This document provides an overview of key aspects of clinical research papers, including their typical structure and components. It outlines the main sections such as the title, abstract, introduction, methods, results, discussion, and references. It also describes important considerations for study design, including defining the study population and ensuring internal and external validity. Common study designs like randomized controlled trials and how to properly implement randomization and blinding are covered.
This document provides an introduction to evidence-based medicine (EBM) and principles of critical appraisal for first year psychiatry residents. It defines EBM as a systematic approach to obtaining clinically relevant information about treatment. Critical appraisal involves carefully examining research to assess validity, results, and relevance. The document outlines the five steps of EBM, different study designs commonly used in EBM like randomized controlled trials and systematic reviews, and factors to consider when critically appraising research like potential biases. Key aspects of randomized trials and systematic reviews are described, along with guidelines to standardize research reporting.
A Graduate Critical Appraisal Assignment for Athletic TrainingJohn Parsons
1) The document discusses a graduated critical appraisal assignment used to teach athletic training students how to critically analyze research studies. 2) It involves having students start with annotating articles and working up to crafting clinical questions, analyzing levels of evidence, and fully critically appraising studies. 3) The assignment is meant to help students develop skills in evidence-based practice and preparing them for real-world clinical decision making.
This document provides an introduction to critical appraisal of research evidence. It discusses the importance of critically appraising research in order to determine the validity, relevance and applicability of findings to clinical practice. Both quantitative and qualitative research methodologies are covered. Key steps in critically appraising systematic reviews, randomized controlled trials and qualitative research studies are outlined. These include assessing the appropriateness of the research question, methodology, analysis and applicability of results. Conducting effective critical appraisal workshops is also addressed.
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 introduction to critical appraisal. It defines critical appraisal as systematically weighing the quality and relevance of research to inform decision making. The document outlines different types of research studies including systematic reviews, randomized controlled trials, cohort studies, and case-control studies. It discusses how to critically appraise studies by assessing their validity, results, and relevance. Key aspects of appraising randomized controlled trials are described such as randomization, blinding, accounting for all participants, and interpreting results including p-values and confidence intervals. The goal is to help readers gain skills to critically evaluate research.
How to scientifically conduct a clinical professional research trial? In the current era of Collaborate or parish, we need to keep this design in our mind.
Enjoy
@copyLeft
This document summarizes a lecture on medical literature, including the basic purpose of research, common study designs, tools for reviewing studies, and principles of writing research manuscripts. The lecture covers estimating the truth, variability in perceptions of research findings, evolving nature of research, basic study designs like randomized trials and observational studies, analytical aspects like measures of association and issues with numerical approaches, standards for assessing research quality like CONSORT and STROBE, and considerations for writing manuscripts like clinical relevance and brevity. An example randomized controlled trial on spironolactone is presented and discussed.
This document provides an introduction to evidence-based medicine (EBM) and principles of critical appraisal for first year psychiatry residents. It defines EBM as a systematic approach to obtaining clinically relevant information about treatment. Critical appraisal involves carefully examining research to assess validity, results, and relevance. The document outlines the five steps of EBM, different study designs commonly used in EBM like randomized controlled trials and systematic reviews, and factors to consider when critically appraising research like potential biases. Key aspects of randomized trials and systematic reviews are described, along with guidelines to standardize research reporting.
A Graduate Critical Appraisal Assignment for Athletic TrainingJohn Parsons
1) The document discusses a graduated critical appraisal assignment used to teach athletic training students how to critically analyze research studies. 2) It involves having students start with annotating articles and working up to crafting clinical questions, analyzing levels of evidence, and fully critically appraising studies. 3) The assignment is meant to help students develop skills in evidence-based practice and preparing them for real-world clinical decision making.
This document provides an introduction to critical appraisal of research evidence. It discusses the importance of critically appraising research in order to determine the validity, relevance and applicability of findings to clinical practice. Both quantitative and qualitative research methodologies are covered. Key steps in critically appraising systematic reviews, randomized controlled trials and qualitative research studies are outlined. These include assessing the appropriateness of the research question, methodology, analysis and applicability of results. Conducting effective critical appraisal workshops is also addressed.
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 introduction to critical appraisal. It defines critical appraisal as systematically weighing the quality and relevance of research to inform decision making. The document outlines different types of research studies including systematic reviews, randomized controlled trials, cohort studies, and case-control studies. It discusses how to critically appraise studies by assessing their validity, results, and relevance. Key aspects of appraising randomized controlled trials are described such as randomization, blinding, accounting for all participants, and interpreting results including p-values and confidence intervals. The goal is to help readers gain skills to critically evaluate research.
How to scientifically conduct a clinical professional research trial? In the current era of Collaborate or parish, we need to keep this design in our mind.
Enjoy
@copyLeft
This document summarizes a lecture on medical literature, including the basic purpose of research, common study designs, tools for reviewing studies, and principles of writing research manuscripts. The lecture covers estimating the truth, variability in perceptions of research findings, evolving nature of research, basic study designs like randomized trials and observational studies, analytical aspects like measures of association and issues with numerical approaches, standards for assessing research quality like CONSORT and STROBE, and considerations for writing manuscripts like clinical relevance and brevity. An example randomized controlled trial on spironolactone is presented and discussed.
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.
Research Methods 2 Critical Appraisal Of Literatureguest0aeecb
This document discusses how to critically appraise literature to inform clinical decision making. It introduces evidence-based medicine as using clinical experience alongside the best available research evidence. It provides guidelines for appraising studies on therapeutic interventions and diagnostic tests, including assessing relevance, validity, results, and applicability. Key aspects include determining if the study design, population, and outcomes match the clinical question, and evaluating the randomization, blinding, analysis, and reliability of results. The goal is to identify the most valid and applicable evidence to resolve a specific clinical dilemma.
The document outlines an agenda for a critical appraisal master class that will cover evidence-based medicine principles, critical appraisal of different study types including clinical studies, lab research, and qualitative work. It provides an introduction to the presenters and an outline of topics to be discussed including evidence-based medicine, critical appraisal keys of validity, applicability and impact. Case studies will also be used to demonstrate how to approach appraising a research paper.
Quantitative critical appraisal october 2015Isla Kuhn
This document provides an introduction to critical appraisal of research articles. It explains that critical appraisal assesses the validity, results, and relevance of studies. Key aspects include evaluating study design, interpreting basic statistics and event rates, and determining applicability of results. Ready-made checklists can help appraise different types of research studies. Understanding concepts like confidence intervals, p-values, and risk ratios is important for interpretation. Practice is needed to develop critical appraisal skills.
Critically appraise evidence based findingsBarryCRNA
The document discusses critical appraisal of evidence-based findings. It defines critical appraisal as assessing the strength and quality of scientific evidence to evaluate its applicability to healthcare decision making. Strength of evidence depends on factors like quality, quantity, and consistency of research. Evidence is ranked in levels based on research design, with systematic reviews and randomized controlled trials having the highest levels of evidence. Evaluating the quality and applicability of evidence involves assessing the validity of results and whether results can be applied to target populations. Statistical evaluation through effect sizes can also aid in appraising evidence.
This document provides an overview of randomized controlled trials (RCTs). It defines RCTs as studies that compare two interventions by randomly assigning participants into groups. The key aspects covered include the importance of randomization for minimizing bias, common types of bias in RCTs, techniques for randomization, and ethical considerations. RCTs are considered the gold standard for inferring causality between an intervention and outcomes.
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.
This document provides an introduction to critical appraisal of literature. It discusses the importance of critically evaluating research to separate reliable evidence from unreliable evidence. It outlines the process of critical appraisal, including asking a focused question, finding relevant evidence, and using appraisal tools to systematically examine research quality, validity, and relevance. The document also introduces some key statistical concepts used in research, such as p-values, confidence intervals, risk reduction, and number needed to treat. The goal of critical appraisal is to make informed decisions about integrating research findings into clinical practice and policy.
This document discusses evidence-based medicine and how libraries can support practitioners. It defines evidence-based medicine as using the best available evidence from research to inform decisions about patient care. The library teaches skills like formulating clinical questions using the PICO framework and identifying appropriate sources and studies to answer questions. Librarians can help practitioners develop search strategies, appraise literature, and apply evidence to patient cases. The document provides examples of using PICO to build clinical questions from practice scenarios.
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.
Critical appraisal is the process of carefully and systematically analyze the research paper to judge its trustworthiness, its value and relevance in a particular context. (Amanda Burls 2009)
A critical review must identify the strengths and limitations in a research paper and this should be carried out in a systematic manner.
The Critical Appraisal helps in developing the necessary skills to make sense of scientific evidence, based on validity, results and relevance.
This document discusses assessing risk of bias during systematic reviews. It defines bias as systematic error that deviates from the truth and can lead to over or underestimating effects. Assessing bias in included studies is important because results may be consistent due to flaws. There are seven domains for assessing bias: selection, performance, detection, attrition, reporting, and other biases. Risk of bias is assessed by reviewing study methods, looking for missing information, and making judgments on pre-specified criteria about the likelihood studies were affected by bias in each domain. Tools like risk of bias tables are used to categorize judgments of low, high, or unclear risk of bias in individual studies.
The document provides guidance on how to critique scientific articles. It discusses evaluating the study design, methodology, population, interventions, outcomes, and statistics. Key aspects to examine include the randomization and blinding methods, comparison groups, sample sizes, narrowness of focus, and appropriate application of statistical tests. The goal is to determine if the evidence presented is sufficient to accept the study's conclusions by considering factors like biases, generalizability, and clinical significance of any findings.
This document provides an overview of research methods and biostatistics. It defines key terms like research, research methods, and statistical analysis. It describes different types of study designs including descriptive studies, analytical studies, experimental studies, and epidemiological study designs. It outlines the characteristics of observational studies like cross-sectional and case-control studies as well as experimental studies. It also discusses appropriate statistical tests to analyze different types of data and research problems. Finally, it lists some online resources and computer software that can be used in statistical analysis.
This document provides an overview of experimental study design. It defines experimental studies as those where the investigator actively attempts to modify a dependent variable by introducing an intervention. It describes different types of experimental studies including clinical trials, field trials, and community trials. It then outlines the typical steps in a clinical trial, including deciding on the trial, forming research questions and hypotheses, defining and selecting the study population, determining inclusion/exclusion criteria, calculating sample size, enrolling and randomly allocating participants, implementing the regimen, measuring variables, following up on outcomes, analyzing results, and reporting findings. Finally, it briefly discusses phases of clinical trials and some variants like cross-over and factorial designs.
How to formulate a researchable question based on picos - PubricaPubrica
Unanswered questions in current clinical practice and interactions dictating alternate treatments will lead to the formulation of a clinical research question. It would help researchers by giving them step-by-step instructions about how to formulate a research question.
Continue Reading: https://bit.ly/3ldryTV
For our services: https://pubrica.com/sevices/research-services/
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When you order our services, We promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Biostatistical experts | High-quality Subject Matter Experts.
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This document provides an overview of evidence-informed decision making and critical appraisal for nursing practice. It defines evidence-informed decision making and its importance for nursing. It also outlines the steps of evidence-informed decision making including formulating a focused, answerable question using PICO/PICOT, searching for and collecting the best evidence, and critically appraising the literature. Criteria for critically appraising different study designs are discussed, including intervention studies. The importance of critical appraisal for nursing practice, policy, and research is emphasized.
This document discusses the importance of keeping up to date with medical literature for physicians. It notes that over 10,000 new articles are published per week, making it impossible for doctors to read everything. The document then provides guidance on critically evaluating medical literature, including understanding study designs and assessing validity, results, and applicability. It emphasizes applying a systematic approach to identify relevant information and avoid bias. Specific guidance is provided on appraising different study types, such as randomized trials, diagnostic tests, systematic reviews, cohort studies, and case-control studies.
Critical appraisal is the process of carefully examining research to judge its validity, relevance, and applicability. It is important to ensure research findings are valid and applicable to one's own population before incorporating them into clinical practice. While research is peer-reviewed, critical appraisal is still needed to avoid misinterpreting results. When critically appraising research, one should examine aspects like the research question, methodology, results, discussion and conclusions to determine the overall quality and implications. Checklists exist to standardize the critical appraisal of different study designs.
1) The document summarizes key aspects of evaluating clinical trials, including types of trials and potential biases.
2) Clinical trials aim to test interventions in a controlled manner to determine safety and effectiveness. Randomized controlled trials (RCTs) are considered the gold standard for limiting biases.
3) However, biases can still influence trials in many ways, such as through selection of participants, administration of interventions, measurement of outcomes, and reporting/publication of results. It is important to critically appraise trials to assess risk of biases.
Introduction to Evidence Based Medicine (EBM)Elsayed Salih
This document provides an overview of evidence-based medicine (EBM), including its definition, importance, and process. It defines EBM as the conscientious use of the best available evidence in making decisions about patient care. The key steps in EBM are asking a clear clinical question using the PICO framework, acquiring evidence through a literature search, appraising the evidence for validity and applicability, and applying the evidence to the individual patient. Examples of question types and appropriate study designs are also discussed.
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.
Research Methods 2 Critical Appraisal Of Literatureguest0aeecb
This document discusses how to critically appraise literature to inform clinical decision making. It introduces evidence-based medicine as using clinical experience alongside the best available research evidence. It provides guidelines for appraising studies on therapeutic interventions and diagnostic tests, including assessing relevance, validity, results, and applicability. Key aspects include determining if the study design, population, and outcomes match the clinical question, and evaluating the randomization, blinding, analysis, and reliability of results. The goal is to identify the most valid and applicable evidence to resolve a specific clinical dilemma.
The document outlines an agenda for a critical appraisal master class that will cover evidence-based medicine principles, critical appraisal of different study types including clinical studies, lab research, and qualitative work. It provides an introduction to the presenters and an outline of topics to be discussed including evidence-based medicine, critical appraisal keys of validity, applicability and impact. Case studies will also be used to demonstrate how to approach appraising a research paper.
Quantitative critical appraisal october 2015Isla Kuhn
This document provides an introduction to critical appraisal of research articles. It explains that critical appraisal assesses the validity, results, and relevance of studies. Key aspects include evaluating study design, interpreting basic statistics and event rates, and determining applicability of results. Ready-made checklists can help appraise different types of research studies. Understanding concepts like confidence intervals, p-values, and risk ratios is important for interpretation. Practice is needed to develop critical appraisal skills.
Critically appraise evidence based findingsBarryCRNA
The document discusses critical appraisal of evidence-based findings. It defines critical appraisal as assessing the strength and quality of scientific evidence to evaluate its applicability to healthcare decision making. Strength of evidence depends on factors like quality, quantity, and consistency of research. Evidence is ranked in levels based on research design, with systematic reviews and randomized controlled trials having the highest levels of evidence. Evaluating the quality and applicability of evidence involves assessing the validity of results and whether results can be applied to target populations. Statistical evaluation through effect sizes can also aid in appraising evidence.
This document provides an overview of randomized controlled trials (RCTs). It defines RCTs as studies that compare two interventions by randomly assigning participants into groups. The key aspects covered include the importance of randomization for minimizing bias, common types of bias in RCTs, techniques for randomization, and ethical considerations. RCTs are considered the gold standard for inferring causality between an intervention and outcomes.
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.
This document provides an introduction to critical appraisal of literature. It discusses the importance of critically evaluating research to separate reliable evidence from unreliable evidence. It outlines the process of critical appraisal, including asking a focused question, finding relevant evidence, and using appraisal tools to systematically examine research quality, validity, and relevance. The document also introduces some key statistical concepts used in research, such as p-values, confidence intervals, risk reduction, and number needed to treat. The goal of critical appraisal is to make informed decisions about integrating research findings into clinical practice and policy.
This document discusses evidence-based medicine and how libraries can support practitioners. It defines evidence-based medicine as using the best available evidence from research to inform decisions about patient care. The library teaches skills like formulating clinical questions using the PICO framework and identifying appropriate sources and studies to answer questions. Librarians can help practitioners develop search strategies, appraise literature, and apply evidence to patient cases. The document provides examples of using PICO to build clinical questions from practice scenarios.
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.
Critical appraisal is the process of carefully and systematically analyze the research paper to judge its trustworthiness, its value and relevance in a particular context. (Amanda Burls 2009)
A critical review must identify the strengths and limitations in a research paper and this should be carried out in a systematic manner.
The Critical Appraisal helps in developing the necessary skills to make sense of scientific evidence, based on validity, results and relevance.
This document discusses assessing risk of bias during systematic reviews. It defines bias as systematic error that deviates from the truth and can lead to over or underestimating effects. Assessing bias in included studies is important because results may be consistent due to flaws. There are seven domains for assessing bias: selection, performance, detection, attrition, reporting, and other biases. Risk of bias is assessed by reviewing study methods, looking for missing information, and making judgments on pre-specified criteria about the likelihood studies were affected by bias in each domain. Tools like risk of bias tables are used to categorize judgments of low, high, or unclear risk of bias in individual studies.
The document provides guidance on how to critique scientific articles. It discusses evaluating the study design, methodology, population, interventions, outcomes, and statistics. Key aspects to examine include the randomization and blinding methods, comparison groups, sample sizes, narrowness of focus, and appropriate application of statistical tests. The goal is to determine if the evidence presented is sufficient to accept the study's conclusions by considering factors like biases, generalizability, and clinical significance of any findings.
This document provides an overview of research methods and biostatistics. It defines key terms like research, research methods, and statistical analysis. It describes different types of study designs including descriptive studies, analytical studies, experimental studies, and epidemiological study designs. It outlines the characteristics of observational studies like cross-sectional and case-control studies as well as experimental studies. It also discusses appropriate statistical tests to analyze different types of data and research problems. Finally, it lists some online resources and computer software that can be used in statistical analysis.
This document provides an overview of experimental study design. It defines experimental studies as those where the investigator actively attempts to modify a dependent variable by introducing an intervention. It describes different types of experimental studies including clinical trials, field trials, and community trials. It then outlines the typical steps in a clinical trial, including deciding on the trial, forming research questions and hypotheses, defining and selecting the study population, determining inclusion/exclusion criteria, calculating sample size, enrolling and randomly allocating participants, implementing the regimen, measuring variables, following up on outcomes, analyzing results, and reporting findings. Finally, it briefly discusses phases of clinical trials and some variants like cross-over and factorial designs.
How to formulate a researchable question based on picos - PubricaPubrica
Unanswered questions in current clinical practice and interactions dictating alternate treatments will lead to the formulation of a clinical research question. It would help researchers by giving them step-by-step instructions about how to formulate a research question.
Continue Reading: https://bit.ly/3ldryTV
For our services: https://pubrica.com/sevices/research-services/
Why Pubrica:
When you order our services, We promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Biostatistical experts | High-quality Subject Matter Experts.
Contact us:
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44-1618186353
This document provides an overview of evidence-informed decision making and critical appraisal for nursing practice. It defines evidence-informed decision making and its importance for nursing. It also outlines the steps of evidence-informed decision making including formulating a focused, answerable question using PICO/PICOT, searching for and collecting the best evidence, and critically appraising the literature. Criteria for critically appraising different study designs are discussed, including intervention studies. The importance of critical appraisal for nursing practice, policy, and research is emphasized.
This document discusses the importance of keeping up to date with medical literature for physicians. It notes that over 10,000 new articles are published per week, making it impossible for doctors to read everything. The document then provides guidance on critically evaluating medical literature, including understanding study designs and assessing validity, results, and applicability. It emphasizes applying a systematic approach to identify relevant information and avoid bias. Specific guidance is provided on appraising different study types, such as randomized trials, diagnostic tests, systematic reviews, cohort studies, and case-control studies.
Critical appraisal is the process of carefully examining research to judge its validity, relevance, and applicability. It is important to ensure research findings are valid and applicable to one's own population before incorporating them into clinical practice. While research is peer-reviewed, critical appraisal is still needed to avoid misinterpreting results. When critically appraising research, one should examine aspects like the research question, methodology, results, discussion and conclusions to determine the overall quality and implications. Checklists exist to standardize the critical appraisal of different study designs.
1) The document summarizes key aspects of evaluating clinical trials, including types of trials and potential biases.
2) Clinical trials aim to test interventions in a controlled manner to determine safety and effectiveness. Randomized controlled trials (RCTs) are considered the gold standard for limiting biases.
3) However, biases can still influence trials in many ways, such as through selection of participants, administration of interventions, measurement of outcomes, and reporting/publication of results. It is important to critically appraise trials to assess risk of biases.
Introduction to Evidence Based Medicine (EBM)Elsayed Salih
This document provides an overview of evidence-based medicine (EBM), including its definition, importance, and process. It defines EBM as the conscientious use of the best available evidence in making decisions about patient care. The key steps in EBM are asking a clear clinical question using the PICO framework, acquiring evidence through a literature search, appraising the evidence for validity and applicability, and applying the evidence to the individual patient. Examples of question types and appropriate study designs are also discussed.
This document outlines the steps for critically appraising a research article on prognosis using the Sudan Evidence-Based Medicine Association template. It includes developing a well-built clinical question using PICO (Patient, Intervention, Comparison, Outcome), outlining the current knowledge and selecting a research article to appraise. Key steps are summarizing the article, assessing validity and applying an appraisal scheme to evaluate relevance, validity, results and applicability of the research. The template provides guidance on critically evaluating different aspects of the study to determine the strength and potential limitations.
Periodontal Research: Basics and beyond – Part II (Ethical issues, sampling, ...naseemashraf2
This document summarizes key ethical and methodological considerations in periodontal research. It discusses issues like obtaining informed consent, maintaining participant confidentiality, and having research approved by an ethics committee. It also covers topics like study design, sampling methods, bias, outcome measures, and evaluating diagnostic tests. Proper planning of these elements is important for generating meaningful, valid and ethical study results.
This document summarizes the key aspects of evaluating clinical trials. In 3 sentences:
Clinical trials aim to determine if new treatments are safe and effective by testing them on people after promising laboratory and animal studies. Different types of clinical trials exist, from uncontrolled to randomized controlled trials, with RCTs being the gold standard as they randomly assign participants to interventions to reduce bias. Properly evaluating trials involves assessing their design, limitations, and results to determine the risk of bias and whether the trial's conclusions are valid and applicable to a specific patient.
Bias in research can occur at any stage from study design to publication. There are several types of bias including selection bias, information bias, and confounding bias. Selection bias occurs when the study sample is not representative of the target population. Information bias results from errors in measuring or classifying exposure and outcome variables. Confounding bias is introduced when a third variable is associated with both the exposure and outcome. Researchers should employ techniques like randomization, matching, and restriction to minimize bias.
This document outlines the key steps in conducting a clinical trial:
1. Drawing up a detailed research protocol that serves as the trial's operating manual.
2. Selecting and screening participants according to eligibility criteria to identify the study population. Sample size is also calculated.
3. Randomly allocating the study participants into experimental and control groups through a process like randomization to reduce bias.
This document provides an overview of clinical trials. It defines a clinical trial and explains that they are conducted under controlled conditions to evaluate potential therapies. It describes the different phases of clinical trials from early safety testing to post-marketing studies. Key aspects of clinical trial design are discussed, including randomization, blinding, controls and study populations. Reasons for terminating a trial early are also mentioned.
This document discusses cohort studies. A cohort study compares outcomes between groups that differ in their exposure to a risk factor. It involves selecting groups of individuals, measuring their exposure to a risk factor, observing them for a defined outcome, and analyzing any association. The key elements are defining the study question, selecting and measuring exposure in study populations, following up to ascertain outcomes, and analyzing results like incidence rates and relative risks. Cohort studies provide strong evidence but require large sample sizes and long follow-up periods.
This document summarizes a journal club presentation about critically appraising papers on dental therapy. It discusses key questions to consider when evaluating randomized controlled trials and systematic reviews relating to new therapeutic interventions. These include whether patient allocation was randomized, all patients were accounted for, blinding was used, groups were similar at outset, clinically important outcomes were assessed, and results can be applied to patients. It also reviews criteria for assessing systematic reviews, such as whether a clear question was asked, inclusion criteria were appropriate, search was comprehensive, study validity was evaluated, and findings were combined correctly.
Research design involves decisions about how to collect and analyze data to answer research questions or solve problems. There are two main types of research design: observational studies and experimental studies. Observational studies observe naturally occurring events without intervention, while experimental studies involve deliberate human intervention to change the course of events. Common research designs include descriptive studies, analytical studies, case-control studies, cohort studies, cross-sectional studies, and randomized controlled trials. Research design aims to ensure valid, unbiased conclusions through careful planning of study type, variables, data collection, and statistical analysis.
The document discusses randomized controlled trials (RCTs), which are considered the gold standard for evaluating causal relationships. It describes key aspects of RCTs such as randomization methods, blinding, allocation concealment, study populations, interventions, follow-up, and outcome assessment. RCTs follow a strict protocol and involve randomly allocating participants into study and control groups to receive different interventions/exposures. The results are then compared to determine the effectiveness of the new treatment or exposure being tested.
critical evaluation of di literature.pptxDrpradeepthi
This document provides an overview of how to evaluate clinical drug studies and literature. It discusses the importance of literature evaluation skills for pharmacists. Key aspects of study methodology that should be evaluated include the journal, investigators, study design, inclusion/exclusion criteria, sample size, controls, outcomes measured, randomization, and blinding. Proper evaluation of studies allows pharmacists to determine which drug therapies have evidence to support improvements in patient care.
Comparing research designs fw 2013 handout versionPat Barlow
This is an updated version of my Comparing Research Designs lecture, which now includes discussions on: (1) common considerations with research design such as bias, reliability, validity, and confounding; and (2) expanded discussion of RCT designs including factorial and cross-over designs.
This document provides an overview of evidence-based medicine (EBM). It defines EBM as integrating the best available research evidence with clinical expertise and patient values. It notes that the amount of medical evidence is increasing exponentially, making it difficult for physicians to keep up-to-date. The document outlines the 5 steps of EBM practice and emphasizes the importance of critically appraising evidence for validity, importance, and applicability to patients. It also discusses assessing the levels, strength, and quality of evidence to determine the strength of recommendations for clinical practice guidelines.
The document discusses designing population-based surveys. It provides examples of research questions for analytic and descriptive studies. It emphasizes that research questions should address what the investigator wants to know about the study population. The document also discusses defining the target population, accessible population, and study population using inclusion and exclusion criteria. It compares different sampling strategies such as simple random sampling, stratified random sampling, and cluster sampling.
1. The document discusses various types of medical research designs including observational and experimental studies.
2. Observational studies are divided into descriptive studies which aim to describe health problems without comparisons, and analytical studies which aim to identify associations between exposures and outcomes.
3. Experimental research designs involve assigning subjects to treatment or control groups randomly to evaluate new interventions while controlling for confounding factors. Randomized controlled trials are considered the gold standard for evaluating new treatments.
This document provides an overview of evidence-based medicine (EBM). It defines EBM as integrating the best available research evidence with clinical expertise and patient values. The key steps of EBM are outlined as formulating a clinical question using PICO (population, intervention, comparison, outcome), searching for evidence, appraising research studies, and applying the evidence to clinical problems. Study designs such as randomized controlled trials and systematic reviews are discussed. Methods for critically appraising studies including assessing validity and determining the clinical importance of results are also summarized.
1) The document discusses a lecture on evidence-based medicine (EBM) and critical appraisal.
2) EBM involves integrating the best available research evidence with clinical expertise and patient values. It includes formulating clinical questions, searching for evidence, appraising research, and applying the evidence to patient care.
3) The lecture reviews the principles of EBM and critical appraisal, including how to formulate answerable clinical questions using the PICO framework, search for evidence, and appraise different types of research studies.
This document provides an overview of diffuse parenchymal lung disease (DPLD) and idiopathic interstitial pneumonias (IIPs). It discusses the classification of IIPs including idiopathic pulmonary fibrosis (IPF), nonspecific interstitial pneumonia (NSIP), respiratory bronchiolitis-associated interstitial lung disease (RB-ILD), and others. It also covers the clinical presentation, diagnostic approach involving history, physical exam, pulmonary function tests, radiological findings on high-resolution CT, and role of bronchoscopy with bronchoalveolar lavage in evaluating these conditions. Key points like reduced diffusing capacity on pulmonary function tests and honeycombing on imaging in IPF
This document provides an overview of scientific writing and research proposals. It discusses types of scientific publications such as journal articles, books, and conference posters. It emphasizes using clear, precise language and proper structure for scientific papers, including titles, introductions, methods, results, and references sections. The document also outlines the key elements of a good research proposal, such as stating the problem, reviewing previous literature, describing the methodology, presenting a timeline and budget, and listing references. Researchers are advised to write proposals that are coherent, informative, and clearly structured to convince readers of the significance and merit of the proposed research.
This document discusses novel treatment options for asthma, focusing on biologic-based targeted therapies. It summarizes the four approved type-2 targeted biologic therapies that target IL-5 and IgE, as well as IL-4 and IL-13. These target key pathways involved in type-2 inflammation like eosinophil recruitment and activation. Emerging therapies also target other inflammatory pathways like IL-17. Characterization of inflammatory biomarkers and phenotypes helps identify patients that may benefit most from specific targeted therapies.
This document provides information on diffuse parenchymal lung disease (DPLD) and idiopathic interstitial pneumonias (IIPs). It begins with an overview of common IIPs including idiopathic pulmonary fibrosis (IPF), other IIPs, familial IIP, IIP with autoimmune features, and smoking-related ILDs. It then discusses diagnosing other ILDs through clinical, radiological findings and management approaches. Specific ILDs covered include CTD-associated ILDs, diffuse cystic lung diseases like lymphangioleiomyomatosis, pulmonary Langerhans cell histiocytosis, pulmonary alveolar proteinosis, and diffuse alveolar damage
1. The document provides an overview of evidence-based medicine (EBM) and the process of critically appraising research evidence. EBM involves integrating the best available research evidence with clinical expertise and patient values and preferences.
2. The key steps of EBM are outlined, including formulating a clear clinical question using PICO (population, intervention, comparison, outcome), searching for and appraising the evidence, and applying the results to the clinical problem.
3. Users' guides are provided for critically appraising different study designs, focusing on whether the results are valid and assessing the magnitude and precision of the treatment effect. Factors like randomization, blinding, follow-up, and equal treatment of groups
1. Transbronchial biopsy is the least invasive approach to obtain a histologic diagnosis for a 60-year-old man with shortness of breath, a history of smoking, and basilar crackles. Objective parameters like 6MWT, DLCO, FVC, and HRCT can assess progression of the disease. Lung transplantation is the best curative treatment.
2. A 50-year-old current smoker with shortness of breath and cough showing findings on HRCT and PFTs would be diagnosed with RB-ILD based on surgical lung biopsy findings.
3. A 40-year-old man with rapid deterioration and bilateral infiltrates on CXR would be diagnosed with acute eosin
Pneumonia can be categorized as community-acquired pneumonia (CAP), healthcare-associated pneumonia (HCAP), hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP). HCAP refers to patients who received recent healthcare but did not stay overnight in the hospital. CAP occurs in people acquired in the community with an annual rate of 5.16 to 6.11 cases per 1000 persons increasing with age. Streptococcus pneumoniae is the most common worldwide cause of CAP. Pneumonia pathogens can be typical bacteria like S. pneumoniae or atypical organisms such as Legionella spp, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
This study analyzed 29 cases of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Saudi Arabia from March to May 2014. Most cases were male Saudi nationals over age 40. Common symptoms were fever, cough and shortness of breath. Patients had abnormal chest imaging and laboratory abnormalities including low white blood cell count. Ten patients (34%) died, generally being older, male smokers with more severe symptoms and worse laboratory and blood gas values. MERS-CoV disproportionately affected health care workers through close contact with infected patients.
Based on the information provided:
- The patient has a UIP pattern on HRCT consistent with IPF.
- His occupational exposure to asbestos 35 years ago could be contributing to the fibrosis.
- His rheumatoid arthritis is seronegative so unlikely the cause.
- A multidisciplinary discussion including review of HRCT, pulmonary function tests and clinical history is needed to determine if he meets criteria for a confident diagnosis of IPF. Given his occupational exposure, other ILDs need to be considered or excluded as well.
The CT scan shows bilateral, basal-predominant reticular opacities and honeycombing. Given the patient's history of asbestos exposure, though brief, the radiological findings are most consistent with a diagnosis of asbestosis. Asbestosis is the correct answer.
This document provides a summary of an presentation on approaches to interstitial lung disease (ILD) and updates in idiopathic pulmonary fibrosis (IPF) management. It begins with an introduction to ILDs and the pulmonary interstitium. It then covers the pathogenesis, classification, epidemiology, clinical assessment including history, exams, tests and tissue sampling, and radiological and pathological findings of ILDs. A significant portion discusses IPF specifically, including prognosis, guidelines for diagnosis, and medical therapies including pirfenidone and nintedanib which have been shown to reduce lung function decline in clinical trials. It concludes with experience using pirfenidone in Saudi Arabia.
Neuromuscular Disorders Respiratory Complications and AssessmentNahid Sherbini
This document discusses respiratory complications and management in patients with neuromuscular disorders. Key points:
- Duchenne muscular dystrophy is the most common childhood muscular dystrophy, causing progressive muscle weakness.
- Respiratory muscle weakness can occur independently of peripheral muscle weakness and should be evaluated through tests like PFTs, MIP, MEP, and cough assessment.
- Non-invasive ventilation may benefit those requiring short term or intermittent support, while invasive ventilation is preferred for acute respiratory failure due to risks of NPPV. Proper respiratory management can extend lifespans.
Hemoptysis is defined as the spitting of blood from the lungs or bronchial tubes. It can be classified based on severity from mild to massive. Common causes include infections like tuberculosis, cancers, vascular abnormalities and vasculitis. Initial management focuses on airway protection, oxygenation and circulation. Bronchoscopy helps identify the bleeding site and allows local measures like lavage, vasoconstrictors and tamponade. For persistent or massive bleeding, bronchial artery embolization or surgery may be needed. Precise localization through CT and arteriography guides definitive treatment.
The national lung screening trial /Nahid SherbiniNahid Sherbini
The National Lung Screening Trial (NLST) compared low-dose CT screening to chest x-ray (CXR) screening for lung cancer in high-risk individuals. Over 53,000 participants were randomized to receive either low-dose CT or CXR screening annually for three years. The primary endpoint was lung cancer mortality. An interim analysis found that low-dose CT screening reduced lung cancer mortality by 20% compared to CXR, with fewer advanced stage cancers detected in the CT group. However, the false positive rate was high at around 95% for both screening methods.
Evaluation of preoperative pulmonary risk By Nahid SherbiniNahid Sherbini
- Pulmonary complications are a major cause of postoperative morbidity and mortality. The risk depends on patient-related factors like age, smoking history, COPD, asthma, obesity, sleep apnea, and heart failure as well as procedure-related factors like the surgical site and duration of anesthesia.
- A thorough preoperative evaluation involves reviewing the patient's history, performing a physical exam, and testing like arterial blood gases, chest x-ray, and pulmonary function tests to determine their risk level. Assigning a risk level helps guide risk reduction strategies in high risk patients.
- Pulmonary complications are a major cause of postoperative morbidity and mortality. The risk depends on patient-related factors like age, smoking history, COPD, asthma, obesity, sleep apnea, and heart failure as well as procedure-related factors like the surgical site and duration of anesthesia.
- A thorough preoperative evaluation involves reviewing the patient's history, performing a physical exam, and testing like arterial blood gases, chest x-ray, and pulmonary function tests to determine their risk level. Assigning a risk level helps guide risk reduction strategies in high risk patients.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
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Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
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Our backs are like superheroes, holding us up and helping us move around. But sometimes, even superheroes can get hurt. That’s where slip discs come in.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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Muscles of Mastication by Dr. Rabia Inam Gandapore.pptx
Reading an article
1. Dr Nahid Sherbini
Consultant Internist & Pulmonologist
Certified from Harvard Medical School in Practice of Clinical
Research
2. Outlines
Contents of a research paper
BASICS OF CLINICAL RESEARCH ARTICLE
• Introduction to Clinical Trials
• Study Questions
• Study Population
• Basic Study Design
• Study Blinding
• The Randomization Process
• Recruitment of Study Participants
BASIC STATISTICS
3. • Title
• Author’s name and affiliation
(Byline)
• Abstract
• Keywords
• Introduction
• Literature review
• Method
• Results
• Discussion
• Conclusion
• References
• Acknowledgements
• Biographical sketch
• Appendices
3
4. Clear and explanatory title
An incomplete sentence
Brief and concise
4
5. Miniature of the text
150 to 200 words
Paragraph or structured
Descriptive or informative
Complete concise sentences
Contents of Abstracts:
Purpose or scope of the paper
Methods
Results, conclusions and recommendations
6
6. Identifies subject area of interest
States the purpose and hypothesis of the study
Provides a statement of the rationale for approach to the problem
studied.
8
7. Establishes context of the study by providing a brief and balanced
review of pertinent published literature available on subject.
General to specific
Name-date citations
9
8. Study design
Participants and their characteristics
When and where study conducted
Sampling method and size
Variables measured
Method of collecting data
How data analyzed: Statistical procedures used
10
9. Objective presentation of key findings without interpretation
Orderly, logical sequence using text and illustrations (figures/tables)
11
10. Answers questions posed in introduction
Interprets results in comparison to what is already known on the subject.
Explains new understanding of the subject based on present results
It tells the readers how present study moved from what was known to
what is new
Outlines limitations of the study
Discusses ideas for future research
12
12. Complete citations for research cited
References are listed in alphabetical order by the first author’s last name
Citations according to style manual, e.g., APA, MLA, Chicago, etc.
14
13. Included as needed
Significant help in thinking, designing, implementing, materials supplied
etc.
Funding agency.
15
15. Phase I
Normal Volunteers
Safety
Dose-Kinetics
Action
Phase II
Patients
Evidence of Activity
Dose
Phase III
Phase IV
Post marketing
Expanded Indications
Safety Studies
16. Phase I
12 - 18 months, 200 volunteers
Phase II
1.5 – 2.5 years, 300 - 500 patients
Phase III and beyond
3 – 4 years, 2000 – 3000 patients
17. Who
Normal physiology
Pathophysiology: rare/severe versus common/complex
What
Observational: retrospective or prospective
Interventional: better
Study Questions
18. Primary question
Most relevant question; sample size
Secondary questions
Can help to clarify the primary question
“Exploratory” or “hypothesis generating”
Insufficient statistical power
Multiple comparisons penalties (type I error)
Ancillary questions
A sub-study within the primary study
Limited generalizability
Study Questions
19. Dependent: outcome
Independent: intervention, predictor
Covariate: may influence the relationship between dependent and independent
variables
Surrogate: more “accessible” outcome, feasible, safe, cost-permissive
Research variables:
22. POPULATION:
Target population: the group of individuals you want to
study
Accessible population: sub-set of individuals that are
available
Study population: included in the study, your sample
Ideally all should have equal characteristics
Study Population
24. Validity
INTERNAL VALIDITY:
Observed results are unbiased estimates of
the relationship between exposure and
outcome
Threats: confounding and bias (e.g. selection
bias, recall bias, detection bias)
May be affected by randomization, allocation
concealment, blinding , study population
25. EXTERNAL VALIDITY:
Unbiased estimate of the relationship between
exposure and outcome in the target population
Generalizability of your findings
Population from you draw your sample
(accessible population) is representative of the
target population
Threats: sampling bias, strict inclusion criteria
Internal validity has to be guaranteed
Validity
26. Homogeneous sample: good for internal, not good for external
validity
Large sample size: not necessarily good for external validity
Broad inclusion criteria: good for external validity
Random sampling: can improve external validity
Important to define inclusion and exclusion criteria: who is in and
who is not in the target population
INTERNAL AND EXTERNAL VALIDITY:
27. Process by which persons from the accessible population become
part of the study population
Study population = random sample of the accessible population =
representative of the target population
Threats: sampling variability or sampling error (by chance, not
bias)
SAMPLING:
28. Probability sampling: at random
Simple random sampling
Systematic sampling
Stratified random sampling
Disproportional sampling
Cluster/multi-stage sampling
Non-probability sampling: not random, most common
Convenience sampling
Snowball sampling
SAMPLING:
29. STUDY DESIGN:
The ultimate goal:
Eliminate systematic error (bias)
Minimize random error (chance, variability)
Ensure the generalizability of study findings
Types of design:
Parallel
Cross-over
Others
Study
Design
30. 32
Other Parallel Groups Designs
R
a
n
d
Plac
Exp
R
a
n
d
Std
Exp
R
a
n
d
Std
Exp
R
a
n
d
Std + Plac
Std + Exp
R
a
n
d
Std
Exp
Exp
Test of Timing
Test of Combination Treatment
Std
Test of Switching
31. FACTORIAL DESIGN:
An example 2 x 2:
Pros: efficiency, test more than one hyphotesis
Cons: possibility of interaction
Threats: if there is interaction you can get misleading results
Placebo Drug A
Placebo Placebo + Placebo Placebo + Drug A
Drug B Drug B + Placebo Drug B + Drug A
32. CROSSOVER DESIGN:
Pros: each subject serves as his/her own control
Cons: possibility of carry over effect or order effect
Washout period may be needed
R
a
n
d
Std
Exp
Exp
Std
Period 1 Period 2
33. BIAS:
May be introduced by study personnel and subjects
If you “know” subject allocation you are susceptible to bias
Intentional or non-intentional
Blinding/masking may reduce the risk
34. TYPES OF BLINDING:
Open label: both the patient and the investigator know allocation
Single blind: patient does not know
Double blind: both the investigator and the patient do not know
Triple blind: both the investigator , the patient, and the
sponsor/statistician do not know
All study personnel should be “blinded”
35. TO ENSURE BLINDING:
When possible make the different study treatments be
identical in appearance, touch, taste, and smell
Have an physician/healthcare provider delivering the
treatment different from physician examining for efficacy
Have an physician examining patient for AEs different from
physician examining for efficacy
Choose an efficacy outcome that is difficult to introduce bias
(e.g. survival)
The packet with the drug contains a label with just the
patient ID
36. Treatment allocation schemes should:
Remove investigator bias in the allocation of participants
Produce treatment groups comparable with respect to known and
unknown risk factors
Guarantee that statistical tests have valid significance levels
Only randomization achieves all three goals
37. Simple/unrestricted randomization: assigns patient to treatment
randomly independently of all other treatment assignments
Cons: long runs, imbalances
Pros: easy
Blocked randomization: block size is a multiple of number of
treatments
Pros: maintains balance
Cons: you can guess the 4th and sometimes the 3rd position
Random block sizes: e.g. 4 or 6 or 8 (for two treatments)
Pros: maintains balance, impossible to guess next allocation
Cons: more complicated
Randomization
38. Stratified randomization:
Patients characteristics (age group, gender, disease severity, etc)
Study center (multicenter trials)
Use limited number of strata
Pick the most important categorical variables
Consider using statistics to “bypass” imbalance of important
variables
Randomization
40. 1. Understanding of study inclusion & exclusion criteria
2. Identification of potential participants
3. Screen for eligibility
4. Obtain informed consent
5. Enrollment into study
41. Burdens
Issues that make enrollment difficult
Barriers
Issues that will prevent enrollment
Benefits:
Medical, financial, altruism
Risks:
Medical: Side effects, assignment to placebo, lack of efficacy
Logistical: Trade off with other time commitments, medical or opportunity
costs
RECRUITMENT:
42. Pool of potential candidates shrinks as it goes through
progressive screens
85-90% of patients in practice will not be eligible for
trial
Total Patients in
Group
Patients found ineligible due
to co-morbidities, lab values
100%
50%
10-15%
Patients Eligible
Fedor, C.; Cola, P. & Pierre, C., D. Responsible Research. p108-9. 2006.
Patients ENROLLED
2-5%
43. Drop outs or premature withdrawals:
Threaten statistical power of the trial
Can introduce bias if drop outs are not randomly
distributed across treatment groups
Necessitates that sites access AE and mortality
status via alternate mechanisms where appropriate
Threaten perception of the trial results
44. “The extent to which the patient continues the agreed-upon mode of
treatment under limited supervision when faced with conflicting
demands”
Examples of non-adherence:
Taking an incomplete/incorrect dose
Taking medication at wrong time
Forgetting to take medication
Stopping the medication before instructed
ADHERENCE
:
45. Non-adherence to follow-up: impact data quality and interpretation
Non-adherence to regimen: impact the power of the study to detect a
clinical effect or potentially effective treatment
Example: changes in dose amount and timing
Adds variance to the outcome
Drug effectiveness may be underestimated
AE may be underestimated
Sample size must increase
Longer/delayed trails
Increased costs
ADHERENCE
:
46. Why is Adherence Important?
- Threatens the ability to complete study
- Misinterpretation of data
- Complicates statistical analyses (ITT vs per protocol)
- Links to drug failure are less clear
- Prolongs studies
- Increased sample size
- Inflates costs
47. NON-ADHERENCE FACTORS:
Participants
Treatment Regimen
Disease and Study Specific Issues
ENHANCING ADHERENCE:
Pre-randomization screening
Run-in period
Test dosing
48. Statistics
TYPE OF DATA:
Qualitative/categorical
Nominal: unordered categories
Ordinal: ordered categories
May be more clinical relevant
Quantitative
Discrete: magnitude and order matters; only specified values
Continuous: not restricted to specified values
Interval scale: zero value is NOT meaningful
Ratio scale: zero value is meaningful
49. MEASURES OF CENTRAL TENDENCY:
Mean: best for normal distributions, sensitive to outliers
Median: best for asymmetric distributions (non-normal)
Mode: best for qualitative data
MEASURES OF DISPERSION:
Variance: sum of the squared deviation of each score from the
mean / N-1
Standard deviation: squared root of the variance
Range, interquartile range (P25th - P 75th), standard error (SE), 95%
confidence interval (CI)
50. TYPES OF TESTS:
One tailed OR two tailed
Direction of the difference known?
Parametric OR non-parametric
Random sampling?
Continuous data (interval or ratio scales)?
Normal distribution?
Equal variances (homogeneity)?
51. Type of data: continuous vs. categorical data
Data distribution: normal vs. non-normal distribution
Number of groups: 2 groups vs more than 2 groups
Type of measures: repeated measures?
What you are looking for: difference vs association vs
prediction
WHAT DO YOU NEED TO KNOW
:
52. Continuous data
Categorical /
binary
Normal
distribution
Non-normal
Compare two groups
(independent variable
- binary)
Unpaired and
paired t-test
Mann-Whitney
Wilcoxon
Chi-square
Fisher’s exact
Compare three or
more groups
(independent variable
- categorical)
ANOVA (one
or n-way
ANOVA)
Kruskal-Wallis
or Friedman
test
Chi-square
Fisher’s exact
Association between
two variables
(independent variable
- continuous)
Pearson
correlation
Spearman
correlation
Association between
three or more
variables
(independent variable
- continuous)
Multiple linear
regression
Multiple
logistic
regression
53. Continuous
(Normal)
Continuous
(Non-normal)
Dichotomous Multi-
Categorical
Failure Time
1
group
1 sample T-test Chi Sq.
(Fisher’s Exact)
Chi Sq.
(Fisher’s
Exact)
2
groups
T-test
Paired T-Test
Wilcoxon Rank
Sum Test
Chi Sq.
(Fisher’s Exact)
McNemar’s
Test
Chi Sq.
(Fisher’s
Exact)
Log-Rank
>2
groups
ANOVA
Linear
Regression
Kruskal Wallis Chi Sq
(Fisher’s Exact)
Logistic Reg.
Chi Sq.
(Fisher’s
Exact)
Logistic Reg.
Log-Rank
Cox Regresion
54. EXAMINE NORMALITY:
Mean = Median = Mode
Skewness and kurtosis
Graphical Assessment
Statistical Tests:
Kolmogorov-Smirnov
Shapiro-Wilk
Normal (Gaussian) Distribution
0
0.05
0.1
0.15
0.2
0.25
2 3.6 5.2 6.8 8.4 10 11.6 13.2 14.8 16.4 18
Probability
Density
55. When does it matter?
Continuous outcome
Small – moderate sample size
Significantly non-normal data
Expected effect size is small
Non-parametric options not available
What are the risks?
Erroneously use parametric tests when data is non-parametric?
False positive results
Erroneously use non-parametric tests when data is parametric?
False negative results (unlikely)
Data Classification in Clinical Research & Sample Size Calculation, Munir Boodhwani, MD, MMSc, FRCSC
56. ANOVA:
Parametric test
Means ANalysis Of VAriance
Compares more than two means/groups
If H0 is rejected, then multiple comparisons/ contrasts between groups
are needed
Post hoc tests: LSD test, Tukey’s HSD, test, Scheffe’s test, Bonferroni
Assumptions: observations are independent, normally distributed data,
homogeneity of variances
57. “OTHERS” ANOVA:
RM ANOVA: Repeated Measures for each subject
(e.g. longitudinal study)
Two-way/factorial ANOVA: two independent variables; main effect +
interaction effect (e.g. study treatment interaction)
ANCOVA: “ANOVA + regression”; comparing means among different
groups while controlling for covariates
58. REGRESSION
Studies the relation between a predictor variable (x) and a response
variable (y)
Both dependent and independent variable are continuous
Can the independent(s) variable(s) predict the dependent variable?
Yi = β0 + β1 Xi
+ ε
Outcome for patient
Dependent variable
InterceptSlope
Predictor/regressor
Independent
variable
Error
term
“noise”
59. Correlation quantifies the degree that two variables are related.
Correlation coefficient (r) = how much one variable tends to change when the other
one does.
Linear regression finds the best line that predicts Y from X.
HMS-CME Principles and Practice of Clinical Research
60. CORRELATION:
Quantifies the degree that two variables are related
Does not mean causation
Pearson product-moment correlation (P)
Spearman's rank correlation (NP)
Correlation coefficent: measures the relationship [r or rho (ρ)]
0 - 0.25 - little or no relationship
0.25 - 0.50 - fair relationship
0.50 - 0.75 - moderate relationship
>0.75 - good to excellent relationship
-1 or 1 - perfect correlation !
61. Usually used as secondary analyses
Correlation coefficient is important to be reported – strength of association
Does not depend on values expressed by x or y and also order does not matter
Correlation is different than causation
Correlation measures linear association (there might be a quadratic association)
Correlation is sensitive to outliers
62. Let us analyze together
Scenario 1 – you have a large sample size:
Using central limit theorem, parametric tests can be used
Differences in p-value are very small when using non-parametric testing
Scenario 2 – you have a small sample size:
Central limit theorem does not apply for parametric tests
Non-parametric tests lack power for small sample sizes
7 or fewer values, mann-whitney is always >0.05
5 or fewer pairs, wilcoxon sign rank is always > 0.05
63. HYPOTHESIS TESTING:
Determines the degree to which your study result can be explained by
chance or sampling variability
A statistically significant difference means it is unlikely due to chance;
not the same as clinical significance
The hypotheses should be defined a priori
Null hypothesis: a=b, treatments are equal
Alternate hypothesis: a ≠ b, treatments are different; difference can be
1-side/direction or 2-side (both directions)
64. AFTER RUNNING YOUR TEST:
Reject null hypothesis: the treatments are different
p value < level of significance
OR
Fail to reject the null hypothesis (“accept the null hypothesis): the
treatment are similar
Attention to the double negative!!!
p value > level of significance
65. Unobserved Truth
in the Population
Ha: Coffee prevents DM
H0: No
association
Observed
in the
Sample
Reject H0:
Treatment
are
different
True positive
(1 – β)
False positive
Type I error (α)
Fail to reject
H0:
Treatments
are similar.
False negative
Type II error (β):
True negative
(1- α)
66. ERRORS IN HYPOTHESIS TESTING:
Error type I
False positive
= probability of committing an error type I
Error type II
False negative
= probability of committing an error type II
1- = power = probability of detecting a difference when one truly exists (true
positive)
67. α (alpha)
aka level of significance
Usually 0.05 (5%)
Probability of type I error (false positive) : rejecting null hypothesis
when it is in fact true
Risk of providing a treatment that actually does not work
β (beta)
Probability of type II error (false negative): failing to detect a difference
when it actually exists
Usually 0.2 (20%)
Risk of not offering a treatment that in fact works
p – value
probability of obtaining a result as extreme or
more extreme than you found in your study by
chance alone
68. Regardless of the statistical procedure, sample
size formulas rely on the same parameters
1. Significance level (α)
2. Desired power (1 – β)
3. Measure of variation of the outcome variable – Ie:
standard deviation (σ)
4. Anticipated treatment/exposure effect (Ha)
69. Screen the published literature: original papers, SR, meta-analysis
Look for SD, variance, 95% CI, standard error, effect size, mean effect
Do a pilot study
Use an analogous study
Expert judgment (clinical meaningful ES)
Minimum Clinically Important Difference (MCID)
HOW DO YOU GET THE DATA YOU
NEED:
70. How sample size changes in response to changes in parameters: α, β,
effect size, measures of variability
Sample size
(total)
Power Incidence rate
intervention
Incidence rate
control
100 73% 10% 30%
200 97% 10% 30%
300 69% 10% 20%
400 81% 10% 20%
400 32% 10% 15%
250 83% 15% 30%
300 89% 15% 30%
400 26% 15% 20%
600 46% 15% 20%
SENSITIVITY
ANALYSIS
71. TRADE-OFFS
Less false positives (type I error) Increase sample size
Less false negatives (type II error) Increase sample size
More power (true positives) Increase sample size
Small exposure effect Increase sample size
More false positives (type I error) Decrease sample size
More false negatives (type II error) Decrease sample size
Less power (true positives) Decrease sample size
Large exposure effect Decrease sample size
72. Use primary outcome
Prefer continuous outcomes (smaller n)
Have balanced samples (more power)
Account for drop-outs
If you have fixed sample sized:
Calculate power a priori: do you really want to do this?
Calculate power post hoc: possibility of a false negative?
SAMPLE
SIZE
73. Time to event data
Not just “survival”: time to rescue medication, time to hospital
admission, etc.
Needs to be defined:
When do you start counting (time origin)
How do measure time (scale)
Define what is your “failure”(event)
Manages “censored” or “incomplete” data
SURVIVAL ANALYSIS:
74. HOW TO DEAL WITH CENSORED DATA:
Not all individuals are observed until they have the event
Censored cannot be related to the probability of the event of interest
Kaplan-Meier Estimation
Numerical: median, 50th percentile, when K-M crosses 0.5 on the y axis
Graphically: survival curve
75. COMPARE SURVIVAL BETWEEN 2 GROUPS:
Without censoring: compare mean time to failure with t-test or Wilcoxon
test
With censoring: log rank test (NP)
CONTROL FOR COVARIATES:
Regression model
Cox Proportional Hazards Regression
Hazard ratio (similar to OR)
76. MISSING DATA:
Important source of bias; reduces power and precision
HOW TO HANDLE IT:
Per protocol (PP), complete-case analysis
Available-case analysis (different n for each analysis)
Weighted procedures (according to likelihood of response)
Intention to treat analysis (ITT)
Single imputation-based procedures:
Mean and median imputation (decrease variance)
Regression imputation (smaller impact on)
Stochastic regression imputation (increase variance)
Last observation carried forward (conservative)
Worst/best case scenario (sensitivity analysis)
Other Issues in
Statistics
77. Missing completely at random: Completely independent of observed and non-
observed data.
Non-missing data constitutes effectively a random sample (example, a rater that becomes sick or
loss of study files)
Missing at random (less stringent): probability of a value being missing will generally
depend on observed values (NOT MISSING VALUES), so it does not correspond
to the intuitive notion of 'random'.
- Old subjects might drop out a treatment because they have walking difficulties – as they
cannot go to the clinic center – however among older subjects, the likelihood of dropping out does not
relate to the outcome.
Missing not at random - present when the pattern of missing data are related to
unobserved data - therefore it is impossible to predict data from other values from
the dataset
Demographic data + baseline performance Follow-up performance
OBSERVED DATA NON-OBSERVED DATA
78. COVARIATE ADJUSTMENT:
Despite randomization there might be imbalances between groups:
e.g. a group might be older and have more females than the other group
[covariates: gender and age]
Advantages:
Improves estimates
Reduces bias
Increases statistical efficiency
Common covariates:
Study center in multicenter studies
Prognostic factors
80. To find out if whether treatment effect is different in patients with a certain
characteristic
Advantages: ideas for new studies, finding groups of patients in whom the
treatment works better
Risks: over interpretation and misleading results; false positives (if p=0.05, 1 in
each 20 comparisons just by chance)
SUB-GROUP ANALYSIS:
81. After primary analysis, often want to look at subgroups
Does effectiveness vary by subgroup?
If drug effective, is it more effective in some populations?
If results overall show no effect, does drug work in subgroup of participants?
Are adverse effects concentrated in some subgroups?
82. SUB-GROUP ANALYSIS versus COVARIATE ADJUSTMENT:
Covariate adjustment: achieve the most accurate p value; increases
precision and power
Sub-group analysis: different responses to the treatment; interaction
between the treatment and a certain characteristic
83. 1. Specified in study protocol have highest validity
Especially if number is small
2. Implied by study protocol
randomization stratified by age, sex or disease stage
3. Subgroups suggested by other trials
4. (Weakest) Subgroups suggested by the data themselves (“fishing” or “data
dredging”)
Example: children under 14 born in October (“month of October victimized by
poststudy analyses biased by knowledge of results”)
5. (Disastrous) Subgroups based on post-randomization variables
84. ?
HOW TO ADDRESS MULTIPLE COMPARISONS:
Bonferroni correction
Fisher’s Least Significance Difference
Duncan
Newman-Keuls
Tukey’s Honestly Significant Difference
Scheffe’s comparison
Disclose error rate (findings by chance alone)
PROBLEM: “overcorrection” increases risk of type II error
85. Meta-analysis refers to the analysis of analyses
the statistical analysis of a large collection of analysis results from individual
studies for the purpose of integrating findings. It connotes a rigorous alternative to
the casual, narrative discussions of research studies which typify our attempts to
make sense of the rapidly expanding literature.
GV Glass (1976). Primary, secondary, and meta-analysis of research. Edu Researcher 5:3-8
META-ANALYSIS:
86. keep up with the enormous amount of research data, judge the quality of
the studies, and integrate findings
Greater precision of effect estimates, and thus reduce probability false
negative results
Consistency of results over different study populations - generalizability
Highlight the limitations of previous studies and contribute to higher
quality of future studies
87. 0. Identification of the need for a review
1. Preparation of a proposal for a review
2. Development of a review protocol
3. Identification of research
4. Selection of studies
5. Study quality assessment
6. Data extraction
7. Data synthesis
8. Report and recommendations
9. Getting evidence into practice
Preparing the review
Reporting/
dissemination
88. Larger studies should be emphasized in the analyses
Weight each ES by its sample size
Weight each ES by the inverse variance (better)
Non-quantitative data synthesis: tables
Quantitive data synthesis: forest plot (OR, ES)
Measure of effect: odds-ratio, risk-ratio, effect size
META-
ANALYSIS:
89. Sensitivity analysis: assess the robustness of the findings
Exclude from the analyses some studies: e. g. older studies, lower quality
studies, extremes of distribution
Heterogeneity: assess variation of outcomes between studies
Cochran’s Q
Publication bias
Begg and the Egger test
Begg funnel plot
META-ANALYSIS:
90.
91.
92. RESEARCH QUESTION
H0: Tight glycemic control will have the same perioperative morbidity
as standard glycemic control
H1: Tight glycemic control will not have the same perioperative
morbidity as standard glycemic control
93. STUDY DESIGN
Interventional
New treatment strategy versus standard care (no placebo)
Randomized and controlled
Multicentric
Phase II trial
95. STUDY POPULATION:
Target population: children 0-36 months undergoing
cardiac surgery with cardiopulmonary bypass
Acessible population: same as above + receiving surgical
treatment Boston and University of Michigan Children’s
Hospital
Study population: same as above + admitted between
September 1006 to May 2012 that were eligible and whose
parents/guardians gave consent
SAMPLING:
Convenience sampling (non-probability sampling)
106. RESULTS
Primary and secondary outcomes: no differences
between groups
Sub-group analyses: no differences
Factors associated with infection risk:
High surgical risk
30 days or younger
Hyperglicemia
Prolonged stay ICU
Post-op glucocorticoid therapy
Not significant when controlling for prolonged ICU
stay
107. INTERNAL VALIDITY:
Threats: convenience sampling, differences in protocol, target population?
Strengths: random allocation, blinding,
No placebo (would be ethical?)
Glucose control in standard care not specified by the protocol
EXTERNAL VALIDITY:
Relative broad inclusion criteria
Sample does no represent all critically ill pediatric patients
Highly trained centers: lower infections and mortality rates anyway