PRO Extension For Patient Reported Outcomes In Non-randomized Controlled Trials

Objectives:Qualitative evidence suggests patient-reported outcome(PRO)information is frequently absent from clinical trial protocols,potentially leading to inconsistent PRO data collection and risking bias.Direct evidence regarding PRO trial protocol content is lacking.The aim of this study was to develop a guideline of patient-reported outcome based on our independent research and development of PRO scale,these scales played a role in non-randomized controlled trials.Taking stroke-PRO as an example to exemplify the protocol checklist.Methods:We performed a literature review to collect and extract important information of PRO related content in non-randomized controlled trials.Then we conducted a PRO-specific protocol checklist describing a non-randomized controlled trial including a primary/secondary PRO,and explained the items with examples.Taking the Stroke-PRO scale made by our research group to exemplify these items.Using the multiple regression analysis to explore the acupuncture combined western medicine therapy on the quality of life in patients with ischemic stroke.Structural equation model was employed in searching the influence of physiological,psychological,social on patient satisfaction.Results:The final checklist included ten parts including List of collaborators,Protocol summary,Objectives and/or hypotheses,Background and rationale,Methods,Datamanagement,Endpoints,Statistical considerations,References and Appendices.Based on the Stroke-PRO to explain the protocol checklist,the univariate analysis showed that age,gender,BMI,education,exercise and the acupuncture combined western medicine therapy were factors which influence the quality of life of patients with ischemic stroke;the multiple regression analysis showed that age was a risk factor,the education,the exercise and the acupuncture combined western medicine were protective factors.Further,by the structural equation model,we found that physical symptoms,self-care ability,depression and family support were the important factors that influenced the treatment satisfaction.Conclusions:We developed a special protocol checklist based on the non-randomized controlled trials.The checklist items can better improve the quality of PRO data collection,standardize reporting format,and guide clinicians and patients to customize treatment plan reasonably,so as to achieve the purpose of precision medicine.