2025 Volume 7 Issue 3 Pages 80-89
BACKGROUND
This study aimed to compare telephone follow-ups for patients with urologic malignancies in Japan before and during the COVID-19 pandemic.
METHODS
Using the database of the Japan Medical Data Center Co., Ltd., we identified patients with urologic malignancies who underwent at least one telephone follow-up between April 2014 and March 2020.
The self-controlled case series method was used to calculate the incidence rate ratio of telephone follow-up utilization for the pandemic using the pre-pandemic period as a reference.
RESULTS
Of the 289 patients, 31 were women. Their median age was 80 years, and the median observation period was 28 months.
The incidence rate ratio for telephone follow-up utilization during the pandemic was 17.8 compared to that of the pre-pandemic period. In an analysis stratified by type of carcinoma, the incidence rate ratios were higher in all strata than they were before the pandemic. However, among male patients with genital malignancies, particularly prostate cancers, the incidence rate ratio was lower than in other strata.
According to analysis stratified by age, the usage of telephone follow-up for men in their 50s or younger was particularly low. Additionally, the interval between face-to-face visits increased in patients over 60 years-of-age.
CONCLUSIONS
The telephone follow-up among patients with urologic malignancies in Japan increased significantly during the early phase of the COVID-19 pandemic. Our results indicate that telephone follow-up can potentially be a valuable patient-doctor communication tool.
The global outbreak of COVID-19 forced medical institutions to reduce visits for non-urgent conditions and postpone hospitalization and surgery to control the risk of infection. To deal with these difficulties, telemedicine has become an essential tool to continue providing medical care to patients without increasing this risk, and its usage and insurance systems are under review in many countries1,2).
Many cities in Western countries enacted lockdown policies early in the pandemic, making it difficult for most departments, including urology, to perform regular outpatient face-to-face consultations. An Italian report noted that 45% of urology outpatients canceled their appointments during the pandemic. Face-to-face consultations decreased from 63% to 9% over the pandemic for those who could be attend in person3).
Although consultation opportunities for the follow-up of malignancies are necessary, significant interruptions in outpatient consultations, drug therapy, and surgical treatment were experienced in many countries4). Therefore considering which patients with malignancies at risk of infection are good candidates for telemedicine is essential.
Boehm et al. examined the eligibility of urologic patients for telemedicine and the risk factors for COVID-19. They reported that patients with urologic malignancies possessed significantly more risk factors for COVID-19 and were more likely to be eligible for telemedicine than were patients with non-neoplastic diseases5). In the field of urological malignancies in Japan, reports regarding long-term clinical outcomes using telemedicine are lacking. However, certain patients such as those with testicular cancer with a good prognosis or with low-risk prostate cancer exhibit a low risk of rapid progression or recurrence but require long-term follow-up and may be good candidates for telemedicine, including telephone follow-ups that have been used in Japan as doctor-to-patient telemedicine.
In Japan, the Medical Practitioners Law prohibits medical treatment without consultation and telemedicine, including telephone follow-up that was not widely used before the 1990s as it was not considered a form of medical consultation6).
However, the Japanese Cabinet and Ministry of Health and Welfare announced a policy to promote the informatization of the medical field, including the development of medical technology. In 1997, remote medical examinations were clearly stated to be legal. However, the policy was restrictive, stating that initial consultations and acute illnesses should be treated in-person and that telemedicine should be used in cases in which hospital visits are difficult such as on remote islands or in isolated areas.
In 2003, seven diseases were listed as examples of those for which telemedicine was indicated; however, the notice could be interpreted that telemedicine was only for these diseases. While the practice of telemedicine was legal, it was unlikely to be used in the field.
The 2011 revised notice indicated no restrictions on target areas or indications for telemedicine if properly practiced. Thereafter, deregulation has been implemented step-by-step. However, the problem with telemedicine in Japan, including telephone follow-up, is the lack of evidence in regular medical practice.
The telemedicine services fee remains unclear and has been calculated as a telephone follow-up fee. In 2018, a new “online medical fee” was established. This fee can be calculated if a device that enables real-time communication is used to treat patients with specific conditions. This new medical fee was clearly separated from the previously established telephone follow-up fee. Although the number of monthly calculations is limited, unlike telephone follow-up, prescriptions can be provided in online medical care.
In April 2020 in response to the COVID-19 pandemic, special measures were established to implement online medical care, and telephone follow-up was notably deregulated. This allowed for telemedicine use from the first visit and the prescription of medication over the phone2).
This study aimed to clarify the use of telephone follow-up for patients with urological malignancies in Japan before and during the COVID-19 pandemic. Additionally, it will help medical institutions to envision telemedicine user trends as telemedicine expands in Japan.
This is a retrospective study using the medical institution claims database collected by the Japan Medical Data Center Co., Ltd. (JMDC, Tokyo, Japan). The JMDC database is a reliable source of information that has been used widely by more than 50 universities, government agencies, pharmaceutical and medical device manufacturers, and life insurance companies in Japan7).
JMDC possesses several databases, and of these, we used the Hospital Database that contracted Japanese medical institutions from April 2014. Data were collected from approximately 270 hospitals (approximately 3% of the total number in the country) throughout Japan for approximately 10 million inpatients and outpatients. These data can be collected regardless of patient insurance status and covers all age patients, even those over 75 years-of-age.
As this study was based on routine surveillance without involving the confidentiality of individual patients whose data were anonymized, ethical review was unnecessary. However, to ensure the scientific nature of the research, this study was approved by the Institutional Review Board of Sapporo Medical University (No. 5-1-68).
PATIENTSThe types of telemedicine are presented in Fig. 16). Here, we collected data through telephone follow-up. Given the deregulation in April 2020, telephone follow-up provided medical instructions based on a medical interview, and medication could not prescribed.
The International Statistical Classification of Disease and Related Health Problems, 10th Revision classification, was appended to each malignancy disease name.
Male patients with genital organ malignancies and renal–urinary tract malignancies were extracted from the database for the time period from April 2014 through November 2020. Diagnoses for medical claims were coded according to the International Statistical Classification of Disease and Related Health Problems, 10th Revision (male genital organ malignancies C60–C63 and renal-urinary tract malignancies C64–C68). Furthermore, patients with at least one telephone follow-up visit were extracted among these subjects using Japanese medical fee (A001) and medical practice codes (112007950, 112008850, 112023350, 112023450, 112015950, and 112023550).
Fig. 2 presents a flow chart of this study. Patients whose observation began after April 2020 or whose age information was lacking were excluded from the analysis. Patients in their 90s were also excluded, as their detailed age information was lacking. Data were also excluded when malignant diseases were marked as “suspected”.
All p-values <0.001
To extract data regarding telephone follow-up visits for malignancies, each patient was matched to the malignant disease and the department that ordered the telephone follow-up. Telephone follow-ups indicated by completely unrelated departments were excluded from the primary analysis.
ACCURACY OF DISEASE CODES AND TREATMENT DETAILSTo avoid data duplication, tumor metastasis was excluded, and only the primary disease was examined. The data were sorted according to medical practice code, and 409 telephone follow-ups were performed for 289 patients.
From the drug data, antineoplastic drugs were extracted by European Pharmaceutical Market Research Association Anatomical Therapeutic Chemical codes and matched with the data of malignant disease names for each patient. Similarly, surgery for malignant tumors was assessed from the surgical and hospitalization data and compared to the malignant disease name data for each patient.
STATISTICAL ANALYSISThe relationships between risk period, control period, and event occurrence are presented in Fig. 3. The control period of observation for each individual was defined as the period from April 2014 through March 2020. In Japan, the reimbursement system reflected special measures for online medical care, including telephone follow-up, starting April 1, 2020. Therefore, the risk period in this study was defined as that from April through November 2020. The self-controlled case series method was used to calculate the incidence rate ratio (IRR) for the risk period using the control period as a reference.
The self-controlled case series method is a conditional Poisson regression that compares the IRR of the control period and risk period outcomes for exposure within individuals8,9). The study design is established by conditioning the number of events observed for each individual in the cohort during the observation period from a retrospective Poisson cohort model.
In such a model, if no relationship exists between exposure and an event, the incidence rates are estimated to be equal for the entire segmental period. If a positive relationship exists between exposure and an event, the incidence rate for a particular post-exposure period can be estimated to be higher than that for the baseline period. Regressions are used to estimate the occurrence of events by period.
In addition to the data regarding telephone follow-ups for malignant tumors, sensitivity analyses were conducted for 1) all telephone follow-ups, 2) data censored at the first hospitalization, and 3) data excluding the hospitalization period from the all-observation period.
Subgroup analyses were performed to calculate risks according to disease and sex and by age group and sex. As the observation period was short (a maximum of 6 years), the analysis used four age groups as time-invariant covariates, including those in their 50s or younger and those in their 60s, 70s, and over 80.
Additionally, we investigated changes in the intervals between visits. Records of face-to-face consultations for malignancies were extracted from the medical practice data by matching the name of the practice, the disease, and the name of the department the patient visited. Hospitalization data were excluded.
The analysis excluded patients with double-cancer and metastatic diseases.
The mean interval between visits in days was calculated for the control and risk period of each patient, and a corresponding t-test was performed. The proportion of patients who repeatedly used telephone follow-up was also examined. Statistical analysis was performed using R (version 4.0.5 for Mac).
Table 1 indicates patient characteristics. This cohort includes patients with at least one telephone follow-up. A total of 289 patients were included in the analysis. Of these, 31 (10.7%) were female. The median age was 80 years (72–84, IQR, same as below). Overall, no difference was observed in the age distribution between male and female patients (median ages 80 72–84) and 78 75–84), respectively). The median observation period was 28 months (17–80), and no patients were excluded due to a short observation period.
| Total No. pts | 289 | |
| Gender (%) | ||
| Female | 31 | (10.7) |
| Male | 258 | (89.3) |
| Median age (IQR) | ||
| All pts | 80 | (72–84) |
| Female | 78 | (75–84) |
| Male | 80 | (72–84) |
| Median observation months (IQR) | 28 | (17–80) |
| No. pts with malignancy (Including double cancer): | ||
| Male genital organs (C60–C63): | 175 | |
| Prostate | 166 | |
| Testis | 9 | |
| Urinary tract (C64–C68): | 133 | |
| Kidney | 33 | |
| Renal pelvis | 8 | |
| Ureter | 9 | |
| Bladder | 83 | |
| No. pts with double or more cancer (%) | 59 | (20.4) |
ICD-10 classification was appended to each malignancy disease name.
Overall, 19 different malignant diseases were observed. Fifty nine (20.4%) patients experienced two or more malignant diseases simultaneously.
The supplementary table presents detailed information regarding anti-cancer drugs in this cohort. Regarding the matching of drug therapy and surgical treatment results with the disease names, two patients were observed to have used drugs that were not indicated for their disease. One patient with prostate cancer was determined to have undergone transurethral resection of the bladder tumor and to have used bacille Calmette-Guerin, the standard treatment for non-muscle invasive bladder cancer. The latter patient also received medication for prostate cancer and was defined in the data analysis as a patient with overlapping prostate and bladder cancers.
PRIMARY ANALYSISThe results of the primary analysis are presented in Table 2. The IRR point estimate for telephone follow-up during the COVID-19 pandemic increased to 17.83 compared to that of the pre-pandemic level. The IRRs of all sensitivity analyses were lower than the primary analysis results, but they were still greater than 10.
| Number of the event | IRR | 95%CI | |
|---|---|---|---|
| All telephone follow-up | 296 | 17.83 | 13.5–23.54 |
| Only Malignancy | 225 | 13.32 | 9.87–17.97 |
| Exclude the hospitalization term | 246 | 11.98 | 8.92–16.1 |
| Censored by the first hospitalization | 222 | 12.9 | 9.55–17.43 |
All p value <0.001
Table 3-A presents the use of telephone follow-up stratified by the type of carcinoma and sex. Patients with multiple cancers were excluded from this analysis. Male patients with genital malignancies were not stratified by sex.
| Num. of the event | IRR | 95%CI | ||
|---|---|---|---|---|
| A. Disease | ||||
| Male genital organs | 152 | 9.56 | 6.75–13.55 | |
| Prostate Ca | 132 | 15.54 | 10.37–23.27 | |
| Urinary tract | ||||
| All | 73 | 34.95 | 17.11–71.40 | |
| Male | 56 | 24.74 | 12.84–47.65 | |
| Female | 17 | 90.10 | 11.57–701.5 | |
| B. Age | ||||
| Under 50s (Only Male Pts) | 22 | 1.19 | 0.44–3.25 | |
| 60s | ||||
| All | 33 | 13.19 | 6.10–28.53 | |
| Male | 30 | 11.11 | 5.04–24.52 | |
| 70s | ||||
| All | 72 | 10.83 | 6.51–18.01 | |
| Male | 70 | 11.06 | 6.59–18.55 | |
| 80s | ||||
| All | 98 | 35.25 | 19.73–62.98 | |
| Male | 88 | 26.47 | 15.16–46.22 |
A: Analysis stratified by disease type and gender
B: Analysis stratified by age and gender
In all strata, point estimation of telephone follow-up utilization was higher than it was before the COVID-19 pandemic. Among male patients with genital malignancies, telephone follow-up was less than ten-fold higher than it was before the pandemic, and the use rate was lower than that in the other strata.
Telephone follow-up utilization stratified by age and gender is presented in Table 3-B. Female patients were not analyzed as strata due to the small number of cases. Men in their 50s or younger exhibited a particularly low IRR of 1.19 for the risk period. In all age groups, the utilization of telephone follow-up increased during the pandemic, but the number of uses and IRR were lower for men in their 50s or younger than they were for the other age groups.
FACE-TO-FACE CONSULTATION INTERVALSOf all patients, there were 219 who underwent face-to-face consultations for malignancy and 143 for whom data for both the control and risk periods were available. Table 4 indicates changes in the intervals between visits according to disease, age, and sex. The mean intervals between face-to-face visits increased in all groups but were not statistically significant in the female and young male groups. The longest period was observed for males in their 80s (48.4 days), and the shortest was observed for females (8.8 days). By disease, the interval between consultations was extended by approximately 40 days in all age groups.
| n | Change in Interval (mean) | 95%CI | |
|---|---|---|---|
| All Pts | 143 | 44.2 | 28.22–60.10 |
| Disease | |||
| Male genital organs (C60–C63) | 92 | 45.7 | 24.13–67.18 |
| Prostate Ca | 87 | 47.5 | 24.81–70.23 |
| Urinary tract (C64–C68) | 51 | 41.5 | 18.40–64.56 |
| Sex | |||
| Male | 133 | 46.8 | 29.80–63.84 |
| Female | 10 | 8.8 | −12.27–29.94 |
| Under 50s (Only Male Pts) | 7 | 44.4 | −37.14–125.9 |
| 60s | 19 | 20.2 | 4.64–35.86 |
| 70s | 51 | 47.6 | 24.15–71.09 |
| 80s | 66 | 48.4 | 19.53–77.19 |
Of the seven male patients in their 50s or younger, 4 possessed testicular tumors. Patients with testicular tumors exhibited long intervals of 140–190 days between visits before the COVID-19 pandemic, and there was little change in the interval between visits during the pandemic.
REPEAT UTILIZATION OF TELEPHONE FOLLOW-UPIn total, 195 patients (67.5%) used telephone follow-up for the first and only time during the risk period. During the risk period, 58 patients (20%) underwent repeated telephone follow-ups. Throughout the observation period, 55 patients used the telephone re-consultation service twice, 10 used it three times, and 12 used it four or more times. Only 10 patients used telephone follow-ups during both the control and risk periods.
In Japan, telephone follow-up has been used as a form of telemedicine and is combined with face-to-face consultations. The insurance reimbursement system in Japan was updated on April 1, 2020 to allow for initial online consultation, including telephone follow-up, instead of regular face-to-face consultation. This policy promoted expanding online medical consultation in Japan during the pandemic. However, unlike in Western countries, Japan did not adopt a rigorous city lockdown policy and instead only requested individuals to refrain from various activities at their own discretion. Therefore, the state of use and diffusion of telemedicine could be significantly lower than that in other countries. In this study, we compared the use of telephone follow-up by Japanese patients with urologic malignancies before and during the pandemic.
The point estimates of telephone follow-up use for the study population during the pandemic were mostly 12- to 17-fold higher than they were before the pandemic. Point estimates of telephone follow-up use increased for all cancer types compared to pre-pandemic levels. The U.S. Centers for Medicare & Medicaid Services reported that the number of Medicare-eligible individuals who used telemedicine in the year just before the COVID-19 pandemic was approximately 910,000. However, since March 2020 after privacy regulations in telemedicine were relaxed, the number jumped to more than 28.25 million, representing a 31-fold increase10). The target population of our study was patients with urological malignancies. Due to the difference in the patient population, we consider that the IRR for telephone follow-up in this study was lower than the IRR reported by the U.S. Centers for Medicare & Medicaid Services that includes patients without malignant tumors.
In this study, the usage of telephone follow-up during the pandemic compared to that before the pandemic was 15.5-fold higher for patients with prostate cancer. However, this rate was lower than for patients with other urological malignancies.
Unlike that for other urological malignancies, the benefit of telemedicine for prostate cancer was reported before the COVID-19 pandemic, with generally favorable results for quality of care and patient satisfaction11). In the Report from the Advanced Prostate Cancer Consensus Conference 2021, 94% of panelists recommended telemedicine for patients with advanced prostate cancer during the active phase of the pandemic. Additionally, 86% of the experts also recommended some form of telemedicine use outside the pandemic phase12). Male patients with genital malignancies in our study tended to exhibit low utilization of telephone follow-up during the pandemic, a different status from that expected based on these previous reports, suggesting the need for improvement in the efficacy and utilization of telemedicine.
Prostate cancer patients require a routine prostate specific antigen checkup by blood sampling, and in many medical facilities the results for blood specimens are available on the same day. We speculate that telephone follow-ups remained the same based on the observation that regular face-to-face consultations were conducted after the blood draws instead of subsequent telephone follow-ups. Telemedicine is expected to reduce contact between patients and medical providers during pandemics, with only blood sampling or imaging tests performed at the medical institution and the results explained via telephone follow-up. Long-term follow-up is necessary to determine the impact of reduced face-to-face visits on the oncologic prognosis.
For the patients, there was no linear correlation between age and utilization. That our study population was affected by certain malignancies and the cohort was predominantly elderly may be important factors. The pandemic IRR was 1.19 compared to the pre-pandemic IRR for men in their 50s or younger, and this was lower than that of the other groups divided by gender and age. Additionally, the average post-pandemic visit interval extension of these patients was shorter than the overall average. These results included patients with stable testicular tumors and patients whose original intervals between visits were six months or more. For these patients, the COVID-19 pandemic was unlikely to be associated with a change in visit behavior.
Ito et al. conducted a literature search in Japanese and English focused on the use of telemedicine in Japan before the COVID-19 pandemic13). They reported that more than 50% of the studies on telemedicine in Japan were related to prevention and early diagnosis. Additionally, many studies involved doctor-to-doctor consultations. They also reported that telemedicine deals with various fields; however, none of the literature included urology. Many reports from outside metropolitan areas such as Tokyo indicate a foundation for community-based telemedicine in each region.
While the usefulness of telemedicine has been reported in several cases, potential hurdles such as software glitches, lack of video-capable equipment or a high-speed internet connection, and individual technological ability exist14). Additionally, reports from the United States indicate that in rural areas, the elderly, ethnic and racial minorities, individuals of low socioeconomic status, and people with low health literacy and low English proficiency are more susceptible to technological barriers15,16). A recent study in Japan demonstrated that telemedicine utilization was higher among younger persons in the early phase of the pandemic. However, as the pandemic continued, utilization significantly increased among older adults. They also suggested a widening gap in the usage of telemedicine during the pandemic in terms of educational attainment and area of residence, but no disparity in income levels was observed17).
LIMITATIONSAddress information was not included in the JMDC database, making the discussion of the urban nature of the residences of the users difficult as it was a database study. Japan possesses many remote islands and mountainous forest areas where access to medical resources is difficult. In such locations, the demand and need for telemedicine are likely higher than they are in urban areas, and working to increase awareness of this service is necessary.
As this was a database study, ascertaining the behavior of the patients when they visited medical institutions that were not registered in the JMDC database was not possible. Although some analogies can be drawn from the name of the disease and medical practice code for the treatment of each individual, accurately identifying the pathology results and treatment details for each patient was difficult. Additionally, the subjects were patients with cancer and may not match the need for telephone follow-ups for other diseases, thus limiting the generalizability of the study. However, the number of patients with continuous repeated use from the control period was small, and the cohort included many patients who first used telephone follow-up due to the COVID-19 pandemic. Based on this, we believe no critical selection bias where the patient population was initially prone to choose telephone follow-up.
Patients who did not use telephone follow-ups were excluded, and comparisons were not made using other statistical methods such as multivariate logistic regression. Assuming a multivariate regression analysis in this study would limit the ability to align patient backgrounds before and during the COVID-19 pandemic and complicate the selection of explanatory variables, the self-controlled case series method has been widely used, particularly for adverse drug and vaccine events. Using this method, we compared risk and control periods for each individual, thus eliminating the need to match patient backgrounds or provide a control group. In this study, adapting this method to the change in telephone follow-up during the COVID-19 pandemic phase is a novel approach.
Also, the observable risk period was less than one year, and changes in telephone follow-ups may be observed over more extended periods. However, from the perspective of understanding the current situation in Japan in the early stages of the pandemic, a risk period of eight months is long enough.
In our study, the usage of telephone follow-ups markedly increased in Japan in the early phase of the COVID-19 pandemic. Our results indicate that telemedicine, including telephone follow-up, is a valuable communication tool for both patients and doctors, with great potential for future pandemic phases.
The authors declare no conflicts of interest in relation to the work presented in this manuscript.
Keiko Fujino: Participated in the writing of the paper and data analysis.
Naoya Masumori: Participated in writing the paper and supervision.
Shiro Hinotsu: Participated in writing the paper, data analysis, and supervision.
