Anthropocentric and White Supremacist Notions of God

A microscopic virus has upended life for all of us everywhere, creating not just a health crisis, but economic and social crises that are highlighting global disparities and calling into question systems and ways of life that we take for granted. Could it be that this virus, also part of creation, is holding up a mirror to us and calling us to a new humility, and a radical transformation of our ways? Is there a larger perspective to God's willingness to suffer with and for creation that calls into question our identification with God as a supreme being and the hierarchical systems that we have constructed based on that identification that has privileged a very few to dictate the fate of so many and have such a negative impact on creation? Can this virus help us to understand God and our place in creation differently? This chapter explores how the COVID-19 pandemic could help us reframe our ‘masters of the universe' thinking and prepare us for a new era where living in harmony with creation will be ever more necessary. © The Editor(s) (if applicable) and The Author(s), under exclusive licence to Springer Nature Switzerland AG 2023.

The benefits of index telephone consultations in patients referred on the two-week wait colorectal cancer pathway.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic led to hospitals in the UK substituting face-to-face (FtF) clinics with virtual clinic (VC) appointments. We evaluated the use of virtual two-week wait (2-ww) lower gastrointestinal (LGI) clinic appointments, conducted using telephone calls at a district general hospital in England. METHODS: Patients undergoing index outpatient 2-ww LGI clinic assessment between 1 June 2019 and 31 October 2019 (FtF group) and 1 June 2020 and 31 October 2020 (VC group) were identified. Relevant data were obtained using electronic patient records. Compliance with national cancer waiting time targets was assessed. Environmental and financial impact analyses were performed. RESULTS: In total, 1,531 patients were analysed (median age=70, male=852, 55.6%). Of these, 757 (49.4%) were assessed virtually via telephone; the remainder were seen FtF (n=774, 50.6%). Ninety-two (6%, VC=44, FtF=48) patients had malignant pathology and 64 (4.2%) had colorectal cancer (CRC); of these, 46 (71.9%, VC=26, FtF=20) underwent treatment with curative intent. The median waiting times to index appointment, investigation and diagnosis were significantly lower following VC assessment (p<0.001). The cancer detection rates (p=0.749), treatments received (p=0.785) and median time to index treatment for CRC patients (p=0.156) were similar. A significantly higher proportion of patients were seen within two weeks of referral in the VC group (p<0.001). VC appointments saved patients a total of 9,288 miles, 0.7 metric tonnes of CO2 emissions and £7,482.97. Taxpayers saved £80,242.00 from VCs. No formal complaints were received from patients or staff in the VC group. CONCLUSION: Virtual 2-ww LGI clinics were effective, safe and were associated with tangible environmental and financial benefits.

A Single-Centre Experience of Telephone Assessment of Patients Referred to Two Week-Wait Colorectal Surgery Clinics in England

Aim: Despite Covid-19, hospitalsin the England, United Kingdom continued to assess and manage patients referred on two week-wait (2WW) suspected cancer referral pathways. Most index clinic assessments of such patients were conducted viatelephone. We retrospectively evaluated adistrict general hospital experience of managing patients on a 2WW suspected lower gastrointestinal tract (LGIT)cancer referral pathway, initially assessed via telephone Method: Data were obtained using a prospectively maintained database and electronic patient records. LGIT 2WW referrals between 01/06/2020to 31/10/2020 were included. Data were retrospectively collated and analysed using Excel (Microsoft Corporation, USA) Results: A total 757 patients (median age = 70, interquartile range = [59-79], female = 47.2%) were identified. The majority (n = 629,83.1%) were white Caucasian. All patients were initially assessed virtually and only 3 (0.4%) were re-assessed face-to- face for their index appointment. Sixteen (2.1%) missed at least one prior appointment. The most common presenting complaints included change in bowel habit, rectal bleeding, weight loss, anaemia and abdominal pain, and 415 (54.8%), 269 (35.5%) underwent endoscopy and imaging respectively as the first investigation. Forty four (5.8%) patients had malignant pathology with the majority (n = 37,84.1%) being colorectal in origin. Of those diagnosed with a primary colorectal malignancy 25 (67.6%) underwent surgical or endoscopic treatment, 3 (8.1%) were referred to chemoradiotherapy and 8 (21.6%) were referred for palliation. Conclusion(s): Patients referred on the 2WW LGIT pathway continued to be assessed and managed despite Covid-19. Index telephone clinic assessments are perhaps as effective a tool as face-to- face assessments, for patients referred on this pathway. This warrants further investigation.

The Use of Telephone Versus Face to Face Appointments in Two Week-Wait Colorectal Surgery Clinics -a Single Centre Experience

Aim: Telephone appointments have replaced face-to- face hospital clinic appointments due to the Covid-19 pandemic. We evaluated the impact of telephone appointments on patients referred on a two week-wait (2WW) suspected lower gastrointestinal tract (LGIT) cancer pathway. Method(s): Two independent patient samples between the 01/06/2019-31/ 10/2019 (face-to- face cohort) and 01/06/2020-31/ 10/2020 (telephone cohort) were identified using a prospectively maintained local database and electronic patient records. Data were retrospectively collated using Excel (Microsoft, USA). Chi-square and Man-Whitney- U statistical tests were performed using SPSS (IBM, USA). Result(s): A total 1531 (median age = 70, interquartile range [IQR] = 60-79, female = 679, 44.4%) were analysed. Of these, 757 (49.4%) were assessed via telephone;the remainder were face-to- face (n = 774,50.6%). The age, gender and ethnicity distributions across the two groups were similar. A total of 92 (6%, telephone = 44, face-to- face = 48) patients had malignant pathology and 64 (4.2%) were colorectal cancer (CRC). Of those with a CRC diagnosis, 46 (3.0%, telephone = 26, face-to- face = 20) underwent surgical or endoscopic treatment with curative intent. There was no significant difference in diagnoses made (P = 0.749) or treatment of CRC (P = 0.785) following telephone versus face-face- appointments. The median waiting times for index appointment, investigation and diagnosis for telephone appointments were significantly lower compared to face-to- face appointments (P < 0.001). There was no significant difference in median time to index treatment for CRC between the two groups (P = 0.156). Conclusion(s): Patients referred to 2WW LGIT clinics were efficiently and safely assessed and manged using telephone clinics during the Covid-19 pandemic. The cost-effectiveness and stakeholder views on permanent use of telephone assessments in these clinics must be evaluated.

Patient-Reported Reasons for Non-Participation in Inpatient COVID-19 Clinical Research: Results from a Multi-Center VA Embedded Randomized Trial

Background. Early in the COVID-19 pandemic, no evidence-proven therapeutics were approved, and thus participation in a clinical trial was often the only way to access experimental medications. However, in the US, participation in medical research is low. Patient-stated factors impacting enrollment decisions are poorly characterized. Thus, the aim of this study was to identify patient-reported reasons for declining enrollment in a COVID-19 clinical trial. Methods. As part of an open-label, pragmatic randomized trial across five VAs from 4/10/20 - 2/3/21, SARS-COV-2 positive inpatients with moderate to severe disease were screened for eligibility. Potentially eligible patients received an informed consent packet with a letter explaining the study and were then contacted remotely to assess willingness to participate. If eligible patients declined to participate, if willing, they were asked an open-ended question about the reasons behind their decision. If they were not able to provide a specific answer, then general categories were offered. Qualitative responses were analyzed using a directed content analysis approach;responses were categorized using previously defined factors that have contributed to decisions not to enroll in other clinical therapeutics trials, primarily conducted in oncology. Results. Among 417 patients screened, 162 met eligibility criteria. Of these, 53 consented (32.7%), 102 declined to participate (62.9%), and 7 were unable to give consent. Themes and examples of reasons for declining participation are presented in Table 1. Among the patients who declined to participate, the four most cited factors were limited perceived benefit, competing priorities, physician or family influence and presence of comorbidities. Several patients reported that their decision was influenced by physician or family recommendation to decline, which was reported as physician lack of support for participation due to the presence of comorbidities or physician perceived lack of benefit given clinical improvement prior to study enrollment. Conclusion. Understanding reasons and attitudes driving enrollment may help investigators address them during the recruitment process and increase participation in clinical trials in the US.

Subcutaneous Sarilumab for the Treatment of Hospitalized patients with Moderate to Severe COVID19 Disease: A Pragmatic, Embedded, Multi-Center Randomized Clinical Trial

Background. The aim of this pragmatic, embedded adaptive trial was to measure the effectiveness of subcutaneous sarilumab in addition to an evolving standard of care for clinical management of inpatients with moderate to severe COVID-19 disease (NCT04359901). The study is also a real-world demonstration of the realization of a prospective learning healthcare system. Methods. Two-arm, randomized, open-label controlled 5-center trial comparing standard care alone to standard care (SOC), which evolved over time, with addition of subcutaneous sarilumab (200 mg or 400 mg anti-IL6R) among hospitalized patients with moderate to severe COVID-19 not requiring mechanical ventilation. The primary outcome was 14-day incidence of intubation or death. The trial used a randomized play-the-winner design and was fully embedded within the EHR system, including the adaptive randomization process. Results. Among 417 patients screened, 162 were eligible based on chart review, 53 consented, and 50 were evaluated for the primary endpoint of intubation or death ( >30% of eligible patients enrolled) (Figure 1). After the second interim review, the unblinded Data Monitoring Committee recommended that the study be stopped due to concern for safety: a high probability that rates of intubation or death were higher with addition of sarilumab to SOC (92.6%), and a very low probability (3.4%) that sarilumab would be found to be superior. Conclusion. This randomized trial of patients hospitalized with COVID-19 and requiring supplemental oxygen but not mechanical ventilation found no evidence of benefit from subcutaneous sarilumab in addition to an evolving standard-of-care. The numbers of patients and events were too low to allow independent conclusions to be drawn, but this study contributes valuable information about the role of subcutaneous IL-6 inhibition in the treatment of patients hospitalized with COVID-19. The major innovation of this trial was the advancement of embedded, point-of-care clinical trials for FDA-approved drugs;this represents a realization of the learning healthcare system. Methods developed and piloted during the conduct of this trial can be used in future investigations to speed the advancement of clinical science.

Index telephone two-week wait lower gastrointestinal clinics as a substitute to face to face outpatient appointments during the COVID-19 pandemic

Purpose/Background: The COVID-19 pandemic led to hospitals in the United Kingdom substituting face-to- face (FtF) clinics with virtual clinic (VC) appointments. We evaluated the impact of virtual two-week wait (2-ww) lower gastrointestinal (LGI) consultations on stakeholders at a district general hospital in England. Methods/Interventions: Patients undergoing index outpatient 2-ww LGI clinic assessment between 01/06/2019-31/ 10/2019 (FtF group) and 01/06/2020-31/ 10/2020 (VC group) were identified. Relevant data were obtained using electronic patient records. Compliance with national cancer waiting time targets (WTT) was assessed. Environmental and financial impact analyses were performed. Results/Outcomes: In total, 1531 patients were analysed (median age = 70, male = 852, 55.6%). Of these, 757 (49.4%) were assessed virtually via telephone;the remainder were seen FtF (n = 774, 50.6%). Ninety two (6%, VC = 44, FtF = 48) patients had malignant pathology and 64 (4.2%) had colorectal cancer (CRC);of these, 46 (71.9%, VC = 26, FtF = 20) underwent treatment with curative intent. The median waiting times to index appointment, investigation and diagnosis were significantly lower following VC assessment (p < 0.001). The cancer detection rates (p = 0.749), treatments received (p = 0.785) and median time to index treatment for CRC patients (p = 0.156) were similar. A significantly higher proportion of patients were seen within two weeks of referral in the VC group (p < 0.001). VC appointments saved patients a total of 9288 miles, 0.7 metric tonnes of CO2 emissions and £7482.97. Taxpayers saved £80,242.00 from VCs. No adverse events or complaints were reported in the VC group. Conclusion/Discussion: Virtual 2-ww LGI clinics were effective, safe and were associated with tangible environmental and financial benefits for stakeholders. (Figure Presented).

The first early access to medicines scheme in relapsed/refractory multiple myeloma

Content: The Early Access to Medicines Scheme (EAMS) aims to provide patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. Here we present an overview of the first EAMS in Relapsed/Refractory Multiple Myeloma (RRMM), where eligible patients could access isatuximab in combination with pomalidomide and dexamethasone. EAMS approval was granted on 02 December 2019, with the first patient enrolled in February 2020 and the last in June 2020 when marketing authorisation was received for isatuximab. Among other key inclusion/exclusion criteria, patients were able to access the scheme only if they had received 3 prior lines of therapy (including lenalidomide and a proteasome inhibitor) and had demonstrated disease progression on the last therapy. After closure of the scheme, data from the anonymised enrolment forms were extracted, and aggregated. Of the 130 requests received, 111 adult patients were approved for enrolment onto the scheme. Across the UK 94 patient requests were from hospitals in England, 10 from Wales, 6 from Scotland and 1 from Northern Ireland. Many operational arrangements had to be in place with each site prior to approving any request. This was to ensure regulatory requirements were met for provision of core information documents, agreement to additional pharmacovigilance and completion of mandatory training on the unlicensed medicine. A total of 85 training sessions were delivered, involving approximately 300 healthcare professionals consisting of consultant haematologists, pharmacists, and nurses. Baseline patient demographics showed 62% were male and 37% female, with one unknown record (<1%). 54 patients were aged less than 65 years, 44 aged 65 75 years and 13 patients over 75. The mean age was 66 years, with the youngest and oldest aged 33 and 83 years, respectively. The table below shows the patients' treatment history at previous lines. In this small population of patients with RRMM, a higher proportion of patients were male and aged under 65. The most frequently used combinations at 1L, 2L and 3L were CTD, VCD and IRD respectively, although much variability of treatment choices was noted. The high uptake in this EAMS reinforced the lack of optimal treatment options available for these difficult-to-treat patients. Furthermore, the scheme was active during emergence of COVID-19 and despite the pandemic, applications continued with an upward trajectory. There is great value in an EAMS to bring earlier patient access to new therapies where there is an unmet need, such as in RRMM. Although resource-intensive, the success of the programme is greatly reliant on a robust internal operational process and good communication with external stakeholders. CTD, cyclophosphamide, thalidomide, dexamethasone;VCD, bortezomib, cyclophosphamide, dexamethasone;VTD, bortezomib, thalidomide, dexamethasone;RD, lenalidomide, dexamethasone;IRD, ixazomib, lenalidomide, dexamethasone;RCD, lenalidomide, cyclophosphamide, dexamethasone.