout their growth. This scenario becomes more pronounced in LMICs, where numerous adversities further jeopardise children's developmental progress. Despite antenatal services providing a pivotal platform to address women's mental health needs, PND treatment remains inaccessible in many LMICs. The World Health Organization advocates interpersonal psychotherapy (IPT) for treating depression. While research from high-income countries has established the efficacy of IPT and group-IPT (g-IPT) for PND, its effectiveness within the LMIC context and its potential benefits for child development remain uncharted. This study seeks to gauge the potency of g-IPT for women with PND in two LMICs. METHODS: This multi-site randomised controlled trial is a continuation of two preceding phases-conceptual mapping and a feasibility study executed in Lebanon and Kenya. Insights gleaned from these phases underpin this comprehensive RCT, which contrasts the efficacy and cost-effectiveness of high-quality standard care (HQ-SC) augmented with g-IPT against HQ-SC in isolation. The trial, characterised as an individually randomised superiority assessment, targets women with postnatal depression in Beirut, Lebanon, and Nairobi, Kenya. It aims to determine if culturally tailored g-IPT, administered within community settings in both countries, outperforms HQ-SC in influencing child developmental outcomes, maternal depression, and the quality of the mother-child bond. DISCUSSION: The SUMMIT trial, designed with pragmatism, possesses the magnitude to evaluate g-IPT within two LMIC frameworks. It seeks to enlighten policymakers, service commissioners, professionals, and users about g-IPT's potential to alleviate maternal PND and bolster child developmental outcomes in LMICs. Additionally, the trial will generate valuable data on the clinical and economic merits of high-quality standard care. TRIAL REGISTRATION: ISRCTN, ISRCTN15154316. Registered on 27 September 2023, https://doi.org/10.1186/ISRCTN15154316.

Clinical Outcomes Following Use of Tranexamic Acid in High Tibial Osteotomy: A Systematic Review.

This study aimed to evaluate the clinical outcomes following administration of tranexamic acid (TXA) in patients undergoing high tibial osteotomy (HTO) through a systematic review of current available evidence. A systematic database search of PubMed, Embase and Cumulative Index of Nursing and Allied Health Literature (CINAHL) was performed from inception up to December 2022, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). Inclusion criteria were (i) randomised control trials, cohort studies or case-control studies that had more than 10 patients; (ii) studies reporting outcomes after TXA administration, of any route, before or after HTO, compared to placebo, control and different doses or routes; and (iii) studies reporting blood loss, including haemoglobin (Hb) drop, estimated blood loss, transfusion requirement and complications. Case reports, reviews, abstracts, non-HTO studies, non-human studies and duplicates were excluded. A synthesized comparison of drain output, wound complications, transfusion requirement and pooled analyses of blood loss and Hb drop was performed. Eleven studies involving 974 patients were included. Nine studies had placebo comparison, and two used single-dose TXA versus multiple doses. All studies reported on postoperative hemoglobin and nine on blood loss. In the six TXA versus placebo studies reporting on total blood loss, the TXA group had a pooled, estimated standardised mean difference (SMD) in blood loss of -2.37 (95% confidence interval (CI) -3.67, -1.07; P = 0.0004). For the Hb drop, on postoperative days (PODs) one, two, and five, the SMDs were -0.97 (95% CI -1.19, -0.75; P < 0.00001) for POD1, -0.74 (95% CI -1.03, -0.46; P < 0.00001) for POD2 and -0.87 (95% CI -1.10, -0.64; P < 0.00001) for POD5. TXA administration in HTO significantly reduces perioperative blood loss. This can greatly improve recovery, reduce complications and shorten length of stay. This is especially pertinent given supply shortages of NHS blood resources.

A nebulised antitumour necrosis factor receptor-1 domain antibody in patients at risk of postoperative lung injury: A randomised, placebo-controlled pilot study.

BACKGROUND: Tumour necrosis factor receptor 1 (TNFR1) signalling mediates the cell death and inflammatory effects of TNF-α. OBJECTIVE: The current clinical trial investigated the effects of a nebulised TNFR1 antagonist (GSK2862277) on signs of lung injury in patients undergoing oesophagectomy. DESIGN: Randomised double-blind (sponsor unblind), placebo-controlled, parallel group study. SETTING: Eight secondary care centres, the United Kingdom between April 2015 and June 2017. PATIENTS: Thirty-three patients undergoing elective transthoracic oesophagectomy. INTERVENTIONS: Patients randomly received a single nebulised dose (26 mg) of GSK2862277 (n = 17) or placebo (n = 16), given 1 to 5 h before surgery; 14 and 16, respectively competed the study. MAIN OUTCOME MEASUREMENTS: Physiological and biochemical markers of lung injury, pharmacokinetic and safety endpoints were measured. The primary endpoint was the change from baseline in pulmonary vascular permeability index (PVPI) at completion of surgery, measured using single-indicator transpulmonary thermodilution. Adjusted point estimates and 95% credible intervals (analogous to conventional confidence intervals) were constructed for each treatment using Bayesian statistical models. RESULTS: The mean change (with 95% credible intervals) from baseline in PVPI on completion of surgery was 0.00 (-0.23, 0.39) in the placebo and 0.00 (-0.24, 0.37) in the GSK2862277 treatment groups. There were no significant treatment-related differences in PaO2/FiO2 or Sequential Organ Failure Assessment score. Levels of free soluble TNFR1, Macrophage Inflammatory Protein-1 alpha and total protein were significantly reduced in the bronchoalveolar lavage fluid of patients treated with GSK2862277 (posterior probability of decrease with GSK2862277 vs. placebo:≥0.977; equivalent to P < 0.05). The frequency of adverse events and serious adverse events were distributed evenly across the two treatment arms. CONCLUSION: Pre-operative treatment with a single 26 mg inhaled dose of GSK2862277 did not result in significantly lower postoperative alveolar capillary leak or extra vascular lung water. Unexpectedly small increases in transpulmonary thermodilution-measured PVPI and extra vascular lung water index at completion of surgery suggest less postoperative lung injury than historically reported, which may have also compromised a clear assessment of efficacy in this trial. GSK2862277 was well tolerated, resulted in expected lung exposure and reduced biomarkers of lung permeability and inflammation. TRIAL REGISTRATION: clinicaltrials.gov: NCT02221037.