Enhancing physical activity during pregnancy using a multi-theory model: a study protocol for a randomised controlled trial in China

Background
Physical inactivity is a global concern and poses serious health risks. Physical inactivity is exacerbated and affects the health of both generations during the special period of pregnancy. Appropriate physical activity (PA) intervention programmes based on health behaviour change theory are lacking. This study aims to evaluate the effectiveness of a PA intervention based on the multi-theory model (MTM) by assessing changes in PA levels, MTM constructs, exercise self-efficacy, quality of life, prenatal depressive symptoms, gestational weight gain and pregnancy and delivery outcomes.

Methods and analysis
This single-centre, parallel, randomised, controlled trial will be conducted at a tertiary care institution in Hangzhou, China. A total of 72 pregnant women without contraindications to exercise at 14–27 weeks+6 days of gestation will be included. Participants will be randomly assigned to either the intervention or control group. The intervention group will engage in a 12 week PA intervention programme based on the MTM and delivered through WeChat, while the control group will receive standard antenatal care. Data will be collected at baseline, 6 weeks of the intervention, 12 weeks of the intervention and within 1 week of delivery. The primary outcomes will include PA levels measured by accelerometers and the PA in Pregnancy Questionnaire, along with the constructs of the MTM. Secondary outcomes will comprise exercise self-efficacy during pregnancy, quality of life, prenatal depressive symptoms, gestation weight gain and pregnancy and delivery outcomes. Data analysis will adhere to the Consolidated Standards of Reporting Trials 2010 statement and follow the intention-to-treat principle.

Ethics and dissemination
The study followed the ethical guidelines approved by the ethics committee of Women’s Hospital School of Medicine Zhejiang University (IRB-20230254-R, Approval Date: 27 July 2023). The results of the study will be submitted for publication and dissemination in a peer-reviewed journal. Participants will receive clarification regarding the study objectives, procedures and will be asked to sign informed consent in written form before the start of the study.

Trial registration number
ChiCTR2400080843. Prospectively registered on 8 February 2024.

Leggi
Gennaio 2025

Developing standards for the implementation of stepped care in child and youth mental health service settings: protocol for a multi-method, delphi-based study

Introduction
Canadian youth mental health (YMH) systems have the potential to urgently tackle the mental health treatment gap currently impacting young people, and stepped care (SC) is one model that can address this need. The adoption of SC models can guide the development of better-connected YMH systems by simplifying transitions and care pathways. To do so requires robust standards that are co-created across stakeholder groups, including with lived experience experts, to ensure the effective implementation of SC models.

Methods and analysis
This study aims to establish standards for implementing SC in Canadian child and YMH service settings by convening and developing a learning alliance (LA) of 65 individuals, translating guiding principles to standards via consensus methods (Delphi study), and operationalising and applying draft standards to three test ecosystems. Members of the LA will be recruited via snowball and purposive recruitment techniques to complete an e-Delphi study over three to four rounds until consensus is achieved. Participants will rank their agreement with including specific clause items in the final standard, and will be given opportunities to provide feedback and suggest revisions during each round. Comments will be analysed, scored and coded accordingly. Once consensus has been achieved, members of the LA will consider the application of these implementation standards in three settings that could benefit from SC. The protocol for this study was registered at Open Science Framework (https://doi.org/10.17605/OSF.IO/J5UNW).

Ethics and dissemination
The protocol has been approved by the Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l’Ouest-de-l’Île-de-Montréal—Mental Health and Neuroscience subcommittee. As part of the ethics approval, informed consent forms for all Delphi participants were created and distributed to participants ahead of the Delphi. This includes parental consent forms for all LA members participating in the study who are under the age of 18. On completion, the project will ultimately support the implementation of SC in diverse service systems and guide the development of a robust and connected mental health delivery system in Canada. The final standard will be shared with relevant government bodies and health planners and disseminated via academic and other platforms.

Leggi
Dicembre 2024

Efficacy in predicting mortality of patients with heart failure using heart rate before intensive care unit discharge: a retrospective cohort study from MIMIC-IV Database

Objective
Heart rate serves as a critical prognostic factor in heart failure (HF) patients. We hypothesise that elevated heart rate in critically ill HF patients on discharge from the intensive care unit (ICU) could be linked to adverse outcomes.

Design
A single-centre retrospective cohort study.

Setting
This study used data collected between 2008 and 2019 from the Medical Information Mart for Intensive Care IV (V.2.0) Database.

Participants
From the 76 943 ICU stays, we enrolled 2365 patients in this study.

Primary and secondary outcome measures
We observed correlations between in-hospital mortality and ICU discharge heart rate of 83.56±15.81 beats per minute (bpm) (survivors) vs 93.84±17.28 bpm (non-survivors, p

Leggi
Dicembre 2024

Protocol for a multi-domain scoping review to identify measures of decision-making ability in an ageing population

Introduction
Deficits in decision-making (DM) can lead to adverse outcomes across multiple domains such as financial management and medical care. By hindering such DM abilities, cognitive impairment (CI) often affects quality of life. Routine screening for CI, however, does not include systematic and comprehensive assessment of DM ability. While there are many DM measures, there is considerable heterogeneity in what constructs are measured and the populations in which they have been validated. This scoping review protocol details the proposed comprehensive examination of published literature on DM measures used in adults aged 45 years and older.

Methods and analysis
Arksey and O’Malley’s (2005) scoping review methodology framework will guide the current scoping review. We will systematically search Embase (Elsevier), MEDLINE (Ovid), PsycINFO (Ebsco), Cochrane Library (Wiley), Web of Science (Clarivate) and Scopus (Elsevier) to identify the studies meeting our eligibility criteria. We will review literature published between January 2018 and November 2023. Following best practice recommendations, a two-stage study selection process will be applied. First, titles and abstracts will be independently reviewed by two reviewers based on our eligibility criteria. Second, full texts will be screened and data will be extracted only from the articles included after the full review. The results of the current scoping review will be reported in adherence to PRISMA-Scr guidelines.

Ethics and dissemination
This study does not require ethics approval as the scoping review methodology involves reviewing results from publicly available published materials. Results of the scoping review will be submitted for publication in a peer-reviewed journal.

Trial registration number
NIA grant number 1U24AG082022-01.

Leggi
Dicembre 2024

Nomogram based on the log odds of negative lymph node/T stage can predict the prognosis of patients with colorectal cancer: a retrospective study based on SEER database and external validation in China

Objectives
This study investigated the prognostic role of log odds of negative lymph node/T stage (LONT) and established a nomogram based on LONT to predict the prognosis in colorectal cancer (CRC) patients.

Design
A retrospective cohort study.

Setting and participants
We enrolled 80 518 CRC patients from the Surveillance, Epidemiology and End Results database between 2010 and 2015. The dataset was split into a training cohort (56 364 patients) and a validation cohort (24 154 patients) at a ratio of 7:3. Furthermore, 500 CRC patients who underwent surgery in the Tenth Affiliated Hospital of Southern Medical University between 1 January 2017 and 20 December 2018, were recruited as the external validation set.

Outcome measures
1-, 3- and 5-year cancer-specific survival (CSS).

Methods
The univariate and multivariate Cox regression analyses were carried out to identify the significant independent prognostic factors of CSS. A nomogram was established based on LONT to predict the prognosis. The performance of the nomogram was comprehensively assessed via the time-dependent receiver operating characteristic curve, concordance index (C-index), calibration curve and decision curve analysis (DCA) comprehensively. Moreover, Kaplan-Meier curves were performed to assess the CSS of the three risk subgroups.

Result
LONT was a significant independent prognostic factor for CSS (LONT1 vs LONT2, HR=0.670, 95% CI 0.642 to 0.698, p

Leggi
Dicembre 2024

'We are not trained to do clinical work: security staff providing physical restraint for NGT feeding in English paediatric wards–a qualitative multi-informant study

Objective
To gain insights into the experience, and impact, of using security staff to facilitate physical restraints for nasogastric tube feeding.

Design
A cross-sectional design using 39 individual interviews, three online focus groups and three written submissions involving young people with lived experience (PWLE), parents/carers, paediatric staff and security staff involved in nasogastric feeding under restraint in paediatric settings in England. Qualitative semistructured interviews were transcribed and thematically analysed.

Participants
53 individuals participated: seven security staff (all men); nine PWLE who experienced the intervention between the ages of 9 and 17 (all female); 20 parents (15 mothers, 5 fathers) and 20 paediatric staff (5 men, 15 women).

Results
Regarding the involvement of security staff, participants spoke in relation to two primary themes (1) short-term impact and (2) long-term impact. Short-term themes included that the intervention felt inappropriate and traumatic while also recognising its lifesaving nature and the fact that involving security guards preserved positive relationships with nursing staff. Longer-term themes included the development of trauma symptoms, while also acknowledging the skill development and improved professional relationships that could result from delivering the intervention.

Conclusions
This lifesaving clinical intervention can negatively impact security staff as much as the patient, parents/carers and paediatric staff. A prebrief and debrief should be seen as part of the ‘process’. Further research is needed to better understand what else can mitigate negative impacts.

Leggi
Dicembre 2024

AI-assisted detection for chest X-rays (AID-CXR): a multi-reader multi-case study protocol

Introduction
A chest X-ray (CXR) is the most common imaging investigation performed worldwide. Advances in machine learning and computer vision technologies have led to the development of several artificial intelligence (AI) tools to detect abnormalities on CXRs, which may expand diagnostic support to a wider field of health professionals. There is a paucity of evidence on the impact of AI algorithms in assisting healthcare professionals (other than radiologists) who regularly review CXR images in their daily practice.

Aims
To assess the utility of an AI-based CXR interpretation tool in assisting the diagnostic accuracy, speed and confidence of a varied group of healthcare professionals.

Methods and analysis
The study will be conducted using 500 retrospectively collected inpatient and emergency department CXRs from two UK hospital trusts. Two fellowship-trained thoracic radiologists with at least 5 years of experience will independently review all studies to establish the ground truth reference standard with arbitration from a third senior radiologist in case of disagreement. The Lunit INSIGHT CXR tool (Seoul, Republic of Korea) will be applied and compared against the reference standard. Area under the receiver operating characteristic curve (AUROC) will be calculated for 10 abnormal findings: pulmonary nodules/mass, consolidation, pneumothorax, atelectasis, calcification, cardiomegaly, fibrosis, mediastinal widening, pleural effusion and pneumoperitoneum. Performance testing will be carried out with readers from various clinical professional groups with and without the assistance of Lunit INSIGHT CXR to evaluate the utility of the algorithm in improving reader accuracy (sensitivity, specificity, AUROC), confidence and speed (paired sample t-test). The study is currently ongoing with a planned end date of 31 December 2024.

Ethics and dissemination
The study has been approved by the UK Healthcare Research Authority. The use of anonymised retrospective CXRs has been authorised by Oxford University Hospital’s information governance teams. The results will be presented at relevant conferences and published in a peer-reviewed journal.

Trial registration number
Protocol ID 310995-B (awaiting approval), ClinicalTrials.gov

Leggi
Dicembre 2024

Incidence and prevalence of antiphospholipid syndrome (APS) in the USA (2016-2019): a retrospective database study

Objective
Few epidemiological studies are reported in the published literature on the incidence or prevalence of antiphospholipid syndrome (APS), and available results are heterogeneous. This study aimed to estimate the incidence and prevalence of APS in the USA, overall and by APS subtype.

Design
A retrospective analysis of APS disease incidence and a cross-sectional analysis of disease prevalence.

Setting
Merative MarketScan Commercial Claims and Encounters Database, and the Medicare Supplemental and Coordination of Benefits Database.

Participants
All individuals with claims for at least two antiphospholipid antibody tests undertaken at least 12 weeks apart and a diagnosis claim for APS as a primary or secondary diagnosis on or after the second antibody test, during the period 1 January 2016 to 31 December 2019.

Main outcome measures
Annual incidence and prevalence of APS and APS subtypes.

Results
In total, 1708 cases of APS were identified during the study period (2016–2019), of which 83% were women. The overall annual standardised incidence rate of APS per 100 000 person-years increased slightly over the study period, from 2.31 in 2016 to 2.71 in 2019. In 2019, the estimated annual prevalence of APS per 100 000 persons was 10.42 per 100 000 persons (95% CI 9.96–10.90). Based on this and US census data, we have estimated that 34 000 persons in the USA were affected by APS in 2019.

Conclusions
These data add to the estimates of prevalence and incidence of APS in the literature, all of which have different strengths and limitations of the different data sources and case ascertainment methods.

Leggi
Dicembre 2024

Prediction of relative survival trends in patients with cutaneous squamous cell carcinoma using a model-based period analysis: a retrospective analysis of the surveillance, epidemiology, and end results database

Objectives
Cutaneous squamous cell carcinoma (CSCC) represents a malignancy characterised by the aberrant proliferation of skin epithelial cells, and certain instances of squamous cell carcinoma (SCC) exhibit features indicative of a heightened proclivity for recurrence, metastasis, and mortality. Tracking the latest survival rates for CSCC is crucial for patient care and public health strategies.

Design
This was a retrospective study.

Setting
The Surveillance, Epidemiology, and End Results (SEER) Programme database was established by the National Cancer Institute in 1973. It is one of the commonly used cancer databases in the United States, covering a variety of tumour types including lung cancer, breast cancer, gastric cancer, colorectal cancer, prostate cancer, etc. It collects cancer diagnosis, treatment and survival data for approximately 50% of the US population, providing systematic evidence support and valuable first-hand information for clinicians’ evidence-based practice and clinical medical research. The data used in this study covers 20 years of information on patients with cutaneous squamous cell carcinoma from 2000 to 2019.

Participants
In this study, we identified a cohort of 2 04 055 patients, comprising 95 287 women and 1 08 768 men, who were diagnosed with CSCC between 2000 and 2019 in the SEER database. The inclusion criteria for this research encompassed individuals aged 15 years and older, availability of data spanning from 2000 to 2019, confirmation through microscopic examination, and the presence of a primary tumour classified as CSCC. Exclusion criteria involved cases solely validated through autopsy or a death certificate, those alive or with indeterminable survival times, and instances with incomplete data.

Outcome measures
The SEER database’s patient trends and relative survival rate for patients with CSCC were evaluated using period analysis method from 2000 to 2019. The anticipated 5 year relative survival rate among CSCC patients for the years 2020 to 2024 was projected using a generalised linear model.

Results
A total of 204,055 CSCC patients were identified, 95 287 women and 1 08 768 men. Most patients were male, white, lived in urban areas, presenting with localised metastases, aged 55–64 years, and had untyped CSCC. During the observation period, the 5 year relative survival rate of CSCC patients showed a slight improvement overall, while the 5 year relative survival rate of some subtypes showed obvious fluctuations. Particularly noteworthy was the substantial amelioration observed in the small cell nonkeratinizing SCC subtype, escalating from 60.4% in 2000 to 72.8% in 2019. The 5 year overall relative survival rates for CSCC patients during the intervals 2000–2004, 2005–2009, 2010–2014, and 2015–2019 documented rates of 62.4%, 63.4%, 64.3%, and 66.3%, respectively. Males had slightly lower survival rates than females, older patients had lower rates than younger patients, and white patients had better outcomes than non-white patients. Urban patients had higher survival rates than rural patients. Patients with distant metastases had significantly lower survival rates.

Conclusion
The temporal span from 2000 to 2019 witnessed a gradual yet delimited increase in survival rates among CSCC patients. This incremental trajectory persists, with a prognosticated survival rate of 67.1 anticipated between 2020 and 2024.

Leggi
Dicembre 2024