Fundamentals of Quality Health Research FH Health Research Intelligence Group

What is Research? “….the systematic process of collecting and analyzing information (data) in order to increase our understanding of the phenomenon about which we are concerned or interested.” (Leedy and Ormrod, 2001) “….the systematic process of collecting and analyzing information (data) in order to increase our understanding of the phenomenon about which we are concerned or interested.” (Leedy and Ormrod, 2001)

FH Research Definitions Research Involving Human Subjects Research involving human subjects is defined as any systematic investigation (including pilot studies, exploratory studies, and academic course work assignments) designed to contribute to generalizable knowledge. Generalizable knowledge consists of facts, theories, principles or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. (The ethical conduct of research and other studies involving human subjects. Section 2.2)

Research Characteristics 1. Originates with question/problem 1. Originates with question/problem 2. Follows a specific plan or procedure 2. Follows a specific plan or procedure 3. Guided by the hypothesis, question or problem 3. Guided by the hypothesis, question or problem 4. Accepts certain critical assumptions 4. Accepts certain critical assumptions 5. Requires collection and interpretation of data 5. Requires collection and interpretation of data 6. Cyclical in nature 6. Cyclical in nature

Types of Health Research Biomedical Research Biomedical Research Clinical Research Clinical Research Health Services/Systems Research Health Services/Systems Research Population Health Research Population Health Research

Health Research Biomedical Research Biomedical Research To understand normal and abnormal functioning at the molecular, cellular, organ system and whole body levels. To understand normal and abnormal functioning at the molecular, cellular, organ system and whole body levels. Includes the development of tools and techniques and new therapies or devices that can improve health and quality of life up to the point where they are tested on human subjects. Includes the development of tools and techniques and new therapies or devices that can improve health and quality of life up to the point where they are tested on human subjects. Does not have a diagnostic or therapeutic orientation. Does not have a diagnostic or therapeutic orientation.

Health Research Clinical Research Clinical Research Targets improving the diagnosis and treatment of disease and injury. Targets improving the diagnosis and treatment of disease and injury. Focus on the health and quality of life of individuals. Focus on the health and quality of life of individuals. Includes research on animal models of human disease, clinical trials and other therapeutic interventions. Includes research on animal models of human disease, clinical trials and other therapeutic interventions.

Health Research Health Services/Systems Research Health Services/Systems Research Multidisciplinary field Multidisciplinary field Aims to improve the efficiency and effectiveness of health professionals and the health care system. Aims to improve the efficiency and effectiveness of health professionals and the health care system. Interventions at the level of practice and policy. Interventions at the level of practice and policy.

Health Research Population Health Research Population Health Research Studies the impact of social and environmental factors on the health of populations/subpopulations. Studies the impact of social and environmental factors on the health of populations/subpopulations. May examine social, cultural, environmental, occupational, and economic factors that determine health status. May examine social, cultural, environmental, occupational, and economic factors that determine health status. Research data is used to identify areas where the health of a population can be improved. Research data is used to identify areas where the health of a population can be improved.

Conducting Research CIHR Evaluation Guidelines Significance and relevance to health Knowledge of the field (cited literature) Clear, testable hypothesis or central research problem Originality and innovation in concept or approach Feasibility of work plan

Significance and Relevance to Health Research begins with the identification of a problem/knowledge gap and formulation of a research question. Identifying this problem can be the hardest part of research. Identifying this problem can be the hardest part of research. The problem or question does not have to be complex. The problem or question does not have to be complex. Where to obtain a research idea Experience in your area of specialty. Experience in your area of specialty. Knowledge of the relevant literature and issues. Knowledge of the relevant literature and issues. Practice guidelines. Practice guidelines. Journal editorials and review articles. Journal editorials and review articles.

Significance and Relevance to Health Good research proposals should: Good research proposals should: Address an important question. Address an important question. State the problem clearly and completely. State the problem clearly and completely. Advance knowledge. Advance knowledge. How do you know if your idea is good? How do you know if your idea is good? Talk to your peers and other experts in your field. Talk to your peers and other experts in your field. Obtain an outside opinion. Obtain an outside opinion. Look to the literature to see if it has already been studied. Look to the literature to see if it has already been studied.

Knowledge of the Field Sources of Research Literature Journal articles – PUBMED, MEDLINE, EMBASE, etc Journal articles – PUBMED, MEDLINE, EMBASE, etc Conference papers - Conference Proceedings Conference papers - Conference Proceedings Dissertations - Dissertation Abstracts Dissertations - Dissertation Abstracts Gray literature (reports, working papers, government documents) Gray literature (reports, working papers, government documents)

Knowledge of the Field What to look for Systematic Reviews Systematic Reviews An approach to summarizing the medical literature where the methods undertaken to conduct the search are reported so that it may be replicated and updated. An approach to summarizing the medical literature where the methods undertaken to conduct the search are reported so that it may be replicated and updated. Meta-analysis Meta-analysis A review that uses quantitative methods to summarize the results. A review that uses quantitative methods to summarize the results. Review Articles Review Articles Original Articles Original Articles

Knowledge of the Field Type of Question Type of Study Therapy Double Blind RCT Diagnosis Controlled Trial Prognosis Cohort Studies, Case Control, Case Series Etiology Cohort Studies Prevention Randomized Controlled Trial Cohort Studies Quality Improvement Randomized Controlled Trial What is the best evidence?

Knowledge of the Field What to use: The levels of evidence (Sackett, 2000) 1A = Systematic Review of Randomized Controlled Trials (RCTs) 1B = RCTs with Narrow Confidence Interval 1C = All or None Case Series 2A = Systematic Review Cohort Studies 2B = Cohort Study/Low Quality RCT 2C = Outcomes Research 3A = Systematic Review of Case-Controlled Studies 3B = Case-controlled Study 4 = Case Series, Poor Cohort Case Controlled 5 = Expert Opinion

Clear, Testable Problem/Hypothesis Factors to consider when developing an hypothesis or statement of the research question: Phase Phase Theory Building Theory Building Testing Testing Theory Extension Theory Extension

Clear, Testable Problem/Hypothesis Factors to consider when developing an hypothesis or statement of the research question: Purpose Purpose Exploration Exploration Description Description Explanation Explanation Prediction Prediction Hypothesis Testing Hypothesis Testing

Clear, Testable Problem/Hypothesis Factors to consider when developing an hypothesis or statement of the research question: Unit of Analysis Unit of Analysis Individual Individual Dyad Dyad Group Group Organizational Unit Organizational Unit Industry Segment / Sector Industry Segment / Sector Community Community Society Society

Clear, Testable Problem/Hypothesis Factors to consider when developing an hypothesis or statement of the research question: Definition Definition Population Population Sampling Frame Sampling Frame Sample Sample

Clear, Testable Problem/Hypothesis Factors to consider when developing an hypothesis or statement of the research question: Time Horizon Time Horizon Snapshot Snapshot Cross- Sectional Cross- Sectional Longitudinal Longitudinal Retrospective Retrospective

Clear, Testable Problem/Hypothesis Factors to consider when developing an hypothesis or statement of the research question: Study Setting Study Setting Natural Natural Contrived Contrived Researcher Influence Researcher Influence

Clear, Testable Problem/Hypothesis Research Design – depends on the research question Descriptive Descriptive Analytic Analytic Experimental Experimental Quasi-Experimental Quasi-Experimental Qualitative Qualitative

Methodology Comparison Quantitative Explanation, prediction Explanation, prediction Test theories Test theories Known variables Known variables Larger sample Larger sample Standardized instruments Standardized instruments Deductive Deductive Qualitative Explanation, description Build theories Unknown variables Smaller sample Observations, interviews Inductive

Clear, Testable Problem/Hypothesis Method: Subjects/Patients/Units of Measure Subjects/Patients/Units of Measure Sample size and justification Sample size and justification Inclusion criteria Inclusion criteria Exclusion criteria Exclusion criteria Procedure Procedure Detailed account of how the research design is executed Detailed account of how the research design is executed Provides information on timelines and measures Provides information on timelines and measures Sufficient information so that it can be replicated Sufficient information so that it can be replicated Analysis Analysis Statistical analysis is appropriate for the research design and will answer the research question Statistical analysis is appropriate for the research design and will answer the research question

Clear, Testable Problem/Hypothesis Methodological Consideration Objectivity/Bias Objectivity/Bias Definitions Definitions Reliability Reliability Validity Validity Assumptions Assumptions Limitations Limitations Confounds Confounds

Originality and Innovation in Concept or Approach Open up a new area Open up a new area Provide a unifying framework Provide a unifying framework Resolve a long-standing question Resolve a long-standing question Thoroughly explore an area Thoroughly explore an area Challenge existing knowledge Challenge existing knowledge Experimentally validate a theory Experimentally validate a theory Produce an efficient system Produce an efficient system Provide needed empirical data Provide needed empirical data Derive superior algorithms Derive superior algorithms Develop new methodology Develop new methodology Develop a new tool Develop a new tool

Feasibility of Work Plan Time Time Human Resources Human Resources Technology Technology Money Money

FH Health Research Intelligence Group How can we help? Grant Facilitator-Writer Grant Facilitator-Writer Conducting a search for funding opportunities Conducting a search for funding opportunities Automatic notification of new funding sources and deadlines Automatic notification of new funding sources and deadlines Identifying a research team Identifying a research team Preparing letters of intent Preparing letters of intent Identifying resources required for conducting the research Identifying resources required for conducting the research Formulating the research budget Formulating the research budget Writing the grant application Writing the grant application Understanding FH and funding agency requirements regarding preparation of specific documents Understanding FH and funding agency requirements regarding preparation of specific documents

FH Health Research Intelligence Group How can we help? Epidemiologist Epidemiologist Specifying the research goal, objectives and hypothesis Specifying the research goal, objectives and hypothesis Identifying measurable outcomes Identifying measurable outcomes Specifying the variables for analysis Specifying the variables for analysis Identifying sources of data Identifying sources of data Developing data collection tools for quantitative or qualitative studies Developing data collection tools for quantitative or qualitative studies Developing the statistical analysis plan Developing the statistical analysis plan Analyzing the data Analyzing the data Understanding how to use statistical software, such as SPSS Understanding how to use statistical software, such as SPSS