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Prospective Pilot Study of Telehealth as Domiciliary Follow-up after Hematopoietic Cell Transplantation during the COVID19 Pandemic (Preprint)

November 2020
JMIR Formative Research 5(3)

DOI:10.2196/26121

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CC BY 4.0

Authors:

Alberto Mussetti

Memorial Sloan Kettering Cancer Center

Maite Antonio Rebollo

Catalan Institute of Oncology

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Background: Patients who have recently received hematopoietic cell transplant (HCT) are at higher risk of acute complications in the first weeks after discharge, especially during the COVID19 pandemic. Objective: The aim of this study was to test the use of a telehealth platform for the follow-up of transplanted patients during the first 2 weeks from discharge. Methods: 21 patients who received autologous or allogeneic HCT for hematological malignancies were screened from the 30th April 2020 to 15th July 2020. The telehealth platform consisted in the daily collection of vital signs and physical or psychological symptoms for 2 weeks after hospital discharge. Required medical devices (oximeter, blood pressure monitor)were given to patients and a dedicated smartphone application was developed to collect this data. Daily medical revision of the data was performed form a hematologist specialized in HCT through a web-based software. Results: Only 12 out of 21 patients were able to enter or complete the study. Technological barriers were the most frequent limiting factor of the study. In the 12 patients who completed the study, adherence in reporting data was high. Patients' experience in using such a system was considered generally good. In 2 cases, the system allowed the early recognition of acute complications. Conclusions: This pilot study showed that application of telehealth systems can be applied in the early post-transplant setting with evident advantage for the physicians and patients in terms of both medical and psychological perspectives. Technological issues still represent a problem in the applicability of such a system, especially for elderly patients. Easier to use technologies could help in the future in expanding the use of telehealth systems in this setting. Clinicaltrial: None.

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Original Paper

Use of Telehealth for Domiciliary Follow-up After Hematopoietic

Cell Transplantation During the COVID-19 Pandemic:Prospective

Pilot Study

Alberto Mussetti1,2, MD; Maria Queralt Salas1,2, MD; Maria Condom1,2, MD; Maite Antonio2,3, MD; Cristian Ochoa2,4,5,

DPhil; Iulia Ivan1,2, MD; David Jimenez Ruiz-De la Torre1,2, MD; Gabriela Sanz Linares1,2, MD; Belen Ansoleaga1,2,

MD; Beatriz Patiño-Gutierrez1, RN; Laura Jimenez-Prat1, RN; Rocio Parody1,2, MD; Ana Sureda-Balari1,2, MD

1Clinical Hematology Department, Institut Català d'Oncologia-Hospitalet, L'Hospitalet de Llobregat, Barcelona, Spain

2Institut d'Investigació Biomèdica de Bellvitge, Barcelona, Spain

3Oncohematogeriatrics Unit, Institut Català d'Oncologia-Hospitalet, Barcelona, Spain

4Psycho-Oncology Unit, Institut Català d’Oncologia, ICOnnecta’t Health Program, Hospital Duran i Reynals, L’Hospitalet de Llobregat, Barcelona,

Spain

5Clinical Psychology and Psychobiology Department, Faculty of Psychology, University of Barcelona, Barcelona, Spain

Corresponding Author:

Alberto Mussetti, MD

Clinical Hematology Department

Institut Català d'Oncologia-Hospitalet

Hospital Duran i Reynals

Avinguda de la Gran Via de l'Hospitalet, 199-203

L'Hospitalet de Llobregat, Barcelona, 08908

Spain

Phone: 34 622188475

Email: amussetti@iconcologia.net

Abstract

Background: Patients who have recently received a hematopoietic cell transplant (HCT) are at higher risk of acute complications

in the first weeks after discharge, especially during the COVID-19 pandemic.

Objective: The aim of this study was to test the use of a telehealth platform for the follow-up of HCT patients during the first

two weeks after discharge.

Methods: In total, 21 patients who received autologous or allogeneic HCT for hematological malignancies were screened from

April 30, 2020, to July 15, 2020. The telehealth platform assisted in the daily collection of vital signs as well as physical and

psychological symptoms for two weeks after hospital discharge. The required medical devices (oximeter and blood pressure

monitor) were given to patients and a dedicated smartphone app was developed to collect this data. The data were reviewed daily

through web-based software by a hematologist specializing in HCT.

Results: Only 12 of 21 patients were able to join and complete the study. Technological barriers were the most frequent limiting

factor in this study. Among the 12 patients who completed the study, adherence to data reporting was high. The patients’experience

of using such a system was considered good. In two cases, the system enabled the early recognition of acute complications.

Conclusions: This pilot study showed that telehealth systems can be applied in the early posttransplant setting, with evident

advantages for physicians and patients for both medical and psychological aspects. Technological issues still represent a challenge

for the applicability of such a system, especially for older adult patients. Easier-to-use technologies could help to expand the use

of telehealth systems in this setting in the future.

(JMIR Form Res 2021;5(3):e26121) doi: 10.2196/26121

KEYWORDS

SARS-CoV-2; COVID-19; hematology; hematopoietic cell transplantation; telemedicine; mortality; surveillance; monitoring;

stem cell; transplant; app; medical device

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Introduction

Patients receiving a hematopoietic cell transplant (HCT) have

a high risk of developing severe acute toxicities in the early

posttransplant period. An increased mortality risk has been

observed in HCT patients who go on to develop COVID-19,

with an estimated mortality rate between 20%-40% [1,2].

Although other hematological procedures can be postponed in

case of emergency, there is an international agreement to not

defer transplant procedures, especially for rapidly progressing

diseases such as acute leukemias and aggressive lymphomas.

Due to this, it is necessary to improve the domiciliary clinical

monitoring of patients who received transplants to rapidly detect

clinical deterioration. In addition, unnecessary in-person visits

that might increase the risk of intrahospital contagion should

be reduced. During the last few years, smart devices for

assessing vital signs or physical activity have emerged as

breakthrough innovations in the oncological setting [3-5]. Digital

technologies allow clinicians to perform real-time monitoring

of a patient’s clinical status. In patients with COVID-19, the

use of devices such as digital oximeters allow for early detection

of clinical deterioration and a safer domiciliary follow-up. This

is of paramount importance for patients who have received

transplants, who have higher COVID-19–related mortality than

the general population.

Methods

The aim of this study (SMARTCOVID19 study) is to report the

feasibility of a real-time patient monitoring system through the

use of a smartphone app and mobile health care devices. The

institutional review board of Institut Catalá d'Oncologia -

Hospitalet approved the study. Inclusion criteria were the

following: those aged >18 years who had received autologous

or allogeneic HCT while hospitalized and have a smartphone

with an operating system able to run the SMARTCOVID19

app. Those who did not have adequate social support were

excluded from the study.

Patient education regarding the use of the platform was provided

by a hematologist at the time of enrollment, which was 1-2 days

before hospital discharge.

Vital signs (heart rate, oxygen saturation, and arterial blood

pressure) were collected daily using clinically validated

oximeters (Onyx II, Nonin Inc) and a blood pressure monitor

(iHealth Track, iHealth Labs), while temperature was measured

using domiciliary thermometers. Patients were educated on how

to measure their respiratory frequency. A checklist of clinical

symptoms was completed daily (presence of cough, myalgia,

headache, fatigue, dyspnea, emesis, odynophagia, rhinitis,

conjunctivitis, and chest pain). An analog visual scale

“thermometer” (0-10) used to detect potential cases of anxiety

or depressive disorders was completed by patients daily. Scores

of >6 resulted in an automatic referral to a psycho-oncologist

through the platform, who would contact the patient and evaluate

whether psychological support was needed via videoconference.

A chat service was available for nonurgent communications.

All data were reported to an online platform through a

smartphone app (“Saludencasa,” Fundación Trilema) compatible

with Apple (iOS Version 9 or higher) and Android systems

(Version 6 or higher). A hematologist with experience with

HCTs reviewed all patient data daily. Programmed alarms were

set in the event of any of the following situations: fever >38 C,

oxygen saturation <92%, tachycardia >125 beats per minute,

hypotension (systolic blood pressure <90 mm Hg, diastolic

blood pressure <60 mm Hg), altered mental status, and persistent

emesis or diarrhea (lasting more than 48 hours). In case of alarm

activation, the hematologist contacted the patient by phone to

evaluate the need for an in-person visit and determine the

clinical management steps that were considered most

appropriate. Outpatient monitoring started from the day of

hospital discharge 2 days and continued for 14 days. The study

accrual period was April 30, 2020, to July 15, 2020. Data were

collected prospectively and all patients signed informed consent

forms. Finally, two weeks after the end of the recruitment period,

patients were contacted by phone and asked to answer a

satisfaction questionnaire.

Results

During the study period, 16 of 21 patients who received

transplants were successfully recruited into the study (76%

feasibility). Reasons for patients not being enrolled were the

following: language incompatibility (1 patient), no consent (1

patient), and no compatible smartphone (3 patients). Of the 16

enrolled patients, the median age was 50 years (range 22-70

years), 38% (n=6) were female, and 94% (n=15) had lymphatic

diseases. In addition, 38% (n=6) of HCTs were autologous and

62% (n=19) were allogeneic.

Of the 16 enrolled patients, 4 were not able to use the app due

to an inability to use smartphone apps in general. Of the

remaining 12 patients, average adherence to reporting study

data (median number of days reported across all patients during

the planned 14-day study period) was as follows: 89% for

temperature, 90% for oxygen saturation, 70% for respiratory

frequency, 85% for cardiac frequency, 89% for blood pressure,

65% for symptoms reporting, and 71% for emotional distress.

Automatic alarms were activated only 3 times: twice for the

presence of clinical symptoms and once for emotional distress.

Only one patient spoke with the psycho-oncologist via

videoconference. In total, 4 patients used the chat service to

communicate with hospital personnel.

Despite the feasibility nature of the study, data collected with

the digital system helped the clinician to recognize calcineurin

inhibitor–induced arterial hypertension in one patient and acute

cutaneous graft-versus-host disease (grade I) in another patient.

Only two patients in this cohort were readmitted within 14 days

of discharge, both due to grade 4 odynophagia related to herpes

simplex virus 1/2 reactivation.

The patients’ responses to the survey questions about their

experience with the telehealth system are reported in Table 1.

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Table 1. Patients’ responses to survey questions about their experience with the telehealth system (n=12).

Mean score (scored from 1-5, where 1=disagree

and 5=agree)

Question

4.67Overall satisfaction with the telehealth system

4.67Did you feel safer at home with the use of the telehealth system?

4.67Do you think that using such a device has improved your domiciliary follow-up?

4.50Was the app easy to use?

3.50When you feel well, would you be comfortable substituting in-person visits with telemedicine?

Discussion

Our prospective study showed that the use of mobile health care

devices and smartphone apps for self-reported outcomes is

feasible in the post-HCT setting. In a study conducted by Nawas

et al [6], it was found that telehealth evaluations could be useful

in the early peritransplant period, with a high satisfaction rate

among patients. In our study, we found that patients felt safer

when using the telehealth system. However, only a few patients

would completely substitute an in-person visit with telehealth

monitoring. This suggests that an in-person visit with a medical

doctor is still the preferred follow-up modality for patients who

have received transplants. Apart from vital signs monitoring

and blood test results, which could be evaluated without the

patient present, other aspects of medical care cannot be replaced

by telehealth. Human contact and empathy are still largely

needed during a visit. With respect to feasibility and adherence,

two observations emerged from our study. The first is that only

57% of the potential patients used the telehealth system in the

end. Technological barriers such as incompatible smartphones

or inexperience in using smartphone apps were the main causes

for study failure. This problem was more frequently observed

in older adult patients living alone or without caregivers able

to help them use the devices. A solution to this could be to

automate data collection through the use of devices that

automatically monitor and report this data. Newer wearable

devices could allow for real-time monitoring of patients’ heart

rate, oxygen saturation, and physical activity in an automated

manner. A second technological issue became apparent when

evaluating the reporting adherence of the people who succeeded

in using the platform. In this case, adherence to reporting clinical

parameters such as respiratory frequency or symptoms was low.

The use of currently available wearable devices could also

resolve this adherence issue. In addition to technical issues, it

is possible that psychological barriers could have contributed

to reducing study adherence. Better patient education on how

to use this system could also improve adherence, and should

always be considered when applying digital medicine. Finally,

the quality of telehealth monitoring should be complemented

and improved by the collection of other clinically relevant

parameters. For example, a virtual physical examination could

be carried out through the use of high-quality video calls, digital

stethoscopes, and weight scales [6,7]. In our study, the system

worked well for detecting acute complications such as infections

and dehydration. It is useful for monitoring the early

posttransplant period, when acute complications are more

frequent. For long-term follow-up, this system should be

implemented with other technologies (eg, ones that allow visual

communication between physicians and patients).

A study limitation was the small number of patients that

completed the study. However, the study population was

considered sufficient for a pilot study. In fact, the results

obtained should be used to improve the design of the next study,

which will recruit a larger number of patients. In addition, the

uptake and use of newer technologies could be influenced by

country or hospital resources. Such a system would not be

feasible to implement within hospitals or health care systems

that cannot afford such expenses. This applicability issue is

common to the majority of studies using newer technologies.

In conclusion, telehealth monitoring could potentially improve

patient follow-up in terms of both physical and psychological

outcomes. This is especially true whenever an external cause

(such as the COVID-19 pandemic) impedes in-person visits.

Technological issues still represent a barrier to the wider

application of telehealth monitoring systems in a medical setting

and these issues should be considered for future studies.

Acknowledgments

We acknowledge all patients and their families, as well as all health care workers and scientists helping in the fight against the

SARS-CoV-2 outbreak. We thank CERCA Programme/Generalitat de Catalunya for institutional support. In addition, we thank

Tarsila Ferro Garcia for her help in finding the resources required to develop the study. We also thank Fundación Trilema for

their free support in creating the platform for the study.

Authors' Contributions

AM contributed to conception and design and data analysis, and prepared the first draft of the manuscript. All authors contributed

to collection and assembly of data, interpretation, and manuscript revision. All authors approved the final manuscript.

Conflicts of Interest

None declared.

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References

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32897885]

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and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective,

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10.1016/S2352-3026(20)30251-9] [Medline: 32798473]

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Clinical Cancer Informatics 2018 Dec(2):1-11. [doi: 10.1200/cci.17.00147]

6. Nawas MT, Landau HJ, Sauter CS, Featherstone CA, Kenny SA, Rodriguez ES, et al. Pilot Study of Telehealth Evaluations

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Abbreviations

HCT: hematopoietic cell transplant

Edited by G Eysenbach; submitted 28.11.20; peer-reviewed by J Mariotti, H Mehdizadeh, P Tripathi; comments to author 30.12.20;

revised version received 31.12.20; accepted 16.01.21; published 12.03.21

Please cite as:

Mussetti A, Salas MQ, Condom M, Antonio M, Ochoa C, Ivan I, Jimenez Ruiz-De la Torre D, Sanz Linares G, Ansoleaga B,

Patiño-Gutierrez B, Jimenez-Prat L, Parody R, Sureda-Balari A

Use of Telehealth for Domiciliary Follow-up After Hematopoietic Cell Transplantation During the COVID-19 Pandemic: Prospective

Pilot Study

JMIR Form Res 2021;5(3):e26121

URL: https://formative.jmir.org/2021/3/e26121

doi: 10.2196/26121

PMID: 33600351

©Alberto Mussetti, Maria Queralt Salas, Maria Condom, Maite Antonio, Cristian Ochoa, Iulia Ivan, David Jimenez Ruiz-De la

Torre, Gabriela Sanz Linares, Belen Ansoleaga, Beatriz Patiño-Gutierrez, Laura Jimenez-Prat, Rocio Parody, Ana Sureda-Balari.

Originally published in JMIR Formative Research (http://formative.jmir.org), 12.03.2021. This is an open-access article distributed

under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits

unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Formative

Research, is properly cited. The complete bibliographic information, a link to the original publication on http://formative.jmir.org,

as well as this copyright and license information must be included.

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Telemedicine with Wearable Technologies in Hematopoietic Cell Transplantation and CAR T-cell Therapy Patients (TEL-HEMATO study) (Preprint)

Article

Dec 2023

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Simple Summary Patients with high-risk acute leukemias and lymphomas undergo stem cell transplantation or cellular therapies to achieve a cure. These are complex treatments that are typically offered by specialty medical centers. Patients are treated and monitored in the hospital for 3–4 weeks due to the potential for life-threatening complications. While it is still in its infancy, the use of telemedicine is changing this treatment paradigm by allowing patients to be in the comfort of their own home. We review data on how telemedicine is being incorporated for patients who receive stem cell transplantation or cellular therapy. Abstract Telemedicine has played an important role in delivering healthcare for primary care, chronic disease patients, and those with solid organ malignancies. However, its application in subspecialties such as hematologic malignancies, hematopoietic cell transplantation (HCT), or chimeric antigen receptor-T cell (CAR-T) therapy is not widespread since physical examination is a vital component in delivering care. During the COVID-19 pandemic, we widely used telemedicine, since protecting our immunocompromised patients became our top priority. The employment of HCT and CAR-T therapies continues to grow for high-risk hematologic malignancies, particularly in older and frail patients who must visit specialty centers for treatment access. Generally, HCT and CAR-T therapy care is highly complex, necessitating commitment from patients, caregivers, and a multidisciplinary team at specialty academic centers. All healthcare systems adapted to the crisis and implemented rapid changes during the COVID-19 public health emergency (PHE). Telemedicine, a vital modality for delivering healthcare in underserved areas, experienced rapid expansion, regardless of the geographic region, during the COVID-19 PHE. The data emerging from practices implemented during the PHE are propelling the field of telemedicine forward, particularly for specialties with complex medical treatments such as HCT and CAR-T therapy. In this review, we examine the current data on telemedicine in HCT and cellular therapy care models for the acute and long-term care of our patients.

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Full-text available

Feb 2022

1-Introdução Não é novidade, que com os avanços da Medicina, muitas das situações de doença grave passaram a ser controladas e deixaram de ser uma ameaça de morte. Os progressos da ciência e da tecnologia, assim como das condições de vida e de saúde pública, conduzem um somar de anos à vida das pessoas. No entanto, viver mais tempo pode ter como consequência viver com doença crónica progressiva e avançada, em situação de fragilidade, por multimorbilidade, dependência para as atividades de autocuidado e declínio cognitivo até ao momento da morte. A investigação tem mostrado que as pessoas em fim de vida sofrem, porque, vivem perdas múltiplas em dimensões relevantes do ser humano. Perdas estas, no domínio físico, psicológico, social e espiritual. Os cuidados paliativos surgem no sentido da resposta abrangente e integrada às necessidades complexas das pessoas com doença crónica avançada e irreversível e com prognóstico limitado de vida, bem como, no acompanhamento de familiares e cuidadores durante as suas perdas e após o luto. Isto porque a necessidade de alívio do sofrimento e angústia severa, relacionados com condições de saúde que ameaçam ou limitam a vida são um imperativo global de saúde e de equidade (Knaul, Farmer, Krakauer, De Lima, Bhadelia., Kwete, 2017). Os cuidados paliativos são cuidados de saúde com o desígnio de ajudar a viver e a reduzir o sofrimento em circunstâncias extremas de fim de vida, diligenciam o acompanhamento centrado na pessoa e suas famílias, otimizando a qualidade de vida, o desenvolvimento do bem-estar humano e maximizando a dignidade dos cuidados. Devem ser prestados por equipas multidisciplinares e em diferentes contextos de saúde, porque lidar com o sofrimento envolve cuidar de questões que vão para além dos sintomas físicos. Os cuidados paliativos são consensualmente considerados um direito humano básico (Radbruch, De Lima, Lohmann, Gwyther & Payne, 2013). Devem fazer parte da oferta de serviços de qualquer sistema de saúde no sentido de garantir um apoio para que a pessoa possa viver o mais ativamente possível até à morte. O cliente alvo de cuidados paliativos pode ser identificado por um conjunto de sintomas ou fatores, incluindo a condição de doença crónica avançada, conjetura limitada de vida e necessidade de prevenção e alívio de qualquer tipo de sofrimento: físico, psicológico, social e espiritual, vivenciado por adultos ou crianças (WHPCA, 2014, 2020).

Pilot Study of Telehealth Evaluations in Patients Undergoing Hematopoietic Cell Transplantation

Article

Full-text available

Feb 2020
BIOL BLOOD MARROW TR

Background: Telehealth involves the use of telecommunication and information technology for the delivery of clinical care and may be a mechanism to alleviate the burden of visits faced by patients undergoing hematopoietic cell transplantation (HCT). Few studies have evaluated the feasibility and acceptability of telehealth visits in the care of HCT patients. Methods: We conducted 27 telehealth visits with 25 patients undergoing HCT using a videoconferencing system that allows for real-time, two-way interactions and administered satisfaction surveys to patients and providers. Results: Of the 25 patients included in the study, 20 (80%) and five (20%) were undergoing autologous and allogeneic HCT, respectively. The telehealth visits were distributed as follows: 3 inpatient visits upon admission for HCT; 11 inpatient visits between 2-14 days post-HCT; 4 inpatient visits prior to discharge after HCT; 8 outpatient, post-HCT follow-up visits; and 1 handoff to a community oncologist. Out of a total of 54 provider assessments, 7 providers (13%) were unable to complete some part of the physical examination, but no provider reported being unable to manage patients' symptoms through telehealth. 81% of patients were either satisfied or very satisfied with the telemedicine session. Overall satisfaction was higher among patients than providers (mean scores 4.12 vs. 2.64; scale 1-5, 1: very poor; 5: excellent). Technological barriers resulting in delays and suboptimal physical examination were largely responsible for provider dissatisfaction. Conclusions: The use of telehealth to deliver comprehensive follow-up care to HCT patients is feasible across different HCT types but is dependent upon quality of data streaming and videoconferencing technologies.

Favorable outcomes of COVID-19 in recipients of hematopoietic cell transplantation

Article

Sep 2020
J CLIN INVEST

Background: Understanding outcomes and immunologic characteristics of cellular therapy recipients with SARS-CoV-2 is critical to performing these potentially life-saving therapies in the COVID-19 era. In this study of recipients of allogeneic (Allo) and autologous (Auto) hematopoietic cell transplant and CD19-directed chimeric antigen receptor T cell therapy (CAR-T) at Memorial Sloan Kettering Cancer Center, we aimed to identify clinical variables associated with COVID-19 severity and assess lymphocyte populations. Methods: We retrospectively investigated patients diagnosed between March 15th and May 7th, 2020. In a subset of patients, lymphocyte immunophenotyping, quantitative real-time PCR from nasopharyngeal swabs, and SARS-CoV-2 antibody status were available. Results: We identified 77 SARS-CoV-2 + cellular therapy recipients (Allo = 35, Auto = 37, CAR-T = 5; median time from cellular therapy 782 days (IQR 354,1611). Overall survival at 30 days was 78%. Clinical variables significantly associated with the composite endpoint of non-rebreather or higher oxygen requirement and death (n events = 25/77) included number of co-morbidities (HR 5.41, P = 0.004), infiltrates (HR 3.08, P = 0.032), and neutropenia (HR 1.15, P = 0.04). Worsening graft-versus-host-disease was not identified among Allo subjects. Immune profiling revealed reductions and rapid recovery in lymphocyte populations across lymphocyte subsets. Antibody responses were seen in a subset of patients. Conclusion: In this series of Allo, Auto, and CAR-T recipients, we report overall favorable clinical outcomes for COVID-19 patients without active malignancy and provide preliminary insights into the lymphocyte populations that are key for the anti-viral response and immune reconstitution. Funding: NIH P01 CA23766, NIH/NCI P30 CA008748.

Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective, multicentre, cohort study

Article

Aug 2020

Background Several small studies on patients with COVID-19 and haematological malignancies are available showing a high mortality in this population. The Italian Hematology Alliance on COVID-19 aimed to collect data from adult patients with haematological malignancies who required hospitalisation for COVID-19. Methods This multicentre, retrospective, cohort study included adult patients (aged ≥18 years) with diagnosis of a WHO-defined haematological malignancy admitted to 66 Italian hospitals between Feb 25 and May 18, 2020, with laboratory-confirmed and symptomatic COVID-19. Data cutoff for this analysis was June 22, 2020. The primary outcome was mortality and evaluation of potential predictive parameters of mortality. We calculated standardised mortality ratios between observed death in the study cohort and expected death by applying stratum-specific mortality rates of the Italian population with COVID-19 and an Italian cohort of 31 993 patients with haematological malignancies without COVID-19 (data up to March 1, 2019). Multivariable Cox proportional hazards model was used to identify factors associated with overall survival. This study is registered with ClinicalTrials.gov, NCT04352556, and the prospective part of the study is ongoing. Findings We enrolled 536 patients with a median follow-up of 20 days (IQR 10–34) at data cutoff, 85 (16%) of whom were managed as outpatients. 440 (98%) of 451 hospitalised patients completed their hospital course (were either discharged alive or died). 198 (37%) of 536 patients died. When compared with the general Italian population with COVID-19, the standardised mortality ratio was 2·04 (95% CI 1·77–2·34) in our whole study cohort and 3·72 (2·86–4·64) in individuals younger than 70 years. When compared with the non-COVID-19 cohort with haematological malignancies, the standardised mortality ratio was 41·3 (38·1–44·9). Older age (hazard ratio 1·03, 95% CI 1·01–1·05); progressive disease status (2·10, 1·41–3·12); diagnosis of acute myeloid leukaemia (3·49, 1·56–7·81), indolent non-Hodgin lymphoma (2·19, 1·07–4·48), aggressive non-Hodgkin lymphoma (2·56, 1·34–4·89), or plasma cell neoplasms (2·48, 1·31–4·69), and severe or critical COVID-19 (4·08, 2·73–6·09) were associated with worse overall survival. Interpretation This study adds to the evidence that patients with haematological malignancies have worse outcomes than both the general population with COVID-19 and patients with haematological malignancies without COVID-19. The high mortality among patients with haematological malignancies hospitalised with COVID-19 highlights the need for aggressive infection prevention strategies, at least until effective vaccination or treatment strategies are available. Funding Associazione italiana contro le leucemie, linfomi e mieloma–Varese Onlus.

Pilot study for the use of wearable devices for patients undergoing oral chemotherapy.

Article

May 2020

e14103 Background: The rapid development of digital technology holds enormous potential to transform the delivery of cancer care. Despite these digital innovations, we still face significant challenges in healthcare in using these emerging digital technologies in the clinical setting. Clinicians generally underestimate the severity and extent of chemotherapy toxicity of patients. This project seeks to conduct an exploratory field study to collect patient feedback on their experiences, and the design/functionality of the prototype of the digital health service platform designed to monitor their symptoms. Methods: Using the National Cancer Institute item library addressing the most common symptoms for chemotherapy toxicity, a digital health platform was designed by Samsung Research America (SRA) and University Hospitals. Patients age ≥ 18 years old, willingness to agree to the consent document, ability to understand use of wearable device and willingness to answer patient reported outcomes questions were included in this study. Patients who are not undergoing oral chemotherapy treatment for their cancer were excluded. Patients were given a phone that had our designed platform along with a watch. The watch had the capability of tracking blood pressure, heart rate, and pulse oximetry. Patients were set up with an electronic account that queried them on patient Reported Outcomes (PRO) regarding potential toxicity they may be experiencing. They were also able to track medication consumption and input their weight. Subjects were be asked to use the wearable device and phone for at least 28 days and no more than 90 days. At the end of the study, a phone survey was attempted. Results: Total patients enrolled: 21. 18/21 (85.7%) patients completed the 90 days of the study. Only 9 patients provided PRO with total number of side effects reported 28 times. Watch device was only utilized by 15/21 (71.4%) patients. On an average across 90 days, these patients wore the watch 430 minutes per day. At the end of the treatment, 5 patients agreed to participate in the phone survey. Three patients stated that they would do similar study in the future noting that the digital platform helped them stay on track and monitor symptoms accurately. Every patient questioned had a complaint regarding the watch functionality. Patients also found it difficult to carry a second phone in addition to their personal phone. Conclusions: Improving our digital health service platform will get us closer to achieving effective bi-lateral patient communication and ultimately improving patient care.

Following-up allogeneic transplantation recipients during the COVID-19 pandemic

Article

May 2020

The Future of Wearable Technologies and Remote Monitoring in Health Care

Article

May 2019

Mobile technology has become a ubiquitous part of everyday life and is changing the way we offer clinical care and perform clinical research. We have unprecedented access to data for one's self-care as well as for sharing with health care providers. Meeting the challenge posed by the influx of wearable device data requires a multidisciplinary team of researchers, clinicians, software developers, information technologists, and statisticians. Although the possibility of what can be achieved with the ever-evolving wearable technologies seems to be unlimited, regulatory agencies have provided a framework to establish standards for clinical applications, which will also affect research applications. Clinical programs and electronic medical records vendors should prepare to establish a framework to implement these technologies into clinicians' workflow and to allow feedback to measure the impact on clinical outcome. In this article, we discuss how a new brand of multidisciplinary care is evolving around mobile health devices and present a vision of up-and-coming technology in this space.

Use of Wearable, Mobile, and Sensor Technology in Cancer Clinical Trials

Article

Jun 2018

As the availability and sophistication of mobile health (mHealth) technology (wearables, mobile technology, and sensors) continues to increase, there is great promise that these tools will be transformative for clinical trials and drug development. This review provides an overview of the current landscape of potential measurement options, including the various types of data collected, methods/tools for collecting them, and a crosswalk of available options. The opportunities and potential drawbacks of mHealth in cancer clinical trials are discussed. Specific concerns related to data accuracy, provenance, and regulatory issues are highlighted, with suggestions for how to address these in future research. Next steps for establishing mHealth methods and tools as legitimate and accepted measures in oncology clinical trials include continuation of regulatory definition by the FDA; establishment of security standards and protocols; refinement and implementation of methods to establish and document data accuracy; and finally, creation of feedback loops wherein regulators receive updates from researchers with better and more timely data, which should decrease trial times and lessen drug development costs. Implementing mHealth technologies into cancer clinical trials has the potential to transform and propel oncology drug development and precision medicine to keep pace with the rapidly increasing developments in genomics and immunology.

Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective, multicentre, cohort study

Oct 2020
737-745

F Passamonti
C Cattaneo
L Arcaini
R Bruna
M Cavo
F Merli
Ita-Hema-Cov Investigators

Passamonti F, Cattaneo C, Arcaini L, Bruna R, Cavo M, Merli F, ITA-HEMA-COV Investigators. Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective, multicentre, cohort study. Lancet Haematol 2020 Oct;7(10):e737-e745 [FREE Full text] [doi: 10.1016/S2352-3026(20)30251-9] [Medline: 32798473]