HSA-6752 Statistics in Health Care Management

HSA-6752 Statistics in Health Care Management

HSA-6752 Statistics in Health Care Management

Florida National University HSA-6752 Statistics in Health Care Management: Assignment Week 1 Student PowerPoint Presentation: Chapters 1 and 2 Objectives: The presentation assignment has several goals. It requires students to apply concepts from Biostatistics, what are the issues, and study designs. The study designs process will allow students to develop observational, randomized and more on clinical trials and designs, a skill they will be using as Healthcare Administrator. Format and Guidelines: The student will create a Power Point Presentation from Chapter 1 and 2 of the Textbook related to Week 1 (Choose your desire topic form these chapters). The Presentation should have a minimum of 12 slides, including Title Page, Introduction, Conclusion, and References. The student must use other textbooks, research papers, and articles as references (minimum 3). EACH PAPER SHOULD INCLUDE THE FOLLOWING: 1. Title Page: Topic Name, Student Name 2. Introduction: Provide a brief synopsis of the meaning (not a description) of the topic you choose, in your own words 3. Content Body: Progress your theme, provide Material, illustrations and Diagram to explain, describe and clarify the Topic you choose. 4. Conclusion: Briefly summarize your thoughts & conclusion to your critique of the articles and Chapter you read. 5. References: The student must use other textbooks, research papers, and articles as references (minimum 3). Dr. Gisela Llamas Florida National University HSA-6752 Statistics in Health Care Management: Assignment Week 1 Student PowerPoint Presentation: Chapter 1 and 2 Grading Sheet Student Name __________________________________ Category Possible Points Presentation style and content. 3 Distributed bibliography w/ 3 additional readings 2 Inclusion of diversity content Pictures, Graphic, etc. 2 Length: Minimum 12 slides 1 Required Format 2 TOTAL 10 Dr. Gisela Llamas Date_____________________ Actual Points ASSIGNMENT GRADING SYSTEM A 90% – 100% B+ 85% – 89% B 80% – 84% C+ 75% – 79% C 70% – 74% D 60% – 69% F 50% – 59% Or less. Dr. Gisela Llamas Chapter 1 Introduction Learning Objectives (1 of 2) • Define biostatistical applications and their objectives • Explain the limitations of biostatistical analysis • Compare and contrast a population and a sample • Explain the importance of random sampling Learning Objectives (2 of 2) • Develop research questions and select appropriate outcome variables to address important public health problems • Identify the general principles and explain the role and importance of biostatostistical analysis in medical, public health, and biological research What Is Biostatistics? (1 of 2) • Application of statistical principles to medical, public health, and biological applications – Collecting, summarizing, and interpreting information and – Making inferences that appropriately account for uncertainty What Is Biostatistics? (2 of 2) Population Sample (unknown information) • Summarize sample • Make inferences about Population Issues and Limitations (1 of 2) • Must clearly define research question • Must choose appropriate study design (i.e., the way in which data are collected) • Must select a sufficiently large, representative sample • Must carefully collect and summarize data Issues and Limitations (2 of 2) • Must quantify uncertainty • Must appropriately account for relationships among characteristics • Must limit inferences to appropriate population Important Questions • • • • • • • • H1N1 outbreak Risk factors for heart disease Drug safety and efficacy High-risk health behaviors Genetic determinants of disease Risk factors for autism Impact of diet and exercise on health Impact of Gulf oil spill on health Issues for Biostatisticians (1 of 2) • Children: Obesity, immunizations, asthma, autism, etc. • Adolescents: Alcohol and tobacco use, depression, STDs, traffic accidents, etc. • Adults: Cancer, CVD, substance abuse, HIV/AIDS, mental health, etc. – What is number one killer of men and women in United States? – What are the risk factors? Issues for Biostatisticians (2 of 2) • • • • • • Research question Study sample Sample size Analytic techniques Inferences—cause/effect Limitations Types of Studies • Laboratory studies • Animal studies • Clinical studies – Observational studies – Experimental trials Research Teams • • • • • • Principal investigator Biostatistician Co-investigators Project manager Statistical programmers Research assistants Biostatistician’s Role on Team • Study design – – – – – Research question Study sample Sample size Enrollment/follow-up strategies Ongoing monitoring • Interim and final analysis • Reporting of results Careers • • • • Pharmaceutical industry Government Academia Health insurance Demand far exceeds supply of qualified biostatisticians today. Training/Skills • • • • • • • • Mathematics background Biostatistics/statistics Public health/biology Computer skills Communication skills Analytic skills Organizational skills Attention to detail Chapter 2 Study Designs Learning Objectives (1 of 2) • List and define the components of a good study design • Compare and contrast observational and experimental study designs • Summarize the advantages and disadvantages of alternative study designs Learning Objectives (1 of 2) • Describe the key features of a randomized controlled trial • Identify the study designs used in public health and medical studies Study Designs • Observational studies – – – – Case report/case series Cross-sectional (prevalence) survey Case-control study Cohort study • Experimental studies – Randomized controlled (clinical) trial Inferences • Observational studies—inferences limited to descriptions and associations; with carefully designed analysis, can make stronger inferences (statistical adjustment) • Experimental studies—cause and effect In all studies—need careful definition of disease (outcome) and exposure (risk factor) Which Design Is Best? • Depends on the study question • What is current knowledge on topic? • How common is disease (and risk factors)? • How long would study take; what are costs? • Ethical issues Case Report/Case Series • Observational study • Case report—detailed report of specific features of case • Case series—systematic review of common features of a small number of cases – Advantage: cost-efficient – Disadvantages: no comparison group, no specific research question Case Series (1 of 2) • Simplest design—description of interesting observations in a small number of individuals • Usually case series do not involve control patients (i.e., patients free of disease) • Usually lead to generation of hypotheses for more formal testing • Criticisms: not planned, no research hypotheses Case Series (2 of 2) • Gottleib (1981) studied five young homosexual men with rare form of pneumonia and other unusual infections. • Initial report was followed by more series (26 cases in NY and CA; “cluster” in southern CA; 34 cases among Haitians, etc.) • Condition termed AIDS in 1982. Cross-Sectional Survey (1 of 2) • Observational study conducted at a point in time – Advantages: cost-efficient, easy to implement, ethical – Disadvantages: no temporal information, non-response bias Cross-Sectional Survey (2 of 2) • Is there an association between diabetes and cardiovascular disease (CVD)? Patients with Diabetes Patients without Diabetes Patients with CVD Prospective Cohort Study • Observational study involving a group (cohort) of individuals who meet inclusion criteria followed prospectively in time for risk factor and outcome information – Advantages: can assess temporal relationships – Disadvantages: need large numbers for rare outcomes, confounding Cohort Study (1 of 3) • Is there an association between hypertension and cardiovascular disease? CVD Hypertension No CVD Cohort CVD No Hypertension No CVD Study Start Time Cohort Study (2 of 3) • Identify a group of individuals that meet inclusion criteria. • Follow prospectively in time. • Assess exposure. • Evaluate outcome status. Cohort Study (3 of 3) • Includes persons exposed and not exposed to risk factor at outset—usually persons are disease free. • Can assess temporal relationship • Problem if disease is rare (small numbers) • Bias is less of an issue than in casecontrol. • Confounding may be a problem. The Framingham Heart Study • 5000+ men and women enrolled in 1948 • Longitudinal cohort study • Exams every 2 years for cardiovascular risk factors—surveillance • Ancillary studies—hearing, exercise, nutrition, neurological studies • 5000+ offspring and spouses enrolled in 1976 • Third generation enrolled in 2002 Selection of Study Sample • Exposure group – Common risk factors—general population (e.g., Framingham Study) – Rare risk factors—special exposure cohort (e.g., soldiers exposed to agent orange) • Comparison group – Similar on all other factors that might affect outcome Case-Control Study (1 of 3) • Observational study involving individuals with (cases) and without (controls) outcome of interest – Advantages: cost and time efficient for rare outcomes – Disadvantages: need careful selection of cases and controls, bias Case-Control Study (2 of 3) • Is there an association between sleep position and sudden infant death syndrome (SIDS)? Sleep prone SIDS Other Sleep prone No SIDS Other Study Start Time Case-Control Study (3 of 3) • Select subjects on the basis of outcome. – Cases have disease. – Controls are free of disease. • Compare groups with respect to proportions with a history of exposure (possible cause). • Investigation is retrospective in time. Sampling • Selection of cases – Need explicit definition to make cases as homogeneous as possible – Debate over whether cases should represent all persons with disease or specific subgroup (limit inferences) • Selection of controls – Should be comparable to cases (same exclusions) – Controls represent non-diseased persons who would have been included as cases if they had disease. Features • Retrospective design • Cost and time efficient • Can get sufficient number of cases (useful for rare conditions) • Can investigate array of exposures • Best for diseases with long latency Issues • Ascertainment of exposure and disease status – Both exposure and disease have occurred—hard to establish temporal relationship • Bias – Selection bias—select cases or controls and some drop out, leaving groups not comparable – Observation bias—knowledge of disease might influence reporting of exposure (over-reporting among cases) – Recall bias—retrospective (long term) Randomized Control Trial (1 of 2) • Experimental study where patients are randomized to receive one of several comparison treatments – Advantages: gold standard from a statistical point of view, minimizes bias and confounding – Disadvantages: expensive, requires extensive monitoring, inclusion criteria can limit generalizability Randomized Control Trial (2 of 2) • Is new drug effective in reducing hyperlipidemia (high total serum cholesterol)? Hyperlipidemia Drug No Hyperlipidemia Sample RANDOMIZE Hyperlipidemia Placebo No Hyperlipidemia Study Start Time Randomized Controlled Trial (Clinical Trial) • Subjects are randomized to one of two (or more) treatments, one of which may be a control treatment. • In the long run, treatment groups will be balanced in known and unknown prognostic factors. • Important that the treatments are concurrent— that the active and control treatments occur in the same period of time • Single- versus multicenter Features • If possible, a study should be double blinded— neither the investigator nor the participant are aware of what treatment the participant is undergoing. • Sometimes it is impossible to blind the participants (for example, when the treatments being compared are medical versus surgical); but often it is possible to ensure that the people evaluating the outcome are unaware of the treatment. Phase I: Safety • First time in humans; main objective to assess toxicity and safety in humans— pharmacokinetics • Usually involves 10 to 15 patients • Subjects are usually healthy. • Some are placebo-controlled. Phase II: Feasibility Study • Focus still on safety • Side effects and adverse events • Efficacy is important—goal is to determine optimal dosage. • Involves a control group, and subjects are randomized. Phase III: Clinical Trial • Focus is efficacy. • Data are collected to monitor safety. • Involves a control group (placebo, active control) • Usually involves 200 to 500 subjects • Subjects are randomized. • At least two centers Phase IV: Post-Marketing • After approval by FDA (based on efficacy proven statistically in two or more studies, New Drug Application (NDA) reviewed within 1 year) • Focus is effectiveness. Critical Components of RCT • Randomization • Control group—ethical issues • Monitoring – Interim analysis – Data and safety monitoring board • Data management • Reporting

HSA-6752 Statistics in Health Care Management
HSA-6752 Statistics in Health Care Management

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