This document provides an overview of various research study designs, including:
- Descriptive studies like case reports, case series, ecological studies, and cross-sectional studies.
- Analytical studies like cohort studies and case-control studies.
- Experimental studies like clinical trials, which can be randomized controlled trials.
It discusses key aspects of designing research like formulating research questions and hypotheses, objectives, biases, and techniques to reduce biases like randomization and blinding.
This document discusses various research designs used in nursing research. It defines research design as the plan or blueprint for conducting a study. Experimental designs aim to identify cause-effect relationships through manipulation of independent variables and use of control groups. True experiments allow the highest level of control but quasi-experiments and pre-experimental designs are also used when true experiments are not possible. Non-experimental designs observe variables without manipulation and are used when variables cannot be manipulated or experiments would be unethical.
This course has been designed to equip the student with the basic research design including research methods in health sciences. The course aims to impart basic knowledge on different types of study design
The document discusses defining researchable questions using the PICOS approach. PICOS stands for Population, Intervention, Comparison, Outcome, and Study design. It is a framework that makes defining research questions easier by identifying the key elements needed to answer the question and develop a search strategy. The document provides examples of how to apply each PICOS element when defining a sample question about using modern medicine versus traditional remedies to treat malaria in African children. It emphasizes that research questions should be clear, answer an evidence need, and be written for a general readership not assuming specialist knowledge.
This document outlines a two-day training program on research methodology. Day 1 covers getting research ideas, conducting a literature review using EndNote, building a conceptual framework, writing objectives, determining study designs, and developing sampling plans and data collection tools. Day 2 focuses on statistical analysis plans, including preparing dummy tables and covering descriptive and analytical statistics. The document provides details on the contents to be covered, including effective literature searches, choosing appropriate study designs, planning for data collection and analysis, and writing for publication.
Critical appraisal of a journal articleDrSahilKumar
This document provides guidance on critically appraising journal articles. It defines critical appraisal as systematically identifying the strengths and weaknesses of research to assess validity and usefulness. Key aspects to evaluate include relevance of the research question, appropriateness of study design, addressing biases, adherence to original protocol, statistical analyses, and conflicts of interest. Checklists like CASP, CONSORT, and STROBE provide frameworks to appraise study methodologies like randomized trials, systematic reviews, and observational studies. The goal of critical appraisal is for clinicians to identify high-quality evidence to inform clinical practice.
Critical appraisal of scientific articles overviewDrsnehas2
This document provides an overview of critical appraisal of scientific articles. It explains that critical appraisal is a systematic process to evaluate the strengths and weaknesses of research to assess its validity and usefulness. The document outlines the aims of critical appraisal as updating knowledge, supporting evidence-based practice, and informing health policies. It then describes how to critically appraise articles by following the structure and evaluating different sections like the title, abstract, methodology, results, and conflicts of interest. Finally, it lists different guidelines for appraising different study designs.
Research in Ayurveda provides scope in theoretical, experimental, and clinical research areas. Theoretical research could explore fundamental Ayurvedic principles like doshas. Experimental research could involve tests described in Ayurvedic texts. Clinical research offers an important domain to develop new treatment protocols by studying Ayurvedic case observations and medicine trials. Research is needed to validate Ayurveda's efficacy, safety, and quality according to modern standards, and to upgrade Ayurveda over time based on new health issues. Researchers face problems with variables like individualized Ayurvedic dosing and assessing non-quantitative concepts.
Critical appraisal presentation by mohamed taha 2Cairo University
This document discusses how to critically appraise a research article. It provides 10 questions to ask when appraising an article, including whether the study question is relevant, if the study design was appropriate, and if the data supports the conclusions. As an example, it summarizes a study that examined the relationship between serum cholesterol levels and exposure to violence in suicide attempters. The study addressed relevant questions, utilized an appropriate cohort study design, and its conclusions were reasonably supported by the collected data.
This document discusses various research designs used in nursing research. It defines research design as the plan or blueprint for conducting a study. Experimental designs aim to identify cause-effect relationships through manipulation of independent variables and use of control groups. True experiments allow the highest level of control but quasi-experiments and pre-experimental designs are also used when true experiments are not possible. Non-experimental designs observe variables without manipulation and are used when variables cannot be manipulated or experiments would be unethical.
This course has been designed to equip the student with the basic research design including research methods in health sciences. The course aims to impart basic knowledge on different types of study design
The document discusses defining researchable questions using the PICOS approach. PICOS stands for Population, Intervention, Comparison, Outcome, and Study design. It is a framework that makes defining research questions easier by identifying the key elements needed to answer the question and develop a search strategy. The document provides examples of how to apply each PICOS element when defining a sample question about using modern medicine versus traditional remedies to treat malaria in African children. It emphasizes that research questions should be clear, answer an evidence need, and be written for a general readership not assuming specialist knowledge.
This document outlines a two-day training program on research methodology. Day 1 covers getting research ideas, conducting a literature review using EndNote, building a conceptual framework, writing objectives, determining study designs, and developing sampling plans and data collection tools. Day 2 focuses on statistical analysis plans, including preparing dummy tables and covering descriptive and analytical statistics. The document provides details on the contents to be covered, including effective literature searches, choosing appropriate study designs, planning for data collection and analysis, and writing for publication.
Critical appraisal of a journal articleDrSahilKumar
This document provides guidance on critically appraising journal articles. It defines critical appraisal as systematically identifying the strengths and weaknesses of research to assess validity and usefulness. Key aspects to evaluate include relevance of the research question, appropriateness of study design, addressing biases, adherence to original protocol, statistical analyses, and conflicts of interest. Checklists like CASP, CONSORT, and STROBE provide frameworks to appraise study methodologies like randomized trials, systematic reviews, and observational studies. The goal of critical appraisal is for clinicians to identify high-quality evidence to inform clinical practice.
Critical appraisal of scientific articles overviewDrsnehas2
This document provides an overview of critical appraisal of scientific articles. It explains that critical appraisal is a systematic process to evaluate the strengths and weaknesses of research to assess its validity and usefulness. The document outlines the aims of critical appraisal as updating knowledge, supporting evidence-based practice, and informing health policies. It then describes how to critically appraise articles by following the structure and evaluating different sections like the title, abstract, methodology, results, and conflicts of interest. Finally, it lists different guidelines for appraising different study designs.
Research in Ayurveda provides scope in theoretical, experimental, and clinical research areas. Theoretical research could explore fundamental Ayurvedic principles like doshas. Experimental research could involve tests described in Ayurvedic texts. Clinical research offers an important domain to develop new treatment protocols by studying Ayurvedic case observations and medicine trials. Research is needed to validate Ayurveda's efficacy, safety, and quality according to modern standards, and to upgrade Ayurveda over time based on new health issues. Researchers face problems with variables like individualized Ayurvedic dosing and assessing non-quantitative concepts.
Critical appraisal presentation by mohamed taha 2Cairo University
This document discusses how to critically appraise a research article. It provides 10 questions to ask when appraising an article, including whether the study question is relevant, if the study design was appropriate, and if the data supports the conclusions. As an example, it summarizes a study that examined the relationship between serum cholesterol levels and exposure to violence in suicide attempters. The study addressed relevant questions, utilized an appropriate cohort study design, and its conclusions were reasonably supported by the collected data.
Qualitative research seeks to understand a research problem from the perspectives of the local population involved. It provides information about the human side of issues by identifying factors like social norms, beliefs, and relationships. When used with quantitative methods, qualitative research can help interpret complex realities and data. Valid qualitative research comprehensively collects data through methods like interviews and observation from participants selected through strategies such as purposive and snowball sampling. It analyzes data appropriately and corroborates findings through techniques including member checking and triangulation.
This document provides an overview of research methodology, including key concepts like types of research, developing a research question, hypotheses, and population and sampling. It begins by defining research and research methodology. It describes the objectives of research methodology as guiding researchers and equipping them with necessary skills. It then covers the main types of research like basic/applied, observational/experimental, qualitative/quantitative, and theoretical/empirical. Several steps in conducting research are outlined, including developing a research question. Guidelines for writing a good research question using the FINER and PICO criteria are provided. The difference between hypotheses and populations and samples are explained.
Systematic Reviews: the researcher's perspective and the research question. E...healthlibaust2012
The document discusses the perspectives of researchers conducting systematic reviews and the importance of developing a clear research question. It emphasizes that a well-constructed question using the PICO/PICo framework is fundamental to guiding the review process, including developing inclusion criteria and an effective search strategy. Researchers may have different levels of experience and understanding of systematic reviews, so librarians play an important role in helping them conceptualize the question and properly carry out the various review steps, such as developing a reproducible search strategy.
This document outlines the key components of a research protocol, including identifying a health problem, formulating research questions and objectives, planning data collection and analysis, and drawing conclusions. It discusses that a research protocol provides a formal written plan and blueprint for conducting research. The major sections covered are introduction, research question/hypothesis, objectives, review of literature, materials and methods, sample size calculation, data collection plan, data analysis plan, implementation plan, ethical considerations, timeline, and references. The goal of a protocol is to clarify the research question and design a scientifically sound methodology to properly address the question.
This document provides an overview of research methodology, including definitions of key terms, the need for research, research objectives, requirements, and types of research. It discusses qualitative and quantitative research approaches. Qualitative research deals with non-quantifiable conditions and is exploratory, while quantitative research defines empirical investigations using statistical techniques with large sample sizes. The document also covers reviewing literature to understand the background and avoid duplication, and identifies various sources for literature reviews.
This document provides guidance on how to write a research protocol. It explains that a research protocol is a document that describes the research question, hypothesis, objectives, design, methodology, statistical considerations and expected outcomes. It emphasizes that the protocol should communicate the need and nature of the study in a simple, clear manner to convince stakeholders. The document outlines the various sections that should be included in a protocol such as introduction, methodology, analysis plan, references and ethics considerations. It stresses that the protocol should indicate how the study will advance scientific knowledge and potentially impact healthcare, policies or further research. The document provides tips for choosing a feasible, novel topic and refining the research question and objectives. It also discusses various study designs, sampling techniques,
This workshop is meant to be an introduction to the systematic review process. Further information about systematic reviews was available through a research guide. http://libguides.ucalgary.ca/content.php?pid=593664
This document discusses STROBE-nut, an extension of the STROBE reporting guidelines for nutritional epidemiology studies. It provides context on reporting guidelines and their importance in addressing research waste from incomplete reporting. STROBE-nut was developed through an expert consensus process to include 24 recommendations for transparently reporting nutritional epidemiology and dietary assessment studies. The goal of STROBE-nut is to improve the completeness and transparency of nutritional epidemiology research publications.
1. This study was a cluster randomized controlled trial that assessed the effects of periodic vitamin A supplementation and deworming on child mortality in 1 million preschool children in North India.
2. The study had a 5-year study period from 1999-2004 and used a 2x2 factorial design to examine the effects of 6-monthly vitamin A supplementation, 6-monthly deworming with albendazole, and their combination on mortality in children aged 1-6 years.
3. The results found that vitamin A supplementation alone did not reduce child mortality as much as expected based on previous trials, reducing mortality by only 4%. However, meta-analysis of this study combined with previous trials still showed an average
Updated - What makes systematic review systematic - Anna Sidorchukadinafeldman
This document provides an outline and overview of a speech on what makes a systematic review systematic from an epidemiological perspective. It discusses key aspects of systematic reviews including how they differ from non-systematic reviews, guidelines for conducting systematic reviews, inclusion of randomized and observational data, assessing risk of bias, and summarizing results. The speaker aims to explain the value added by systematic reviews over traditional literature reviews in providing objective and replicable summaries of evidence on a topic.
A well recognised form of research is called systematic reviews on specific point. Why do we need them and How they can be done?? this talk is trying to answer these questions in a simple way
This document provides guidance on writing a research proposal for health research. It outlines 12 chapters covering key aspects of developing a proposal such as formulating the research problem, reviewing relevant literature, developing objectives and hypotheses, describing the research methodology and implementation plan, preparing a budget, and including appendices and a title page with abstract. The purpose of a research proposal is to communicate the topic of interest and demonstrate the researcher's ability to identify an interesting research question to potential supervisors and donors to obtain approval and support for the study.
This document discusses cross-sectional study designs for epidemiological research. A cross-sectional study involves identifying a population at a single point in time and collecting data on exposures and outcomes without influencing either. Key advantages are allowing estimates of disease prevalence and descriptions of population characteristics. Limitations include inability to determine causality and potential for confounding biases. The document outlines appropriate dietary assessment tools, study design considerations, and analytical methods for cross-sectional research.
Systematic Reviews: the process, quantitative, qualitative and mixed methods ...healthlibaust2012
This document discusses systematic reviews and their process. It defines systematic reviews as attempts to identify, appraise, and synthesize all empirical evidence that meets pre-specified eligibility criteria to answer a given research question. It notes there are quantitative, qualitative, and mixed methods reviews. The document outlines the steps in conducting a systematic review, including developing a protocol and research question, locating studies, assessing studies, extracting and analyzing data, and presenting results.
Research requires properly planned methodology. I would like to recommend that researchers to focus on these 4 critical steps. If these steps are fulfilled, you will find it easy to conduct your research.
This study evaluated the lateral tarsal strip technique for correcting lower eyelid ectropion in 30 patients (41 eyelids). Patients were divided into groups based on the type of ectropion: involutional, paralytic, or cicatricial. Most patients presented with tearing. The technique successfully corrected ectropion in 35 eyelids, while 6 required additional procedures. The lateral tarsal strip proved effective for correcting ectropion, especially when lateral canthal tendon laxity is present.
This is lesson 6 of the course on Research Methodology conducted at the Faculty of Social Sciences and Humanities of the Rajarata University of Sri Lanka
This document provides an introduction to research methodology for 4th year midwifery students. It defines health research and describes the different types of research. The types of research are classified based on their objectives (basic vs applied), design (experimental vs non-experimental), population studied (individual vs population), level of analysis (biomedical, clinical, epidemiological, health systems), time required (cross-sectional vs longitudinal), data and techniques used (quantitative vs qualitative vs mixed methods). The purpose, scope, and characteristics of health research are also outlined.
Qualitative research seeks to understand a research problem from the perspectives of the local population involved. It provides information about the human side of issues by identifying factors like social norms, beliefs, and relationships. When used with quantitative methods, qualitative research can help interpret complex realities and data. Valid qualitative research comprehensively collects data through methods like interviews and observation from participants selected through strategies such as purposive and snowball sampling. It analyzes data appropriately and corroborates findings through techniques including member checking and triangulation.
This document provides an overview of research methodology, including key concepts like types of research, developing a research question, hypotheses, and population and sampling. It begins by defining research and research methodology. It describes the objectives of research methodology as guiding researchers and equipping them with necessary skills. It then covers the main types of research like basic/applied, observational/experimental, qualitative/quantitative, and theoretical/empirical. Several steps in conducting research are outlined, including developing a research question. Guidelines for writing a good research question using the FINER and PICO criteria are provided. The difference between hypotheses and populations and samples are explained.
Systematic Reviews: the researcher's perspective and the research question. E...healthlibaust2012
The document discusses the perspectives of researchers conducting systematic reviews and the importance of developing a clear research question. It emphasizes that a well-constructed question using the PICO/PICo framework is fundamental to guiding the review process, including developing inclusion criteria and an effective search strategy. Researchers may have different levels of experience and understanding of systematic reviews, so librarians play an important role in helping them conceptualize the question and properly carry out the various review steps, such as developing a reproducible search strategy.
This document outlines the key components of a research protocol, including identifying a health problem, formulating research questions and objectives, planning data collection and analysis, and drawing conclusions. It discusses that a research protocol provides a formal written plan and blueprint for conducting research. The major sections covered are introduction, research question/hypothesis, objectives, review of literature, materials and methods, sample size calculation, data collection plan, data analysis plan, implementation plan, ethical considerations, timeline, and references. The goal of a protocol is to clarify the research question and design a scientifically sound methodology to properly address the question.
This document provides an overview of research methodology, including definitions of key terms, the need for research, research objectives, requirements, and types of research. It discusses qualitative and quantitative research approaches. Qualitative research deals with non-quantifiable conditions and is exploratory, while quantitative research defines empirical investigations using statistical techniques with large sample sizes. The document also covers reviewing literature to understand the background and avoid duplication, and identifies various sources for literature reviews.
This document provides guidance on how to write a research protocol. It explains that a research protocol is a document that describes the research question, hypothesis, objectives, design, methodology, statistical considerations and expected outcomes. It emphasizes that the protocol should communicate the need and nature of the study in a simple, clear manner to convince stakeholders. The document outlines the various sections that should be included in a protocol such as introduction, methodology, analysis plan, references and ethics considerations. It stresses that the protocol should indicate how the study will advance scientific knowledge and potentially impact healthcare, policies or further research. The document provides tips for choosing a feasible, novel topic and refining the research question and objectives. It also discusses various study designs, sampling techniques,
This workshop is meant to be an introduction to the systematic review process. Further information about systematic reviews was available through a research guide. http://libguides.ucalgary.ca/content.php?pid=593664
This document discusses STROBE-nut, an extension of the STROBE reporting guidelines for nutritional epidemiology studies. It provides context on reporting guidelines and their importance in addressing research waste from incomplete reporting. STROBE-nut was developed through an expert consensus process to include 24 recommendations for transparently reporting nutritional epidemiology and dietary assessment studies. The goal of STROBE-nut is to improve the completeness and transparency of nutritional epidemiology research publications.
1. This study was a cluster randomized controlled trial that assessed the effects of periodic vitamin A supplementation and deworming on child mortality in 1 million preschool children in North India.
2. The study had a 5-year study period from 1999-2004 and used a 2x2 factorial design to examine the effects of 6-monthly vitamin A supplementation, 6-monthly deworming with albendazole, and their combination on mortality in children aged 1-6 years.
3. The results found that vitamin A supplementation alone did not reduce child mortality as much as expected based on previous trials, reducing mortality by only 4%. However, meta-analysis of this study combined with previous trials still showed an average
Updated - What makes systematic review systematic - Anna Sidorchukadinafeldman
This document provides an outline and overview of a speech on what makes a systematic review systematic from an epidemiological perspective. It discusses key aspects of systematic reviews including how they differ from non-systematic reviews, guidelines for conducting systematic reviews, inclusion of randomized and observational data, assessing risk of bias, and summarizing results. The speaker aims to explain the value added by systematic reviews over traditional literature reviews in providing objective and replicable summaries of evidence on a topic.
A well recognised form of research is called systematic reviews on specific point. Why do we need them and How they can be done?? this talk is trying to answer these questions in a simple way
This document provides guidance on writing a research proposal for health research. It outlines 12 chapters covering key aspects of developing a proposal such as formulating the research problem, reviewing relevant literature, developing objectives and hypotheses, describing the research methodology and implementation plan, preparing a budget, and including appendices and a title page with abstract. The purpose of a research proposal is to communicate the topic of interest and demonstrate the researcher's ability to identify an interesting research question to potential supervisors and donors to obtain approval and support for the study.
This document discusses cross-sectional study designs for epidemiological research. A cross-sectional study involves identifying a population at a single point in time and collecting data on exposures and outcomes without influencing either. Key advantages are allowing estimates of disease prevalence and descriptions of population characteristics. Limitations include inability to determine causality and potential for confounding biases. The document outlines appropriate dietary assessment tools, study design considerations, and analytical methods for cross-sectional research.
Systematic Reviews: the process, quantitative, qualitative and mixed methods ...healthlibaust2012
This document discusses systematic reviews and their process. It defines systematic reviews as attempts to identify, appraise, and synthesize all empirical evidence that meets pre-specified eligibility criteria to answer a given research question. It notes there are quantitative, qualitative, and mixed methods reviews. The document outlines the steps in conducting a systematic review, including developing a protocol and research question, locating studies, assessing studies, extracting and analyzing data, and presenting results.
Research requires properly planned methodology. I would like to recommend that researchers to focus on these 4 critical steps. If these steps are fulfilled, you will find it easy to conduct your research.
This study evaluated the lateral tarsal strip technique for correcting lower eyelid ectropion in 30 patients (41 eyelids). Patients were divided into groups based on the type of ectropion: involutional, paralytic, or cicatricial. Most patients presented with tearing. The technique successfully corrected ectropion in 35 eyelids, while 6 required additional procedures. The lateral tarsal strip proved effective for correcting ectropion, especially when lateral canthal tendon laxity is present.
This is lesson 6 of the course on Research Methodology conducted at the Faculty of Social Sciences and Humanities of the Rajarata University of Sri Lanka
This document provides an introduction to research methodology for 4th year midwifery students. It defines health research and describes the different types of research. The types of research are classified based on their objectives (basic vs applied), design (experimental vs non-experimental), population studied (individual vs population), level of analysis (biomedical, clinical, epidemiological, health systems), time required (cross-sectional vs longitudinal), data and techniques used (quantitative vs qualitative vs mixed methods). The purpose, scope, and characteristics of health research are also outlined.
This document provides an overview of research methods and designs. It discusses qualitative and quantitative research methods, with qualitative focusing on lived experiences and meanings and quantitative focusing on numerical data. It also discusses different types of study designs, including observational studies like cross-sectional and longitudinal, and experimental designs like clinical and community trials. Experimental research allows investigators to actively alter variables to evaluate relationships, while considering factors like the purpose of the study, strength of evidence desired, time and resources available, and ethics.
The document discusses evidence-based orthodontics. It begins with definitions of evidence and evidence-based dentistry. It then discusses the history and evolution of evidence-based practice from the 19th century to present day. The need for evidence-based orthodontics is described as providing patients with the currently best available care. Clinical scenarios are presented and critically appraised based on evidence from the literature. Different study designs and hierarchies of evidence are reviewed. The importance of evidence-based decision making in orthodontics is emphasized.
Presentation how to write a research protocolSushma Sharma
This document provides guidance on developing a research protocol. It explains that a protocol establishes the design and methodology for a research study. The key components of a protocol include the title, introduction/background, objectives, study design, population and recruitment, variables, data collection tools, analysis plan, timeline, and dissemination strategy. Developing a clear protocol is important to gain approval, plan the study, avoid mistakes, and evaluate the research. It should provide enough detail that the study could be replicated by others.
This slide contains B.Pharm 8th Sem Biostatistics and research methodology, Unit-3.
Topic covered: Designing the methodology, Sample size determination and Power of a study, Report writing
and presentation of data, Protocol, Cohorts studies, Observational studies, Experimental studies,
Designing clinical trial, various phases.
Study designs & amp; trials presentation1 2Praveen Ganji
This document defines and describes different types of clinical research studies and trials. It discusses meta-analyses, systematic reviews, randomized controlled trials, cohort studies, case-control studies, cross-sectional studies, case reports, editorials, animal research, laboratory research, and clinical trial phases. For each type of study, it provides brief explanations of their purpose and advantages and disadvantages. It also defines key statistical concepts like p-values and standard deviation.
This document discusses key components of research articles and the research process. It defines sections like the abstract, introduction, methods, results, discussion and references. It also explains important research concepts such as independent and dependent variables, limitations, and the difference between qualitative and quantitative research. The overall summary is that this document provides guidance on the structure and methodology of research articles and studies.
This document provides an overview of qualitative and quantitative research methods, mixed methods research, and how research can be used to inform patient-centered care in dentistry. It discusses the differences between qualitative and quantitative research in terms of objectives, data collection and analysis. It also reviews inductive and deductive approaches and the hypothetico-deductive model. The document then examines how qualitative and quantitative methods can be combined in mixed methods research, providing examples of sequential and concurrent mixed methods designs. Finally, it discusses how evidence-based dentistry and an understanding of patient preferences are important for providing patient-centered care.
This document provides an overview of how to conduct a systematic review. It begins by defining what a systematic review is and why they are important for evidence-based practice. It then outlines the key steps in conducting a systematic review, including formulating an answerable question using PICO(T), performing a comprehensive literature search, selecting studies and extracting data in an unbiased manner, critically appraising the evidence, and synthesizing the data. The document emphasizes that systematic reviews need to follow a structured, systematic process and make all methods explicit to minimize bias. It also discusses challenges that can arise in systematic reviews like database, publication, and language biases.
1. unit 3 part I- intro with (a) Observational studies – descriptive and anal...Ashesh1986
This document provides an overview of epidemiological study designs and research ethics. It begins by acknowledging the sources used to prepare the presentation. The objective is to understand epidemiological study design types, including observational and interventional studies. Observational studies are further broken down into descriptive and analytical designs, as well as ecological studies. Descriptive designs aim to simply describe health-related events, while analytical designs seek to establish relationships between exposures and outcomes. Ecological studies analyze data at the group level rather than the individual level. The document discusses various study design considerations and limitations. It emphasizes the importance of choosing appropriate study designs and addressing potential biases and confounding. Finally, it recommends further readings on epidemiological study design topics.
The critical appraisal process examines research to judge its validity and relevance. It involves summarizing key aspects of research articles like the introduction, methods, results and discussion sections. Important tools for appraisal include the PICO method to assess the research question, and CASP checklists tailored to different study designs. Proper appraisal helps identify clinically relevant papers and supports evidence-based decision making.
This document provides an overview of research in medical and health fields. It discusses the importance of health research, defines different types of medical research including basic, applied, quantitative, qualitative, experimental and non-experimental research. It also outlines various research methodologies like descriptive research, exploratory research, cross-sectional research, longitudinal research and case study research. The document emphasizes that medical research facilitates learning, highlights issues, and helps advance treatment, diagnosis and understanding of human health problems through the scientific method.
This document provides an overview of key concepts in research methodology, including:
1) It describes the basic steps in the research process, including defining the research question, reviewing literature, choosing a study design, data analysis, and dissemination.
2) Common study designs like randomized controlled trials, cohort studies, and case-control studies are explained.
3) Key aspects of developing a research question like making it feasible, interesting, novel, and relevant are outlined.
4) The importance of choosing an appropriate study design to answer the research question is emphasized.
nursing research Chapter 5 for pbn 3rd year pu PU nepalpurnamepurna
This document summarizes different types of research including basic research, applied research, quantitative research, qualitative research, historical research, conceptual research, empirical research, operational research, evaluation research, and action research. It provides descriptions of each type of research and compares some of their key differences. For example, it notes that basic research aims to advance knowledge for its own sake while applied research aims for practical application. The document also discusses different research designs such as descriptive research, analytical research including cross-sectional, case-control and cohort studies, and experimental research.
This document provides an overview of critical appraisal and how to appraise a cohort study. It discusses the key elements of cohort studies, including their use in identifying environmental and lifestyle factors that influence health outcomes. The document also provides a sample cohort study paper and the CASP checklist for appraising cohort studies. It addresses appraising elements like selection of study participants, measurement of exposures, follow-up, and consideration of confounding factors.
This document provides an introduction to the course "Design and Analysis of Clinical Trials". It discusses how clinical research uses statistics to investigate medical treatments and assess benefits of therapies. Statistics allow for reasonable inferences from collected data despite variability in patient responses. The course covers fundamental concepts of clinical trial design and analysis including phases of trials, randomization, sample size, treatment allocation, and ethical considerations. It aims to teach students how to generalize trial results to populations and combine empirical evidence with medical theory using statistical methods.
This document provides an introduction to the course "Design and Analysis of Clinical Trials". It discusses how clinical research uses statistics to investigate medical treatments and assess benefits of therapies. Statistics allow for reasonable inferences from collected data despite variability in patient responses. The course covers fundamental concepts of clinical trial design and analysis including phases of trials, randomization, sample size, treatment allocation, and ethical considerations. It aims to teach students how to generalize trial results to populations and combine empirical evidence with medical theory using statistical methods.
This document provides an overview of evidence-based orthodontics. It defines evidence-based orthodontics as integrating the best available research evidence with clinical expertise and patient values. The need for evidence-based orthodontics is that it allows practitioners to provide the currently best care available to patients. Evidence-based orthodontic practice differs from traditional practice by regularly accessing new evidence, identifying risk factors, and providing continuous, patient-centered, and efficient care. Systematic reviews are used to summarize research evidence in an unbiased manner to inform clinical decision making.
This document discusses evaluation methods for cardiotonic drugs, which are used to treat congestive heart failure. It describes both in vivo and in vitro methods. For in vivo methods, it outlines several animal models used, including rat models (such as coronary ligation and aortic banding), dog models (like chronic rapid pacing and volume overload), and rabbit models. These allow testing of drugs on intact animals and evaluation of factors like cardiac output and neurohormonal levels. In vitro methods described involve isolated tissue preparations and cell cultures to assess effects on a mechanistic level.
Dr. Sneha Dange will present on the pharmacotherapy of glaucoma. The presentation will cover the anatomy of the eye relevant to glaucoma, the goals of glaucoma treatment, and an overview of current pharmacotherapy options including beta blockers, alpha agonists, prostaglandin analogues, cholinergic agonists, carbonic anhydrase inhibitors, and hyperosmotic agents. Recent advances discussed will include antioxidants, forskolin, and Ginkgo biloba as complementary treatments.
Pharmacotherapy of Neurodegenrative diseases DrSnehaDange
This document provides an overview of various neurodegenerative diseases and their pharmacotherapy. It discusses the mechanism of neuronal cell death including protein misfolding and aggregation, excitotoxicity, and apoptosis. Several neurodegenerative diseases are then examined in more detail, including Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, Huntington's disease, and others. For each disease, the document discusses aspects such as pathology, genetics, clinical features, and pharmacotherapy options.
Pharmacotherapy of Cardiac arrhythmiasDrSnehaDange
This document provides an overview of pharmacotherapy for cardiac arrhythmias. It discusses the normal conduction pathway in the heart and mechanisms of arrhythmogenesis. Cardiac arrhythmias are classified and characteristics of different types are described including extrasystoles, supraventricular tachycardia, atrial flutter, atrial fibrillation, ventricular tachycardia and ventricular fibrillation. Antiarrhythmic drugs are classified according to the Vaughan Williams system with details provided on mechanisms and examples for Class IA, IB, IC, II, III and IV drugs.
This document provides an overview of dermatopharmacology and summarizes key topics including skin structure, principles of topical drug application, antimicrobial agents, antifungal agents, antiviral agents, immunosuppressants, and recent advances. It discusses the structure of the epidermis and dermis, formulations for topical drug delivery, potency classifications of topical corticosteroids, mechanisms and indications for various antimicrobial, antifungal and antiviral agents.
The document discusses various antiviral drugs used to treat viral infections. It begins by describing viruses and their replication cycles. It then classifies antiviral drugs based on their mechanisms of action and discusses individual drugs used to treat herpes viruses, influenza viruses, hepatitis viruses, cytomegalovirus, and more. Key drugs mentioned include acyclovir, valacyclovir, famciclovir for herpes, oseltamivir and zanamivir for influenza, and ganciclovir and valganciclovir for cytomegalovirus. The document provides details on the mechanisms, uses, and side effects of many commonly used antiviral medications.
This document provides an overview of pharmacotherapy for pain management. It discusses the physiology of pain including the ascending and descending pain pathways. It describes the different types of pain and classifications. For pharmacotherapy, it explains the WHO three-step ladder approach starting with non-opioid analgesics like NSAIDs, then weak opioids, and finally strong opioids. It provides details of commonly used non-opioid and opioid analgesics, their dosages, properties and side effects. The document emphasizes a multidisciplinary approach for pain management including pharmacotherapy, physiotherapy, and cognitive behavioral therapy.
This document discusses adverse drug reactions (ADRs). It defines ADRs and differentiates them from adverse drug events. It also defines serious adverse events. The document then covers the history of ADR monitoring and reporting, classifications of ADRs by type and category, organ-specific ADRs, and ADR reporting through pharmacovigilance programs. Overall, the document provides an overview of key concepts regarding ADRs, their classification, and monitoring.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
2. Overview
Key areas
Types of Research Study Designs
Randomized controlled clinical trials
Conclusion
6-Apr-22
Research Study Designs 2
3. Research
• Research is defined as the creation of new knowledge
and/or the use of existing knowledge in a new and creative
way so as to generate new concepts, methodologies and
understandings.
6-Apr-22
Research Study Designs 3
4. Dimension of health research
• Theoretical research and applied research
• Preventive and therapeutic research
• Bench based research and bedside research
• Exploratory research and confirmatory research
• Implementation research and translational research
6-Apr-22
Research Study Designs 4
• Planning stage
• Team work
• Review
Scientific review: novelty, rationality, justification
Ethics review: human subjects protection
Regulatory review: foreign funding, intellectual property
5. Objectives of health research
• Getting additional or new information
• Verifying and confirming available information
• Explaining cause and effect relationship
• Testing new drugs, vaccines, tools or interventions for prevention,
treatment and control of a disease
• Evaluating ongoing programs and assessing feasibility of new programs
6-Apr-22
Research Study Designs 5
6. The life cycle of research
6-Apr-22
Research Study Designs 6
7. Key areas in Research
Spell out research question
State research hypothesis
Formulate objectives
6-Apr-22
Research Study Designs 7
8. Research question
• Uncertainty about something in the population that the investigator
wants to resolve by making measurements in the study population
• Uncertainty = ‘data needs’
• What the investigator wants to know
• Clear question facilitates to
Choose the most optimal design
Identify who should be included, what the outcomes should be, and when the
outcomes need to be measured
6-Apr-22
Research Study Designs 8
9. Categories of research question
6-Apr-22
Research Study Designs 9
• Involve observations to measure quantity
• No comparison groups / interventions
Descriptive questions
• Involve comparisons / interventions to test a
hypothesis
Analytical questions
What is extent of walking practiced by diabetics (type 2 diabetes)
regularly? [Descriptive question]
In order to improve management of type 2 diabetes, we wish to know
whether brisk walking by diabetics for atleast one hour daily reduce
fasting blood sugar level as compared to those who do not?
[Analytical question]
10. Research hypothesis
• A specific version of research question
Summarizes main elements of study
Establishes basis for test(s) of statistical significance
• Stated for analytical questions with comparison groups
• Descriptive questions DO NOT require hypothesis
• Focused around the primary objective
6-Apr-22
Research Study Designs 10
11. 6-Apr-22
Research Study Designs 11
What is extent of walking practiced by diabetics (type 2 diabetes)
regularly? [Descriptive question]
In order to improve management of type 2 diabetes, we wish to know
whether brisk walking by diabetics for atleast one hour daily reduce
fasting blood sugar level as compared to those who do not?
[Analytical question]
Among diabetics (type 2 diabetes) from the study area, who do brisk
walking for atleast one hour daily results in average reduction of 10
mg% of fasting blood sugar level as compared to those who do not
Research hypothesis
12. Research objectives
• Framing/writing a research question in scientific/epidemiological
language
• Be clear about the type of question:
Descriptive questions {measuring a quantity}
Analytical/experimental questions {testing a hypothesis}
• Make use of no more than one verb for each
• Sort as primary and secondary
6-Apr-22
Research Study Designs 12
13. Research objectives
• Descriptive: Estimating a quantity
Use the verb “Estimate”
E.g., Estimate prevalence of physical activity
• Analytical: Testing a hypothesis
Use the verb “Determine”
E.g., Determine whether exercise reduces blood sugar level
6-Apr-22
Research Study Designs 13
14. Challenges/Errors in designing and implementation of
research studies
• Random error representing wrong result due to chance
Minimized by increasing sample size and increasing precision
• Systematic error results due to bias
Minimized by improving study design
• Confounders (affect both study variable & outcome)
Minimized by proper study design and through stratified analysis
• Effect modifiers (alter negatively the relationship between study variable
and outcome)
Good to be aware & not to include them in the study
6-Apr-22
Research Study Designs 14
15. Types of study design
Qualitative studies or Quantitative studies
Observational studies or Experimental studies
Retrospective studies or Prospective studies
6-Apr-22
Research Study Designs 15
16. Quantitative versus Qualitative research methods
6-Apr-22
Research Study Designs 16
Quantitative Qualitative
Data Numbers Text
View of the world Social reality - measuring
investigators point of view
Social reality interpreted
and experienced from
participant point of view
Logic of enquiry Deductive – testing formal
hypotheses
Inductive – understanding
of processes derived from
data
Research design Ensures repeatability Interpretation of
responses by participants
Validity Objective (reliability) Subjective (credibility)
17. 6-Apr-22
Research Study Designs 17
Focus Group
Discussions
• Open-ended group
interviews
• Usually 6-8 ‘similar’
participants
• Similar age, gender,
socio-economic status,
education, cognitive
structures, perceptions
of their social
environment, normative
beliefs
• Moderator and note-
taker
• Flexible interview guide
In-depth (Individual)
Interviews
• Open-ended
interviews
• Most in-depth - Why
behaviors are
practiced?
• Data on how people
think and talk
Participant
Observation
• The researcher
becomes participant
in social event or
group under study and
records observations
Qualitative research : (methods)
18. Qualitative research :
How to use qualitative research methods?
• A preliminary step in developing a quantitative study
• To help understand the results of a quantitative study
• The primary data collection method
6-Apr-22
Research Study Designs 18
19. Qualitative research :
How are qualitative research methods useful?
• Identify health determinants Underlying behaviours Attitudes
Perceptions
• Shed light on the success of intervention
• Understanding of policy, social and legal context in which decisions
are made
• Explain social and programmatic obstructions in use of services
6-Apr-22
Research Study Designs 19
21. 6-Apr-22
Research Study Designs 21
Did investigator assign
exposure?
Experimental study Observational study
Analytical
study
Random allocation Comparison group?
YES NO
Descriptive
study
NO
YES
RCT
Non-
random
ized
YES NO
Cohort
Study
Case-
control
22. Case reports
• Detailed presentation of a single case
• New or unfamiliar diseases
• Rare manifestations
• Generate hypothesis regarding pathophysiological mechanism
• Published in journals in separate section under case series
6-Apr-22
Research Study Designs 22
Descriptive study
23. Case series
• Study of larger group of patients (> 10) with a particular disease
• Findings due to disease or due to chance
• Gives clinical pictures of a disease
• Absence of comparison group
• Eg., A case series on uncommon disease pneumocystis pneumonia
observed in 5 gay men which leads to discovery of AIDS
6-Apr-22
Research Study Designs 23
Descriptive study
24. Ecological studies
6-Apr-22
Research Study Designs 24
• Group as the unit of analysis and see possible reasons why problem is
occurring
• No individual-level information on the distribution of exposure and
disease
Eg., average intake of fat in particular state & then get prevalence of CVD in
that state
• Useful to generate hypothesis (establish correlation)
Eg., state with high per capita consumption of fat also has high incidence of CVD
Descriptive study
25. Cross sectional study
• Observation of a cross-section of a population at a single point in
time
Unit of observation and analysis: The individual
• Collect information about disease burden or magnitude of disease
Also known as “prevalence studies”
• Recruitment of study participants
Population
Population sample
• Observation for the presence of:
One or more outcomes
One or more exposures
6-Apr-22
Research Study Designs 25
Descriptive study
26. Uses of Cross sectional study
• Estimate prevalence of disease or their risk factors
• Distribution of health problem by time, place and person
Plan health care services delivery
• Set priorities for disease control
• Generate hypotheses
• Examine evolving trends
Before / after surveys
6-Apr-22
Research Study Designs 26
Descriptive study
27. Cross sectional study
• Advantages
Fairly quick and easy to perform
Less expensive
• Limitations
Not useful to study disease etiology
Not suitable for the study of rare diseases
Exposure and outcome can not be linked very well
6-Apr-22
Research Study Designs 27
Descriptive study
28. Cohort study
• Cohort - group of people sharing some common characteristics
• No randomization
• Prospective: follow groups forward in time from exposure to defined
outcome of interest (disease)
• Provide a direct estimate of relative risk: the probability of
developing disease during a given time period
6-Apr-22
Research Study Designs 28
Analytical study
30. Cohort study
• Relative risk =
Incidence of disease in exposed = a/a+b
Incidence of disease in unexposed = c/c+d
6-Apr-22
Research Study Designs 30
Analytical study
Diseased Non-
Diseased
Total
Exposed a b a+b
Unexposed c d c+d
a+c b+d a+b+c+d
This part is known at start of study
Interpreting Relative risk
•RR=1
•Incidence in exposed and unexposed is same
•Exposure is not associated with disease
•RR > 1
•Incidence in exposed is higher than unexposed
•Exposure is positively associated with disease
•RR < 1
•Incidence in exposed is lower than unexposed
•Exposure is negatively associated with disease
32. Cohort study
Strengths
• Allows calculation of incidence
• Examine multiple outcomes for a
given exposure
• Good for investigating rare
exposures
Weakness
• May have to follow large numbers
of subjects for a long time
• Expensive and time consuming
• Not good for rare diseases
• Not good for diseases with a long
latency
• Loss to follow up can introduce bias
6-Apr-22
Research Study Designs 32
Analytical study
33. Case control study
• Focus on the etiology of a disease or health issue
• Patients with a particular health concern / characteristic /
disease are taken and then followed retrospectively for exposure
• Matched with “controls”
• Data often is collected by searching through patient histories or
through patient recall surveys
6-Apr-22
Research Study Designs 33
Analytical study
35. Case control study
Odds that case was exposed
• Odds ratio= Odds that control was exposed
= [a/c]/[b/d] = ad/bc
6-Apr-22
Research Study Designs 35
Analytical study
Research Study Designs
Diseased Non-
Diseased
Total
Exposed a b a+b
Unexposed c d c+d
a+c b+d a+b+c+d
This part is known at start of study
Interpreting Odds Ratio
•OR=1
•Odds of exposure among cases and controls are same
•Exposure is not associated with disease
•OR > 1
•Odds of exposure among cases are higher than controls
•Exposure is positively associated with disease
•OR < 1
•Odds of exposure among cases are lower than controls
•Exposure is negatively associated with disease
36. Case control study
Strengths
• Good for examining rare outcomes
or outcomes with long latency
• Relatively quick to conduct,
inexpensive
• Requires comparatively few
subjects
• Multiple exposures or risk factors
can be examined
Weakness
• Susceptible to recall bias
• Selection of an appropriate
comparison group is difficult
• Rates (incidence) of disease in
exposed and unexposed
individuals cannot be determined
6-Apr-22
Research Study Designs 36
Analytical study
37. Clinical trial
6-Apr-22
Research Study Designs 37
Clinical trials translate results of basic scientific research into better
ways to prevent, diagnose, or treat disease
Experimental study
To evaluate new forms of therapy or prevention methods such as
New drugs/ treatment
New medical / health care technology
New organization/ delivery system of health care
New methods of primary prevention
New programs of screening or early detection
38. Randomized controlled trials
• A clinical trial is a planned experiment designed to assess the
efficacy of prophylactic / diagnostic / therapeutic agents, devices,
regimens, procedures etc. applied to human subjects by comparing
the outcomes in a group of patients treated with a test treatment
with those patients receiving a control treatment
6-Apr-22
Research Study Designs 38
Experimental study
41. Bias
• Systematic error in an epidemiological study, occurring during data
collection, compilation, analysis and interpretation
• It can simply called as “deviation from the truth”
• Bias can occur during –
Before the trial starts
Actual course of the trial
Reporting of a trial
Dissemination of the trial
Uptake phase of trial
6-Apr-22
Research Study Designs 41
42. Techniques to control bias
6-Apr-22
Research Study Designs 42
Randomization Blinding
43. Randomization
Randomization is a statistical procedure by which the participants are
allocated into groups usually called "study“ and "control" groups, to receive
or not to receive an experimental, preventive or therapeutic procedure or
intervention
Gives each patient equal chance of being assigned to any of groups
Benefits of randomization
• Eliminates the selection bias,
• Balances the groups with respect to many known and unknown confounding or
variables
• Forms the basis for statistical tests
6-Apr-22
Research Study Designs 43
44. Randomization
1. Simple randomization
• Randomization based on a single sequence of random assignments is
known as simple randomization eg., flipping a coin
2. Block randomization
• Blocking is the arranging of experimental units in groups (blocks) that
are similar to one another
• Blocks are small and balanced with predetermined group assignments,
which keeps the numbers of subjects in each group similar at all time
6-Apr-22
Research Study Designs 44
45. Randomization
3. Stratified randomization
• Non-homogenous population is divided into homogenous groups called as
strata & then sample is drawn randomly from each stratum
• Can be used to achieve balance among groups in terms of subject’s
baseline characteristics (co-variates)
4. Cluster randomization
• Cluster is randomly selected group which is geographical group
• Used in vaccination programme
• Each cluster forms a unit of the trial and either active or comparator
intervention is administered for each cluster
6-Apr-22
Research Study Designs 45
46. Blinding
6-Apr-22
Research Study Designs 46
To minimize biases in the conduct of a clinical trial and in the interpretation
of its results
1.Open label
2.Single blind
3.Double blind
4.Triple blind
Subject/Participant
Investigator
(Clinicians/data collectors)
Monitoring committee
(Analysts/Sponsors)
47. Uncontrolled Trials
• There is no control group for comparison
• Not possible to use blinding and randomization to minimize bias
• Used to test new experimental interventions for diseases for which
no established, effective treatments are available and the prognosis
is universally poor without therapy
• Outcomes for research participants receiving the experimental
intervention are compared with the outcomes before the availability
of the intervention
6-Apr-22
Research Study Designs 47
48. Selection of controls
• A control group in a clinical trial is a group of individuals used as a
comparison for a group of participants who receive the experimental
treatment.
• Main purpose - to permit investigators to determine whether an
observed effect is truly caused by the experimental intervention
being tested or by other factors
• Control group serve as a baseline
6-Apr-22
Research Study Designs 48
50. Control Arm Options
1. Placebo Control –
Placebo- inert substance – looks exactly like test drug but contains no drug
No standard treatment exists, standard treatment is ineffective/inappropriate
Given as an add-on treatment to an already existing regimen
2. No treatment control
Subjects are randomly assigned to test treatment or to no treatment
Subjects, investigators are not blind to treatment
6-Apr-22
Research Study Designs 50
51. Control Arm Options
3. Active control –
Compare “new drug” to standard or standard to combination therapy that
involves the standard + “new drug”
4. Dose response control –
Subjects are randomized to one of several fixed dose groups
5. External control (including historical) –
Compares a group of subjects receiving test treatment with a group of patients
external to study
Can be historical, i.e, group of patients treated at an earlier time
6-Apr-22
Research Study Designs 51
52. Advantages & Disadvantages of RCTs
Advantages
•The only effective method known to control selection bias
•Controls confounding bias without adjustment
•Facilitates effective blinding in trials
Disadvantages
•May be complex and expensive
•Ethical challenges are more
6-Apr-22
Research Study Designs 52
53. Superiority trials :
Aim of this randomized controlled trial (RCT) is to show that one
treatment is superior to another
Non-inferiority trials :
Aim is to show that an experimental treatment is not (much) worse than
a standard treatment or at least have same benefits
Equivalence:
Aims at showing that two treatments are not too different in
characteristics in a clinical manner
6-Apr-22
Research Study Designs 53
54. 6-Apr-22
Research Study Designs 54
Traditional designs for
clinical trials
Parallel group trials
Cross over trials
Factorial design
Add on design
Randomized
withdrawal design
Early escape design
Special Design issues for
small clinical trials
N- of- 1 design
Decision analysis-
based design
Risk based
allocation design
Miscellaneous Designs
Cluster randomized
design
Placebo Challenging
design
Trial format
55. Parallel group trial Design
6-Apr-22
Research Study Designs 55
Treatment Group/ Arm Control Group/ Arm
• Efficacy of treatment is compared using two groups (Treatment vs Control
group)
• Most common clinical design
• Complete randomized design in which each patient receives one and
only one treatment in a randomized fashion
Exp. Drug
56. Matched Pair Parallel Design
6-Apr-22
Research Study Designs 56
Pair A Pair B Pair C Pair D
• In this method, subjects are grouped into pairs possessing same
characteristics who might be expected to respond similarly to
treatments
• Matching of patients is done before randomization
57. Cross over design
6-Apr-22
Research Study Designs 57
Group A Group B
RANDOMIZATION
Drug A
Drug A
Drug B
Drug B
WASH OUT PERIOD
WASH OUT PERIOD
58. Factorial designs
6-Apr-22
Research Study Designs 58
2×2 Factorial design
Used when it is desired to study effect of
two or more treatments as well as their
interaction with different treatments
+
Drug A Drug B Drug A+B Neither Drug
59. Add- on Design
6-Apr-22
Research Study Designs 59
Group A Group B
Placebo-controlled trial of an experimental
intervention is tested with people already receiving
an established, effective treatment
Std. treatment
Novel drug
Std. treatment
+
+
60. Randomized withdrawal Design
6-Apr-22
Research Study Designs 60
• Individuals who respond positively to an experimental
intervention are randomized to continue receiving that
intervention or to receive a placebo
• Return of symptoms in placebo group causes withdrawal of
subject from that group.
Exp. Intervention
Withdrawn
from study
61. Early escape design
6-Apr-22
Research Study Designs 61
Intervention Arm Placebo Arm
• Participants are removed from study if symptoms
reached a defined level or they fail to respond to a
defined extent
• Patient could then be switched over to another
therapy, including test treatment if appropriate.
Exp. Intervention
Predefined negative
efficacy criterion
62. Risk based Allocation Design
6-Apr-22
Research Study Designs 62
• This design allows individuals at higher risk or with
greater disease severity to benefit from a
potentially superior experimental treatment
•Advantages: Ethically more justifiable
•Disadvantage: It is a non-randomized design.
Individuals with lesser
risk or lesser disease
severity
Potentially superior
Experimental
treatment
Relatively inferior
Experimental
treatment
Individuals with
higher risk or greater
disease severity
63. 6-Apr-22
Research Study Designs 63
Phase Design
I Open label
Non-randomized
Dose escalation
Non-blind
Uncontrolled
II IIa - Placebo control, not- multi centered
IIb - Placebo/ active control, Multicentric
III Active controlled
Randomized
Double blinded
Parallel
Non-inferiority
Multicentric
IV Uncontrolled
Observational
Various designs in phases of clinical trial
64. Conclusion
• No research study design is perfect and no design provides optimum
answer to all research questions – optimum design should be chosen
• Success of clinical trial- appropriate clinical design, control group
• Blinding, randomization - minimize bias
• Randomized controlled trials – gold standard
6-Apr-22
Research Study Designs 64
65. References
• Basic courses in biomedical research; Indian Council of Medical Research,
National Institute of Epidemiology
• Lawrence J. Appel. Primer on the Design, Conduct, and Interpretation of
Clinical Trials. Clin J Am Soc Nephrol 1: 1360–1367, 2006
• Kenneth F Schulz, David A Grimes. Blinding in randomised trials: hiding who
got what. THE LANCET 2002 ,359:2
• ICH E8 ,9,10 guidelines : general consideration for clinical trials, current
step 4 version, 1997
6-Apr-22
Research Study Designs 65