PMID- 36266618
OWN - NLM
STAT- MEDLINE
DCOM- 20221024
LR  - 20221027
IS  - 1471-2288 (Electronic)
IS  - 1471-2288 (Linking)
VI  - 22
IP  - 1
DP  - 2022 Oct 20
TI  - An innovative approach based on real-world big data mining for calculating the 
      sample size of the reference interval established using transformed parametric 
      and non-parametric methods.
PG  - 275
LID - 10.1186/s12874-022-01751-1 [doi]
LID - 275
AB  - BACKGROUND: Currently, the direct method is the main approach for establishment 
      of reference interval (RI). However, only a handful of studies have described the 
      effects of sample size on establishment of RI and estimation of sample size. We 
      describe a novel approach for estimation of the sample size when establishing RIs 
      using the transformed parametric and non-parametric methods. METHODS: A total of 
      3,697 healthy participants were enrolled in this study. We adopted a two-layer 
      nested loop sample size estimation method to determine the effects of sample size 
      on RI, using thyroid-related hormone as an example. The sample size was selected 
      as the calculation result when the width of the confidence interval (CI) of the 
      upper and lower limit of the RI were both stably < 0.2 times the width of RI. 
      Then, we calculated the sample size for establishing RIs via transformed 
      parametric and non-parametric methods for thyroid-related hormones. RESULTS: 
      Sample sizes for thyroid stimulating hormone (TSH), as required by parametric and 
      non-parametric methods to establish RIs were 239 and 850, respectively. Sample 
      sizes required by the transformed parametric method for free triiodothyronine 
      (FT3), free thyroxine (FT4), total triiodothyronine (TT3) and total thyroxine 
      (TT4) were all less than 120, while those required by the non-parametric method 
      were more than 120. CONCLUSION: We describe a novel approach for estimating 
      sample sizes for establishment of RI. A corresponding open-source code has been 
      developed and is available for applications. The established method is suitable 
      for most analytes, with evidence based on thyroid-related hormones indicating 
      that different sample sizes are required to establish RIs using different methods 
      for analytes with different variations.
CI  - (c) 2022. The Author(s).
FAU - Ma, Chaochao
AU  - Ma C
AD  - Department of Laboratory Medicine, Peking Union Medical College, Peking Union 
      Medical College Hospital, Chinese Academy of Medical Science, 100730, Beijing, PR 
      China.
FAU - Hou, Li'an
AU  - Hou L
AD  - Department of Laboratory Medicine, Peking Union Medical College, Peking Union 
      Medical College Hospital, Chinese Academy of Medical Science, 100730, Beijing, PR 
      China.
FAU - Zou, Yutong
AU  - Zou Y
AD  - Department of Laboratory Medicine, Peking Union Medical College, Peking Union 
      Medical College Hospital, Chinese Academy of Medical Science, 100730, Beijing, PR 
      China.
FAU - Ma, Xiaoli
AU  - Ma X
AD  - Department of Laboratory Medicine, Peking Union Medical College, Peking Union 
      Medical College Hospital, Chinese Academy of Medical Science, 100730, Beijing, PR 
      China.
FAU - Wang, Danchen
AU  - Wang D
AD  - Department of Laboratory Medicine, Peking Union Medical College, Peking Union 
      Medical College Hospital, Chinese Academy of Medical Science, 100730, Beijing, PR 
      China.
FAU - Hu, Yingying
AU  - Hu Y
AD  - Department of Laboratory Medicine, Peking Union Medical College, Peking Union 
      Medical College Hospital, Chinese Academy of Medical Science, 100730, Beijing, PR 
      China.
FAU - Song, Ailing
AU  - Song A
AD  - Department of Laboratory Medicine, Peking Union Medical College, Peking Union 
      Medical College Hospital, Chinese Academy of Medical Science, 100730, Beijing, PR 
      China.
FAU - Cheng, Xinqi
AU  - Cheng X
AD  - Department of Laboratory Medicine, Peking Union Medical College, Peking Union 
      Medical College Hospital, Chinese Academy of Medical Science, 100730, Beijing, PR 
      China.
FAU - Qiu, Ling
AU  - Qiu L
AD  - Department of Laboratory Medicine, Peking Union Medical College, Peking Union 
      Medical College Hospital, Chinese Academy of Medical Science, 100730, Beijing, PR 
      China. lingqiubj@163.com.
AD  - State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical 
      College, Peking Union Medical College Hospital, Chinese Academy of Medical 
      Science, 100730, Beijing, PR China. lingqiubj@163.com.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20221020
PL  - England
TA  - BMC Med Res Methodol
JT  - BMC medical research methodology
JID - 100968545
RN  - Q51BO43MG4 (Thyroxine)
RN  - 06LU7C9H1V (Triiodothyronine)
RN  - 9002-71-5 (Thyrotropin)
SB  - IM
MH  - Humans
MH  - *Thyroxine
MH  - *Triiodothyronine
MH  - Sample Size
MH  - Reference Values
MH  - Thyrotropin
MH  - Data Mining
PMC - PMC9585851
OTO - NOTNLM
OT  - Data mining
OT  - Reference interval
OT  - Sample size
COIS- The authors declare that they have no competing interests.
EDAT- 2022/10/21 06:00
MHDA- 2022/10/25 06:00
PMCR- 2022/10/20
CRDT- 2022/10/20 23:59
PHST- 2022/03/25 00:00 [received]
PHST- 2022/10/06 00:00 [accepted]
PHST- 2022/09/07 00:00 [revised]
PHST- 2022/10/20 23:59 [entrez]
PHST- 2022/10/21 06:00 [pubmed]
PHST- 2022/10/25 06:00 [medline]
PHST- 2022/10/20 00:00 [pmc-release]
AID - 10.1186/s12874-022-01751-1 [pii]
AID - 1751 [pii]
AID - 10.1186/s12874-022-01751-1 [doi]
PST - epublish
SO  - BMC Med Res Methodol. 2022 Oct 20;22(1):275. doi: 10.1186/s12874-022-01751-1.