Differential effects of diet and physical activity interventions in pregnancy to prevent gestational diabetes mellitus and reduce gestational weight gain by level of maternal adiposity: a protocol for an individual patient data (IPD) meta-analysis of randomised controlled trials

Introduction
Women and their infants are at increased risk of complications if gestational diabetes mellitus (GDM) or excessive gestational weight gain (GWG) occurs in pregnancy. Weight management interventions in pregnancy, consisting of diet and physical activity components are targeted based on maternal body mass index (BMI). However, the relative effectiveness of interventions targeted based on alternative measures of adiposity to BMI is unclear. This individual patient data (IPD) meta-analysis aims to explore whether interventions are more effective at preventing GDM and reducing GWG in women according to their level of adiposity.

Methods
The International Weight Management in Pregnancy Collaborative Network has a living database of IPD from randomised trials of diet and/or physical activity interventions in pregnancy. This IPD meta-analysis will use IPD from trials identified from systematic literature searches up until March 2021, where maternal adiposity measures (eg, waist circumference) were collected prior to 20 weeks’ gestation. A two-stage random effects IPD meta-analysis approach will be taken for each outcome (GDM and GWG) to understand the effect of early pregnancy adiposity measures on the effect of weight management interventions for GDM prevention and GWG reduction. Summary intervention effects with 95% CIs) will be derived along with treatment covariate interactions. Between-study heterogeneity will be summarised by I2 and tau2 statistics. Potential sources of bias will be evaluated, and the nature of any missing data will be explored and appropriate imputation methods adopted.

Ethics and dissemination
Ethics approval is not required. The study is registered on the International Prospective Register of Systematic Reviews (CRD42021282036). Results will be submitted to peer-reviewed journals.

PROSPERO registration number
CRD42021282036.

Leggi
Marzo 2023

Ultrasound-guided Jamshidi needle puncture to reduce radiation exposure during percutaneous pedicle screw placement: study protocol for a randomised controlled trial

Introduction
Percutaneous pedicle screw placement (PPSP) is a minimally invasive procedure highly dependent on fluoroscopic guidance, which results in increased radiation exposure and prolonged operative time. Ultrasound can image the lumbar paravertebral anatomy and the needle trajectory in real time, which may help reduce the use of fluoroscopy and radiation dose in PPSP. We will conduct a parallel randomised controlled trial to mainly investigate the effect of ultrasound guidance in radiation reduction during PPSP.

Methods and analysis
A total of 42 patients will be recruited and randomly assigned to the intervention group and the control group at a 1:1 ratio. In the intervention group, we will use ultrasound in combination with fluoroscopy to guide the insertion of the Jamshidi needles. In the control group, PPSP will be performed under conventional fluoroscopic guidance. The primary outcomes are the cumulative fluoroscopy time (s), radiation dose (mGy) and exposure times of screw placement. The secondary outcomes are insertion time of guidewire, rate of pedicle perforation, rate of facet joint violation, visual analogue scale for back pain, Oswestry Disability Index and complications. The participants, outcome assessors and data analysts will be blinded to allocation.

Ethics and dissemination
The trial was approved by the research ethics committee of Shengjing Hospital, China Medical University. The results will be presented at academic seminars and submitted for publication in peer-reviewed journals.
This study involves human participants and was approved by Research Ethics Committee of Shengjing Hospital, China Medical University reference number:2022PS704K. Participants gave informed consent to participate in the study before taking part.

Trial registration number
ChiCTR2200057131.

Leggi
Marzo 2023

Use of tranexamic acid (TXA) to reduce preterm birth and other adverse obstetrical outcomes among pregnant individuals with placenta previa: a systematic review protocol

Introduction
Placenta previa is a placental implantation pathology where the placenta overlies the internal endocervical os. Placenta previa affects approximately 4 per 1000 pregnancies and increases the risk of antepartum bleeding, emergent preterm labour and emergency caesarean sections. Currently, placenta previa is managed through expectant management. Guidelines primarily revolve around the mode and timing of delivery, in-hospital admissions and surveillance. However, the methods to prolong pregnancy have not proven to be clinically effective. Tranexamic acid (TXA), an antifibrinolytic agent, is effectively used to prevent and treat postpartum haemorrhage as well as menorrhagia, with limited adverse effect, and may prove to be an effective treatment for placenta previa. The objective of this systematic review protocol is to review and synthesise the evidence of TXA use for antepartum haemorrhage in placenta previa.

Methods and analysis
Preliminary searches were conducted on 12 July 2022. We will search MEDLINE, EMBASE, CINAHL, Scopus and the Cochrane Central Register of Controlled Trials. Grey literature resources such as clinical trials registries (ClinicalTrials.gov and the WHO’s International Clinical Trials Registry) and preprint servers (Europe PMC and Open Science Framework) will also be searched. The search terms will comprise of index headings and keyword searches related to TXA and the placenta or antepartum bleeding. Cohort and randomised and non-randomised trials will be considered. The target population is pregnant people, of any age, with placenta previa. The intervention is TXA given in the antepartum period. The main outcome of interest is preterm birth before 37 weeks, however, all perinatal outcomes will be collected. Title and abstract will be screened by two reviewers and any conflict will be discussed and evaluated by a third reviewer. The literature will be summarised in narrative form.

Ethics and dissemination
No ethics approval is required for this protocol. Findings will be disseminated through peer-review publication, lay summaries and conference presentations.

PROSPERO registration number
CRD42022363009).

Leggi
Marzo 2023

Evidence-Based Strategies to Reduce Suicide Mortality Among Patients With Cancer

Since 1999, the US suicide rate has increased by more than 30%. Numerous studies have demonstrated that suicide mortality is elevated among people with cancer, especially cancers with lower 5-year survival. In this issue of JAMA Oncology, Potter et al report that patients who underwent surgery for cancers with lower 5-year survival also died of suicide much sooner than patients with less deadly cancers, implicating the importance of screening patients with cancer for psychiatric conditions and suicide risk. In addition, the data highlight the importance of ensuring access to evidence-based psychological and behavioral treatments both before and after cancer surgery. Approximately 1 in 6 patients have a preexisting psychiatric condition. Apart from an association with suicide mortality, psychiatric conditions can adversely affect a range of outcomes, including increased perioperative complications, longer hospital stays, higher rates of readmission, and increased risk of postoperative suicidal ideation. Preoperative or perioperative treatment of psychiatric conditions may therefore lead to improved outcomes.

Leggi
Marzo 2023

Implementation of the national Getting it Right First Time orthopaedic programme in England: a qualitative case study analysis

Objective
To describe the implementation and impact of the Getting it Right First Time (GIRFT) national orthopaedic improvement programme at the level of individual National Health Service (NHS) Trusts.

Design
Qualitative case studies conducted at six NHS Trusts, as part of a mixed-methods evaluation of GIRFT.

Setting
NHS elective orthopaedic surgery in England.

Participants
59 NHS staff.

Intervention
Improvement bundle, including bespoke routine performance data and improvement recommendations for each organisation, delivered via ‘deep-dive’ visits to NHS Trusts by a senior orthopaedic clinician.

Results
Although all case study sites had made improvements to care, very few of these were reportedly a direct consequence of GIRFT. A range of factors, operating at three different levels, influenced their ability to implement GIRFT recommendations: at the level of the orthopaedic team (micro—eg, how individuals perceived the intervention); the wider Trust (meso—eg, competition for theatre/bed space) and the health economy more broadly (macro—eg, requirements to form local networks). Some sites used GIRFT evidence to support arguments for change which helped cement and formalise existing plans. However, where GIRFT measures were not a Trust priority because of more immediate demands—for example, financial and bed pressures—it was less likely to influence change.

Conclusion
Dynamic relationships between the different contextual factors, within and between the three levels, can impact the effectiveness of a large-scale improvement intervention and may account for variations in implementation outcomes in different settings. When designing an intervention, those leading future improvement programmes should consider how it sits in relation to these three contextual levels and the interactions that may occur between them.

Leggi
Febbraio 2023

Four 2×2 factorial trials of smartphone CBT to reduce subthreshold depression and to prevent new depressive episodes among adults in the community-RESiLIENT trial (Resilience Enhancement with Smartphone in LIving ENvironmenTs): a master protocol

Introduction
The health burden due to depression is ever increasing in the world. Prevention is a key to reducing this burden. Guided internet cognitive–behavioural therapies (iCBT) appear promising but there is room for improvement because we do not yet know which of various iCBT skills are more efficacious than others, and for whom. In addition, there has been no platform for iCBT that can accommodate ongoing evolution of internet technologies.

Methods and analysis
Based on our decade-long experiences in developing smartphone CBT apps and examining them in randomised controlled trials, we have developed the Resilience Training App Version 2. This app now covers five CBT skills: cognitive restructuring, behavioural activation, problem-solving, assertion training and behaviour therapy for insomnia. The current study is designed as a master protocol including four 2×2 factorial trials using this app (1) to elucidate specific efficacies of each CBT skill, (2) to identify participants’ characteristics that enable matching between skills and individuals, and (3) to allow future inclusion of new skills. We will recruit 3520 participants with subthreshold depression and ca 1700 participants without subthreshold depression, to examine the short-term efficacies of CBT skills to reduce depressive symptoms in the former and to explore the long-term efficacies in preventing depression in the total sample. The primary outcome for the short-term efficacies is the change in depressive symptoms as measured with the Patient Health Questionnaire-9 at week 6, and that for the long-term efficacies is the incidence of major depressive episodes as assessed by the computerised Composite International Diagnostic Interview by week 50.

Ethics and dissemination
The trial has been approved by the Ethics Committee of Kyoto University Graduate School of Medicine (C1556).

Trial registration number
UMIN000047124.

Leggi
Febbraio 2023

Does increasing physician volume in primary healthcare facilities under the hierarchical medical system help reduce hospital service utilisation in China? A fixed-effects analysis using province-level panel data

Objective
To examine whether increases in physician volume in primary healthcare facilities are associated with reduced utilisation of hospital outpatient and inpatient services after China facilitated the establishment of the hierarchical medical system.

Design
We used a two-way fixed-effects regression to examine the association between the annual number of physicians in primary healthcare facilities and that of patient visits per physician, inpatient admissions and total expenses per outpatient visit in public hospitals during 2010–2014 and 2015–2019. Variables were log transformed to ensure the normal distribution of the data.

Setting
Province-level data of all 31 provinces in mainland China from 2010 to 2019 were collected from the China Health Statistics Yearbook published by the China Health Commission.

Participants
All 31 provinces in mainland China.

Primary and secondary outcome measures
The annual number of outpatient visits per physician, hospital admission and total expenses per outpatient visit in public hospitals.

Results
During 2015–2019, we found that, on average, a 1% increase in the number of primary healthcare physicians was accompanied by a 0.19% (95% CI –0.33% to –0.05%) reduction in the annual number of visits per physician in public hospitals, and a 0.31% (95% CI –0.52% to –0.10%) reduction in patient visits in city-administered hospitals. No significant associations were found between 2010 and 2014. We also did not observe any significant associations between primary healthcare physician volume and hospital admissions or outpatient expenses during neither 2010–2014 and 2015–2019.

Conclusions
In the context of the hierarchical medical system, enhancing physician volume in primary healthcare facilities helps reduce outpatient visits in public hospitals, especially city-administered hospitals. However, more efforts are required to be continuously made to improve primary healthcare capacity to avoid preventable hospital admissions and outpatient expenses.

Leggi
Febbraio 2023