W3-L3 (DSA 458) Overview of Research Designs and The Health Research Process (7.09.2023).pdf

Research Methodology (DSA 4580) Overview of Research Designs and The Health Research Process Academic Year: 2023-2024 Fifth Year DSA 4580 WEEK 3 LECTURE 3 Abdulhamid Al Ghwainem, BDS, MSc, DClinDent Pediatric Dentistry Assistant Professor in Pediatric Dentistry [email protected] Thursday,...

Research Methodology (DSA 4580) Overview of Research Designs and The Health Research Process Academic Year: 2023-2024 Fifth Year DSA 4580 WEEK 3 LECTURE 3 Abdulhamid Al Ghwainem, BDS, MSc, DClinDent Pediatric Dentistry Assistant Professor in Pediatric Dentistry [email protected] Thursday, 7 September 2023 Copyright © 2023 by PSAU, Abdulhamid Al Ghwainem Disclaimer DISCLAIMER The information presented in this lecture is offered for educational and informational purposes and should not be construed as medical, dental, or research advice. While the amount of information in this handout is vast, and I make every effort to be as current and thorough as possible, the information cannot be taken as a reference manual or textbook. Please note that you should read the required textbooks as specified in the course curriculum and lecture references. 2 Notice WARNING Materials used in connection with this course or lecture may be subject to copyright protection. This material has been reproduced and communicated to you by or on behalf of Prince Sattam Bin Abdulaziz University. Materials may include, but are not limited to: documents, slides, images, audio, and video. Materials in this course are only for the use of students enrolled in this course, for purposes associated with this course, and may not be retained for longer than the class term. Unauthorized retention, duplication, distribution, or modification of copyrighted materials may be the subject of copyright protection by law. For more information, visit the Saudi Authority for Intellectual Property. Do not remove this notice 3 Outline § Research designs. § Classifications of research designs. § Common study designs used for health research. § Choice of research designs. § The research process. 4 Lecture Objectives By the end of this session, you should be able to: § Define research design and highlight its importance. § Classify and differentiate between different research approaches and designs. § Identify and relate different studies approaches and designs for health research . § Differentiate between exposure and outcome for epidemiological studies. § Recognize and summarize common study designs used for health research. § Memorize the hierarchy of evidence. § Select most appropriate research approaches and designs. § List the research process and steps. 5 Meaning of Research Designs § A research design is the process that guides researchers on how to collect, analyse and interpret observations. § It is a logical model that guides the investigator in the various stages of the research. § Research design must, at least, contains: (a) a clear statement of the research problem; (b) procedures and techniques to be used for gathering information; (c) the population to be studied; and (d) methods to be used in processing and analysing data 6 This Photo by Unknown Author is licensed under CC BY Research Approaches and Designs Several classifications of study designs are possible, depending on what research strategies are used: § Primary versus Secondary/Tertiary Research § Deductive versus Inductive Research § Qualitative versus Quantitative Research § Conceptual versus Empirical Research § Applied versus Fundamental Research § Descriptive versus Analytical Research § Non-interventional (Observational) versus Interventional Research 7 This Photo by Unknown Author is licensed under CC BY Primary versus Secondary/Tertiary Research Collect new data from individuals Primary Research r Review and synthesize the existing literature tia r e T Sec Re onda sea ry rch rch a e es yR Analyze existing data 8 Primary versus Secondary/Tertiary Research 9 Primary versus Secondary/Tertiary Research 10 Deductive vs Inductive Research Deductive Research Inductive Research Covered in the previous lecture 11 Quantitative vs Qualitative Research Qualitative Quantitative § Gathering numerical data and factual knowledge under controlled conditions § Examines relationships and sometimes the strength of relationships between variables using statistical techniques • Deductive § Measure and test § Objective § Data collection: quantitative data based on precise measurements § Data analysis: identify statistical relationships Quantitative Research Qualitative Research Covered in the previous lecture 12 § Exploring people’s subjective experiences and opinions in order better to understand and give meaning to social phenomena. § Examines the underlying reasons, motivations, trends and opinion using narrative report with contextual description and direct quotations from respondents • Inductive § Observe and interpret § Subjective § Data collection: qualitative data such as interviews, focus groups, observations and notes § Data analysis: identify patterns, features and themes Conceptual vs Empirical Research Empirical Conceptual § Focuses on theoretical exploration and development of concepts and ideas § Deals with abstract and hypothetical concepts § Aims to generate new knowledge or refine existing theories § Does not involve direct observation or collection of empirical data § Provides a theoretical foundation for empirical research Conceptual Research Empirical Research 13 § Focuses on gathering empirical evidence and testing hypotheses § Deals with real-world observations and data § Aims to test hypotheses, validate theories, or solve practical problems § Involves direct observation, data collection, and analysis of empirical data § Builds upon conceptual frameworks by testing and validating them Basic vs Applied Research Applied Basic § Carried out to satisfy intellectual curiosity § Has no immediate application § Primary goal is to contribute to knowledge Basic Research Applied Research 14 § Carried out to find answers to practical problems § Does have an immediate application § Primary goal is to find the solution of a problem; why or how the solution works are secondary concerns Descriptive versus Analytical Research Analytical Descriptive Describes Is more exploratory Profiles characteristics of the groups. Focuses on what? Assumes no hypothesis Does not require comparisons (between groups or overtime). § Try to minimize the precision of estimates. § § § § § § Descriptive Research Analytical Research 15 § Explains § Is more explanatory § Analyses why groups have characteristics. § Focuses on why? § Assumes and hypothesis § Requires comparisons (between groups or overtime). § Try to maximize power to defect differences if they exist. Non-interventional versus Interventional Research Interventional Non-interventional § Does not intentionally assign any participants to an intervention § Observe participants and track health outcomes over time § Also known as A nonclinical/observational study § Fairly easy to conduct § Less time § Low cost Observational Research Interventional Research 16 § Assigns participants to receive A particular exposure § Tests an intervention or treatment like a potential drug, medical device, activity, or procedure in people § Also known as a clinical trial/clinical study/experimental study § Difficult to conduct § More time § High cost Putting all this together 17 Research Approaches and Designs Algorithm for classifying the types of research, this scheme is intended to classify the study types as clearly as possible. Medical Research Primary Research Epidemiological Research Basic Research Theoretical § § § § Method development § (physics, chemistry § biology, § bioinformatics) § Analytical § measurement procedure Imaging procedure Test development assessment procedure Weaker evidence Secondary Research Applied Cell research Animal research Stem cell research Genetics Tissue banking Clinical Research Descriptive Case Report A report on a single patient with an outcome of interest Case Series A report on a series of patients with an outcome of interest. No control group is involved Analytical Surveillance Study Report obtained from the databases that follow and record a health problem for a certain time Qualitative Ecological Cross-sectional Examines the relationship between exposure and outcome by examining population-level data rather than individuallevel data 18 Exposure and Exposure ← Outcome outcome are at the same time Meta-analysis QuasiExperimental Research Randomised Controlled Trial Case-control Systematic Review Cohort Exposure → Outcome Stronger evidence Research Approaches and Designs § Epidemiology: the study of the distribution and determinants of health in human populations § Health: “a state of complete physical, mental, and social wellbeing, and not merely the absence of disease or infirmity” (WHO) § Determinants of health: the biological, behavioral, social, environmental, political, and other factors that influence the health status of individuals and populations § Health research: the investigation of health and disease or any of the factors that contribute to the presence or absence of physical, mental, and social health among individuals, families, communities, nations, or the world population 19 Research Approaches and Designs § Descriptive epidemiology studies: observational studies that quantify how often various health-related exposures and outcomes occur in a population – they answer questions like “what?,” “who?,” “where?,” and “when?” § Analytic epidemiology studies seek to identify the risk factors (or protective factors) for various adverse health outcomes or to test the effectiveness of interventions intended to improve health status – they answer questions like “why?” and “how?” 20 Research Approaches and Designs § Clinical research evaluates the best ways to prevent, diagnose, and treat adverse health issues that adversely affect individuals and families § Population health research focuses on the health outcomes and the determinants of health in groups of humans – Public health: the actions taken to promote health and prevent illnesses, injuries, and early deaths at the population level § Most clinical and population health studies have a research question that emphasizes one particular exposure, outcome/disease, or population 21 Research Approaches and Designs Many topics in population health research can be expressed with the formula: “Is [exposure] related to [disease / outcome] in [population]?” § Exposure: a personal characteristic, behavior, environmental encounter, or intervention that might change the likelihood of developing a health condition § Outcome: an observed event such as the presence of disease in a participant in an observational study or the measured endpoint in an experimental study § Population: a group of individuals, communities, or organizations 22 Research Approaches and Designs § Eight common study designs used for health research will be highlighted in this lecture § Many research projects use variations of one of these approaches, and in others a hybrid of two approaches might be suitable § A diversity of designs can be valid and helpful for collecting and analyzing new data, analyzing existing data, and reviewing the literature in the health sciences § The study design selected for a particular project must be appropriate for the goals of the study 23 Research Approaches and Designs § Case Report: a in depth or intensive report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient Hospital/Clinical notes/records Journal Article § Case Series: a description of the characteristics and outcomes among a series of individuals with either a disease or an exposure (no control group) Journal Article Hospital/Clinical notes/records 24 Research Approaches and Designs § Cross-sectional Study: the observation of a defined population at a single point in time or time interval. Exposure and outcome are determined simultaneously. Gold standardin diagnosis and screening research Present Future Pro- Population Can compare groups within one sample Sample Past Retro- Data collected at one time point on one representative sample Direction of time Starting point in time 25 Research Approaches and Designs § Case-control Study: identifies patients with a particular outcome (cases) and control patients without the outcome (Controls). Looks back and explores possible risk factors to anoutcome Past Retro- Exposed Present Population Future Pro- Cases Exposed Controls Sample Unexposed Unexposed Data always collected retrospectively at one time point on one representative sample Direction of time Starting point in time 26 Research Approaches and Designs § Prospective Cohort study: identifies two groups (cohorts) of patients one which received the exposure of interest, and one which did not. Follows these cohorts forward for the outcome of interest. Very useful in causation as well as prognosis research Past Retro- Present Population Future Pro- Outcome Exposed Unexposed Sample No outcome Outcome No outcome Data collected prospectively at multiple time points on one representative sample Direction of time Starting point in time 27 Research Approaches and Designs § Retrospective Cohort Study: identifies two groups (cohorts) of patients to examine the relationship between the exposure and the outcome. Follows thesecohorts backwards for theoutcome of interest. No outcome Present Population Exposed Hospital/Clinical notes/records Outcome Future Pro- Unexposed Sample Past Outcome Retro- No outcome Data always collected retrospectively from Hospital/Clinical notes/records on one representative sample Direction of time Starting point in time 28 Research Approaches and Designs Past Retro- Present Cross-Sectional Study Case-Control Study Prospective Cohort Study Retrospective Cohort Study Direction of time Starting point in time 29 Future Pro- Case-Control vs Retrospective Cohort Case-Control Study § Retrospective cohort studies can be confused with case-control studies. § While they are both types of retrospective observational studies, they are NOT the same. § Retrospective cohort studies use seconadry research/ excisting data, such as medical records or databases, to identify a group of people with an exposure or risk factor in common. § Then look back in time to observe how the health outcomes developed. § Case-control studies rely on primary research, comparing a group of participants with a condition of interest to a group lacking that condition in real time. § Cohort studies in general are more longitudinal in nature than case-control studies. § They don’t always have a control group, because members of the cohort are primarily selected because they already share a particular characteristic. Retrospective Cohort Study 30 Research Approaches and Designs § Randomized Controlled Trial (RCT): An experimental/interventional study in which participants are randomly allocated to an interventional group and a control group § Interventional group gets an intervention § Control/comparison group gets something different (no intervention, a placebo, different intervention) § Outcomes in each group are compared to determine the effect of the intervention § RCT involves concurrent enrolment and follow-up of both groups § Gold standard in testing the efficacy of an intervention § Only difference between groups should be the interventions § Infer causality: can attribute differences in outcomes to the differences in the treatment 31 Research Approaches and Designs §Randomized Controlled Trial (RCT): An experimental/interventional study in which participants are randomly allocated to an interventional group and a control group §Only difference between groups should be the interventions §Outcomes in each group are compared to determine the effect of the intervention Present Future Pro- Population Outcome Sample No outcome randomization and blinding Exposed/Intervention Outcome No outcome Unexposed/Control Data collected prospectively at multiple time points on one representative sample Direction of time Starting point in time 32 Compare outcomes and results Research Approaches and Designs § Systematic Review: identifies and critically appraises all research on a specific topic, and combines validstudies;increasinglyimportantinevidence-basedmedicine;differentfromreview article (which is a summary of more than one paper on a specific topic, and which may or may not be comprehensive); § Meta-analysis:a systematicreviewthatuses quantitativemethodstosummarisetheresults. This Photo by Unknown Author is licensed under CC BY Literature Review Systematic Review Meta-analysis 33 Research Approaches and Designs 34 Research Approaches and Designs 35 Research Approaches and Designs • The time required for collecting and analyzing data varies from study to study • Researchers with limited budgets or timelines need to select study approaches that align with their resources and time constraints 36 Research Approaches and Designs 37 Hierarchy of Evidence: This Photo by Unknown Author is licensed under CC BY 38 Research Approaches and Designs A series of questions can help identify the most suitable approach: § Do new data need to be collected, or are there existing data sources that can be used to answer the study question? § If new data will be collected, is an experimental study required or can the study question be answered using non-experimental methods? § Is the research question based primarily on exposure status, disease status, or membership in a particular population? § Are there time constraints? 39 Research Approaches and Designs 40 The Research Process/Steps § Research is the process of systematically and carefully investigating a subject in order to discover new insights about the world § Five steps: 1. 2. 3. 4. 5. Identify a study question Select a general study approach Design the study and collect data Analyze data Write and share a report about the findings Identify study question Select study approach Design study and collect data 41 Analyse data Report findings The Research Process/Steps § Everyone can do meaningful research § The best way to learn about health research it to do real research Identify study question Select study approach Design study and collect data 42 Analyse data Report findings Break Out Session Instructions: § Identify the research design of the provided research papers § Describe the research aim and main findings 43 Break Out Session Feedback 44 Break Out Session Article Title Research Design Reference 1 Histological comparison of pulpal inflammation in primary teeth with occlusal or proximal caries Basic Research Kassa, D., Day, P., High, A., & Duggal, M. (2009). Histological comparison of pulpal inflammation in primary teeth with occlusal or proximal caries. International journal of paediatric dentistry, 19(1), 26–33. https://doi.org/10.1111/j.1365-263X.2008.00962.x 2 Dental caries is a preventable infectious disease Literature Review Balakrishnan, M., Simmonds, R. S., & Tagg, J. R. (2000). Dental caries is a preventable infectious disease. Australian dental journal, 45(4), 235–245. https://doi.org/10.1111/j.1834-7819.2000.tb00257.x. 3 Erupted compound odontoma: case report of a 15-year-old Sudanese boy with a history of traditional dental mutilation Case Report Amailuk, P., Grubor, D. (2008). Erupted compound odontoma: case report of a 15-year-old Sudanese boy with a history of traditional dental mutilation. Br Dent J 204, 11–14. https://doi.org/10.1038/bdj.2007.1184 4 Amelogenesis Imperfecta with Coronal Resorption: Report of Three Cases Case Series Bhatia, S. K., Hunter, M. L., & Ashley, P. F. (2015). Amelogenesis Imperfecta with Coronal Resorption: Report of Three Cases. Dental update, 42(10), 945–950. https://doi.org/10.12968/denu.2015.42.10.945 5 Development of a decision aid for children faced with the decision to undergo dental treatment with sedation or general anaesthesia Qualitative Research Hulin, J., Baker, S. R., Marshman, Z., Albadri, S., & Rodd, H. D. (2017). Development of a decision aid for children faced with the decision to undergo dental treatment with sedation or general anaesthesia. International journal of paediatric dentistry, 27(5), 344–355. https://doi.org/10.1111/ipd.12267 6 Prevalence of dental trauma in 5-6- and 12-14-year-old boys in Riyadh, Saudi Arabia Cross-sectional Al-Majed, I., Murray, J. J., & Maguire, A. (2001). Prevalence of dental trauma in 5-6- and 12-14-year-old boys in Riyadh, Saudi Arabia. Dental traumatology : official publication of International Association for Dental Traumatology, 17(4), 153–158. https://doi.org/10.1034/j.16009657.2001.170403.x 7 Relationship between Severe Early Childhood Caries and dental development Case-control Hazar Bodrumlu, E., Demiriz, L., & Toprak, S. (2018). Relationship between Severe Early Childhood Caries and dental development. European journal of paediatric dentistry, 19(2), 156–160. https://doi.org/10.23804/ejpd.2018.19.02.11 8 Comparison of Short-Term Oral Impacts Experienced by Patients Treated with Invisalign or Conventional Fixed Orthodontic Appliances Retrospective Cohort Alajmi, S., Shaban, A., & Al-Azemi, R. (2020). Comparison of Short-Term Oral Impacts Experienced by Patients Treated with Invisalign or Conventional Fixed Orthodontic Appliances. Medical principles and practice : international journal of the Kuwait University, Health Science Centre, 29(4), 382–388. https://doi.org/10.1159/000505459 9 Long-term impact of powered toothbrush on oral health: 11-year cohort study Prospective Cohort Pitchika, V., Pink, C., Völzke, H., Welk, A., Kocher, T., & Holtfreter, B. (2019). Long-term impact of powered toothbrush on oral health: 11-year cohort study. Journal of clinical periodontology, 46(7), 713–722. https://doi.org/10.1111/jcpe.13126 10 Randomized controlled trial comparing glass fiber posts and cast metal posts Randomized Controlled Trial Sarkis-Onofre, R., Amaral Pinheiro, H., Poletto-Neto, V., Bergoli, C. D., Cenci, M. S., & Pereira-Cenci, T. (2020). Randomized controlled trial comparing glass fiber posts and cast metal posts. Journal of dentistry, 96, 103334. https://doi.org/10.1016/j.jdent.2020.103334 11 Rotary Versus Reciprocation Root Canal Preparation: Initial Clinical Quality Assessment in a Novice Clinician Cohort Randomized Controlled Trial Hamid, H. R., Gluskin, A. H., Peters, O. A., & Peters, C. I. (2018). Rotary Versus Reciprocation Root Canal Preparation: Initial Clinical Quality Assessment in a Novice Clinician Cohort. Journal of endodontics, 44(8), 1257–1262. https://doi.org/10.1016/j.joen.2018.04.017 12 Predictability of resin bonded bridges - a systematic review Systematic Review Balasubramaniam G. R. (2017). Predictability of resin bonded bridges - a systematic review. British dental journal, 222(11), 849–858. https://doi.org/10.1038/sj.bdj.2017.497 13 How to Intervene in the Root Caries Process? Systematic Review and Meta-Analyses Systematic Review and Meta-analyses Meyer-Lueckel, H., Machiulskiene, V., & Giacaman, R. A. (2019). How to Intervene in the Root Caries Process? Systematic Review and MetaAnalyses. Caries research, 53(6), 599–608. https://doi.org/10.1159/000501588 45 References Required: Neale, J., 2020. Research methods for health and social care. Bloomsbury Publishing. Jacobsen, K.H., 2020. Introduction to health research methods: A practical guide. Jones & Bartlett Publishers. Additional: Bowling, A., 2014. Research methods in health: Investigating health and health services. Maidenhead, United Kingdom: Open University Press. Creswell, J.W. and Creswell, J.D., 2018. Research design: Qualitative, quantitative, and mixed methods approaches. Sage publications. World Health Organization. Regional Office for the Western Pacific, 2001. Health research methodology : a guide for training in research methods. 2nd ed.. WHO Regional Office for the Western Pacific. https://apps.who.int/iris/handle/10665/206929 Next Lecture: Step 1: Identifying a Study Question Identify study question Select study approach Design study and collect data Thank you! Any questions [email protected] Analyse data Report findings Identify study question Select study approach Design study and collect data Analyse data Report findings 48