混合研究方法在癌症临床研究中的创新应用Innovative Approaches Using Mixed Methods Procedures in Clinical Cancer Research 费 麦克富布赖特项目社会科学杰出讲席教授中国医学科学院肿瘤研究所

CICAMS 1/5/2017

北京市海淀区学院路 38 号，北京大学医学部， 100191电子邮件： mfetters@umich.edu手机 : 188-1172-8603 微信 : MikeFetters

Colorectal Cancer Website Project

结肠直肠癌网站项目Michigan Department of Community Health Colorectal Cancer Screening Behavioral Interventions. Michigan Department of Community Health Multi-media Decision Aid to Promote Colorectal Cancer

建立网站，以使用混合方法研究促进结肠直肠癌的筛查 Developing a Website to Improve Colorectal Cancer (CRC) Screening Using Mixed Methods Research 大多数美国人没有认识到他们应该关心 CRC ，或者不知道选择哪种筛查方法 Most Americans not

aware that they should be concerned about CRC or which screening method to choose

对选择筛查方法有效的 CRC 网站可能提高公众的认识，并且促使他们采取行动 An effective CRC Web site to choose a screening approach might improve awareness and prompt action

目标：建立网站来促进 CRC 筛查，并且确定网站的有效性 Objective: Develop a Web site to promote CRC screening and to determine Web site effectiveness

三阶段混合方法项目的阶段 Stages of the Three-Phase Mixed Methods Project

三阶段混合方法研究（ MMR ）项目的目标Purpose of 3-phase MMR project:1) 评估之前没有筛查过 CRC 的非裔美国人和白种人个体的态度和观点，开发网站内容 to assess attitudes and perspectives of African

American and Caucasian individuals not previously screened for CRC to develop content

2) 开发、测试并优化交互性网站，关注其内容、可用性以及网址导航，并且 to develop, pilot and refine the interactive website with attention to content, usability, and navigation, and

3) RCT 中，将作为先前未筛查患者的干预的交互式网站与促进结肠直肠癌筛查的非交互式标准网站进行比较，以评估 CRC 筛查的依从性 to compare interactive website with standard website in RCT with unscreened patients to assess compliance with CRC screening

多阶段 MMR 干预式项目Multi Stage MMR Intervention Project

调查关于 CRC 筛查的知识、态度以及想法 Survey on Knowledge, attitudes, beliefs on CRC screening

焦点小组：患者希望在网站上获得的信息 Focus Groups ： information patients want on website

定量 Quantitative

定性 Qualitative

开展 CRC 预防网站访谈、调查以及观察 Develop CRC prevention websiteInterviews, surveys, observations

定性 Qualitative

RCT ：比较“新网站”与标准网站 RCT comparing “new website” with standard

定量 Quantitative

Ruffin MT IV, Creswell JW, Jimbo M, Fetters MD. Factors influencing choices for colorectal cancer screening. J Community Health, 34:79-89, 2009. PM19082695.

以前未筛查的非裔美国人和白种人美国人，其来自郊区、城区和农村地区，年龄≥ 50 岁 Previously unscreened African American and Caucasian American people ≥50 years of age from suburban, urban and rural areas

定性QUALITATIVE

总体的结果以及解读 Overall Results and Interpretation

步骤 Procedures•10 个焦点小组 10 Focus groups成果 Product•关于 CRC 筛查的定性观点 Qualitative views about CRC screening

步骤 Procedures•对焦点小组内 93 个对象的调查 Survey of 93 focus group subjects成果 Product•认识、想法以及人口统计信息Knowledge, beliefs, demographics

定量 quantitative

Ruffin MT IV, Creswell JW, Jimbo M, Fetters MD. Factors influencing choices for colorectal cancer screening among previously unscreened African and Caucasian Americans: Findings from a triangulation mixed methods investigation.J Community Health, 34:79‑89, 2009.

聚敛性的混合方法设计Convergent Mixed Methods Design

多阶段 MMR 干预式项目Multi Stage MMR Intervention Project

调查关于 CRC 筛查的知识、态度以及想法 Survey on Knowledge, attitudes, beliefs on CRC screening

焦点小组：患者希望在网站上获得的信息 Focus Groups ： information patients want on website

定量 Quantitative

定性 Qualitative

开展 CRC 预防网站访谈、调查以及观察 Develop CRC prevention websiteInterviews, surveys, observations

定性 Qualitative

RCT ：比较“新网站”与标准网站 RCT comparing “new website” with standard

定量 Quantitative

Fetters MD, Ivankova NV, Ruffin MT, Creswell JW, Power D. Developing a website in primary care. Fam Med, 36(9):651-9, 2004.PM15467943

多阶段 MMR 干预式项目Multi Stage MMR Intervention Project

调查关于 CRC 筛查的知识、态度以及想法 Survey on Knowledge, attitudes, beliefs on CRC screening

焦点小组：患者希望在网站上获得的信息 Focus Groups ： information patients want on website

定量 Quantitative

定性 Qualitative

开展 CRC 预防网站访谈、调查以及观察 Develop CRC prevention websiteInterviews, surveys, observations

定性 Qualitative

RCT ：比较“新网站”与标准网站 RCT comparing “new website” with standard

定量 Quantitative

Ruffin M, Fetters MD, Jimbo M. Preference-based electronic decision aid to promote colorectal cancer screening: Results of a RCT. Prev Med, 45:267-73, 2007. PM17689600.

OR +3.23 (2.7-3.50 95% CI for probability of being screened for Colorectal Web site compared to control

在虚拟现实 (M-PathicVR™) 中对专业态度建模并且进行人文沟通教学Modeling Professional Attitudes and Teaching Humanistic Communication in VR (M-PathicVR™)

NIH (NCI) #3R03LM010052-0151NIH (NCATS) #5R44TR000360State of Wisconsin SBIR-Advance Grant

研究团队 Research Team主要研究者 Co PIs Frederick W. Kron Michael D. Fetters

合作者 Collaborators Mark W. Scerbo Casey B. White Monica L. Lypson Miguel A. Padilla Gayle A. Gliva-McConvey, Lee Belfore

Lee, II Temple West Amelia M. Wallace Timothy C. Guetterman Lauren S. Schleicher Rebecca A. Kennedy Rajesh S. Mangrulkar James F. Cleary Stacy C. Marsella Daniel M. Becker

顾问 Consultants Paul Ekman Erika Rosenberg Michael Chmilar C. Donald Combs Mekbib Gemeda Thomas Hubbard Stacie Buckler Michael Lukela Kelly Poszywak Joel Purkiss Sally Santen Jamie Schingeck Leslie Blackhall Randy Canterbury Anne Chapin Francis Nelson Norman Oliver Connie Dresser Eric Young Rebecca Hill Jeff Young

研究背景：沟通 Background: Communication

沟通不良Poor Communication

满意度降低Decreased Satisfactio

n

患者流失Patient attrition

团队运作变差Poorer team

functioning

收入降低Poorer

Outcomes

有关伤害 / 错误 / 医疗过失的诉讼Harm/errors/

malpractice lawsuits

多阶段 MMR 干预式项目Multi Stage MMR Intervention Project

医学生和教师使用虚拟人BBN 模块来检查定量得分，并且暴露后的访谈用于评估经验 Medical students and faculty take Virtual Human BBN Module to examine quan score, and post-exposure interviews to assess experience

在住院医师之间的双向组间比较，用于评估关于癌症护理中姑息治疗的沟通改善 Two-way group comparison among residents to assess improvement in communicating about palliation for cancer care

MMR

焦点小组构建关键特征：虚拟人的外貌、声音、类型 Focus Groups to build key features look, voice, type of virtual human

定性 Qualitative在现实临床情景中，在接触虚拟人模拟的学生和暴露于 CBL 对照的学生之间进行 RCT ，考察高级沟通表现 RCT examining advanced communication performance in realistic clinical scenario between students exposed to virtual human simulation and students exposed to CBL control

MMR

定量 Quantitative

多阶段 MMR 干预式项目Multi Stage MMR Intervention Project

医学生和教师使用虚拟人BBN 模块来检查定量得分，并且暴露后的访谈用于评估经验 Medical students and faculty take Virtual Human BBN Module to examine quan score, and post-exposure interviews to assess experience

在住院医师之间的双向组间比较，用于评估关于癌症护理中姑息治疗的沟通改善 Two-way group comparison among residents to assess improvement in communicating about palliation for cancer care

MMR

焦点小组构建关键特征：虚拟人的外貌、声音、类型 Focus Groups to build key features look, voice, type of virtual human

定性 Qualitative在现实临床情景中，在接触虚拟人模拟的学生和暴露于 CBL 对照的学生之间进行 RCT ，考察高级沟通表现 RCT examining advanced communication performance in realistic clinical scenario between students exposed to virtual human simulation and students exposed to CBL control

MMR

定量 Quantitative

方法 Methods

设计：单盲、混合方法、多站点 RCT Design: Single-blinded, mixed-methods, multisite RCT

地点：东弗吉尼亚医学院，密歇根大学和弗吉尼亚大学医学院 Setting: Eastern Virginia Medical School, University of

Michigan, & University of Virginia Med Schools 参与者：在合乎标准的二年级医学生中，

421名 (87.5%) 参与了本研究 Participants: Of eligible 2nd-year med students, 421

(87.5%) participated

图 1. M-PathicVR 测试中的参与者流程图 Figure 1. Participant Flow through the M-PathicVR Trial

Study Hypotheses and MMRQs

OSCE Evaluatio

n

OSCE Evaluatio

n

H1 H1H2MMRQ3

结论 Results

H1: 与培训前相比， Mpathic 组的得分在培训后在跨文化沟通以及专业间沟通场景中得到改善 MPathic score improved pre-post, intercultural and inter-

professional scenarios (p<.001) H2: 在多个组中， Mpathic 组的 OSCE综合得分较佳 (p=.01)

OSCE composite score between groups better for MPathic (p=.01)

MMRQ: MPathic 组中的学生在态度量表测试中表现更好 (p<.001) Student attitudes’ scale more positive for MPathic (p<.001)

混合方法评价Mixed Methods Evaluation

• 受到 MPathic-VR 培训的学生看重：Students who trained with MPathic-VR valued • 其将非语言沟通技能传授给学生 its teaching

nonverbal communication skills, • 提供及时反馈，并且 providing immediate feedback,

and • 让学生对于带情绪的沟通对象有所准备 preparing

them for emotionally charged encounters (p < .0001)

讨论 Discussion

MPathic-VR 能有效地进行高级沟通技能培训 MPathic-VR effective in training advanced communication skills

M-PathicVR 学生将技能迁移到不同的临床场境 M-PathicVR students transferred skills into a different clinical

scenario MMR 评价表明，交互性受到重视

MMR evaluation illustrates interactivity strongly valued 研究示例性地说明了MMR 在创新癌症医学教育研究中的价值

Research exemplifies value of MMR in innovative cancer medical education research

Physician Communication About Cancer in China, Japan and Thailand

中国、日本和泰国关于癌症的医患沟通

研究团队 Research Team

美国 USA Michael D. Fetters, MD, MPH, MA; U of M, USA中国 China Yali Cong, PhD, PUHSC Hongling Chu Qiong Luo Yinong Wei日本 Japan Hisako Kakai, PhD, Aoyama Gakuin University Nobutaro Ban, MD, PhD, Nagoya University Shiho Teshigawara, MD, Nagoya University 泰国 Thailand Kittitouch Soontornwipast, EdD, Thammasat University Watcharaporn Paorohit, PhD, Bhumibol Adulyadej Hospital, Royal

Thai Air Force Nursing College

研究背景 Background

西方哲学和文化强调患者在家属的支持下作出决定 Western philosophy and culture emphasizes the patient making the

decision with support of the family东方哲学和文化强调家属为病人做决

Eastern philosophy and culture emphasizes the family in decision making for a patient

对共同决策模式的兴趣在增强 Growing interest in shared decision making model

利用这个机会考察家属在决策过程中的作用，从而思考不同策略之间的细微差别 Opportunity to examine family in decision making to consider

nuances in different approaches

研究目的 Objective

本研究旨在了解在中国、日本和泰国关于癌症的医患沟通方法以及经验 This research seeks to understand physician approaches to

and experiences with cancer communication in China, Japan and Thailand.

来自日本的历史调查研究发现 Previous Survey

Findings From Japan

基于文化困境，起草调查表并优化 DraftSurvey & Update based on Cultural

Dilemmas

中国、日本和泰国关于癌症的医患沟通：多相混合方法研究计划Physician Cancer Communication in China, Japan and Thailand: A Multiphase Mixed Methods Research Proposal

定量 QUAN

Procedure: review most releant findingsOutcome: Identify most critical issues, delete irrelevant; update for Japan

中国的半结构化访谈 Semi-Structured InterviewsIn China

Procedures: 11 triad inter-views of Doc/Pt/Fam (n=33)Outcome: CulturallyImportant issues relativeto cancer communication In China

定性 QUAL

Procedures: Draft project instrument based on previous experience, DM literature, and recent QUAL research from China; sumbit IRR; Translate back/translate finstrument to identify translation dilemmasOutcome: IRB review, and translation into cultural ; cultural adaptation baseed on translation procedures2) Ready for pilot distribution in Chinese, Japanese and Thai

在中国、日本和泰国分发调查表 Distribute survey in

China, Japan & Thailand

定量 + 定性QUAN + qual

Procedures: Distribute instrument to all physicians in university-affiliated hospitalOutcome: Prevalence of attitudes about cancer communication items in China and Japan

医生在关于癌症的沟通经验，以及医生有关癌症的沟通态度的普遍性 Physician experiences with

cancer communication, and

prevalence of physician attitudes

about cancer communication, DM

Shared DM in 3 countries

Outcomes: Prevalence of attitudes about cancer communication items in China and Japan; Binational contemporary comparison of China and Japan; Historical comparisions with US data from 1961 and 1979

对调查表进行实验性测试，并且定稿 Pilot and Finalize

Instrument

定性 + 定量qual + quan

Procedures:Cognitive test draft instrument; Pilot-test draft instrument; incorporate findings into instrumentOutcome: Survey finalized and ready for distribution in Chinese,Japanese & Thai languages

共同决策方面的文献 Literature on

shared decision makingProcedure: Identify

relevant literatureOutcome: Identify most critical issues, updates for Chna, Japan & Thailand

定性 qual

定性 qual

讨论 Discussion

在过去三十年中，混合方法研究成为一门新兴学科 Mixed Methods Research emerged as a new discipline over the past 3 decades

多门学科在使用 MMR 方面非常活跃，尤其是医学 Various Disciplines, especially the health Sciences very actively using MMR

可能在癌症研究中得到广泛应用 Many possible applications in cancer research

Asia Regional Mixed Methods International Research AssociationThird Japan Society of Mixed Methods Research Meeting Osaka, 8/4-6, 2017

行为与社会科学研究办公室 The Office of Behavioral and Social Sciences Research (OBSSR)Helen I. Meissner, Ph. D., Office of Behavioral and Social Sciences Research

http://obssr.od.nih.gov/mixed_methods_research/pdf/Best_Practices_for_Mixed_Methods_Research.pdf

《医学中混合研究方法的最佳实务》Best Practices for Mixed Methods Research in the Health Sciences