Use of a Smartphone Self-assessment App for a Tobacco-Induced Disease (COPD, Cardiovascular Diseases, Cancer) Screening Strategy and to Encourage Smoking Cessation: Observational Study.

BACKGROUND: Patient self-assessment via a mobile app detects actionable symptoms and has been shown to detect lung cancer relapses early, thereby lengthening survival. OBJECTIVE: The purpose of this study was to assess the incidence of chief symptoms associated with the main tobacco-induced pathologies in both current and ex-smokers through a self-assessment smartphone app and to evaluate the app's capacity to encourage users to quit smoking or reduce consumption, as well as its impact on early lung cancer stages at the time of diagnosis. METHODS: Current and ex-smokers were recruited through an advertising campaign in Sarthe county (France) proposing the free download of a smartphone app. App users were asked to answer 13 questions related to symptoms associated with tobacco-induced diseases (chronic obstructive pulmonary disease [COPD], cardiovascular diseases, cancer). In the event of any positive answer, a message was displayed recommending the user to consult a physician. In addition, they were asked about smoking cessation intention before and after answering these 13 questions. Finally, incidence of stage 1 or 2 lung cancers diagnosed during the launch period of our application was evaluated by comparing data from various sources to those from the same period during the previous year. RESULTS: Of the 5671 users who were eligible for evaluation, an alert was sent to the majority (4118/5671, 72.6%), with a higher incidence for current smokers (2833/3679, 77.0% vs 1298/1992, 65.2%; P<.001). The most frequent symptoms triggering the notifications were fatigue (2023/5671, 35.7%), cough (1658/5671, 29.2%), dyspnea (1502/5671, 26.5%), and persistent chest pain (1286/5671, 22.7%). Of the current smokers, 14.0% (515/3679) showed symptoms suggesting COPD, 15.5% (571/3679) showed symptoms suggesting stable angina, 12.4% (455/3679) probably had lower extremity artery disease, and 6.8% (249/3679) had possible cancer. Of the users, 36.5% (1343/3679) claimed that they thought about quitting smoking, and 48.7% (1795/3679) had thought about reducing their consumption. Surgery-eligible stage 1 and 2 lung cancer incidence was 24% (14/58) during the study period versus 9% (5/54) during the previous year in Sarthe county (P=.04), whereas it remained unchanged in the neighboring county of Maine-et-Loire. CONCLUSIONS: A majority of current and ex-smokers showed worrying symptoms, and the use of a self-assessment smartphone app may drive a majority of smokers toward the intention of smoking cessation or decreasing consumption. A randomized study should be performed to confirm this intention and to support the potential increase of symptomatic lung cancer detection at early, surgery-accessible stages. TRIAL REGISTRATION: ClinicalTrials.gov NCT04048954; https://www.clinicaltrials.gov/ct2/show/NCT04048954.

What value do digital health solutions bring, what are the funding mechanisms and evaluations?

Digital health is currently booming, providing major innovations, particularly in terms of changing the practices of the stakeholders in the healthcare system as a whole. It allows our healthcare system to draw on new synergies between independent, hospital and medico-social professionals, as well as on high-performance digital tools for the benefit of all, users, patients and professionals. These tools, or digital solutions, have a strong potential to improve the healthcare system but also a strong potential for economic development. In this respect, the great diversity of existing and future digital solutions, as well as their vast fields of application, are prompting public and private stakeholders in the sector to question their integration into our healthcare system. The resulting challenges concern the identification of the targets they are intended for, the values they embody and, as a result, the methods of funding and evaluation. At a time when the first reimbursement terms for digital solutions are taking shape in the context of the Social Security Financing Bill for 2022, the roundtable wished to propose 8 recommendations to help structure exchanges between the various stakeholders and initiate avenues of work around the integration of digital solutions into the healthcare system. The main orientations are based on the proposal of a common and transparent reflection methodology around the technical scope of these solutions, the values they bring and the funding mechanisms. Other work will be necessary beyond the points addressed by the round table in order to go into greater depth on certain themes such as the adaptation of existing funding methods to the momentum and specificities of digital technology or the development of research work on the evaluation of the value claimed by these digital solutions.

Analysis of COVID-19 Transmission Sources in France by Self-Assessment Before and After the Partial Lockdown: Observational Study.

BACKGROUND: We developed a questionnaire on a web application for analyzing COVID-19 contamination circumstances in France during the second wave of the pandemic. OBJECTIVE: This study aims to analyze the impact on contamination characteristics before and after the second partial lockdown in France to adapt public health restrictions to further prevent pandemic surges. METHODS: Between December 15 and 24, 2020, after a national media campaign, users of the sourcecovid.fr web application were asked questions about their own or a close relative's COVID-19 contamination after August 15, 2020, in France. The data of the contamination's circumstances were assessed and compared before and after the second partial lockdown, which occurred on October 25, 2020, during the second wave of the pandemic and was ongoing on December 24, 2020. RESULTS: As of December 24, 2020, 441,000 connections on the web application were observed. A total of 2218 questionnaires were assessable for analysis. About 61.8% (n=1309) of the participants were sure of their contamination origin, and 38.2% (n=809) thought they knew it. The median age of users was 43.0 (IQR 32-56) years, and 50.7% (n=1073) were male. The median incubation time of the assessed cohort was 4.0 (IQR 3-5) days. Private areas (family's or friend's house) were the main source of contamination (1048/2090, 50.2%), followed by work colleagues (579/2090, 27.7%). The main time of day for the contamination was the evening (339/961, 35.3%) before the lockdown and was reduced to 18.2% (86/473) after the lockdown (P<.001). The person who transmitted the virus to the user before and after the lockdown was significantly different (P<.001): a friend (382/1317, 29% vs 109/773, 14.1%), a close relative (304/1317, 23.1% vs 253/773, 32.7%), or a work colleague (315/1317, 23.9% vs 264/773, 34.2%). The main location where the virus was transmitted to the users before and after the lockdown was significantly different too (P<.001): home (278/1305, 21.3% vs 194/760, 25.5%), work (293/1305, 22.5% vs 225/760, 29.6%), collective places (430/1305, 33% vs 114/760, 15%), and care centers (58/1305, 4.4% vs 74/760, 9.7%). CONCLUSIONS: Modalities of transmissions significantly changed before and after the second lockdown in France. The main sources of contamination remained the private areas and with work colleagues. Work became the main location of contamination after the lockdown, whereas contaminations in collective places were strongly reduced. TRIAL REGISTRATION: ClinicalTrials.gov NCT04670003; https://clinicaltrials.gov/ct2/show/NCT04670003.

A Self-Assessment Web-Based App to Assess Trends of the COVID-19 Pandemic in France: Observational Study.

BACKGROUND: We developed a self-assessment and participatory web-based triage app to assess the trends of the COVID-19 pandemic in France in March 2020. OBJECTIVE: We compared daily large-scale RT-PCR test results to monitor recent reports of anosmia through a web-based app to assess the dynamics of emergency department visits, hospitalizations, and intensive care unit (ICU) admissions among individuals with COVID-19 in France. METHODS: Between March 21 and November 18, 2020, users of the maladiecoronavirus.fr self-triage app were asked questions about COVID-19 symptoms. Data on daily hospitalizations, large-scale positive results on RT-PCR tests, emergency department visits, and ICU admission of individuals with COVID-19 were compared to data on daily reports of anosmia on the app. RESULTS: As of November 18, 2020, recent anosmia was reported 575,214 times from among approximately 13,000,000 responses. Daily anosmia reports during peak engagement with the app on September 16, 2020, were spatially correlated with the peak in daily COVID-19-related hospitalizations in November 2020 (Spearman rank correlation coefficient [ρ]=0.77; P<.001). This peak in daily anosmia reports was observed primarily among young adults (age range 18-40 years), being observed 49 days before the peak of hospitalizations that corresponded to the first wave of infections among the young population, followed by a peak in hospitalizations among older individuals (aged ≥50 years) in November 2020. The reduction in the daily reports of anosmia associated with the peaks in the number of cases preceded the reduction in daily hospitalizations by 10 and 9 days during the first and the second waves of infection, respectively, although the reduction in the positivity rates on RT-PCR tests preceded the reduction in daily hospitalizations by only 2 days during the second wave of infections. CONCLUSIONS: Data on daily reports of anosmia collected through a nationwide, web-based self-assessment app can be a relevant tool to anticipate surges in outbreaks, hospitalizations, and ICU admission during the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov NCT04331171; https://clinicaltrials.gov/ct2/show/NCT04331171.

Epidemiological Observations on the Association Between Anosmia and COVID-19 Infection: Analysis of Data From a Self-Assessment Web Application.

BACKGROUND: We developed a self-assessment and participatory surveillance web application for coronavirus disease (COVID-19), which was launched in France in March 2020. OBJECTIVE: Our objective was to determine if self-reported symptoms could help monitor the dynamics of the COVID-19 outbreak in France. METHODS: Users were asked questions about underlying conditions, sociodemographic status, zip code, and COVID-19 symptoms. Depending on the symptoms reported and the presence of coexisting disorders, users were told to either stay at home, contact a general practitioner (GP), or call an emergency phone number. Data regarding COVID-19-related hospitalizations were retrieved from the Ministry of Health. RESULTS: As of March 29, 2020, the application was opened 4,126,789 times; 3,799,535 electronic questionnaires were filled out; and 2,477,174 users had at least one symptom. In total, 34.8% (n=1,322,361) reported no symptoms. The remaining users were directed to self-monitoring (n=858,878, 22.6%), GP visit or teleconsultation (n=1,033,922, 27.2%), or an emergency phone call (n=584,374, 15.4%). Emergency warning signs were reported by 39.1% of participants with anosmia, a loss of the sense of smell (n=127,586) versus 22.7% of participants without anosmia (n=1,597,289). Anosmia and fever and/or cough were correlated with hospitalizations for COVID-19 (Spearman correlation coefficients=0.87 and 0.82, respectively; P<.001 for both). CONCLUSIONS: This study suggests that anosmia may be strongly associated with COVID-19 and its severity. Despite a lack of medical assessment and virological confirmation, self-checking application data could be a relevant tool to monitor outbreak trends. TRIAL REGISTRATION: ClinicalTrials.gov NCT04331171; https://clinicaltrials.gov/ct2/show/NCT04331171.

Challenges and caveats of a multi-center retrospective radiomics study: an example of early treatment response assessment for NSCLC patients using FDG-PET/CT radiomics.

BACKGROUND: Prognostic models based on individual patient characteristics can improve treatment decisions and outcome in the future. In many (radiomic) studies, small size and heterogeneity of datasets is a challenge that often limits performance and potential clinical applicability of these models. The current study is example of a retrospective multi-centric study with challenges and caveats. To highlight common issues and emphasize potential pitfalls, we aimed for an extensive analysis of these multi-center pre-treatment datasets, with an additional 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) scan acquired during treatment. METHODS: The dataset consisted of 138 stage II-IV non-small cell lung cancer (NSCLC) patients from four different cohorts acquired from three different institutes. The differences between the cohorts were compared in terms of clinical characteristics and using the so-called 'cohort differences model' approach. Moreover, the potential prognostic performances for overall survival of radiomic features extracted from CT or FDG-PET, or relative or absolute differences between the scans at the two time points, were assessed using the LASSO regression method. Furthermore, the performances of five different classifiers were evaluated for all image sets. RESULTS: The individual cohorts substantially differed in terms of patient characteristics. Moreover, the cohort differences model indicated statistically significant differences between the cohorts. Neither LASSO nor any of the tested classifiers resulted in a clinical relevant prognostic model that could be validated on the available datasets. CONCLUSION: The results imply that the study might have been influenced by a limited sample size, heterogeneous patient characteristics, and inconsistent imaging parameters. No prognostic performance of FDG-PET or CT based radiomics models can be reported. This study highlights the necessity of extensive evaluations of cohorts and of validation datasets, especially in retrospective multi-centric datasets.

Cost-Effectiveness of Web-Based Patient-Reported Outcome Surveillance in Patients With Lung Cancer.

INTRODUCTION: A multicenter randomized clinical trial in France found an overall survival benefit of web-based patient-reported outcome (PRO)-based surveillance after initial treatment for lung cancer compared with conventional surveillance. The aim of this study was to assess the cost-effectiveness of this PRO-based surveillance in lung cancer patients. METHODS: This medico-economic analysis used data from the clinical trial, augmented by abstracted chart data and costs of consultations, imaging, transportations, information technology, and treatments. Costs were calculated based on actual reimbursement rates in France, and health utilities were estimated based on scientific literature review. Willingness-to-pay thresholds of €30,000 per quality-adjusted life year (QALY) and €90,000 per QALY were used to define a very cost-effective and cost-effective strategy, respectively. Average annual costs of experimental and control surveillance approaches were calculated. The incremental cost-effectiveness ratio was expressed as cost per life-year gained and QALY gained, from the health insurance payer perspective. One-way and multivariate probabilistic sensitivity analyses were performed. RESULTS: Average annual cost of surveillance follow-up was €362 lower per patient in the PRO arm (€941/year/patient) compared to control (€1,304/year/patient). The PRO approach presented an incremental cost-effectiveness ratio of €12,127 per life-year gained and €20,912 per QALY gained. The probabilities that the experimental strategy is very cost-effective and cost-effective were 97% and 100%, respectively. CONCLUSIONS: Surveillance of lung cancer patients using web-based PRO reduced the follow-up costs. Compared to conventional monitoring, this surveillance modality represents a cost-effective strategy and should be considered in cancer care delivery.

Early assessment of metabolic response by 18F-FDG PET during concomitant radiochemotherapy of non-small cell lung carcinoma is associated with survival: a retrospective single-center study.

BACKGROUND AND PURPOSE: We performed a retrospective single-center study to assess if midtreatment 18F-FDG PET/CT could predict local control and survival in patients with locally advanced non-small cell lung cancer treated with concurrent chemoradiotherapy. METHODS: Thirty-one consecutive patients with unresectable or locally advanced lung cancer (T2-4 N0-3 M0) were treated with concurrent chemoradiotherapy in our center. Each patient received 18F-FDG PET/CT before treatment and at midtreatment time when a radiation therapy dose of 30 Gy was delivered. We assessed several PET/CT parameters as follows: SUV max, ΔSUV mean, ΔSUV max, variation of hypermetabolic tumor volume, and the variation of tumor total lesion glycolysis (ΔTLG). Univariate analysis was performed, and a stepwise procedure was used to define final multivariate model. RESULTS: The ΔTLG was statistically correlated to overall survival (OS) (P = 0.035), progression-free survival (P = 0.023), and local control (P = 0.043) in univariate analysis. A decrease in TLG over 15% was statistically correlated to a better OS (P = 0.007; hazards ratio [HR], 7.439; 95% confidence interval [CI], 1.168-28.897) and progression-free survival (P = 0.010; HR, 5.695; 95% CI, 1.506-21.537) in univariate analysis. In multivariate analysis, ΔTLG superior to -15% was significantly correlated to a worse OS (P = 0.020; HR, 5.973; 95% CI, 1.324-26.953). CONCLUSIONS: Early assessment of TLG response by 18F-FDG PET/CT during concomitant radiochemotherapy of non-small cell lung cancer might be associated with survival.