Telehealth utilization in gynecologic oncology clinical trials
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved..
OBJECTIVE: Prior to the COVID-19 pandemic, telehealth visits and remote clinical trial operations (such as local collection of laboratory tests or imaging studies) were underutilized in gynecologic oncology clinical trials. Current literature on these operational changes provides anecdotal experience and expert opinion with few studies describing patient-level safety data. We aimed to evaluate the safety and feasibility of telehealth and remote clinical trial operations during the COVID-19 Pandemic.
METHODS: Gynecologic oncology patients enrolled and actively receiving treatment on a clinical trial at a single, academic institution during the designated pre-Telehealth and Telehealth periods were identified. Patients with at least 1 provider or research coordinator telehealth visit were included. Patient demographics, health system encounters, adverse events, and protocol deviations were collected. Pairwise comparisons were performed between the pre-Telehealth and Telehealth period with each patient serving as their own control.
RESULTS: Thirty-one patients met inclusion criteria. Virtual provider visits and off-site laboratory testing increased during the Telehealth period. Delays in provider visits, imaging, and laboratory testing did not differ between time periods. Total and minor protocol deviations increased in incidence during the Telehealth period and were due to documentation of telehealth and deferment of non-therapeutic testing. Major protocol deviations, emergency department visits, admissions, and severe adverse events were of low incidence and did not differ between time periods.
CONCLUSIONS: Telehealth and remote clinical trial operations appeared safe and did not compromise clinical trial protocols in a small, single institutional study. Larger scale evaluations of such trial adaptations should be performed to determine continued utility following the Pandemic.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:177 |
|---|---|
| Enthalten in: |
Gynecologic oncology - 177(2023) vom: 15. Okt., Seite 103-108 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Andriani, Leslie [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Clinical trial protocol |
|---|
| Anmerkungen: |
Date Revised 24.10.2023 published: Print-Electronic Citation Status Publisher |
|---|
| doi: |
10.1016/j.ygyno.2023.08.011 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM361570023 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM361570023 | ||
| 003 | DE-627 | ||
| 005 | 20231226085425.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.ygyno.2023.08.011 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1205.xml |
| 035 | |a (DE-627)NLM361570023 | ||
| 035 | |a (NLM)37659265 | ||
| 035 | |a (PII)S0090-8258(23)01440-3 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Andriani, Leslie |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Telehealth utilization in gynecologic oncology clinical trials |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 24.10.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a OBJECTIVE: Prior to the COVID-19 pandemic, telehealth visits and remote clinical trial operations (such as local collection of laboratory tests or imaging studies) were underutilized in gynecologic oncology clinical trials. Current literature on these operational changes provides anecdotal experience and expert opinion with few studies describing patient-level safety data. We aimed to evaluate the safety and feasibility of telehealth and remote clinical trial operations during the COVID-19 Pandemic | ||
| 520 | |a METHODS: Gynecologic oncology patients enrolled and actively receiving treatment on a clinical trial at a single, academic institution during the designated pre-Telehealth and Telehealth periods were identified. Patients with at least 1 provider or research coordinator telehealth visit were included. Patient demographics, health system encounters, adverse events, and protocol deviations were collected. Pairwise comparisons were performed between the pre-Telehealth and Telehealth period with each patient serving as their own control | ||
| 520 | |a RESULTS: Thirty-one patients met inclusion criteria. Virtual provider visits and off-site laboratory testing increased during the Telehealth period. Delays in provider visits, imaging, and laboratory testing did not differ between time periods. Total and minor protocol deviations increased in incidence during the Telehealth period and were due to documentation of telehealth and deferment of non-therapeutic testing. Major protocol deviations, emergency department visits, admissions, and severe adverse events were of low incidence and did not differ between time periods | ||
| 520 | |a CONCLUSIONS: Telehealth and remote clinical trial operations appeared safe and did not compromise clinical trial protocols in a small, single institutional study. Larger scale evaluations of such trial adaptations should be performed to determine continued utility following the Pandemic | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Clinical trial protocol | |
| 650 | 4 | |a Clinical trials | |
| 650 | 4 | |a Decentralization of clinical trial | |
| 650 | 4 | |a Gynecologic cancer | |
| 650 | 4 | |a Telehealth | |
| 650 | 4 | |a Telemedicine | |
| 700 | 1 | |a Oh, Jinhee |e verfasserin |4 aut | |
| 700 | 1 | |a McMinn, Erin |e verfasserin |4 aut | |
| 700 | 1 | |a Gleason, Emily |e verfasserin |4 aut | |
| 700 | 1 | |a Koelper, Nathanael C |e verfasserin |4 aut | |
| 700 | 1 | |a Chittams, Jesse |e verfasserin |4 aut | |
| 700 | 1 | |a Simpkins, Fiona |e verfasserin |4 aut | |
| 700 | 1 | |a Ko, Emily M |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Gynecologic oncology |d 1972 |g 177(2023) vom: 15. Okt., Seite 103-108 |w (DE-627)NLM000614610 |x 1095-6859 |7 nnns |
| 773 | 1 | 8 | |g volume:177 |g year:2023 |g day:15 |g month:10 |g pages:103-108 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.ygyno.2023.08.011 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 177 |j 2023 |b 15 |c 10 |h 103-108 | ||