A core outcome measurement set of clinical trials in open posterior lumbar spinal surgery (COMS-OPLSS) based on comprehensive communication and cooperation between doctors and patients

The open posterior lumbar spine surgery (OPLSS) mainly includes (posterior lumbar fusion surgery which is mostly used and a few posterior lumbar non-fusion surgery. Compared with posterolateral approach and lateral approach, posterior approach may be more advantageous, especially for most of the fusion operations, which can provide a larger bone contact surface between intervertebral bone grafts, improve load sharing, provide sufficient channels to completely decompress neural devices, restore the height of nerve foramen, and restore the ability of segmental lordosis at relevant levels. Spinal related diseases, especially degenerative diseases, have a high incidence rate and disability rate. The choice of outcome indicators to evaluate the efficacy of clinical intervention is a problem that we have always paid close attention to. However, the diversity, incompleteness and uneven quality of outcome indicator measurement tools bring a high risk of bias to research and practice. In order to assist clinicians and researchers in selecting the most appropriate outcome indicator measurement tools, a team of international multidisciplinary researchers with qualitative research and health care background launched a COSMIN (consensus based health measurement tool selection criteria) initiative in 2005, aiming to select the most appropriate outcome indicator measurement tool by developing evaluation tools. The International Union for health outcome measurement (ICHOM) recommends three core outcome indicators: physical function, pain intensity and HRQOL for LBP. Its purpose is to provide a set of standard results for routine clinical monitoring. In addition to the three core result areas, the consensus level of 10 other areas is higher than that of other areas: work ability, psychological function, pain intervention, use of medical services, self-evaluation of health, entertainment and leisure, time aspect of pain, social function, work efficiency and sleep function. The outcome indicators of lumbar symptom improvement involves all aspects of patients' lives, so the measurement tools also need to be constantly improved and updated. To select an appropriate outcome indicator measurement tools, we must first judge the quality of the outcome indicator measurement tools and need to evaluate the evidence about its measurement characteristics in the target population to guide clinical treatment decisions. After classifying the commonly used low back pain evaluation scales according to the core measurement fields, and summarizing and analyzing the content, validity, reliability and responsiveness of the measurement tools, it is found that people have developed a variety of measurement tools to evaluate the low back function, pain intensity and quality of life of patients with low back pain. However, the proportion of subjective or objective indicators used to evaluate the status of patients is different in different measurement tools, even the indicators concerned by different evaluation systems are quite different. Therefore, the choice of different measurement tools may lead to different results. Whether the measurement tools can truly reflect the state of patients remains to be further studied. On the other hand, the measurement tools have the problem of incomplete coverage, which is not enough to reflect the most concerned aspects of patients. The measures currently used to treat low back pain may lead to wrong evaluation of treatment effect and patient rehabilitation. For the measurement tools of outcome indicators in the clinical research of spinal related diseases and their heterogeneity, there are few existing research results in the world, and there is no core measurement set of open posterior lumbar spine surgery. Therefore, our study will develop a core outcome measurement set of open posterior lumbar spinal surgery (COMS-OPLSS) based on comprehensive communication and cooperation between doctors and patients to reflect the postoperative experience and life needs of patients, hoping to provide reference for the selection of measurement tools in the field of clinical research in the future.

Contributors

1. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China
2. The first clinical medical college, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China
3. School of Pharmaceutical Science, Peking University,100191, P.R.China
4. International Research Center for Medicinal Administration, Peking University,100191, P.R.China

Duoduo LI (Professor/ Chief physician) is the principal supervisor and his team includes the principal investigators.

Further Study Information

Current Stage: Ongoing
Date: July 2022 - June 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

- Recommendations for outcome measures (measurement/how)

Method(s)

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

According to the COSMIN method, this study will be mainly divided into three processes. The first step is to systematically review the clinical studies of the open posterior lumbar spine surgery, screen these clinical research literatures, extract the selection of clinical trial measurement tools, form a preliminary result index set, and publish score review, systematic review and network meta-analysis. The second step is to conduct a Delphi survey on experts and patients to further evaluate the importance of each outcome indicator. The third step is to hold an expert consensus meeting and invite well-known experts in this field to discuss and reach a consensus on the optimization of oplss clinical trial measurement tools.