ABSTRACT
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.
ABSTRACT
Primary sclerosing cholangitis (PSC) is a cholestatic disorder wherein liver transplant is the definitive treatment for advance stages. However, recurrence of PSC after liver transplant is of concern which can leads to graft failure and may require retransplant. There is limited data on outcomes of living donor liver transplant (LDLT) in PSC. Also, in LDLT as donors are related there is possibility of disease recurrence. So, we conducted this retrospective study to analyse the outcomes of LDLT in PSC at a tertiary liver transplant centre in north India. Methods: We conducted a retrospective analysis of 3213 transplant recipients who underwent LDLT from January 2006 to May 2021. Of these 26 (0.80%) patients has PSC as indication for liver transplantation (PSC=24, PSC/AIH overlaP=2). Data analysis was done to look for baseline demographics, clinical details, transplant outcomes, PSC recurrence and survival. Results: Mean age of study group was 42(±13.8) years and 19 (73.1%) were males. All patients had decompensated cirrhosis at time of transplant. Mean CTP score and MELD score were 9.5(±1.8) and 18.9(±7.1) respectively. 16 patients received modified right lobe graft, 7 extended right lobe graft and 5 patients received left lateral graft. Average graft weight and GRWR were 633.5(IQR 473.5-633.5) grams and 1.23(SD±0.42) respectively. Most common biliary anastomosis was hepaticojejunostomy, done in 19(73.1%) while duct to duct anastomosis was performed in 7(26.9%) patients. Median follow- up was 96(36-123) months. One patient had ulcerative colitis and none had cholangiocarcinoma. Two (7.7%) patients had bile leak during early post-transplant period. Three (11.1%) patients developed graft rejection and managed successfully with steroid pulses. Three patients died during early post-transplant period while 7 deaths occurred during long term follow-up including one death due to COVID-19. Five (19.2%) patients had recurrence of PSC of which 2 patients lost their grafts including one after retransplantation. The overall 1 year and 5-year survival rates were 88.5% and 75% respectively. Conclusion: LDLT can be performed in PSC with good long-term outcomes with a risk of PSC recurrence in about 1/5th patients.