Scoping studies are an increasingly popular approach to reviewing health research evidence. In an effort to provide guidance to authors undertaking scoping studies, Arksey and O'Malley  developed a six-stage methodological framework: 1) identifying the research question, 2) searching for relevant studies, 3) selecting studies, 4) charting the data, 5) collating, summarizing, and reporting the results, and 6) consulting with stakeholders to inform or validate study findings (optional). Although Arksey and O'Malley think that consulting with stakeholders is optional, Levac’ D  recommends consulting with stakeholders in scoping review. As far as our research is concerned, because the development of SDM in China is not mature enough, and we are also in the trial stage of SDM research, so it is particularly important for this study to consult with stakeholders. This framework provided an excellent methodological foundation. The study findings will be reported following the Preferred Reporting Items for Systematic reviews and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR) reporting guidelines .
Stage 1: identifying the research question
We are interested in the origin and development history of SDM in mainland China. So we want to trace back the starting time, research methods, fund types and the publication status of SDM research in mainland China. Whereas, our primary focus are three research questions. Theories and frameworks are means for identifying and defining research questions . Therefore, the following questions are determined based on the three core elements of ODSF. First of all, we want to examine the healthcare decision needs of Chinese population. In this part, we want to answer current Chinese decision type/timing, decison stage, decisional needs and their most frequent manifestations in the areas of inadequate knowledge/information, unclear values, decisional conflict/uncertainty, and inadequate support. Secondly, to understand the decision support interventions of SDM in mainland China, we should learn the SDM theories, process, tools, imlpementation determinants in the SDM from previous studies. Finally, in order to clarify the effect of the SDM in mainland China , we should describe the outcomes of the shared decision-making in mainland China.
By answering these questions, we can gain a comprehensive understanding of the development process of SDM in mainland China and the gaps between China and western studies. Moreover, the results may inform future theoretical and empirical studies.
Stage 2: identifying relevant studies
With the assistance of an experienced research librarian, we will search three English databases: Ovid MEDLINE English electronic database: the Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE. We will also search four Chinese databases: China National Knowledge Infrastructure, Wan Fang Database, The VIP Database, and China Biology Medicine. These four Chinese databases are the largest and most commonly used databases, which can basically cover all the literature published in Chinese journals . All databases will be searched from 1968 (this year was chosen as the starting year due to the prevalence of SDM publications since that time ) to present. The retrieval will not be limited to published peer-reviewed literature but also include unpublished grey literature. Grey literature will be searched using Baidu scholar search tools (https://xueshu.baidu.com/). These strategies will ensure that documents on SDM in mainland China are identified in the search of literature.
The search is limited to the study of SDM in mainland China. The definition of SDM in this study includes researches on demands and experience of both healthcare provider and patients for SDM, researches on the SDM participation process of patients and their families when facing difficult medical decision-making, researches on the development and application of patient’ decision aids. We will conduct a preliminary search in one English and one Chinese database to check whether the search strategies are appropriate. If required, the search strategy will be modified to improve the quantity and relevance of the findings. A preliminary search strategy has been developed for MEDLINE and is shown in online supplementary Appendix A. This search strategy will be modified as required so that it can be used with other electronic databases. There will be no limitations to the date or language of the published articles, nor will there be limitations pertaining to the geographic location of the publication. This step will be completed by April 2021.
Stage 3: study selection
This study will integrate all the studies on SDM in mainland China as thoroughly as possible, so we developed a relatively broad initial eligibility criteria. Inclusion criteria are 1) The research setting is located in the mainland China. 2) Study design: no restrictions on the study design. 3) Research topics: healthcare provider and patients make medical decisions together, the development and use of patient decision-making aids, SDM related demands and experience of healthcare provider and patients. 4) Context: any place providing medical services. 5) There is no limitation to the research object and disease type. Exclusion criteria are 1) Non-empirical research; 2) Conference proceedings, book chapters.
Following execution of the search strategy, the first stage of the selection process will take place. Titles and abstracts of publications will be read independently by two members (LH and XL) of the research team and deemed eligible if inclusion and exclusion criteria are met. Covidence (Covidence systematic review software, Veritas Health Innovation, Melbourne, Australia) will be used to facilitate the screening and data extraction. This software supports research teams in tracking the number of duplicate articles, facilitating the independent screening of the articles by two team members (LH and XL) and tracking the eligibility process. Studies that are duplicates, irrelevant or unrelated will be removed from the study at this time. If the relevancy of the publication is unclear from the title or abstract, we will temporarily include this kind of literature and conduct a second screening in the next step of full-text screening. This process will be completed on the first 20 citations and Cohen’s kappa will be calculated. A minimum kappa of 0.80 will be set as a threshold to achieve before continuing with the study selection process. In this stage, team members will discuss the inclusion and exclusion criteria regularly, and modify the initial inclusion and exclusion criteria as necessary.
Once completed, the second stage of the selection process will commence. The eligible publications screened in the first stage will be independently read in full by two investigators (MM and LH) to further establish whether the publication contains data/research relevant to informatics SDM in mainland China. When agreement cannot be reached, another two investigators (JZ, XL) will be consulted. Finally, the PRISMA flow diagram will be populated with the search and eligibility screening findings, and used to provide a visual of the data selection process.
Stage 4: data collection
The identified articles and documents that meet all of the eligibility criteria will be thoroughly read, and relevant data will be extracted by the investigators ( XL, JZ, LH, MM ). We will design a content extraction chart. The chart will be divided into two sections. The first section is “basic characteristics”, in this section, we will extract the basic information of the publication, including title, journal, authors’ names, country, language, year of publication, fund type, study design and setting. The second section is “ODSF research questions”. It includes three main questions that reflect the objectives of this review. we focused on the decisional needs in the study on SDM in mainland China in the first part. In this part, we want to extract the basic information of patients who participate in the shared decision-making, their decisional needs, methods used to identify the decisional needs, and the manifestations of decision needs. The second part is concerned with the decision support intervention of SDM in mainland China. we will extract the relevant theories used to inform the SDM study, processes, tools, promoting factors and barriers related to implementing SDM. The third part is the outcomes of the shared decision-making. The outcomes reported in the SDM studies will be extracted. We are also open to other key information that we consider important, but cannot be collated to ODSF. So, in the process of literature extraction, if other contents related to the research objective are found (which cannot be placed in the chart), researchers will adjust the chart.
The final included literatures will be divided into four parts, and the content will be extracted independently by four researchers (XL, JZ, LH, MM). In the process of extraction, any researcher can initiate a discussion on the extraction content at any time. If consensus cannot be achieved, YH will adjudicate. Online supplementary Appendix B shows the proposed data extraction table.
Stage 5: data summary and synthesis of results
The charted data from published articles and grey literature will be analysed using two main strategies. 1) A descriptive numerical summary. We will describe the basic characteristics and other numerical data by calculating their number and proportion. 2) A qualitative framework analysis approach will be used to synthesize the qualitative data. The framework method sits within a broad family of analysis methods often termed thematic analysis or qualitative content analysis . By applying approach, we can identify commonalities and differences in qualitative data, before focusing on relationships between different parts of the data, thereby seeking to draw descriptive and/or explanatory conclusions clustered around categories. Generally, our strategy is to conduct coding on those qualitative data and map them into ODSF. There is no specific classification of implementation determinants of SDM in ODSF. We will choose the Consolidated Framework for Implementation Research (CFIR) framework  to guide the coding and classification of the implementation determinants of SDM. CFIR was developed by unifying key implementation constructs across 19 theories to build a comprehensive, “meta-framework” that examines various aspects of implementation, including technology features, characteristics of individuals, and features of the implementation settings . The CFIR was chosen to guide the coding of determinants because of its comprehensiveness, allowing for the categorization of diverse implementation factors across a variety of studies and healthcare settings [55,56]. Specifically, two researchers (Xl, LH) will do open coding of the chart data independently, i.e. coding anything that might be relevant from as many different perspectives as possible . After coding the chart data, all researchers involved would meet to compare the codes they have applied to reach an agreement. Codes are then be grouped together into categories, which are then mapped in ODSF and CFIR. In addition, if some codes may not be classified into any ODSF categories, we will report the new findings beyond ODSF. Therefore, some new SDM related concepts and specific connotations that ODSF does not mention may appear in our final analysis results. After the previous process is completed, we will conceptualize a preliminary framework on SDM based on ODSF from a China context perspective.
Stage 6: consultation
As Levac’ suggested , involving SDM participations in the research process can also make researchers distinguish the research results that need to be focused on more clearly. We will invite SDM research stakeholders to participate in this meeting including healthcare professionals (SDM researchers, clinical nurses, physicians, and nurse managers) and patients who have conducted or are going to take part in SDM process in their healthcare settings. To facilitate a meaningful and effective discussion among panel members, we will only invite six healthcare professionals and two patients. We will share our preliminary research findings with the panel in advance and hold a one-hour meeting with them. The aim of this meeting will be to (1) make sure that our findings are clear, understandable, and meaningful to them; (2) confirm that the results of the study are consistent with their experience; and (3) make a list of recommendations on how to implement SDM in Chinese Context ( if possible ).
Ethics and dissemination:
Since the scoping review methodology consists of reviewing and synthesizing published data, this part of the study is not subject to ethical approval. Ethical approval and informed consent will be obtained prior to the consultation stage.