Comparison of Teleconsultations and In-Person Consultations from Outpatients with Rheumatoid Arthritis, During the COVID-19 Pandemic: An Internal Audit of Medical Notes

Introduction

Telemedicine can be defined as the provision of health care services and education over a distance through the use of telecommunication technology. It is currently considered a positive experience for patients with rheumatic diseases and their rheumatologists.^1–9 With the COVID-19 pandemic, telemedicine acceptance was confirmed in the rheumatology field,^10–15 and benefits extended to reducing clinic traffic and encouraging social distancing,¹⁶ mediating the patient’s communication with the primary physician,¹⁷ and preventing patients’ outcomes deterioration related to health care interruption.¹⁸

Meanwhile, concerns, such as the lack of physical examination in addressing musculoskeletal problems, the inability to have laboratory tests,^11,12 the technology barriers, and the digital divide, were raised. In addition, evidence for a superior or even equal effectiveness of telemedicine compared with in-person care is weakened owing to relevant methodological biases, wide heterogeneity of interventions, and the limited number of published randomized studies in the field.^19,20

In June 2020, the American College of Rheumatology (ACR) supported telemedicine as a tool with the potential to increase access and improve care for patients with rheumatic diseases in conjunction with periodic in-person assessments.²¹ The ACR highlighted that the standard of care provided remotely through telemedicine should be consistent with related in-person health care services and that the provision of telemedicine should be properly documented.

To date, few studies have addressed these two principles endorsed by the ACR^22,23 and adopted by international guidelines,²⁴ limiting a comprehensive approach to the role of telemedicine in rheumatology. Moreover, potential disagreement of rheumatologists’ treatment decisions based on telemedicine patient-generated data with traditional in-person clinic-based decisions have been raised, particularly in some clinical contexts such as treatment tapering or cessation.^25,26 If confirmed, clinical and ethical implications of telemedicine use might be the potential overtreatment of patients with the disease under control.

With the above considerations in mind, the primary objective was to compare the quality of care (based on medical record abstraction) between in-person consultations (QIP) and telephone consultations (QTP) from rheumatoid arthritis (RA) outpatients during the COVID-19 pandemic. A secondary objective was to compare the compliance with Federal regulations related to medical records, between medical notes documentation derived from in-person consultations (CIP) and telephone consultations (CTP). Finally, the potential association between the consultation modality and the treatment recommendation was analyzed.

Methods

Team of Analysis

Two physicians carried out a retrospective analysis and medical notes abstraction, which corresponded to a rheumatological consultation, performed at the outpatient clinic of the Department of Immunology and Rheumatology (OCDIR) of a tertiary care level center for rheumatic diseases, the Instituto Nacional de Ciencias Médicas y Nutrición Salvador-Zubirán (INCyN-SZ). The two physicians were previously trained regarding study objectives, participated in the elaboration and pilot testing of the abstraction form, and were supervised by two rheumatologists. Abstractors inter- and intraobserver correlations were calculated in 30–50 medical notes and were ≥0.90 after pilot testing.

Abstraction form Development and Pilot Testing

A literature search failed to identify validated tools in Spanish suitable to address the primary objective. The conceptualization of content related to the abstraction form was driven by rheumatologists’ clinical experience in patient care (virtual and in-person consultations) during the COVID-19 pandemic. The form content was proposed by a multidisciplinary committee of two general practitioners, two rheumatologists, and one doctorate in Medical Sciences who agreed on five components and their respective items and scale responses. Subsequently, the form was constructed by one coauthor and independently reviewed and approved by the remaining members of the committee and a rheumatologist not involved in its design (face and content validity).

In brief, component-1 included information about the rheumatic consultation and the underlying RA, and the sociodemographic characteristics. Component-2 (Table 1) included six quality measures locally adapted, five of them endorsed by the ACR^22,27 and consisted of the documentation (or not) of disease activity, of prognosis and functional status, of Disease Modifying Anti-Rheumatic Drug (DMARD) prescription, and prolonged glucocorticoids prescription with a management plan. The documentation of tuberculosis screening performed before the first biologic DMARD initiation^22,27 was not considered owing to its anecdotic representation in the final sample of notes of which data were analyzed (one patient). In addition, the documentation of a change in therapy of disease activity was also considered a quality measure.³

Component-3 evaluated compliance to appropriate medical notes/documentation according to local federal regulations²⁸ and included the underlying diagnosis, current clinical presentation, vital signs (applicable only to in-person consultations), relevant laboratory and imaging results, prognosis, and the treatment recommendations. Component-4 considered the precise documentation of the treatment recommendation (not recorded, no changes in the treatment recommendation, treatment intensification, and treatment reduction), while recording the disease activity status (not recorded, with disease activity, and without disease activity). Finally, component-5 considered the documentation of therapeutic recommendations for potential comorbidities (data will not be presented).

A pilot test was performed in 50 medical notes, randomly selected to test abstraction form performance and abstractors inter- and intraobserver correlations. Minor changes were incorporated into the abstraction form.

Selection and Calculation of the Sample

At first, all the medical consultations to RA patients (in-person or telephone consultations) performed at the OCDIR between July and December 2020 were identified. This period was selected considering the ORCID was re-installed in June 2020 after its complete closure for 3 months. Then, a stratified random sampling strategy was applied (software available at website www.randmization.com) while two stratums of notes were defined, either related to in-person consultations or telephone consultations. In the final sample, quotes were considered to ensure that in-person and telephone consultations-related medical notes distribution was representative of that of consultation modalities to RA patients, in the OCDIR, during the study period (2,161 medical notes were identified and 64% corresponded to in-person consultations).

To achieve the primary objective, we estimated a sample size of 324 medical notes related to the rheumatic assessment of RA patients, assuming that 40% of the in-person-related medical notes will have documentation of disease activity (considered a quality-care criterion²²) versus 25% in telephone consultations-related medical notes, based on the data of Ferucci et al.³ The final number considered a 20% addition for the potential of missed documentation of rheumatic assessments and ORCID-related assessments not intended to the follow-up of the underlying RA.

Statistical Analysis

The quality of care was based on medical record abstraction and scored as the number of criteria met divided by the number of criteria applicable to the patient-related medical note (minimum of four, maximum of six), and was expressed as a percentage (from 0 to 100), where higher numbers are translating into a better quality of the care provided. A similar approach was used to define compliance with Federal regulations related to medical records.²⁷

Descriptive statistics included frequencies and percentages, mean (± standard deviation [SD]) for normally distributed variables, and median (interquartile range [IQR]) for non-normally distributed variables.

The characteristics of the medical notes related to in-person assessments were compared with those related to phone consultations using the χ² test (for the categorical variables), and Student’s t-test and Mann–Whitney U-test (for continuous variables with normal and non-normal distribution, respectively).

Logistic regression analysis was used to investigate the association between the clinical assessment modality (telephone vs. in-person) and the treatment recommendation (dependent variable) while considering the patient´s age, the disease duration, the physician degree, and the disease activity level (Yes/No).

All statistical analyses were performed using the Statistical Package for the Social Sciences version 21.0 (IBM Corp., Armonk, NY). A value of p ≤ 0.05 was considered statistically significant.

Ethics

The Research Ethics Committee of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán approved the study (reference number: IRE-3943).

Results

Characteristics of the Medical Notes, the Underlying Rheumatic Disease, and of the Patients Involved in the Clinical Assessments

A total of 224 medical notes were reviewed. Ten additional medical notes were discarded because they did not correspond to a rheumatologic follow-up assessment. There were 208 (64.2%) medical notes related to in-person consultations and 114 (35.2%) telephone consultations.

Overall, medical notes corresponded to long-standing RA, with 17 years (median, 10–24) of disease duration. Medical notes were related to primarily middle-aged (age, mean ± SD: 56.2 ± 12.8 years) women (n = 284 [87.7%]), with medium-low socioeconomic level (n = 295 [91%]), and (median, IQR) 9 (6–13) years of education.

Comparison of data related to in-person and telephone consultations is summarized in Table 2. Patients assigned to in-person consultations were younger (55 years of age [46–63] vs. 60.5 years [51.3–68.8], p ≤ 0.001) and had shorter disease duration compared with patients assigned to telephone consultations (16.5 years [10–22] vs. 19 years [11–28], p = 0.010). Also, in-person consultations were more frequently performed by a certified rheumatologist (vs. trainees in rheumatology) compared with telephone consultations: 190 (91.3%) versus 93 (80.2%), p = 0.005.

Comparison of QIP and QTP

The (median, IQR) overall notes quality of care was 50% (50–75%). In-person consultations had better quality of care score than telephone consultations: QIP 60% (60–75%) versus QTP 50% (25–60%), p ≤ 0.001.

Differences in the quality of care between in-person and telephone consultations were related to disease activity and prognosis documentation and the prolonged prescription of glucocorticoids with a documented management plan, as summarized in Table 3. Of note, the overall quality of care of the medical notes was similar between certified rheumatologists and trainees in rheumatology: 50 (50–75) versus 60 (50–77.5), p = 0.180. In addition, an association between being a trainee in rheumatology and the quality of the medical note was discarded (odds ratio [OR]: 5.195, 95% confidence interval [CI]: 1.46–11.852, p = 0.126).

Comparison of CIP and CTP

Overall, compliance with Federal regulations related to medical charts was 83% (80–83%), without differences between in-person consultations (83% [83–100%]) and telephone consultations (vs. 80% [80–80%], p = 0.15). The documentation of the underlying diagnosis, current clinical presentation, and relevant laboratory and imaging results were very good (93.8% to 99.4%), and of ≥1 vital sign and the treatment recommendation (complete or partial) were good (72.1% and 88.8%, respectively). In comparison, documentation of the prognosis was poor (47.8%) (Table 3). Compliance content was similar between in-person consultations and telephone consultations but for the documentation of the disease-related prognosis, as summarized in Table 4.

Association Between the Consultation Modality and the Treatment Recommendation

There were 209 (65.5%) medical notes where disease activity was recorded, 142 (67.9%) without disease activity, and 67 (37.1%) had disease activity. Telephone consultation was the only significant risk factor for no changes in the treatment recommendation (OR: 2.113, 95% CI: 1.284–3.479, p = 0.003).

Analysis was repeated in 142 clinical notes, which documented the absence of disease activity, and the results were consistent. Having a telephone consultation was a significant risk factor for no changes in the treatment recommendation (OR: 6.646, 95% CI: 1.398–31.606, p = 0.017), whereas it was protective for a reduction in the treatment recommendation (OR: 0.111, 95% CI: 0.014–0.895, p = 0.039). Meanwhile, the telephone consultation modality was neither associated with changes in the treatment recommendation (OR: 0.876, 95% CI: 0.191–4.012, p = 0.864), nor to increased treatment recommendation (OR: 1.194, 95% CI: 0.299–4.757, p = 0.802), in the clinical notes with disease activity documented.

Discussion

This study is the first audit on differences between the quality of care, the compliance with local regulations related to medical records documentation, and the treatment indication, between in-person consultations and telephone consultations, in the clinical context of RA outpatient’s follow-up, during the COVID-19 pandemic. Clinical audits enable an accurate, direct, and quantitative analysis of patient care data and are valuable tools for improving performance in implementing guidelines-recommended procedures, assessing the quality of clinical care, and maintaining high-quality professional performance.^29–31

First, we observed that in-person consultations had a better quality of care than telephone consultations, related to disease activity and prognosis documentation and the prolonged prescription of glucocorticoids with a documented management plan. Our primary objective focused on clinical quality measures developed by the ACR using a multifaceted approach.^22,27 Selected measures covered disease activity, functional status, and treatment, and as patient’s safety-quality measure we considered the prolonged glucocorticoids prescription with a management plan.²² Clinical records are the primary source of written evidence of the care provided to patients and the best source to evaluate the quality and appropriateness of clinical care.^32,33 In addition, the evaluation of how professionals record information is highly recommended by health care organizations.^34–36

Our results align with previous publications where telerheumatology does not achieve a standard of care similar to in-person consultations,³⁷ in great part explained by the lack of physical examination.^9,24,37,38 Mair et al.³⁹ compared electronic health records from rheumatic patients in follow-up appointments through telephone, in 4 weeks during the COVID-19 alert Level-4 lockdown, and a similar 4-week period in 2019. Although the characteristics of the patients were similar, there were differences in patient assessment outcomes and interventions; for telemedicine visits only 12.7% of patients were deemed to have active disease compared with 21% for in-person visits. Ferucci et al.³ compared telemedicine incorporated or not to usual follow-up care for patients with RA to in-person only care.

The only quality measure that differed between groups was the proportion of visits in which disease activity was documented, but did not remain associated at the multivariate analysis.

Second, in-person and telephone consultations had similar compliance with Federal regulations related to medical charts. Delivering optimal-quality patient care depends on the accurate, reliable, and timely flow of information, and patient records provide an essential reference for care providers’ decision-making. In addition, most health care systems have a legal requirement to document all patient-relevant information and decisions.⁴⁰

Our results show a positive although a heterogeneous picture of the quality of the documentation. In-person and telephone consultations had similar compliance with Federal regulations related to medical charts, although the disease-related prognosis was more frequently documented during in-person consultations. Overall, documentation of the prognosis was poor (<50% of the medical notes), particularly when compared with the criteria left, which were documented in ≥72% of the medical notes.

Previous studies have shown that physicians accurately document primary diagnosis, similar to ours.⁴¹ Meanwhile, prognosis must be challenging to define in the context of RA, a long-standing disease frequently complicated with comorbidities. In the general population, demographic characteristics, societal factors, and living conditions determine to some degree the risk of disease, disability, and quality of life; these factors also apply to people with RA, in addition to more specific disease-related factors such as disease activity level,⁴² and might be more frequently suspected or perceived during in-person consultations.

Our results confirm that the relevance of documentation in clinical practice might still not be fully appreciated.²⁹ Even more, the switch from paper-based to complete electronic documents does not necessarily imply higher quality in all aspects of medication documentation, but rather reveal new challenges.⁴³

Third, we observed that telephone consultation was a significant risk factor for no changes in the treatment recommendation, particularly in the absence of disease activity; in this clinical context, it was also found to be protective for a reduction in the treatment recommendation.

Similar results had been reported.^39,44 A retrospective study compared the electronic records of two groups of New Zealander patients with diverse rheumatic diseases. The first group corresponded to telephone appointments (n = 340) during 4 weeks from March to April 2020, and the second group, attended in-person appointments (n = 210) from March to April 2019. Changes in DMARDs and other treatments were considered significant outcomes. For patients deemed to have active disease, a lower proportion had DMARD changes or any form of intervention during telemedicine visits. We could not confirm these results in our “active patients,” which might be related to more explicit guidelines for intensifying pharmacological treatment when active inflammatory arthritis is documented⁴⁵ and physicians’ awareness of subclinical disease activity.

Kulcsar et al.⁴⁴ reported the challenges and accomplishments of an early telemedicine program from Lebanon through a retrospective review of patients’ charts between October 2011 and January 2013. Authors found that patients went without aggressive therapy for inflammatory arthritis for longer than the recommended 6 weeks according to the current guidelines, which was suggested to be related to the lack of musculoskeletal training for the presenter and the inability to perform a physical examination. Thus, it seems that telephone consultation might not provide sufficient clinical information about disease activity to give rheumatologists the confidence to make changes in the treatment. In this regard, a survey of 75 rheumatologists identified that the vast majority (64%) reported both under and overtreatment fear.³⁸

The clinical and ethical implications of the overtreatment suggested by our results are related to the consequent imbalance between disease activity control and the potential adverse effects related to the treatment. This imbalance might be relevant as RA patients with low-disease activity accept remote monitoring by telephone or an app.⁴⁶ However, recent studies also suggest that telehealth services could positively impact disease activity, medication adherence, physical activity, and self-efficacy levels in patients with RA provided these interventions are well-designed, versatile, and adaptive.^24,47

The study has some limitations. First, it is a single-center retrospective study that limits the external results’ validity. Second, as for all studies that include patient-reported variables, responder bias is possible. Third, results are reported based on medical notes documentation, whereas rates of missing data varied depending on the variable analyzed. However, there is evidence that even with critical components missing by humans, automated chart review, which is desirable for quality assessment, is impractical and demands clarity and precision that often prove too costly in time and money in open systems such as health care to supply.²³ Finally, we did not use a retrospective chart review instrument specifically designed to assess the quality of the medication documentation.²⁹

Conclusions

This study identified that in the clinical context of RA patients’ follow-up during the COVID-19 pandemic, the quality of care provided by telephone consultations was below the standard of care related to in-person consultations and impacted the treatment decision. The study complements the current knowledge of the topic and helps delineate RA patients’ characteristics and clinical statuses as more suitable to benefit from telemedicine. It also confirms rheumatologists’ fears of potential patient overtreatment with telemedicine. The study design, a clinical audit of patient-care data, is unique to address the topic and can be implemented in clinical settings at reasonable costs. Finally, this study contributes to delineating how rheumatologists and health care organizations should adopt and integrate telerheumatology into their existing practice.

Authors’ Contributions

Conceptualization and Visualization: G.A.G.-B, I.C.Y., G.H.-M., V.P.-R; Data curation: G.A.G.-B, V.A.E.-G, S.S.V.-H; Formal analysis: G.A.G.-B, I.C.Y., V.P.-R.; Investigation: G.A.G.-B, I.C.Y., G.H.-M, V.P.-R.; Methodology: G.A.G.-B., I.C.Y., G.H.-M., V.P.-R.; Software: I.C.Y.; Supervision: G.A.G.-B., I.C.Y., V.P.-R.; Validation: G.A.G.-B., I.C.Y., G.H.-M., V.P.-R.; Writing original daft: V.P.-R.; Writing—review and editing: G.A.G.-B, I.C.Y., V.A.E.-G., S.S.V.-H., G.H.-M., V.P.-R. All authors contributed equally to this work.

Disclosure Statement

No competing financial interests exist.

Funding Information

No funding was received for this article.