What Do Physicians Think About the Use of Telemedicine to Recruit and Assess Participants in mHealth-Related Clinical Studies as a Consequence of the COVID-19 Pandemic?
Introduction
The COVID-19 pandemic led to striking changes in health care delivery1 and clinical research.2,3 The need to minimize social interactions and to use quarantine to prevent infection transmission created an opportunity to expedite the implementation and dissemination of telehealth technologies, including telemedicine appointments. In the United States, between March 2 and April 14, 2020, the number of telemedicine visits increased up to 4,345%1; steep increases were also observed in European countries.4
In clinical research, patient recruitment and assessment are traditionally based on one or more in-person visits. Studies that rely on face-to-face contacts cannot just be transformed into digital formats without adjusting several methodological and ethical aspects.5 This poses a major challenge in the context of a pandemic, such as COVID-19.
In fact, COVID-19 led to a tremendous disruption of clinical research with up to 80% of non-COVID-19 trials being stopped or interrupted.6 Patient enrolment and recruitment were identified as the most impacted study activities.7 As a mitigation strategy, European8 and U.S.9 regulatory entities recommended that, whenever feasible, virtual patient visits should be considered, but suggested that starting new studies or recruiting new patients should be critically assessed under the premise that patient safety always prevails.
Nevertheless, studies on mHealth technologies to validate remote monitoring solutions that can be used to follow-up patients during a pandemic were considered necessary.10,11 To meet the need for further studies while ensuring patient safety, designing study protocols based exclusively on virtual visits and data collection, whenever feasible, could be a suitable alternative. However, the acceptance of virtual studies to assess mHealth technologies was not previously described.
This study aimed to evaluate physician’s opinion and availability to participate in mHealth-related clinical studies with patient recruitment and assessment via telemedicine and to identify characteristics associated with the willingness to participate.
Methods
This was a cross-sectional, observational, anonymous web survey-based study including all the 237 physicians (general practitioners [GP], allergists, pulmonologists, and pediatricians from Portugal and Spain) that cooperated with the INSPIRERS project. INSPIRERS is an asthma mHealth project aiming to develop and evaluate a mHealth app to measure and improve medication adherence in adolescents and adults with persistent asthma.12
The web-survey, implemented in the Google™ Forms platform, was sent by email and made available between May 28 and June 11, at the end of the first COVID-19 wave in Portugal. The survey included questions about general physicians’ characteristics and clinical practice before the COVID-19 pandemic and at the date of the survey completion. It also assessed physician’s availability and perceived difficulties to recruit patients for mHealth-related clinical studies using telemedicine technologies (with a checklist of anticipated difficulties and free text).
Ethical approval was obtained from the Ethics Review Board from the Faculty of Medicine of University of Porto (01/CEFMUP/2021).
STATISTICAL ANALYSIS
Independent sample t-test, Wilcoxon signed-rank test, McNemar test, and chi-squared test were used for comparisons according to the variable type and distribution; Bonferroni correction was applied in multiple comparisons.
Univariate and then multivariable logistic regressions were performed to identify characteristics associated with the availability to participate in mHealth-related clinical studies with patient recruitment and assessment via telemedicine. Variables with a p-value ≤0.30 in the univariate analysis were selected for inclusion in the multivariable regression. The final model was chosen based on a stepwise selection method avoiding the inclusion of highly correlated variables (e.g., medical specialty and type of care) and accounting for model quality (overall percentage of correct prediction and Nagelkerke R square) and fitting (Hosmer and Lemeshow test). All statistical analyses were performed with IBM SPSS Statistics version 26.0 (IBM Corporation™, Armonk, NY).
Results
One hundred and twenty physicians (51% response rate) participated; 64% were female and the mean (SD) age was 41(12) years (Supplementary Table S1). At the time the questionnaire was answered, two-thirds (n = 79) of the physicians had face-to-face appointments, more than 90% (n = 113) had telephone appointments, and only 14% (n = 17) had video appointments (Supplementary Table S2).
Most (74%, n = 89) physicians considered mHealth-related clinical studies with patient recruitment and assessment via telemedicine viable and were available to participate (83% in secondary care vs. 63% in GP, p = 0.011). However, 62% (55/89) anticipated lower recruiting capacity and 40% (36/89) an increased difficulty in obtaining quality data (Fig. 1); these difficulties were the most frequently anticipated by both GP and secondary care physicians (Supplementary Table S3). Eighteen percent (n = 21) considered these studies unviable and 8% (n = 10) considered them viable but they would be unavailable to participate.
Fig. 1. Physician’s perceived viability and self-reported availability to recruit and assess patients via telemedicine in the context of mHealth clinical studies (A). Panels (B–D) present, respectively, the difficulties anticipated by physicians available to participate in these studies, the reasons for considering them viable but being unavailable to participate and the reasons for considering them unviable. aincreased difficulty in data collection (n = 2), lack of adequate equipment to perform video appointments (n = 1), perceived patient difficulty in the use of digital technologies (n = 1) or study understanding (n = 1), lower access to patients with stable disease (n = 1), and increased difficulty in convincing patients to participate (n = 1) and in supporting study procedures during the visit (n = 1). black of practice performing video appointments (n = 1) and due to department changes related to the COVID-19 pandemic (n = 1). clack of adequate equipment to perform video appointments (n = 2), personal difficulty presenting the study through digital technologies (n = 1) and impossibility of carrying out physical examination (n = 1).
The most frequently perceived barrier was the lack of patient availability (52%, 16/31), but the absence of adequate equipment and difficulties related to obtaining informed consent through digital technologies were also reported by both GP and secondary care physicians (Fig. 1 and Supplementary Table S3).
In a multivariable logistic regression model, physicians aged 40 years or younger and those from a secondary care specialty (vs. GP) were significantly more likely to be available to participate (odds ratio [OR], with 95% confidence interval [95% CI]: 4.25 [1.26–14.28] and 10.66 [2.80–40.51], respectively). The use of apps in personal life or in clinical practice was also associated with higher odds of being available (OR [95% CI]: 4.58 [1.57–13.40] and 7.37 [1.76–30.86], respectively; Table 1).
| UNADJUSTEDa | ADJUSTEDb | |||||
|---|---|---|---|---|---|---|
| OR | 95% CI | p-VALUE | OR | 95% CI | p-VALUE | |
| Physician’s personal characteristics | ||||||
| Sex, female (vs. male) | 1.62 | 0.70–3.73 | 0.256 | NI | ||
| Age, years | 0.98 | 0.95–1.02 | 0.288 | NI | ||
| Age group, ≤40 years (vs. >40 years) | 1.59 | 0.70–3.63 | 0.270 | 4.25 | 1.26–14.28 | 0.019 |
| Specialist (vs. resident) | 0.99 | 0.41–2.36 | 0.973 | NI | ||
| Years of clinical practice | 0.99 | 0.96–1.03 | 0.575 | NI | ||
| Setting, private (vs. public) | 1.33 | 0.14–12.43 | 0.801 | NI | ||
| Secondary care (vs. General practice) | 2.94 | 1.26–6.89 | 0.013 | 10.66 | 2.80–40.51 | 0.001 |
| Medical specialty | NI | |||||
| General practice | Ref. | 0.043 | ||||
| Allergy and immunology | 2.61 | 0.97–7.00 | 0.058 | |||
| Other specialties | 3.53 | 1.07–11.65 | 0.038 | |||
| Country and region | NI | |||||
| North (Portugal) | Ref. | 0.178 | ||||
| Center (Portugal) | 0.99 | 0.37–2.64 | 0.986 | |||
| Other Portuguese regions and Spain | 3.38 | 0.89–12.90 | 0.075 | |||
| Current clinical practice | ||||||
| Total number of patients per week | 1.00 | 0.99–1.02 | 0.607 | NI | ||
| Having face-to-face appointments | 1.57 | 0.68–3.65 | 0.291 | NI | ||
| Average durationc | 1.00 | 0.92–1.09 | 0.995 | NI | ||
| Average number of patients/week | 1.00 | 0.97–1.03 | 0.951 | NI | ||
| Average proportion of patientsd | 1.00 | 0.98–1.01 | 0.575 | NI | ||
| Having telephone appointments | 4.25 | 0.89–20.17 | 0.069 | NI | ||
| Average durationc | 1.03 | 0.95–1.10 | 0.498 | NI | ||
| Average number of patients/week | 0.99 | 0.98–1.01 | 0.335 | NI | ||
| Average proportion of patientsd | 1.00 | 0.99–1.02 | 0.977 | NI | ||
| Having video appointments | 6.58 | 0.83–51.82 | 0.074 | NI | ||
| Average durationc | 34.41 | 0.00 | 0.996 | NI | ||
| Average number of patients/week | 1.02 | 0.89–1.16 | 0.801 | NI | ||
| Average proportion of patientsd | 1.04 | 0.97–1.12 | 0.223 | NI | ||
| Type of appointments (summary)e | NI | |||||
| Only telephone appointments | Ref. | 0.135 | Ref. | 0.280 | ||
| Face-to-face ± telephone appointments | 1.54 | 0.63–3.73 | 0.345 | 1.26 | 0.44–3.55 | 0.669 |
| Video ± face-to-face ± telephone appointments | 8.35 | 0.99–70.77 | 0.052 | 6.66 | 0.65–68.43 | 0.111 |
| Patterns of physician app use/recommendation | ||||||
| App use in personal life | 2.67 | 1.13–6.30 | 0.025 | 4.58 | 1.57–13.40 | 0.005 |
| App use in clinical practice | 2.95 | 0.97–8.98 | 0.056 | 7.37 | 1.76–30.86 | 0.006 |
| App recommendation to patients | 2.87 | 1.24–6.64 | 0.014 | NI | ||
Discussion
To our knowledge, this is the first study showing that up to three-quarters of physicians with at least one previous participation in clinical research involving face-to-face visits consider mHealth-related clinical studies with patient recruitment and assessment via telemedicine technologies feasible and are available to participate. In a challenging period when clinical research has been disrupted, finding solutions to resume suspended studies or to kick off new investigations is of utmost importance. Digital technologies might be a game changer in this context.2,3
In clinical trials there was a 6-fold-increase in the use of remote patient interactions (57% vs. 9% pre-COVID-19) and this change to virtual care is expected to persist after the COVID-19 pandemic.13 Telemedicine clinical visits, remote patient monitoring, online patient recruitment, and eConsent were the interventions that clinical trial investigators selected as the most interesting and that they believed would bring more value to research.13 In fact, in a survey of 25 organizations with ongoing clinical trials in the United States, telemedicine was the most frequently adopted technology during the COVID-19 pandemic and eConsent was perceived as one of the simplest innovations to implement, despite the fact that only less than half of the organizations were already using it.14
Although most of the published data reports to clinical trials, real-life observational studies, predictably, face similar challenges. In a mHealth-related clinical study with virtual patient recruitment and assessment, at least eConsent and telemedicine visits would be needed, and the recent experience related to the fast implementation of digital technologies in clinical research demonstrated that it can be achieved in weeks instead of months or years, as previously thought.13 Nevertheless, in our sample, the lack of adequate equipment to perform video appointments and difficulties related to obtaining informed consent during telemedicine visits were among the most reported barriers to study implementation and participation, and were underlying the perception of lack of study viability and the unavailability to participate.
Even in those physicians that reported being available to participate, some concerns regarding patient recruitment and data quality were raised. In fact, these digital approaches still require rigorous validation and standardization before they can substitute the existing methods.13 Moreover, our findings suggest that additional training, especially targeting remote data collection methods and communication skills through telemedicine, might be needed even for physicians with previous research experience.
In this study, physicians who were available to participate in mHealth-related clinical studies with patient recruitment and assessment via telemedicine were more likely to be ≤40 years of age, from secondary care specialties, and to use apps either in personal life or in clinical practice. Knowledge of the factors that are associated with a greater willingness to participate in these studies might support a more efficient site and investigator selection for clinical research.
A previous study reported that younger health care workers (vs. those with >50 years old) use digital technology more frequently, are more confident and present less anxiety using it, and are more prone to perceive it as useful and to have positive attitudes towards technology.15 The increased availability shown by younger doctors might be related to a higher digital literacy in this age group. Nevertheless, in the multivariable model, the significant association with the age group was present even after adjusting for app use, suggesting that additional aspects might be underlying this relationship. However, we did not collect data to fully assess digital literacy and we cannot exclude it as the major reason for the association with age.
Secondary care physicians have traditionally been more involved in clinical research than GP specialists. A 2018 report from the National Institute for Health Research, in England, found that, out of the 7,840 general practices in England, only 32% were active in research, in contrast with 99% of hospital trusts.16 In our study, all physicians participated in at least one previous clinical study, but we did not assess the overall research experience, which might have influenced their availability. Moreover, most GP physicians were having telephone appointments and only 7% had video appointments. The lack of experience with video appointments may also play a role.
As only physicians collaborating with the INSPIRERS project were invited to participate in this study, most working in Portugal, these results cannot be directly generalized to physicians with different backgrounds. Nevertheless, the inclusion of physicians with previous research experience in mHealth, gives a valuable background that allows the responding physicians to focus more on the technology being assessed (telemedicine) than on other general research difficulties that would be present in a mHealth-related study irrespective of the method that is used to recruit and assess patients.
Another limitation is that this study only explored physician’s opinion. It is also important to explore the patient’s perspective regarding participation in virtual studies to assess mHealth technologies and to evaluate its relationship with digital literacy. In fact, to be successful, all stakeholders in clinical research should be open to and find virtual mHealth studies acceptable.
Most physicians were available to participate in mHealth-related clinical studies with patient recruitment and assessment via telemedicine, despite identifying some barriers. Age group, medical specialty, and app use were associated with the willingness to participate in virtual mHealth studies.
Authorship Confirmation Statement
All persons who meet authorship criteria are listed as authors, and all authors certify that they have participated sufficiently in the work to take public responsibility for the content, including participation in the concept, design, analysis, writing, or revision of the article. A.M.P. wrote the article draft with input from all other authors; C.J. and S.M. were responsible for data collection; A.M.P., R.Al., R.Am., M.A.C., and C.J. performed the analysis and interpretation of data. All authors were involved in the study design and all approved the final version of the article.
Acknowledgments
We thank the physicians of the INSPIRERS group.
Disclosure Statement
No competing financial interests exist.
Funding Information
This work was funded by ERDF (European Regional Development Fund) through the operations: POCI-01-0145-FEDER-029130 (“mINSPIRE—mHealth to measure and improve adherence to medication in chronic obstructive respiratory diseases—generalization and evaluation of gamification, peer support and advanced image processing technologies”) co-funded by the COMPETE2020 (Programa Operacional Competitividade e Internacionalização), Portugal 2020 and by Portuguese Funds through FCT (Fundação para a Ciência e a Tecnologia).
This article was supported by National Funds through FCT—Fundação para a Ciência e a Tecnologia, I.P., within CINTESIS, R&D Unit (reference UIDB/4255/2020).
Supplementary Material
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