Alternative Medicine

Course: Principles of Research Course Code: RES100 Times & Location: Wednesdays 9:00 am – 10:50 am Classroom 4 Course Coordinator/ Instructor Please use your ndnet.ccnm.edu email account or Moodle for all communication Office Hours: Appointments set up via email Office Location: Rm 2029 (2nd floor faculty wing) Teaching Assistants Evaluation: PERCENT DUE DATE Progressive CAP Assignment 40% Due Dates (submitted via Moodle) Part 1 October 7, 2015 *Please check both the gradebook as well as the Part 1 + 2 November 11, 2015 assignment sections of Moodle to view feedback/marks All parts December 9, 2015 Discussion Forum Participation 20% Week 5, 6 and 9 Final Exam 40% TBA – Final Exam Period Required Texts: There is no required text for this course. Lecture material and some posted material are considered required reading. Recommended Texts: Greenhalgh, T. How to Read a Paper: The Basics of Evidence-Based Medicine. 5th Ed. London: Blackwell Publishing Ltd., 2014 Straus, SE., et al. Evidence Based Medicine: How to Practice and Teach It. Toronto:Churchill Livingstone, 2011 Lewith, G et al. Clinical Research in Complementary Therapies: Principles, Problems and Solutions. Toronto: Churchill Livingstone, 2002. RES100 Supplemental Course notes package. These will not be printed, but are available for download and viewing through Moodle. The material in the notes package is not considered required reading, but exists to supplement the material discussed in the lectures for students looking for more information regarding the various lecture topics. Suggested Additional Resources Riegelman, RK. Studying a Study & Testing a Test: How to Read the Medical Evidence 5th Ed. Lippincott Williams & Wilkins. 2005. Forrest, JL., et al. Evidence-Based Decision Making: A Translational Guide for Dental Professionals. Lippincott, Williams & Wilkins. 2009. Kane, M. Research Made Easy in Complementary & Alternative Medicine. Toronto: Churchill Livingstone, 2004 Katz, D. Clinical Epidemiology & Evidence-Based Medicine: Fundamental Principles of Clinical Reasoning and Research. Oxford University Press, 2001. Course Description: The course is designed to provide students with an introductory understanding of research methods, clinical epidemiology, evidence -based medicine (EBM) and research issues pertaining to the practice of medicine, with a focus on naturopathic interventions. This course challenges students to engage in critical thinking and develop the process of accessing, interpreting and applying valid information from the medical literature to educate themselves and their patients, and to assist in clinical decision making. (Prerequisites: none) Course Outcomes: Upon completion of this course students are expected to: Have an appreciation of the scientific method and the value of research and evidence based medicine in general. Understand and be able to identify the basic types of clinical epidemiological studies including: randomized controlled trials, cohort studies, case-control studies, systematic reviews, case reports, n-of-1 studies, and whole systems research. Be able to critically appraise the above types of studies in clinical epidemiology and across the spectrum of disciplines within naturopathic medicine. Know how to ask (and answer) a clinical question using the principles and tools of evidence-based medicine and clinical epidemiology Have an understanding and familiarity with statistical tools used in clinical epidemiology. Demonstrate the ability to access and apply research to clinical questions. Know where to look and how to access resources in order to answer clinical questions Know how to report an Adverse Event Report Pedagogy: The course material will be discussed primarily through lecture format. An online (Moodle) discussion forum will accompany some weekly topics where example studies will be critiqued and discussed. Regular class participation and interaction is greatly encouraged. Practical Sessions: There are two practical/instructional sessions in the course. The LRC Research Tutorial and Practical session will be led by the LRC staff. Attendance is strongly encouraged for this lecture as it will be the only time you receive formal instruction regarding how to access the LRC’s collection of medical resources. The critical appraisal help session will occur partway through the course. Attendance is strongly encouraged, but is not mandatory. This is the only opportunity to meet with your TA and the instructor to discuss the paper selected for your progressive assignment and group presentation. Moodle Discussion Forums: Students are assigned one of two groups for the duration of the year. In weeks 5, 6 and 9 there will be two example articles posted for discussion that pertain to the week’s learning objectives. Students are required to post comments, questions and criticisms of the particular journal article. Different articles will be posted for each group. Discussion forums will be moderated by the course TAs. Participation in the discussion forums will be graded for each and marks will be assigned based on posts being relevant to the paper/discussion at hand, replying to direct questions and utilization of lecture/class information. It is expected that students post twice during the time period the discussion forum is open. Posts must contribute to the discussion at hand; posts stating simple agreement/disagreement or posts that otherwise do not contribute new information to the discussion will not be counted. The discussion forum will remain open for marking for one week following the lecture in question. For example, the discussion forums for week 5 will open at the end of class and remain open for marking until 8:55am the following week Attendance: Important announcements related to the course will be communicated at the beginning of the lecture and/or via the Moodle discussion board. Although no grade is associated with lecture attendance, all material discussed in class, regardless of whether or not it appears on posted lecture notes, is considered exam material. Therefore it is strongly recommended that you attend each class in order to take part in, and learn from, class discussions. Evaluation: All assignments, papers and exams must be completed for a course grade. The minimum passing grade for the course is 65% and “Pass” on all Pass/Fail requirements. Students achieving a final grade below 65% will be required to write a supplemental examination or retake the course, as determined by the Department of Academics. Examinations are based on the course and lecture objectives, lecture content and assigned readings. Graded assignments that are handed in late will be given a penalty of 5% per academic day late. Weekends are assessed as being 1 day. For example, an assignment that is due on Friday and handed in on Tuesday will have 15% deducted from the achieved grade. Students can expect feedback/grades reported in Moodle 2 weeks following the due date of the assignment. Progressive Assignment This independent assignment is designed to foster critical appraisal skills of medical literature and is submitted in parts throughout the course. Following the submission of parts 1 and 2 you will be given feedback from your TA regarding the quality of the submission. The assignment will not be assigned a formative mark until the entire assignment is submitted (parts 1 through 3), which is due on the final day of regularly scheduled class. This is an independent project and therefore each student is expected to submit a unique paper. Plagiarism will not be tolerated and will be reported to the Academic Department. Choose a topic of interest related to the utility of a naturopathic intervention in a specific population of people, and pose this question using the PICO model (Part 1A). Search for a primary randomized controlled trial publication that is relevant to your question and obtain the article in full text (Part 1B). Critically appraise the paper using the CAP outline posted in Moodle (Part 2) Discuss whether or not the question has been answered satisfactorily, what else might be needed, and how this information should be applied to patient care (Part 3). Part 1A Question sets the stage for interesting discussion Target population is defined 5 marks Intervention is specific Comparative population/treatment is clearly defined Outcome is clearly defined Etiology and prevalence of condition in Canada discussed and referenced appropriately (5 marks) Justification for choosing question discussed: o Safety and effectiveness of alternatives (naturopathic and/or medical) 5 marks o Anticipated or perceived needs and values of patients who may use intervention o Reason for personal interest in topic o Relative success in treating using other methods based on available research Part 1B Three searches performed with a variety of term combinations For each search 5 marks for o Search terms used are listed each search o Limits set are identified, if used 15 marks o PubMed MeSH terms or MeSH classification tree specified, if applicable total o Databases searched are identified (minimum of 2 different databases) o Numbe r of articles each search returned is stated o Summary of search results is clear and concise (table format recommended) (3 marks) Overall search strategy is rationalized in a clear and concise manner (3 marks) Search strategy rationalization is relevant to what was actually performed (4 marks) Mark out of 40 Worth 15% of final assignment mark Part 2 Full text access to article obtained (1 mark) Article selected is a randomized controlled trial pdf of article submitted (section cannot be marked without article submission) CAP format summary is used and followed correctly o Aim is clearly stated (1 mark) o Design is correctly stated (1 mark) o Participants are fully described (age, sex, medical diagnosis, how assigned into treatment/control groups, etc) (2 marks) o Interventions are described fully, including dosages/frequency/details of intervention as provided in the article, for each intervention group and control group. (4 marks) o Main outcome measures clearly stated (measured endpoints listed) (3 marks) o Summary of key findings and results (including statistical significance) provided in a concise manner (use of tables recommended) (10 marks) Information taken from paper is referenced as shown in example CAPs Relative or absolute risk reduction calculated or stated, if discussed in article Adverse reactions discussed along with statistical significance, if applicable Participant retention discussed, if applicable o Authors conclusion stated succinctly (1 mark) o Quality of evidence correctly stated (1 mark) 15 marks o Conflicts of interest stated. If none are declared, that is stated (1 mark) o Cost effectiveness discussed, if applicable o Discussion is concise and relevant to article Discussion is in student’s own words Discussion is referenced appropriately Limitations of article stated o Minimal spelling mistakes and grammatical errors o Overall CAP is clear and concise Overall gaps in the research are mentioned in the CAP (likely in Discussion or Further Work sections) Mark out of 40 Worth 50% of final assignment grade. Part 3 How student would you go about finding further evidence given what was learned in Part 2 is discussed and new knowledge gaps or areas of further research are identified (5 marks) Application of results to patient management stated (5 marks) o Application of results correlates with what was concluded in the article How the information gathered in Part 2 assists in answering the question identified in part 1 is discussed (5 marks) Other research that supports or contradicts the evidence obtained in Part 2 is discussed within the context of the article being appraised, and the relevance to the question initially being asked (10 marks) o A minimum of 4 references are used (additional to the article appraised in part 2) How the information gathered in parts 1 through 3 can be applied in a clinical setting is discussed and justified (3 marks) Whether or not there is good evidence available to make a clinical decision is discussed (3 marks) If the question was altered from Part 1, justification for altering the question is discussed and justified 3 marks Absence of spelling mistakes and grammatical errors Part 3 is no longer than 1000 words Parts 1 through 3 Overall style, creativity, interest, grammar/spelling (8 marks) Mark out of 34 Worth 25% of final assignment grade Referencing Student adheres to proper Vancouver style referencing and references appropriately throughout assignment. Student synthesizes information taken from articles as appropriate, and does not cut and paste material from articles Charts, graphs and tables are all referenced Mark out of 20 Worth 10% of final assignment grade RES100 - LECTURE SCHEDULE Fall 2014 Instructor and Readings 1 Sept 9 Introduction to Lecturer: Adam Gratton, ND RES100 Course Syllabus (Moodle) 2 Sept 16 Introduction to Lecturer: Adam Gratton, ND Evidence Based Course Notes – Section B: Evidence Based Medicine Medicine (EBM) Chapters 6, 8 and 9 Course Notes – Section A Chapters 1-5 3 Sept 23 LRC Search Skills and Instructor: Michael D. Reansbury Resource Orientation Practical Course Notes – Section B: Evidence Based Medicine Chapter 7. Accessing the Literature 4 Sept 30 Practical Researching Lecturer: Research Residents for Patient Care 5 Oct 7 Randomized Lecturer: Adam Gratton, ND MOODLE Controlled Trials Course Notes – Section C: Randomized Controlled Trials. DISCUSSION Ch. 12 FORUM 6 Oct 14 Systematic Reviews, Lecturer: Adam Gratton, ND MOODLE Meta-Analyses and Course Notes – Section C: Systematic Reviews. Ch. 13 DISCUSSION Narrative Reviews FORUM 7 Oct 19 – 23 Mid Term Exam Week 8 Oct 28 CAP tutorial session Q & A for Part 2 of assignment with Dr. Gratton and Research Residents 9 Nov 4 Cohort Studies Lecturer: Adam Gratton, ND MOODLE Case-Control Studies Course Notes – Section C: Cohort. Ch. 15 and Care- DISCUSSION Control Ch. 16 FORUM 10 Nov 11 NDs as Researchers Guest Lecturer: Dr. Lynne Shinto ND 11 Nov 18 Whole Systems Lecturer: Adam Gratton, ND Research & Course Notes – Section C: Whole Systems Research. Ch. Qualitative Research 14 12 Nov 25 Preclinical research, Lecturer: Adam Gratton, ND Adverse Reaction Course Notes – Section C: Preclinical. Ch. 18 Reporting, Outcomes & Critical Appraisal Section C: Adverse Reactions. Ch 17 and Appendix: Techniques Adverse reaction reporting 13 Dec 2 Case Reports, N of 1 Lecturer: Adam Gratton, ND studies and Practice- Course Notes – Section C: Case Reports Ch. 17 & 14 based research 14 Dec 9 Clinical Decision Lecturer: Adam Gratton, ND Making & Review Course Notes – Section C: Critiquing EBM. Ch 19 & Clinical Decision Making. Ch 20 McAlister et al. User’s guide to the medical literature XX. Integrating research evidence with the care of the individual patient JAMA, 2000, 283(21):2829-36 15 Dec. 14 - 23 Exam Week – (final exam date TBA) The Academic Department reserves the right to make any changes in the schedule. LECTURE OUTLINE By the end of each lecture, the student will be able to: Introduction to RES100 Understand the course requirements and overall course objectives Understand the assessment breakdown, requirements and due dates for each assessment Appreciate the value of research and evidence based medicine (EBM) Understand the need for critical appraisal of published health research Understand the scientific method and how it shapes the development of scientific research Be able to describe and generate valid hypotheses and predictions Understand and describe the principles of causation Introduction to Evidence Based Medicine Know how to understand and apply the PICO model to approaching research Understand the process/steps of approaching EBM Be able to identify different types of health related research Understand and be able to apply basic concepts in biostatistics to medical care such as: Populations, samples, sampling, incidence, prevalence Descriptive statistics, distributions, measures of variance, absolute and relative risk, number needed to treat/harm, sensitivity and specificity Describe and identify causality, bias, chance, confounding, and association and know how this can influence the validity and reliability of research findings LRC Search Skills and Resource Orientation Practical Understand how to access and use various LRC resources to search, collect and prioritize evidence Practical Researching for Patient Care Understand how to access and use various internet based resources to search, collect and prioritize evidence Understand how and where a clinician would look to research to inform their clinical decision and how they would use it to educate their patient Understand basic approaches to clinical decision making Randomized Controlled Trials Describe the design and methodology of RCTs Understand the goal of randomization and how to assess whether or not an RCT achieves it Identify inherent strengths and weaknesses of the RCT design and assess its quality based on design (JADAD, CONSORT) and relevance to practice/individual patients Identify the difference between surrogate and hard endpoints and understand the importance of the study outcomes measure in drawing conclusions and applying results in patient care. Identify factors that would influence the external/internal validity of an RCT Systematic Reviews and Narrative Reviews Describe the design and methodology of narrative reviews, systematic reviews and meta-analyses Identify inherent strengths and weaknesses of each design and how to assess quality based on design (eg. PRISMA) and relevance to practice/individual patients Identify the importance of the study intervention outcome measure in drawing conclusions and applying results in patient care Generate a search strategy for a hypothetical systematic review Understand the unique graphical means of reporting data in published systematic reviews and meta-analyses Describe why the systematic review with meta-analysis is considered superior to the RCT CAP Practical Understand aspects of their original research publication selected for the basis of their progressive assignment that were unclear or confusing through asking relevant and appropriate questions of the research residents and/or course coordinator Cohort Studies & Case-Control Studies Describe the design and methodology of observational studies (cohort and case-control) Identify inherent strengths and weaknesses of each design and how to assess quality based on their design (eg. MOOSE) and relevance to practice/individual patients and public health Identify the importance of the study population and outcome measure in drawing conclusions and applying results in patient care. Generate a list of confounding factors that may highly influence the conclusion of an observational study Identify factors that would influence the external/internal validity of an RCT Understand why case-control studies are considered higher on the EBM pyramid compared to cohort studies Whole Systems and Qualitative Research Describe the design, methodology and intention of whole systems research design Describe variants to the RCT design and discuss their applicability to naturopathic research Identify inherent strengths and weaknesses of each of the designs and how to assess quality based on model validity Identify the importance of the study outcome measure in drawing conclusions and applying results in patient care. Understand the role and value of qualitative research Preclinical research and Critical Appraisal Techniques Describe the design and methodology of pre-clinical research Describe the process of drug development in Canada Understand the differences between foods, drugs and natural health products Identify inherent strengths and weaknesses of the preclinical research and how to assess relevance to practice/individual patients Case reports, N of 1, & Practice-based Research Describe the design and methodology of case reports, case series and n-of-1 trials Identify inherent strengths and weaknesses of each design and how to assess quality and application to individual patients Identify the importance of blinding and bias in drawing conclusions from individual research designs and ‘anecdotal’ research. Describe factors that would influence internal/external validity regarding case series publications Evaluation: PERCENT DUE DATE Progressive CAP Assignment 40% Due Dates (submitted via Moodle) Part 1 October 7, 2015 *Please check both the gradebook as well as the Part 1 + 2 November 11, 2015 assignment sections of Moodle to view feedback/marks All parts December 9, 2015 Discussion Forum Participation 20% Week 5, 6 and 9 Final Exam 40% TBA – Final Exam Period Required Texts: There is no required text for this course. Lecture material and some posted material are considered required reading. Recommended Texts: Greenhalgh, T. How to Read a Paper: The Basics of Evidence-Based Medicine. 5th Ed. London: Blackwell Publishing Ltd., 2014 Straus, SE., et al. Evidence Based Medicine: How to Practice and Teach It. Toronto:Churchill Livingstone, 2011 Lewith, G et al. Clinical Research in Complementary Therapies: Principles, Problems and Solutions. Toronto: Churchill Livingstone, 2002. RES100 Supplemental Course notes package. These will not be printed, but are available for download and viewing through Moodle. The material in the notes package is not considered required reading, but exists to supplement the material discussed in the lectures for students looking for more information regarding the various lecture topics. Suggested Additional Resources Riegelman, RK. Studying a Study & Testing a Test: How to Read the Medical Evidence 5th Ed. Lippincott Williams & Wilkins. 2005. Forrest, JL., et al. Evidence-Based Decision Making: A Translational Guide for Dental Professionals. Lippincott, Williams & Wilkins. 2009. Kane, M. Research Made Easy in Complementary & Alternative Medicine. Toronto: Churchill Livingstone, 2004 Katz, D. Clinical Epidemiology & Evidence-Based Medicine: Fundamental Principles of Clinical Reasoning and Research. Oxford University Press, 2001. Course Description: The course is designed to provide students with an introductory understanding of research methods, clinical epidemiology, evidence -based medicine (EBM) and research issues pertaining to the practice of medicine, with a focus on naturopathic interventions. This course challenges students to engage in critical thinking and develop the process of accessing, interpreting and applying valid information from the medical literature to educate themselves and their patients, and to assist in clinical decision making. (Prerequisites: none) Course Outcomes: Upon completion of this course students are expected to: Have an appreciation of the scientific method and the value of research and evidence based medicine in general. Understand and be able to identify the basic types of clinical epidemiological studies including: randomized controlled trials, cohort studies, case-control studies, systematic reviews, case reports, n-of-1 studies, and whole systems research. Be able to critically appraise the above types of studies in clinical epidemiology and across the spectrum of disciplines within naturopathic medicine. Know how to ask (and answer) a clinical question using the principles and tools of evidence-based medicine and clinical epidemiology Have an understanding and familiarity with statistical tools used in clinical epidemiology. Demonstrate the ability to access and apply research to clinical questions. Know where to look and how to access resources in order to answer clinical questions Know how to report an Adverse Event Report Pedagogy: The course material will be discussed primarily through lecture format. An online (Moodle) discussion forum will accompany some weekly topics where example studies will be critiqued and discussed. Regular class participation and interaction is greatly encouraged. Practical Sessions: There are two practical/instructional sessions in the course. The LRC Research Tutorial and Practical session will be led by the LRC staff. Attendance is strongly encouraged for this lecture as it will be the only time you receive formal instruction regarding how to access the LRC’s collection of medical resources. The critical appraisal help session will occur partway through the course. Attendance is strongly encouraged, but is not mandatory. This is the only opportunity to meet with your TA and the instructor to discuss the paper selected for your progressive assignment and group presentation. Moodle Discussion Forums: Students are assigned one of two groups for the duration of the year. In weeks 5, 6 and 9 there will be two example articles posted for discussion that pertain to the week’s learning objectives. Students are required to post comments, questions and criticisms of the particular journal article. Different articles will be posted for each group. Discussion forums will be moderated by the course TAs. Participation in the discussion forums will be graded for each and marks will be assigned based on posts being relevant to the paper/discussion at hand, replying to direct questions and utilization of lecture/class information. It is expected that students post twice during the time period the discussion forum is open. Posts must contribute to the discussion at hand; posts stating simple agreement/disagreement or posts that otherwise do not contribute new information to the discussion will not be counted. The discussion forum will remain open for marking for one week following the lecture in question. For example, the discussion forums for week 5 will open at the end of class and remain open for marking until 8:55am the following week Attendance: Important announcements related to the course will be communicated at the beginning of the lecture and/or via the Moodle discussion board. Although no grade is associated with lecture attendance, all material discussed in class, regardless of whether or not it appears on posted lecture notes, is considered exam material. Therefore it is strongly recommended that you attend each class in order to take part in, and learn from, class discussions. Evaluation: All assignments, papers and exams must be completed for a course grade. The minimum passing grade for the course is 65% and “Pass” on all Pass/Fail requirements. Students achieving a final grade below 65% will be required to write a supplemental examination or retake the course, as determined by the Department of Academics. Examinations are based on the course and lecture objectives, lecture content and assigned readings. Graded assignments that are handed in late will be given a penalty of 5% per academic day late. Weekends are assessed as being 1 day. For example, an assignment that is due on Friday and handed in on Tuesday will have 15% deducted from the achieved grade. Students can expect feedback/grades reported in Moodle 2 weeks following the due date of the assignment. Progressive Assignment This independent assignment is designed to foster critical appraisal skills of medical literature and is submitted in parts throughout the course. Following the submission of parts 1 and 2 you will be given feedback from your TA regarding the quality of the submission. The assignment will not be assigned a formative mark until the entire assignment is submitted (parts 1 through 3), which is due on the final day of regularly scheduled class. This is an independent project and therefore each student is expected to submit a unique paper. Plagiarism will not be tolerated and will be reported to the Academic Department. Choose a topic of interest related to the utility of a naturopathic intervention in a specific population of people, and pose this question using the PICO model (Part 1A). Search for a primary randomized controlled trial publication that is relevant to your question and obtain the article in full text (Part 1B). Critically appraise the paper using the CAP outline posted in Moodle (Part 2) Discuss whether or not the question has been answered satisfactorily, what else might be needed, and how this information should be applied to patient care (Part 3). Part 1A Question sets the stage for interesting discussion Target population is defined 5 marks Intervention is specific Comparative population/treatment is clearly defined Outcome is clearly defined Etiology and prevalence of condition in Canada discussed and referenced appropriately (5 marks) Justification for choosing question discussed: o Safety and effectiveness of alternatives (naturopathic and/or medical) 5 marks o Anticipated or perceived needs and values of patients who may use intervention o Reason for personal interest in topic o Relative success in treating using other methods based on available research Part 1B Three searches performed with a variety of term combinations For each search 5 marks for o Search terms used are listed each search o Limits set are identified, if used 15 marks o PubMed MeSH terms or MeSH classification tree specified, if applicable total o Databases searched are identified (minimum of 2 different databases) o Numbe r of articles each search returned is stated o Summary of search results is clear and concise (table format recommended) (3 marks) Overall search strategy is rationalized in a clear and concise manner (3 marks) Search strategy rationalization is relevant to what was actually performed (4 marks) Mark out of 40 Worth 15% of final assignment mark Part 2 Full text access to article obtained (1 mark) Article selected is a randomized controlled trial pdf of article submitted (section cannot be marked without article submission) CAP format summary is used and followed correctly o Aim is clearly stated (1 mark) o Design is correctly stated (1 mark) o Participants are fully described (age, sex, medical diagnosis, how assigned into treatment/control groups, etc) (2 marks) o Interventions are described fully, including dosages/frequency/details of intervention as provided in the article, for each intervention group and control group. (4 marks) o Main outcome measures clearly stated (measured endpoints listed) (3 marks) o Summary of key findings and results (including statistical significance) provided in a concise manner (use of tables recommended) (10 marks) Information taken from paper is referenced as shown in example CAPs Relative or absolute risk reduction calculated or stated, if discussed in article Adverse reactions discussed along with statistical significance, if applicable Participant retention discussed, if applicable o Authors conclusion stated succinctly (1 mark) o Quality of evidence correctly stated (1 mark) 15 marks o Conflicts of interest stated. If none are declared, that is stated (1 mark) o Cost effectiveness discussed, if applicable o Discussion is concise and relevant to article Discussion is in student’s own words Discussion is referenced appropriately Limitations of article stated o Minimal spelling mistakes and grammatical errors o Overall CAP is clear and concise Overall gaps in the research are mentioned in the CAP (likely in Discussion or Further Work sections) Mark out of 40 Worth 50% of final assignment grade. Part 3 How student would you go about finding further evidence given what was learned in Part 2 is discussed and new knowledge gaps or areas of further research are identified (5 marks) Application of results to patient management stated (5 marks) o Application of results correlates with what was concluded in the article How the information gathered in Part 2 assists in answering the question identified in part 1 is discussed (5 marks) Other research that supports or contradicts the evidence obtained in Part 2 is discussed within the context of the article being appraised, and the relevance to the question initially being asked (10 marks) o A minimum of 4 references are used (additional to the article appraised in part 2) How the information gathered in parts 1 through 3 can be applied in a clinical setting is discussed and justified (3 marks) Whether or not there is good evidence available to make a clinical decision is discussed (3 marks) If the question was altered from Part 1, justification for altering the question is discussed and justified 3 marks Absence of spelling mistakes and grammatical errors Part 3 is no longer than 1000 words Parts 1 through 3 Overall style, creativity, interest, grammar/spelling (8 marks) Mark out of 34 Worth 25% of final assignment grade Referencing Student adheres to proper Vancouver style referencing and references appropriately throughout assignment. Student synthesizes information taken from articles as appropriate, and does not cut and paste material from articles Charts, graphs and tables are all referenced Mark out of 20 Worth 10% of final assignment grade RES100 - LECTURE SCHEDULE Fall 2014 Instructor and Readings 1 Sept 9 Introduction to Lecturer: Adam Gratton, ND RES100 Course Syllabus (Moodle) 2 Sept 16 Introduction to Lecturer: Adam Gratton, ND Evidence Based Course Notes – Section B: Evidence Based Medicine Medicine (EBM) Chapters 6, 8 and 9 Course Notes – Section A Chapters 1-5 3 Sept 23 LRC Search Skills and Instructor: Michael D. Reansbury Resource Orientation Practical Course Notes – Section B: Evidence Based Medicine Chapter 7. Accessing the Literature 4 Sept 30 Practical Researching Lecturer: Research Residents for Patient Care 5 Oct 7 Randomized Lecturer: Adam Gratton, ND MOODLE Controlled Trials Course Notes – Section C: Randomized Controlled Trials. DISCUSSION Ch. 12 FORUM 6 Oct 14 Systematic Reviews, Lecturer: Adam Gratton, ND MOODLE Meta-Analyses and Course Notes – Section C: Systematic Reviews. Ch. 13 DISCUSSION Narrative Reviews FORUM 7 Oct 19 – 23 Mid Term Exam Week 8 Oct 28 CAP tutorial session Q & A for Part 2 of assignment with Dr. Gratton and Research Residents 9 Nov 4 Cohort Studies Lecturer: Adam Gratton, ND MOODLE Case-Control Studies Course Notes – Section C: Cohort. Ch. 15 and Care- DISCUSSION Control Ch. 16 FORUM 10 Nov 11 NDs as Researchers Guest Lecturer: Dr. Lynne Shinto ND 11 Nov 18 Whole Systems Lecturer: Adam Gratton, ND Research & Course Notes – Section C: Whole Systems Research. Ch. Qualitative Research 14 12 Nov 25 Preclinical research, Lecturer: Adam Gratton, ND Adverse Reaction Course Notes – Section C: Preclinical. Ch. 18 Reporting, Outcomes & Critical Appraisal Section C: Adverse Reactions. Ch 17 and Appendix: Techniques Adverse reaction reporting 13 Dec 2 Case Reports, N of 1 Lecturer: Adam Gratton, ND studies and Practice- Course Notes – Section C: Case Reports Ch. 17 & 14 based research 14 Dec 9 Clinical Decision Lecturer: Adam Gratton, ND Making & Review Course Notes – Section C: Critiquing EBM. Ch 19 & Clinical Decision Making. Ch 20 McAlister et al. User’s guide to the medical literature XX. Integrating research evidence with the care of the individual patient JAMA, 2000, 283(21):2829-36 15 Dec. 14 - 23 Exam Week – (final exam date TBA) The Academic Department reserves the right to make any changes in the schedule. LECTURE OUTLINE By the end of each lecture, the student will be able to: Introduction to RES100 Understand the course requirements and overall course objectives Understand the assessment breakdown, requirements and due dates for each assessment Appreciate the value of research and evidence based medicine (EBM) Understand the need for critical appraisal of published health research Understand the scientific method and how it shapes the development of scientific research Be able to describe and generate valid hypotheses and predictions Understand and describe the principles of causation Introduction to Evidence Based Medicine Know how to understand and apply the PICO model to approaching research Understand the process/steps of approaching EBM Be able to identify different types of health related research Understand and be able to apply basic concepts in biostatistics to medical care such as: Populations, samples, sampling, incidence, prevalence Descriptive statistics, distributions, measures of variance, absolute and relative risk, number needed to treat/harm, sensitivity and specificity Describe and identify causality, bias, chance, confounding, and association and know how this can influence the validity and reliability of research findings LRC Search Skills and Resource Orientation Practical Understand how to access and use various LRC resources to search, collect and prioritize evidence Practical Researching for Patient Care Understand how to access and use various internet based resources to search, collect and prioritize evidence Understand how and where a clinician would look to research to inform their clinical decision and how they would use it to educate their patient Understand basic approaches to clinical decision making Randomized Controlled Trials Describe the design and methodology of RCTs Understand the goal of randomization and how to assess whether or not an RCT achieves it Identify inherent strengths and weaknesses of the RCT design and assess its quality based on design (JADAD, CONSORT) and relevance to practice/individual patients Identify the difference between surrogate and hard endpoints and understand the importance of the study outcomes measure in drawing conclusions and applying results in patient care. Identify factors that would influence the external/internal validity of an RCT Systematic Reviews and Narrative Reviews Describe the design and methodology of narrative reviews, systematic reviews and meta-analyses Identify inherent strengths and weaknesses of each design and how to assess quality based on design (eg. PRISMA) and relevance to practice/individual patients Identify the importance of the study intervention outcome measure in drawing conclusions and applying results in patient care Generate a search strategy for a hypothetical systematic review Understand the unique graphical means of reporting data in published systematic reviews and meta-analyses Describe why the systematic review with meta-analysis is considered superior to the RCT CAP Practical Understand aspects of their original research publication selected for the basis of their progressive assignment that were unclear or confusing through asking relevant and appropriate questions of the research residents and/or course coordinator Cohort Studies & Case-Control Studies Describe the design and methodology of observational studies (cohort and case-control) Identify inherent strengths and weaknesses of each design and how to assess quality based on their design (eg. MOOSE) and relevance to practice/individual patients and public health Identify the importance of the study population and outcome measure in drawing conclusions and applying results in patient care. Generate a list of confounding factors that may highly influence the conclusion of an observational study Identify factors that would influence the external/internal validity of an RCT Understand why case-control studies are considered higher on the EBM pyramid compared to cohort studies Whole Systems and Qualitative Research Describe the design, methodology and intention of whole systems research design Describe variants to the RCT design and discuss their applicability to naturopathic research Identify inherent strengths and weaknesses of each of the designs and how to assess quality based on model validity Identify the importance of the study outcome measure in drawing conclusions and applying results in patient care. Understand the role and value of qualitative research Preclinical research and Critical Appraisal Techniques Describe the design and methodology of pre-clinical research Describe the process of drug development in Canada Understand the differences between foods, drugs and natural health products Identify inherent strengths and weaknesses of the preclinical research and how to assess relevance to practice/individual patients Case reports, N of 1, & Practice-based Research Describe the design and methodology of case reports, case series and n-of-1 trials Identify inherent strengths and weaknesses of each design and how to assess quality and application to individual patients Identify the importance of blinding and bias in drawing conclusions from individual research designs and ‘anecdotal’ research. Describe factors that would influence internal/external validity regarding case series publications