Developing a Core outcome set of Traditional Chinese Medicine on Traumatic Optic Neuropathy

Traumatic optic neuropathy (TON) is an injury to the optic nerve or anterior optic system caused by injuries, often resulting in permanent visual field impairment or blindness. In clinical practice, traditional Chinese medicine plays a important role in the treatment of TON. A certain number of randomized controlled studies have been done in the treatment of TON by traditional Chinese medicine. However, the outcome indicators of TON by traditional Chinese medicine vary greatly and are not standardized, which is not conducive to meta-analysis and cannot prove the effectiveness of traditional Chinese medicine. At the same time, there may be problems with selective outcome reporting. It is very important to establish the core index set for the clinical trial of traumatic optic neuropathy of traditional Chinese medicine.

Contributors

Eye hospital China academy of Chinese medical sciences

WANG ying is the chief physician of acupuncture and neuro-ophthalmology , as well as the principal investigator of the study.

Further Study Information

Current Stage: Ongoing
Date: October 2019 - October 2020
Funding source(s): Beijing Key Traditional Chinese Specialized Medical Consortium Service Mode Construction Project-acupuncture department (number: zz-2013-16)


Health Area

Disease Category: Eyes & vision

Disease Name: Traumatic optic neuropathy

Target Population

Age Range: 7 - 80

Sex: Either

Nature of Intervention: Traditional Chinese Medicine

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Systematic review

First, we will systematically evaluate the outcome indicators of all studies on the treatment of traumatic optic neuropathy with traditional Chinese medicine, and produce the initial outcome indicators list.
Second, we will identify the stakeholder groups participating in the Delphi process and Consensus conference, including: caregivers and patients, Patient/support group representatives, methodologists, policy makers, researchers, pharmaceutical companies, pharmaceutical experts,reseatchers and linical experts,
The first round of Delphi process:
Survey method: more than 200 non-experts were asked to rate the importance of each outcome indicator through questionnaires sent by email.
Survey contents: list of initial outcome indicators, and collect new outcome indicators not included in the list of initial outcome indicators.
Evaluation mechanism: participants are required to score according to the importance of each indicator. If they are not sure, they can choose "not sure".If at least 70% of Stakeholder groups in the first round consider an indicator important, then proceed to the second round. If there are any new indicators, all of them will be graded in the second round.

Second round of Delphi process:
Participants: all members who have completed the first round of the Delphi survey will be surveyed
Survey method: same as the first round
Evaluation mechanism:We will inform them that the evaluation results and distribution of scores for each indicator in the first round, and ask them to re-grade the indicator, taking into account the responses of other participants.The specific scoring principle is the same as in the first round. If the score is changed significantly, they are required to provide reasons for the change.

Then, we will have the consensus conference:
Participants: steering committee and expert group members, and Stakeholder groups in the Delphi process.
How to implement: all Stakeholder groups' assessment result will be prioritized. Attendees can discuss each outcome indicator and then anonymously rate it.If an outcome measure achieves a "critical" score of at least 70% for a Stakeholder group, it will be recommended first.

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