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Effectiveness and cost-effectiveness of a structured integrated post-pulmonary embolism follow-up care model (Attend-PE): a rationale and protocol for a multicentre clinical pre-post study
Introduction
Patients with pulmonary embolism (PE) experience impaired functional ability and reduced quality of life long after discharge from the hospital. However, there are no structured follow-up programmes in Denmark for these patients, and there is considerable variation in practice patterns of post-PE management. No studies have investigated the effectiveness of structured follow-up care models in patients with PE. This study aims to investigate the effect and cost-effectiveness of a structured integrated post-pulmonary embolism follow-up care model (Attend-PE) compared with usual care. The Attend-PE model outlines a structured approach for in-hospital follow-up, involving group-based patient education, individual consultations and systematic use of patient-reported outcome measures to assess the patient’s physical and psychological well-being.
Methods and analysis
The study is conducted in Denmark, where the healthcare system is tax-funded and services are freely available for all citizens, with an expected inclusion of 2000 patients in total. A pre-post-intervention study design is used to compare outcomes in the post-implementation cohort with the pre-implementation cohort. The co-primary outcomes are (1) health-related quality of life (patient-reported outcome, PRO) and (2) adherence to medical treatment (register-based data). Secondary outcomes include PROs on disability, treatment satisfaction, self-management, anxiety, depression and work productivity, and register-based outcomes, including recurrent PE, bleeding, mortality and healthcare use. Register-based data will be assessed at baseline (date of PE event), 6 and 12 months, while PRO-data will be assessed at 6 and 12 months after the PE event. The health economic evaluation of the Attend-PE model will include a cost-effectiveness analysis and a cost-utility analysis.
Ethics and dissemination
The project will be conducted by the Declaration of Helsinki. In accordance with the Danish Act on Health Research Ethics §14, the study is exempt from approval. The use of survey responses in research (in anonymous form) is, however, contingent on participants’ consent, and the invitation letter therefore included information about the purpose of the study and participants’ rights to withdraw consent at any time, and that completion of the questionnaire is considered as consent to their survey data to be included in research.
Study findings will be disseminated in scientific peer-reviewed journals, at national and international conferences, and for staff and decision-makers at participating hospitals and patients and relatives via the Danish Heart Association.
Trial registration number
Clinicaltrials.gov NCT06037096.
Efficacy of combining aspirin with hydroxychloroquine in pregnancies at high risk for pre-eclampsia: a prospective, multicentre, open-label, single-arm clinical trial, investigator-initiated study (HUGS study)
Introduction
The use of hydroxychloroquine (HCQ) during pregnancies complicated by systemic lupus erythematosus or refractory antiphospholipid antibody syndrome has demonstrated a significant ability to prevent pre-eclampsia (PE). As such, the potential for the administration of HCQ to prevent PE in other high-risk pregnancies is an important clinical research agenda among maternal and fetal medicine specialists. Mechanistically, the anti-inflammatory and immunomodulatory effects of HCQ can offer vascular protection and inhibit the placental dysfunction-associated thrombotic changes underlying the pathophysiology of PE, fetal growth restriction (FGR) and fetal death in utero (FDIU). Placenta-mediated complications exhibit a distinctive overlapping syndrome between pregnancies, and low-dose aspirin is the only prevention method currently in use. This study investigated the effects of improvements in outcomes with HCQ administration in high-risk pregnancies complicated by a previous experience of PE, FGR or FDIU.
Methods and analysis
This multicentre, open-label, single-arm trial commenced on 31 May 2022, in three tertiary hospitals in Korea. Pregnant women with a prior history of PE, FGR or FDIU are eligible to participate. This single-arm study set the previous study with the most similar inclusion criteria, aspirin dose and drug administration period as the comparison group. The required sample size was determined to be 58, with an expected dropout rate of 10%.
Ethics and dissemination
This study protocol was approved by the following institutions and committees: Institutional Review Boards of Chung-Ang University Gwangmyeong Hospital (2304-082-056), Samsung Medical Center (2021-11-087-003) and Kyungpook National University Chilgok Hospital (2021-06-005-006) and the Ministry of Food and Drug Safety. The results will be disseminated to the general public, grant funder, maternal–fetal medicine specialists and other researchers.
Trial registration number
NCT05287321.
Linee guida su diagnosi e gestione del diabete e prediabete
Cost-effectiveness of long-acting progestogens versus the combined oral contraceptives pill for preventing recurrence of endometriosis-related pain following surgery: an economic evaluation alongside the PRE-EMPT trial
Objectives
To evaluate the cost-effectiveness of long-acting progestogens (LAP), including levonorgestrel-releasing intrauterine system (LNG-IUS) and depot-medroxyprogesterone acetate (DMPA), compared with the combined oral contraceptives pill (COCP) in preventing recurrence of endometriosis-related pain postsurgery.
Design
Within-trial economic evaluation alongside a multicentre, pragmatic, parallel-group, open-label, randomised controlled trial (Preventing Recurrence of Endometriosis by means of Long-Acting Progestogen Therapy trial).
Setting
Thirty-four UK hospitals recruiting participants from November 2015 to March 2019.
Patients
Four hundred and five women aged 16–45 years undergoing conservative endometriosis surgery.
Interventions
The ratio of 1:1 randomisation to receive LAPs (LNG-IUS or DMPA) or COCP.
Main outcome measures
The primary evaluation was a cost-utility analysis based on cost per quality-adjusted life-year (QALY) gained at 3 years. We adopted a UK National Health Service perspective. Secondary analyses in the form of cost-effectiveness analysis based on a range of outcomes were also undertaken.
Results
For the primary analysis, the COCP group incurred an additional cost of £533 (95% CI £52 to £983) per woman compared with LAPs. Treatment with COCP generated additional QALYs of 0.031 (95% CI –0.079 to 0.139) compared with the LAP group over 36-month follow-up. The incremental cost-effectiveness ratio for COCP compared with LAPs is therefore approximately £17 193 per QALY. The probabilistic sensitivity analysis suggested that there was a 54.7% probability that COCP would be cost-effective at the £20 000/QALY threshold. The secondary analyses revealed results more in favour of LAPs.
Conclusion
Although the COCP has a slightly higher probability of being cost-effective at £20 000/QALY threshold, there remains considerable uncertainty, with only marginal differences in outcomes between the two treatments. The lower rates of further surgery and second-line medical treatment for women allocated to LAPs may make this option preferable for some women.
Trial registration number
ISRCTN 97865475.
Linea guida sulla diagnosi, monitoraggio e gestione dell’asma
State-of-the-art performance of deep learning methods for pre-operative radiologic staging of colorectal cancer lymph node metastasis: a scoping review
Objectives
To assess the current state-of-the-art in deep learning methods applied to pre-operative radiologic staging of colorectal cancer lymph node metastasis. Specifically, by evaluating the data, methodology and validation of existing work, as well as the current use of explainable AI in this fast-moving domain.
Design
Scoping review.
Data sources
Academic databases MEDLINE, Embase, Scopus, IEEE Xplore, Web of Science and Google Scholar were searched with a date range of 1 January 2018 to 1 February 2024.
Eligibility criteria
Includes any English language research articles or conference papers published since 2018 which have applied deep learning methods for feature extraction and classification of colorectal cancer lymph nodes on pre-operative radiologic imaging.
Data extraction and synthesis
Key results and characteristics for each included study were extracted using a shared template. A narrative synthesis was then conducted to qualitatively integrate and interpret these findings.
Results
This scoping review covers 13 studies which met the inclusion criteria. The deep learning methods had an area under the curve score of 0.856 (0.796 to 0.916) for patient-level lymph node diagnosis and 0.904 (0.841 to 0.967) for individual lymph node assessment, given with a 95% confidence interval. Most studies have fundamental limitations including unrepresentative data, inadequate methodology, poor model validation and limited explainability techniques.
Conclusions
Deep learning methods have demonstrated the potential for accurately diagnosing colorectal cancer lymph nodes using pre-operative radiologic imaging. However, several methodological and validation flaws such as selection bias and lack of external validation make it difficult to trust the results. This review has uncovered a research gap for robust, representative and explainable deep learning methods that are end-to-end from automatic lymph node detection to the diagnosis of lymph node metastasis.
Predictors of upper limb motor recovery in stroke survivors: a pre-post test study design
Objectives
The study aimed to assess the predictors of upper limb motor recovery in stroke survivors.
Design
Pre–post test study design.
Setting
Conducted in two centres (First Level Hospital and University Teaching Hospital in Lusaka).
Participants
Patients living with stroke accessing physiotherapy services at the two public hospitals. A total of 52 patients were recruited at the start of the study, 6 were lost to follow-up and 46 completed the study.
Intervention
Conventional physiotherapy for 8 weeks (5 September 2022–28 October 2022).
Primary outcome
Motor function measured using a Fugl-Meyer assessment of the upper extremity.
Results
Analysis was conducted on 46 participants. A significant difference was observed between the level of motor function at baseline and after 8 weeks of treatment (p=0.0183). At baseline, 50% of participants had mild motor function, which improved after 8 weeks, with 69.6% having mild motor function. Stroke patients with severe motor function impairment at baseline were associated with 0.01 times likelihood of having mild motor function impairment after 8 weeks of physiotherapy treatment (AOR 0.01; 95 % CI 0.00 to 0.16; p=0.002).
Conclusion
The motor function of stroke patients continues to improve over time. This study demonstrated that initial upper limb motor function impairment could be used as a predictor for upper limb motor function.