Evidence map›Paper›PMID 35869466›Full record

GuidelineBMC pediatrics2022

Guideline for the management of pediatric off-label use of drugs in China (2021).

Min Meng, Enmei Liu, Bo Zhang, Quan Lu, Xiaobo Zhang, Bin Ge, Ye Wu, Li Wang, Mo Wang, Zhengxiu Luo and 28 more

Abstract readPractice Guideline
PubMed Full text at PMC Publisher
In one paragraph

Guideline in BMC pediatrics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Review
  3. Review
  4. Article
  5. Observational
  6. Article
  7. Observational
  8. 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

38 authors.

Min Meng *Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Enmei Liu *Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Bo ZhangDepartment of Pharmacy, Peking Union Medical College Hospital, Beijing, 100730, China.
Quan LuDepartment of Pulmonology, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200040, China.
Xiaobo ZhangChildren's Hospital of Fudan University, Shanghai, 201102, China.
Bin GeGansu Provincial Hospital, Lanzhou, 730000, China.
Ye WuPeking University First Hospital, Beijing, 100034, China.
Li WangPeking University, Beijing, 100871, China.
Mo WangDepartment of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Zhengxiu LuoDepartment of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Ziyu HuaDepartment of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Xiaoling WangBeijing Children's Hospital, Capital Medical University, Beijing, 100045, China.
Wei ZhaoShandong University, Jinan, 250100, China.
Yi ZhengShandong University, Jinan, 250100, China.
Xinan WuThe First Hospital of Lanzhou University, Lanzhou, 730000, China.
Ruiling ZhaoChildren's Hospital of Shanxi, Taiyuan, 030012, China.
Wenbo MengThe First Hospital of Lanzhou University, Lanzhou, 730000, China.
Li XiangBeijing Children's Hospital, Capital Medical University, Beijing, 100045, China.
Gang WangDepartment of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Yuntao JiaDepartment of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Yongchuan ChenThe First Affiliated Hospital of Third Military Medical University (Army Medical University), Chongqing, 400038, China.
Xiaoyan DongDepartment of Pulmonology, Shanghai Children's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200040, China.
Lina HaoChildren's Hospital Affiliated to Shandong University, Jinan, 250022, China.
Chengjun LiuDepartment of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Meng LvDepartment of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Xufei LuoSchool of Public Health, Lanzhou University, Lanzhou, 730000, China.
Yunlan LiuSchool of Public Health, Lanzhou University, Lanzhou, 730000, China.
Quan ShenDepartment of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Wenjuan LeiGansu Provincial Hospital, Lanzhou, 730000, China.
Ping WangEvidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, 730000, China.
Yajia SunEvidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, 730000, China.
Juanjuan ZhangSchool of Public Health, Lanzhou University, Lanzhou, 730000, China.
Ling WangSchool of Public Health, Lanzhou University, Lanzhou, 730000, China.
Ruobing LeiDepartment of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Tianchun HouDepartment of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Bo YangDepartment of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China.
Qiu LiDepartment of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China. liqiu809@hospital.cqmu.edu.cn.
Yaolong ChenDepartment of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, Chongqing, 400014, China. chenyaolong@lzu.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe "Law on Doctors of the People's Republic of China," which was officially implemented on March 1, 2022, emphasizes the requirements for rational drug use and the necessity for appropriate management of off-label drug use. The safety and ethical considerations related to off-label drug use are different in children than in adults. There is so far no management guideline for pediatric off-label use of drugs in China, and the applicability of foreign guidelines is limited. Establishing a localized evidence-based management guideline for pediatric off-label use of drugs to support the national legislation and clinical practice is of critical importance.

methodsWe established a guideline working group, including experts from a broad range of disciplines and developed recommendations following the guidance of the World Health Organization Handbook and the Chinese Medical Association. The following themes were identified by questionnaires and expert interviews to be of great concern in the management of off-label drug use in children: general principles and characteristics of management of pediatric off-label drug use; establishment of expert committees; evidence evaluation; risk-benefit assessment; informed consent; monitoring and assessment of the risk; and monitoring and patient education. Two rounds of Delphi surveys were organized to determine the final recommendations of this guideline. We graded the recommendations based on the body of evidence, referring to the evaluation tool of the Evidence-based management (EBMgt) and the Oxford Center for Evidence-Based Medicine: Level of Evidence (March 2009).

resultsWe developed the first guideline for the management of pediatric off-label use of drugs in China.

conclusionsThe guideline is to offer guidance for pediatricians, pharmacists, medical managers, policymakers, and primary care physicians on how to manage off-label drug use in pediatrics and to provide recommendations for Chinese healthcare policy in the future.

Indexed as

Off-Label UsePhysiciansAdultChildChinaDrug LabelingEvidence-Based MedicineHumansPediatriciansChildrenGuidelineManagementOff-label use of drugs

Identifiers

PMID35869466
PMCPMC9307429

What OpenQuestion holds

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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.