W8-L8 (DSA 458) Randomized Controlled Trials PDF

Research Methodology (DSA 4580) Step 2: Selecting a Study Approach Randomized Controlled Trials Academic Year: 2023-2024 Fifth Year DSA 4580 WEEK 8 LECTURE 8 Abdulhamid Al Ghwainem, BDS, MSc, DClinDent Pediatric Dentistry Assistant Professor in Pediatric Dentistry [email protected] Thursd...

Research Methodology (DSA 4580) Step 2: Selecting a Study Approach Randomized Controlled Trials Academic Year: 2023-2024 Fifth Year DSA 4580 WEEK 8 LECTURE 8 Abdulhamid Al Ghwainem, BDS, MSc, DClinDent Pediatric Dentistry Assistant Professor in Pediatric Dentistry [email protected] Thursday, 12 October 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 § Classifications of research designs. § How to choose a research design. § Randomized controlled trials. 4 Lecture Objectives By the end of this session, you should be able to: § Identify and relate different studies approaches and designs for health research. § Select most appropriate research approaches and designs. § Define randomized controlled trial and highlight its importance, key features, advantages and disadvantages. § Understand and calculate rate ratio and efficacy of randomized controlled trials. § Differentiate between cross-sectional,case-control and cohort studies and randomized control trials. 5 Research Process/Steps Research: answering questions in logical and systematic ways Question Answer Research methodology: how to get from Question to Answer 6 Research Process/Steps Research: answering questions in logical and systematic ways Question Answer Research methodology: how to get from Question to Answer Identify study question Select study approach Design study and collect data 7 Analyse data Report findings Research Process/Steps Research: answering questions in logical and systematic ways Identify study question Select study approach Design study and collect data 8 Analyse data Report findings Research Approaches and Designs § Study design refers to the methods and methodologies used in research to gather the data needed to explore a specific question. § Some research questions are best approached by statistical analysis of data. This is quantitative research. § Others are better answered by looking for patterns, features or themes in the data. This is qualitative research. Illustrates how research methodology and research method relate to each other. Source: Andiappan and Wan (2020) 9 Research Approaches and Designs Study designs in medical research have similar components (as we’d expect from the PICO): • A defined population (P) from which groups of subjects are studied • Outcomes (O) that are measured And for experimental and analytic observational studies: • Interventions (I) or exposures (E) that are applied to different groups of subjects 10 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 11 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 Study Designs Decision Tree is not completely exhaustive but covers most basics designs All Types Of Research Designs And Approaches Secondary Research All Types of Reviews Systematic Review Metaanalysis Is it a primary research (collecting new data) or a secondary research (synthesizing already published research)? Primary Research Basic Is it a basic research (e.g.: laboratory research) or clinical research (e.g.: involving human subjects)? Clinical Is there an intervention or experimental group? Yes Yes No Analytical Study Is there a comparison or Interventional/Experi Observational Study mental Study control group? No What is the starting point for research? Randomised Controlled Trial Non-randomised Controlled Trial Descriptive Study Exposure and Outcome at the same time Survey (Crosssectional) Outcome Exposure Case-control Study Cohort Study Case Report Case Series Analytical Crosssectional Study Qualitative Study Based on the work of Grimes et al., (2002). Grimes, D. A., & Schulz, K. F. (2002). “An overview of clinical research: The lay of the land”. The Lancet, 359(9300), 57-61 12 Randomized Controlled Trials: overview § James Lind and Scurvy Trial in 1747. § Claimed to be the First Clinical Trial in history. § First Trial looked at a sample of 12 sailors from a broader population (all the sailors) and tested whether exposing part of these sailors to an intervention of interest (citric acid), and the other part of sailors to a different intervention (other dietary acids), resulted in different outcomes (improved symptoms) for the two parts of the sample § He subsequently found that only sailors who consumed citric acid in the form of oranges and lemons improved from scurvy. 13 This Photo by Unknown Author is licensed under CC BY-NC-ND Randomized Controlled Trials: overview § Experimental studies are the gold standard for assessing causality § A controlled trial is an experiment in which some of the participants are assigned to an intervention group and some are assigned to a non-active comparison group § In a randomized controlled trial (RCT), some participants are randomly assigned to an active intervention group, the remaining participants are assigned to a control group, and all participants from both groups are followed forward in time to see who has a favorable outcome and who does not A RCT can be used in the following instances: § Gold standard for ascertaining the efficacy and safety of a treatment § To answer patient-related questions § The development of new drugs 14 Randomized Controlled Trials: overview Which clinical questions does RCT best answer? § Effectiveness: Is a proposed intervention as effective as the established intervention? § Side effects: Does a proposed intervention have worse side effects than the established intervention? § Cost of treatment: Which intervention for a specific condition results in less cost to a healthcare service? § Patient adherence to treatment: Which intervention are patients more likely to positively respond to? § Duration of effect of treatment: Which intervention provides longer-lasting benefit? 15 Randomized Controlled Trials: overview § 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 § Only difference between groups should be the interventions § Infer causality: can attribute differences in outcomes to the differences in the interventions 16 Randomized Controlled Trials: overview §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 17 Compare outcomes and results Randomized Controlled Trials: overview 18 Randomised Controlled Trials: overview Key Features Of Randomized Controlled Trial Studies Aim/Objective Compare outcomes in participants assigned to an intervention or control group Research Question Does the exposure (intervention) cause the outcome? Case/Sample/Population Similar participants are randomly assigned to an intervention or control group When you use this design Assessing causality Requirement/Resources The experiment is ethically acceptable and justifiable Steps 1. 2. 3. 4. 5. What to look for Noncompliance, randomization, blinding and other bias Key statistical measure Efficacy Decide on the intervention and eligibility criteria Define what will will constitute a favorable outcome Decide what control is appropriate comparison for the intervention Decide on blinding Select the method for randomization 19 Advantages and Disadvantages of Randomised Controlled Trials § Disadvantages: • Expensive • Time consuming • A large number of participants may be required • Subject exclusion may limit ability to generalize findings to other patients • Subjects may not comply with treatment assignments • Ethically problematic at times - a trial is sometimes stopped early if dramatic effects are seen § Advantages: • Allow for rigorous evaluation of a single variable • Potentially eradicate bias • Confounding factors can be controlled • Best method to study causal relationship • Control on time span • Evaluate effectiveness and efficiency of health services 20 Randomised Controlled Trials: overview § Experimental study designs require careful definitions of: – The intervention – The type of control that will be used and why it is appropriate – How participants will be assigned to exposure groups – The end point that will constitute a favorable outcome for the trial § Experimental studies also require careful consideration of the ethical challenges associated with assigning participants to an exposure 21 Randomised Controlled Trials: intervention § Intervention: a strategic action intended to improve individual and/or population health status – Prevention science: the scientific study of which preventive health interventions are effective in various populations, how successful the interventions are, and how well they can be scaled up for widespread implementation 22 Randomised Controlled Trials: intervention § The first step in an experimental study is to carefully define the intervention that participants assigned to the active intervention group will receive and to decide on the person, place, and time (PPT) criteria for the study § The description should state exactly: – What the intervention will be – The eligibility criteria for participants – Where and how participants will receive the intervention – When, how often, and for what duration participants will receive the intervention 23 Randomised Controlled Trials: outcomes § A superiority trial aims to demonstrate that a new intervention is better than some type of comparison, not merely as good as the comparison § An equivalence trial aims to demonstrate that a new intervention is as good as some type of comparison § A noninferiority trial aims to demonstrate that a new intervention is no worse than some type of comparison 24 Randomised Controlled Trials: outcomes § Because the term “better” can be defined in so many ways, the researcher must carefully define what constitutes a favorable outcome for an individual participant and for the experimental study as a whole § These measures of success must be stipulated prior to the initiation of the study 25 Randomised Controlled Trials: outcomes 26 Randomised Controlled Trials: controls § Experimental studies usually assign some participants to the active intervention and the remainder to a control group § One commonly used type of control is a placebo, an inactive comparison that is similar to the therapy being tested § When the goal of the experiment is to test whether a new therapy is better than a current one, it is appropriate to compare the new therapy to some standard of care, an existing therapy that is used as a comparison for a new therapy being experimentally tested 27 Randomised Controlled Trials: controls 28 Randomised Controlled Trials: controls • Sometimes the goal is to determine how much of an intervention is required, so varying doses and durations may be tested and compared to one another • A factorial design tests several different interventions in various combinations within one trial The split-mouth design is a popular design in oral health research. In the most common split-mouth study, each of two treatments are randomly assigned to either the right or left halves of the dentition. 29 Randomised Controlled Trials: controls § A crossover design that randomly assigns some participants to receive the active intervention first and then the control, and assigns the others to receive the control first and then the active intervention § In a crossover study, both groups may take a break between the two arms of the experiment (a washout period when patients receive no treatment) to reduce carryover effects, the residual effects from the first part of an experimental study that may bias the results of the second part of a crossover study if a sufficient washout period between the two arms of the study is not implemented 30 Randomised Controlled Trials: controls § Although experimental studies sometimes include a control group of participants who are randomly assigned to maintain their usual routines, this method is usually not preferred § Hawthorne effect: a type of bias that occurs when participants in a study change their behavior for the better because they know they are being observed § When there are ethical concerns about withholding a potentially lifesaving intervention from some participants, it may be possible for participants to serve as their own controls § Before-and-after study: a non-randomized experimental study that measures the same individuals before and after an intervention so that each participant’s “before” status can serve as that individual’s control 31 RCTs control bias by randomization and blinding 32 Randomised Controlled Trials: blinding § Blinding (or masking): an experimental design element that keeps participants (and sometimes some members of the research team) from knowing whether a participant is in the active intervention group or the control group – Single-blind: only the participants do not know whether they are in an active group or a control group – Double-blind: neither the participants nor the investigators know which participants are in an active or control group – Triple-blind: all of the precipitants, investigators and statisticians are blinded to the intervention and control groups 33 Randomised Controlled Trials: Randomization § Randomization: the assignment of participants to an exposure group in an experimental study using a chance-based method that minimizes several types of possible bias § Randomization: participants are randomly allocated to treatment or control group = equal groups - Acceptable methods of randomization include random numbers, either from tables or computer-generated - Unacceptable methods include last digit of date of birth, date seen in clinic etc. § Randomization also mitigates the allocation bias that might occur as a result of non-random assignment of participants to experimental study groups, such as when people with different exposure histories are not equally distributed across treatment arms 34 Randomised Controlled Trials: Randomization A variety of approaches can be used to randomly allocate participants to an active intervention group or a control group: § Simple randomization: the use of a coin toss, a random number generator, or some other simple mechanism to randomly assign each individual in an experimental study to one of the exposure groups § Simple and easy to implement. 35 Randomised Controlled Trials: Randomization A variety of approaches can be used to randomly allocate participants to an active intervention group or a control group: § Stratified randomization: the division of a population into subgroups prior to randomly but systematically assigning each individual within each subgroup to one of the exposure groups in an experimental study, § Is often used to avoid confounding factors § To ensure equal distribution of participants with a characteristic (e.g., gender, age, race, disease severity) thought to affect outcome. 36 Randomised Controlled Trials: Randomization A variety of approaches can be used to randomly allocate participants to an active intervention group or a control group: § Block randomization: an allocation method that randomly assigns groups of people to an intervention group and other groups of people to a control group § Randomize subjects into groups that result in equal sample sizes § Confounding factors? 37 Randomised Controlled Trials: Randomization 38 Randomised Controlled Trials: Randomization § Some experimental studies use non-randomized approaches because randomization is unethical or is not feasible § A quasi-experimental design is an experimental study that assigns participants to an intervention or control group using a non-random method § A natural experiment is a research study in which the independent variable is not manipulated by the researcher but instead changes due to external forces § Independent variable vs dependent variable? 39 Randomised Controlled Trials: ethics § Experimental studies involve a particularly high level of ethical risk because the researcher assigns participants to exposures they do not choose and may have been unlikely to encounter had they not volunteered to participate in a research project § Equipoise: experimental research should be conducted only when there is genuine uncertainty about which treatment will work better § Researchers must put in place a system for monitoring adverse reactions and must identify the conditions under which an experiment would be discontinued early, either because the exposure proves to be risky or because the new intervention appears to be so beneficial that keeping it from the control group would be unethical. 40 Randomised Controlled Trials: ethics Since the RCT is an experiment carried out on humans, a lot of ethical issues come into the picture. The following are the most important ethical considerations: § Prior Knowledge: the researcher should know from previous evidence that the intervention or the exposure of interests is beneficial. In other words, it must be proven that the intervention or the exposure of interests is a non-efficacious and not withholding a superior intervention from the participants. § Informed Consent: a clear, detailed and comprehensive consent should be reviewed and approved by the appropriate Institutional Review Board (IRB) and signed by the participants. § Stopping Rules: clear criteria and conditions at the start of trial should be outlined under which the trial should be41 stopped Randomised Controlled Trials: ethics Since the RCT is an experiment carried out on humans, a lot of ethical issues come into the picture. The following are the most important ethical considerations: § Adverse reaction: a negative side effect of a medication, vaccination, or other exposure, or another bad outcome related to a study § Adverse event: a negative outcome that may be the direct result of a studyrelated exposure or may be a coincidental occurrence that is not directly related to the study but happens after an individual receives a study-related exposure § Adverse events that occur during a research study must be immediately reported to the appropriate IRB 42 Randomised Controlled Trials: ethics 43 Randomised Controlled Trials: analysis § The analysis of RCT is similar to that in a cohort to study where the Relative Risk (RR) could be calculated § The RR is the ratio that compares the incidence rate among the exposed to the incidence rate in the unexposed 44 Randomised Controlled Trials: analysis § Contingency table (also called a crosstab): a row-by-column table that displays the counts of how often various combinations of events happen § Two-by-two (2×2) table: a contingency table displaying two variables that have been divided into dichotomous (yes/no) categories -In the 2×2 table for a RCT, the columns are for outcome status (disease = yes, and no disease= no) and the rows are for intervention status (exposed = yes, and unexposed = no) Intervention Yes No Total Disease a c a+c No disease b d b+d Relative Risk (RR) in a RCT = [a/(a+b)]/[c/(c+d)] Incidence rate in the exposed = a/a+b Incidence rate in the unexposed =c/c+d 45 Total a+b c+d a+b+c+d Randomised Controlled Trials: analysis For a RCT, the RR is the ratio that compares the incidence rate among the exposed to the incidence rate in the unexposed 46 Randomised Controlled Trials: analysis § There are generally two types of analysis that are usually carried out to address different objectives of the trial: 1. Efficacy analyses 2. Effectiveness analyses 47 Randomised Controlled Trials: Efficacy analysis § Efficacy: assess the efficacy of the intervention on the outcome among those who actually take the intervention. § A measure of the success of an intervention that is calculated as the proportion of individuals in the control group who experienced an unfavorable outcome but could have expected to have a favorable outcome if they had been assigned to the active group instead of the control group § Accordingly, the researchers adjusts the analyses to take into consideration, those who switched and those who didn’t comply. –A high efficacy is an indication that an intervention is successful 48 Randomised Controlled Trials: Efficacy analysis Intervention A B Total Disease 10 27 37 No disease 362 345 437 Total 372 372 744 Incidence rate ratio (RR)= [a/(a+b)]/[c/(c+d)] Incidence rate in the exposed = a/a+b= 10/372= 0.0267 Incidence rate in the unexposed =c/c+d= 27/372= 0.0726 Incidence rate ratio or Relative Risk or Risk Ratio (RR)= [a/(a+b)]/[c/(c+d)] = 0.0267/0.0726 = 0.368 49 Randomised Controlled Trials: Efficacy analysis RR provides an initial interpretation for the incidence rate ratio: • RR = 1 (or close to 1): the incidence rate was the same (or about the same) in the exposed and in the unexposed • RR > 1: the incidence rate was greater in the exposed than in the unexposed, suggesting that the exposure was risky • RR < 1: the incidence rate was lesser in the exposed than in the unexposed, suggesting that the exposure was protective 50 Randomised Controlled Trials: Efficacy analysis § § § § Intervention Disease No disease Total A 10 362 372 B 27 345 372 Total 37 707 744 Incidence rate ratio or Relative Risk or Risk Ratio (RR)= [a/(a+b)]/[c/(c+d)] = 0.0267/0.0726 = 0.368 Efficacy = 1 - RR = 1- 0.368 = 0.632 = 63.2% Efficacy = Incidence rate in the unexposed (c/c+d) - Incidence rate in the exposed (a/a+b)/ Incidence rate in the unexposed (c/c+d) = [c/(c+d)]-[a/(a+b)]/ [c/(c+d)] = 0.07260.0267/0.0726 = 0.632 = 63.2% Absolute Risk Reduction (ARR): absolute amount by which the intervention reduces (or increases) the risk of outcome = [c/(c+d)]-[a/(a+b)] = 0.07260.0267 = 0.0459 = 4.59% 51 Randomised Controlled Trials: NNT analysis § Number needed to treat (NNT): the expected number of people who would have to receive a treatment to prevent an unfavorable outcome in one of those people (or, alternately stated, to achieve a favorable outcome in one person) – NNT=1/ARR – A small NNT indicates a more effective intervention – The higher the NNT, the less effective the treatment. – Ideal NNT=1 52 Randomised Controlled Trials: NNT analysis § § § § Intervention Disease No disease Total A 10 362 372 B 27 345 372 Total 37 707 744 Incidence rate ratio or Relative Risk or Risk Ratio (RR)= 0.0267/0.0726 = 0.368 Efficacy = 1 - RR = 1- 0.368 = 0.632 = 63.2% Absolute Risk Reduction (ARR) = 0.0459 = 4.59% NNT = 1/ARR = 1 / 0.0459 = 21.79 53 Randomised Controlled Trials: analysis § Number needed to harm (NNH): the number of people who would need to receive a particular treatment in order to expect that one of those people would have a particular adverse outcome –A large NNH indicates a safer intervention § Effectiveness is calculated with the same equation as efficacy, but refers to results obtained under real-world, less-than-ideal conditions § Efficiency is an evaluation of the cost-effectiveness of an intervention that is based on both its effectiveness and resource considerations 54 Randomised Controlled Trials: analysis § A treatment-received analysis of experimental data includes only the participants who were fully compliant with their assigned intervention or comparison protocol –Used for calculating efficacy § A treatment-assigned analysis (or intention-to-treat analysis) includes all participants, even if they were not fully compliant with their assigned protocol –Used for calculating effectiveness 55 Randomised Controlled Trials: analysis 56 Randomised Controlled Trials: analysis 57 The Sources of Bias in RCTs § Bias can be introduced because of the design, conduct, or analysis of studies § Low risk of bias: we can attribute differences in outcomes to the differences in the treatment given and not other variables (confounding) 58 Validity § Internal validity: the extent to which the study is free from bias § External validity: the extent to which the results apply outside the study setting § If a study is internally valid, we then assess the study’s external validity a.k.a. generalizability – Can you use the results in your situation? – Assess whether your patients/setting are similar enough to those in the study 59 Critical Appraisal Tools and Checklists of RCTs: § Consolidated Standards of Reporting Trials (CONSORT): http://www.consort-statement.org/ § Critical Appraisal Skills Programme ( CASP): https://casp-uk.net/ § Joanna Briggs Institute (JBI checklist): https://jbi.global/critical-appraisal-tools § The Center for Evidence-Based Management (CEBMa checklist): https://cebma.org/resources-and-tools/what-is-critical-appraisal/ § SIGN Critical Appraisal Notes and Checklists: https://www.sign.ac.uk/what-we-do/methodology/checklists/ § Cochrane Risk of Bias: https://methods.cochrane.org/bias/resources 60 Critical Appraisal Tools and Checklists of RCTs: • Factors to look for: § Selection, performance and attrition bias (e.g.: allocation, randomization, stratification, blinding, loss to follow up) § Sample size (power calculation). § Inclusion and exclusion criteria § Confounding § Data collection § Appropriate statistical analysis § Follow up of participants (intention to treat). § Presentation of results (clear, precise) § Applicability to local and general population 61 Randomised Controlled Trials: examples Halabi, D., Escobar, J., Alvarado, C., Martinez, N., & Muñoz, C. (2018). Chlorhexidine for prevention of alveolar osteitis: a randomised clinical trial. Journal of applied oral science : revista FOB, 26, e20170245. https://doi.org/10.1590/1678-7757-2017-0245 Agrawal, R., Khanduja, R., Singhal, M., Gupta, S., & Kaushik, M. (2022). Clinical Evaluation of Stainless Steel Crown versus Zirconia Crown in Primary Molars: An In Vivo Study. International journal of clinical pediatric dentistry, 15(1), 15–19. https://doi.org/10.5005/jp-journals-10005-2134 62 Break Out Session Instructions: Scan the following QR codes: § Identify and explain the design of the research § What are the PICO, sampling technique, inclusion and exclusion criteria, allocation ratio, randomization and blinding? § What are the main findings? 63 Break Out Session Feedback 64 Putting all this together 65 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 66 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 Study Designs Decision Tree is not completely exhaustive but covers most basics designs All Types Of Research Designs And Approaches Secondary Research All Types of Reviews Systematic Review Metaanalysis Is it a primary research (collecting new data) or a secondary research (synthesizing already published research)? Primary Research Basic Is it a basic research (e.g.: laboratory research) or clinical research (e.g.: involving human subjects)? Clinical Is there an intervention or experimental group? Yes Yes No Analytical Study Is there a comparison or Interventional/Experi Observational Study mental Study control group? No What is the starting point for research? Randomised Controlled Trial Non-randomised Controlled Trial Descriptive Study Exposure and Outcome at the same time Survey (Crosssectional) Outcome Exposure Case-control Study Cohort Study Case Report Case Series Analytical Crosssectional Study Qualitative Study Based on the work of Grimes et al., (2002). Grimes, D. A., & Schulz, K. F. (2002). “An overview of clinical research: The lay of the land”. The Lancet, 359(9300), 57-61 67 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 World Health Organization. Regional Office for the Eastern Mediterranean. (2004). A practical guide for health researchers. https://apps.who.int/iris/handle/10665/119703 References Cited references: § Andiappan, V., Wan, Y.K. Distinguishing approach, methodology, method, procedure and technique in process systems engineering. Clean Techn Environ Policy 22, 547–555 (2020). § Grimes, D. A., & Schulz, K. F. (2002). “An overview of clinical research: The lay of the land”. The Lancet, 359(9300), 57-61 Next Lecture: Step 2: Selecting a Study Approach Qualitative Studies Identify study question Select study approach Design study and collect data Thank you! Any questions [email protected] Analyse data Report findings