Evaluating interventions for informed consent for surgery (ICONS) :Protocol for the development of a core outcome set

Abstract Background The concept of informed consent is fundamental to medical practice. Shortcomings in the process can lead to patient complaints, litigation, unmet expectations and poor outcomes. Consent research has focused on developing tools to improve patient recall and understanding. However, the definitions, methods of measurement and timing of measurement vary widely across the studies that have been done. Although a Cochrane review has reported that many of these interventions appear to work, the high level of heterogeneity in outcome reporting prevents the identification of those interventions that work best and why they do so. It is also not clear which outcomes are most important to each party involved in the consent process and why. Methods/design This project will develop a core outcome set for assessing the effects of interventions aimed at improving informed consent for surgery and other invasive procedures for adult patients with the capacity to consent for themselves. We will conduct a systematic review of the qualitative and quantitative literature to identify outcomes used to date in consent research and map these into domains. A series of semi-structured key stakeholder interviews will also be used to identify relevant outcomes. These processes will produce a list of potential outcomes for assessing the effects of interventions to improve consent, which will be refined through an international Delphi survey and consensus webinars involving key stakeholders to produce the core outcome set. Discussion The ICONS study aims to develop a core outcome set for use in trials and reviews of interventions designed to improve the informed consent process for surgery and other invasive procedures. Our aim is that this core outcome set will reduce the level of selection and reporting bias in consent research and help clinicians to compare tools to improve consent

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

Abstract 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. </jats:sec

An unusual cause of abdominal distension: intraperitoneal bladder perforation secondary to intermittent self-catheterisation

We report a strikingly unusual case of traumatic intraperitoneal perforation of an augmented bladder from clean intermittent self-catheterisation (CISC), which presented a unique diagnostic challenge. This case describes a 48-year-old T1 level paraplegic, who had undergone clamshell ileocystoplasty for detrusor overactivity, presenting with abdominal distension, vomiting and diarrhoea. Initial investigations were suggestive of disseminated peritoneal malignancy with ascitic fluid collections, but the ascitic fluid was found to be intraperitoneal urine from a perforation of the urinary bladder. This was associated with an inflammatory response in the surrounding structures causing an appearance of colonic thickening and omental disease. Although the diagnostic process was complex due to this patient’s medical history, the treatment plan initiated was non-operative, with insertion of an indwelling urinary catheter and radiologically guided drainage of pelvic and abdominal collections. Overdistension perforations of augmented urinary bladders have been reported, but few have described perforation from CISC

Informed consent – Are we appropriately assessing the process?

AimsThere is no standardised measure of the validity of consent. Over 300 million invasive procedures take place globally each year. This study aims to define a core outcome set (COS) for informed consent for therapy.MethodsA prospective mixed method study was undertaken in line with a published protocol and the COS was developed in accordance with Core Outcome Measures in Effectiveness Trials (COMET) methodology. This included a systematic review of outcomes in studies of consent, semi-structured interviews and prioritisation of outcomes using a 2-round modified Delphi technique. Two consensus webinars were used to ratify outcomes for inclusion in the final COS.Results36 outcome domains for valid consent were identified and developed by systematic review. 41 semi-structured interviews were conducted with key consent stakeholders (with significant patient involvement) 164 participants from key stakeholder groups across 8 countries completed Delphi Round 1 and 125 completed round 2. 11 of 40 outcomes met the “consensus in” criteria, with 6 meeting “consensus in” in all stakeholder groups. These were included directly in the final COS and the other 5 that met “consensus in” in some but not all stakeholder groups were discussed in consensus webinars. 9 outcomes were defined for the final COS.ConclusionThis is the first study to define a COS for research into informed consent for therapy. It defines what outcomes are most important to all key stakeholders in the consent process and is a step forward in standardising consent research