Digital consent in gynecology: an evaluation of patient experience.

INTRODUCTION: The surgical consent process is a crucial discussion between patient and surgeon, which is predominantly documented utilizing hand-written forms. The exchange of individualized information allows the patient to make a truly informed decision. Digital consent (also known as electronic consent or e-consent) has been shown to improve accuracy of information provided without increasing the time taken to consent patients. We aimed to evaluate patient experience and effectiveness of digital consent in a gynecology department in a tertiary London Teaching Hospital. METHODS: A questionnaire was designed and completed by 100 patients undergoing gynecological surgery: 50 consented using paper and 50 consented digitally. The questionnaire included 8 statements, with five possible answers to select, ranging from strongly agree to strongly disagree, on a standard five-point Likert Scale. Patients were all female and categorized into age groups (deciles) and asked whether consent was taken digitally or on paper. Data were collected between January and July 2021. RESULTS: Most responses were positive with 87% (694/800) of responses to the questions being either strongly agree or agree. Patients who were consented using paper selected 'strongly agree' 43.5% (174/400) of the time in comparison to 64.8% (259/400) of the time when they were consented digitally. The majority, 86% (43/50), of digitally consented patients received a copy of the consent form in comparison to 18% (9/50) of those consented using paper. On average, the patients consented digitally were older than their paper-consented counterparts (49-58 and 59-68 respectively). The mean scores for the questions relating to the ease of reading the form, ease of understanding the form, understanding of the potential complications, and overall satisfaction were higher in those digitally consented (p < 0.05). DISCUSSION: Overall, patients were satisfied with both methods of consent. However, individuals who were consented digitally reported higher levels of satisfaction throughout the consent process, compared to paper consent. These data suggest that digital consent is an acceptable alternative to paper consent for patients and facilitates adherence to national consent guidance, which stipulates patients should be given the information they request.

Comparing shared decision making using a paper and digital consent process. A multi-site, single centre study in a trauma and orthopaedic department.

INTRODUCTION: The importance of shared decision making (SDM) for informed consent has been emphasised in the updated regulatory guidelines. Errors of completion, legibility and omission have been associated with paper-based consent forms. We introduced a digital consent process and compared it against a paper-based process for quality and patient reported involvement in shared decision making. METHODS: 223 patients were included in this multi-site, single centre study. Patient consent documentation was by either a paper consent form or the Concentric digital consent platform. Consent forms were assessed for errors of legibility, completion and accuracy of content. Core risks for 20 orthopaedic operations were pre-defined by a Delphi round of experts and forms analysed for omission of these risks. SDM was determined via the 'collaboRATE Top Score', a validated measure for gold-standard SDM. RESULTS: 72% (n = 78/109) of paper consent forms contained ≥1 error compared to 0% (n = 0/114) of digital forms (P < 0.0001). Core risks were unintentionally omitted in 63% (n = 68/109) of paper-forms compared to less than 2% (n = 2/114) of digital consent forms (P < 0.0001). 72% (n = 82/114) of patients giving consent digitally reported gold-standard SDM compared to 28% (n = 31/109) with paper consent (P < 0.001). CONCLUSION: Implementation of a digital consent process has been shown to reduce both error rate and the omission of core risks on consent forms whilst increasing the quality of SDM. This novel finding suggests that using digital consent can improve both the quality of informed consent and the patient experience of SDM.

Surgical consent practice in the UK following the Montgomery ruling: A national cross-sectional questionnaire study.

BACKGROUND: The Supreme Court case of Montgomery vs Lanarkshire Health Board in 2015 was a landmark case for consent practice in the UK which shifted focus from a traditional paternalistic model of consent towards a more patient-centered approach. Widely recognised as the most significant legal judgment on informed consent in the last 30 years, the case was predicted to have a major impact on the everyday practice of surgeons working in the UK National Health Service (NHS). Two years after the legal definition of informed consent was redefined, we carried out an audit of surgical consent practice across the UK to establish the impact of the Montgomery ruling on clinical practice. MATERIALS & METHODS: Data was collected by distribution of an electronic questionnaire to NHS doctors working in surgical specialities with a total of 550 respondents. RESULTS: 81% of surgical doctors were aware of the recent change in consent law, yet only 35% reported a noticeable change in the local consent process. Important barriers to modernisation included limited consent training, a lack of protected time for discussions with patients and minimal uptake of technology to aid decision-making/documentation. CONCLUSIONS: On the basis of these findings, we identify a need to develop strategies to improve the consent process across the NHS and limit the predicted rise in litigation claims.

Surgical consent: the world's largest Chinese Whisper? A review of current surgical consent practices.

As the law around surgical consent continues to evolve, surgeons and those in training risk being caught red-faced and defenceless. Despite repeated concerns regarding surgical consent being raised by the General Medical Council of the UK, how much is changing on the National Health Service shop floor? This report investigates the variation between consenting practices for six common general surgical operations in 123 individual operations. Results showed that only 20% of mentioned operative complications for each operation were being documented on >75% of consent forms. The vast majority of mentioned complications were mentioned inconsistently, leading to patients being given grossly varying information preoperatively. Reassuringly, only 4.1% of consent procedures were done by those not in core surgical training (junior resident) or above, but nonetheless significant omissions were observed. When consenting a patient for an emergency exploratory laparotomy, an operation carrying a 14% chance of death, a risk of death was only documented in 28% of cases. Trainees failed to document the possibility of an orchidectomy in 30% of scrotal exploration cases. Data showed that complication incidences were only documented for 0.004% of the 721 complications mentioned in total, and a consent process was documented in the chronological notes in only 38% of cases. Seventy-seven per cent of surgical trainees surveyed across four UK deaneries stated that they would strongly support an online and mobile consenting resource detailing the recommended mentionable risks and incidences. Is it time for the traditional consenting approach to give way to an evidence-based gold standard?

Whipple's in the valleys: a case of Whipple's with thrombocytopenia and endocarditis.

INTRODUCTION: This case report details the second described case of Whipple's disease-related thrombocytopenia in the medical literature. Whipple's disease is a rare multisystem infection caused by the actinomycete Tropheryma whipplei, first described by George Whipple in 1907. The key clinical manifestations are weight loss, diarrhoea and malabsorption, but arthralgia and endocarditis are also well described. CASE PRESENTATION: A 62-year-old Caucasian female presented with weight loss, anaemia and behavioural changes but denied any abdominal symptoms. Thrombocytopenia subsequently developed rapidly. Bone marrow examination showed abundant megakaryocytes in keeping with peripheral platelet sequestration. In addition, there was significant polyclonal plasmacytosis. She was also found to have a 1.6 cm tricuspid vegetation. The diagnosis was confirmed by presence of foamy macrophages on duodenal biopsy, positive periodic acid-Schiff staining and visualisation of T whipplei actinomycetes on electron microscopy. Tissue PCR performed mid-treatment showed traces of T whipplei DNA. The infection was treated with a 2-week intravenous course of ceftriaxone followed by 12 months of oral co-trimoxazole. The thrombocytopenia and anaemia resolved rapidly with antibiotic therapy, her behaviour returned to normal and she remains clinically well. CONCLUSIONS: This report confirms the association of thrombocytopenia with Whipple's disease, likely due to peripheral platelet sequestration, which resolves rapidly with treatment. In patients with a long history of unintended weight loss, Whipple's disease is a rare but important differential diagnosis as it is ultimately fatal if left untreated.