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Beneficial value of [18F]FDG PET/CT in the follow-up of patients with stage III non-small cell lung cancer (NVALT31-PET study): study protocol of a multicentre randomised controlled trial

Por: Billingy · N. E. · Verberkt · C. A. · Bahce · I. · Hassing · M. J. · Schoorlemmer · J. · Sarioglu · M. · Senan · S. · Aarntzen · E. H. J. G. · Comans · E. F. I. · Kievit · W. · Teerenstra · S. · Jacobs · C. · Keijser · A. · Heuvel · M. M. v. d. · Becker-Commissaris · A. · Walraven · I
Introduction

Patients with stage III non-small cell lung cancer (NSCLC) are at high risk of developing post-treatment recurrences (50–78%) during follow-up. As more effective treatments are now available, especially for patients with oligometastatic disease, earlier detection of recurrences may prolong survival and health-related quality of life (HRQOL). With the use of 2'-deoxy-2'-[18F]fluoroglucose positron emission tomography/CT ([18F]FDG PET/CT) during follow-up, recurrences may be detected earlier. Therefore, the primary objective of this study is to compare the 3-year overall survival of patients with stage III NSCLC during follow-up surveillance with [18F]FDG PET/CT versus follow-up with conventional CT (usual care). Secondary objectives address the number, location and timing of recurrences, as well as HRQOL, cost-effectiveness and patient experiences of PET/CT scans.

Methods and analysis

In this multicentre randomised controlled clinical trial, 690 patients with stage III NSCLC (8th edition International Association for the Study of Lung Cancer (IASLC) Tumor, Nodes, Metastasis (TNM) classification) who completed curative intended treatment and started follow-up care (which may include adjuvant therapy) will be randomised 1:1 to either the intervention ([18F]FDG PET/CT) or the control group (CT). Patients will undergo follow-up scans during visits at 6, 12, 18, 24 and 36 months. Data will be collected using validated questionnaires, electronic case report forms and data extractions from the electronic health records. Additionally, blood samples will be collected, and interviews will be conducted.

Ethics and dissemination

The study protocol has been approved by the Medical Ethical Committee of the Radboudumc and review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences. Data will be published in a data repository or other online data archive.

Trial registration number

NCT06082492.

Pain Services in the Netherlands: A Cross‐Sectional Questionnaire Study on Organisation, Tasks and Responsibilities

ABSTRACT

Aims

Providing an overview of the organisation, tasks, and responsibilities of acute and transitional pain services in the Netherlands.

Design

Cross-sectional questionnaire study.

Methods

An online questionnaire was sent to representatives of Dutch hospital pain services performing inpatient surgery. It included items on organisation, staffing, education, roles, tasks and responsibilities. Data were analysed descriptively.

Results

Of the surveyed hospitals, 92.2% reported having an acute pain service, while only 6.5% had a transitional pain service. Most pain services (acute pain services 76.3%, transitional pain services 80.0%) are part of the anaesthesiology department. Staffing includes anaesthesiologists, nurses, and/or nurse anaesthetists, with or without pain specialisation. Acute pain service teams monitor complex pain management techniques. Nearly all acute pain services (89.8%) provide pain management training, and 60% monitor hospital-wide pain management quality. All transitional pain services monitored opioid use post-discharge and conducted follow-up calls with patients.

Conclusions

Acute pain services are well established in Dutch hospitals, whereas transitional pain services remain limited. Organisational structures, tasks, and responsibilities vary, with key challenges in staffing, service organisation, and education. Future research should focus on optimising staffing, expanding transitional pain services, the role of the pain nurse, and establishing a national pain management education framework.

Implications for the Profession and Patient Care

This study highlights the significant impact of pain nurses as a central professional within the interdisciplinary team, contributing to quality care and education, ultimately benefiting patients.

Impact

This study provides a current overview of pain services in the Netherlands, supporting pain nurses in innovating pain services, highlighting key challenges and opportunities for improvement.

Reporting Method

STROBE checklist.

Patient/Public Involvement

None.

Non-invasive electrophysiological monitoring vs conventional monitoring during labour in a tertiary obstetric care centre in the Netherlands: study protocol of a cohort intervention random sampling study (NIEM-II study)

Introduction

Conventional cardiotocography (CTG) has been used extensively to monitor the fetal condition during labour. However, conventional non-invasive monitoring is limited by the difficulty of obtaining an adequate signal quality, particularly in the case of obese parturients. Furthermore, the rate of operative deliveries keeps rising despite the ability for conventional intrapartum monitoring. Electrophysiological monitoring is an alternative technique that has been developed over the past decades to improve signal quality. This non-invasive, transabdominal and wireless alternative measures fetal heart rate by fetal electrocardiography (NI-fECG), and uterine activity by electrohysterography (EHG). Both NI-fECG and EHG have been proven to be more accurate and reliable than conventional non-invasive methods and are less affected by maternal Body Mass Index. Nevertheless, it is still unknown whether electrophysiological intrapartum monitoring leads to better obstetric and neonatal outcomes. This study aims to investigate whether electrophysiological monitoring during labour affects the number of operative interventions compared with conventional monitoring during labour.

Methods and analysis

This is a single-centre cohort intervention random sampling study which will be performed in a tertiary obstetric care centre. In total, 3471 term pregnant women with a singleton fetus in cephalic position and indication for continuous fetal monitoring during labour will be included. Eligible women will be prospectively included in the cohort for conventional monitoring. From these women, 90.9% of women will be randomly sampled and will be offered electrophysiological monitoring. A historical cohort of an additional 2100 women who received conventional monitoring will be added to the conventional group. This historical cohort was collected between April 2019 and February 2023. The primary outcome will be the number of operative interventions during labour. Secondary outcome measures include maternal and neonatal outcomes, patient and healthcare professional perspectives and costs.

Ethics and dissemination

This study received approval from the Medical Ethics Committee of Máxima Medical Centre (W22.071) on 1 November 2023. All participants will provide informed consent prior to data collection. Results of the study will be disseminated in peer-reviewed scientific journals and conference presentations.

Trial registration number

NCT06135961.

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