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Real-world data have become increasingly important in medical science and healthcare. A new, effective, and practically feasible statistical design is needed to unlock the potential of real-world data that decision-makers and practitioners can use to meet people’s healthcare needs. In the first half of the study, we validated our proposed new method by simulation, and in the second half, we conducted a clinical study on actual real-world data. We proposed the “Exact Matching Algorithm Using Administrative Health Claims Database Equivalence Factors (AHCDEFs)” using a target trial emulation framework. The simulation trials were conducted 500 times independently, considering the misclassification and chance errors of all variables and competing events of outcome. Two conventional methods, multivariate and propensity score analyses, were compared. Next, we estimated the effect of specific health guidance provided in Japan on the prevention of diabetes onset and medical expenditures. Our proposed novel method for real-world data returns improved estimates and fewer type I errors (the probability of erroneously determining that there is a difference when, in fact, there is no difference) than conventional methods. We quantitatively demonstrated the effectiveness of specific health guidance in Japan in preventing the onset of diabetes and reducing medical expenditures during five years. We proposed a new method for analyzing real-world data and an exact-matching algorithm using AHCDEFs. The larger the number of patients available for analysis, the more the AHCDEFs that can be matched, thereby removing the influence of confounding factors. This method will generate significant evidence when applied to real-world data.

Abstract Previous estimates determined prevalence of hypothyroidism (HT) to be 4.6% of the US population. This study aimed to update estimates of HT prevalence in the United States by retrospective analysis of 2 datasets. Data on HT type (overt or subclinical HT) and treatment were collected from the 2009-2010 and 2011-2012 National Health and Nutrition Examination Survey (NHANES) cycles. From the Optum administrative claims database, medical and pharmacy claims were collected between January 1, 2012, and December 31, 2019. Patients were defined as having HT if, per given year, they had >1 prescription for HT treatment, >1 claim indicating an HT diagnosis, or thyroid-stimulating hormone levels >4.0 mIU/L (NHANES arm). For both studies, treatment was defined as any evidence of synthetic or natural thyroid hormone replacement, identified by pharmacy claims or patient surveys. Data are reported as percentage of patients with HT and treatments received. Between 2009 and 2012, HT prevalence remained around 9.6% of the US population. The administrative claims dataset showed that HT prevalence grew from 9.5% in 2012 to 11.7% in 2019 and that >78% of patients received thyroxine (T4) monotherapy. Similarly, the NHANES dataset showed that T4 replacement therapy was the most common treatment for HT. From 2012–2019, patients with untreated HT grew from 11.8% to 14.4%. The prevalence of HT in the United States has steadily increased since 2009. Likewise, the percentage of hypothyroid-diagnosed patients not receiving treatment also increased, suggesting that the increased prevalence may be due to increased cases of subclinical HT.

In countries with unrestricted access to healthcare, such as Japan, patients may initiate a drug at a clinic or hospital and then may visit another hospital when outcome events occur. Theoretically, an insurance-based database can capture all outcomes, whereas a hospital-based database can only capture outcomes when patients visit that hospital. We examined the difference in outcome event coverage between insurance-based and hospital-based databases in Japan, and its impact on pharmacoepidemiology studies, using diabetes drug use and cardiovascular events as an example. Using the JMDC payer database, we identified new users of sodium-glucose cotransporter-2 (SGLT2) inhibitors or dipeptidyl peptidase-4 (DPP-4) inhibitors as the first choice of treatment for type 2 diabetes. Composite outcome was defined as the first hospitalization with a diagnosis of heart failure, stroke, or myocardial infarction. Among patients who initiated drug use at hospitals, we estimated the proportion of events captured in the same hospital among all events recorded in the insurance data. Subsequently, considering a hypothetical hospital-based database study (in which outcome events could only be captured in the same hospital), we estimated an adjusted hazard ratio (aHR) for SGLT2 DPP-4 inhibitors. There were 72,556 and 39,214 new users of DPP-4 and SGLT2 inhibitors, respectively, with no history of cardiovascular events, including 18,325 and 9,478 who initiated treatments at hospitals, respectively. Among the 18,325 patients who initiated DPP-4 inhibitors, 195 events occurred, of which 94 (48%) could be captured in the same hospital. Among the 9,478 patients who initiated SGLT-2 inhibitors, 89 events occurred, of which 40 (45%) could be captured in the same hospital. The aHR (95% confidence interval) was 0.74 (0.49-1.12) in the hypothetical hospital-based database study, whereas it was 0.88 (0.64-1.21) in the insurance-based analysis. A sensitivity analysis restricted to hospitals in the Japanese Diagnosis Procedure Combination (DPC) system showed that the percentage exceeded 50% for both the composite and individual disease events. This Japanese study revealed that nearly half (over half when restricted to DPC hospitals) of cardiovascular events were captured in the same hospital where the diabetes drug was initiated.

BackgroundThe survival rate of chronic dialysis patients in Japan remains the highest worldwide, so there is value in presenting Japan’s situation internationally. We examined whether aggregate figures on dialysis patients in the National Database of Health Insurance Claims and Special Health Checkups of Japan (NDB), which contains data on insured procedures of approximately 100 million Japanese residents, complement corresponding figures in the Japanese Society for Dialysis Therapy Renal Data Registry (JRDR).MethodsSubjects were patients with medical fee points for dialysis recorded in the NDB during 2014–2018. We analyzed annual numbers of dialysis cases, newly initiated dialysis cases– and deaths.ResultsCompared with the JRDR, the NDB had about 6–7% fewer dialysis cases but a similar number of newly initiated dialysis cases. In the NDB, the number of deaths was about 6–10% lower, and the number of hemodialysis cases was lower, while that of peritoneal dialysis cases was higher. The cumulative survival rate at dialysis initiation was approximately 6 percentage points lower in the NDB than in the JRDR, indicating that some patients die at dialysis initiation. Cumulative survival rate by age group was roughly the same between the NDB and JRDR in both sexes.ConclusionThe use of the NDB enabled us to aggregate data of dialysis patients. With the definition of dialysis patients used in this study, analyses of concomitant medications, comorbidities, surgeries, and therapies will become possible, which will be useful in many future studies.

Alectinib is the first‐line therapy for anaplastic lymphoma kinase‐positive non‐small‐cell lung cancer. Although some guidelines have recommended using other anaplastic lymphoma kinase inhibitors after alectinib failure, evidence for such regimens in patients who fail to respond to alectinib is limited. This study involved using administrative claims data from acute care hospitals in Japan. We extracted the data of 634 patients diagnosed with lung cancer between September 1, 2014, and January 31, 2023, who received alectinib treatment before treatment with another anaplastic lymphoma kinase inhibitor. We assessed distributions of patients according to their treatment sequencing and prognosis among three periods defined based on the initial marketing dates of lorlatinib and brigatinib. The type of anaplastic lymphoma kinase inhibitors after alectinib failure changed over time. In the most recent period, lorlatinib (58%) and brigatinib (40%) became predominant. Two‐year overall survival improved over time (47%–84%), accompanied by an increased 2‐year proportion of patients who continuously used anaplastic lymphoma kinase inhibitors after alectinib failure (13%–44%). The times to treatment discontinuation of the regimen between patients treated with lorlatinib and brigatinib were similar, with a hazard ratio of 1.02 (95% confidence interval, 0.64–1.64) in the period after marketing brigatinib. This study provides insights into the evolving treatment landscape for patients with anaplastic lymphoma kinase‐positive non‐small‐cell lung cancer who experience failed alectinib treatment and highlights the need for further studies and data accumulation to determine the optimal treatment strategy. Alectinib is the preferred initial treatment for anaplastic lymphoma kinase (ALK)‐positive non‐small‐cell lung cancer, but when it fails, there is limited evidence for using other ALK inhibitors. This study observed changing trends in post‐alectinib treatment patterns, with lorlatinib and brigatinib becoming more common and 2‐year survival and 2‐year times to treatment discontinuation of the regimen improved over time. Our study provides insights into the evolving treatment landscape for patients with ALK‐positive non‐small‐cell lung cancer who experience failed alectinib treatment.

Background Antibiotic resistance is increasing among urinary pathogens, resulting in worse clinical and economic outcomes. We analysed factors associated with antibiotic-resistant bacteria (ARB) in patients hospitalized for urinary tract infection, using the comprehensive French national claims database. Methods Hospitalized urinary tract infections were identified from 2015 to 2017. Cases (due to ARB) were matched to controls (without ARB) according to year, age, sex, infection, and bacterium. Healthcare-associated (HCAI) and community-acquired (CAI) infections were analysed separately; logistic regressions were stratified by sex. Results From 9460 cases identified, 6468 CAIs and 2855 HCAIs were matched with controls. Over a 12-months window, the risk increased when exposure occurred within the last 3 months. The following risk factors were identified: antibiotic exposure, with an OR reaching 3.6 [2.8–4.5] for men with CAI, mostly associated with broad-spectrum antibiotics; surgical procedure on urinary tract (OR 2.0 [1.5–2.6] for women with HCAI and 1.3 [1.1–1.6] for men with CAI); stay in intensive care unit > 7 days (OR 1.7 [1.2–2.6] for men with HCAI). Studied co-morbidities had no impact on ARB. Conclusions This study points out the critical window of 3 months for antibiotic exposure, confirms the impact of broad-spectrum antibiotic consumption on ARB, and supports the importance of prevention during urological procedures, and long intensive care unit stays.

BackgroundReal-world data on optimal cancer pain management remain scarce. We describe prescription patterns of analgesics in Japanese cancer patients with bone metastases.MethodsNational hospital-based claims data were analyzed. Adults with first diagnosis of cancer during 2015–2019 and first diagnosis of bone metastasis after the initial cancer diagnosis were included. Skeletal-related events (SREs) were identified with disease and receipt codes. ResultsAmong the 40,507 eligible patients (age [mean ± SD], 69.7 ± 11.7 years), lung (25.3%), prostate (15.6%), breast (10.9%), and colorectal (10.7%) cancers were common primary tumors. Time (mean ± SD) between primary cancer diagnosis and bone metastases was 306.9 ± 490.4 days; median survival time from bone metastases was 483.0 days. Most patients used acetaminophen (62.7%, 117.5 days/year) and nonsteroidal anti-inflammatory drugs (NSAIDs; 75.3%, 170.0 days/year). Commonly used opioids included oxycodone (39.4%; 479.3 days/year), fentanyl (32.5%; 52.6 days/year), morphine (22.1%; 130.9 days/year), and tramadol (15.3%; 143.0 days/year). Internal medicine, surgery, respiratory, urology, and orthopedics treated 19.4%, 18.5%, 17.6%, 17.3%, and 13.0% of patients, respectively. Prescription patterns varied inter-department. Overall, 44.9% of patients developed SRE (bone pain requiring radiation [39.6%] or orthopedic surgery [2.9%]; hypercalcemia, 4.9%; pathological fracture, 3.3%; spinal cord compression, 0.4%). Analgesics use by patients with SREs was 1.8- to 2.2-fold in the postsymptomatic vs the presymptomatic period. SRE patients had numerically lower survival probabilities than non-SRE patients. Opioid use increased considerably in the month before death. ConclusionIn Japanese cancer patients with bone metastases, acetaminophen, NSAIDs, and weak or strong opioids were commonly used; their use increased after SREs developed. Opioid use increased closer to death.

Introduction Recent data on the prevalence of metabolic syndrome in Japanese patients with type 2 diabetes (T2D) are limited. Methods This retrospective, cross-sectional, observational study investigated the prevalence of metabolic syndrome in patients with T2D using a Japanese administrative claims database. Patients with a T2D diagnosis, prescription of a hypoglycemic agent, and one or more annual health checkups in 2020 were included. Trends in the prevalence of metabolic syndrome by sex and body mass index (BMI) subgroup were assessed. Results The study cohort consisted of 155,653 patients (men, 81.6%; mean age 54.6 ± 8.5 years). Patients with metabolic syndrome had a higher mean BMI (29.1 ± 4.5 kg/m 2 versus 25.2 ± 4.5 kg/m 2 ) and mean waist circumference (98.3 ± 10.0 cm versus 87.9 ± 11.2 cm) compared to those without metabolic syndrome. Overall, the prevalence of metabolic syndrome was 43.0% in patients with T2D, with prevalence higher in men (46.6%) than women (27.0%). The prevalence increased across BMI subgroups from 17.3% in the < 25 kg/m 2 subgroup, to 54.6% and 66.1% in the 25 to < 30 and ≥ 30 kg/m 2 subgroups, respectively. A greater proportion of patients with metabolic syndrome had cardiovascular or renal comorbidities (BMI < 25, 0.3–2.0%; BMI 25 to < 30, 0.7–6.2%; BMI ≥ 30 kg/m 2 , 0.7–6.8%) and cardiovascular drug usage (BMI < 25, 1.3–9.0%; BMI 25 to < 30, 3.8–31.1%; BMI ≥ 30 kg/m 2 , 3.5–37.0%) in the higher BMI subgroups compared to the BMI < 25 kg/m 2 subgroup. Conclusion The prevalence of metabolic syndrome in Japanese patients with T2D was 43.0% and increased with higher BMI. In patients with T2D and metabolic syndrome, cardiovascular drug usage and comorbidities increased in patients with a higher BMI. These data highlight the importance of managing metabolic parameters in addition to glycemic control in Japanese patients with T2D, particularly in patients with metabolic syndrome and BMI ≥ 25 kg/m 2 .

Background Limited evidence exists regarding the impact of baseline functional and cognitive impairments on the outcomes of patients with pneumonia. Methods We used medical and long‐term care administrative databases in a prefecture in Japan that contained care need levels assessed using the national standardized certification system. We identified patients aged ≥65 years who were hospitalized for pneumonia between June 2014 and October 2018. The impairments were classified into four categories based on estimated total daily care time: no care needs, support levels 1–2, care needs level 1 (estimated care time of 25–49 min), care needs level 2–3 (50–89 min), and care needs level 4–5 (≥90 min). The primary outcome was the in‐hospital mortality rate. Secondary outcomes were death and care needs at 6 months and 1 year after admission. We evaluated the outcomes based on care need levels and conducted multivariate analyses adjusting for potential confounders. Results A total of 15,537 patients (mean age 83.9 years) were included. The in‐hospital mortality rates for patients with no care needs, support levels 1–2 and care needs level 1, care needs levels 2–3, and care needs levels 4–5 were 10.5%, 15.9%, 21.1%, and 24.7%, respectively. The proportions of patients who died or experienced worsening care needs at 6 months were 43.6%, 60.4%, 60.0%, and 50.2%, respectively. Multivariable analyses demonstrated independent associations of preexisting care needs with both in‐hospital mortality and long‐term outcomes. Conclusion Preexisting long‐term care needs are associated with short‐ and long‐term outcomes in older inpatients with pneumonia.

Pulmonary arterial hypertension (PAH) is a fatal disease that often occurs at an early age. In recent years, aggressive treatment with multiple drugs from the early‐stage diagnosis is expected to improve the prognosis. Indeed, a high rate of initial combination therapy and excellent treatment outcomes have been reported from specialized centers for PAH in Japan. However, information on PAH epidemiology, including non‐PAH specialized centers in Japan, is unclear. To address the above, we conducted a retrospective observational cohort study from April 2008 to September 2020 using real‐world evidence from a large‐scale administrative database (Medical Data Vision) to examine baseline characteristics, comorbidities, and treatment profiles of Japanese patients with PAH. Five hundred and eighteen patients with PAH (treatment‐naive PAH, age 67.2 ± 15.9) were identified through our comprehensive approach which combined PAH disease codes, medications, and diagnostic procedures. Moreover, we showed that a larger proportion of patients received monotherapy in their initial treatment (66%) compared to those receiving combination therapy (34%). During the 1‐year follow‐up after PAH diagnosis, 13% of patients increased their PAH medications while other patients either decreased their PAH medications (6%) or discontinued PAH treatment (27%). The 3‐ and 5‐year event‐free survival rates of all‐cause death were 72% and 64%, respectively. This is the first large‐scale administrative database study that provides insights into real‐world PAH management in Japan. This study highlighted a different PAH clinical landscape which included a larger portion of the elderly population, higher initial monotherapy treatment, and lower survival rates than previous studies.