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1.
Cancer Research Conference ; 83(5 Supplement), 2022.
Article in English | EMBASE | ID: covidwho-2271599

ABSTRACT

Background: Mammographic screening programmes reduce breast cancer mortality, but detect many small tumours with favourable biological features which may not progress during a woman's lifetime. Screen-detected cancers are treated with standard surgery and adjuvant therapies, with associated morbidities. There is a need to reduce overtreatment of good prognosis tumours and numerous studies have evaluated the omission of radiotherapy in this context. However, there is little evidence to support surgical de-escalation, although percutaneous minimally invasive treatment approaches have been described. Vacuum-assisted excision (VAE) is in widespread use for management of benign lesions and lesions of uncertain malignant potential. SMALL (ISRCTN 12240119) is designed to determine the feasibility of using this approach for treatment of small invasive tumours detected within the UK NHS Breast Screening Programme (BSP). Method(s): SMALL is a phase III multicentre randomised trial comparing standard surgery with VAE for screendetected good prognosis cancers. The main eligibility criteria are age >=47 years, unifocal grade 1 tumours with maximum diameter 15mm, which are strongly ER/PR+ve and HER2-ve, with negative clinical/radiological axillary staging. Patients are randomised 2:1 in favour of VAE or surgery;with no axillary surgery in the VAE arm. Completeness of excision is assessed radiologically, and if excision is incomplete, patients undergo open surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm but may be omitted following surgery. Co-primary end-points are: 1. Noninferiority comparison of the requirement for a second procedure following excision 2. Single arm analysis of local recurrence (LR) at 5 years following VAE Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure. This ensures sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. To ensure that the trial as a whole only has 5% alpha, the significance level for each co-primary outcome is set at 2.5% with 90% power. The Data Monitoring Committee will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A novel feature of SMALL is the integration of a QuinteT Recruitment Intervention (QRI), which aims to optimise recruitment to the study. Recruitment challenges are identified by analysing recruiter/patient interviews and audiorecordings of trial discussions, and by review of trial screening logs, eligibility and recruitment data and study documentation. Solutions to address these are developed collaboratively, including individual/group recruiter feedback and recruitment tips documents. Result(s): SMALL opened in December 2019, but recruitment halted in 2020 for 5 months due to COVID-19. At 7st July 2022, 142 patients had been randomised from 26 centres, with a randomisation rate of approximately 45%, and a per site recruitment rate of 0.4-0.5 patients/month, approaching the feasibility recruitment target of 144 patients. Drawing from preliminary QRI findings and insights from patient representatives, a recruitment tips document has been circulated (on providing balanced information about treatments, encouraging recruiters to engage with patient preferences, and explaining randomisation). Individual recruiter feedback has commenced, with wider feedback delivered across sites via recruitment training workshops. Conclusion(s): Despite pandemic-related challenges, SMALL has an excellent recruitment rate to date and is expected to have a global impact on treatment of breast cancer within mammographic screening programmes.

2.
Police Practice and Research ; 2023.
Article in English | Scopus | ID: covidwho-2259468

ABSTRACT

Depolicing is a behavior that occurs when law enforcement officers disengage from proactive police work. Despite the term's more recent popularity, these behaviors have been identified in policing literature for decades. Scholars have primarily tried to quantify the depolicing phenomenon through the lens of public scrutiny and the Ferguson Effect. However, there are currently no quantitative studies that have attempted to examine the multitude of reasons as to why depolicing behavior could potentially occur. The current inquiry uses survey data retrieved from eight municipal law enforcement agencies to further examine potential predictors of depolicing. The predictor variables consisted of public scrutiny, liability concerns, organizational unfairness, burnout, physical danger, COVID-19, and years of experience. Our results indicate that public scrutiny, liability concerns, COVID-19, and years of experience are all significant and positive predictors of depolicing. We also found that agency location and rank significantly impacted depolicing behavior. The findings and limitations are discussed. © 2023 Informa UK Limited, trading as Taylor & Francis Group.

3.
Sociology ; 2023.
Article in English | Scopus | ID: covidwho-2230068

ABSTRACT

Symbolic boundaries shape how we see and understand both ourselves and those around us. Amid periods of crisis, these boundaries can appear more salient, sharpening distinctions between ‘us' and ‘them' and reinforcing inequalities in the social landscape. Based on 50 in-depth interviews about pandemic experiences among Canadians with disabilities and chronic health conditions, we examine how this community distinguishes between the ‘deserving' and ‘undeserving', and how emotions related to blame and resentment inform the boundaries they draw. We find that people with disabilities and chronic health conditions drew boundaries based on unequal health statuses and vulnerabilities and between those who are and are not legitimately entitled to government aid. Underlying these dimensions are a familiar set of moral tropes that respondents use to assert their own superiority and to inveigh their frustrations. Together, they play an important role in solidifying boundaries between groups, complicating public perceptions of policy responses to crisis. © The Author(s) 2023.

4.
Pediatric Critical Care Medicine Conference: 11th Congress of the World Federation of Pediatric Intensive and Critical Care Societies, WFPICCS ; 23(11 Supplement 1), 2022.
Article in English | EMBASE | ID: covidwho-2190816

ABSTRACT

BACKGROUND AND AIM: Widely-implemented restricted family presence (RFP) policies/practices during the COVID-19 pandemic were counter to family centered values embraced by many PICUs. This study explored the impact of implementing and enforcing these policies on Canadian PICU clinicians. METHOD(S): Cross-sectional survey of Canadian PICU clinicians. We developed an online, self-administered, survey to assess 1. Family presence policy and practice changes;2. Experience and opinions;3. Moral distress (Moral Distress Thermometer);and 4. Impact (Impact of Event Scale [IES] and attributable stress [5-point Likert scale]). Analysis included descriptive statistics, t-tests, one-way ANOVA;biand multi-variable stepwise regression assessed correlations. RESULT(S): Of 388 respondents representing 17/19 PICUs, 368 (94.1%) indicated that they experienced RFP policies and were predominantly female (n=333, 90.7%), English speaking (n=338, 91.8%), and RN (n=240, 65.2%). Incongruence between RFP policies/practices and PICU values was perceived by 66% (n=217). Most (n=235, 71%) felt their opinions were not valued when implementing policies. Though restrictions were perceived as beneficial to clinicians (n=252, 76%) and families (n=236, 75%), and 52% (n=171) felt RFP made their work easier, 57% (n=188) disagreed that their RFP experience was mainly positive. The median (IQR) reported moral distress was 5 (2-6) (n=307, scale 0-10);the strongest predictor was perception of differential impact of RFP on families. The mean (SD) total IES score (n=290, 78.8%) was 29.7 (10.5), suggesting moderate traumatic stress. For 56% (n=176) there was increased/significantly increased attributable stress. CONCLUSION(S): PICU-based RFP rules, designed and implemented without clinician input, caused increased emotional burden.

5.
Pediatric Critical Care Medicine Conference: 11th Congress of the World Federation of Pediatric Intensive and Critical Care Societies, WFPICCS ; 23(11 Supplement 1), 2022.
Article in English | EMBASE | ID: covidwho-2190777

ABSTRACT

BACKGROUND AND AIM: National surveys soliciting family experiences present challenges and opportunities. We performed a pan-Canadian, multi-centered, online survey of family experiences with restricted family presence in PICU during COVID-19. Sites chose from 6 respondent approach methods. This sub-study explores relationships between invitation methods and response rates. METHOD(S): Information was collected from the 11 participating sites via e-mail-based survey to determine: eligible participant numbers;invitation method;time from PICU admission to survey invitation;contact methods for bereaved and non-bereaved families;participation barriers and facilitators. Responses were quantified using descriptive statistics and Spearman's rank order correlation. Free texts were inductively coded. RESULT(S): Sites invited families of PICU patients admitted during 4-month periods, beginning March 2020 (n=9) and/or November 2020 (n=3). Invitations were sent a mean (SD) of 7.7 (2.8) months post-admission. The overall survey response rate was 270/1005 invited families (27%). The mean institution response rate was 27% (SD=13%, range 4-50%) and was highest for sites using postal invite with telephone follow-up (43%, n=2), followed by telephone approach (26%, n=7), text message paired with social media posts and posters (22%, n=1), and postal invite alone (n=1, 8%). Bereaved families received a personalized telephone call. Time from admission to invitation was inversely correlated with response rate (rs = -0.70, p=0.02). Most common recruitment barriers were lack of funded research personnel (n=4) and REB requiring initial contact by care team rather than researchers (n=3). CONCLUSION(S): Multi-centre surveys with unfunded site participation face challenges. Postal invitation with telephone follow-up may improve response rates.

6.
Pediatric Critical Care Medicine Conference: 11th Congress of the World Federation of Pediatric Intensive and Critical Care Societies, WFPICCS ; 23(11 Supplement 1), 2022.
Article in English | EMBASE | ID: covidwho-2190733

ABSTRACT

BACKGROUND AND AIM: Family centered care is a core value adopted by most healthcare providers (HCPs) working in North American PICUs. Restricted family presence (RFP) policies adopted during the COVID-19 pandemic threatened this value, with the potential for significant impact. This study explores how implementing and enforcing RFP policies impacted bedside HCPs in PICUs. METHOD(S): We conducted a national, online, selfadministered cross-sectional survey of bedside HCPs from all 19 Canadian PICUs about their experience with RFP. The Impact of Event Scale (IES), an existing validated scale, was included as a survey instrument. Prior to completing the scale, respondents were asked to describe the impactful experience(s) that they planned to reference. The resulting free-text responses were inductively coded for emergent themes, which were discussed for consensus. RESULT(S): 146/388 survey respondents completed the IES (94% English speaking;62% RN, 18% MD, 15% RT;87% self-identified women). Six themes related to impactful situations or events emerged from the event descriptions: 1. Concern about the impact on the patient and family (n=57);2. Non-family centered end-of-life situations (n=43, including 5 who reported family members unable to be present for a death);3. Separating families and denying access (n=36);4. The general, overall experience (n=25), a subtheme of which was "RFP was a positive or neutral experience" (n=13);5. Policies and enforcement felt unjust and unfair (n=23);and 6. Family member non-compliance and aggressive reactions (n=15). CONCLUSION(S): Bedside HCPs experienced multiple impactful, potentially trauma-inducing situations related to RFP.

7.
Pediatric Critical Care Medicine Conference: 11th Congress of the World Federation of Pediatric Intensive and Critical Care Societies, WFPICCS ; 23(11 Supplement 1), 2022.
Article in English | EMBASE | ID: covidwho-2190732

ABSTRACT

BACKGROUND AND AIM: Due to the COVID-19 pandemic, restricted family presence (RFP) policies were rapidly developed and implemented. PICU leadership was instrumental in dissemination, clarification, and policy enforcement. However, the experience of PICU leaders has not been explored. This study examines the lived experience of physician leads and operational/clinical managers with RFP policies and practices in the PICU. METHOD(S): Qualitative descriptive study. We invited physician leads and managers from all Canadian PICUs to participate in telephone or virtual, audio-recorded, semi-structured interviews, which were transcribed. We performed inductive content analysis: three researchers generated a codebook, two independent coders met regularly to compare codes and refine the codebook, and three researchers organized the data into themes. RESULT(S): We interviewed 9 managers and 15 physician leads from 13 Canadian PICUs. We identified 6 main themes. (1) Operationalizing the policies required enhancement and adaptation of usual leadership roles while (2) working in the middle of organizational hierarchy. (3) The RFP policies made explicit the need to balance stakeholder safety with compassion in caring for the sickest children. (4) Most PICU leaders perceived unintended effects of the RFP policies as having a negative impact on families, healthcare providers, and family centered care. (5) Implementing, communicating, and enforcing restrictions took personal tolls on many of the leaders. (6) Leaders recognized multiple opportunities for policy improvements. CONCLUSION(S): RFP policies had significant professional and personal impacts on PICU leaders, who identified both unintended consequences of and future opportunities for restricted presence policies.

8.
Pediatric Critical Care Medicine Conference: 11th Congress of the World Federation of Pediatric Intensive and Critical Care Societies, WFPICCS ; 23(11 Supplement 1), 2022.
Article in English | EMBASE | ID: covidwho-2190731

ABSTRACT

BACKGROUND AND AIM: In response to the COVID-19 pandemic, multiple Canadian PICUs restricted presence to one caregiver. Though patients could receive support, sources of caregiver support were limited. We sought to examine caregiver support during PICU admission under restricted family presence policies. METHOD(S): We conducted a cross-sectional survey of caregiver experience with restriction policies in Canadian PICUs. Support, or lack thereof, emerged as a dominant theme. Hence, in this sub-study, open-ended questions were analyzed using inductive content analysis, focusing on the concept of support. Likert-scale questions related to being alone at a PICU bedside were summarized using descriptive statistics. RESULT(S): 250 respondents experienced restriction policies (Mean [SD] age 38.8[8.4] years;226[91%] primarily Englishspeaking;230[92%] post-secondary education;208[83%] in a maternal role). Of 187 responses referring to the most difficult aspects of RFP policies, 84 (45%) addressed lack of support. Respondents felt alone in facing the admission and its associated experiences (n=32). RFP resulted in unmet needs for: emotional/moral support (n=42);a specific person's presence (n=28);and respite (n=10). Lack of support impaired medical care, communication, and decisionmaking (n=23). Weighted for strength of agreement, the top situation in which respondents were alone and both wished for a support person (n=9, 81.8%) and felt it was traumatic being alone (n=6, 85.7%) was when their child died. Nonweighted, the highest agreement was when the child's condition worsened (n=99 [89.2%] "wanted support" and n=94 [87.8%] "it was traumatic"). CONCLUSION(S): Restricted family presence policies in PICUs limited caregivers' access to social support systems, resulting in unmet needs and traumatic experiences.

9.
Palgrave Critical University Studies ; : 265-286, 2022.
Article in English | Scopus | ID: covidwho-2128419

ABSTRACT

In this chapter, we discuss the ways in which COVID-19 created a different kind of pandemic opportunity for faculty, students, and staff to resist the expansion of neoliberal policies and practices in higher education. We highlight student actions across the nation;labor actions by campus essential workers;the increasing unionization and mobilization of graduate students, faculty, and campus staff responding to risky management decisions in the COVID context on top of pre-pandemic attacks on workers’ dignity, autonomy, and wages. We argue these emergent waves of collective action can be understood as resistance to racialized disaster patriarchal capitalism, and part of the larger fight for the soul of higher education against the opportunism, austerity, sacrifice, and disposability politics that aim to put profit before people. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

10.
Palgrave Critical University Studies ; : 219-232, 2022.
Article in English | Scopus | ID: covidwho-2128418

ABSTRACT

In this chapter, we examine the relationship between pandemic tuition increases and student debt, the latter not only an American experience but a growing global concern. In the midst of the fight against COVID, many administrators in the U.S. decided to increase tuition for students and their families, in many instances, several times over, in what we described as akin to other forms of price-gouging of vulnerable people and communities during disasters. Additionally, we argue that the link between tuition increases and student debt is not accidental but an outcome of decades of policy decisions that have led to a systemic failure of government, particularly in the United States, to support the institution of higher education, and education more broadly. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

11.
Palgrave Critical University Studies ; : 167-180, 2022.
Article in English | Scopus | ID: covidwho-2128417

ABSTRACT

In this chapter, we argue that the ongoing transformation of American higher education by educational technology, finance, and management corporations to establish and expand online instruction is a key ingredient of the toxic soil in which so-called pandemic necessary responses took root. We look closely at one of the most widely promoted educational technology products during the COVID-19 pandemic, namely what is known as the “hyflex” or “blendflex” modality of instruction. One of the most profound transformations of teaching in the remote learning era, the hyflex modality has crept into the higher education pandemic restart plans of some state legislatures, and suggests a disturbing synergy between educational technology firms, enrollment management firms, online program management corporations, college and university presidents, and state legislators. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

12.
Palgrave Critical University Studies ; : 155-165, 2022.
Article in English | Scopus | ID: covidwho-2128416

ABSTRACT

In this chapter, we turn our gaze to campus reopening plans and COVID mitigation strategies enacted by colleges and universities in the early months of the pandemic. We found that higher education administrators’ pandemic responses were consistent with concerns for institutions’ bottom line, expressed largely in fears of losing enrollment, rather than the concern for the well-being of their students, their employees, and the community at large. We examine the dual response of colleges and universities ready to embrace public health solutions on the one hand, and stubborn refusals to heed science in favor of political conformity on the other, even when that repudiation is at odds with the best science, with the will of the faculty, and at the urging of student leaders. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

13.
Palgrave Critical University Studies ; : 145-154, 2022.
Article in English | Scopus | ID: covidwho-2128415

ABSTRACT

In this chapter, we show how an already severely weakened commitment to academic shared governance was further undermined during COVID-19 through the workings of “pandemic task forces” established on campuses around the country that often served as vehicles to carry management agendas under the guise of “faculty consultation.” We examine a disturbing set of illustrations of both the implicit and also explicit allocation of COVID response team authority to campus executives in student affairs and athletics, as opposed to faculty-supported leaders in academic affairs. We explore the various manifestations of these exercises in the manufacture of consent, including those that are entangled with local and state officials. We discuss the consequences for faculty power, control over curriculum, and the conditions of teaching and learning. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

14.
Palgrave Critical University Studies ; : 57-104, 2022.
Article in English | Scopus | ID: covidwho-2128414

ABSTRACT

In this chapter, we focus on academic labor cost and control strategies that U.S. college and university administrators took during COVID-19 that were presented as pandemic austerity measures, but had precipitating factors and deeper roots in “workforce reduction plans.” We argue that such austerity measures have been displaced and have exacerbated the crisis of administrative bloat. We argue that the familiar management tactic of manufacturing fear, uncertainty, and distrust (F.U.D.) to destabilize and undercut unions persists and has been repurposed during the COVID-19 crisis on college campuses across the United States. We particularly focus on the ways in which higher education executives deployed narratives of fiscal emergency to justify labor and program reductions, despite clear budget justifications, and in many cases, while otherwise increasing their wealth. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

15.
Palgrave Critical University Studies ; : 29-55, 2022.
Article in English | Scopus | ID: covidwho-2128413

ABSTRACT

In this chapter, we take the long view of the history of higher education in the U.S. to better explain the magnitude of what happened in the COVID era, how it came to be possible and why. We review key moments in the trajectory of the re-engineering of the university as an arm of business and show that the metamorphosis began as early as the First Gilded Age, expanded throughout the twentieth century, and accelerated with the rise of neoliberalism in the 1980s and into the Second Gilded Age. We outline key ways in which racialized disaster patriarchal capitalism has played out in higher education just prior to the outbreak of COVID-19, and end with a short preview of the books’ remaining chapters. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

16.
Palgrave Critical University Studies ; : 1-27, 2022.
Article in English | Scopus | ID: covidwho-2128412

ABSTRACT

In this chapter, we introduce the book’s central thesis that global education corporations along with higher education administrators in the U.S. and other Western democracies seized on the COVID-19 pandemic as an opportunity to further advance a neoliberal education agenda consistent with the principles and practices of “disaster capitalism” (Klein, The shock doctrine: The rise of disaster capitalism. Metropolitan Books, 2007). We review existing scholarship of neoliberalism and disaster capitalism in higher education, expanding the conceptual framing toward a feminist intersectional political economy perspective that informs our analysis throughout the book. In doing so, we argue that the current crisis in higher education operates squarely within a larger context of advanced global capitalism fueled by variable and historically situated racial structures and hetero-patriarchies that particularly sacrifice students without race, class or gender privilege. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

17.
Palgrave Critical University Studies ; : 1-369, 2022.
Article in English | Scopus | ID: covidwho-2126198
18.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009658

ABSTRACT

Background: Mammographic screening programmes reduce breast cancer mortality but detect many small tumours with favourable biology which may not progress. These are treated with surgery and adjuvant therapies, but associated morbidities mean there is a need to reduce overtreatment. Minimally invasive treatments such as vacuum-assisted excision (VAE) have been described but there is no prospective randomised evidence to support their routine use. SMALL (ISRCTN 12240119) is designed to establish the feasibility of using VAE to treat small tumours detected within the UK NHS Breast Screening Programme (BSP). Methods: Phase III multicenter randomized trial comparing surgery with VAE for screen-detected good prognosis cancers. Eligibility criteria are age ≥47 years, unifocal grade 1 tumors (maximum diameter 15mm), strongly ER/PR+ve and HER2-ve, with negative axillary staging. Patients are randomized 2:1 to VAE or surgery, with no axillary surgery in the VAE arm. Excision is assessed radiologically, and if incomplete, patients undergo surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm. Coprimary end-points are: (1) Non-inferiority comparison of the requirement for a second procedure. (2) Single-arm analysis of local recurrence (LR) at 5 years after VAE. Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure, ensuring sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. The DMC will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A QuinteT Recruitment Intervention (QRI) is integrated throughout SMALL to optimize recruitment and informed consent. Recruitment challenges are identified by analyzing recruiter/ patient interviews, audio-recordings of trial discussions, and by review of screening, eligibility and recruitment data and study documentation. Solutions are developed collaboratively, including recruiter feedback and recruitment tips documents. Results: SMALL opened in December 2019, but recruitment halted for 5 months due to COVID-19. At 11th February 2022, 91 patients had been recruited from 22 centers, with an approached/consented ration of 50%. Drawing from preliminary QRI findings, a recruitment tips document has been circulated (on discussing SMALL, providing balanced information on treatment options and explaining randomization). Individual recruiter feedback has commenced, with wider feedback planned shortly. Conclusion: Despite pandemic-related challenges, SMALL has excellent recruitment to date and is expected to have a global impact on treatment of screen-detected breast cancer.

19.
Cancer Research ; 82(4 SUPPL), 2022.
Article in English | EMBASE | ID: covidwho-1779443

ABSTRACT

Background:. Mammographic screening programmes have been shown to reduce breast cancer mortality. However, they detect many small tumours with favourable biological features which may not progress during a woman's lifetime. These are treated with standard surgery and adjuvant therapies, which have associated morbidities. Thus, there is a need to reduce overtreatment of good prognosis tumours found by screening. Minimally invasive treatment approaches have been described but there is no prospective randomised evidence to support their routine use. Vacuum-assisted excision (VAE) is in widespread use for management of benign lesions and lesions of uncertain malignant potential. SMALL (ISRCTN 12240119) is designed to determine the feasibility of using this approach for treatment of small invasive tumours detected within the UK NHS Breast Screening Programme (BSP). Methods:. SMALL is a phase III multicentre randomised trial comparing standard surgery with VAE for screen-detected good prognosis breast cancers. The main eligibility criteria are age ≥47 years, screen-detected unifocal grade 1 tumours with maximum diameter 15mm, which are strongly ER/PR+ve and HER2-ve, with negative clinical/radiological axillary staging. Patients are randomised 2:1 in favour of VAE or surgery;with no axillary surgery in S the VAE arm. Completeness of excision is assessed radiologically, and if excision is incomplete, patients undergo open surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm but may be omitted following surgery. Co-primary end-points are:1.Non-inferiority comparison of the requirement for a second procedure following excision2.Single arm analysis of local recurrence (LR) at 5 years following VAE. Recruitment of 800 patients over 4 years will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure. This ensures sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. To ensure that the trial as a whole only has 5% alpha, the significance level for each co-primary outcome is set at 2.5% with 90% power. The Data Monitoring Committee will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A QuinteT Recruitment Intervention (QRI) is integrated throughout SMALL to optimise recruitment and informed consent. Recruitment challenges are identified by analysing recruiter/patient interviews and audio-recordings of trial discussions, and by review of screening, eligibility and recruitment data and study documentation. Solutions to address these are developed collaboratively, including individual/group recruiter feedback and recruitment tips documents. Results:. SMALL opened in December 2019, but recruitment halted in 2020 due to suspension of the NHS BSP for 5 months due to COVID-19. As of 1st July 2021, 55 patients had been approached in 10 centres, with 33 patients randomised (randomisation rate 60%). A further 23 centres are in set-up, with 8 suspended due to the pandemic. Drawing from preliminary QRI findings and insights from patient representatives, a recruitment tips document has been circulated (on introducing and discussing SMALL, providing balanced information. on treatment options and explaining randomisation). individual recruiter feedback has commenced, with wider feedback planned shortly. Conclusion:. Despite pandemic-related challenges, SMALL has an excellent recruitment rate to date and is expected to have a global impact on treatment of breast cancer within mammographic screening programmes. SMALL is funded by the UK NIHR HTA programme, award 17/42/32.

20.
Biological Psychiatry ; 91(9):S129, 2022.
Article in English | EMBASE | ID: covidwho-1777997

ABSTRACT

Background: The COVID-19 pandemic is an ongoing stressor that has resulted in millions of deaths and worsening of psychiatric health worldwide. However, we lack knowledge regarding the influence of specific behavioral and neural factors that may alleviate the impact of the pandemic on mental health. Thus, we assessed whether pre-pandemic resilient coping strategy engagement and frontolimbic circuitry influence depression and anxiety symptoms during the pandemic. Methods: In 72 young adults (72.2% female, mean age 24 years), we assessed depression and anxiety symptoms (BDI and SCARED-A), resilient coping strategies (CD-RISC), and resting-state functional connectivity (FC) of frontolimbic circuitry using fMRI. We conducted general linear models to test preregistered hypotheses that 1) less resilient coping pre-pandemic and 2) weaker frontolimbic FC pre-pandemic would predict more severe symptoms during the pandemic;and 3) coping would interact with FC to predict symptoms during the pandemic. Results: Anxiety symptoms worsened during the pandemic as compared to pre-pandemic, while depression symptoms improved (ps<0.001). Less resilient coping predicted more severe depression symptoms during the pandemic (p=0.023). Weaker frontolimbic FC pre-pandemic predicted more severe obsessive-compulsive (p=0.015) and separation anxiety symptoms (p=0.040) during the pandemic. Resilient coping interacted with frontolimbic FC to predict depression (p<0.001), obsessive-compulsive (p=0.041), panic (p=0.017), and generalized anxiety (p=0.027) symptoms during the pandemic. Conclusions: Less coping strategy engagement and weaker frontolimbic FC may represent risk factors for poor psychiatric health during the pandemic. This research may inform efforts to ameliorate the adverse psychological effects of the COVID-19 pandemic, as well as subsequent global stressful events. Supported By: This work was supported by the National Institutes of Health (NIH) Director’s Early Independence Award (DP5OD021370) to DGG;Brain and Behavior Research Foundation (National Alliance for Research on Schizophrenia and Depression;NARSAD) Young Investigator Award to DGG;and National Science Foundation Graduate Research Fellowship Program Award to BHG and JCF. Keywords: Depression, Anxiety, Brain Imaging, fMRI, Coping Strategies, COVID-19 Pandemic

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