PMID- 37667583
OWN - NLM
STAT- MEDLINE
DCOM- 20230906
LR  - 20230907
IS  - 1598-6357 (Electronic)
IS  - 1011-8934 (Print)
IS  - 1011-8934 (Linking)
VI  - 38
IP  - 35
DP  - 2023 Sep 4
TI  - Developing Operational Definitions Related to Helicobacter pylori Eradication 
      Therapy.
PG  - e278
LID - 10.3346/jkms.2023.38.e278 [doi]
LID - e278
AB  - BACKGROUND: The lack of well-established operational definitions is a major 
      limitation of Helicobacter pylori eradication studies that use secondary 
      databases. We aimed to develop and validate operational definitions related to H. 
      pylori eradication therapy. METHODS: Operational definitions were developed by 
      analyzing a nationwide H. pylori eradication registry and validated using 
      real-world data from hospital medical records. The primary endpoint was the 
      sensitivity of the operational definitions in identifying individuals who 
      received H. pylori eradication therapy. The secondary endpoint was the 
      sensitivity and specificity of the operational definition in identifying 
      successful H. pylori eradication therapy. RESULTS: H. pylori eradication therapy 
      was defined as a prescription for one of the following combinations: 1) proton 
      pump inhibitor (PPI) + amoxicillin + clarithromycin, 2) PPI + amoxicillin + 
      metronidazole, 3) PPI + metronidazole + tetracycline, 4) PPI + amoxicillin + 
      levofloxacin, 5) PPI + amoxicillin + moxifloxacin, or 6) PPI + amoxicillin + 
      rifabutin. In the validation set, the sensitivity of the operational definition 
      for identifying individuals who received H. pylori eradication therapy was 99.7% 
      and 99.8% for the first- and second-line therapies, respectively. Operational 
      definition to determine success or failure of the H. pylori eradication therapy 
      was developed based on a confirmatory test and the prescription of rescue 
      therapy. The sensitivity and specificity of the operational definition for 
      predicting successful eradication were 97.6% and 91.4%, respectively, in 
      first-line therapy and 98.6% and 54.8%, respectively, in second-line therapy. 
      CONCLUSION: We developed and validated operational definitions related to H. 
      pylori eradication therapy. These definitions will help researchers perform 
      various H. pylori eradication-related studies using secondary databases.
CI  - (c) 2023 The Korean Academy of Medical Sciences.
FAU - Park, Chan Hyuk
AU  - Park CH
AUID- ORCID: 0000-0003-3824-3481
AD  - Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang 
      University College of Medicine, Guri, Korea.
FAU - Jung, Sun-Young
AU  - Jung SY
AUID- ORCID: 0000-0003-2032-112X
AD  - College of Pharmacy, Chung-Ang University, Seoul, Korea.
AD  - Department of Global Innovative Drugs, The Graduate School of Chung-Ang 
      University, Seoul, Korea.
FAU - Lee, Ju Won
AU  - Lee JW
AUID- ORCID: 0000-0003-2956-3344
AD  - College of Pharmacy, Chung-Ang University, Seoul, Korea.
AD  - Department of Global Innovative Drugs, The Graduate School of Chung-Ang 
      University, Seoul, Korea.
FAU - Yang, Hyo-Joon
AU  - Yang HJ
AUID- ORCID: 0000-0002-0265-672X
AD  - Division of Gastroenterology, Department of Internal Medicine and 
      Gastrointestinal Cancer Center, Kangbuk Samsung Hospital, Sungkyunkwan University 
      School of Medicine, Seoul, Korea.
FAU - Kim, Joon Sung
AU  - Kim JS
AUID- ORCID: 0000-0001-9158-1012
AD  - Division of Gastroenterology, Department of Internal Medicine, Incheon St. Mary's 
      Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
FAU - Kim, Beom Jin
AU  - Kim BJ
AUID- ORCID: 0000-0002-0938-6697
AD  - Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, 
      Korea.
FAU - Choi, Soo In
AU  - Choi SI
AUID- ORCID: 0000-0001-6156-5898
AD  - Division of Gastroenterology, Department of Internal Medicine, Inje University 
      Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.
FAU - Seo, Seung In
AU  - Seo SI
AUID- ORCID: 0000-0003-4417-0135
AD  - Department of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym 
      University College of Medicine, Seoul, Korea.
FAU - Lee, Joongyub
AU  - Lee J
AUID- ORCID: 0000-0003-2784-3772
AD  - Department of Preventive Medicine, Seoul National University College of Medicine, 
      Seoul, Korea.
FAU - Kim, Jae Gyu
AU  - Kim JG
AUID- ORCID: 0000-0002-4841-9404
AD  - Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, 
      Korea. jgkimd@cau.ac.kr.
CN  - Korean Research Association for Helicobacter and Microbiome
LA  - eng
PT  - Journal Article
DEP - 20230904
PL  - Korea (South)
TA  - J Korean Med Sci
JT  - Journal of Korean medical science
JID - 8703518
RN  - 140QMO216E (Metronidazole)
RN  - 0 (Anti-Bacterial Agents)
RN  - 804826J2HU (Amoxicillin)
RN  - 0 (Proton Pump Inhibitors)
SB  - IM
MH  - Humans
MH  - *Helicobacter pylori
MH  - Metronidazole/therapeutic use
MH  - Research Design
MH  - Anti-Bacterial Agents/therapeutic use
MH  - Amoxicillin/therapeutic use
MH  - Proton Pump Inhibitors/therapeutic use
PMC - PMC10477078
OTO - NOTNLM
OT  - Eradication
OT  - Helicobacter pylori
OT  - Operational Definition
COIS- The authors have no potential conflicts of interest to disclose.
EDAT- 2023/09/05 06:42
MHDA- 2023/09/06 06:42
PMCR- 2023/09/04
CRDT- 2023/09/05 02:43
PHST- 2023/02/19 00:00 [received]
PHST- 2023/04/26 00:00 [accepted]
PHST- 2023/09/06 06:42 [medline]
PHST- 2023/09/05 06:42 [pubmed]
PHST- 2023/09/05 02:43 [entrez]
PHST- 2023/09/04 00:00 [pmc-release]
AID - 38.e278 [pii]
AID - 10.3346/jkms.2023.38.e278 [doi]
PST - epublish
SO  - J Korean Med Sci. 2023 Sep 4;38(35):e278. doi: 10.3346/jkms.2023.38.e278.