The core outcome set of clinical trials in open posterior lumbar spinal surgery (COS-OPLSS): A doctor-patient co-constructing and cross-disciplinary collaborative research

The spine related diseases have the characteristics of high incidence rate, high time and economic cost, long course of disease, easy repetition and high disability rate. They are also the main reasons for people's limited activities and absence in most parts of the world, and consume huge costs of the health care system. Spinal degenerative disease is a common health problem, which will lead to disability, reduce the quality of life, weaken the ability to work, and pose a huge economic burden to patients and society. Open posterior lumbar spinal surgery (OPLSS)is currently the most common and widely accepted effective method for the treatment of spinal diseases in the world to alleviate the symptoms and signs caused by spinal canal stenosis and instability caused by various factors. Several studies have shown that the effective rate of posterior lumbar open surgery is between 89% and 97%. Although OPLSS can effectively intervene such diseases, many patients still face serious physical, psychological and social problems after operation. However, we do not know about their life experience after operation. Although postoperative clinical trials are very common, there are problems of incomplete report of outcome indicators, and it is not clear whether the reported results are the results concerned by patients. With the development of the times, the change of social environment and the progress of medical treatment, the physiological, psychological and social status of patients will also change. People have higher and higher requirements for health, but there are more chronic diseases than ever before. The medical system as well as demography are becoming more and more complex. People may pay more attention to exploring patients' experience of medical services and diseases. Therefore, doctors should realize that the impact of OPLSS on patients includes not only symptoms and signs, but also many social factors. This is why the doctor-patient co-constructing and cross-disciplinary collaborative medical model is very important. If the core outcome set may achieve the purpose, they must be relevant to the key issues that patients encounter every day and may be the key to solve the problem of inconsistency of the above outcomes. There are few existing research results in the world about core outcome set of open posterior lumbar spinal surgery (COS-OPLSS). Based on doctor-patient co-constructing and cross-disciplinary collaborative guiding ideology, this study is a patient-centered interdisciplinary cooperation related pioneering research work, which may enable researchers to build a core outcome set in line with clinical practice on the basis of a better and more in-depth understanding of the long-term situation of patients, combined with the advantages of methodological experts and clinical experts, so as to provide reference for future clinical research.

Contributors

1. *Professor Duoduo LI (Professor/ Chief physician), Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China
2. **Professor Xing YU (Professor/ Chief physician), Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China
3. *Professor Sheng HAN,School of Pharmaceutical Science, Peking University; International Research Center for Medicinal Administration, Peking University, Beijing, 100191, P.R.China
4. *Dr Yi YUAN, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China
5. *Dr Luyao CHENG, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China
6. *Dr Xia LI, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China
6. *Dr Yena GAN, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China
7. Dr Ting ZHOU, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China
8. Dr Qiushi YU, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China
9. Dr Ziqing CHEN, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China
10. Dr Jiali YU, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China
11. Dr Hejing TANG, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China
Note:
* principal investigator
** principal supervisors

Further Study Information

Current Stage: Ongoing
Date: September 2022 - September 2026
Funding source(s): 2019 "cultivation plan for famous teachers" Beijing University of traditional Chinese medicine, Beijing, China


Health Area

Disease Category: Orthopaedics & trauma

Disease Name: Lumbar spinal stenosis

Target Population

Age Range: 6 - 120

Sex: Either

Nature of Intervention: Surgery

Stakeholders Involved

- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Economists
- Epidemiologists
- Ethicists
- Families
- Methodologists
- Regulatory agency representatives
- Researchers
- Statisticians

Study Type

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

Method(s)

- Consensus conference
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
- Nominal group technique (NGT)
- Semi structured discussion
- Survey
- Systematic review

This study will be divided into three rounds of NGT according to the COSMIN method as follows: The step 1 is to define the conceptual framework the research needs to use to measure the content of the research and then we will review the prospective and retrospective studies of the open posterior lumbar spinal surgery (OPLSS) systematically, screen these clinical research literatures, extract the result index data, form a preliminary result index set, publish the score review, systematic review as well as network meta-analysis. The step 2, first, is that the research team will provide the participants with all the questionnaires found in the literature search, so that our discussion and consensus could be fully informed. Then a Delphi survey will be conducted among experts and patients to further evaluate the importance of each outcome indicator. The last step will be to hold an expert consensus meeting and invite well-known experts in this field to discuss and reach a consensus on the clinical core outcome indicators of the OPLSS. The specific details include the following:
(1) Nominal group technique (NGT)
(2) Literature review
(3) Systematic review
(4) Survey
Semi structured discussion: roundtable
Semi structured discussion: meeting(s)
Semi structured discussion: workshop(s)
(5) Consensus conference
(6) Consensus meeting
(7) Delphi process
(8) Focus group(s)