Recruitment of Patients during the Pandemic in Interact3 Trial: Indian Experience

Background and Aims: The case fatality rate of acute spontaneous intracerebral hemorrhage (ICH) is high 54% at 1 year, and only 12% to 39% of survivors achieve long term functional independence. The INTEnsive care bundle with blood pressure Reduction in Acute Cerebral haemorrhage Trial (INTERACT3) was an international, multicentre, cluster-randomized clinical trial to assess a multifaceted goal-directed care bundle of physiological management in patients with acute ICH. We aimed to study the challenges encountered in recruitment during the pandemics in India. Method(s): Between August 2020 and October 2022, all adult patients presenting with spontaneous ICH within 6 hours from symptom onset were enrolled under the standard of usual care management until they are informed of crossing over to intervention and to be contacted at 6 months follow-up. Result(s): Six out of ten screened centres participated. The pandemic posed many challenges to the recruitment of patients in the trial: The ethics committee meetings were interrupted, preventing us enrolling more sites. Fewer patients presented to hospital due to fear of covid, economic crisis, transportation barriers, delayed presentation beyond 6 hours due to poor triaging, delay in RTPCR testing, slow referrals, unwillingness to followup in outpatient clinic. Solutions: frequent virtual meetings with ethics committees were held by site PIs, RTPCR switched to rapid testing, ER physicians trained to rapidly identify ICH cases and trial strategy was modified at each centre to boost recruitment. Conclusion(s): Alternative approaches for rapid triaging and modified strategies to recruitment are needed to overcome challenges of implementing a stroke trial during a pandemic.

A Description of COVID-19 Lifestyle Restrictions Among a Sample of Rural Appalachian Women.

Background: COVID-19 has led to swift federal and state response to control virus transmission, which has resulted in unprecedented lifestyle changes for U.S. citizens including social distancing and isolation. Understanding the impact of COVID-19 lifestyle restrictions and related behavioral risks is important, particularly among individuals who may be more vulnerable (such as rural women with a history of substance use living in Appalachia). Purpose: The overall purpose of this study was to better understand the perceptions of lifestyle changes due to COVID-19 restrictions among this vulnerable group. Methods: The study included a mixed methods survey with a convenience sample of rural women (n=33) recruited through a closed, private Facebook group. Results: Study findings indicated that COVID-19 restrictions related to limited social activities and interactions with family and friends had a significant impact on women. Implications: Findings suggest that social isolation may have a number of unintended consequences for rural women, and implications for rural health practitioners are discussed.

Acute Leukemia and COVID-19: The Johns Hopkins Experience

Introduction: At the beginning of the COVID-19 pandemic in the United States, some states combated viral spread via lockdowns. In Maryland, where Johns Hopkins Hospital (JHH) is located, the closures began with public schools (March 12, 2020;3/12/20);followed by bars, restaurants, movie theaters, gyms and gatherings of >50 people (3/16/20) with 250 Maryland State Police troopers being activated to aid in enforcement. All non-essential businesses were closed on 3/23/20, with a statewide “stay-at-home order” announced on 3/30/20. At this time, we anecdotally noted a decline in the number of adult patients presenting to JHH with new diagnoses of acute leukemia (AL). In this retrospective study, we quantified changes in new AL diagnoses over this period. Methods: The study was approved by the JHH IRB. All patients with new presentations of AL undergo diagnostic flow cytometry (FC) analysis at our institution on peripheral blood and/or bone marrow samples. The FC database was searched for new diagnoses of adult (≥ 18 years) and pediatric (<18 years) AL during the following timeframes: [1] 3/13-6/10/20 (90 days after the first announced restriction) and [2] 2/11-3/12/20 (30 days prior to the first restriction). The database was searched for the same time periods in 2019 (3/13-6/10/19 and 2/10-3/12/19). A diagnosis of AL was considered new if the patient had not previously been diagnosed with AL or evolved to AL from an underlying myeloid neoplasm. Clinical data were collected from the electronic medical record. We used a Fisher's exact test to compare the distribution of new patients in the 30 days prior and 90 days following the announced COVID-19 restrictions in Maryland in 2020 to that of new patients in the corresponding time periods for 2019. The Cochran-Armitage test was used to compare trends in new patients with AL in the 30 days prior and 90 days following COVID-19 restrictions, as compared to the same time period in 2019. Statistical significance was defined as a p-value <0.05. Results: Between 3/13- 6/10/20, there were 25 new diagnoses of AL (11 women/14 men) with a median age of 51 years (range: 2.6 - 89 years;10 pediatric/15 adult). During the same 90 day period in 2019, there were 32 new diagnoses of AL (18 women/14 men) with a median age of 63 years (range: 8 - 93 years;2 pediatric/30 adult). Figure 1 shows the distribution of new AL diagnoses in adult patients by date of presentation. This decrease was most pronounced in the first 30 days, in which only one new adult patient with AL presented to JHH. The distribution of adult patients diagnosed in the 30 days prior and 90 days following the March 2020 restrictions was significantly different from the corresponding time period in 2019 (p=0.03);however, the overall trend of new adult AL diagnoses in the 30 days prior and the 90 days following the March 2020 restrictions was not significantly different from the corresponding time period in 2019 (p= 0.77). Of note, many patients with AL reported symptoms that overlapped with those of COVID-19 including fatigue (40%), dyspnea (35%) and fever (22%). 35.1% of patients diagnosed with AL after restrictions had no characteristic symptoms of COVID-19, as compared to 12.5% of patients diagnosed with AL during this period in 2019 (Table 1). Discussion: These data suggest that new presentations of adult AL were delayed by COVID-19-related restrictions. Given the acuity of AL, this delay may have affected clinical outcomes. Interestingly, pediatric new AL cases did not decrease during this time period. The reasons are unclear, though parents appear to have remained willing to seek care for their children even during the uncertain days at the beginning of the pandemic, perhaps due to the media reporting that COVID-19 infection was less aggressive in young people. Given the possibility of additional lockdowns due to COVID-19 variants or new pandemics, these data highlight the importance of encouraging patients to seek care in the event of illness, screening patients for both infectious and non-infectious diseas , and ensuring that routine medical care remains accessible. [Formula presented] Disclosures: Brown: Kura: Membership on an entity's Board of Directors or advisory committees;Amgen: Membership on an entity's Board of Directors or advisory committees;Takeda: Membership on an entity's Board of Directors or advisory committees;Novartis: Membership on an entity's Board of Directors or advisory committees;KIte: Membership on an entity's Board of Directors or advisory committees. Webster: AmGen: Consultancy;Pfizer: Consultancy.

Group intervention for pediatric patients with functional constipation: Telehealth as an opportunity for increased access and engagement

Background: Behavioral interventions for functional constipation (FC) are demonstrated to improve success rates and soiling frequency relative to medical treatment alone. Group treatments serving multiple patient-families (PFs) enhance social support and access to behavioral interventions. Intervention for Soiling, fecal Incontinence, and reToileting (I-SIT) is a group treatment for patients diagnosed with FC, with or without fecal incontinence, and their caregivers, implemented at Children's Hospital of Philadelphia. Sessions are facilitated by licensed psychologists and billed as health and behavior group intervention. Satisfaction with the I-SIT program is extremely high (100% of PFs would highly recommend I-SIT to another family) but enrollment has been consistently lower than capacity. Low enrollment has been attributed to logistical barriers (scheduling, distance). Given staffing requirements for in-person I-SIT, low enrollment results in patient:staff ratios that limit access to behavioral interventions. To address enrollment barriers, I-SIT was adapted to a virtual telehealth platform which was able to be implemented during the COVID-19 pandemic. The goal of this quality improvement (QI) project was to increase enrollment to I-SIT by adapting to a telehealth platform while maintaining high PF satisfaction. Method: Gastroenterologists referred patients (ages 5-10) to GI Psychologists for assessment and eligible patients were referred to I-SIT. All enrolled patients had a diagnosis of FC (with or without fecal incontinence). Exclusion criteria included need for individualized intervention due to psychiatric or developmental comorbidity or use of interpreter. Nine families participated in I-SIT across three cohorts during FY2017-2018. In person I-SIT was delivered by two psychologists across 4 weekly, 1 hour sessions with separate child and caregiver groups. Eleven families participated in virtual I-SIT across three cohorts during FY2020-2021. Virtual I-SIT was delivered by one psychologist via family sessions (child and caregiver together). Virtual I-SIT Cohorts 1 and 2 were delivered using the same schedule as in person I-SIT. Virtual I-SIT Cohort 3 was delivered across 3 biweekly, 90 minute sessions due to provider schedule, with caregiver only portions of each session in response to Cohorts 1 and 2 feedback. Content was identical across delivery platforms and included FC education, goal-setting, behavioral strategies for medication adherence and structured toilet sitting, collaborating with schools, and coping with social concerns. Following completion of I-SIT and virtual I-SIT, caregivers completed a 7-item satisfaction survey including quantitative and qualitative items. Completers of virtual I-SIT completed an additional 5 item telehealth survey regarding session duration, frequency, and format to inform QI efforts. Results: Primary outcome of enrollment increased with virtual I-SIT (11 telehealth patients in 3 cohorts compared to 9 in-person patients in 3 cohorts). Given decreased staffing requirements for telehealth format and increased enrollment, access to behavioral interventions for FC is improved with virtual I-SIT (3.67 telehealth patients per psychologist;1.5 in-person patients per psychologist). Engagement is also improved with virtual I-SIT (81% virtual group completers;67% in person group completers). Acceptability of virtual I-SIT was also high for group completers (1 PF prefers in-person;4 PFs prefer virtual;4 PFs unsure). Our balancing metric of patient satisfaction did show signs of decreased satisfaction with Cohort 3 of virtual I-SIT. All group completers from in-person Cohorts 1-3 and virtual Cohorts 1 and 2 would “highly recommend” I-SIT or virtual I-SIT while two PFs in virtual Cohort 3 indicated they would recommend virtual I-SIT and one reported feeling neutral. Duration, frequency, and number of sessions differed for virtual Cohort 3, and one PF was enrolled after brief screening rather than full assessment. Cohort 3 feedback indicated preference for former duration and umber of sessions (60 minutes or less, 4+ sessions) which may explain the decline in satisfaction. Conclusion: Enrollment to a group intervention and access to behavioral interventions for pediatric patients with FC and their families was increased with conversion to a telehealth format while maintaining satisfaction and increasing engagement. Family feedback suggests telehealth group format should include caregiver-only portions and shorter group sessions. To continue our quality improvement effort to increase enrollment, our next intervention will focus on improved advertising and consideration of primary care referrals. Future directions also include inclusion of FC outcome measures and digital adaptation of educational materials (e.g., videos, mobile phone applications).

The Respiratory Drive

The central phrase linking the coronavirus pandemic to the Black Lives Matter demonstrations to the climate change crisis is "I can't breathe." What, if anything, does psychoanalysis have to say about breathing? Looking at Freud, Ferenczi, Rank, Winnicott, Lacan, and some current philosophical thoughts, the authors consider a neglected "respiratory drive" and its relationship to the death drive, giving us new insight into this unprecedented moment.