Radiological imaging is a central facet of the multidisciplinary evaluation of suspected child physical abuse. Current guidelines for the imaging of suspected child physical abuse are often unclear, incomplete and highly variable regarding recommendations on critical questions, thereby risking clinical heterogeneity, unstructured decision-making and missed diagnoses. We, therefore, aim to develop and report an evidence-based and consensus-derived international guideline for the radiological investigation of index and contact children in the context of suspected physical abuse and to ascertain areas of scientific uncertainty to inform future research priorities.
The international guidelines for the imaging investigation of suspected child physical abuse (IGISPA) consensus group includes formal representation from 127 recognised experts across 14 subspecialties, six continents and 32 national and/or international organisations. Participants will be divided into five longitudinal subgroups (indications for imaging, skeletal imaging, visceral imaging, neuroimaging and postmortem imaging) with three cross-cutting themes (radiography, genetics and adaptations for low- and lower-middle-income countries). Each subgroup will develop preliminary consensus statements via integration of current evidence-based guidelines, systematic literature review and the clinical expertise of a multinational group of experts. Statements will then undergo anonymised voting in a modified e-Delphi process and iterative revision until consensus (≥80% agreement) is achieved. Final statements will undergo both internal and external peer review prior to endorsement.
As an anonymous survey of consenting healthcare professionals, this study did not require ethical approval. Experts provided written informed consent to participate prior to commencement of the modified Delphi process. The IGISPA consensus statement and any subsequent guidance will be published open access in peer-reviewed medical journals.
Heart failure is an important health problem and patients are generally older with several comorbidities. Multidisciplinary heart failure care is therefore recommended. However, there is little evidence in real-world settings on how to involve primary care health professionals and how to evaluate such programmes. The main objective of this study is to integrate and evaluate several disease management interventions in a primary care setting.
Prospective, non-randomised, observational implementation study with a mixed-methods process evaluation conducted over 3 years (2020–2022).
Primary care practices and two regional hospitals (one tertiary, one secondary) in the Leuven region, Belgium, serving approximately 100 000 inhabitants.
100 general practitioners (GPs) from 19 practices participated. A total of 96 patients were included in the disease management programme. Inclusion criteria for patients included high-risk status for heart failure (HF) readmission, based on clinical criteria. Exclusion criteria were not explicitly defined but participation required informed consent.
Four interventions were implemented: (1) online HF education for GPs, (2) reimbursed natriuretic peptide (NP) testing, (3) patient education by trained primary care HF educators and (4) a structured transitional care protocol posthospital discharge.
Primary outcomes included GP self-efficacy in HF management, NP testing rates, HF registration in electronic health records and patient self-efficacy (9-item European Heart Failure Self-Care Behaviour Scale (EHFScB-9)). Secondary outcomes included patient quality of life (Short Form-12 questionnaire (SF-12)), hospital readmission rates and provider satisfaction.
GPs felt more competent in the management of HF after an online education (eight point increase in self-efficacy score after 6 months follow-up, (CI 2.9 to 13, p
The IMPACT-B study demonstrated that an integrated disease management programme for HF could be implemented and assessed in routine clinical practice. The programme resulted in increased awareness and registration of HF in primary care, increased self-management of patients and improved follow-up after discharge, although these results should be interpreted cautiously given the uncontrolled pre-post study design.
Trial registration NCT04334447 (clinicaltrials.gov).
For patients with perihilar cholangiocarcinoma (pCCA), surgical resection remains the sole treatment modality that can potentially result in cure. Unfortunately, the majority of patients present with unresectable tumours or are excluded from surgical treatment due to complications like cholangitis affecting their performance status. In the Netherlands, recommended first-line treatment for patients with unresectable pCCA is palliative chemotherapy with gemcitabine and cisplatin. This regimen yields an estimated median overall survival (OS) of 11.7–15.2 months, highlighting the urgent need for novel treatment options. The STRONG I trial, a phase I study in patients with unresectable pCCA, was completed in 2020. Its aim was to assess the feasibility and toxicity profile of adding stereotactic body radiation therapy (SBRT) to chemotherapy. SBRT, delivered in 15 fractions of 4.0 Gray (Gy), was considered to be feasible and safe, with no dose-limiting toxicity being observed. The 1-year local tumour control rate was 80% and the 1-year OS rate 100%, with maintenance of quality of life (QoL). These results encouraged us to initiate the STRONG II trial, aiming to investigate the efficacy of adding SBRT to chemotherapy in a larger patient cohort.
STRONG II is a single-arm, multicentre phase II study. Patients with non-metastatic unresectable pCCA (T1-4, N0-2) are eligible. A total of 30 patients will be enrolled in six academic centres in the Netherlands and two in Belgium. SBRT will be delivered in 15 fractions of 4.0–4.5 Gy. The primary endpoint is local tumour control, defined by Response Evaluation Criteria in Solid Tumours (RECIST) V.1.1. Secondary endpoints include toxicity, biliary stent-related events, progression-free survival, OS and QoL using the EuroQoL five-dimensional, five-level (EQ-5D-5L) questionnaire, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) and the EORTC Biliary Module (QLQ-BIL21). In addition, we will explore the predictive value of the peripheral immunological status (immune-related proteins and serum functional immunological status assay) and its dynamics in determining survival outcomes. For this explorative translational study, two blood samples will be collected, one before the start of chemotherapy and another after completing chemotherapy.
Approval of the study was obtained on 5 June 2024 by the Medical Ethics Review Committee of Erasmus Medical Center Rotterdam, the Netherlands (ID: NL86210.078.24). The anticipated time frame for patient enrolment is July 2024 to December 2027. The main study findings will be published in peer-reviewed medical journals, and presented at national and international conferences.
NCT06493734 (ClinicalTrials.gov).