Enhanced womens decision-making power after the Suchana intervention in north-eastern Bangladesh: a cluster randomised pre-post study

Objectives
Women’s decision-making power is a dimension of empowerment and is crucial for better physical and psychosocial outcomes of mothers. Suchana, a large-scale development programme in Bangladesh, actively provided social interventions on behaviour change communication to empower women belonging to the poorest social segment. This paper aims to assess the impact of the Suchana intervention on various indicators related to women’s decision-making power.

Design, setting and participants
The evaluation design was a cluster randomised pre-post design with two cross-sectional surveys conducted among beneficiary women with at least one child aged

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Agosto 2022

Indocyanine green clearance test in liver transplantation: defining cut-off levels for graft viability assessment during organ retrieval and for the prediction of post-transplant graft function recovery – the Liver Indocyanine Green (LivInG) Trial Study Protocol

Introduction
Viability assessment of the graft is essential to lower the risk of liver transplantation (LT) failure and need for emergency retransplantation, however, this still relies mainly on surgeon’s experience. Post-LT graft function recovery assessment is also essential to aid physicians in the management of LT recipients and guide them through challenging decision making.
This study aims to trial the use of indocyanine green clearance test (IGT) in the donor as an objective tool to assess graft viability and in the recipient to assess graft function recovery after LT.

Methods and analysis
This is an observational prospective single-centre study on consecutive liver transplant donors and recipients.

Primary objective
To determine the capability of IGT of predicting graft viability at the time of organ retrieval. Indocyanine green will be administered to the donor and the plasma disappearance rate (PDR) measured using the pulsidensitometric method. Some 162 IGT donor procedures will be required (α, 5%; β, 20%) using an IGT-PDR cut-off value of 13% to achieve a significant discrimination between viable and non-viable grafts.

Secondary objective
IGT-PDR will be measured at different time-points in the LT recipient: during the anhepatic phase, after graft reperfusion, at 24 hours, on day 3 and day 7 after LT. The slope of IGT values from the donor to the recipient will be evaluated for correlation with the development of early allograft dysfunction.

Ethics and dissemination
This research protocol was approved by Fondazione Policlinico Universitario Agostino Gemelli IRCCS Ethics Committee (reference number: 0048466/20, study ID: 3656) and by the Italian National Transplant Center (CNT) (reference number: Prot.11/CNT2021). Liver recipients will be required to provide written informed consent. Results will be published in international peer-reviewed scientific journals and presented in congresses.

Trial registration number
NCT05228587.

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Agosto 2022

Mediating effect of kinesiophobia between self-efficacy and physical activity levels in post-CABG patients: protocol for a prospective, multicentre, cross-sectional study in China

Introduction
Physical activity (PA) can improve cardiac function, exercise capacity, and quality of life, in addition to reducing mortality by 20%–30% and preventing the recurrence of adverse cardiovascular events in patients following coronary artery bypass graft (CABG). However, PA levels are low in patients after CABG. This study intends to explore the mediating effect of kinesiophobia between self-efficacy and PA levels in patients following CABG.

Methods and analysis
The proposed study constitutes a prospective, multicentre and cross-sectional study comprising 413 patients. Four teaching hospitals with good reputations in CABG will be included in the study. All of them are located in Beijing, China, and provide medical service to the whole country. This study will assess the following patient-reported outcome measures: demographic information, International Physical Activity Questionnaire-Long, Social Support Rating Scale, Cardiac Exercise Self-Efficacy Instrument, Multidimensional Fatigue Inventory, Hospital Anxiety and Depression Scale, and Tampa Scale for Kinesiophobia Heart.

Ethics and dissemination
This study conforms to the principles of the Declaration of Helsinki and relevant ethical guidelines. Ethical approval has been obtained from the Ethics Committee of The Sixth Medical Centre of PLA General Hospital (approval number: HZKY-PJ-2022–2). All study participants will provide written informed consent. Findings from this study will be published in Chinese or English for widespread dissemination of the results.

Trial registration number
Chinese Clinical Trial Register, ChiCTR2100054098.

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Luglio 2022

Post-COVID pain and quality of life in COVID-19 patients: protocol for a meta-analysis and systematic review

Introduction
During the COVID-19 pandemic, approximately 10%–35% of COVID-19 infected patients experience post-COVID sequela. Among these sequelae, pain symptoms should not be neglected. In addition, the sequelae of COVID-19 also decrease the quality of life of these populations. However, meta-analyses that systematically evaluated post-COVID pain are sparse.

Methods and analysis
A comprehensive screening will be performed by searching MEDLINE and Embase without language restriction from inception to August 2021. Cohort studies, case–control studies, cross-sectional studies and case series will be included. Case report and interventional studies will be excluded. Studies with less than 20 participants will be also excluded. We aim to investigate the prevalence of pain-related symptoms in patients after the acute phase of COVID-19. The impact of COVID-19 on the quality of life and pain symptoms among these populations in the post-acute phase will also be evaluated. ROBINS-I tool will be used to assess the risk of bias of cohort studies. The risk of bias tool developed by Hoy et al will be used to assess the risk of bias of prevalence studies. Metaprop command in Stata will be used to estimate the pooled prevalence of pain symptoms. DerSimonian and Laird random-effects models will be used to calculate the pooled relative risks. All analyses will be calculated using Stata software (V.15.0; StataCorp)

Ethics and dissemination
Ethics approval is not required. Results of our study will be submitted to a peer-review journal.

PROSPERO registration number
CRD42021272800.

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Luglio 2022

Association between terminal pleural elastance and radiographic lung re-expansion after therapeutic thoracentesis in patients with symptomatic pleural effusion: a post-hoc analysis of a randomised trial

Objectives
Recurrent symptomatic effusions can be durably managed with pleurodesis or placement of indwelling pleural catheters. Recent pleurodesis trials have largely relied on lung re-expansion on post-thoracentesis radiograph as an inclusion criterion rather than pleural elastance as determined by manometry, which is an important predictor of successful pleurodesis. We investigated the association between lung re-expansion on post-pleural drainage chest imaging and pleural physiology, with particular attention to pleural elastance over the final 200 mL aspirated.

Design
Post-hoc analysis of a recent randomised trial.

Setting and participants
Post-results analysis of 61 subjects at least 18 years old with symptomatic pleural effusions estimated to be at least of 0.5 L in volume allocated to manometry-guided therapeutic thoracentesis in a recent randomised trial conducted at two major university hospitals in the USA.

Primary outcome measures
The primary outcome was concordance of radiographic with normal terminal pleural elastance over the final 200 mL aspirated. We label this terminal elastance ‘visceral pleural recoil’, or the tendency of the maximally expanded lung to withdraw from the chest wall.

Results
Post-thoracentesis chest radiograph and thoracic ultrasound indicated successful lung re-expansion in 69% and 56% of cases, respectively. Despite successful radiographic lung re-expansion, visceral pleural recoil was abnormal in 71% of subjects expandable by radiograph and 77% expandable by ultrasound. The sensitivity and positive predictive value of radiographic lung re-expansion for normal visceral pleural recoil were 44% and 24%, respectively.

Conclusion
Radiographic lung re-expansion by post-thoracentesis chest radiograph or thoracic ultrasound is a poor surrogate for normal terminal pleural elastance. Clinical management of patients with recurrent symptomatic pleural effusions guided by manometry rather than post-thoracentesis imaging might produce better outcomes, which should be investigated by future clinical trials.

Trial registration number
NCT02677883; Post-results.

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Luglio 2022

Differences in emergency nurse triage between a simulated setting and the real world, post hoc analysis of a cluster randomised trial

Objectives
In the TRIAGE trial, a cluster randomised trial about diverting emergency department (ED) patients to a general practice cooperative (GPC) using a new extension to the Manchester Triage System, the difference in the proportion of patients assigned to the GPC was striking: 13.3% in the intervention group (patients were encouraged to comply to an ED or GPC assignment, real-world setting) and 24.7% in the control group (the assignment was not communicated, all remained at the ED, simulated setting). In this secondary analysis, we assess the differences in the use of the triage tool between intervention and control group and differences in costs and hospitalisations for patients assigned to the GPC.

Setting
ED of a general hospital and the adjacent GPC.

Participants
8038 patients (6294 intervention and 1744 control).
Primary and secondary outcome measures proportion of patients with triage parameters (reason for encounter, discriminator and urgency category) leading to an assignment to the ED, proportion of patients for which the computer-generated GPC assignment was overruled, motivations for choosing certain parameters, costs (invoices) and hospitalisations.

Results
An additional 3.1% (p

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Luglio 2022