ICMJEのRecommendations では、Methodsにおいて記載すべき技術的情報について、下記の通り定められています。

Technical Information

Specify the study’s main and secondary objectives—usually identified as primary and secondary outcomes. Identify methods, equipment (give the manufacturer’s name and address in parentheses), and procedures in sufficient detail to allow others to reproduce the results. Give references to established methods, including statistical methods (see below); provide references and brief descriptions for methods that have been published but are not well-known; describe new or substantially modified methods, give the reasons for using them, and evaluate their limitations. Identify precisely all drugs and chemicals used, including generic name(s), dose(s), and route(s) of administration. Identify appropriate scientific names and gene names.”



研究の主要・副次的目的(一般に主要評価項目、副次的評価項目)を明らかにする。用いられた手法、機器 (括孤内に製造メーカーと所在地を記載)、手順について、他の研究者が結果を再現できるよう詳細を記載する。統計手法(後述の「統計解析」の項を参照)も含め、すでに確立されている手法については、文献を引用する。発表されているが一般に知られていない手法については、文献引用とともに簡単な説明を加える。新しい手法や大幅な変更を加えた手法については、説明とともに、その手法を用いた理由と、その限界も示す。使用したすべての薬剤や化学物質について、一般名、投与量、投与経路を正確に記載する。生物学名および遺伝子名を適切に記載する。



✅ 主要・副次的目的


  • The primary endpoint was progression-free survival, as determined by the independent review committee.
  • The primary endpoint was the change in FEV1 by spirometry at week XX after treatment.



  • Low-density lipoprotein (LDL) was isolated from plasma by ultracentrifugation (Beckman Coulter Inc., CA).
  • Statistical analysis was carried out using SAS version XX (SAS institute, Cary, NC).



  • Blood pressure was measured according to recommended guidelines [Reference].
  • Pain severity was measured using visual analog scale [Reference].



  • Patients received Drug A XX mg/kg by intravenous infusion on day 1 of a 21-day cycle.
  • Drug B was taken orally once daily at XX mg/day for 3 months.



  • The study enrolled patients with advanced non-small-cell lung cancer (NSCLC) harbouring mutations in EGFR gene.
  • Patients aged >5 years with blood cultures positive for Klebsiella pneumoniae were enrolled.



  • Articles were identified through searches of MEDLINE from 20XX to 20XX. Search terms included AA, BB and CC. All prospective randomized clinical studies were included.