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.

Impact of the National Lockdown Due to the COVID-19 Pandemic On Upper Limb Trauma Workload in Central London: A Multi-Centre Longitudinal Observational Study During Implementation and Ease of National Lockdown.

Background: This study assessed the impact of the COVID-19 pandemic on acute upper limb referrals and operative case-mix at the beginning and ease of British lockdown. Methods: A longitudinal multicentre observational cohort study was conducted for both upper limb trauma referrals and operative case-mix over a 12-week period (6 weeks from the beginning and 6 weeks from the ease of the national lockdown). Statistical analysis included median (± median absolute deviation), risk and odds ratios, and Fisher's exact test to calculate the statistical significance, set at p ≤ 0.05. Results: There was a 158% (n = 456 vs. 177) increase in upper limb referrals and 133% (n = 91 vs. 39) increase in the operative trauma caseload at the ease of lockdown compared with its commencement. An increase in sporting injuries was demonstrated (p=0.02), specifically cycling (p=0.004, OR=2.58). A significant increase in COVID-19 testing was demonstrated during the ease of lockdown (p=0.0001) with more patients having their management changed during the beginning of the pandemic (9.6% vs. 0.7%, p=0.0001). Of these patients, 47% went on to have delayed surgery within 6 months. No patients who underwent surgery tested positive for COVID-19 infection within 14 days post-operatively and no mortalities were recorded at 30 days. Conclusion: The ease of lockdown has seen upper limb referrals and operations more than double compared to early lockdown. With no patients testing positive for COVID-19 within 14 days of the procedure, this demonstrates that having upper limb surgery during the current pandemic is safe.

Impact of the COVID-19 pandemic on paediatric orthopaedic trauma workload in central London: a multi-centre longitudinal observational study over the "golden weeks".

Background and purpose - The COVID-19 pandemic has been recognised as an unprecedented global health crisis. This study assesses the impact on a large acute paediatric hospital service in London, evaluating the trends in the acute paediatric orthopaedic trauma referral caseload and operative casemix before (2019) and during (2020) COVID-19 lockdown. Patients and methods - A longitudinal retrospective observational prevalence study of both acute paediatric orthopaedic trauma referrals and operative caseload was performed for the first 6 "golden weeks" of lockdown. These data were compared with the same period in 2019. Statistical analyses included median (± median absolute deviation), risk and odds ratios as well as Fisher's exact test to calculate the statistical significance, set at p ≤ 0.05. Results - Acute paediatric trauma referrals in 2020 were reduced by two-thirds compared with 2019 (n = 302 vs. 97) with a halving risk (RR 0.55) and odds ratios (OR 0.43) of sporting-related mechanism of injuries (p = 0.002). There was a greater use of outpatient telemedicine in the COVID-19 period with more Virtual Fracture Clinic use (OR 97, RR 84, p < 0.001), and fewer patients being seen for consultation and followed up face to face (OR 0.55, RR 0.05, p < 0.001). Interpretation - The impact of the COVID-19 pandemic has led to a decline in the number of acute paediatric trauma referrals, admissions, and operations during the COVID period. There has also been a significant change in the patient pathway with more being reviewed via the means of telemedicine to reduce the risk of COVID-19 transmission and exposure. More work is required to observe for similar trends nationwide and globally as the pandemic has permanently affected the entire healthcare infrastructure.