Impact of the COVID-19 pandemic on new starts to oral oncology medications in the US

Introduction The COVID-19 pandemic has had a significant impact on healthcare delivery. Although others have documented the impact on new cancer diagnoses, trends in new starts for oncology drugs are less clear. We examined changes in new users of oral oncology medications in the US following COVID-19 stay-at-home orders in 2020 compared to prior years. Methods We examined prescription data for members enrolled with a national pharmacy benefits manager in the US from January 1-October 31 of 2018, 2019, and/or 2020. This is a retrospective, observational study comparing new users per 100,000 members per month for all oral oncology drugs, and separately for breast, lung, and prostate cancer, leukemia, and melanoma oral drugs. We performed a difference-in-differences analysis for change in new users from pre-period (prior to pandemic-induced disruption, January-March), to post-period (following pandemic-induced disruption, April-October), between 2020 and 2019, and 2020 and 2018. Results New oral oncology drug users per 100,000 members per month declined by an additional 11.3% in the 2020 post-period compared to 2019 ( p = 0.048). New oral breast cancer drug starts declined by an additional 14.0% in the 2020 post-period compared to 2019 ( p = 0.040). Similar but non-significant trends were found between 2020 and 2018. No significant differences were found between post-period monthly new starts of leukemia, melanoma, lung or prostate cancer disease-specific oral medications. Conclusions Long-term implications of delays in cancer treatment initiation are unclear, although there is concern that patient outcomes may be negatively impacted.

15. Real-World Changes in Clostridioides difficile infection (CDI) Treatment Utilization and Clinical Outcomes Associated with Updated 2017 IDSA Guidelines among Medicare Beneficiaries in the U.S

Background The 2017 IDSA CDI guideline update phased out metronidazole (MTZ) and recommended vancomycin (VAN) or fidaxomicin (FDX) for first-line use. This study examined changes in CDI antibiotic use and clinical outcomes among Medicare beneficiaries with CDI pre- vs. post- the guideline update. Methods This retrospective claims analysis used 2016-2018 national Medicare claims data. The two study samples included continuously eligible fee-for-service Medicare beneficiaries aged ≥66 years with a new CDI diagnosis followed by an antibiotic fill in the pre-period (04/01/2017-09/30/2017) and post-period (04/01/2018-09/30/2018), respectively. Outcomes included type of CDI antibiotic received; sustained response and CDI recurrence. Multivariable regressions compared pre- vs. post-period outcomes while controlling for sociodemographic and clinical factors. Results The pre-period (N=7,389) and post-period (N=7,746) samples had similar characteristics (59% > 75 years, 32% male). Post-guideline update, absolute rates of MTZ use declined 27.7% (relative change [RC] -34.1%, p< 0.001) and VAN use increased 26.9% (RC +150.2%, p< 0.001) (Figure 1). While FDX use increased 0.8% (RC +87.8%, p< 0.001), overall use remained low (1.63%). Surprisingly, clinical outcomes did not improve between the pre- and post-period (Table 1). Even after adjustment, overall sustained response rates decreased (Odds Ratio [OR]: 0.93, p=0.0197) and overall CDI recurrence rates increased (OR: 1.13, p=0.0018) slightly in the post- vs. pre-period. Additional analyses by type of antibiotic showed that VAN (55.0% and 35.1%) was similar in outcomes to MTZ (54.2% and 33.0%), whereas FDX (71.4% and 20.9%) had higher sustained response and lower CDI recurrence rates, respectively (Figure 2). Figure 1. First-line use of CDI treatments, pre- vs. post- the guideline update, among Medicare beneficiaries with CDI Table 1. Clinical outcomes, pre- vs. post- the guideline update, among Medicare beneficiaries with CDI Figure 2. Clinical outcomes* by type of index CDI treatment among Medicare beneficiaries with CDI Note Pooled rates among patients on each index CDI treatment across the pre- and post-index periods. Conclusion The 2017 IDSA guideline update was associated with a substantial increase in VAN use and decrease in MTZ use. FDX use rates remained low (< 2%). Overall CDI outcomes did not improve post guideline update despite the shift to guideline-indicated VAN. This may be because VAN was not associated with meaningfully improved outcomes relative to MTZ. However, improved outcomes seen with FDX relative to VAN and MTZ suggest potential benefits from its greater use in Medicare patients. Disclosures Erik R. Dubberke, MD, MSPH, Ferring (Grant/Research Support)Merck (Consultant)Pfizer (Consultant, Grant/Research Support)Seres (Consultant)Summit (Consultant) Justin T. Puckett, BA, COVIA Health Solutions (Employee) Engels N. Obi, PhD, Merck & Co. (Employee, Shareholder) Sachin Kamal-Bahl, PhD, AbbVie (Consultant)Arena Pharmaceuticals, Inc. (Consultant)COVIA Health Solutions (Employee)Janssen, Inc. (Consultant)Merck (Consultant, Shareholder)Novartis (Consultant)Pfizer, Inc. (Consultant, Shareholder)PhRMA (Consultant) Kaushal Desai, PhD, AstraZeneca Pharmaceuticals (Shareholder)Merck & Co. Inc. (Employee) Bruce Stuart, PhD, COVIA Health Solutions (Consultant) Jalpa A. Doshi, PhD, Acadia (Consultant, Advisor or Review Panel member)Allergan (Advisor or Review Panel member)Biogen (Grant/Research Support)Boehringer Ingelheim (Other Financial or Material Support, Scientific lecture)Catabasis (Consultant)Humana (Grant/Research Support)Janssen, Inc. (Consultant, Grant/Research Support)MeiraGTX (Consultant)Merck (Grant/Research Support, Advisor or Review Panel member)Novartis (Grant/Research Support)Otsuka (Advisor or Review Panel member)Regeneron (Grant/Research Support)SAGE Therapeutics (Consultant)Sanofi (Grant/Research Support)Shire (Advisor or Review Panel member)The Medicines Company (Advisor or Review Panel member)

181. Potential Benefit of Masking and other COVID-19 Infection Prevention Measures on Late-Onset Infections in the NICU

Background Incidence of blood stream infections (BSI) among NICU admissions remains high, with associated mortality and morbidity. Due to COVID-19, there are increased infection prevention (IP) measures in NICUs including universal masking for all healthcare workers and families, social distancing, visitation restrictions, and increased attention to hand hygiene. These measures may also affect late-onset infection rates and offer understanding of novel interventions for prevention. Methods We examined infection rates during the 24 months prior to implementation of COVID-19 IP measures (PRE-period) compared to the months after implementation from April 2020 (POST-period). Late-onset infections were defined as culture-confirmed infection of the blood, urine, or identification of respiratory viral pathogens. An interrupted time series analysis of infection per 1000 patient days was performed based on a change-point Poisson regression with a lagged dependent variable and the number of patient days used as offsets. Each month was treated as independent with additional analysis using an observation-driven model to account for serial dependence. Results Multicenter analysis to date included all infants cared for at three centers (Level 3 and 4) from 2018-2020. Monthly BSI rates decreased in the POST-period at the three centers (Figure 1). At all centers actual BSI rate was lower than the expected rate in the POST-period (Figure 2). The combined BSI rate per 1000 patient days was 41% lower compared to the rate prior to implementation (95% CI, 0.42 to 0.84, P=0.004) (Table 1). In subgroup analysis by birthweight, infants< 1000g had a 39% reduction in BSI (P=0.023), for1000-1500g patients there was a 44% reduction (P=0.292) and in those > 1500g there was a 53% reduction (0.083). Figure 1. PRE and POST MASKING and other COVID Infection Prevention Measures and Monthly BSI Rates. Figure 2. PRE and POST MASKING and other COVID infection prevention measures and BSI Trends. At all centers actual BSI rate was lower than the expected rate for that center in the POST period. UVA and Duke showed a baseline decrease and Pennsylvania Hospital showed a downward trend in infection rates. There was an approximate decrease in expected bloodstream infection events at Pennsylvania Hospital by 7 events, at UVA by 22 events and at Duke by 23 events. Overall, all three centers saw a decrease in their expected infections after COVID-19 infection prevention measures were implemented. Table 1. Percent reduction in Bloodstream Infection at each center. Conclusion In this preliminary analysis, we found a reduction of BSI after the implementation of COVID-19 infection prevention measures. Additionally, there were fewer viral infections, though there were a limited number of episodes. Further analyses of multicenter data and a larger number of patients will elucidate the significance of these findings and the role some of these IP measures such as universal masking may have in infection prevention in the NICU. Disclosures All Authors: No reported disclosures

MARMA THERAPY: A NEW APPROACH OF AYURVEDA IN POST-COVID-19 STRESS MANAGEMENT

Introduction: Ayurveda is an ancient science of medicine and surgery, here many of the treatment procedures are described for combat diseases, i.e., Ksharkarma (procedure with the help of base), Agnikarma (procedure with the help of fire), Siravedhan (procedure with the help of puncturing blood vessels), Panchkarma (purification proce- dure) etc. In this science Marma (vital point) therapy is like a blessing to a human being. It is a stimulation therapy of specific points. Now these days, stress arises as a major problem in COVID-19 recovered patients. It is very common to all age groups. Major causes are lack of proper classes of students, unemployment, lack of social inter- action due to isolation and health status anxiety during COVID-19 infection. It arises during and post COVID-19 but especially in the post period of infection. In stress, Marma therapy has an important role because it helps to maintain the equilibrium of the body by working on body humour. Objective: To provide costless, chemical-free and effective treatment for post-COVID-19 patients. Data Source: Relevant various Ayurvedic literature, Samhitas (classical books), modern literature, journals, magazines and online available materials. considered. Review Method: Relevant various data source materials were considered for this. Result: stress will be relieved because this therapy acts directly on hormones secretion which is responsible for relieving stress. Conclusion: By this ther- apy, a patient gets relief without any expenses and the most important is that without using hormonal treatment. Marma therapy in stress can relieve stress by maintaining calmness in the brain, it helps to maintain the brain's proper functioning. By this therapy, not only the stress but stress-related other complications can be treated. Keywords: Marma therapy, COVID-19, post-covid-19, stress.

Impact of a care bundle for patients with blunt chest injury (ChIP): A multicentre controlled implementation evaluation

Background Blunt chest injury leads to significant morbidity and mortality. The aim of this study was to evaluate the effect of a multidisciplinary chest injury care bundle (ChIP) on patient and health service outcomes. ChIP provides guidance in three key pillars of care for blunt chest injury—respiratory support, analgesia and complication prevention. ChIP was implemented using a multi-faceted implementation plan developed using the Behaviour Change Wheel. Methods This controlled pre-and post-test study (two intervention and two non-intervention sites) was conducted from July 2015 to June 2019. The primary outcome measures were unplanned Intensive Care Unit (ICU) admissions, non-invasive ventilation use and mortality. Results There were 1790 patients included. The intervention sites had a 58% decrease in non-invasive ventilation use in the post- period compared to the pre-period (95% CI 0.18–0.96). ChIP was associated with 90% decreased odds of unplanned ICU admissions (95% CI 0.04–0.29) at the intervention sites compared to the control groups in the post- period. There was no significant change in mortality. There were higher odds of health service team reviews (surgical OR 6.6 (95% CI 4.61–9.45), physiotherapy OR 2.17 (95% CI 1.52–3.11), ICU doctor OR 6.13 (95% CI 3.94–9.55), ICU liaison OR 55.75 (95% CI 17.48–177.75), pain team OR 8.15 (95% CI 5.52 –-12.03), analgesia (e.g. patient controlled analgesia OR 2.6 (95% CI 1.64–3.94) and regional analgesia OR 8.8 (95% CI 3.39–22.79), incentive spirometry OR 8.3 (95% CI 4.49–15.37) and, high flow nasal oxygen OR 22.1 (95% CI 12.43–39.2) in the intervention group compared to the control group in the post- period. Conclusion The implementation of a chest injury care bundle using behaviour change theory was associated with a sustained improvement in evidence-based practice resulting in reduced unplanned ICU admissions and non-invasive ventilation requirement. Trial registration ANZCTR: ACTRN12618001548224, approved 17/09/2018

ABORTION: A NEVER-ENDING INTERDISCIPLINARY DEBATE

This study is the second part of the examination, considering the multifaceted feature of debates surrounding the termination of pregnancy. Although we may suppose that the so-called pro-life and pro-choice supporters have already paved their rigid ways of thinking with no possibility or hope for any modification, it might come as a surprise to learn that even Christian and Buddhist points of view can be tuned. Health-related disciplines, such as psychology keep reflecting on the issues of abortion with more and more emphasis on the post period of it.

Caesarean delivery rate changes after audit and feedback with the Ten Group Classification System in a French perinatal network: a retrospective pre–post study

Objective : To study changes in caesarean delivery (CD) rates between maternity wards in a perinatal network after implementation of the Ten Group Classification System (TGCS) in an audit with feedback. Design A retrospective pre–post study of all births from 1 January 2012 to 31 December 2018. Setting A French perinatal network of 10 maternity wards in the Yvelines district of France. Population All live births of gestational age ≥24 weeks in the network. Methods During the pre-period (1 January 2012 to 31 December 2014), the audit and feedback provided only overall CD rates. During the post-period (1 January 2015 to 31 December 2018), CD rates for each TGCS group were provided. Regression models, adjusted for maternal characteristics and maternity ward, were used to compare CD rates globally and for each TGCS group. Variability of CD rates between maternity wards was analysed using the coefficients of variation. Main outcome measure CD rates. Results There were 51 082 women who delivered during the pre-period and 63 964 during the post-period. The overall CD rate did not decrease (24.5% during the pre-period versus 25.1% during the post-period). There were no significant differences in CD rates for any TGCS group after adjustment for maternity, maternal age and socio-demographic characteristics. Nor did audit implementation decrease CD rate variability between maternity wards or within TGCS groups. Conclusion Implementation of an audit-and-feedback cycle using the TGCS did not decrease either CD rates or variability between maternity wards.

Use of the Bacterial Lysate OM-85 in the Paediatric Population in Italy: A Retrospective Cohort Study

Background: In Italy, the bacterial lysate OM-85 (Broncho-Vaxom®, Broncho-Munal®, Ommunal®, Paxoral®, Vaxoral®) is registered for the prophylaxis of recurrent respiratory tract infections (RTIs) in adults and children above one year of age, but there are limited data on its use in the paediatric population. We aim to estimate the impact of OM-85 treatment on RTIs and antibiotic prescriptions in children. Methods: This study included children aged 1 to 14 years enrolled in Pedianet, a paediatric general practice research database, from January 2007 to June 2017, having at least one prescription of OM-85. Children with less than 12 months of follow-up before (PRE period) and after (POST period) the OM-85 prescription were excluded. The frequency of antibiotic prescriptions and the frequency of RTI episodes in the PRE and POST periods were compared through the post-hoc test. Subgroup analysis was performed in children with recurrent RTIs. Results: 1091 children received 1382 OM-85 prescriptions for a total follow-up of 619,525.5 person-years. Overall, antibiotic prescriptions decreased from a mean of 2.8 (SD (standard deviation) 2.7) prescriptions in the PRE period to a mean of 2.2 (SD 2.6) prescriptions in the POST period (p < 0.0001). RTIs decreased from a mean of 3.4 (SD 2.9) episodes in the PRE period to a mean of 2.5 (SD 2.6) episodes in the POST period (p < 0.0001). No change in antibiotic class was noted, and co-amoxiclav remained the preferred therapy in 28% of cases, followed by amoxicillin. These results were confirmed among children with recurrent RTIs. Conclusions: OM-85 is effective in preventing both antibiotic prescriptions and RTIs in children.

THE EFFECT OF A BOARDING RESTRICTION PROTOCOL ON EMERGENCY DEPARTMENT CROWDING

ABSTRACT Background Access block due to a lack of hospital beds causes emergency department (ED) crowding. We initiated the boarding restriction protocol that limits ED length of stay (LOS) for patients awaiting hospitalization to 24 hours from arrival. This study aimed to determine the effect of the protocol on ED crowding. Method This was a pre-post comparative study to compare ED crowding before and after protocol implementation. The primary outcome was the red stage fraction with more than 71 occupying patients in the ED (severe crowding level). LOS in the ED, treatment time and boarding time were compared. Additionally, the pattern of boarding patients staying in the ED according to the day of the week was confirmed. Results Analysis of the number of occupying patients in the ED, measured at 10-minute intervals, indicated a decrease from 65.0 (51.0-79.0) to 55.0 (43.0-65.0) in the pre- and post-periods, respectively (p<0.0001). The red stage fraction decreased from 38.9% to 15.1% of the pre- and post-periods, respectively (p<0.0001). The proportion beyond the goal of this protocol of 24 hours decreased from 7.6% to 4.0% (p<0.0001). The ED LOS of all patients was similar: 238.2 (134.0-465.2) and 238.3 (136.9-451.2) minutes in the pre- and post-periods, respectively. In admitted patients, ED LOS decreased from 770.7 (421.4-1587.1) to 630.2 (398.0-1156.8) minutes (p<0.0001); treatment time increased from 319.6 (198.5-482.8) to 344.7 (213.4-519.5) minutes (p<0.0001); and boarding time decreased from 298.9 (109.5-1149.0) to 204.1 (98.7-545.7) minutes (p<0.0001). In the pre-period, boarding patients accumulated in the ED on weekdays, with the accumulation resolved on Fridays; this pattern was alleviated in the post-period. Conclusions The protocol effectively resolved excessive ED crowding by alleviating the accumulation of boarding patients in the ED on weekdays. Additional studies should be conducted on changes this protocol brings to patient flow hospital-wide.

354 Trends in the Drug-Sparing Effects for Benzodiazepines and Prescription Opioids among Insomnia Patients on Suvorexant in the US

Introduction Use of benzodiazepines to treat insomnia has been associated with serious side effects and abuse potential. Insomnia patients are at high risk of opioid abuse and better sleep patterns may help to reduce opioid use. This study examined the trend in the use of benzodiazepines and prescription opioids before and after initiation of suvorexant in insomnia patients. Methods The study analyzed 2015–2019, Optum Clinformatics Data Mart. Insomnia patients, identified using ICD-9/10 codes and prescribed suvorexant were included. The study included incident (newly diagnosed) and prevalent cohorts of insomnia patients. The proportion of patients on benzodiazepines or prescription opioids were calculated for 12 monthly intervals before (pre-period) and after initiation of suvorexant (post-period). Interrupted time series (ITS) analysis was conducted to assess trends for use of benzodiazepine or prescription opioids over time. Results A total of 5,939 patients from the incident insomnia cohort and 18,920 from the prevalent cohort were included. For the incident cohort, mean age was 64.47 (SD: 15.48), 63% were females, 71% had Medicare Advantage coverage, 59% had Charlson comorbidity index score (CCI) ≥ 1, 27% had an anxiety disorder and 16% had substance abuse disorder. Prevalent insomnia cohort was similar but had higher CCI. Results from ITS suggested that at the beginning of the pre-period, 28% of incident insomnia patients used either opioids or benzodiazepines with the rate of use in the pre-period increasing by 0.11% per month. In the post-period, the rate of use decreased by 0.33% per month. About 26% patients used benzodiazepines or opioids at 12-month after suvorexant initiation. In the absence of suvorexant, this proportion would have been 31%. Similar findings were observed for the prevalent insomnia cohort. A larger decrease was observed for opioid use than benzodiazepines. Conclusion The rate of benzodiazepines or prescription opioid use decreased over time after the initiation of suvorexant. Suvorexant has the potential to reduce the use of opioids and benzodiazepines among insomnia patients. Further research is needed to confirm these findings. Support (if any) This study was sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.