A Mixed Research Method Was Used To Explore The Similarities And Differences Of The Importance Of The Outcome Indicators Of Chronic Low Back Pain Between Doctors And Patients

Background:Chronic back pain(CBP)is a global multiple disease,which causes physical,psychological and social burden on people’s life,and has important clinical and economic impacts.Its diagnosis,treatment,unified evaluation of outcome still pose great challenges to clinicians and researchers.The clinical outcome of patients with chronic musculoskeletal pain is related to a variety of complex factors.Bio-psychosocial integrated models are necessary in the assessment of back pain;however,physical,psychological,and social factors are not all reflected in the core outcomes of chronic back pain.In addition,not all outcomes that are important to patients are evaluated in clinical trials,and there may be differences in how clinicians and patients evaluate the condition.The composition of clinical trial outcomes will influence policy and practice and should ensure their importance to patients.In conclusion,patients’ expectations and needs should be taken into account when selecting appropriate outcome measures for clinical or research purposes.Objective:The aims of this paper are to develop a patient-oriented outcome framework and compare views of people with CBP and doctors about prioritizing outcomes in CBP clinical trial.Method:This is a mixed method research,which consists of three parts:1)Thematic synthesis about qualitative study on the experience or expectation of patients with CBP based on the outcome framework,so as to provide a wider perspective for the evaluation of CBP outcome from the point of view of patients’ values.Searching databases PubMed,EMbase,CINAHL,PsyclNFO,Web of Science,SinoMed,CNKI,VIP and Wanfang Data and the research publication time from the time of database establishment to March 2020.After using the criteria of the Australian JBI evidence-based Health Care Center for qualitative research to critical appraisal;the research results were analyzed by thematic synthesis method and classified according to the conceptual framework of outcome recommended by the COMET website.2)This study samples patients with CBP and conduct semi-structured interviews with them according to the interview outline to understand the influence of CBP on patients.Based on the conceptual framework of outcome recommended by the COMET website,we use theme analysis to summarized outcomes for the supplement of CBP outcome measurement domain,so as to construct the outcome framework of CBP from the perspective of patients.3)Combined with the outcomes obtained from the relevant literatures of clinical trials of CBP in our research group,the entry pool of CBP outcomes was formed.Patients with CBP and clinicians use 9-point Likert scale to evaluate the importance of all outcomes,and the similarities and differences in the views of the prioritizing measuring outcomes between clinicians and patients were compared.The more important it is,the higher the score is,and there are four grades:unimportant,generally important,very important,and incomprehension.Evaluation criteria:"very important" outcomes:≧85%"very important" and<15%"unimportant";"unimportant "outcomes:<15%"very important"and ≧85%"unimportant";others are "generally important".Results:23 studies were included.4 themes and 15 sub-themes were identified:physiological/clinical(musculoskeletal and connective tissue outcomes,general outcomes),life impact(physical functioning,social functioning,role functioning,emotional functioning,cognitive functioning,global quality of life,delivery of care,perceived health status),resource use(economic,need for further intervention,social/carer burden),adverse events(drug side effects,surgical effectiveness and safety).Patient interview results include 4 subject categories and 11 subcategories:physiological/clinical(musculoskeletal and connective tissue outcomes,general outcomes),life impact(physical functioning,social functioning,role functioning,emotional functioning,global quality of life),resource use(economic,need for further intervention,social/carer burden),adverse events(surgical effectiveness and safety).Based on the results of qualitative systematic review and semi-structured interview,4 core areas,15 outcome domains and and 40 outcomes were identified.The all outcomes of CBP are scored by clinicians and patients.Three outcomes were rated as "very important" by patients:pain or discomfort,activities of daily living and adverse events.The remaining outcomes were rated as"important".Four outcomes were rated as "very important" by clinicians:effective rate,pain or discomfort,activities of daily living and motor function.The remaining outcomes were rated as"important".There was no "unimportant" outcome for both patients and clinicians.Through Mann-Whiteney U test,there were statistically significant differences in 9 outcomes importance rating,which were Spinal deformities outcomes(P=0.033),bone-related outcomes P=0.001),intervertebral disc outcomes(P=0.000),weight-bearing difficulties(P=0.009),impact on sexual life or sexual function(P=0.026),perceptions of body image and appearance(P=0.008),quality-adjusted life years(P=0.010),health care utilization rate(P=0.002)and analgesic dosage(P=0.001).There was no statistical significance in the clinician-patient importance scores of the remaining outcomes.Conclusion:Chronic back pain has negative effects on the physical,psychological and social aspects of patients.The real expectations of patients should be fully considered in the field of outcome measurement and CBP management.There was no difference in the rating of"very important" outcomes between clinicians and patients with CBP,but there were differences in some rating of "general important" outcomes.