亲爱的患者：

　　Dear patients:

　　我们将邀请您参加一项“中西医合作脾胃病医患共建式循证病历探索研究”，用来探索中西医合作治疗脾胃病（消化疾病）的临床疗效评价方法。在您决定是否参加这项研究之前，请尽可能仔细阅读以下内容，它可以帮助您了解该项研究以及为何要进行这项研究，研究的程序和期限，参加研究后可能给您带来的益处、风险和不适。如果您愿意，您也可以和您的亲属、朋友一起讨论，或者请您的医生给予解释，帮助您做出决定。

　　We will invite you to participate in anevidence-based medical history research which is based on the combination of western and traditional Chinese medicine theory and requires cooperation between doctors and patients. The research is to explore clinical methods to evaluate efficacy when using the combination of western and traditional Chinese medicine to treat spleen and stomach diseases (digestive diseases). Before you decide whether to participate in the research, please read carefully the following content which may help you understand why the researchwill be conducted, what are the procedures, how long will the research last as well as the benefits, risks and discomfort brought by participating in the research. You can discuss with your relatives and friends or ask for advice from your doctor to make a decision.

　　研究介绍

　　Introduction to the Research

　　一、研究背景和研究目的

　　Ⅰ Background and Purpose of the Research

　　1、疾病负担和治疗现状

　　1. The Burden of Diseases and Present Situation of Treatment

　　门诊的启示：门诊总是见到患者拿出一张纸来，“大夫，我怕忘了，写下来，我看看这几个问题”。写的纸条也有长有短。简单就是列举的条目，还有写在病历本上的，复杂的讲述着求医的过程，更精致的，还有画的图表，并且编辑的纲举目张，然后打印出来。由此，我们可以看得出来，临床诊疗的实际需求，需要患者的积极参与。同时门诊时间的不足，需要医生和患者的互相了解。

　　窗体顶端

　　Inspiration from outpatient department: patientsoften took a piece of paper to see the doctor and said “I'm afraid that I might forget so I wrote some notes to remind me of why Icame here."Their notes could be as short as an entry list or complex with detailswritten on a medical history book about how to communicate with the doctor. Some patients even had printed notes with charts neat and tidy. Thus, we can see that an active participation of patients is needed in clinical diagnosis. Meanwhile, the consulting hours is inadequate, which requires mutual understanding between doctors and patients.

　　窗体底端

　　实际临床中矛盾和问题：医生和患者关注的方向不同，医生关注患者症状的同时，更重视客观指标的状况，而患者更关心自身症状的改善，这在临床实际中，有时候是统一的，有时候分离的，症状和实际病情不一定平行，这是一个现实的矛盾。

　　co窗体顶端

　　Contradictions and problems in clinic: doctors and patients have different concerns. Compared with the patient’s symptoms, doctors pay more attention to objective indicators.Patients care more about whether their conditions are getting improved. In clinic, the concerns of the two parts sometimes do not accord with each other for symptoms and actual conditions do not necessarily parallel, which is an existed contradiction.

　　临床疗效评价研究的现实：临床疗效的评价，对于医学科学的发展，是一个关键问题，也是新药研发和卫生健康事业的重大关注。随着医学科学的发展，从生活质量的关注，到患者报告的结局指标（PRO，Patient Report Outcome）量表的研发，更多的医学科学家把关注的目光投向了患者的感受，而疗效评价的主要指标，也在向患者的感受倾斜，如何评价干预措施的有效性，需要，综合医生患者两个方面的评价指标呼之欲出。同时，从当前的研究看出，重视患者的价值取向，可以更全面的评价临床疗效，然而，完全凭借患者评价，不免以偏概全。考虑，综合医生患者共同评价，来建立临床疗效评价体系可能会有助于全面客观的评价疗效。运用医患两个方面的评价，是否可以作为更好的疗效评价方法，是一个需要研究的问题。

　　The reality of clinical efficacy evaluation research: evaluation of clinical efficacy is a key issue for the development of medical science as well as a major concern of drug development and health undertakings. With the development of medical science and growing concerns about living quality, the patient report outcome scale has been developed and more medical scientists have put emphasis on patient’s feelings. In addition, the main indicators of efficacy evaluation have cared more about patient’s feelings. Now, a comprehensive indicator which combines the two aspects of doctors and patients needs to be established. At the same time, seen from the current study, a more comprehensive evaluation of clinical efficacy can be achieved if the patients’ values are considered. However,judging efficacy all by patients’ feelings can be biased. So, a comprehensive indicator considering both doctors and patients needs to be added to build a clinical efficacy evaluation system and that may help get an objective overall evaluation. Whether to adopt this comprehensive indicator needs further discussion.

　　循证医学之叙事医学的诊疗模式：循证医学的思维和理念引领了当前世界医学潮流，其三要素包括医生的经验，当前最佳诊疗措施以及患者的价值取向，这三方面缺一不可，同样重要。在诊疗中如何体现患者的价值取向，也是我们医生思考的问题，诊疗的记录，以医生记录的为导向，专业角度客观，需要更多关注患者的感受。

　　The medical practice pattern of narrative medicine, evidence-based medicine:evidence-based medicinethinking and ideas have led the trend of current world medicine. The three elements of evidence-based medicine are the doctor’s experience, current best diagnosis and treatment measures, and values of patients. The three parts are indispensable and equally important. To reflect the patients’ values in diagnosis and treatment is a major concern of doctors. At the same time, the records of diagnosis and treatment should be doctor-oriented, professional and objective, and considering more of patients.

　　2、研究目的

　　建立中西医合作消化内科常见疾病的医患共建式纸质及网络病历，探讨新的疗效评价方法和体系增强医患互信，增加医患彼此交流时间，从就诊之前就开始沟通。

　　2. The Purpose of the Research

　　To build a doctor-patient paper and online medical history record system in terms of common digestive diseases using integrative medical treatment, to explore new efficacy evaluation methods and systems, to enhance mutual trust between doctors and patients, to increase communication time between doctors and patients, and create opportunities for them to do so before patients go to the hospital.

　　3、研究方法

　　3. Research Methods

　　开放性病例对照观察队列研究，自身疗效评价及同期患者配对队列研究，方法学对照。

　　Open case-control observational cohort study, self-efficacy evaluation and matching same-period patientscohort study, the control methodology.

　　4、研究药物

　　4. The Drugs Used in the Research

　　中西医合作治疗的药物和方法

　　The drugs and methods used in the research are based on the combination of traditional Chinese medicine and western medicine.

　　5、研究参加单位与纳入患者例数

　　本研究由中国中医科学院西苑医院负责，属于“国家自然科学基金资助项目“中西医合作脾胃病医患共建式循证病历探索研究”(项目批准号：81303151)”预计纳入患者360例。

　　5. Institutions Involved in the Research and the Number of Cases

　　The research is conducted by Xiyuan Hospital, China Academy of Chinese Medical Sciences, and belongs to the “Natural Science Foundation of China funding project”. The name of the project is “Doctor-Patient Evidence-Based Medical History Research on Digestive Diseases Using Combination of Western and Traditional Chinese Medicine” (project approval number: 81303151). The research is expected to include 360 cases of patients.

　　本研究遵从赫尔辛基宣言原则，已经得到中国中医科学院西苑医院伦理委员会批准（批准号：2014XL083-2），同意进行临床研究。

　　This research complied with the Declaration of Helsinki principles and wasapproved by the ethics committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences(approval number: 2014XL083-2) to conduct a clinical research.

　　二、哪些人适宜参加研究

　　Ⅱ Who are appropriate to participate in the research?

　　如果您希望能够参加我们的研究，您需要符合以下条件：

　　If you want to participate in our research, you need to meet the following conditions:

　　1、明确诊断为功能性消化不良，胃食管反流病，慢性非萎缩性胃炎，胃癌前病变，消化性溃疡，肠易激综合征，溃疡性结肠炎，慢性便秘疾病的患者（网络管理两个病种：胃癌前病变，胃食管反流病）

　　窗体顶端

　　1. A clear diagnosis of functional dyspepsia, gastroesophageal reflux disease, chronic non-atrophic gastritis, precancerous lesions of gastric carcinoma, peptic ulcers, irritable bowel syndrome, ulcerative colitis, chronic constipation (two conditions are managed by network: precancerous lesions of gastric carcinoma, gastroesophageal reflux disease)

　　2、有三甲医院的消化科胃镜或者肠镜明确诊断

　　2. A confirmed diagnosis of gastroscope or enteroscope by digestive department of top three hospitals.

　　3、有三甲医院病理诊断明确

　　3. A confirmed pathological diagnosis by top three hospitals.

　　4、签署知情同意书

　　4. Signed information consent form.

　　5、同意电子及影像记录诊疗过程

　　5. Agreed to be taken electronic and video records of treatment process.

　　三、哪些人不宜参加研究

　　Ⅲ Who are not appropriate to participate in the research?

　　如果您有下面列出的疾病，或者其他特殊情况，您将不能参加我们的研究：

　　If you have the diseases listed below, or other special circumstances, you will not be able to participate in our research:

　　1、诊断不明确，胃镜或者肠镜检查时间超过6个月

　　1. The diagnosis is not clear or it has been more than 6 months since the endoscope or enteroscope was done.

　　2、不愿意提供个人信息，不希望进入研究的患者

　　2. Unwilling to provide personal information, or unwilling to participate in the research.

　　3、有重大精神疾患，难以控制自己的行动，无法配合的患者。

　　3. The patient has a major mental illness or has difficulty controlling his behavior.

　　4、除消化系统外，伴随有两个及以上系统疾病的患者

　　4. In addition to digestive system diseases, the patient has other illnesses in another two or more systems.

　　5、不识字，无法理解知情同意，无法自行签署知情同意书的患者

　　5. The patient can not read, can not understand the informed consent or can not sign the informed consent by themselves.

　　四、如果参加研究将需要做什么

　　Ⅳ What are you required to do?

　　1、请认真阅读并签署知情同意书

　　1. Please read carefully and sign the information consent from.

　　2、正常诊疗，如实告知诊疗的感受，按期随访。

　　2. Take routine treatment, tell about true feelings after treatment and have follow-ups on schedule.

　　3、接受电话随访，允许诊疗时电子记录情境。

　　3. Be prepared for telephone follow-up and allow electronic records when taking medical treatment.

　　五、参加研究可能的受益

　　Ⅴ What are the possible benefits of participating in the research?

　　1、患者将可能从本项研究中受益。优先得到门诊加号，确保诊疗连续性，并得到重点关注。得到医师的健康管理，并常年进行健康指导。

　　1. The patient may benefit from the research. For example, the patient has priority to go to the outpatient service and thus guarantee a consecutive treatment as well as special attention from doctors. The patient can also get the doctor’s health management and long-term health guidance.

　　2、您将在研究期间获得良好的医疗服务，比如您可以与您的研究者保持更直接的联系，并能得到更多更详细的治疗该疾病的医疗信息和指导。

　　2. You will get good medical care service during the research. For example, you can maintain a direct relation with your investigator and obtain more detailed information and guidance for your condition.

　　六、参加研究可能的不适、不方便

　　Ⅵ What are the possible inconvenience brought by participating in the research?

　　1、我们将尽全力避免由于本研究给您可能带来的不便。您在研究期间需要按时到医院随访，接受检查、症状体征记录、领取药物，这些都可能给其造成麻烦或带来不便。整个研究期间，您预计可能需要到医院5次以上甚至多年接受随访及相关检查，每次可能会占用您大约15分钟到半个小时的时间。

　　1. We will make every effort to avoid any inconvenience brought by the research. During the research period, you are required to go to the hospital on schedule, take exams, note down symptoms and signs, and get your medicine. You are expected to go to hospital for 5 times or more and have years of follow-ups and related inspection. The inspections will take you about 15 minutes to half an hour each time.

　　2、此外，任何药物可能出现无效的情况，以及因治疗无效或者因合并其他疾病等原因而导致病情继续发展。我们会积极治疗，一切以患者利益为先，改用其他可能有效的治疗措施。

　　2. In addition, if unexpected cases happen, for example, the drugs are not effective, the treatment turns out to be useless or the disease is complicated with other diseases so that the patient’s condition develops,we will take active measures and switch to other potentially effective treatments all for patient’s interests.

　　七、有关费用

　　Ⅶ The costs.

　　研究可能会产生随访的电话及交通费用，我们将为您提供100元的电话及交通补助，根据科研经费管理，需要提供身份证号及北京银行或者工商银行的卡号，1个月的随访后，将通过医院的财务给您发放到银行卡。

　　Follow-up research may produce telephone and transportation costs sowe will provide you with 100 yuan for phone and transportation subsidies.According to the research fund management, your ID number and bank card number are required. The bank could be Bank of Beijing or Industrial and Commercial Bank of China. After one-month follow-up, the grant will begiven to your card through the hospital's financial.

　　个人信息是保密的吗？

　　Is personal information kept confidential?

　　您的医疗记录（研究病历/CRF、检查的复印件等）将完整地保存在医院，医生会将化验检查结果记录在您的研究病历上。

　　1. Your medical records(research records/CRF, copies of the test, etc.) will all be kept in the hospital. At the same time, your test results will be recorded on your research records by the doctors.

　　本课题组办公室研究者、研究者或研究者助理、伦理委员会代表及医疗管理部门将被允许查阅该医疗记录。

　　The office researchers, researchers and researcher assistants of the project team, as well as the ethics committee representatives and medical management department will have access to the records.

　　任何有关本项研究结果的公开报告将不会披露您的个人身份。我们将在法律允许的范围内，尽一切努力保护您个人医疗资料的隐私。

　　Any public report concerning this research will not mention your identity. We will try our best to protect your privacy as far as the law is concerned.

　　除本研究以外，有可能在今后的其他研究中会再次利用您的医疗记录。您现在也可以声明拒绝除本研究外的其他研究利用您的医疗记录。

　　2.Apart from this research, other researches in the future may refer to your records too. But you can declare to refuse this reference.

　　3、研究者对所有患者的影像资料存放在本课题专用的移动硬盘中，供原始资料溯源以及课题组分析结果时使用，硬盘由主要研究者李博保存，本硬盘不做他用，不得外借，如有影像内容泄露，侵犯了患者隐私，主要研究者李博将承担相应法律责任。

　　3.All the video materials are kept in a special hard disk for dating back and result analysis. Kept by researcher Li Bo, the hard disk is inclusive and only for this research. If any video materials are leaked out, the main researcher Li Bo will take the related legal responsibilities.

　　九、怎样获得更多的信息？

　　How to get more information?

　　1、您可以在任何时间提出有关本项研究的任何问题。您的医生将给您留下他/她的电话号码以便能回答您的问题。

　　1. You can raise any question about this research at any time. Your doctor will give you his or her phone number so that your questions can be answered.

　　2、如果您对参加研究有任何建议和疑问，请与您的医生联系。如果您对参加研究有任何不满或意见，您可以和伦理委员会办公室联系。

　　2. If you have any advice or question about participating in this research, please contact your doctor. If you have any dissatisfaction or complaints, please contact the ethnics committee office.

　　3、如果在研究过程中有任何重要的新信息，可能影响您继续参加研究的意愿时，您的医生将会及时通知您。

　　3. Your doctor will inform you immediately of any important new information that may affect your willingness in joining in the research.

　　十、可以自愿选择参加研究和中途退出研究

　　Participate in or drop out in the middle of the research willingly

　　是否参加完全取决于您的自愿。您可以拒绝参加此项研究，或在研究过程中的任何时间退出研究，这都不会影响您和医生的关系，都不会影响对您的医疗或有其他方面利益的损失。

　　You can participate in or drop out of the research voluntarily. You can refuse to join in the research or drop out at any time, and neither of them would affect your relation with the doctor, your benefits in medical care or other aspects.

　　医生或研究者出于对您的最大利益考虑，可能会随时中止您参加本项研究。

　　To maximize your benefits, the doctor or researcher assistant may stop your participation at any time.

　　如果您不参加本项研究，或中途退出，还有很多其它可替代的治疗药物。您不必为了治疗您的疾病而必须选择参加本项研究。

　　If you refuse to take part in the research or drop out, you can still have alternative drugs instead of participating unwillingly for your disease.

　　如果您因为任何原因从研究中退出，您可能被询问有关您使用药物的情况。如果医生认为需要，您也可能被要求进行实验室检查和体格检查。

　　You may be asked about your trialed drug if you drop out. The doctor may also need you to have a laboratory test or physical test if necessary.

　　如果您选择参加本项研究，我们希望您能够坚持完成全部研究过程。

　　Once you participate, we hope that you could stick to it until the end.

　　现在该做什么？

　　What to do now?

　　是否参加本项研究由您自己决定。您可以和您的家人或者朋友讨论后再做出决定。

　　Whether to participate or not is your own choice. You can make a decision after discussing with your family members or friends.

　　在您做出参加研究的决定前，请尽可能向您的医生询问有关问题，直至您对本项研究完全理解。

　　Before deciding, ask your doctor about the research until it comes across completely.

　　感谢您阅读以上材料。如果您决定参加本项研究，请告诉您的医生或研究助理，他/她会为您安排一切有关研究的事务。

　　Thank you for your reading. If you have made up your mind to participate, please inform your doctor or researcher assistant. They will arrange everything concerned for you.

　　请您保留这份资料。

　　Please keep this material.

　　知情同意书?同意签字页

　　Informed consent?page for signature

　　临床研究名称：中西医合作脾胃病医患共建式循证病历观察研究

　　Name of the clinical research: observation and research on doctor-patient joint evidence-based records of gastroenteropathy treated by integration of Chinese medicine and western medicine

　　临床研究负责单位：中国中医科学院西苑医院

　　Responsible unit of the clinical research: Xiyuan Hospital, China Academy of Traditional Chinese Medicine

　　伦理审查批件号：2014XL083-2

　　Ethical review approval number:2014XL083-2

　　同意声明

　　Declaration of Consent

　　我已经阅读了上述有关本研究的介绍，而且有机会就此项研究与医生讨论并提出问题。我提出的所有问题都得到了满意的答复。

　　I have read the above introductions and discussed with my doctor about it. All my doubts have been satisfactorily responded.

　　我知道参加本研究可能产生的风险和受益。我知晓参加研究是自愿的，我确认已有充足时间对此进行考虑，而且明白：

　　I am aware of the risks and benefits of this research. After fully consideration，I understand and willingly join in the research.

　　我可以随时向医生咨询更多的信息。

　　My doctor is available at any time for more information.

　　我可以随时退出本研究，而不会受到歧视，医疗待遇与权益不会受到影响。

　　I can drop out at any time without discrimination and influence on my medical benefits.

　　我同样清楚，如果我中途退出研究，我会将病情变化告诉医生，完成相应的检查，这将对我本人和整个研究十分有利。

　　I am also aware that if I drop out in the middle, I will inform my doctor of the changes of disease condition and finish the related tests, which would benefit the research as well as myself.

　　如果因病情变化，我需要采取任何其他的药物治疗，我会在事先征求医生的意见，或在事后如实告诉医生。

　　If there is a change in my condition and another drug is needed, I would consult my doctor for advice before or tell the doctor honestly after.

　　我同意该课题组办公室、研究者或研究者助理、伦理委员会代表及医疗管理部门查阅我的研究资料。

　　I allow the project office, the researchers and the researcher assistant, as well as the ethics committee representatives and medical management department to refer to my research materials.

　　我同意□ 或拒绝□ 除本研究以外的其他研究利用我的医疗记录。

　　I agree□ or reject□ that my medical records be used in other researches.

　　我将获得一份经过签名并注明日期的知情同意书副本。

　　I will get a copy of the signed and dated informed consent.

　　我了解，我的隐私将得到很好的保护，影像资料仅供本研究溯源及分析使用。

　　I know that my privacy will be well protected and the video materials will only be used for dating back and analyzing this research.

　　最后，我决定同意参加本项研究，并保证尽量遵从医嘱。

　　In the end, I agree to participate in the research and try to follow the doctors’ instructions.

　　我确认：

　　□  我已经充分理解知情同意书，对不明白的问题都已经得到了满意的答复，并自愿参加本项研究。

　　□  我已经在知情同意书上签字并收到了知道同意书的副本。

　　I confirm:

　　□  I have fully understood the informed consent and got satisfactory answers for all questions. I am willing to participate in the research.

　　□  I have signed on the informed consent and got a copy of it.

　　患者签名：＿ ＿ ＿ ＿　＿ ＿ ＿ ＿ 年 ＿ ＿ 月 ＿ ＿ 日

　　患者联系电话：＿ ＿ ＿ ＿ ＿手机号：＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿

　　备用联系人电话：＿ ＿ ＿ ＿ ＿ 手机号：＿ ＿ ＿ ＿ ＿ ＿ ＿ ＿

　　Patient’s signature: ＿ ＿ ＿ ＿ year＿ ＿ month ＿ ＿ date

　　Patient’s phone number:

　　Alternative phone number:

　　我确认已向患者解释了本试验的详细情况，包括其权利以及可能的受益和风险，并给其一份签署过的知情同意书副本。

　　I confirm that I have explained to the patient the details of the research, as well as his or her rights , possible benefits and risks. The patient has also received a copy of the signed informed consent.

　　医生签名：＿ ＿ ＿ ＿ 日期：＿ ＿ ＿ ＿ 年 ＿ ＿ 月 ＿ ＿ 日

　　李博医生联系电话： 手机号：+86 ********

　　Doctor’s signature:＿ ＿ ＿ ＿ 年 ＿ ＿ 月 ＿ ＿ 日

　　Dr. Li Bo’s phone number:+86 ***********

　　中国中医科学院西苑医院伦理委员会办公室联系电话：010-62835646。

　　Phone number of ethnics committee office of Xiyuan Hospital, China Academy of Traditional Chinese Medicine: 010-62835646