はじめに
これまで、MID-NETとDeSCデータベースについてご紹介しました。
本記事ではリアルワールドデータ株式会社（RWD社）のデータベース（RWD-DB）の特徴（強み・限界）や研究実績についてご紹介します。
DB研究を実施する際は、DBの特徴やデータの限界だけでなく、DB研究を利用した先行研究の論文を参考にすることも有用ですので、是非ご参考にしてください。
RWD-DBの概要（特徴）
RWD-DBは、RWD社が病院の診療情報や健康診断の情報を電子化し、2015年7月に運用を開始した商用データベースです。一般社団法人 健康・医療・教育情報評価推進機構（HCEI）と連携し、医療機関が保有するカルテ等の診療情報や、自治体が保有する健康診断の健診情報が集積・保管されています。
RWD-DBの特徴（強み・限界）は以下の通りです。
| 強み | 限界 | |
| 集団の特性 |
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| データの規模 |
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| データの質 |
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| 規制当局とのやりとり |
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RWD-DBを活用したDB研究一覧
- 2023年10月11日時点（Pubmed検索（非該当論文を除外）＋リアルワールドデータ株式会社の公式ウェブサイトより収集）
- National Library of Medicine’s PubMed using the following criteria: (“Japan”[Mesh] OR “Japan” OR “Japans”) AND (“RWD database” OR “Real World Data Co., Ltd.” OR “real world data database” OR “real world database” OR “RWD” OR “Real World Data Co” OR “HCEI” OR “Education Information Evaluation Institute” OR “electronic medical record” from 2019 – 2023).
| No. | Title | Authors | Journal | Year | Research Theme | Area of Disease | Disease |
| 1 | 製薬企業におけるRWD系データベースのユースケースとこれからの課題 | 但馬匠, 他 | 薬理と臨床 | 2019 | Others | ||
| 2 |
製薬企業でのリアルワールドデータ活用の取り組み ―電子カルテデータを利用した実臨床の把握および治験データ再現の可能性について― |
鈴木將之, 他 | Therapeutic Research | 2019 | Others | ||
| 3 | Electronic health record nested pragmatic randomized controlled trial of a reminder system for serum lithium level monitoring in patients with mood disorder: KONOTORI study protocol | Seki T, Aki M, Kawashima H, et al. | Trials | 2019 | Real world treatment practice | Mental illness | Mood disorder |
| 4 | The General Understanding and Perceptions of the Practical Use of School Health Records: A Questionnaire Survey of Parents from Seven Local Municipalities in Japan | Ide K, Yoshida S, Kimura T, et al. | School Health | 2020 | Others | ||
| 5 | Association of maternal prepregnancy weight and early childhood weight with obesity in adolescence: A population-based longitudinal cohort study in Japan | Yoshida S, Kimura T, Noda M, et al. | Pediatr Obes | 2020 | Investigation of risk factors | Endocrine/Metabolic disease | Obesity |
| 6 | Validity of Claims Diagnosis Codes for Cardiovascular Diseases in Diabetes Patients in Japanese Administrative Database | Ono Y, Taneda Y, Takeshima T, et al. | Clin Epidemiol | 2020 | Validation | Endocrine/Metabolic disease | Diabetes |
| 7 |
A Real-World Observational Study Evaluating the Probability of Glycemic Control with Basal Insulin or Glucagon-Like Peptide-1 Receptor Agonist in Japanese Patients with Type 2 Diabetes |
Baxter M, Morimoto Y, Tamiwa M, et al. | Diabetes Ther | 2020 | Effectiveness research | Endocrine/Metabolic disease | Type 2 diabetes |
| 8 | Comparative Effectiveness of Sodium-Glucose Cotransporter-2 Inhibitors Versus Other Classes of Glucose-Lowering Medications on Renal Outcome in Type 2 Diabetes | Takeuchi M, Ogura M, Minoura T, et al. | Mayo Clin Proc | 2020 | Real world treatment practice | Endocrine/Metabolic disease | Type 2 diabetes |
| 9 | Variation of treatment decision-making for laryngeal cancer in Japan a retrospective observational study using a claim- and electronic medical record-based database | Fujiwara T, Mizuta M, Nango E, Tamaki H. | Ann Clin Epidemiol | 2021 | Real world treatment practice | Cancer | Laryngeal cancer |
| 10 | Identification and Validation of Hemophilia-Related Outcomes on Japanese Electronic Medical Record Database (Hemophilia-REAL V Study) | Fujiwara T, Miyakoshi C, Kanemitsu T, et al. | J Blood Med | 2021 | Validation | Blood disease | Hemophilia A |
| 11 | A Real-World, Observational Study of the Initiation, Use, and Effectiveness of Basal-Bolus or Premixed Insulin in Japanese People with Type 2 Diabetes | Miyoshi H, Baxter M, Kimura T, et al. | Diabetes Ther | 2021 | Real world treatment practice | Endocrine/Metabolic disease | Type 2 diabetes |
| 12 | Influence of acetaminophen on renal function: a longitudinal descriptive study using a real-world database | Ide K, Fujiwara T, Shimada N, Tokumasu H. | Int Urol Nephrol | 2021 | Real world treatment practice | Urinary disease | Renal function |
| 13 | Improvement in the appropriate antimicrobial usage for treating pediatric acute otitis media in Japan: A descriptive study using nation-wide electronic medical record data | Kono M, Sugita G, Itahashi K, et al. | J Infect Chemother | 2021 | Real world treatment practice | Ear disease | Acute Otitis Media |
| 14 | Initiating SGLT2 inhibitor therapy to improve renal outcomes for persons with diabetes eligible for an intensified glucose-lowering regimen: hypothetical intervention using parametric g-formula modeling | Takeuchi M, Ogura M, Inagaki N, Kawakami K. | BMJ Open Diabetes Res Care | 2022 | Real world treatment practice | Endocrine/Metabolic disease | Type 2 diabetes |
| 15 | Factors affecting creatine phosphokinase elevation during daptomycin therapy using a combination of machine learning and conventional methods | Imai S, Kashiwagi H, Sato Y, et al. | Br J Clin Pharmacol | 2022 | Investigation of risk factors | Musculoskeletal disease | Musculoskeletal toxicity |
| 16 | Burden of congenital hemophilia A requiring treatment in Japan: The HIKOBOSHI study | Nagao A, Ioka A, Nakamura T, et al. | Res Pract Thromb Haemost | 2022 | Real world treatment practice | Blood disease | Congenital hemophilia A |
| 17 | Using Japanese big data to investigate novel factors and their high-risk combinations that affect vancomycin-induced nephrotoxicity | Imai S, Kadomura S, Miyai T, et al. | Br J Clin Pharmacol | 2022 | Investigation of risk factors | Others | Vancomycin-induced nephrotoxicity |
| 18 | Accuracy of algorithms to identify patients with a diagnosis of major cancers and cancer-related adverse events in an administrative database: a validation study in an acute care hospital in Japan | Fujiwara T, Kanemitsu T, Tajima K, et al. | BMJ Open | 2022 | Validation | Cancer | Lung cancer, breast cancer, colorectal cancer, ovarian cancer, bladder cancer, prostate cancer |
| 19 | Effect of timing of bronchodilator therapy initiation on exacerbations in patients with chronic obstructive pulmonary disease: a retrospective cohort study | Yamada H, Matsumoto I, Makita N, et al. | Respir Res | 2022 | Real world treatment practice | Respiratory disease | Chronic obstructive pulmonary disease (COPD) |
| 20 | Association Between Empirical Anti-Pseudomonal Antibiotics for Recurrent Lower Respiratory Tract Infections and Mortality: A Retrospective Cohort Study | Shiroshita A, Yamamoto S, Anan K, et al. | Int J Chron Obstruct Pulmon Dis | 2022 | Effectiveness research | Respiratory disease | Lower respiratory tract infections |
| 21 | Machine Learning Models Predicting Cardiovascular and Renal Outcomes and Mortality in Patients with Hyperkalemia | Kanda E, Okami S, Kohsaka S, et al. | Nutrients | 2022 | Clinical prediction | Endocrine/Metabolic disease | Hyperkalemia |
| 22 | Longitudinal study of body mass index and percentage of overweight in Japanese children grouped by maturity | Masubuchi R, Noda M, Yoshida S, Kawakami K. | Endocr J | 2022 | Patient survey | Endocrine/Metabolic disease | Childhood obesity |
| 23 | Impact of COVID-19 pandemic-associated reduction in respiratory viral infections on childhood asthma onset in Japan | Matsumoto N, Kadowaki T, Takanaga S, et al. | J Allergy Clin Immunol Pract | 2022 | Patient survey | Respiratory disease | Childhood asthma |
| 24 | Utilization of glucagon-like peptide-1 receptor agonists and changes in clinical characteristics in patients with type 2 diabetes by chronic kidney disease stage in Japan: A descriptive observational study using a nationwide electronic medical records database | Hirose N, Tsujimoto N, Katayose T, Chin R. | Diabetes Obes Metab | 2022 | Real world treatment practice | Endocrine/Metabolic disease | Type 2 diabetes, chronic kidney disease |
| 25 | Association between biopsies for anti-neutrophil cytoplasmic antibody-associated vasculitis and prognosis: a retrospective cohort study | Hashimoto H, Takeuchi M, Kawakami K. | Clin Rheumatol | 2022 | Effectiveness research | Blood disease | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) |
| 26 | Early corticosteroid dose tapering in patients with acute exacerbation of idiopathic pulmonary fibrosis | Anan K, Kataoka Y, Ichikado K, et al. | Respir Res | 2022 | Investigation of risk factors | Respiratory disease | Idiopathic pulmonary fibrosis |
| 27 | Seasonal influenza, its complications and related healthcare resource utilization among people 60 years and older: A descriptive retrospective study in Japan | Hagiwara Y, Harada K, Nealon J, et al. | PLoS One | 2022 | Analysis of medical resource/cost | Infection | Influenza |
| 28 | Descriptive epidemiology of COVID-19 in Japan 2020: insights from a multihospital database | Takeuchi M, Inokuchi S, Kimura T, et al. | Ann Clin Epidemiol | 2023 | Real world treatment practice | Infection | COVID-19 |
| 29 | Validity of Using Japanese Administrative Data to Identify Inpatients With Acute Pulmonary Embolism: Referencing the COMMAND VTE Registry | Kuwauchi A, Yoshida S, Takeda C, et al. | J Epidemiol | 2023 | Validation | Cardiovascular disease | Acute pulmonary embolism |
| 30 | Use of Japanese big data from electronic medical records to investigate risk factors and identify their high-risk combinations for linezolid-induced thrombocytopenia | Inoue Y, Takekuma Y, Miyai T, et al. | Eur J Clin Pharmacol | 2023 | Investigation of risk factors | Blood disease | Thrombocytopenia |
| 31 | Anemia Treatment, Hemoglobin Variability, and Clinical Events in Patients With Nondialysis-Dependent CKD in Japan | Kuragano T, Okami S, Tanaka-Mizuno S, et al. | Kidney360 | 2023 | Real world treatment practice | Blood disease | Anemia in nondialysis-dependent CKD |
| 32 | Systemic steroid therapy for pneumonic chronic obstructive pulmonary disease exacerbation: A retrospective cohort study | Shiroshita A, Anan K, Takeshita M, KataokaY. | PLoS One | 2023 | Effectiveness research | Respiratory disease | Chronic obstructive pulmonary disease (COPD) |
| 33 | A Retrospective Claims Database Study to Clarify Disease Burden of Severe Asthma Patients with Type 2 High or Low Inflammation | Harada N, Makita N, Fukui K, et al. | J Asthma Allergy | 2023 | Real world treatment practice | Respiratory disease | Severe asthma |
| 34 | Real-World Hepatic Safety of Oral Acetaminophen Versus Loxoprofen/Celecoxib: Using a Nationwide Electronic Medical Record Database | Okumura Y, Kimura T, Inokuchi S, et al. | J Clin Pharmacol | 2023 | Investigation of adverse events, side effects, and complications | Digestive diseases | Liver injury |
| 35 | Relationship between the dose titration and adherence of mirogabalin in patients with peripheral neuropathic pain depending on renal function: a nationwide electronic medical record database study | Kato K, Kodama S, Shiosakai K, Kimura T. | Expert Opin Pharmacother | 2023 | Rate of medication adherence/treatment continuation | Neurological disease | Peripheral neuropathic pain |
| 36 | Survival outcomes among patients with multiple myeloma in the era of novel agents: exploratory assessment using an electronic medical record database in Japan | Uno S, Midorikawa S, Inoue K, et al. | PLoS One | 2023 | Real world treatment practice | Cancer | Multiple myeloma |
| 37 | Four-year treatment continuation rates of osteoporosis drugs with different dosing intervals throughout Japan | Idei K, Ryu K, Miura S, et al. | Geriatr Gerontol Int | 2023 | Rate of medication adherence/treatment continuation | Musculoskeletal disease | Osteoporosis |
| 38 | Electronic Health Record-Nested Reminders for Serum Lithium Level Monitoring in Patients With Mood Disorder: Randomized Controlled Trial | Seki T, Aki M, Furukawa TA, et al. | J Med Internet Res | 2023 | Effectiveness research | Mental illness | Mood disorders |
| 39 | Persistence and Safety of Golimumab in Elderly Patients with Rheumatoid Arthritis and Renal Dysfunction in a Real-World Setting | Yokoyama S, Ishii Y, Masuda J. | Drugs Real World Outcomes | 2023 | Real world treatment practice | Musculoskeletal disease | Rheumatoid Arthritis |
| 40 | The effect of preoperative rehabilitation on the prevention of postoperative ileus in colorectal cancer patients | Ushida K, Yamamoto Y, Hori S, et al. | Support Care Cancer | 2023 | Effectiveness research | Cancer | Colorectal cancer |
| 41 | Risk of parkinsonism and related movement disorders with gabapentinoids or tramadol: A case-crossover study | Ri K, Fukasawa T, Yoshida S, et al. | Pharmacotherapy | 2023 | Investigation of adverse events, side effects, and complications | Neurological disease | Parkinsonism and related movement disorders |
| 42 | Risk Factor Analysis of Vancomycin-Induced Nephrotoxicity in Paediatric Patients Aged 0-1 Year Using Japanese Medical Database | Miyai T, Takekuma Y, Kashiwagi H, et al. | Biol Pharm Bull | 2023 | Investigation of risk factors | Others | Vancomycin-induced nephrotoxicity |
| 43 | Longitudinal impact of the COVID-19 pandemic on the development of mental disorders in preadolescents and adolescents | Matsumoto N, Kadowaki T, Takanaga S, et al. | BMC Public Health | 2023 | Investigation of risk factors | Mental illness | COVID-19, eating disorders, schizophrenia, mood disorders, somatoform disorders |
RWD-DBを活用したDB研究の内訳と傾向
RWD-DBを活用したDB研究及び報告は2023年10月11日時点で43件です。
研究テーマや対象とする疾患領域の内訳は以下の通りです。
【研究テーマの内訳】
- 治療実態調査 15件
- リスク因子調査 7件
- 有効性調査 6件
- バリデーション 4件
- 有害事象・副作用・合併症調査 2件
- 服薬アドヒアランス・治療継続率 2件
- 患者実態調査 2件
- 臨床予測 1件
- 医療資源分析・コスト 1件
- その他 3件
【疾患領域の内訳】
- 内分泌・代謝疾患 9件
- 呼吸器疾患 6件
- 血液疾患 5件
- がん 4件
- 筋骨格系疾患 3件
- 精神疾患 3件
- 神経疾患 2件
- 感染症 2件
- 耳疾患 1件
- 泌尿器疾患 1件
- 循環器疾患 1件
- その他 2件
【傾向】
RWD-DBを活用したDB研究のテーマごとの内訳を見てみると、多岐に渡る研究領域・疾患領域に利用されていることが分かります。中でも、特に治療実態の把握を目的とした記述研究が多い傾向にあります。その理由として、RWD-DBがあらゆる医療機関（急性期、慢性期、公的医療機関、民間医療機関等）や疾患、年齢層をカバーしていることが挙げられます。RWD-DBは、電子カルテ（医療機関）由来のDBでありながら、自治体が保有する健康診断の健診情報も集積・保管されており、その点がRWD-DBの最大の強みと言えます。
JMDCやMDVといった他の大きな商用DBや、NDB（レセプト情報・特定健診等情報データベース）等の公的DBと比較すると総登録者数の点で劣るものの、RWD-DBは収集されているデータの特性を見ても汎用性が高く、幅広い研究領域・疾患領域に利活用できるDBと言えます。
最後に
本記事では、RWD-DBの特徴（強み・限界）、DB研究一覧、RWD-DBを活用した研究の傾向についてご紹介しました。DB研究を実施する際は、過去研究の論文を参考にし、各DBがどのような研究目的に利用されているかを理解することが非常に有用です。RWD-DBの利用を検討される方に向けて、本記事が参考になると幸いです。
今後もRWD Naviを通じて、医療情報DBの特徴や各DBを利用した過去研究を紹介していきます。
本メディアを通じてリアルワールドデータの活用の取り組みを広げていきたいと考えていますので是非ご参考にしてください。
※DBに関するご相談も受け付けていますので、こちらよりお問い合わせください。
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- DeSCデータベースを用いたデータベース（DB）研究一覧と研究事例の紹介
