Special Issue:Family Medicine and Community Health Research
Primary care (PC) is a unique clinical specialty and research discipline with its own perspectives and methods. Research in this field uses varied research methods and study designs to investigate myriad topics. The diversity of PC presents challenges for reporting, and despite the proliferation of reporting guidelines, none focuses specifically on the needs of PC. The Consensus Reporting Items for Studies in Primary Care (CRISP) Checklist guides reporting of PC research to include the information needed by the diverse PC community, including practitioners, patients, and communities. CRISP complements current guidelines to enhance the reporting, dissemination, and application of PC research findings and results. Prior CRISP studies documented opportunities to improve research reporting in this field. Our surveys of the international, interdisciplinary, and interprofessional PC community identified essential items to include in PC research reports. A 2-round Delphi study identified a consensus list of items considered necessary. The CRISP Checklist contains 24 items that describe the research team, patients, study participants, health conditions, clinical encounters, care teams, interventions, study measures, settings of care, and implementation of findings/results in PC. Not every item applies to every study design or topic. The CRISP guidelines inform the design and reporting of (1) studies done by PC researchers, (2) studies done by other investigators in PC populations and settings, and (3) studies intended for application in PC practice. Improved reporting of the context of the clinical services and the process of research is critical to interpreting study findings/results and applying them to diverse populations and varied settings in PC.
In 2023, the Consensus Reporting Items for Studies in Primary Care (CRISP) Working Group introduced a consensus checklist aimed at enhancing the quality, practicality, and dissemination of research reports in general practice and primary care. The editorial team of the Chinese General Practice Journal translated the CRISP checklist into Chinese and conducted a review of the current status of primary care research in China. The review identifies major problems in the field, including six common problems: "author-centered orientation" "overemphasis on authority" "uncritically adopting international experience" "lack of rigor in reporting methodologies" "inclusion of excessive and redundant information" and "lack of transparency". Finally, the editorial team encourages authors, editors, and reviewers in China to adopt the CRISP checklist to improve the quality of primary care research reports. Additionally, the review provides specific recommendations for applying the CRISP Checklist in various subfields, such as discipline development research, clinical research, health services research, health policy research, medical education research, and community epidemiological research.
There were many problems in the methodological theory of the formulation of clinical practice guidelines in in the real world situation, and the lack of consideration of the actual situation leads to the decline of the guidance for the formulation of guidelines. Through an in-depth analysis of the various difficulties related to theory and practice in the formulation of the guidelines, including the deviation between methodological theory and practice in the formulation of guidelinesn, lack of empirical studies of large samples related to guideline development, after the empirical application of methodological theory, the reports of limitations and future research recommendations were insufficient and not standardized. To improve the guidance of future guidelines, our team put forward a number of methodology recommendations, including advocating for empirical research that validates methodological theories, develop large sample empirical research and comparative research, standardize the content and form of reports on limitations and future research recommendations after empirical research, in order to provide reference for guidelines develop methodology researchers and guideline development groups.
Currently, the results of lung sound auscultation with either physical or electronic stethoscopes still rely mainly on the doctor's professional auscultation identification ability, which has not yet been able to realise intelligent diagnosis and interpretation. When patients are affected by lung diseases at home, they are unable to detect lung abnormalities on their own and delay treatment; when they are in the process of rescue and treatment of respiratory infectious diseases, in-ear stethoscopes are easily contaminated and cause nosocomial infections. Although stethoscopic sounds contain a wealth of information about health status, the lack of standardised collection methods, classification criteria and analysis tools has limited the objective analysis and application of stethoscopic sounds in practice. In this study, the data collection, arrangement and database design of the lung auscultation sound were carried out by using the unified auscultation sound collection equipment and process. The study used the software MetlabR2017a for data management and analysis to create a database of lung auscultation sounds in a healthy group and a group of patients with lung disease. A database of lung auscultation sounds was established for healthy groups and groups of patients with lung diseases. A standard set of classification of auscultatory tones, labelling specifications, audio characteristic signal parameters were developed. Building a system for storing, managing and analysing lung auscultation sound data to provide important data support for research related to the screening and monitoring of lung diseases and the translation of medical artificial intelligence applications. The study accumulated the experience of building an audio database of lung auscultation sounds, provided a useful reference for the management and analysis of the audio database, and laied the foundation for supporting the subsequent application of medical artificial intelligence-assisted auscultation in the screening and monitoring of lung diseases, which was of great medical value and practical application.
Mixed methods research is a third research paradigm that integrates qualitative and quantitative research. By combining the advantages of qualitative and quantitative research and analyzing specific problems more widely and deeply, it can increase the universality of research results and is applicable to study complex problems. At present, the application of mixed method in domestic medical research is still in the early stage, and there is no unified standard in the reporting specifications. The Mixed Methods Article Reporting Standard (MMARS) is one of the Journal Article Reporting Standards (JARS). This paper comprehensively introduces MMARS and interpret MMARS through example applications, in order to provide reference for improving the quality of reporting.
This article aims to help beginners in general practice and primary healthcare research clarify the standard operating procedures and understand that the "rigor" of case study is based on strict adherence to standard implementation procedures. The paper began with a literature review to sort out the development of case studies, overview the connotation, historical background, and applicable issues of case study. Then, the standard operational procedures of case study were introduced step by step, with specific examples to illustrate the application of case studies in general practice and primary healthcare. Step 1: plan initiation to determine whether to conduct a case study. Step 2: plan design to select appropriate cases and types of case study. Step 3: work preparation, researchers training and pilot study. Step 4: data collection to obtain data from multiple sources. Step 5: data analysis to obtain conclusions based on evidence. Step 6: report writing and communication with readers. Case study is suitable for addressing the "what" "how" and "why" questions in general practice and primary healthcare, with a broad application prospect.
Lumbar disc herniation is one of the most common causes of low back pain, and the number of cases has been increasing year by year in recent years. High-quality guidelines can standardize clinical diagnosis and treatment behaviors and improve medical quality, and screening and formulating high-quality guidelines are of great significance for standardizing the clinical practice of lumbar intervertebral disc herniation.
To systematically evaluate the methodological quality of clinical practice guidelines and expert consensus for lumbar intervertebral disc herniation, and to analyze the high-quality guidelines and consensus recommendations, in order to provide reference for the prevention and treatment of lumbar intervertebral disc herniation.
Clinical practice guidelines and expert consensus on lumbar intervertebral disc herniation were searched from the establishment of each database to October 31, 2023. At the same time, Dangdang.com and others were manually searched to obtain the guidelines for lumbar intervertebral disc herniation published in the form of monographs. After the consistency evaluation was passed by two researchers, the methodological quality of the included guidelines and consensus was evaluated using the AGREE Ⅱ tool, and the high-quality guidelines and consensus recommendations were analyzed.
A total of 15 guidelines and consensus were included, and the final recommendation level of 9 guidelines was B (can be recommended after modification), and 6 guidelines and consensus were C (not recommended for the time being). Recommendations mainly include bed rest, medication, surgical treatment, etc.
The methodological quality of the clinical practice guidelines and expert consensus for lumbar intervertebral disc herniation needs to be further improved, and some treatment methods are controversial, and the recommendations of the guidelines need to be further improved and unified to optimize clinical practice.
In-depth interview is to understand the life experience and lifestyle of a certain social group through in-depth conversation with the respondents, explore the formation process of specific phenomena, and propose ideas and recommendations to solve problems. In-depth interview has been widely used in the study of primary care research. Thus, understanding its basic concept and mastering the design and application process are essential to master this method. This paper comprehensively describes the research process of in-depth interview research according to the 3 stages at before, during and after the research. Before formally conducting in-depth interview research, researchers need to understand its basic concepts, characteristics and limitations related to the research purpose and process, and identify which studies are applicable. In the design and implementation of in-depth interview research, researchers should focus on the main steps of the research in four stages: recruitment of interviewees, design and modification of interview guide, collection of interview data, and analysis of interview data. After completing the data analysis of the in-depth interview, researchers need to write a research paper referring to the report specification of qualitative research to increase the credibility of research results and the transparency of the research process. In addition, this paper recommends five fields suitable for in-depth interviews in primary care research, and introduces learning resources for researchers to master in-depth interview methods. Through the introduction of in-depth interview research method, this paper aims to help researchers in the field of general practice/primary care to master a method suitable for scientific research, and provide methodology reference for improving the quality of qualitative research in this field in China.
Health literacy is closely associated with health status, most domestic studies tend to use multidimensional and multi-item tools for assessing health literacy, lacking simple and effective assessment methods.
To simplify health literacy scale and conduct psychometric test within the Chinese population.
Adults aged 18 years and above were selected from the "China Family Health Index Survey (2021) " for this investigation. Based on inclusion and exclusion criteria, a total of 7 449 participants were selected and randomly divided into two sample sets, including 3 680 cases in sample set 1 and 3 769 cases in sample set 2. The general information questionnaire, Short-form Health Literacy Questionnaire (HLS-SF12), Perception Social Support Scale (PSSS), and Family Health Scale Short-form (FHS-SF) were administered to the respondents. Classical test theory (CTT) and the Mokken model in item response theory (IRT) were used to screen the original items, and validation analyses such as reliability and validity of the simplified scales were also conducted.
A 9-item version (HLS-SF9) and a 4-item version (HLS-SF4) were simplified by using CTT and the Mokken model, respectively. Both the HLS-SF9 and the HLS-SF4 had no ceiling effect or floor effect, and the Cronbach's α coefficients for both were 0.913 and 0.842, with split-half reliabilities of 0.871 and 0.815, respectively. The exploratory factor analysis of HLS-SF4 revealed one common factor, accounting for 67.813% of the cumulative variance, with factor loadings exceeding 0.81 for each item. The confirmatory factor analysis of HLS-SF9 showed that χ2/df was 10.844, goodness of fit index (GFI) was 0.985, adjusted goodness of fit index (AGFI) was 0.971, normative fit index (NFI) was 0.986, comparative fit index (CFI) was 0.987, and root mean squared error of approximation (RMSEA) was 0.051. The correlation analysis demonstrated positive correlation of HLS-SF9 and HLS-SF4 with PSSS (r=0.367, 0.292, P<0.001), as well as FHS-SF (r=0.340, 0.237, P<0.001), respectively. The intraclass correlation coefficients (ICC) (95%CI) for the criterion validity of HLS-SF9 against HLS-SF12 was 0.989 (0.988-0.999), while for HLS-SF4 against HLS-SF12 was 0.892 (0.886-0.899) .
The simplified health literacy scales have good reliability and validity, which are reliable and effective tools for assessing the health literacy of the Chinese population. Researchers can choose the scale according to the needs of research precision (HLS-SF9) or assessment time (HLS-SF4) .
Cross-sectional study is one of the classic research design methods, which is widely used in clinical research. Cross-sectional study designs are used to answer a large number of scientific questions in general practice research. This includes not only the investigation of population health characteristics, disease characteristics or health service status, but also a variety of research scenarios such as the construction of disease screening and diagnosis methods for community people. Therefore, this paper will sort out and summarize the key points of cross-sectional research in the field of general medicine, and provide reference for future research work. In the field of general practice, cross-sectional studies can be used for status description, comparative analysis, correlation factor analysis and exploration of community screening diagnostic methods. The clinical development of cross-sectional studies should include two stages, study design and study implementation. The design stage includes accurate extraction of study objectives, defining clinical factors such as study population, study factors and outcome indicators, and determining the method of sample acquisition, determining the basis for sample size and rational statistical analysis strategies. In the implementation stage, complete research plan and case report form should be used to present research design ideas, and data collection should be carried out under the premise of ethical approval. Meanwhile, quality of data management and statistical analysis methods in the plan should be strictly implem.
This study outlines statistical methods and practical steps for designing and developing valid and reliable questionnaires in primary care. A series of studies on questionnaire development and scale design are reviewed and a standardized process for scale design in the primary care is developed. The process involves key and practical steps in the scale design process as well as statistical methods, which is illustrated with examples of previous relevant studies within the field. The suggested seven-step approach to developing a questionnaire in the primary care is: (1) defining the construction of measurement; (2) generating the pool of items; (3) selecting the scoring system and response format; (4) pre-testing (assessing content validity and face validity, etc.) ; (5) eliminating items by item analysis; (6) evaluating the scale initially, including evaluating the reliability and validity of the scale, and factor analysis or Rasch analysis; (7) re-evaluating the scale to re-examine the nature of the scale, including retesting reliability and constructing validity. In general, the studies on scale design should strictly follow the standardized steps of scale development, and the integrated use of Rasch model and factor analysis can make the measurements more objective.
Researches about prediction models based on machine learning in primary care developed rapidly in recent years, but there are few researches about the design features and methodological quality.
To systematacially summarize and analyze the design features and methodological quality of researches about prediction models based on machine learning in primary care.
Researches about prediction models based on machine learning in primary care was searched in PubMed, Embase, CNKI, Wanfang Data published from base-building to 2023-02-21, descriptive summary and description methods were used to analyze the basic characteristics of the included literature, types of prediction models, sample size, handling method of missing value, types of machine learning algorithms, model performance evaluation index and prediction efficiency, and model verification method.
Totally 30 literature were enrolled, involving 106 prediction models, thereinto 17 literature were published between 2021 and 2023; research topics: respiratory disease in 6 literature, tumour in 4 literature, outpatient appointment in 3 literature; sample size over 1 000 in 26 literature (accounting for 86.67%, 95%CI=68.36%-95.64%) ; using machine learning methods to hand missing value in 7 literature; 65 prediction models used tree-based machine learning algorithm, in which random forest was the most frequently used (accounting for 32.08%, 95%CI=23.53%-41.95%) ; 61 prediction models used AUC of ROC or consistency (C statistic) as the differentiation evaluation index (accounting for 57.55%, 95%CI=47.57%-66.97%), but only 14 prediction models reported prediction models (accounting for 13.21%, 95%CI=7.67%-21.50%) ; the differentiation of most of the 106 prediction models was good, but bias risk assessment results of 92 prediction models were high-risk (accounting for 86.79%, 95%CI=78.50%-92.33%) ; only 7 literature involved prediction models conducted the external validation.
Researches about prediction models based on machine learning in primary care increase gradually in the past three years, in which the topics mainly involve respiratory disease, tumour, outpatient appointment and so on; there are significant difference in sample size and handling method of missing value in the 106 prediction models, most of the 106 prediction models are with good differentiation, but most of them did not conducted the external validation, and the overall risk of bias is relatively high.
General practice has significant interdisciplinary characteristics, both qualitative research and mixed methods research are applicable to scientific research in this field. In recent years, there has been a steady increase in the number of relevant academic papers published in China, but the overall quality of the literature has not been systematically assessed.
To explore the methodological quality of qualitative and mixed methods research literature published in the field of primary care and general practice.
From August 2022 to April 2023, four investigators analyzed and assessed the methodological quality of qualitative and mixed methods research published in the field of primary care and general practice in China in 2021 using the qualitative assessment tools of Critical Appraisal Skills Programme (CASP) and Mixed Methods Appraisal Tool (MMAT), respectively. The researchers were grouped in pairs and independently for information extraction and quality evaluation.
A total of 35 qualitative research and 9 mixed methods research were included. Among the qualitative research, 23 literature (65.71%) did not sufficiently considered ethical issues; recruitment of participants was not discussed in 94.29% (33/35) of the research; the relationship between the researcher and the participants was not adequately considered in 82.86% (29/35) of the research; 42.86% (15/35) of the research had a sample size of <20 participants and data saturation was not discussed in 25.71% (9/35) of the research. Major problems with mixed methods research included the fact that: 8/9 of the research did not explicitly report the type of mixed methods research design and 8/9 of the research failed to effectively integrate the different components of the study to answer the research question.
The methodological quality of such qualitative and mixed methods research in primary care and general practice published in 2021 in China is still partially limited, especially in the ethics, reliability and information saturation among qualitative research, and the integration among mixed methods research, which should be further strengthened by training in research methodology and strict adherence to research design and reporting statements in order to improve the quality of research and even evidence for decision making.
At a time when healthcare reforms are being implemented in the new era, the scientific research output in the field of general practice and primary care in China has grown rapidly in recent years. However, the methodological quality of the literature is unclear.
To evaluate the methodological quality of representative quantitative studies and systematic reviews/guidelines in the field of general practice and primary care in China in 2021, to reveal the overall methodological quality characteristics of scientific papers in this field.
A sample of 449 papers was selected from a total of 3 122 papers collected in the Primary Care and General Practice Research Paper Productivity Report in China in 2021. A methodological quality assessment group consisting of 22 researchers in the field of public health and general practice from different institutions was organized to evaluate the quality of 320 of these papers (71.3%) using six different quality assessment tools for different study designs (cross-sectional studies, cohort studies, pre- and post-intervention studies, randomized controlled trials, systematic reviews, guidelines and consensus) by working in pairs and under the training and guidance of an expert in evidence-based medical methodology. Descriptive statistics method was used to report the overall quality assessment results of the various types of research papers.
Of the 114 cross-sectional research papers, quality issues were prevalent in the areas of "whether the source population was representative of the study's target population" (41.2%) , "whether the reliability and validity of the survey instrument could be conclusively demonstrated" (32.5%) , "whether the survey is clinically meaningful" (26.3%) ; of the 25 cohort study papers, quality issues were more concentrated in the areas of "whether the cohort was adequately followed up" (44.0%) and "whether the co-intervention was similar among groups" (56.0%) ; of the 34 pre- and post-intervention studies, quality issues were mostly found in the areas of "whether the target outcome was measured multiple times before and after the intervention" (97.1%) , "whether the sample size was large enough to generate confidence in the study results" (82.4%) , and "whether the study participants were representative of the eligible population" (61.8%) ; of the 122 randomized controlled trials, quality concerns were mostly in the areas of "blinding of different stakeholders" (25.4%-61.5%) , "adequate concealment of random allocation" (41.8%) , and "other risks of bias" (72.1%) ; of the 19 systematic reviews, quality issues were mostly found in the areas "is the source of funding for the included studies reported" (100.0%) , "were the methods of the review developed before the start of the review" (94.7%) , "was heterogeneity reasonably discussed and explained" (84.2%) , and "was the risk of bias of individual studies considered" (84.2%) . Finally, the quality of all six clinical guidelines/consensus was rated low.
The scientific research output of recent years in the field of primary care and general practice in China is still of limited quality in general, which is particularly evident in the categories of cross-sectional studies, pre- and post-intervention studies, randomized controlled trials, guidelines and consensus. This highlights the urgency and importance of strengthening systematic training in basic research in this area of research in China, increasing the importance of research and evidence-based reporting standards, and developing pragmatic methodological specifications for the development of guidelines.
Shared decision-making is a practice that fully reflects the idea of patient-centered care, but its clinical implementation process is not ideal. Physicians are main participants to promote the implementation of shared decision-making, but there are few studies on their behaviors in shared decision-making.
To explore the process and main behavioral characteristics of physicians' participation in shared decision-making, offering evidence for the promotion and implementation of shared decision-making in clinical practice.
A mixed-methods convergent design was used to collect quantitative and qualitative data. In the quantitative study, convenience sampling method was used to select in-service physicians (n=360) from a grade A tertiary hospital in Shanghai to attend a questionnaire survey from May to December 2020 to understand the status of their participation in shared decision-making. K-means clustering was conducted to analyze the distribution characteristics of physicians' participation in shared decision-making. In the qualitative study, 23 physicians selected from the participants of the quantitative study using convenience sampling and purposive sampling from June to December 2020 were recruited to attend semi-structured interviews to explore the process and experience of their participation in shared decision-making and identify the main behavioral characteristics of them in each part of the process of shared decision-making.
Quantitative data analysis: in all, 325 (90.3%) of the physicians who returned responsive questionaries were included for analysis. The average total score of their participation behavior in shared decision-making was (80.44±14.88) . The further analysis found that physicians had the highest participation in behaviors of "Explain the advantages and disadvantages of the treatment options to my patient" (4.38±0.74) and "I told my patient that there are different options for treating his/her medical condition" (4.30±0.84) ; physicians had the lowest participation in behaviors of "I made clear to my patient that a shared decision needs to be made" (3.72±1.22) and "My patient and I selected a treatment option together" (3.74±1.03) . The results of cluster analysis showed that the behavioral characteristics of physicians' participation in shared decision-making could be divided into three groups, namely informed consent group, partial patient participation group and shared decision-making group. Qualitative data analysis: physicians' participation behaviors in shared decision-making included building up the awareness of shared decision-making, providing the patient with information, examining patient comprehension of the information, clarifying patient values, co-assessment (of the feasibility of the options) , reaching a decision and decision implementation. Analysis of the mixed-methods research results showed that in the decision-making process, physicians paid more attention to the provision of information, and ignored the behavioral factors of promoting patient participation at the level of doctor-patient communication. The behavioral characteristics of physicians' participation in shared decision-making were different.
The physicians' participation behavior in shared decision-making was limited. And they may have misunderstandings about the behavior process of shared decision-making. To promote the practical implementation of shared decision-making in clinical practice, it is suggested to help physicians clarify the process of shared decision-making via interventions enhancing their knowledge and attitudes regarding shared decision-making, deepen their understanding of shared decision-making through scenario simulation and role-playing, and improve their recognition of patient values in decision-making.
General practice research focuses on a range of topics, such as patients' physical health and mental health, physicians' competencies and career motivation, quality of healthcare and physician-patient relationships and cooperation. However, these are not resolved well only using quantitative research which is still dominated in the field of general practice. In this case, qualitative method is often required, although it is considered to be subjective, and is mainly used to describe a phenomenon that is little known in a small sample. Mixed methods research, which incorporates qualitative and quantitative research and combines the advantages of both, can analyze specific problems more extensively and intensively, is suitable for studying complex problems, and for general practice research as an approach integrating clinical medicine and sociology. However, mixed methods research in general practice is still in its early phase in China, and the standardization of its design and implementation needs to be improved. For better elaborating the key points in the design and implementation of mixed methods research, we detailed a study using mixed methods, providing a reference for general practitioners to carry out mixed methods research.
With the deepening of health care reform in China, primary care and general practice researches have developed rapidly in recent years, and the number of papers published has increased rapidly.
Summarize and analyze the scientific research papers published in the field of primary care and general practice in China in 2021, explore the characteristics in the number of papers published, journals published, regions, institutions, research categories, research methods, and the number of authors.
Based on the disciplinary definition of the research concepts, themes and methods in this field, combining scoping review methods and bibliometric techniques, scientific research papers published by researchers in Chinese scientific research institutions in 2021 included in the CNKI, Wanfang, PubMed, and Web of Science database were retried, induced and analyzed. In this paper, combined with the scope review method and bibliometric technology, a systematic search and quantitative analysis were carried out on scientific research papers in the fields of primary care and general practice published by researchers in Chinese scientific research institutions in 2021 included in the CNKI, Wanfang, PubMed, and Web of Science databases.
There are 3 122 original research papers published in the fields of primary care and general practice in China in 2021. The number of papers published by primary care institutions accounted for 57.69%, but most of the papers were completed by a single authoramong such institutions. Papers published by the eastern primary care institutions accounted for 80.12%. The research category is dominated by clinical research (58.23%) and health services researches (27.07%) , the co-occurrence analysis of keywords by VOSviewer shows that the research themes focus on "chronic disease management" and "contracted family doctor services", these papers mostly used randomized controlled trials (40.87%) and cross-sectional survey studies (36.71%) in research methods. The vast majority of papers in primary care and general practice field are published in non-core and non-SCI/SSCI journals (76.75%) , and only 6.98% of papers are published in SCI/SSCI journals.
The productivity level of primary care and general practice research in China has now reached the highest level in the world, of which the primary care institutions in the eastern region have made major contributions. The research topics in the primary care and general practice field are close to institutional practice and national health policy. However, there are still a series of problems and challenges in this field, such as the lack of cooperation among researchers in primary care institutions, the large number of studies using randomized controlled trial methods may have problems such as quality concerns and low recognition of research in this field in China by international SCI/SSCI journals.
As a simple, rapid and effective research method, test-negative design (TND) has been widely used to support the evaluation of post-marketing effectiveness of vaccines and efficacies of interventions in healthcare institutions, showing a magnificent prospect of application. With the emergence of new derivative types such as real-time TND and cluster-randomized TND, TND has also been gradually applied to the exploration of disease risk factors and effectiveness evaluation of interventions. However, there are still few related research reports in China. We introduced the basic principles, methods and essentials of implementation, newly derivative types such as real-time TND and cluster-randomized TND, advantages and limitations of TND, as well as its applications in assessing post-marketing effectiveness for vaccines and efficacies of interventions, providing a theoretical and practical basis for researchers in China to carry out relevant research.
Traditional Chinese Drugs has proven to have unique merits in treating chronic atrophic gastritis (CAG) , but needs to be verified further by high-quality large-sample clinical studies. We detailed the technique essentials of clinical trial protocol design and assessment for CAG treated with Traditional Chinese Drugs, which may be used as a methodological reference for clinical trial protocol design for CAG treated using Traditional Chinese Drugs, promoting the quality improvement of relevant studies. Then we discussed the essentials of relevant clinical trial protocol design, especially the selection of outcome indicators, in accordance with the attributes of Traditional Chinese Drugs, and features and actual needs of such trials, providing ideas for comprehensive evaluation of efficacy of Traditional Chinese Drugs in treating CAG.
本文对《欧洲全科医学/家庭医学和基本医疗保健科研纲要》的中文译稿进行了重点摘登。该文件由欧洲全科医学科研网络制订,包括7部分内容:序言、导言、方法、结果、独立章节,讨论和启示。作为在欧洲发展全科医学科研的核心指南,该文件对欧洲的全科医学学科和科研发展产生了深远的影响。欧洲的全科医学体系和以此为基础而构建的学科理论共识与我国全科医学当前的实际情况可能更为接近。因篇幅所限,本文刊登了其中最重要,对中国研究者也最实用的5部分内容,包括:(1)导言——全科医学的核心能力/特征以及全科医学科研的意义;(2)结果——全科医学的6个核心领域(基本保健管理、"以人为本"的照护、解决具体问题的技能、综合的方法、以社区为导向、整体的方法)的科研范畴,研究需求和适用方法;(3)独立章节——如何发展基本的科研能力和避免常见的科研失误;(4)讨论——未来的全科医学科研重点;(5)启示——科学协会、研究机构、患者参与、科研工作、期刊、科研政策在发展学科方面应注重的问题。因欧洲的全科医学体制和我国较为相似,且存在一定的科研发展代差,该文件在当前阶段也可为我国全科医学研究者所用,基于全科医学学科的视角,从概念、分类学、范围和科研方法等方面,为我国全科医学科研的发展提供参照。