8. スタチンによる骨折予防効果,再現性がない
8
方法 Meier et al (2000) van Staa et al (2001)
データ源 General Practice Research
Database
General Practice Research
Database
研究法 症例対照研究 症例対照研究
オッズ比
(95%信頼区
間)
0.12 (0.04, 0.41) 0.59 (0.31, 1.13)
曝露の定義 インデックス日 (イベント
発現日) から30日未満にお
けるスタチン処方
インデックス日 (イベン
ト発現日) から6か月以内
におけるスタチン処方
マッチング
因子
年齢 (5歳刻み) など 年齢 (各歳) など
Meier CR et al: JAMA. 2000 Jun 28;283(24):3205-10.
van Staa TP et al: JAMA. 2001 Apr 11;285(14):1850-5.
18. ISPE報告ガイドラインの構成
大項目 項目数
A. データ源 8
B. 研究法の全体像 1
C. 適格基準 12
D. 曝露の定義 5
E. 追跡期間 2
F. アウトカムの定義 3
G. 共変量の定義 4
H. 対照群の抽出法 3
I. 統計ソフトウェア 1
18Wang SV et al: Value Health. 2017 Sep;20(8):1009-1022.
21. A1. データ提供者
◼記載事項
◆データ源の名称とデータ提供の組織名
◼事例
⚫ Our cohort study was conducted in commercially insured patients using
the MarketScan health care database provided by Truven (January 1,
2003, through September 30, 2009).[1]
⚫ We used the 2000-2014 Truven Health Analytics MarketScan
Commercial Claims and Encounters databases covering the years 2000
to 2014.[2]
21
[1] Fralick M et al: JAMA Intern Med. 2018 Jan 1;178(1):55-63.
[2] Seamans MJ et al: JAMA Intern Med. 2018 Jan 1;178(1):102-109.
22. A2. データ抽出日
◼記載事項
◆常に更新されているデータ源からデータを抽
出した日 (あるいはバージョン番号) (例: ベン
ダーが研究目的にデータを切り出した日)
◼事例(がみあたらない)
⚫ The source data for this research study was cut by [data vendor] on
January 1st, 2017. The study included administrative claims from Jan 1st
2005 to Dec 31st 2015.
22Wang SV et al: Value Health. 2017 Sep;20(8):1009-1022.
25. A4. データ源の範囲
◼記載事項
◆研究に使用したデータの期間
◼事例
⚫ Our cohort study was conducted in commercially insured patients using
the MarketScan health care database provided by Truven (January 1,
2003, through September 30, 2009).[1]
⚫ We used the 2000-2014 Truven Health Analytics MarketScan Commercial
Claims and Encounters databases covering the years 2000 to 2014.[2]
25
[1] Fralick M et al: JAMA Intern Med. 2018 Jan 1;178(1):55-63.
[2] Seamans MJ et al: JAMA Intern Med. 2018 Jan 1;178(1):102-109.
26. A5. データの種類
◼記載事項
◆情報の領域 (例: 医事会計システム,電子カル
テ,入院・外来,プライマリケア・セカンダリ
ケア,薬局,検査,レジストリ)
◼事例
⚫ This database includes inpatient, outpatient, and pharmaceutical claims
of more than 75 million employees, retirees, and dependents from more
than 150 payers across all states.[1]
⚫ MarketScan contains standardized, deidentified, person-level information
on enrollment, paid inpatient and outpatient services and procedures,
and outpatient pharmacy dispensing claims of employer-sponsored
commercial insurance beneficiaries, their spouses, and dependents.[2]
26
[1] Fralick M et al: JAMA Intern Med. 2018 Jan 1;178(1):55-63.
[2] Seamans MJ et al: JAMA Intern Med. 2018 Jan 1;178(1):102-109.
27. A6. レコードリンケージ
◼記載事項
◆レコードリンケージあるいは通常データベー
スに含まれていないデータ (例: 診療録調査,
調査データ)
◼事例
⚫ We used the United States Renal Data System (USRDS), a national
registry for ESRD [end-stage renal disease], linked to Medicare claims
to define a cohort of beneficiaries with ESRD who received their first LVAD
between 2003 and 2013.[1]
⚫ Data for this study came from PT-MED [Project Talent–Medicare], a
linkage of sociobehavioral data collected from high school students in
1960 to participants’ Medicare claims and expenditures data.[2]
27
[1] Bansal N et al: JAMA Intern Med. 2018 Feb 1;178(2):204-209.
[2] Huang et al: JAMA Network Open. 2018;1(5):e181726.
28. A7. データクリーニング
◼記載事項
◆欠測値や異常値の処理法 (データ源レベルでの
処理あるいはプロジェクトごとの処理)
◼事例(がみあたらない)
⚫ (データ源レベル) All dispensing claims that were missing day’s supply
or had 0 days’ supply were removed from the source data tables.
⚫ (プロジェクトレベル) When calculating duration of exposure for our study
population, we ignored dispensation claims that were missing or had 0
days’ supply.
28Wang SV et al: Value Health. 2017 Sep;20(8):1009-1022.
29. A8. 標準化形式への変換法
◼記載事項
◆標準化された形式へのデータの変換法
◼事例
⚫ We used three US claims databases: 1. Truven Commercial Claims and
Encounters (CCAE), 2. TruvenMarketScan Medicare Supplemental
Beneficiaries (MDCR), and 3. OptumInsight‘s de‐identified
ClinformaticsTMDatamart (Optum). …(中略)… All the databases were
converted to the Observational Medical Outcomes Partnership
(OMOP) common data model (CDM) (Stang et al., 2010). One advantage
of a standardized format and content is that the same analytic code can be
applied to all three databases (Voss et al., 2015).
29Cepeda MS et al: Depress Anxiety. 2018 Mar;35(3):220-228.
42. C1. 研究への組み入れ日
◼記載事項
◆参加者をコホートに組み入れる最初の日 (イン
デックス日)
◼事例
⚫ We included patients 55 years or older who filled a new prescription for
telmisartan or ramipril (no fills for either drug or any other ACE-I or ARB
during the prior 180 days). Cohort entry date was the first day of a
prescription fill.[1]
⚫ The cohort entry date was set as the date of the first COPD outpatient
visit or the discharge date from a COPD hospitalization.[2]
42
[1] Fralick M et al: JAMA Intern Med. 2018 Jan 1;178(1):55-63.
[2] Wang MT et al: JAMA Intern Med. 2018 Feb 1;178(2):229-238.
43. C2. 組み入れ単位
◼記載事項
◆参加者をコホートに組み入れる単位 (例: 患者
単位あるいはエピソード単位)
◼事例
⚫ For this study, we identified all adult hospitalizations (aged ≥18 years)
between 1 January and 31 December 2014 that were associated with a
procedure code corresponding to peripheral arterial revascularization
(endovascular or surgical). (中略) Patients were allowed to contribute
more than 1 admission as long as it occurred more than 30 days after
any previously included admission or readmission.
43Secemsky EA et al: Ann Intern Med. 2018 Jan 16;168(2):93-99.
44. C3. 適格基準の順序
◼記載事項
◆適格基準を適用する順序,具体的には,イン
デックス日を設定する前あるいは後に適格基準
を適用しているか否か
◼事例
⚫ Cohort entry date was the first day of a prescription fill. As in
ONTARGET, we included patients with a diagnosis of coronary artery
disease, peripheral artery disease, cerebrovascular disease, or diabetes
mellitus during the 180 days before cohort entry.[1]
⚫ The cohort entry date was set as the date of the first COPD outpatient
visit or the discharge date from a COPD hospitalization. We excluded
patients who had received any LABA-LAMA [long-acting β2-agonists-
antimuscarinic antagonists] therapy or who lacked continuous health
insurance coverage for 1 year preceding cohort entry.[2]
44
[1] Fralick M et al: JAMA Intern Med. 2018 Jan 1;178(1):55-63.
[2] Wang MT et al: JAMA Intern Med. 2018 Feb 1;178(2):229-238.
45. C4. 加入期間
◼記載事項
◆インデックス日の前に,参加者がデータ源に
含まれることを保証する期間
◼事例
⚫ Potentially eligible patients must have had at least 6 month of
continuous enrollment in a participating health plan before the date
of cohort entry.[1]
⚫ The study population included all beneficiaries in this database who were
11 years or older who had an induced abortion between January 1, 2011,
and December 31, 2014, in an ASC or office-based setting and who were
enrolled in their insurance plan for at least a year prior to the index
abortion and at least 6 weeks after the abortion.[2]
45
[1] Fralick M et al: JAMA Intern Med. 2018 Jan 1;178(1):55-63.
[2] Roberts SCM et al: JAMA. 2018 Jun 26;319(24):2497-2506.
46. C5. 加入のギャップ
◼記載事項
◆データ源への加入状況を評価するアルゴリズ
ム,間隔を設定するか否かを含む
◼事例(がみあたらない)
⚫ Patients entered the cohort on the date of their first dispensation for Drug
X or Drug Y after at least 180 days of continuous enrolment (30 day
gaps allowed) without dispensings for either Drug X or Drug Y.
46Wang SV et al: Value Health. 2017 Sep;20(8):1009-1022.
47. C6. 適格基準の評価期間
◼記載事項
◆適格基準を評価する期間
◼事例
⚫ We identified a cohort of ED[emergency department] patients in 2011
to 2012 with a diagnosis of chest pain or angina pectoris among patients
ages 18 to 64 (eFigure in the Supplement).[1]
⚫ Household members entered either the opioid or NSAID cohort at the
index date anchored to the date of initiation by Patient 0. Eligible index
dates were those occurring between January 1, 2001, and December
31, 2014, to ensure observation of the 1-year baseline.[2]
47
[1] Sandhu AT et al: JAMA Intern Med. 2017 Aug 1;177(8):1175-1182.
[2] Seamans MJ et al: JAMA Intern Med. 2018 Jan 1;178(1):102-109.
49. C8. コードの時間的関係
◼記載事項
◆コードの時間的関係。インデックス日に適
格基準などの測定期間が含まれるかを明ら
かにする。
◼事例
⚫ Patients were excluded if they were younger than 20 years of age at the
index date or if they had a medical history of PAD [peripheral artery
disease], DVT [deep venous thrombosis], or PE [pulmonary embolism]
before or on the index date (see eTable 1 in the Supplement for ICD-9-
CM codes)
49Chang SL et al: JAMA. 2018 Feb 27;319(8):807-817.
50. C9. 診断区分
◼記載事項
◆診断区分の限定 (例: 主傷病 vs. 副傷病)
◼事例
⚫ We identified CVD [cardiovascular disease] cases as patients who had
made an inpatient or emergency department (ER) visit with a primary
diagnosis of coronary heart disease (International Classification of
Diseases, 9th Revision, Clinical Modification [ICD-9-CM], codes 410–414),
cardiac arrhythmia (code 427), heart failure (code 428), or ischemic stroke
(codes 433-434).
⚫ Patients must have had a primary or nonprimary diagnosis of at least
one of the International Classification of Diseases, Ninth Revision, Clinical
Modification (ICD-9-CM) codes (Table 1), referred to collectively as
‘‘dysphonia’’ diagnoses.
50
[1] Wang MT et al: JAMA Intern Med. 2018 Feb 1;178(2):229-238.
[2] Cohen SM et al: Otolaryngol Head Neck Surg. 2012 Dec;147(6):1099-107.
51. C10. ケアのセッティング
◼記載事項
◆ケアのセッティングの限定 (例: 入院,救急,
介護施設)
◼事例
⚫ We identified a cohort of ED[emergency department] patients in 2011
to 2012 with a diagnosis of chest pain or angina pectoris among patients
ages 18 to 64 (eFigure in the Supplement).[1]
⚫ This retrospective cohort study included household members of patients
who initiated use of prescription opioids or prescription NSAIDs
based on outpatient pharmacy dispensing claims (henceforth, we refer
to the index patient as “Patient0”).
51
[1] Sandhu AT et al: JAMA Intern Med. 2017 Aug 1;177(8):1175-1182.
[2] Seamans MJ et al: JAMA Intern Med. 2018 Jan 1;178(1):102-109.
52. C11. 曝露のウォッシュアウト
◼記載事項
◆曝露が新規であることを保証するための
ウォッシュアウト期間
◼事例
⚫ We included patients 55 years or older who filled a new prescription for
telmisartan or ramipril (no fills for either drug or any other ACE-I or
ARB during the prior 180 days).[1]
⚫ We excluded patients who had received any LABA-LAMA [long-acting
β2-agonists- antimuscarinic antagonists] therapy or who lacked
continuous health insurance coverage for 1 year preceding cohort
entry.[2]
52
[1] Fralick M et al: JAMA Intern Med. 2018 Jan 1;178(1):55-63.
[2] Wang MT et al: JAMA Intern Med. 2018 Feb 1;178(2):229-238.
53. C12. アウトカムのウォッシュアウト
◼記載事項
◆アウトカムが新規であることを保証するため
のウォッシュアウト期間
◼事例
⚫ We included a baseline period of 6 months prior to the index date.
Patients were excluded if they met any of the following criteria: sex
unknown; 中略; and having an outcome(s) of interest in the baseline
period.[1]
⚫ We also excluded patients who had received a cancer diagnosis (other
than nonmelanoma skin cancer) at any time before cohort entry, as well as
those previously hospitalized for hypoglycemia (ICD-10 codes E15,
E16.0, E16.1, and E16.2, in primary or secondary position) in the year
before cohort entry.[2]
53
[1] Chang HY et al: JAMA Intern Med. 2018 Sep 1;178(9):1190-1198.
[2] Fournier JP et al: JAMA Intern Med. 2015 Feb;175(2):186-93.
57. D1. 曝露の種類
◼記載事項
◆曝露の種類 (例: 新規使用,継続使用,累積,
時間依存)
◼事例(新規使用)
⚫ To prevent survivor bias and covariate measurement bias, we selected a
“new users design” over “all statin users.”ref We defined a new user as
anyone who received statin treatment (simvastatin, pravastatin,
lovastatin, fluvastatin, rosuvastatin, atorvastatin) for the first time ever, or
who initiated statin treatment with no such pharmay invoicing
recorded during the previous 18 months.
57Ramos R et al: BMJ. 2018 Sep 5;362:k3359.
58. D1. 曝露の種類
◼事例(新規・継続使用)
⚫ We examined all LABA and LAMA prescription records in the year before
the index date for both cases and controls. Specifically, drug use was
classified into current (≤30 days), recent (31-90 days), past (91-180
days), and remote (>180 days) use based on the most recent
prescription date preceding the index date. Current users were further
classified as new users if they had no other dispensing records in the
31 to 365 days before the index date and prevalent users otherwise.
58
30日以内に処方
インデックス日
31~365日に処方なし
30日以内に処方31~365日に処方あり
新規使用
継続使用
Wang MT et al: JAMA Intern Med. 2018 Feb 1;178(2):229-238.
59. D1. 曝露の種類
◼事例(時間依存)
⚫ For the primary exposure of interest, for each day of follow-up, we
classified exposure to antidiabetic drugs into six categories that were
not mutually exclusive: any sitagliptin use, any metformin use, any
sulfonylurea use, any thiazolidinedione use, other oral antidiabetic drug
use (acarbose, meglitinides, pramlintide), and any insulin use.
59
インデックス日
Eurich DT et al: BMJ. 2013 Apr 25;346:f2267
シタグリプチン処方処方なし
メトフォルミン処方 処方なし メトフォルミン処方
スルホニルウレア処方処方なし
60. D2. 曝露によるリスク持続期間
◼記載事項
◆曝露によりイベントが発現しうると想定され
るリスク持続期間(exposure risk window)。薬剤の
場合は誘導期間の最小値と最大値の差となる。
◼事例
⚫ Exposure status was assigned based on the initiated medication, and
follow-up began on the initiation date. …(中略)… Each patient's exposure
risk window ended when the subject had been without antidepressant
supply for 14 days.[1]
⚫ The exposure risk window for the primary analysis was 7–60 days
following each dose.[2]
60
[1] Schneeweiss S et al: Arch Gen Psychiatry. 2010 May;67(5):497-506.
[2] Liu EY et al: CMAJ. 2018 May 28;190(21):E648-E655.
62. D2a. 誘導期間
◼記載事項
◆インデックス日以降に,曝露した期間あるい
は非曝露した期間として,アウトカムを評価し
ない期間(induction period)
◼事例
⚫ All exposures were lagged by one year to account for a minimum
latency period and to minimise reverse causality. Thus, patients initiating
a glucose lowering drug were considered unexposed until one year
after the date of the first prescription and considered exposed
thereafter.
62Hicks BM et al: BMJ. 2016 Oct 20;355:i5340.
63. D2b. 残薬
◼記載事項
◆リフィルが早まった場合における,残薬への
対処法
◼事例
⚫ We separately addressed early drug refills using an approach that
attempts to balance possible stockpiling with other situations in which the
patient has used up the earlier prescription. Toward that end, we used a
7-day limit for early refills for both dabigatran and warfarin, such that
for any refill that occurred within 7 days before the predicted end of a first
prescription, the additional days were added to the end of the second
prescription for consecutive prescriptions.
63Go AS et al: Ann Intern Med. 2017 Dec 19;167(12):845-854
7日分 2日追加
7日分 (2日重複)
64. D2c. 曝露継続の猶予期間
◼記載事項
◆想定されるよりも処方間隔が空く場合におけ
る,曝露が継続しているとみなす方法
◼事例
⚫ In primary analyses, we allowed a grace period of up to 7 days between
the estimated end date of any prescription and the start date of the
next prescription, based on the days‘ supply information from each,
to consider a patient continuously exposed to the drug of interest.
64
処方 (7日間) 処方なし (7日間) 処方 (7日間)
処方 (21日間)
Go AS et al: Ann Intern Med. 2017 Dec 19;167(12):845-854.
65. D2d. 曝露の延長
◼記載事項
◆最終処方時における投与日数を超えて,曝露
とみなす期間
◼事例
⚫ We defined each individual’s last date of observation as the earliest of
the following 6 dates: (1) the last date of continuous exposure to the
assigned medication, which was the last day of continuous drug at
hand plus 30 days (we used 30 days to account for the clearance of
the drug since the half-life of SGLT-2 inhibitors is hours)ref ; (2) the
date prior to the switch to or the addition of other newer agents; (後略)
65
処方 (7日間) 処方なし
処方 (37日間)
Chang HY et al: JAMA Intern Med. 2018 Sep 1;178(9):1190-1198.
66. D3. スイッチ/増強療法
◼記載事項
◆他の曝露が始まった場合の対処法
◼事例
⚫ We defined each individual’s last date of observation as the earliest of
the following 6 dates: (1) the last date of continuous exposure to the
assigned medication, which was the last day of continuous drug at hand
plus 30 days (we used 30 days to account for the clearance of the drug
since the half-life of SGLT-2 inhibitors is hours)ref ; (2) the date prior to
the switch to or the addition of other newer agents; (後略)
66Chang HY et al: JAMA Intern Med. 2018 Sep 1;178(9):1190-1198.
68. D5. 曝露の測定期間
68
◼事例(症例対照研究)
⚫ We examined all LABA and LAMA prescription records in the year
before the index date for both cases and controls. Specifically, drug use
was classified into current (≤30 days), recent (31-90 days), past (91-180
days), and remote (>180 days) use based on the most recent prescription
date preceding the index date. Current users were further classified as new
users if they had no other dispensing records in the 31 to 365 days before
the index date and prevalent users otherwise.
Wang MT et al: JAMA Intern Med. 2018 Feb 1;178(2):229-238.
30日以内に処方
インデックス日
31~365日に処方なし
69. D5. 曝露の測定期間
◼事例(コホート研究)
⚫ Participants were classified into four groups on the basis of physician
follow-up within 30 days postdischarge: no physician follow-up
(reference group), follow-up by a PCP [primary care physician] only,
follow-up by a psychiatrist only, and follow-up by both a PCP and
psychiatrist.
69Kurdyak P et al: Psychiatr Serv. 2018 Jan 1;69(1):61-68.
インデックス日
(退院日)
再入院の測定期間 (180日間)
フォローアップ受診
の測定期間 (30日間)
73. E1-2. 追跡期間と打ち切り
◼事例
⚫ For each patient, follow-up for outcomes began the day after
treatment initiation. Patients were censored at occurrence of the
outcome of interest, treatment discontinuation (14 day grace period
from end of days’ supply), death, disenrollment, prescription dispensation
of another anticoagulant, or end of available data.
73
インデックス日
(抗凝固剤の新規使用)
追跡期間 (血栓塞栓症などの発症)
打ち切り
(イベント発生/治療中断/死亡/離脱/他
剤への変更/データ源の最終日)
Wang SV et al: BMJ. 2016 May 24;353:i2607.
74. E1-2. 追跡期間と打ち切り
◼事例
⚫ All patients were followed from the year after cohort entry until a first
ever diagnosis of bladder cancer (malignant and in situ), or censored on
death from any cause, end of registration with the general practice, or
end of the study period (31 July 2014), whichever occurred first.
74
インデックス日
(糖尿病薬の新規使用)
追跡期間 (膀胱がんの発症)誘導期間 (1年間)
打ち切り
(死亡/登録中止/データ源の最終日)
Tuccori M et al: BMJ. 2016 Mar 30;352:i1541.
77. F1. イベント発生日
◼記載事項
◆イベント発生日の定義
◼事例(曝露の測定時点)
⚫ Because IV [intravenous] iron-associated anaphylaxis cases reported from
clinical trials and spontaneous adverse events indicate that anaphylaxis
generally occurs within a few hours of IV iron administration,ref
anaphylaxis cases in this study were limited, for the primary analysis, to
only those captured on the same date as the IV iron administration,
which may plausibly increase the positive predictive value of the
algorithm.
77Wang et al: JAMA. 2015 Nov 17;314(19):2062-8.
投与日のアナフィ
ラキシー反応
静注デキストラ
ン鉄
超短期
78. F1. イベント発生日
◼事例(退院時診断の入院日)
⚫ Our outcome was severe hypotension requiring hospital admission.
The outcome was ascertained as a primary hospital discharge diagnosis
of hypotension (ICD-9-CM codes 458.0, 458.1, or 458.9). This algorithm
has been used in a previous study,ref the event was considered to occur
on the first day of admission to hospital, and the ascertainment can be
considered validated as a falsification endpoint.ref
78Bird ST et al: BMJ. 2013 Nov 5;347:f6320.
高血圧による入院日
(退院時診断)塩酸タムスロシン
短~長期
79. F3. 妥当性
◼記載事項
◆アウトカムの定義の妥当性
◼事例
⚫ The primary clinical outcome comprised hospitalization for an acute
coronary syndrome or stroke and all-cause mortality. We also examined
each of these outcomes separately. We used a validated claims-based
definition for each outcome, with positive predictive values ranging
from 86% to 96%.ref [1]
⚫ Our primary outcome was a composite of myocardial infarction, stroke, or
hospitalization for congestive heart failure using the primary discharge
diagnosis code for an inpatient visit (see eTable 1 in the Supplement for
International Classification of Diseases, Ninth Revision codes). These
definitions have satisfactory measurement characteristics; the positive
predictive value for myocardial infarction was 93% or higher; stroke, 81%
or higher; and congestive heart failure, 87% or higher.ref [2]
79
[1] Gagne JJ et al: Ann Intern Med. 2014 Sep 16;161(6):400-7.
[2] Fralick M et al: JAMA Intern Med. 2018 Jan 1;178(1):55-63
82. G1. 共変量の測定期間
◼記載事項
◆共変量を測定する期間
◼事例
⚫ In addition to age and sex, data on the following potential confounders
were collected from Medicare claims during the 12-month period
preceding the index date: history of food allergies, history of drug
allergy, asthma, chronic obstructive pulmonary disease, coronary heart
disease, hypertension, and indications for IV iron use (eAppendixes 2 and 3
in the Supplement).
82Wang et al: JAMA. 2015 Nov 17;314(19):2062-8.
83. G2. 併存症・リスクスコア
◼記載事項
◆リスクスコアの計算に使用する構成要素や重み
◼事例
⚫ The Romano modification of the Charlson Comorbidity Index, based on
inpatient and outpatient claims in the year before RCC [renal cell carcinoma]
treatment, was used as a summary measure of comorbidity burden.ref [1]
⚫ The adapted Diabetes Complications Severity Index score measures an
individual’s diabetes severity using claims only and is the sum of 7
diabetes complications graded by severity as 0, 1, or 2 (as the severity
increases, the score increases); it ranges from 0 to 13 (0 indicates no
complications and 13 indicates the most severe complications).ref [2]
83
[1] Talenfeld AD et al: Ann Intern Med. 2018 Jul 17;169(2):69-77.
[2] Chang HY et al: JAMA Intern Med. 2018 Sep 1;178(9):1190-1198.
84. G3. 受療に関する統計量
◼記載事項
◆特定期間における受診回数や検査回数の算定
法。ケアのセッティングや受診/検査の種類を
層別することがある。
◼事例
⚫ We measured potential confounders in the 180-day baseline period
preceding each patient’s index date. Demographic variables included age,
sex, and race. Health service utilization variables included the number
of unique drugs dispensed, number of hospitalizations, number of
cardiovascular diagnoses, number of days in the hospital, number of
physician office visits, and number of physician office visits with
cardiovascular diagnoses.
84Gagne JJ et al: Ann Intern Med. 2014 Sep 16;161(6):400-7.
88. 追跡開始 追跡終了
H1. 抽出法
◼事例(risk-set sampling)
⚫ We matched each case to up to 100 controls. Controls were randomly
selected by risk set sampling from all cohort members whose follow-up
did not end before the index date of the considered case (that is, among
individuals still at risk of an admission for heart failure).
88Arfè A et al: BMJ. 2016 Sep 28;354:i4857.
●症例群
●時間がマッチした対照群
患者1
患者2
患者3
患者4
患者5
89. H2. マッチング因子
◼記載事項
◆症例群にマッチした対照群を抽出するために
使用する変数
◼事例
⚫ Control participants were matched to case patients by index date as well
as by age (individual years) and county of residence on that date.
89Wiese AD et al: Ann Intern Med. 2018 Mar 20;168(6):396-404.
90. H3. マッチングの構成比
◼記載事項
◆マッチングの構成比 (固定あるいは変動)
◼事例
⚫ We used incidence density sampling to randomly select up to 20 cohort
members at risk but without laboratory-confirmed IPD (control
participants) per case patient.
90Wiese AD et al: Ann Intern Med. 2018 Mar 20;168(6):396-404.
91. 推奨文献
91
データベースによる治療
効果研究の留意事項
Hudson M et al: Nat Rev Rheumatol. 2016 Jun;12(6):358-66.
Food and Drug Administration: https://www.fda.gov/downloads/drugs/guidances/ucm243537.pdf
FDAによる安全性
比較研究の指針