Acceleration of opportunistic atrial fibrillation screening for elderly patients in routine primary care.

Cardio-embolic ischemic stroke caused by atrial fibrillation is more severe compared with other types of stroke, such as lacunar infarction and atherothrombotic infarction in patients without atrial fibrillation. Therefore, it is important to prevent cardio-embolic ischemic stroke by detecting atrial fibrillation early in at-risk patients and administering appropriate anticoagulation therapy. This prospective observational study aimed to evaluate the effectiveness of opportunistic atrial fibrillation screening at 12 primary clinics in Japan. The study included a 12-month pre-campaign period and a 12-month campaign period. During the campaign period, an awareness campaign was conducted to encourage physicians to be mindful of screening patients aged ≥65 years for atrial fibrillation by checking their pulses and performing subsequent electrocardiography when an irregular pulse was detected. The primary outcome was the proportion of patients with newly diagnosed atrial fibrillation. A sub-analysis focusing on first-time outpatients was performed. There were 9921 and 10,282 patients with no history of atrial fibrillation in the pre-campaign and campaign periods, respectively. In the whole population, the proportion of patients with newly diagnosed atrial fibrillation was 0.9% throughout the pre-campaign and campaign periods. In the sub-analysis limited to first-time outpatients, the detection proportion increased from 1.6% to 1.9% during the campaign period. In terms of age stratification, a large increase in detection was observed, especially among patients aged 65-74 years (detection increased from 0.9% to 1.5%) and ≥85 years (detection increased from 2.9% to 3.3%) during the campaign period. Our findings suggest the feasibility of opportunistic atrial fibrillation screening in routine primary care practice in Japan. Of note, our findings suggest that opportunistic atrial fibrillation screening targeting first-time outpatients may be of clinical value.

Quality of Life in Japanese Patients with Dysmenorrhea Treated with Ethinylestradiol 20 µg/Drospirenone 3 mg in a Real-World Setting: An Observational Study.

BACKGROUND: Dysmenorrhea affects approximately 80% of women in Japan and has a negative impact on health-related quality of life (HRQoL). Low-dose estrogen/progestin combined oral contraceptives have been shown to reduce the severity of dysmenorrhea symptoms. This study characterized HRQoL in Japanese women with dysmenorrhea before and after ethinylestradiol/drospirenone (EE/DRSP) treatment. METHODS: This prospective, observational study recruited 531 patients, of which 186 were evaluated after treatment with EE 20 µg/DRSP 3 mg for dysmenorrhea in a 24/4 cyclic regimen. The primary endpoints were mean baseline and post-treatment 36-Item Short-Form Health Survey version 2.0 (SF-36v2) scores for study patients compared with the general female population of Japan (calculated using norm-based scoring), and mean changes in study patient SF-36v2 scores between baseline and 6 to 8 treatment cycles. RESULTS: Compared with Japanese norms, women with dysmenorrhea had lower pre-treatment SF-36v2 scores, except for the physical functioning domain. After 6-8 cycles of EE/DRSP treatment, all 8 SF-36v2 domain scores were significantly higher than baseline. The greatest improvements were observed in bodily pain and social functioning (mean change [standard deviation (SD)]: physical functioning: 1.4 [5.7], role physical: 3.2 [8.1], bodily pain: 7.8 [10.0], general health: 3.0 [7.0], vitality: 2.7 [8.1], social functioning: 3.5 [9.8], role emotional: 3.3 [9.2], and mental health: 3.0 [7.3]; p< 0.001 for all). Compared with the Japanese general population, study patients' post-treatment scores were significantly higher for the general health domain (p= 0.008) and physical summary scores (p= 0.033). CONCLUSION: Dysmenorrhea has a profound impact on all aspects of functioning and well-being. This study, conducted in a real-world setting, found that physical, social, and mental HRQoL improved significantly after a cyclic regimen of EE/DRSP in Japanese patients with dysmenorrhea. This regimen may have the potential to provide an effective option to improve patient HRQoL. TRIAL REGISTRATION: Study sample was drawn from patients enrolled in a post-marketing surveillance study, registered June 20, 2011 (NCT01375998).

Burden of Menstrual Pain Measured by Heatmap Visualization of Daily Patient-Reported Data in Japanese Patients Treated with Ethinylestradiol/Drospirenone: A Randomized Controlled Study.

PURPOSE: Dysmenorrhea negatively affects women's quality of life and poses a considerable economic burden. A recent study in Japanese patients with dysmenorrhea (NCT01892904) reported a significant reduction in the number of days with menstrual pain after treatment with a flexible extended regimen of ethinylestradiol (EE)/drospirenone (DRSP) compared with a cyclic regimen. However, individual patients' menstrual pain patterns and intensities were not indicated. Heatmapping was used to visualize menstrual pain patterns and intensities by re-evaluating the previously published data from NCT01892904. PATIENTS AND METHODS: NCT01892904 was a Phase III, multicenter, randomized, open-label, active-control study of 212 women aged ≥20 years randomized 1:1 to receive flexible extended or 28-day cyclic EE/DRSP treatment. Daily pain levels were recorded in patient diaries, and menstrual pain patterns and intensities were visualized using heatmapping. Patients were stratified by baseline dysmenorrhea scores and primary or secondary dysmenorrhea. RESULTS: The heatmap data demonstrated that EE/DRSP reduced the degree of menstrual pain. Regular peaks of menstrual pain were alleviated in the extended regimen group but were still observed in the cyclic regimen group. While a decrease in the days with menstrual pain was observed in patients with higher baseline dysmenorrhea scores (5-6), those with lower baseline scores (3-4) were more likely to experience lower intensities of menstrual pain. Although pain relief was less likely in patients with secondary dysmenorrhea, those who had lower baseline dysmenorrhea scores (3-4) and received the flexible extended regimen experienced a greater reduction in the number of days with menstrual pain than those who received the cyclic regimen. CONCLUSION: Heatmapping effectively visualized the daily burden of menstrual pain in Japanese patients with dysmenorrhea. The analysis using heatmaps suggested that the flexible extended EE/DRSP treatment regimen was more likely to alleviate the regular occurrence of menstrual pain peaks compared with the cyclic regimen.

Cost-effectiveness of rivaroxaban versus warfarin for stroke prevention in non-valvular atrial fibrillation in the Japanese healthcare setting.

Aims: This article aimed to examine the cost-effectiveness of rivaroxaban in comparison to warfarin for stroke prevention in Japanese patients with non-valvular atrial fibrillation (NVAF), from a public healthcare payer's perspective.Materials and methods: Baseline event risks were obtained from the J-ROCKET AF trial and the treatment effect data were taken from a network meta-analysis. The other model inputs were extracted from the literature and official Japanese sources. The outcomes included the number of ischaemic strokes, myocardial infarctions, systemic embolisms and bleedings avoided, life-years, quality-adjusted life-years (QALYs), incremental costs and incremental cost-effectiveness ratio (ICER). The scenario analysis considered treatment effect data from the same network meta-analysis.Results: In comparison with warfarin, rivaroxaban was estimated to avoid 0.284 ischaemic strokes per patient, to increase the number of QALYs by 0.535 per patient and to decrease the total costs by ¥118,892 (€1,011.11) per patient (1 JPY = 0.00850638 EUR; XE.com, 7 October 2019). Consequently, rivaroxaban treatment was found to be dominant compared to warfarin. In the scenario analysis, the ICER of rivaroxaban versus warfarin was ¥2,873,499 (€24,446.42) per QALY.Limitations: The various sources of data used resulted in the heterogeneity of the cost-effectiveness analysis results. Although, rivaroxaban was cost-effective in the majority of cases.Conclusion: Rivaroxaban is cost-effective against warfarin for stroke prevention in Japanese patients with NVAF, giving the payer WTP of 5,000,000 JPY.

Impact of care coordination on oral anticoagulant therapy among patients with atrial fibrillation in routine clinical practice in Japan: a prospective, observational study.

BACKGROUND: Care coordination between general practitioners (GPs) and cardiovascular specialists is expected to play a key role in establishing appropriate oral anticoagulant (OAC) treatment in atrial fibrillation (AF) patients. The aim of this study was to assess the impact of care coordination on oral anticoagulant therapy in the management of AF in Japan. METHODS: This study was a multi-center, single-arm, prospective cohort study with retrospective chart and claims data review for historical controls. The study included three study periods: a 12-month pre-campaign period; a 12-month campaign period for AF screening and care coordination; and a 3-month post-campaign period for follow-up of care coordination. During the campaign period, patients aged ≥65 years who attended participating GP clinics underwent opportunistic AF screening by GPs under the campaign. At the discretion of the GP, newly diagnosed AF patients after the screening were referred to a cardiovascular specialist for care coordination. To assess the impact of care coordination and evaluate the effects of the campaign, implementation of care coordination, antithrombotic therapies, and patient-reported outcomes were compared between patients with and without care coordination, and between patients during the pre-campaign and campaign periods. RESULTS: There were 86 newly diagnosed AF patients during the pre-campaign period and 90 during the campaign period. The percentage of patients with care coordination increased from 3.5% (3/86) in the pre-campaign period to 14.4% (n = 13/90) during the campaign period. The percentage of patients who received OAC therapies, according to the definition from the Japanese AF medication guideline, increased from 55.8% (48/86) to 71.1% (64/90) during the campaign period regardless of care coordination. Younger patients were referred to cardiovascular specialists for care coordination. Implementation of OAC therapy did not differ between patients with and without care coordination. Adherence to OAC therapy was low regardless of care coordination. CONCLUSIONS: This GP-targeted campaign was effective at raising awareness regarding the implementation of care coordination and appropriate OAC therapy at local clinical practices in Japan. Improvement of adherence to OAC therapy in elderly patients is a critical issue, and measures such as education programs targeted to patients and healthcare professionals should be undertaken.

Psychometric validation of anti-clot treatment scale and treatment satisfaction questionnaire for medication version II in Japanese patients with atrial fibrillation.

Aims: The Anti-Clot Treatment Scale (ACTS) and Treatment Satisfaction Questionnaire for Medication version II (TSQM-II) are validated treatment satisfaction patient-reported outcome (PRO) instruments. The ACTS includes two domains: Burdens and Benefits; the TSQM-II includes four: Effectiveness, Side Effects, Convenience, and Global Satisfaction. Japanese-language versions of the ACTS and TSQM-II have been developed and linguistically validated. This study aimed to assess their psychometric properties in Japanese patients with atrial fibrillation (AF). Materials and methods: ACTS and TSQM-II data from 534 patients with AF were collected in a Japanese post-marketing surveillance study of a direct oral-anticoagulant, rivaroxaban. Four key psychometric properties, in line with best practice guidelines from the US Food and Drug Administration, were examined using traditional psychometric methods: acceptability, scaling assumptions, reliability (i.e. internal consistency reliability, test-retest reliability), and construct validity (i.e. convergent validity and known groups). Results: ACTS Burdens and Benefits and TSQM-II Effectiveness, Convenience, and Global Satisfaction scales were found to be acceptable (e.g. item-level missing data at baseline <4%), with all scales having good internal consistency (Cronbach's alpha > 0.80). test-retest reproducibility intraclass correlation coefficients for the ACTS Burdens and Benefits were 0.59 and 0.65, respectively, and between 0.54-0.61 for the TSQM-II scales. Known-groups validity for the ACTS and TSQM-II was supported by differences in scale scores by positive and negative impact (p < 0.05). Correlations between the ACTS and TSQM-II (convergent validity) were lower than expected (range r = 0.09-0.48), but in line with the original ACTS development study. Limitations: Evaluation of test-retest reproducibility was limited by assessment period, which was longer (3 months) than recommended guidelines (usually up to 2 weeks). Conclusions: Overall, Japanese versions of ACTS and TSQM-II scales satisfied internal consistency reliability and traditional validity criteria. Our study supports the ACTS and TSQM-II as appropriate PRO instruments to measure satisfaction with anticoagulant treatment in Japanese patients with AF. Trial registration: NCT01598051, clinicaltrials.gov; registered April 20, 2012.

Treatment preferences among Japanese women with dysmenorrhea: results from a discrete choice experiment study.

PURPOSE: To examine patient preferences for oral and intrauterine system treatments for dysmenorrhea in Japan. PATIENTS AND METHODS: A discrete choice experiment was conducted to assess the willingness to accept trade-offs among hypothetical treatment profiles. An internet-based survey was administered to women 18-49 years of age who self-reported a dysmenorrhea diagnosis or experienced dysmenorrhea at least once in the past 6 months (N=309). Choice questions included pairs of treatments presented with different attributes: mode of administration, reduction in bleeding after 6 months, chance of symptoms becoming "improved", nausea, weight gain, irregular bleeding, and risk of venous thromboembolism. Relative importance (RI) estimates were computed. RESULTS: The mean respondent age was 35.8 years (standard deviation =7.0), and 85 women (27.5%) reported that they had previously used hormonal therapy for dysmenorrhea. Treatment preference was most strongly associated with mode of administration (RI=49.8%), followed by chance of irregular bleeding (RI=17.3%). In contrast, treatment preference was most weakly associated with chance of weight gain (RI=2.4%) and reduction in bleeding after 6 months (RI=0.8%). Respondents preferred oral treatments: for twice-daily regimen, odds ratio (OR)=4.90; for once-daily fixed cyclic regimen, OR=4.20; and for once-daily flexible extended regimen, OR=2.44; whereas for intrauterine system, OR=0.02 (p<0.001 for all). Those with prior hormonal therapy experience exhibited the same pattern. CONCLUSION: Mode of administration factored heavily in dysmenorrhea treatment preferences. Women of reproductive age preferred oral medication, especially twice-daily regimen and once-daily fixed cyclic regimen. Findings can potentially help to improve physician-patient communication and treatment decision making. Physicians should consider factors that can influence patient preference to optimize treatment acceptance and adherence.

Patient-reported treatment satisfaction with rivaroxaban in Japanese non-valvular atrial fibrillation patients: an observational study.

OBJECTIVES: Rivaroxaban has previously been shown to be as efficacious and safe as warfarin for the prevention of stroke in non-valvular atrial fibrillation (NVAF). Therefore, treatment satisfaction becomes an important consideration. Here we examine treatment satisfaction in Japanese NVAF patients who were switched from warfarin to rivaroxaban. METHODS: Patient-reported outcome (PRO) data were collected as part of a prospective, multi-center, post-marketing surveillance (PMS) of a direct oral-anticoagulant, rivaroxaban, in Japan. The Anti-Clot Treatment Scale (ACTS) and the Treatment Satisfaction Questionnaire for Medication version II (TSQM-II) were collected at baseline, month 3, and month 6. Change in scores from baseline to month 3 and month 6 were assessed. Exploratory analyses included change in scores by patient characteristics. Safety and effectiveness of rivaroxaban were also assessed. RESULTS: ACTS Burdens scores significantly improved at month 3 (54.6 ± 6.3) and month 6 (54.5 ± 6.5) compared to baseline (51.0 ± 7.6) (p < .001). ACTS Benefits score remained stable over time (baseline = 10.1 ± 2.8, month 3 = 10.2 ± 3.1, month 6 = 10.1 ± 3.1). Mean TSQM-II sub-scale scores significantly improved at month 3 and month 6 compared to baseline for all four domains (all p < .001). CONCLUSIONS: Findings suggest treatment satisfaction may improve in Japanese NVAF patients after a switch from warfarin to rivaroxaban. Higher treatment satisfaction may translate into improved treatment adherence, which is critical for the long-term prevention of stroke.

Treatment patterns and healthcare resource utilization and costs in heavy menstrual bleeding: a Japanese claims database analysis.

AIMS: Heavy menstrual bleeding (HMB) is a highly prevalent condition, characterized by excessive menstrual blood loss and cramping, that interferes with activities of daily life. The aim of this study was to investigate treatment patterns in HMB in Japan, and to assess healthcare resource utilization and costs among women newly-diagnosed with the condition. MATERIALS AND METHODS: This study retrospectively analyzed health insurance data available in the Japan Medical Data Center (JMDC) database on women aged 18-49 years who were newly-diagnosed with primary or secondary HMB. Treatment patterns were analyzed, and healthcare utilization and costs were evaluated and compared to matched controls. RESULTS: The study included a total of 635 patients, 210 with primary HMB and 425 with secondary HMB. In the primary HMB cohort, 60.0% of patients received one or more pharmacological or surgical treatments, compared with 76.2% in the secondary HMB cohort. The most commonly prescribed medications in all patients were hemostatic agents (28.7%), traditional Chinese medicine (TCM) (12.1%), and low-dose estrogen progestins (LEPs) (10.1%). After adjustment for patient baseline characteristics, healthcare costs were 1.93-times higher in primary HMB cases (p < .0001) and 4.44-times higher in secondary HMB cases (p < .0001) vs healthy controls. Outpatient care was the main cost driver. LIMITATIONS: The main limitations of this study are related to its retrospective nature, and the fact that only reimbursed medications were captured in the source database. CONCLUSIONS: A substantial proportion of HMB patients did not receive the recommended treatments. Healthcare costs were considerably increased in the presence of an HMB diagnosis.

Evaluation of the treatment patterns and economic burden of dysmenorrhea in Japanese women, using a claims database.

PURPOSE: This study aimed to describe treatment patterns and estimate health care resource utilization and associated costs among Japanese women with dysmenorrhea, using a claims database. METHODS: This was a retrospective analysis using health insurance data from the Japan Medical Data Center, assessing female patients aged 18-49 years with newly diagnosed primary or secondary dysmenorrhea. Treatment pattern analyses focused on hormonal medications, analgesics, hemostatic agents, traditional Chinese medicine (TCM), and gynecological surgeries. Data were collected on health care resource utilization and costs associated with medications, imaging procedures, and inpatient and outpatient care in both patients and matched controls. RESULTS: The analysis included 6,315 women with dysmenorrhea (3,441 primary; 2,874 secondary). The most commonly prescribed initial therapies were low-dose estrogen progestins (LEPs, 37.7%) and TCM (30.0%), with substantial differences between primary (LEPs: 27.4%, TCM: 38.8%) and secondary (LEPs: 50.2%, TCM: 19.5%) dysmenorrhea cohorts. Surgery was conducted in <5% of all patients. Both primary and secondary cohorts of dysmenorrhea had significantly higher mean total health care costs compared to controls within the 1-year period following diagnosis (Case-primary: 191,680 JPY [1,916 USD]; secondary: 246,488 JPY [2,465 USD], Control-primary: 83,615 JPY [836 USD]; secondary: 90,711 JPY [907 USD]) (p<0.0001). After adjusting for baseline characteristics, these costs were 2.2 and 2.9 times higher for primary and secondary dysmenorrhea cohorts, respectively, compared with matched controls, (both p<0.0001). The main driver of these excess costs was outpatient care, with eight additional physician visits per year among dysmenorrhea patients compared to controls (p<0.0001). CONCLUSION: Considerable heterogeneity in treatment patterns was observed, with relatively low utilization of LEPs in patients with primary dysmenorrhea and those treated by internal medicine physicians. Total annual health care costs were approximately 2-3 times higher in patients with dysmenorrhea compared to women without the condition.