Impact of providing at-home medical device kits on remote monitoring of individuals with cystic fibrosis

Background: Cystic fibrosis (CF) is a chronic, multi-system disease that can greatly affect quality of life, so it is important for people with CF to be closely evaluated. Routine care includes measurement of basic vital signs, which allows providers to assess respiratory, cardiovascular, and nutritional status, all of which are aspects people with CF at high risk of decompensation because of the disease's pathophysiology [1]. Providing patients with home devices can improve access to vital sign monitoring, which in turn can expand the scope of telehealth and bring attention to daily changes in a patient's overall health [2]. We predict that providing patients with medical devices to monitor vitals will benefit their overall health and wellbeing. Method(s): Medical device kits were offered to patients coming for their routine in-person visits at VCU Health Mayland Medical Center. Each kit contained a tape measure, pulse oximeter, thermometer, blood pressure apparatus, and weight scale. Before receiving the kit, patients who agreed to participate in the study filled out a pre-distribution survey that was modeled after the Centers for Disease Control and Prevention Health- Related Quality of Life-14. If patients did not know how to use a device, health care staff instructed them on its use. Twoweeks after they received the kit, patients were emailed a post-distribution survey that assessed the usefulness of each medical device. Result(s): Seventeen of 18 patients (94.4%) agreed to participate in the study. From the pre-distribution survey, 11.8% of patients frequently monitored their vitals;94.1% of those believed that using the devices would help improve the maintenance of their health, and 82.3% were aware of normal values for blood pressure, pulse, oxygen level, and body temperature and how to measure height and weight. All six of the 17 (35.3%) patients who responded to the post-distribution survey stated that the devices had worked as intended and that they did not find the devices too time consuming. Of the five devices that patients received, most patients found the pulse oximeter and blood pressure apparatus to be useful (100%), followed by the weight machine (75%), thermometer (50%), and tape measure (0%). Conclusion(s): Although most patients agreed that monitoring their vital signs at home would help maintain or enhance their health (94.1%), before this study, only two (11.8%) indicated that they regularly self-measured their vital signs. Overall, patients received being provided home devices was overall positively, with the pulse oximeter and blood pressure apparatus being the most popular. Reasons included ease of access and ability to self-triage and determine the urgency of seeing a health care provider if feeling unwell. The results of this study highlight not only patient desires to be more involved with their health, but also the importance of continuing to find ways to optimize remote monitoring during this COVID era.Copyright © 2022, European Cystic Fibrosis Society. All rights reserved

CHEMORADIATION WITH OR WITHOUT METFORMIN IN LOCALLY ADVANCED CERVICAL CANCER: PHASE II RANDOMIZED TRIAL Kathy Han1

Purpose: Tumour hypoxia is associated with poor response to radiation (RT) and chemotherapy, and worse treatment outcome. We previously discovered a novel mechanism of metformin in a xenograft model: enhancing tumour RT response by inhibiting tumour cell oxygen consumption. Our population-based study showed that cumulative dose of metformin after cervical cancer diagnosis was independently associated with a decreased risk of cervical cancer-specific mortality in diabetic women. Based on the pre-clinical and retrospective data, we hypothesized that metformin would decrease tumour hypoxia and improve tumour response to RT in locally advanced cervical cancer. Materials and Methods: A window-of-opportunity, Phase II randomized trial was performed in women with Stage IB-IVA cervical adenocarcinoma, squamous cell or adenosquamous carcinoma. Patients underwent screening positron emission tomography (PET) imaging with hypoxia tracer fluoroazomycin arabinoside (FAZA). Those with non-hypoxic tumour (no FAZA uptake) were excluded. Patients with FAZA uptake were randomized centrally in a 2:1 ratio (in favour of metformin) to receive either metformin in combination with standard chemoRT or standard chemoRT alone. Metformin was started at 850mg once daily x 3 days, followed by 850mg twice daily throughout the entire duration of external radiotherapy. A second FAZA-PET/CT scan was performed after one week of metformin or no intervention in control group, just before start of chemoRT. The hypoxic volume was defined as all voxels within a tumour with standardized uptake values (SUVs) greater than three standard deviations (SD) from the mean gluteus maximus muscle SUV value. The hypoxic fraction (HF) was defined as the ratio of the number of hypoxic voxels to the total number of tumour voxels. The primary endpoint was absolute mean change in HF between the two FAZA-PET scans, compared using the Wilcoxon sign rank test. Disease-free survival (DFS) was defined as the duration of time from randomization to the time of relapse or death, and compared using the log-rank test. Target accrual was 48 patients;the study was closed early to accrual due to FAZA availability and the COVID-19 pandemic. Results: Of the twenty patients who consented, six were excluded due to no FAZA uptake and one withdrew. The median age of the 13 enrolled patients was 52;eight (62%) had squamous cell carcinoma and eight had Stage IIB disease. HF of the 10 patients in the metformin arm decreased by an average of 10.2% (from 44.4 to 34.2%) ± SD 16.9% after one week of metformin, compared to an average increase of 4.7% (from 29.1 to 33.8%) ± 11.5% for the three patients in the control arm (p=0.027). With a median followup of 2.8 years, the two-year DFS was 67% for the metformin arm versus 33% for control (p=0.09). Conclusions: Metformin decreases cervical tumour hypoxia with a trend towards improved DFS in this trial. A larger confirmatory trial is warranted.

IMPACT OF MAIL-IN SPUTUM CULTURES IN DELIVERY OF CYSTIC FIBROSIS CARE VIA TELEHEALTH

TOPIC: Education, Research, and Quality Improvement TYPE: Original Investigations PURPOSE: Cystic fibrosis (CF) is a multi-organ disease due to a mutation in the cystic fibrosis transmembrane conductance regulator gene. The mutation causes viscous mucus to accumulate in vital organs including the lungs. The thick mucus layers serve as sites of infection which are a significant cause of morbidity and mortality in CF patients. Sputum samples assess the types of pathogens that colonize CF patients’ lungs and can be used to guide treatment. Prior to the COVID-19 pandemic, sputum cultures were almost exclusively collected in the clinical setting. The purpose of this study was to examine the effectiveness of at-home collection of sputum samples. Specifically, we aimed to see if mail-in sputum samples can replace samples collected in clinic, thereby increasing accessibility of remote CF care. METHODS: Adult and pediatric patients were provided a mail-in sputum kit from the clinic along with instructions on collecting and shipping samples. Kits were completed by 7 adult and 32 pediatric patients from March 2020 to April 2021. The samples were shipped via FedEx to the microbiology lab for processing. The results were then compared with those of the patients’ previous hospital cultures from 2017-2020 for pediatrics and 2019-2020 for adults for reliability. The mail-in cultures were considered reliable if the patients’ previous in-clinic sputum samples had grown at least 50% of the same pathogens grown from the mail-in sample. RESULTS: Mail-in samples were reliable for 85.7% of the adult patients and 92.9% of the pediatric patients. Four pediatric patients were excluded from the study because they had not completed an in-hospital sputum sample. CONCLUSIONS: Given that the pathogens between adult and pediatric cultures were reliable 85.7% and 92.9% of the time respectively, mail-in sputum cultures appear to be an effective form of remote maintenance care in CF patients. Implementing mail-in culture protocols can expand the efficacy of telehealth in routine CF patient care. CLINICAL IMPLICATIONS: Future studies should look at optimizing patient education on mail-in sputum collection to facilitate ease of access. The usage of mail-in cultures can minimize the need for CF patients to come into the hospital for testing and in-clinic visits. DISCLOSURES: No relevant relationships by Madihah Alam, source=Web Response No relevant relationships by Sarah Barrett, source=Web Response Advisory Committee Member relationship with PARI Please note: 2019 Added 04/14/2021 by Nauman Chaudary, source=Web Response, value=Honoraria Moderator relationship with PARI Please note: 2021 Added 04/14/2021 by Nauman Chaudary, source=Web Response, value=Consulting fee Advisory Committee Member relationship with DYMEDSO Please note: 2021 Added 04/14/2021 by Nauman Chaudary, source=Web Response, value=Consulting fee No relevant relationships by Karen Lo, source=Web Response

IMPACT OF PORTABLE SPIROMETERS IN DELIVERY OF CYSTIC FIBROSIS CARE VIA TELEHEALTH

TOPIC: Education, Research, and Quality Improvement TYPE: Original Investigations PURPOSE: Cystic fibrosis (CF) is a chronic, multi-system disorder with significant morbidity and mortality. Consequently, long-term maintenance of this disease is heavily dependent on regular monitoring and treatments. The delivery of telehealth has become a topic of increasing importance since the onset of the COVID-19 pandemic. As such, portable spirometers have gained popularity in at-home care for CF patients. Forced expiratory volume (FEV1) is important clinical data used to assess the status of a patient’s disease and to guide their treatment plans. The purpose of this study was to examine the reliability of portable FEV1 values in comparison to hospital FEV1 values in order to explore novel approaches for remote CF monitoring during the SARS CoV-2 pandemic. METHODS: Funding from the Cystic Fibrosis Foundation and VCU Adult CF Center was used to provide patients with a ZEPHYRx home spirometry kit. Patients were provided instructional materials and were coached on how to use and maintain the device by dedicated respiratory therapists (RT). FEV1 values were reported through the ZEPHYRx Breathe Easy mobile app and these values were tracked from May 2020 to April 2021. The number of times these values fell at or above 90% of the patients’ best hospital FEV1 in the last 12 months was calculated as a percentage. The ZEYPHRx home spirometry values were deemed reliable if the percentage was ≥ 50%. RESULTS: The ZEPHYRx home spirometry kit provided reliable FEV1 values for 81% of the 48 patients who used the device. Compliance rate of the total 64 patients who received the home spirometry kit was 75%. The non-compliant patients were omitted from the final calculation. CONCLUSIONS: In conclusion, the study was successful in determining the reliability of utilizing ZEPHYRx home spirometry kits. The results of this study will expand the scope and efficacy of telehealth for the care of CF patients. CLINICAL IMPLICATIONS: Future studies can analyze the use of the kits in a longitudinal fashion to normalize their use in CF patient care. Including home spirometry kits as part of routine CF care will minimize patients’ visits to the clinic and therefore exposure to pathogens. DISCLOSURES: No relevant relationships by Madihah Alam, source=Web Response No relevant relationships by Sarah Barrett, source=Web Response Advisory Committee Member relationship with PARI Please note: 2019 Added 04/14/2021 by Nauman Chaudary, source=Web Response, value=Honoraria Moderator relationship with PARI Please note: 2021 Added 04/14/2021 by Nauman Chaudary, source=Web Response, value=Consulting fee Advisory Committee Member relationship with DYMEDSO Please note: 2021 Added 04/14/2021 by Nauman Chaudary, source=Web Response, value=Consulting fee No relevant relationships by Karen Lo, source=Web Response

Chemoradiation With or Without Metformin in Locally Advanced Cervical Cancer: Phase II Randomized Trial

Tumor hypoxia is associated with poor response to radiation (RT) and chemotherapy, and worse treatment outcome. We previously discovered a novel mechanism of metformin in a xenograft model: enhancing tumor RT response by inhibiting tumor cell oxygen consumption. Our population-based study showed that cumulative dose of metformin after cervical cancer diagnosis was independently associated with a decreased risk of cervical cancer-specific mortality in diabetic women. Based on the pre-clinical and retrospective data, we hypothesized that metformin would decrease tumor hypoxia and improve tumor response to RT in locally advanced cervical cancer. A window-of-opportunity, phase II randomized trial was performed in women with stage IB-IVA cervical adenocarcinoma, squamous cell or adenosquamous carcinoma. Patients underwent screening positron emission tomography (PET) imaging with hypoxia tracer fluoroazomycin arabinoside (FAZA). Those with non-hypoxic tumor (no FAZA uptake) were excluded. Patients with FAZA uptake were randomized centrally in a 2:1 ratio (in favor of metformin) to receive either metformin in combination with standard chemoRT or standard chemoRT alone. Metformin was started at 850mg once daily x 3 days, followed by 850mg twice daily throughout the entire duration of external radiotherapy. A second FAZA-PET/CT scan was performed after 1 week of metformin or no intervention in control group, just before start of chemoRT. The hypoxic volume was defined as all voxels within a tumor with standardized uptake values (SUVs) greater than 3 standard deviations (SD) from the mean gluteus maximus muscle SUV value. The hypoxic fraction (HF) was defined as the ratio of the number of hypoxic voxels to the total number of tumor voxels. The primary endpoint was absolute mean change in HF between the two FAZA-PET scans, compared using the Wilcoxon sign rank test. Disease-free survival (DFS) was defined as the duration of time from randomization to the time of relapse or death and compared using the log-rank test. Target accrual was 48 patients;the study was closed early to accrual due to FAZA availability and the COVID-19 pandemic. Of the twenty patients who consented, 6 were excluded due to no FAZA uptake and 1 withdrew. The median age of the 13 enrolled patients was 52;8 (62%) had squamous cell carcinoma and 8 had stage IIB disease. HF of the 10 patients in the metformin arm decreased by an average of 10.2% (from 44.4% to 34.2%) ± SD 16.9% after 1 week of metformin, compared to an average increase of 4.7% (from 29.1% to 33.8%) ± 11.5% for the 3 patients in the control arm (P = 0.027). With a median follow-up of 2.8 years, the 2-year DFS was 67% for the metformin arm vs 33% for control (P = 0.09). Metformin decreases cervical tumor hypoxia with a trend towards improved DFS in this trial. A larger confirmatory trial is warranted. [ABSTRACT 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 abstract 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 abstract. (Copyright applies to all Abstracts.)

Multicenter assessment of telehealth experience of care in adult people with cystic fibrosis

Background: The 2019 novel coronavirus pandemic (COVID-19) necessitated a rapid shift from conducting multidisciplinary cystic fibrosis (CF) care from in-person to telehealth-based visits. Given infrequent use of telehealth in the CF chronic care model prior to this time, experience of care in this new paradigm for patients is unknown. Objective: To determine experience of telehealth in the care model of patients in adult CF centers and assess barriers to future visits. Methods: Adults across 3 CF centers were issued online surveys via email and text link within one week of the patient's first telehealth visit in fashion under IRB approval. In the survey, patients identified their CF care site and their age range. The survey focused on three themes to assess telehealth experience of care: convenience of the visit, level of concern with absence of usual in-person assessments (pulmonary function testing (PFT), weight, sputum culture, vital signs and physical exam), and the role of telehealth in their future care. Using a 5-point Likert scale of concern, we defined 1 as not concerning and 5 as very concerning. Low level of concern was defined as a score of 2 or less. Results: Between March and June 2020, 90 adults with CF were surveyed at 3 CF centers following telehealth visits. Participants' ages were consistent with usual range of adult CF patients. The majority (71%) had not participated in a telehealth visit before March 2020. During the multidisciplinary visits, MD/DOs were seen most often (91% of visits), followed by advanced practice providers (32%), registered dietitians (31%), registered nurses (13%), and social workers (12%). Nearly all respondents (93%) were satisfied with the overall treatment experience and found utilizing telehealth services convenient. Almost all (96%) felt that their issues and concerns were addressed during the visit. The concern for lack of usual in-person assessments varied: 68% indicated low concern with lack of vital signs and physical exam, 80% indicated low concern with lack of weight measurement, 52% for lack of throat/sputum culture, while only 41% indicated low concern with lack of PFTs. When asked how many future care visits would be preferred to be telehealth, 7% indicated all visits, 35% indicated most visits, 50% indicated some visits, and 8% indicated none. Nearly all respondents (97%) were interested in home lung function assessment. Conclusions: These data show that telehealth is well-received in the adult CF population, despite lacking hallmarks of routine care, such as PFTs and sputum culture. This study supports the notion that multidisciplinary telehealth care should be a key component in the chronic CF care model, even after the COVID-19 pandemic, but provisions for home assessments are needed. Additional survey and longitudinal data for ongoing patient attitude is being analyzed to gain a larger understanding of the necessary components for the role of longitudinal telehealth in the CF chronic care model.