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1.
JAMA Oncology ; 22:22, 2022.
Article in English | MEDLINE | ID: covidwho-2034690

ABSTRACT

Importance: Extended-interval dosing of pembrolizumab (400 mg every 6 weeks) was approved by US Food and Drug Administration (FDA) in April 2020 as an alternative to standard-interval dosing (200 mg every 3 weeks). Extended-interval dosing may enhance access, alleviate patient and health system financial toxicity, and improve patient quality of life, particularly during the COVID-19 pandemic. Neither adoption nor effectiveness of extended interval in the US has been adequately described. Objective: To describe adoption of extended-interval dosing of pembrolizumab since its FDA approval and to measure its preliminary real-world effectiveness compared with standard-interval dosing. Design, Setting, and Participants: This was a retrospective cohort study that used data from the Veterans Health Administration (VHA), a US-based, nationwide single-payer health system. Participants were veterans who were prescribed single-agent pembrolizumab within the VHA between April 1, 2020, and July 1, 2021. Patients receiving combinations of pembrolizumab and cytotoxic chemotherapy or tyrosine kinase inhibitors were excluded. A subcohort of veterans with non-small cell lung cancer (NSCLC) was also identified using claims-based codes. Exposures: Single-agent pembrolizumab at extended or standard intervals. Main Outcomes and Measures: The number and proportion of single-agent pembrolizumab prescriptions that were extended compared with standard interval. Effectiveness was described in terms of time-to-treatment discontinuation (TTD) and extended- to standard-interval pembrolizumab prescriptions were compared using Cox proportional hazards regression. Results: A total of 835 veterans (mean age [SD], 70.9 [8.7] years;809 [96.9%] men) began single-agent pembrolizumab during the study period (all-diseases cohort), and of these, 234 (mean [SD] age, 71.6 [7.3] years;225 [96.2%] men) had NSCLC (NSCLC cohort). Extended-interval adoption reached its steady state plateau of approximately 35% by January 2021;65% of participants who began standard-interval single-agent pembrolizumab received only standard-interval dosing during the treatment course. In analysis consistent with the intention-to-treat principle, no differences in TTD were observed between standard- and extended-interval dosing in either the all-diseases cohort (HR, 1.00;95% CI, 1.00-1.00) or the NSCLC cohort (HR, 1.00;95% CI, 1.00-1.00). Conclusions and Relevance: This retrospective cohort study found that extended-interval dosing comprised a minority of single-agent pembrolizumab prescriptions despite the FDA approval and its potential health system and public health benefits. The findings support the TTD equivalence of standard- and extended-interval pembrolizumab across indications, complementing clinical pharmacology and single-arm clinical trial data in melanoma. This study provides further support for extended-interval pembrolizumab dosing.

2.
Journal of Medical Internet Research ; 24(8), 2022.
Article in English | EMBASE | ID: covidwho-2009803

ABSTRACT

Background: The RAND/UCLA Appropriateness Method (RAM), a variant of the Delphi Method, was developed to synthesize existing evidence and elicit the clinical judgement of medical experts on the appropriate treatment of specific clinical presentations. Technological advances now allow researchers to conduct expert panels on the internet, offering a cost-effective and convenient alternative to the traditional RAM. For example, the Department of Veterans Affairs recently used a web-based RAM to validate clinical recommendations for de-intensifying routine primary care services. A substantial literature describes and tests various aspects of the traditional RAM in health research;yet we know comparatively less about how researchers implement web-based expert panels. Objective: The objectives of this study are twofold: (1) to understand how the web-based RAM process is currently used and reported in health research and (2) to provide preliminary reporting guidance for researchers to improve the transparency and reproducibility of reporting practices. Methods: The PubMed database was searched to identify studies published between 2009 and 2019 that used a web-based RAM to measure the appropriateness of medical care. Methodological data from each article were ed. The following categories were assessed: composition and characteristics of the web-based expert panels, characteristics of panel procedures, results, and panel satisfaction and engagement. Results: Of the 12 studies meeting the eligibility criteria and reviewed, only 42% (5/12) implemented the full RAM process with the remaining studies opting for a partial approach. Among those studies reporting, the median number of participants at first rating was 42. While 92% (11/12) of studies involved clinicians, 50% (6/12) involved multiple stakeholder types. Our review revealed that the studies failed to report on critical aspects of the RAM process. For example, no studies reported response rates with the denominator of previous rounds, 42% (5/12) did not provide panelists with feedback between rating periods, 50% (6/12) either did not have or did not report on the panel discussion period, and 25% (3/12) did not report on quality measures to assess aspects of the panel process (eg, satisfaction with the process). Conclusions: Conducting web-based RAM panels will continue to be an appealing option for researchers seeking a safe, efficient, and democratic process of expert agreement. Our literature review uncovered inconsistent reporting frameworks and insufficient detail to evaluate study outcomes. We provide preliminary recommendations for reporting that are both timely and important for producing replicable, high-quality findings. The need for reporting standards is especially critical given that more people may prefer to participate in web-based rather than in-person panels due to the ongoing COVID-19 pandemic.

4.
Sleep ; 45(SUPPL 1):A22-A23, 2022.
Article in English | EMBASE | ID: covidwho-1927382

ABSTRACT

Introduction: The COVID-19 pandemic has been associated with profound biopsychosocial changes for children, potentially affecting their health and wellbeing. Among these changes are altered sleep patterns and screen time use, however, no work has examined interactions between these two behaviors in the context of the pandemic. Here, we used longitudinal data from the Adolescent Brain Cognitive Development (ABCD) Study® to investigate changes in both sleep and screen time, and their relationship, from before and across the first year of the COVID-19 pandemic in young adolescents. Methods: More than 5000 adolescents (11-14 years;48% girls) completed digital surveys about their sleep and daily screen time use before the pandemic and across six timepoints during 2020- 2021, as part of the ongoing ABCD Study®. Random intercept linear mixed effect models (LMMs) were used to examine longitudinal associations between bedtime, wake-up time, and daily screen time use (social media, gaming), considering age, sex, and school effects. Results: Adolescents' wake up time was delayed (R2 = 0.51;~1.5 hour) during May-August 2020 relative to the pre-pandemic assessment (p<0.01), which was partially related to the summer break (p<0.01), before advancing to earlier times in October 2020. Bedtimes also delayed at all pandemic assessments (R2=0.62;~1 hour), even after starting the new school year (p<0.01), particularly in older adolescents (p<0.01) and girls (p<0.01). Recreational screen time was dramatically higher across the first year of the pandemic, relative to pre-pandemic (p<0.01;~45min social media, ~20min video gaming). More time spent with screen related activities was associated with later bedtimes and wake up times (p<0.01), across the pandemic, with effects being evident in male and female adolescents. Conclusion: Our findings show profound changes in sleep timing and screen time use across the pandemic in young adolescents, and critically, that excessive screen time negatively impacts sleep. As adolescents increasingly turn to more screen usage, these data highlight the need to promote their balanced and informed use of social media platforms, video games, and other digital technology to ensure adequate opportunity to sleep and maintain other healthy behaviors during this critical period of developmental change.

5.
Diabetic Medicine ; 39(SUPPL 1):131-132, 2022.
Article in English | EMBASE | ID: covidwho-1868615

ABSTRACT

Background: Prior to the covid-19 pandemic glucagon-like peptide (GLP-1) education was delivered face-to- face by diabetes specialist nurses. This service is now predominately virtual, with diabetes dietitians hosting online groups to deliver education. Aim: To evaluate the clinical outcomes of GLP-1 therapy education delivered online compared to face-to- face education sessions. Methods: Data were collated from 53 patients prior to the restrictions imposed by the covid-19 pandemic (Group A) and 53 patients who were educated virtually (Group B). The demographics of the patient group including duration of diabetes, gender, age, body mass index (BMI), Hba1c on referral and Hba1c change after four months of GLP-1 therapy were compared. Results: Group A was 45% male, with a mean age of 57 years, 10% had type 2 diabetes for over 10 years and 88% had a BMI between 30-39 kg/m2. The range of HbA1c at referral was 62-121mmol/ mol and mean improvement in HbA1c after 4 months of GLP-1 therapy in Group A was 24.3 ± 15.3mmol/mol. Group B was 55% male, with a mean age of 56 years, 43% had type 2 diabetes for over 10 years and 51% had a BMI of over 40 kg/m2. The range of HbA1c at referral was between 61-117mmol/ mol and the mean improvement in HbA1c after 4 months of GLP-1 therapy in Group B was 23.8 ± 17.5mmol/mol. Conclusions: The launch of virtual education for patients starting on GLP-1 therapy has been successful and maintained significant improvements in HbA1c after 4 months of treatment.

6.
Gastroenterology ; 160(6):S-27-S-28, 2021.
Article in English | EMBASE | ID: covidwho-1598935

ABSTRACT

Background: The COVID-19 pandemic has temporarily reduced capacity in many endoscopyunits, creating long backlogs, which have the potential to worsen patient outcomes. Aims:To evaluate the impact of two evidence-based strategies for offloading colonoscopy demandduring and after the first wave of the pandemic: (1) An “Extend” strategy, in which theinterval for low-risk adenoma (LRA) patients who are currently “due” is extended from 5years to 7 years;(2) An “Exchange” strategy, in which all referrals for screening colonoscopyare changed to fecal immunochemical testing (FIT);(3) a combination of “Extend+Exchange.”Methods: We developed a discrete-event simulation of an endoscopy unit in an integratedhealthcare system with a caseload of 110 procedures weekly. We assumed capacity initiallyfell to 5% of pre-COVID levels for 10 weeks (as a result of the pandemic), and incrementallyincreased back to 100% by 30 weeks. Each week, 113 patients were referred with thefollowing indications, in order of priority: diagnostic colonoscopy (23% of referrals) and upper endoscopy (28%), high-risk adenoma (HRA) surveillance (10%), LRA surveillance(17%), and screening colonoscopy (22%). The highest priority patients were always seenfirst, while others joined a queue. Outcomes included average wait time, number of patientsseen, and queue size at model’s end. The base unit of time was weeks. Model length was150 weeks. One-way sensitivity analyses were performed for all variables. Each strategy wassimulated 500 times in C++ and compared to a base case in which no offloading strategieswere used. Results: In the base case, 3,023 patients remained in queue at 150 weeks, andthe average wait time was 22.5 weeks overall. The wait time for screening colonoscopy was69.9 weeks. With the Extend strategy, 1,293 patients remained in queue at 150 weeks, theaverage wait time was 14.2 weeks overall, and the wait time for screening colonoscopy was41.6 weeks. With Exchange, no patients remained in queue at 150 weeks, and the averagewait time was 9.9 weeks. Because no screening colonoscopies were done, there was no waittime for this indication. The Extend+Exchange strategy yielded similar results, but the averagewait time was 5.3 weeks. In all four strategies, nearly equivalent numbers of patients wereseen for HRA surveillance (range 2,496-2,511), diagnostic colonoscopy (range 4,547-5,062),and upper endoscopy (3,749-3,759), with similar wait times. None of the strategies hadwait times for upper endoscopy or diagnostic colonoscopy exceeding 5 weeks. Conclusions:Without offloading strategies, prolonged queues and wait times developed, especially forscreening colonoscopies. Substituting FIT for screening colonoscopy (Exchange) is the singlestrategy with the greatest potential to mitigate these problems, without which patients maysuffer harm caused by limited access.(Figure Presented)Figure 1. Average wait time by indication under usual care, and three evidence-based strategies for offloading endoscopy demand during the COVID-19 pandemic.

7.
Journal of the American College of Surgeons ; 233(5):e75, 2021.
Article in English | EMBASE | ID: covidwho-1466564

ABSTRACT

Introduction: Older adults comprise an increasing proportion of emergency general surgery (EGS) admissions and face high morbidity and mortality. We created a geriatric surgical service with geriatric and palliative expertise to mitigate risks of hospitalization most hazardous to older patients. In this study, we identified geriatric surgical service interventions most relevant to EGS patients. Methods: We conducted a retrospective chart review of patients >75 years admitted to the EGS service at our urban tertiary care hospital with a score >3 by the FRAIL scale, a five-point frailty screening instrument, or history of dementia. The geriatric surgical service, led by a dually-board certified geriatric and palliative care specialist, consulted on these patients from January 2020-January 2021;a hiatus was taken for the COVID-19 pandemic. Consults included a comprehensive geriatric assessment and calculated a modified Rockwood Frailty Index. Hospital admission characteristics and consultation components were collected via chart review. Results: Forty patients were evaluated (median age 82 years (IQR 78-89), 55.0% female). The most common admission diagnosis was small bowel obstruction (32.5%). 62.5% of patients underwent >1 surgical procedure. Median time to geriatric consult from admission was 3 days (IQR 1.0-4.3). By Frailty Index, 58% were moderately or severely frail. Interventions included medication changes (97.5%), symptom management (82.5%), delirium prevention and management (65.0%), mobility and function recommendations (65.0%), serious illness conversations (55.0%), and code status change (17.5%). Conclusion: Geriatric service involvement identifies and addresses a high burden of both geriatric and palliative care needs in older adult EGS patients.

9.
American Journal of Respiratory and Critical Care Medicine ; 203(9), 2021.
Article in English | EMBASE | ID: covidwho-1277106

ABSTRACT

Introduction: Before the COVID-19 pandemic, 20-30% of family members had symptoms of Post-Traumatic Stress Disorder (PTSD) or anxiety, while 15-30% had symptoms of depression. Interventions supporting family members have reduced burden of these symptoms. COVID-19 has resulted in prolonged ICU stays, high morbidity/mortality, and hospital policies severely limiting family presence at the bedside. We hypothesized the combination of prolonged critical illness and the necessary reduction of family presence would lead to high rates of PTSD, anxiety, and depression;likely higher than observed in previous studies. Methods: This was a multicenter study including 12 US hospitals, 8 academic and 4 community-based hospitals. A consecutive sample of family members of all patients with COVID-19 receiving ICU admission during the spring US peak in 2020 were called 3-4 months after the patients' ICU admission, except for New York City hospitals where a random sample was generated given the large number of hospitalizations. Consented participants completed the Impact-of- Events Scale-6 (IES-6;scored 0-30, higher scores indicate more symptoms of PTSD), Hospital-Anxiety- Depression Score (HADS, scored 0-20 for anxiety and 0-20 for depression, higher scores indicate more symptoms), and a subset of questions from Family-Satisfaction in the ICU-27 (FS-ICU27;scored on a Likert scale 1 to 5, with higher scores indicating more positive responses) selected as most likely impacted by restrictive family presence.Results: There were 945 eligible family members during the study period. Of those, 594 were contacted and 269 (45.3%) consented and completed surveys. The mean IES-6 score was 12.6 (95% CI 11.8- 13.4) with 65.4% having a score of 10 or greater, consistent with high levels of symptoms of PTSD. The mean score on the HADS-anxiety was 9.4 (95% CI 8.8-10.1) with 59.5% having a score of 8 or greater, consistent with high levels of symptoms of anxiety. Finally, the mean score for the HADS-depression was 8.0 (95% CI 7.3-8.7) with 47.6% having scores of 8 or greater, consistent with high level of symptoms of depression. The mean response for the FSICU27 questions of “I felt I had control” was 3.5 (95% CI 3.3-3.6), “I felt supported” was 3.8 (95% CI 3.6-4.0), and “I felt included” was 4.3 (95% CI 4.2-4.4).Conclusion: The consequences of a family member admitted to the ICU with COVID-19 infection are significant. We identify rates of PTSD, anxiety, and depression higher than recorded in non-COVID population. Further analysis is warranted to understand modifiable risk factors for developing these symptoms.

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