ABSTRACT
Introduction: PREPARE is a pragmatic clusterrandomized crossover trial that compares the effectiveness of two common pre-operative antiseptic skin solutions to reduce the risk of surgical site infection after orthopedic fracture surgery. The trial compares 2% chlorhexidine in 70% isopropyl alcohol (ChloraPrep™) versus 0.7% iodine povacrylex in 74% isopropyl alcohol (DuraPrep™), and recruiting sites alternate study solutions every 2 months. Before the US national response to the COVID-19 pandemic, all PREPARE trial clinical sites obtained informed consent in person at the hospitals or fracture clinics. However, after 13 March 2020, the COVID-19 restrictions limited inperson consenting at some hospitals. Affected clinical sites were encouraged to transition to telephone consent, which was already included as a consent option in the PREPARE protocol. We aimed to determine how COVID-19 restrictions impacted the number of enrolling clinical sites and participant enrollment in the PREPARE trial. Methods: Prior to implementing telephone consent, clinical sites had to determine local logistics and obtain institutional review board approval for telephone consent scripts and procedures from the central or local institutional review boards. We descriptively evaluated the number of clinical sites that switched to telephone consent, the number of clinical sites that had to pause enrollment, and the length of the enrollment pauses. We evaluated monthly enrollment at the following time periods: (1) prior to the COVID-19 restrictions (1 July 2019 to 13 March 2020), (2) immediately after the COVID-19 restrictions in place (March, April, and May 2020), and (3) from 1 June 2020 to 30 November 2020. Results are stratified by open and closed fractures and are summarized using descriptive statistics. Results: At the time of the pandemic, 13 clinical sites were participating in the PREPARE trial. Eleven (84.6%) clinical sites paused enrollment due to COVID- 19 restrictions. The median length of enrollment pause was 44 days (range = 7-92 days;interquartile range = 54 days). By 16 June 2020, all clinical sites resumed enrollment. The average monthly enrollment before the COVID-19 restrictions was 198 closed fracture participants (SD = 22, range = 161-227) and 41 open fracture participants (SD = 16, range = 22-60). The enrollment rate was the lowest in April 2020, when 47 closed fracture participants and nine open fracture participants were enrolled. By June 2020, enrollment began increasing. From 1 June 2020 to 30 November 2020, the average monthly enrollment rate was 183 closed fracture participants (SD = 30, range = 129-206) and 44 open fracture participants (SD = 12, range = 24-61), which was close to pre-COVID enrollment. Monthly enrollment between 2019 and 2020 was similar, except for the months of March to May 2020 for closed fracture enrollment (p = 0.001) and March and April 2020 for open fracture enrollment (p = 0.04) cohorts. Conclusion: By pre-emptively including telephone consent in the PREPARE protocol, clinical sites were quickly and ethically adapting their procedures for obtaining informed consent via telephone. Although multiple sites paused enrollment, the enrollment pause was brief and had minimal impact on enrollment. A highly pragmatic design allowed for minimal interruptions to enrollment during the pandemic.
ABSTRACT
Politicians are skilled language users who deploy words strategically and pay close attention to the emotions that those words evoke. We examined the emotional characteristics of over 92 million words spoken by Canadian Members of Parliament between 2006 and 2021. The analysis brought together the Warriner, Kuperman, and Brysbaert (Behav. Res., 2013, 45, 1191-1207) database of valence (positivity) ratings for English and the Canadian Hansard, which contains a transcription of parliamentary speech. Results revealed that the positivity of words used by politicians in parliament was significantly related to both political and social variables. Politicians increased the positivity of their language after the onset of the COVID-19 crisis. Within the time of the crisis, word positivity was linked statistically to month-by-month case counts, indicating a very fine-grained sensitivity to social realities. Our analysis also revealed a fine-grained sensitivity of word valence to political realities. As expected, parties in power used more positive language than those in opposition. In addition, our analysis revealed that individual parties have characteristic levels of word positivity and that those levels change in accordance with political changes as specific as whether or not the party in power holds a majority of seats in parliament. These findings suggest that the emotional properties of words used by Members of Parliament are reliably indexed to sociopolitical dynamics. The findings also suggest that the methodology of linking individual word ratings to Hansard Documents (which are used to document Parliamentary activities in over 25 countries) can provide a key tool for the understanding of specific crises such as the COVID-19 global pandemic as well as more general social and political trends across countries and languages. © Gallant and Libben.