Procedure Specific Consent Forms for Laparoscopic Cholecystectomy

Background: Surgical consent forms can be difficult for patients to read and understand. Important points including procedure details, relevant complications and alterative treatment options are often lost in the communication process. Furthermore, surveys have found that patients struggle to grasp basic surgical concepts. Procedure specific consent forms (PSCFs) have been shown to improve the process of surgical consent. This is partly because they provide a standardised list of complications and their incidence, presented in a uniform, legible format without any abbreviations. However, despite their benefits, PSCFs are nationally underused. Cholecystectomy is one of the most common operations performed in the United Kingdom. Due to the pandemic disrupting elective surgical lists, the backlog of patients with biliary pathology has increased. More patients are therefore presenting to the on-call surgical team with biliary disease. Many trusts employ an Emergency Surgery Ambulatory Care (ESAC) list to offload the stretched emergency service. Our aim was to assess the variability of cholecystectomy consent forms amongst this cohort of patients, subsequently review patient understanding and evaluate whether the introduction of a procedure specific consent form improved this understanding. Method(s): We performed a prospective audit of laparoscopic cholecystectomy consent forms using the ESAC service. These consent forms were all obtained from patient's paper notes and assessed individually for variables. The first loop of the audit assessed the consent form used for the first 20 patients allocated to the ESAC list. Subsequently, each patient was telephoned post-operatively and asked a series of standardised questions which were adapted from a published questionnaire. Following this, we introduced a Procedure Specific Consent Form (PCSF) for laparoscopic cholecystectomies, with the agreement of all consultant surgeons who perform this operation in the trust. The second loop of the audit assessed another 20 patients from the emergency list, after the introduction of the PCSF. Similarly, patients were later telephoned to assess understanding. Over both loops, each consent form was assessed for the scope of their included complications and measured against the NHS-recognised list of potential adverse outcomes. Secondly, the legibility of the consenter's writing and the use of any abbreviations was noted. Legibility was evaluated by two doctors independently to reduce subjectivity. Result(s): The first loop revealed that all forms contained infection and bleeding;90% included injury to bile duct;80% included injury to viscera and risks from general anaesthetic;75% included blood clots and bile leak;and only 55% included post-cholecystectomy syndrome. The additional complications included were pain, herniae, covid risk, retained stone, collection, pancreatitis, failure and death;with an even higher degree of variability. The 20 forms were 95% legible, with 50% of them containing one or more acronyms. Relating to the post-op questionnaire, >80% of patients remembered details surrounding their operation, however only 60% could recall basic potential complications. After PCSF introduction, itwas used in 10 of the second loop cases,with the remaining 10 using traditional Consent Form 1 (non-PSCF). The non-PSCF group demonstrated similar variability in the complications included, with identical legibility rates and acronym usage. Again, only 60% of patients were able to accurately define the associated complications. Of the PSCFs, 100% were legible and 0% used acronyms, and the list of complications was standardised with 100% compliance with NICE and RCS England guidance. Notably, 90% of patients accurately recalled potential complications and nearly all were satisfied with their level of understanding prior to signing the consent form. Conclusion(s): This Quality Improvement Project demonstrated that hand written Consent Forms are highly variable, especially regarding the list of complications. We also found that while the were largely legible, half of the consent forms contained acronyms. Lastly, patients were satisfied with the information provided to them and could recall knowledge on the nature of the surgery, but many were not able to recollect important potential complications. The use of a PSCF allowed for a standardised, easily accessible, legible consent form devoid of misinterpretable acronyms. This was reflected in the patient questionnaire, where patients were able to recall details of the surgery and were satisfied with their level of understanding. This was reaffirmed by their grasp of the complications, where 90% of patients could recall potential adverse risks, compared to 60% in the Form 1 groups. This audit demonstrates the benefit of PSCFs from a legislative and litigative standpoint, but more importantly from the standpoint of patient understanding and holistic care. We recommend the use of PSCFs in the process of all surgical consent, to help ensure patient understanding and subsequent satisfaction.

Investigating the association between COVID-19 vaccination and care home outbreak frequency and duration.

OBJECTIVES: At the end of 2020, many countries commenced a vaccination programme against SARS-CoV-2. Public health authorities aim to prevent and interrupt outbreaks of infectious disease in social care settings. We aimed to investigate the association between the introduction of the vaccination programme and the frequency and duration of COVID-19 outbreaks in Northern Ireland (NI). STUDY DESIGN: We undertook an ecological study using routinely available national data. METHODS: We used Poisson regression to measure the relationship between the number of RT-PCR confirmed COVID-19 outbreaks in care homes, and as a measure of community COVID-19 prevalence, the Office for National Statistics COVID-19 Infection Survey estimated the number of people testing positive for COVID-19 in NI. We estimated the change in this relationship and estimated the expected number of care home outbreaks in the absence of the vaccination programme. A Cox proportional hazards model estimated the hazard ratio of a confirmed COVID-19 care home outbreak closure. RESULTS: Care home outbreaks reduced by two-thirds compared to expected following the introduction of the vaccination programme, from a projected 1625 COVID-19 outbreaks (95% prediction interval 1553-1694) between 7 December 2020 and 28 October 2021 to an observed 501. We estimated an adjusted hazard ratio of 2.53 of the outbreak closure assuming a 21-day lag for immunity. CONCLUSIONS: These findings describe the association of the vaccination with a reduction in outbreak frequency and duration across NI care homes. This indicates probable reduced harm and disruption from COVID-19 in social care settings following vaccination. Future research using individual level data from care home residents will be needed to investigate the effectiveness of the vaccines and the duration of their effects.

The Impact of the COVID-19 Pandemic on Liver Surgery in South Wales

Introduction: As the COVID-19 pandemic continues, it is increasingly apparent that the victims of the pandemic are not just those who contract the virus, but also the innumerable patients with other life limiting conditions who have had access to potentially life-saving surgery delayed due to lack of inpatient beds. Like many, our hospital initially cancelled all elective surgery but was able to re-instate it relatively quickly owing to the development of a “green pathway.” We sought to review how the pandemic has impacted hepatobiliary surgery at our unit. Methods: Our prospectively maintained database was interrogated to identify all surgical activity in our unit during 2019 (pre-COVID) and 2020 (COVID). Results: Our green pathway involves patients isolating for 14 days prior to admission to a separate ward with dedicated junior doctors who do not see non-green patients. Between January 1st and December 31st 2020, 129 patients underwent exploration with a view to liver resection. 106 resections were undertaken. This compares to 152 explorations with 123 resections in 2019. In 2020, our median length of stay was 6 days (1-41). Twelve patients (9%) developed a significant (CD 3 or 4) complication. There was no inpatient mortality. Median length of stay in 2019 was also 6 days (1-69). Twelve patients (8%) had significant morbidity. A single patient died (0.7%) Conclusion: In spite of the COVID pandemic, our unit has managed to continue to offer a high volume tertiary hepatobiliary surgical service without an increase in length of stay, morbidity or mortality.