Is elective surgery during the COVID-19 pandemic safe? A multi-center prospective study in a high incidence area

Elective surgery; COVID-19 pandemicCirugía electiva; Pandemia de COVID-19Cirurgia electiva; Pandèmia de COVID-19Objective: The aim of this study was to describe the evolution of patients admitted for elective orthopaedic surgery during the immediate post-COVID-19 peak of the pandemic. Methods: This is a multi-center, observational study conducted in 8 high complexity hospitals of Catalonia, one of the highest COVID-19 incidence areas in Spain. We included patients ≥18 years of age undergoing elective surgery (total knee or hip arthroplasty, knee or hip revision arthroplasty, shoulder or knee arthroscopy, hand or wrist surgery, forefoot surgery, or hardware removal) after the COVID-19 peak (between May 5th and June 30th, 2020). The main exclusion criterion was a positive result for SARS-CoV-2 PCR within the 7 days before the surgery. The primary outcomes were postoperative complications within 60 days (+/-30) or hospital readmission due to a COVID-19 infection. Following the recommendations of the International Consensus Group (ICM), elective surgeries were re-started when the nationwide lockdown was lifted. Before the surgery, patients were contacted by phone to rule out any exposure to confirmed COVID-19 cases, a reverse transcription-polymerase chain reaction (PCR) assay was performed in all patients 48-72 hours before hospital admission, and they were asked to maintain home confinement until the day of the surgery. Results: 675 patients were included: 189 patients in the arthroplasty group (28%) and 486 in the ambulatory surgery group (72%). Mean [SD] age was 57.6 [15.3] years. The mean Charlson Comorbidity Index score was 2.21 (SD = 2.01, Min = 0, Max = 13). A total of 84 patients (12.75%) obtained an American Society of Anesthesiologists (ASA) score ≥ 3, showing no association between the ASA score and the risk of developing COVID-19 symptoms at follow-up (χ 2 (4) = 0.77, P = 0.94). The mean occupation rate of hospital beds for COVID-19 patients was 13% and the mean occupation rate of critical care beds for COVID-19 patients was 27% at the time of re-introducing elective surgeries. These were important rates to consider to decide when to reintroduce elective surgeries after lockdown. Surgical time, time of ischemia and intra-operative bleeding were not related with a higher risk of developing COVID-19 post-operatively (χ 2 (1) = 0.00, P = 0.98); (χ 2 (2) = 2.05, P = 0.36); (χ 2 (2) = 0.37, P = 0.83). Only 2 patients (0.3 %) presented with a suspected COVID-19 infection at follow-up. None of them presented with pneumonia or required confirmation by a reverse transcription PCR assay. Hospital re-admission was not needed for these patients. Conclusion: The risk of developing COVID-19 during the immediate post-COVID-19 peak in a region with a high incidence of COVID-19 has not been proved. These data suggest that elective orthopaedic surgeries can be resumed when assertive and strict protocols are followed

Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials

An amendment to this paper has been published and can be accessed via the original article

Accelerated surgery versus standard care in hip fracture (HIP ATTACK) : an international, randomised, controlled trial

Background: Observational studies have suggested that accelerated surgery is associated with improved outcomes in patients with a hip fracture. The HIP ATTACK trial assessed whether accelerated surgery could reduce mortality and major complications. Methods: HIP ATTACK was an international, randomised, controlled trial done at 69 hospitals in 17 countries. Patients with a hip fracture that required surgery and were aged 45 years or older were eligible. Research personnel randomly assigned patients (1:1) through a central computerised randomisation system using randomly varying block sizes to either accelerated surgery (goal of surgery within 6 h of diagnosis) or standard care. The coprimary outcomes were mortality and a composite of major complications (ie, mortality and non-fatal myocardial infarction, stroke, venous thromboembolism, sepsis, pneumonia, life-threatening bleeding, and major bleeding) at 90 days after randomisation. Patients, health-care providers, and study staff were aware of treatment assignment, but outcome adjudicators were masked to treatment allocation. Patients were analysed according to the intention-to-treat principle. This study is registered at ClinicalTrials.gov (NCT02027896). Findings: Between March 14, 2014, and May 24, 2019, 27 701 patients were screened, of whom 7780 were eligible. 2970 of these were enrolled and randomly assigned to receive accelerated surgery (n=1487) or standard care (n=1483). The median time from hip fracture diagnosis to surgery was 6 h (IQR 4\u20139) in the accelerated-surgery group and 24 h (10\u201342) in the standard-care group (p<0\ub70001). 140 (9%) patients assigned to accelerated surgery and 154 (10%) assigned to standard care died, with a hazard ratio (HR) of 0\ub791 (95% CI 0\ub772 to 1\ub714) and absolute risk reduction (ARR) of 1% ( 121 to 3; p=0\ub740). Major complications occurred in 321 (22%) patients assigned to accelerated surgery and 331 (22%) assigned to standard care, with an HR of 0\ub797 (0\ub783 to 1\ub713) and an ARR of 1% ( 122 to 4; p=0\ub771). Interpretation: Among patients with a hip fracture, accelerated surgery did not significantly lower the risk of mortality or a composite of major complications compared with standard care. Funding: Canadian Institutes of Health Research

Outcomes after perioperative SARS-CoV-2 infection in patients with proximal femoral fractures: an international cohort study

Objectives Studies have demonstrated high rates of mortality in people with proximal femoral fracture and SARS-CoV-2, but there is limited published data on the factors that influence mortality for clinicians to make informed treatment decisions. This study aims to report the 30-day mortality associated with perioperative infection of patients undergoing surgery for proximal femoral fractures and to examine the factors that influence mortality in a multivariate analysis. Setting Prospective, international, multicentre, observational cohort study. Participants Patients undergoing any operation for a proximal femoral fracture from 1 February to 30 April 2020 and with perioperative SARS-CoV-2 infection (either 7 days prior or 30-day postoperative). Primary outcome 30-day mortality. Multivariate modelling was performed to identify factors associated with 30-day mortality. Results This study reports included 1063 patients from 174 hospitals in 19 countries. Overall 30-day mortality was 29.4% (313/1063). In an adjusted model, 30-day mortality was associated with male gender (OR 2.29, 95% CI 1.68 to 3.13, p80 years (OR 1.60, 95% CI 1.1 to 2.31, p=0.013), preoperative diagnosis of dementia (OR 1.57, 95% CI 1.15 to 2.16, p=0.005), kidney disease (OR 1.73, 95% CI 1.18 to 2.55, p=0.005) and congestive heart failure (OR 1.62, 95% CI 1.06 to 2.48, p=0.025). Mortality at 30 days was lower in patients with a preoperative diagnosis of SARS-CoV-2 (OR 0.6, 95% CI 0.6 (0.42 to 0.85), p=0.004). There was no difference in mortality in patients with an increase to delay in surgery (p=0.220) or type of anaesthetic given (p=0.787). Conclusions Patients undergoing surgery for a proximal femoral fracture with a perioperative infection of SARS-CoV-2 have a high rate of mortality. This study would support the need for providing these patients with individualised medical and anaesthetic care, including medical optimisation before theatre. Careful preoperative counselling is needed for those with a proximal femoral fracture and SARS-CoV-2, especially those in the highest risk groups. Trial registration number NCT0432364

Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal