Association between body composition and weight retention from early pregnancy to 42 days postpartum: a retrospective cohort study

Objective
To evaluate the association between body composition from early pregnancy to 42 days postpartum and postpartum weight retention (PPWR).

Design
This retrospective cohort study was conducted at Chengdu Shuangliu Maternal and Child Health Care Hospital from June 2020 to December 2021.

Setting
The study was conducted in Sichuan Province, southwestern China.

Participants
A total of 673 pregnant women at 6–13 weeks of gestation were included.

Outcome measures
Demographic and health information of participants was collected from the electronic medical record system using a self-designed questionnaire. Body fat percentage (PBF), fat mass (FM), fat-free mass (FFM), lean mass (LM) and protein were measured using bioelectrical impedance analysis. Logistic regression and restricted cubic spline (RCS) analyses were performed to examine the association between body composition and PPWR.

Results
During early pregnancy, compared with the bottom quartile group, women in the top quartile group of PBF and FM levels had a 51% (95% CI 0.24 to 0.99) and 64% (95% CI 0.17 to 0.76) lower risk of PPWR, respectively. For each SD increase in PBF and FM levels, the risk of PPWR decreased by 29% (95% CI 0.55 to 0.91) and 35% (95% CI 0.50 to 0.85), respectively. In contrast, at 42 days postpartum, for each SD increase in PBF, FM, FFM and LM levels, the PPWR risk elevated by 251% (95% CI 2.70 to 4.62), 315% (95% CI 3.15 to 5.57), 56% (95% CI 1.30 to 1.89), and 71% (95% CI 1.42 to 2.09). RCS analysis revealed that PBF and FM levels during early pregnancy were negatively correlated with the risk of PPWR (p-overall

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Effectiveness of a community-based rehabilitation programme following hip fracture: results from the Fracture in the Elderly Multidisciplinary Rehabilitation phase III (FEMuR III) randomised controlled trial

Objective
To determine whether an enhanced community rehabilitation intervention (the Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) intervention) was more effective than usual National Health Service care, following surgical repair of hip fracture, in terms of the recovery of activities of daily living (ADLs).

Design
Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1:1 allocation ratio.

Setting
Participant recruitment in 13 hospitals across England and Wales, with the FEMuR intervention delivered in the community.

Participants
Patients aged over 60 years, with mental capacity, recovering from surgical treatment for hip fracture and living in their own home prior to fracture.

Interventions
Usual rehabilitation care (control) was compared with usual rehabilitation care plus the FEMuR intervention, which comprised a patient-held workbook and goal-setting diary to improve self-efficacy, and six additional therapy sessions delivered in-person in the community, or remotely during COVID-19 restrictions (intervention), to increase the practice of exercise and ADL.

Primary and secondary outcome measures
Primary outcome was the Nottingham Extended Activities of Daily Living (NEADL) scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy-International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Outcomes were collected by research assistants in participants’ homes, whenever possible, but had to be collected remotely during COVID-19 restrictions.

Results
In total, 205 participants were randomised (n=104 experimental; n=101 control). Trial processes were adversely affected by the COVID-19 pandemic. There were 20 deaths, 34 withdrawals and three lost to follow-up. At 52 weeks, there was no significant difference in NEADL score between the FEMuR intervention and control groups. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values also found no significant difference with a mean difference of 0.1 (95% CI –1.1, 1.3). There were no significant between-group differences in secondary outcomes. Sensitivity analyses, examining the impact of COVID-19 restrictions, produced similar results. A median of 4.5 extra rehabilitation sessions were delivered to the FEMuR intervention group, with a median of two sessions delivered in-person. Instrumental variable regression did not find any effect of the amount of rehabilitation on the main outcome. There were 53 unrelated serious adverse events (SAEs) including 11 deaths in the control group: 41 SAEs including nine deaths in the FEMuR intervention group.

Conclusions
The FEMuR intervention was not more effective than usual rehabilitation care. The trial was severely impacted by COVID-19. Possible reasons for lack of effect included limited intervention fidelity (fewer sessions than planned and remote delivery), lack of usual levels of support from health professionals and families, and change in recovery beliefs and behaviours during the pandemic.

Trial registration number
ISRCTN28376407.

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Effectiveness of a community-based rehabilitation programme following hip fracture: results from the Fracture in the Elderly Multidisciplinary Rehabilitation phase III (FEMuR III) randomised controlled trial

Objective
To determine whether an enhanced community rehabilitation intervention (the Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) intervention) was more effective than usual National Health Service care, following surgical repair of hip fracture, in terms of the recovery of activities of daily living (ADLs).

Design
Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1:1 allocation ratio.

Setting
Participant recruitment in 13 hospitals across England and Wales, with the FEMuR intervention delivered in the community.

Participants
Patients aged over 60 years, with mental capacity, recovering from surgical treatment for hip fracture and living in their own home prior to fracture.

Interventions
Usual rehabilitation care (control) was compared with usual rehabilitation care plus the FEMuR intervention, which comprised a patient-held workbook and goal-setting diary to improve self-efficacy, and six additional therapy sessions delivered in-person in the community, or remotely during COVID-19 restrictions (intervention), to increase the practice of exercise and ADL.

Primary and secondary outcome measures
Primary outcome was the Nottingham Extended Activities of Daily Living (NEADL) scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy-International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Outcomes were collected by research assistants in participants’ homes, whenever possible, but had to be collected remotely during COVID-19 restrictions.

Results
In total, 205 participants were randomised (n=104 experimental; n=101 control). Trial processes were adversely affected by the COVID-19 pandemic. There were 20 deaths, 34 withdrawals and three lost to follow-up. At 52 weeks, there was no significant difference in NEADL score between the FEMuR intervention and control groups. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values also found no significant difference with a mean difference of 0.1 (95% CI –1.1, 1.3). There were no significant between-group differences in secondary outcomes. Sensitivity analyses, examining the impact of COVID-19 restrictions, produced similar results. A median of 4.5 extra rehabilitation sessions were delivered to the FEMuR intervention group, with a median of two sessions delivered in-person. Instrumental variable regression did not find any effect of the amount of rehabilitation on the main outcome. There were 53 unrelated serious adverse events (SAEs) including 11 deaths in the control group: 41 SAEs including nine deaths in the FEMuR intervention group.

Conclusions
The FEMuR intervention was not more effective than usual rehabilitation care. The trial was severely impacted by COVID-19. Possible reasons for lack of effect included limited intervention fidelity (fewer sessions than planned and remote delivery), lack of usual levels of support from health professionals and families, and change in recovery beliefs and behaviours during the pandemic.

Trial registration number
ISRCTN28376407.

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Investigation of trial registration as part of a research integrity assessment of randomised controlled trials in COVID-19 evidence syntheses: a meta-epidemiological study

Objectives
Prospective registration of randomised controlled trials (RCTs) is an international standard of good clinical practice but is often neglected by evidence synthesis producers. This study aims to assess prospective registration of RCTs included in evidence syntheses as part of a research integrity assessment and examine its impact on the study pool.

Design
Meta-epidemiological study.

Data sources
COVID-19 Cochrane reviews (CRs) and non-Cochrane systematic reviews (SRs) in MEDLINE via PubMed up to 9 June 2022.

Eligibility criteria
RCTs from CRs and SRs evaluating 13 investigational medicinal products for SARS-CoV-2 and COVID-19.

Data extraction and synthesis
We assessed prospective trial registration in RCTs according to domain 2 of the research integrity assessment tool. Prospective registration is defined as registration before participant enrolment. We extracted the trial registration number, registration date, study start date and inconsistencies in dates between study report and registration. RCTs were categorised as ‘no concern’, ‘awaiting classification’ and ‘exclude’. We also analysed the relationship between study settings, publishing journals and prospective registration.

Results
We included 188 RCTs. In the primary study report, 91% reported a trial registration number. In 84 RCTs, either not or retrospectively registered or with missing or inconsistent dates, we searched and/or contacted study authors for prospective registrations, resolving 17 RCTs. Ultimately, 58% of RCTs were prospectively registered and considered ‘no concern’, 15% were ‘awaiting classification’ due to inconsistent or missing information and 27% were either not registered or retrospectively registered and categorised as ‘exclude’. Prospective registration was higher in larger or international multicentre RCTs and in RCTs conducted in Europe.

Conclusions
If prospective trial registration is required for inclusion in evidence syntheses, only 6 out of 10 COVID-19 RCTs would be eligible. Restricting eligibility to prospectively registered RCTs would include most large and international multicentre RCTs but exclude many smaller and non-European RCTs.

Protocol registration
The protocol is available on OSF (https://osf.io/3bzeg).

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At-home Breast Oncology care Delivered with EHealth solutions (ABODE) study protocol: a randomised controlled trial

Introduction
The COVID-19 pandemic disrupted healthcare delivery for patients with breast cancer. eHealth solutions enable remote care and may improve patient activation, which is defined as having the knowledge, skills and confidence to manage one’s health. Thus, we developed the Breast Cancer Treatment Application (app) for patients and practitioners to use throughout the cancer care continuum. The app facilitates virtual assistance, delivers educational resources, collects patient-reported outcome measures and provides individualised support via volunteer e-coaches. Among newly diagnosed patients with breast cancer, we will compare changes in patient activation, other patient-reported outcomes and health service outcomes over 1 year between those using the app and Fitbit, and those receiving standard care and Fitbit only.

Methods and analysis
This randomised controlled trial will include 200 patients with breast cancer seen at a tertiary care cancer centre in Ontario, Canada. The intervention group (n=100) will use the app in addition to standard care and Fitbit for 13 months following diagnosis. The control group (n=100) will receive standard care and Fitbit only. Patients will complete questionnaires at enrolment, 6 and 12 months post-diagnosis to measure patient activation (Patient Activation Measure-13 score), distress, anxiety, quality of life and experiences with their care and information received. All patients will also receive Fitbits to measure activity and heart rate. We will also measure wait times and number of visits to ambulatory care services to understand the impact of the app on the use of in-person services.

Ethics and dissemination
Ethics approval was obtained on 6 January 2023. Protocol version 2.0 was approved on 6 January 2023. The trial is registered with ClinicalTrials.gov. Study findings will be disseminated via publication in a peer-reviewed journal and shared with participants, patient programmes and cancer awareness groups. The app has also been approved as a secure communication method at our trial institution, thus we are well-positioned to support future integration of the app into standard care through collaboration with our hospital network.

Trial registration number
NCT05989477.

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Factors related to nurses knowledge and attitudes towards pain management: a cross-sectional study of 32 tertiary hospitals in Anhui province, China

Objective
Recognising and managing pain was considered an essential clinical skill for nurses. This study aimed to assess nurses’ knowledge of pain management and the factors associated with it.

Design
A cross-sectional survey was conducted in Anhui province, China, using the Knowledge and Attitudes Survey Regarding Pain (KASRP) (2014). Multiple linear regression analysis identified factors associated with nurses’ KASRP Scores.

Setting
The study was carried out in 32 tertiary hospitals in Anhui province, China, from 21 May to 13 July 2023.

Participants
6928 registered nurses.

Outcome measures
The main outcome was the KASRP Score, reflecting nurses’ knowledge and attitudes towards pain management. We assessed the associations between sociodemographic factors, knowledge-sharing behaviours (KSBs) and KASRP Scores.

Results
Among the 6928 nurses analysed, the average KASRP Score was 17.70±3.57, corresponding to a correct response rate of 44.55%. Gender (p=0.003), professional title (p

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Understanding tissue injury and remodelling in eosinophilic oesophagitis: development towards personalised medicine

Eosinophilic oesophagitis (EoE) is a chronic, immune-mediated condition characterised by eosinophilic infiltration of the oesophagus, leading to significant morbidity due to oesophageal dysfunction. The pathogenic course of EoE begins with tissue injury, marked by the intricate interplay of oesophageal barrier dysfunction and T helper 2-mediated inflammation. In response to tissue damage, a subsequent phase of tissue remodelling features a complex interaction between epithelial cells and stromal cells, aimed at tissue repair. The persistence of inflammation drives these mechanisms towards oesophageal fibrostenosis, mainly through the transforming growth factor-dependent, myofibroblast-driven accumulation of the extracellular matrix. Currently, treatment options for EoE are limited, with dietary intervention, proton pump inhibitors and oral steroids serving as first-line therapies. Dupilumab, an antiinterleukin (IL) 4/IL-13 agent, is the only biologic that has been approved by European and American regulatory authorities. However, emerging OMIC technologies significantly advance our understanding of EoE pathogenesis, revealing novel cellular and molecular mechanisms driving the disease. This progress has accelerated the identification of new therapeutic targets and agents, some already under clinical investigation, potentially expanding our therapeutic arsenal and paving the way for more personalised approaches. In this evolving landscape, artificial intelligence (AI) has shown great potential to further elaborate on the complexities of EoE heterogeneity, offering standardised tools for diagnosis, disease phenotyping, and prediction of treatment response. Though still in their early stages, integrating OMICs and AI marks a pivotal step towards precision medicine in EoE.

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Detection of large flat colorectal lesions by artificial intelligence: a persistent weakness and blind spot

Message Computer-aided detection (CADe) has increased adenoma detection in randomised trials. However, unlike other detection adjuncts, CADe is lesion specific, that is, it is trained on a specific set of lesions. If the training does not include sufficient examples of precancerous lesion subsets, CADe may not perform adequately for lesions in that subset. In a prospective assessment of a second-generation CADe programme in 165 colonoscopies, we identified 26 flat lesions ≥10 mm in 17 patients. The endoscopist identified 22 of 26 lesions before the CADe programme. In 13 lesions, the CADe either generated no detection signal or only a signal over part of the lesion after colonoscope position or luminal inflation adjustment. Thus, the second-generation CADe algorithm, like the first generation, frequently fails to effectively detect large flat colorectal lesions, which are likely very important lesions that a CADe programme should identify. Details The first CADe…

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