The effectiveness of the Orla INR Remote Monitoring service was assessed in a first Digi-HTA assessment in 2022, and the evaluation material gathered at that time will also be taken into account in this assessment.
The benefits to be achieved through the product
The Orla INR Remote Monitoring service enables the patient to conduct self-measurement and self-care. Health care professionals can shift the responsibility for measurement and treatment to the patient while retaining a full picture of the patient’s measurement results and medication decisions. The purpose of the service is to improve the patient’s management of their anticoagulation treatment. The treatment is considered to be in balance when the time in therapeutic range (TTR) is over 80%. [1]
The service can be used in two ways:
- Self-measurement: Patients measure their own INR value, on the basis of which future dosage of medication is determined by the responsible professionals. The patient can view the dosage instructions in the mobile app. 2. Self-care: Patients measure their own INR value and determine their own dosage of medication. Health care personnel can observe the values and doses of medication (= remote monitoring).
Research evidence relating to the product under evaluation
The aim of the Oulunkaari INR remote monitoring project was to improve the INR balance of patients receiving warfarin treatment and to evaluate the effectiveness of remote monitoring in primary health care. During the course of the project (1 May 2022 – 31 May 2023), 45 patients implemented a self-measurement regimen, measuring their INR values autonomously. A nurse determined the dosage and the next follow-up appointment. Seven patients implemented a self-care regimen by independently measuring the INR value and determining their own medication dosage. The nurse offered support if needed. All of the patients lived independently, and their age ranged from 37 to 92 years. [1]
There were a total of 12 INR nurses using the Orla INR Remote Monitoring service, six of whom responded to the feedback questionnaire. In the spring 2023 feedback survey, the professionals’ recommendation index (NPS, Net Promoter Score) was +60. Respondents estimated that working hours spent on treating INR patients decreased by one half when patients were switched to remote monitoring. [1]
In the patient feedback questionnaire, the NPS was +86. The questionnaire was sent to 50 patients, 41 of whom responded. Patients and their relatives were very complimentary of the savings in money and time achieved through self-monitoring and self-care. During the project, the treatment balance, i.e. TTR, of the patients improved overall. Prior to remote monitoring, patients had a median TTR of 71.7%, and at the end of the project the median TTR was 82%. [1]
The service provider has carried out real-time monitoring of 58 patients in five different localities. Based on these results, the time in therapeutic range (TTR) was 70.71% before prior to the remote monitoring period and 75.72% towards the end of the remote monitoring period (the difference is not statistically significant). Prior to remote monitoring, 13 of the patients were at the target TTR level of > 80%, at the end of the period there were 29 patients at target level (difference statistically significant). [1]
The results demonstrate that for some patients remote monitoring is suitable and their treatment balance improves, but on the other hand, there are patients for whom it is not appropriate and causes their treatment balance to deteriorate. According to the satisfaction questionnaire issued by the service provider, both patients and organisations have been satisfied with the service. [1]
Literature reviews
Systematic reviews of the subject have been published, indicating that self-measurement and self-care are at least as good as ordinary care [2,3,4,5].
Dhippayom et al. (2024) published a systematic overview and a network meta-analysis comparing the four warfarin treatment modalities: standard care, anticoagulation management services, patient self-measurement and patient self-care. A total of 28 randomised controlled trials (RCT) encompassing a total of 8,100 patients treated with warfarin were included in the review.
No statistically significant differences in overall mortality, incidence of major bleeding, strokes, or TIA seizures, or hospitalisation rates were observed between treatment modalities. The only treatment type that indicated a statistically significant reduction in relative risk (RR) of thromboembolic events was self-care. Compared to anticoagulation management services, the risk was reduced (RR = 0.42; 95% CI [0.18-0.99]), but the certainty of the evidence was low. Compared to standard treatment, the risk was similarly reduced (RR = 0.41; 95% CI [0.24-0.71]) with a moderate certainty of evidence. This effect was observed especially in studies with a follow-up of more than 12 months (RR = 0.41; 95% CI [0.23-0.72]) and in patients who had just started warfarin treatment (RR = 0.42; 95% CI [0.22-0.81]).
The study also looked at the effects of treatment modalities on INR balance and found that self-care improved TTR by 7.39% on an average 95% CI [2.39-12.39] and self-measurement by 7.85% on an average 95% CI [1.82-13.88], as compared to standard treatment. However, the certainty of evidence in both of the above cases was assessed to be very low. [2]
The Cochrane review looked at self-measurement and self-care as a unit. RR for thromboembolic events decreased compared to standard therapy (RR = 0.58; 95% CI [0.45-0.74]), but there were no differences in risk of major bleeding (RR = 0.95; 95% CI [0.80-1.12]) or mortality (RR = 0.85; 95% CI [0.71-1.01]). When considering self-care only, the risk decreased for thromboembolic events (RR = 0.47; 95% CI [0.31-0.70]) and mortality (RR = 0.55; 95% CI [0.36-0.84]), but there was no difference with regard to major bleeding. When considering self-measurement only, the risk of thromboembolic events (RR = 0.69; 95% CI [0.49-0.97]) decreased, but such a decrease was not observed for major bleeding or mortality. 16 studies reported INR values at the target level (tests in range). In 15 of these, results improved in the self-measurement or self-care groups. It should be noted that the quality of the evidence was not very good in any of the studies included. [3]
With regard to all studies, it should be taken into account that self-measurement and self-care patients have taken INR measurements more often than those in ordinary care. In the studies, the interval has typically been 1 week and in real-time studies 2 weeks. In the standard treatment regimen, INR values are measured once a month. This more frequent measurement of INR may contribute to improved treatment balance.
All of the studies note that self-measurement or self-care are not suitable options for all patients. Therefore, special attention should be paid to patient selection, and in the initial stages, the effectiveness of the treatment should be monitored closely. The remote monitoring services used in the examinations have varied, but all are based on the implementation of digital systems to facilitate communication between professionals and patients.
Other observations from the studies
Several follow-up studies covering real-time, actual use have been published, encompassing a larger group of patients and over a longer follow-up period. Of these, a Spanish study concluded that self-measurement and self-care are at least as effective as standard care. [6] A Danish register-based study compared self-care with direct oral anticoagulants (DOACs). The study demonstrated that self-care is safe and effective for properly trained patients. Patients undergoing self-care have a lower risk of stroke than patients undergoing DOAC treatment. There were no differences in the risk of major bleeding or mortality. [7]
Other recommendations and assessments
The National Institute for Health and care Excellence (NICE) conducted an assessment on self-measurement and self-care in the United Kingdom in 2014 [8]. In 2021, Canada’s CADTH (Canadian Agency for Drugs and technologies in Health) examined the experiences of patients and relatives [9]. In 2015, Swedish researchers examined the cost-effectiveness of self-measurement and self-care [10].
