ABSTRACT
Background: The conduct of clinical trials during COVID-19 created challenges to ensuring access to clinical trials, healthy clinical teams, and patients. Innovative methods such as remote patient follow-up and monitoring visits can lead to successful completion of device trials. Objective(s): The INGEVITY+ Active Fixation Pace/Sense Lead Study examined the safety/ efficacy of the INGEVITY+ Lead in a prospective, non-randomized, multicenter, post-approval study. Method(s): Subjects met indications for a pacing device with INGEVITY+ leads implanted in the RA and RV. The primary safety endpoint was the 3-month lead-related complication-free (LRC-free) rate. The primary efficacy endpoint evaluated the 3-month pacing capture threshold with the secondary efficacy endpoint evaluating the other lead-related electrical parameters. Implanter experience was assessed. Telephone visits with LATITUDE remote transmission of lead measurement data and remote monitoring visits were allowed. Result(s): A total of 201 leads were evaluated in 101 subjects, 46.8% female with a mean age of 73.2 years, at 13 centers in the United States. The study took 6.8 months, with a median follow-up of 3.4 months. The 3-month follow-up was completed by 98% of subjects, of which 36% were remote. A total of 98% of monitoring visits were done remotely. The study met all primary and secondary endpoints. The LRC-free rate through 3-months was 98.5% (lower CL 95.4%). Three leads were repositioned and reimplanted;two were RA dislodgements, and one was a RA perforation and hemothorax requiring thoracentesis. The pacing capture threshold was <= 2V in 98.9% of subjects with a mean of 0.77 V at 0.4-ms pulse width, mean pacing impedance of 712 ohms, and a median P-wave amplitude of 4.3 mV, and median R-wave amplitude of 15.9 mV at 3- months. No helix performance issues were reported. The mean turn count for helix extension was 6.7 and retraction was 7.6. More than 85% of physicians rated the lead as 'very good' or higher on all aspects of lead handling. Conclusion(s): The INGEVITY+ Lead was found to be safe and effective with a very favorable implant experience. This study was entirely conducted successfully during COVID-19 with remote follow-up and monitoring visits, and nearly half of the subjects were females.
ABSTRACT
The coronavirus disease 2019 (COVID-19) pandemic created an increased need for youth services in a system that was already strained and underfunded. The move to remote learning disrupted access to school-based mental health services and limited the exposure of youth to mandatory reporters. Youth receiving services from community-based programs associated with juvenile probation were also affected by the lack of service access. This research provides a synthesis and critical examination of the literature on the delivery of trauma-informed services during COVID-19. Trauma-informed care recognizes the range of traumas that youth experience, including the trauma associated with a global pandemic that exacerbated racial and economic issues for families that were already experiencing marginalization. This research provides recommendations at the institutional, organizational, and interactional levels for maintaining continuity of youth services during COVID-19 as well as lessons learned for future practice. © 2022 selection and editorial matter, Nazneen Khan;individual chapters, the contributors
ABSTRACT
Complementary and alternative medicine (CAM) use has been well-documented among cancer patients, with increasing public awareness of non-traditional treatments in the era of COVID-19. However, the temporal trends in usage at the patient level have not been well defined. We sought to characterize trends in what CAM interventions patients used before, during and after cancer treatment. An NCI-designated cancer center and a comprehensive cancer center prospectively enrolled adult cancer patients onto a cross-sectional survey assessing CAM use between 2020 and 2021. The survey evaluated perceptions and use of CAM, including vitamins/minerals, herbal supplements and alternative medicines, diets, and mind/body therapies. Types of CAM utilized were self-reported by use before, during and after primary cancer treatment. Differences in utilization were analyzed with two-proportion z-tests. Among 749 patients enrolled, 578 (77%) reported using CAM. Among CAM users, the most popular interventions used at some point included multivitamins (60%), vitamin D (58%), prayer (48%), vitamin C (35%), massage (33%), meditation (28%), fish oil (24%), probiotics (21%), turmeric (20%), CBD products (19%), chiropractic manipulation (17%), marijuana (16%) and vegetarian diet (12%). Vitamin use nearly universally declined over the before → during → after period, for example multivitamin (52% → 39% → 31%, p<0.01), vitamin D (37% → 42% → 30%, p<0.01), and calcium (21% → 24% → 15%), p<0.01). No vitamin consumption increased after treatment compared to before. Multiple herbal supplements increased during treatment but stayed higher than pre-treatment levels, including CBD (5.4% → 13% → 8.2%, p<0.01), marijuana (6.0% → 12% → 7.9%, p<0.01) and turmeric (9.1% → 13% → 9.3%). Many specialized diets were adopted during treatment but were not continued afterward, including vegetarian (5.4% → 8.3% → 5.5%), vegan (2.2% → 5.2% → 2.2%), ketogenic (3.3% → 4.3% → 2.6%), alkaline (1.2% → 3.6% → 1.9%) and raw food (0.9% → 1.4% → 0.3%). Mind/body intervention use also nearly universally decreased over the before to after period, such as chiropractic manipulation (16% → 7.4% → 5.9%, p<0.01), yoga (12% → 12% → 9.2%) or pilates (34.2% → 2.2% → 1.6%). Some increased during treatment but decreased after, like acupuncture (8.0% → 12% → 5.9%, p<0.01) or meditation (18% → 23% → 15%, p<0.01), with the largest decrease being in prayer (43% → 44% → 32%, p<0.01). Although CAM use is known to be common, the patterns of use before, during and after treatment have not been well-defined. Herbal supplements were the most likely to continue to be used after cancer treatment. General health maintenance, wellness and mind/body interventions largely decreased below pre-treatment levels after treatment, regardless of utilization during treatment. [ FROM AUTHOR] Copyright of International Journal of Radiation Oncology, Biology, Physics is the property of Pergamon Press - An Imprint of Elsevier Science and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)
ABSTRACT
The use of complementary and alternative medicine (CAM) has been associated with detrimental effects on survival outcomes in cancer patients compared to standard of care medical interventions. CAM has received a significant increase in public awareness and interest in recent years. We sought to understand use patterns and perceptions in radiotherapy patients. Data was collected from a cross-sectional survey of prospectively enrolled adult cancer patients, conducted at an NCI-designated cancer center and a comprehensive cancer center between 2020 and 2021. Cancer patients who received or were recommended radiotherapy were selected for analysis and grouped by CAM use. CAM users analyzed were those reporting use of enteral and parental interventions, including alternative medicines, special diets and herbal, vitamin and mineral supplements, and excluding mind/body practices. Differences between CAM users and non-users were analyzed with χ2 and two-sample t-tests. Predictors of CAM use were identified with multivariable logistic regression. Of the 749 respondents, 445 (59%) received or were recommended radiotherapy. Of those 445, 297 (67%) used enteral or parenteral CAM. Among CAM users, 81% were satisfied and 77% felt CAM was effective for intended use. The most common goal of CAM therapy was symptom management (44%), although CAM use as a curative-intent treatment (31%) was common. Compared to non-users, CAM users were more likely to be female (76% vs 62%, p<0.01), have self-reported incurable disease (73% vs 62%, p=0.04), to feel CAM is safe (45% vs 9%, p<0.01), effective at curing cancer (26% vs 11%, p<0.01), effective at managing symptoms (42% vs 20%, p<0.01), more likely to trust naturopaths (33% vs 22%, p=0.02) or chiropractors (26% vs 15%, p=0.01), more likely since COVID-19 to have a more favorable view of CAM (79% vs 42%, p=0.01) or use CAM (61% vs 40%, p=0.04), but less likely to decline recommended surgery (7% vs 19%, p<0.01) or recommended radiotherapy (5% vs 11%, p=0.03). No differences were noted between CAM users and non-users in trust of physicians or any media. Predictors of enteral or parenteral CAM use included female gender (OR 1.4, p=0.04), breast cancer (OR 2.1, p=0.03), colon cancer (OR 3.5, p=0.01), and metastatic cancer (OR 2.2, p<0.01). The use of CAM is common among patients receiving or recommended radiotherapy, with nearly one-third of patients using CAM as a cancer cure. However, radiotherapy patients using CAM were less likely than non-users to decline other recommended therapies, dispelling the notion that CAM-users are more likely to eschew standard-of-care treatments, at least in this cohort. Understanding the patterns and perceptions of CAM use in radiotherapy patients is essential for improving patient-physician communication and treatment decision-making. [ FROM AUTHOR] Copyright of International Journal of Radiation Oncology, Biology, Physics is the property of Pergamon Press - An Imprint of Elsevier Science and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)
ABSTRACT
Background: Complementary and alternative medicine (CAM) use has been associated with worse survival outcomes in cancer patients compared to standard of care therapies. CAM has received a significant increase in public awareness and interest in the COVID-19 pandemic era. We sought to understand how the COVID-19 pandemic affected CAM use and perceptions in cancer patients. Methods: Data was collected from adult cancer patients prospectively enrolled on a cross-sectional survey conducted at an NCI-designated cancer center and a comprehensive cancer center between 2020 and 2021. The survey included questions assessing changes in patient attitude towards CAM and likelihood of using CAM, both relative to prior to COVID-19. Analyzed CAM users included those taking vitamin, mineral and herbal supplements, alternative medicines and special diets, and excluded mindbody practices as the focus of this analysis was on enteral and parenteral CAM therapies. Differences in the impact of COVID-19 on CAM use beliefs and practices between CAM users and non-users were analyzed with χ2 and two-sample t-tests. Results: Out of 749 respondents, 578 (77%) used any CAM and 470 (63%) used enteral or parenteral CAM. Results shown in table. Compared to prior to COVID- 19, CAM users were more likely to view CAM more favorably (12% vs 5%, p < 0.01), while non-users were more likely to have an unchanged opinion (90% vs 84%, p = 0.03). Females had higher rates of viewing CAM more favorably than males (80% vs 58%, p = 0.04). Patients who viewed CAM more favorably had higher rates of self-reported incurable cancer (36% vs 11%, p = 0.04), declining recommended hormone therapy (22% vs 0%, p < 0.01), and higher trust of social media (19% vs 0%, p = 0.02) and websites (24% vs 0%, p < 0.01). Since the start of COVID-19, CAM users were more likely to report increased likelihood of using CAM (12% vs 6%, p = 0.01). Patients who were more likely to use CAM had higher rates of declining recommended chemotherapy (12% vs 0%, p = 0.02), and higher trust of social media (15% vs 2%, p = 0.01) and websites (28% vs 7%, p < 0.01). Conclusions: During the COVID-19 pandemic, attitudes on CAM use in oncology patients have become increasingly polarizing. Patients with favorable attitudes toward CAM were likely to decline recommended standard of care therapy and more like to use CAM since COVID-19. This data helps characterize shifting attitudes toward CAM and may help guide shared decision-making between physician and patient.