Evidence map›Paper›PMID 32046752›Full record

ArticleTrials2020

Improving the accuracy and efficacy of diagnosing polycystic ovary syndrome by integrating metabolomics with clinical characteristics: study protocol for a randomized controlled trial.

Cheng-Ming Ni, Wen-Long Huang, Yan-Min Jiang, Juan Xu, Ru Duan, Yun-Long Zhu, Xu-Ping Zhu, Xue-Mei Fan, Guo-An Luo, Yi-Ming Wang and 3 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Cheng-Ming NiDepartment of Endocrinology, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Nanjing Medical University, Wuxi, 214023, China.
Wen-Long HuangDepartment of Endocrinology, Jiangyin People's Hospital, Wuxi, 214400, China.
Yan-Min JiangDepartment of Endocrinology, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Nanjing Medical University, Wuxi, 214023, China.
Juan XuDepartment of Endocrinology, Jiangyin People's Hospital, Wuxi, 214400, China.
Ru DuanDepartment of Good Clinical Practice (GCP), The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi, 214023, China.
Yun-Long ZhuDepartment of Endocrinology, The Affiliated Wuxi Maternal and Child Health Centers Clinical Hospital of Nanjing Medical University, Wuxi, 214023, China.
Xu-Ping ZhuDepartment of Endocrinology, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Nanjing Medical University, Wuxi, 214023, China.
Xue-Mei FanKey Laboratory of Bioorganic Phosphorus Chemistry and Chemical Biology (Ministry of Education), Department of Chemistry, Tsinghua University, Beijing, 100000, China.
Guo-An LuoKey Laboratory of Bioorganic Phosphorus Chemistry and Chemical Biology (Ministry of Education), Department of Chemistry, Tsinghua University, Beijing, 100000, China.
Yi-Ming WangKey Laboratory of Bioorganic Phosphorus Chemistry and Chemical Biology (Ministry of Education), Department of Chemistry, Tsinghua University, Beijing, 100000, China.
Yan-Yu LiDepartment of Endocrinology, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Nanjing Medical University, Wuxi, 214023, China.
Qing HeDepartment of Good Clinical Practice (GCP), The Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi, 214023, China. heqing0510@163.com.
Lan XuDepartment of Endocrinology, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Nanjing Medical University, Wuxi, 214023, China. xulan126@126.com.

Funding

Science and Technology Development Fund of Wuxi Z201807
6 · The paper itself

Abstract

backgroundPolycystic ovary syndrome (PCOS) is a complex endocrine syndrome with poorly understood mechanisms. To provide patients with PCOS with individualized therapy, it is critical to precisely diagnose the phenotypes of the disease. However, the criteria for diagnosing the different phenotypes are mostly based on symptoms, physical examination and laboratory results. This study aims to compare the accuracy and efficacy of diagnosing PCOS by integrating metabolomic markers with common clinical characteristics.

methodsThis is a prospective, multicenter, analyst-blinded, randomized controlled trial. Participants will be grouped into (1) people without PCOS (healthy control group), (2) patients diagnosed with PCOS based on clinical indices (experimental group 1), and (3) patients diagnosed with PCOS based on metabolomic indices (experimental group 2). A total of 276 participants, including 60 healthy people and 216 patients with PCOS, will be recruited. The 216 patients with PCOS will be randomly assigned to the two experimental groups in a 1:1 ratio, and each group will receive a different 6-month treatment. The primary outcome for the experimental groups will be the effect of PCOS treatment. DISCUSSION: The results of this trial should help to determine whether using metabolomic indices is more accurate and effective than using clinical characteristics in diagnosing the phenotypes of PCOS. The results could provide a solid foundation for the accurate diagnosis of different PCOS subgroups and for future research on individualized PCOS therapy.

trial registrationChinese Clinical Trial Registry, ID: ChiCTR-INR-1800016346. Registered 26 May 2018.

Indexed as

MetabolomicsAdolescentAdultBiomarkersFemaleHormonesHumansLipid MetabolismMiddle AgedMulticenter Studies as TopicPhysical ExaminationPolycystic Ovary SyndromeProspective StudiesRandomized Controlled Trials as TopicYoung AdultBiomarkersHormonesAccuracy and efficacyClinical signs and symptomsMetabolomicsPolycystic ovary syndrome

Identifiers

PMID32046752
PMCPMC7014640

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.