Conectar
Outcome reporting in studies on sacrococcygeal teratoma (SCT) is highly heterogeneous, which limits comparability across studies and thus hampers the development of international treatment guidelines.
Variation in treatment and access to facilities contributes to differences in outcome reporting between centres and countries. Establishing a Core Outcome Set (COS) can improve consistency in outcome reporting and facilitate global collaboration and data comparison. We therefore aim to develop a Core Outcome Set for SCT (COS-SCT) using the Delphi method to achieve consensus on key outcomes. This will enhance the standardisation of outcome reporting and improve the quality of research and clinical care for SCT patients globally.
The development of the COS-SCT will consist of three phases. First, a systematic review will be performed to identify outcomes reported in studies on the surgical treatment of SCT in children. Second, an international Delphi survey will be conducted among key stakeholders, including clinicians, researchers and patient representatives, to establish consensus on outcome prioritisation. Finally, a consensus meeting with representatives from all stakeholder groups will be held to ratify the final Core Outcome Set. The study will follow methodological guidance from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and will be developed and reported in accordance with the Core Outcome Set Standards for Development (COS-STAD) and Core Outcome Set Standards for Reporting (COS-STAR).
The medical research ethics committee of the Amsterdam University Medical Centre (Amsterdam UMC) confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study, and therefore a full review by the ethics committee is not required. This study is registered in the COMET initiative database. Results will be disseminated in peer-reviewed academic journals and conference presentations.
Trial registration number: COMET registration number 3485
To explore the perceived importance of essential Value-Based Healthcare (VBHC) and patient-centred care elements within operational military healthcare among wounded service members (WSM), military surgeons (MS) and medical commanders, and to identify preconditions that enable the delivery of patient-centred care and relevant medical outcomes during military operations.
A two-round Delphi study was conducted following the Accurate Consensus Reporting Document guideline. An initial list of 17 preconditions was developed through a narrative-style literature review and expert-panel discussion. Preconditions were rated on a four-point Likert scale (‘not important’ to ‘very important’) to reach consensus on ‘military-oriented’ preconditions for patient-centred trauma care.
An in-person expert-panel meeting and subsequent online Delphi surveys conducted between March 2020 and September 2022.
The expert panel consisted of Dutch military healthcare leaders and clinical specialists. A total of 30 participants completed both Delphi rounds, including 17 MS and commanding officers (Group 1) and 13 WSM (Group 2) with deployment experience in Uruzgan, Afghanistan, ensuring balanced representation of care providers, facilitators and recipients.
Primary outcome: identification of military-oriented preconditions essential for patient-centred and value-based trauma care. Secondary outcome: conceptual contribution to the future development of patient-centred outcome measures for military trauma populations.
Consensus was reached on 10 preconditions perceived as important or very important. While Group 1 prioritised operational readiness and procedural efficiency, Group 2 emphasised communication, shared decision-making and family involvement. Both groups rated informed consent, timely treatment registration and patient safety as the most critical elements, demonstrating convergence between logistic-oriented and patient-oriented perspectives.
Integrating VBHC principles into military medical doctrine can reconcile operational readiness with patient-centred care. The consensus-based preconditions identified in this study provide a foundation for developing measurable outcomes that reflect value for both patients and the military health system and can guide future VBHC implementation in trauma-related operational care.
Inguinal hernia repair is one of the most frequently performed operations in the paediatric population and can be performed according to two approaches: open or laparoscopic. At present, decisive evidence about the best treatment strategy is lacking and consequently, there is an ongoing debate about the most (cost-)effective treatment for the paediatric inguinal hernia. The aim of the Hernia Endoscopic oR opeN repair In chIldren Analysis—trial (HERNIIA2-trial) is to estimate the (cost-)effectiveness of the laparoscopic percutaneous internal ring suturing (PIRS) technique compared with open repair in children aged 0–16 years with a primary unilateral inguinal hernia.
A national multicentre randomised controlled trial will be performed including 464 children aged 0–16 years with a primary unilateral inguinal hernia. Patients will be randomised between the open or PIRS technique. The primary outcome is the number of reoperations within 2 years after primary surgery. Secondary outcome measures are: operative and postoperative complications, total duration of surgery, postoperative pain, length of admission, time to normal daily activities, cosmetic appearance of the scar, social and healthcare costs and health-related quality of life. Furthermore, cost-effectiveness will be assessed from a societal and healthcare perspective.
The protocol was approved by the ethics committee of the Amsterdam University Medical Hospital. Informed consent will be obtained by parents and, if possible, according to age, by patient. The study will be conducted according to the principles of the Declaration of Helsinki (2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and Good Clinical Practice. Study findings will be disseminated through scientific publications, conferences and patient-friendly materials. The national study network of participating centres will facilitate rapid dissemination and implementation within the Netherlands and potentially abroad.
ClinicalTrials.gov PRS (ID NCT06451432).
To gain insight into healthcare professionals' perceptions and needs regarding hospital-to-home transitions.
Qualitative phenomenological study.
Hospital and primary care professionals participated in focus groups and interviews. Participants were recruited from a Dutch University hospital and from our networks between May and September 2023. Data were analysed using thematic analysis.
We conducted seven focus groups and twelve interviews. Three themes emerged: “Collaboration and information exchange between professionals”, “Coordination and continuity of care”, and “Interaction between professionals, patients, and families”.
This study suggests that professionals would benefit from clear guidelines and arrangements for communication with colleagues to support care coordination and continuity. Collaboration and information sharing are essential for providing integrated, patient-centred care. Additionally, involving patients and families in decision-making regarding hospital-to-home transitions, in a way that considers their needs, is important for effective care.
This study highlights the importance of clear communication and collaboration between professionals to ensure continuity of care. It emphasises the need for integrated care, where patients and families are actively involved without being overwhelmed.
Transitions from hospital-to-home are often hindered by fragmented, non-individualised care. Improved collaboration, clear coordination, and patient-family involvement can address this. This research can positively impact professionals across different settings, policymakers, and advocacy groups aiming to improve integrated patient-centred care.
The interview guide was developed with professionals who reviewed it and provided feedback. Professionals provided us with their lived experiences by participating in interviews and focus groups.
This study adhered to the COREQ guidelines.
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