Management of cryptoglandular anal fistula is characterised by wide variation in diagnostic strategies, surgical techniques and outcome reporting, limiting comparison between studies and hindering evidence-based guideline development. This study aims to implement a standardised core outcome measurement set within a large international observational framework and to evaluate the feasibility of a scalable digitally supported model for global collaborative surgical research.
Cryptoglandular anal fistula treatment is a prospective, international, multicentre observational study comprising two components: a short-term audit capturing clinician-reported outcomes at 3 months and a long-term cohort capturing clinician- and patient-reported outcomes over twelve months. Adults undergoing surgery for primary or recurrent cryptoglandular anal fistula are eligible, excluding non-cryptoglandular aetiologies. Data are collected using secure electronic case report forms and digitally administered patient-reported outcome measures, with paper alternatives available where required. Outcomes are defined according to the Anal Fistula Core Outcome Measurement Set and include clinical and radiological healing, recurrence, complications, reintervention, development of additional fistulas, symptoms, psychological impact of treatment, continence, quality of life and additionally work productivity. The study was designed around a predefined nine-step framework, including multidisciplinary coordination, central ethical approval to support local submissions, artificial intelligence-assisted translation of study materials with native review and implementation of secure digital data capture systems. Based on previous European Society of Coloproctology studies and expected centre volumes, the audit arm aims to include approximately 1000 patients and the cohort arm 500 to 750 patients.
Central ethical approval has been obtained from the Medical Ethics Review Committee of the Maastricht University Medical Centre+ under METC 2024-0374 (audit arm) and METC 2024-0361 (cohort arm) with local approvals or waivers secured in participating countries according to national regulations. Written informed consent is obtained for cohort participation. Results will be disseminated through peer-reviewed publications and international conferences, with the aim of informing future guideline development and supporting patient-centred care in cryptoglandular anal fistula management.
This analysis aimed to explore how local health system strategies and plans seek to tackle health and care inequalities and address national policies. Specifically, the analysis considered alignment with five national priority areas: restoring services inclusively, mitigating digital exclusion, ensuring the completeness and timeliness of datasets, accelerating preventative programmes and strengthening leadership and accountability. In addition, the analysis explored the extent to which systems are engaging with the Core20PLUS5 approach, which targets the most deprived 20% of the population (‘Core 20’) and population groups experiencing disproportionately poor access, outcomes or experiences of care (‘PLUS’).
Integrated Care Systems (ICSs) are statutory partnerships that bring together healthcare, social care, local government and wider system organisations to collaboratively address the root causes of ill health and health inequalities. We conducted a document analysis of available ICS strategies, 5-year plans and health inequalities plans published in England between 1 January 2022 and 31 July 2023. A total of 43 strategy documents, 38 5-year plans and 7 health inequalities plans were analysed. A data extraction framework was used to guide reviewers and independent quality assurance was completed to ensure internal validity, intrarater reliability, and reproducibility of the project.
The analysis highlighted good alignment with national healthcare inequalities policies and local approaches to tackling healthcare inequalities, with the majority of systems citing the Core20PLUS5 framework. There was notable variation between systems on the adoption of the framework with the children and young people’s framework being less widely considered than the adult’s framework. Across systems, equity-focused tools were widely used, and numerous systems had developed outcome frameworks to monitor progress. Leadership for health inequalities was strengthened with senior leadership roles being established to hold integrated care boards accountable for improving access, experiences and outcomes. However, competing priorities, particularly concerning implementations of new organisational models and multiple national priorities, were evident within the plans which may challenge progress on reducing health and healthcare inequalities.
The review concluded that while progress has been made in adopting national healthcare inequalities policies and steers, significant variation exists between systems, possibly reflecting local population needs and varying levels of maturity of the systems across England. The review highlights the need for further evaluations at both national and local levels, allowing for further development of the systems. Additionally, consistent and sustainable funding and more robust training for health inequalities leadership roles is needed to ensure equitable access, experience and outcomes.