PANC Study (Pancreatitis: A National Cohort Study): national cohort study examining the first 30 days from presentation of acute pancreatitis in the UK

Background Acute pancreatitis is a common, yet complex, emergency surgical presentation. Multiple guidelines exist and management can vary significantly. The aim of this first UK, multicentre, prospective cohort study was to assess the variation in management of acute pancreatitis to guide resource planning and optimize treatment. Methods All patients aged greater than or equal to 18 years presenting with acute pancreatitis, as per the Atlanta criteria, from March to April 2021 were eligible for inclusion and followed up for 30 days. Anonymized data were uploaded to a secure electronic database in line with local governance approvals. Results A total of 113 hospitals contributed data on 2580 patients, with an equal sex distribution and a mean age of 57 years. The aetiology was gallstones in 50.6 per cent, with idiopathic the next most common (22.4 per cent). In addition to the 7.6 per cent with a diagnosis of chronic pancreatitis, 20.1 per cent of patients had a previous episode of acute pancreatitis. One in 20 patients were classed as having severe pancreatitis, as per the Atlanta criteria. The overall mortality rate was 2.3 per cent at 30 days, but rose to one in three in the severe group. Predictors of death included male sex, increased age, and frailty; previous acute pancreatitis and gallstones as aetiologies were protective. Smoking status and body mass index did not affect death. Conclusion Most patients presenting with acute pancreatitis have a mild, self-limiting disease. Rates of patients with idiopathic pancreatitis are high. Recurrent attacks of pancreatitis are common, but are likely to have reduced risk of death on subsequent admissions

Future informed consent research – a step in the wrong direction!

IntroductionOver 300 million invasive procedures occur globally every year, each requiring patient informed consent. No single outcome measure exists for measurement of the informed consent process. A core outcome set (COS) for informed consent for therapy consisting of 9 outcomes has been developed to define what outcomes matter to key stakeholders in the informed consent process. We aimed to identify the frequency of uptake of the COS consent outcomes in future randomised control trials.MethodsA systematic review of prospectively registered randomised control trial protocols was performed. The online trial registries World Health Organisation (WHO) International Clinical Trials Registry Platform (ICTRP) and the US National Library of Medicine ClinicalTrials.gov were searched. All studies assessing interventions designed to improve the informed consent process were considered.Results627 registered protocols were identified of which 22 met the inclusion criteria. Only two core outcomes were reported in any prospective interventional consent trial protocols. Patient satisfaction with the consent process and patient satisfaction with the amount of information were observed which employed unvalidated tools. Patient knowledge was the predominant primary outcome measure (n=20). Unvalidated measurement tools were used in all cases. Patient anxiety, decisional regret and decisional conflict were the only outcomes consistently measured using validated measurement tools.ConclusionThe use of unvalidated outcome measurement tools in future consent trials are widespread. This review has highlighted the clear disconnect between chosen outcomes in future consent trial protocols and an established informed consent COS, limiting the potential value of outputs in future consent trials.Take-home messageA clear disconnect exists between the outcome measures used in prospective consent randomised trials and an established core outcome set for informed consent for therapy