513-611A STUDY DESIGN AND ANALYSIS I
COURSE SCHEDULE
Revised, September 30, 2003
* Article in 3rd course pack available from Copies Nova
** Article available in PDF format on web-page
Friday September 5, 11:00 – 12:30
LECTURE 1: INTRODUCTION TO MEASUREMENT
Topics covered:
Types and purposes of measurement
Sources of data
Types of variable/level of measurement
Scale types
Required readings
Chapter 2: Measurement. In: Kramer MS. Clinical Epidemiology and Biostatistics, A Primer for Clinical Investigators and Decision-Makers. New York: Springer-Verlag, 1988: 11-7.
Chapter 4: Scaling responses. In: Streiner DL, Norman GR. Health measurement scales. A practical guide to their development and use. Second edition. New York: Oxford University Press, 1995: 28-53.
Friday September 12, 11:00 – 12:30
LECTURE 2: SCREENING AND DIAGNOSTIC TESTS
Topics covered:
Normal and abnormal
Reproducibility
Validity: “gold” or criterion standard
Sensitivity, specificity, predictive value
Likelihood ratio
Receiver operating characteristic (ROC) curves
Bias in assessment of validity of tests: spectrum, verification, information
Required readings
Chapter 16: Diagnostic tests. Kramer MS. Clinical epidemiology and biostatistics, a primer for clinical investigators and decision-makers. New-York: Springer-Verlag, 1988: 201-16.
Additional readings
Jaeschke R, Guyatt G, Sackett DL. Users' guides to the medical literature III. How to use an article about a diagnostic test . A. Are the results of the study valid? JAMA 1994; 271(5):389-91.
Jaeschke R, Guyatt GH, Sackett DL. Users' guides to the medical literature. III. How to use an article about a diagnostic test. B What are the results and will they help me in caring for my patients? JAMA 1994; 271(9):703-7.
Friday September 19, 11:00 – 12:30
LECTURE 2 (cont)
Monday September 22, 11:00 – 12:30
LECTURE 3: VALIDITY AND RELIABILITY OF SCALES
Topics covered:
Reliability: internal consistency
test-retest reliability
alternate form reliability
interrater and intrarater agreement
Validity: content and face validity
criterion validity: concurrent and predictive
construct validity
Bias: social desirability, acquiescent response set
Introduction to kappa coefficient and other reliability measures
Introduction to responsiveness
Required readings
Ferris LE, Norton PG. Chapter 6: Basic concepts in reliability and validity. In: Stewart, M et. al. Tools for primary care research. Newbury Park: Sage Publications, Inc, 1992: 64-76.
Guyatt G, Feeny D, Patrick D. Measuring health-related quality of life. Ann Intern Med 1993; 118:622-9.
Magaziner J. The use of proxy respondents in health studies of the aged. Chapter 8 in: Wallace RB & Woolson RF, The Epidemiologic Study of the Elderly. Oxford University Press, 1992.
Additional readings
McCusker J, Cole M, Bellavance F et al. Reliability and validity of a new measure of severity of delirium. Int Psychogeriatr 1998; 10(4):421-33.
Monday, September 29, 9:00 – 10:30
GUEST LECTURE: DEVELOPMENT AND TESTING OF A SCALE
Susan Stock, MD
Monday, September 29, 11:00 – 12:30
SMALL GROUP EXERCISE 1: STUDIES OF MEASUREMENTS
Topics covered:
Measurement of:
Quality of life
Utilization of health services
Comorbidity
Satisfaction with care
Cognitive impairment
Required readings
McDowell I, Kristjansson B, Hill G et al. Community screening for dementia: The mini mental state exam (MMSE) and modified mini-mental state exam (3MS) compared. J Clin Epidemiol 1997; 50(4):377-83.
Poses RM, McClish DK, Smith WR et al. Prediction of survival of critically ill patients by admission comorbidity. J Clin Epidemiol 1996; 49(7):743-7.
Salomon L, Gasquet I, Mesbah M et al. Construction of a scale measuring inpatients' opinion on quality of care. Int J Qual Health Care 1999; 11(6):507-16.
Essink-Bot M, Krabbe P, Bonsel G et al. An empirical comparison of four generic health status measures: The Nottingham Health Profile, the Medical Outcomes Study 36-item short form health survey, the COOP/WONCA charts, and the EuroQol instrument. Med Care 1997; 35(5):522-37.
Roberts RO, Bergstralh EJ, Schmidt L et al. Comparison of self-reported and medical record health care utilization measures. J Clin Epidemiol 1996; 49(9):989-95.
Monday, October 6, 9:00 – 10:30
LECTURE 4: SURVEY DESIGN
Topics covered:
Sampling: random (simple and stratified, systematic, cluster, multistage)
Data collection
Sources of bias in survey estimates: selection and information
Required readings
Kelsey JL, Whittemore AS, Evans AS, Thompson WD. Chapter 12: Methods of sampling and estimation of sample size. Kelsey JL, Whittemore AS, Evans AS, Thompson WD. Methods in observational epidemiology. Second edition. New York: Oxford University Press, 1996: 311-40.
Cummings SR, Stewart AL, Hulley SB. Chapter 15: Designing questionnaires and data collection instruments. In: Hulley SB et al. Designing Clinical Research. Second edition. Philadelphia: Lippincott Williams & Wilkins, 2001: 231-45.
Loney P, Chambers L, Bennett K et al. Critical appraisal of the health research literature: Prevalence or incidence of a health problem. Chronic Dis Can 1998; 19(4):170-6.
Additional readings
Theis B, Frood J, Nishri D et al. Evaluation of a risk factor survey with three assessment methods. Chronic Dis Can 2002; 23(1):1-12.
O'Toole BI, Battistutta D, Long A et al. A comparison of costs and data quality of three health survey methods: mail, telephone and personal home interview. Am J Epidemiol 1986; 124(2):317-28.
Canadian Study of Health and Aging Working Group. Study methods and prevalence of dementia. Can Med Assoc J 1994; 150(6):899-913.
Monday, October 6, 11:00 – 12:30
SMALL GROUP PRESENTATIONS 1: STUDIES OF MEASUREMENTS
Monday, October 20, 11:00 – 12:30
LECTURE 5: INTRODUCTION TO SURVEILLANCE
Topics covered:
Objectives of surveillance
Public health vs health care surveillance
Elements of a surveillance system: case definition, indicators, population under surveillance, cycle of surveillance, confidentiality, incentives to participation
Surveillance methods: active vs passive, notifiable disease, sentinel events
Cross-sectional and longitudinal approaches
Sources of bias
Required readings
Buehler JW. Chapter 22: Surveillance. Rothman KJ, Greenland S. Modern epidemiology. Second edition. Philadelphia: Lippincott-Raven Publishers, 1998: 435-57.
Brook R, McGlynn E, Cleary P. Part 2: Measuring quality of care. N Engl J Med 1996; 335(13):966-70.
Donabedian 9:00 - 10:25 Evaluating the quality of medical care. Milbank Mem Fund Q 1966; 44(suppl 3):166-203.
Monday, October 27, 11:00 – 12:30
GUEST LECTURE: COMMUNICABLE DISEASE SURVEILLANCE
Robert Allard, MD CM, MSc, FRCPC
Required reading
*Declich S, Carter A. Public health surveillance: Historical origins, methods and evaluation. Bull WHO 1994; 72(2):285-304
Friday, October 31, 9:00 – 10:30
LECTURE 6: DESCRIPTIVE FOLLOW-UP STUDIES
Topics covered:
Natural history of disease and prognosis
Survival analysis: Kaplan-Meier survival curves
Cox proportional hazards analysis, hazard ratio (conceptual introduction)
Required readings
Gordis L. Chapter 5: The natural history of disease: Ways of expressing prognosis. In: Gordis L. Epidemiology. Philadelphia: W.B. Saunders Company, 1996: 77-88.
Laupacis A, Wells G, Richardson S, Tugwell P. Users' guides to the medical literature: V. How to use an article about prognosis. JAMA 1994; 272(3):234-7
Meinert CL. Chapter 18: Data analysis requirements and procedures. In: Meinert CL. Clinical Trials. Design, conduct, and analysis. New York: Oxford University Press, 1986: 185-95.
Monday, November 3, 9:00 – 10:30
SMALL GROUP EXERCISE 2: SURVEYS/SURVEILLANCE
Topics covered:
Surveillance/surveys of the following:
Asthma
Adverse events in hospitals
HIV testing in injecting drug users
Diabetes
High blood pressure
Required readings
Donoghoe MC, Rhodes TJ, Hunter GM et al. HIV testing and unreported HIV positivity among injecting drug users in London. AIDS 1993; 7:1105-11.
Thomas E, Studdert D, Burstin H et al. Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care 2000; 38(3):261-71.
Hassan MR, Kabir AL, Mahmud AM et al. Self-reported asthma symptoms in children and adults of Bangladesh: findings of the national asthma prevalence study. Int J Epidemiol 2002; 31(2):483-8.
Bjerregaard P, Jorgensen M, Lumholt P et al. Higher blood pressure among Inuit migrants in Denmark than among the Inuit in Greenland. J Epidemiol Community Health 2002; 56:279-84.
Harvey J, Craney L, Kelly D. Estimation of the prevalence of diagnosed diabetes from primary care and secondary care source data: Comparison of record linkage with capture-recapture analysis. J Epidemiol Community Health 2002; 56:18-23.
Friday, November 7, 9:00 – 10:30
LECTURE 7: EVALUATION OF INTERVENTIONS
Types of intervention (prevention, screening, treatment)
Efficacy and effectiveness
Structure, process, and outcome evaluation
Quasi-experimental designs:
introduction to social science terminology
natural experiments
concurrent vs historical controls
time-series studies
Observational designs: case-control and cohort studies
Sources of bias
Required readings
Gordis L. Chapter 16: Using epidemiology to evaluate health services. Gordis L. Epidemiology. Philadelphia: W.B Saunders Company, 1996: 217-28.
McKee M, Britton A, Black N et al. Interpreting the evidence: Choosing between randomised and non-randomised studies. BMJ 1999; (319):312-5.
Rundall TG. Evaluation of health services programs. Chapter 63 in Public Health and Preventive Medicine. Ed. J. Last, 12th edition Appleton-Century-Crofts,1986
*Tamblyn R, Laprise R, Hanley JA, Abrahamowicz M, Scott S, Mayo N, Hurley J et al. Adverse events associated with prescription drug cost-sharing among poor and elderly persons. JAMA 2001; 285(4):421-9
Friday, November 7, 11:00 – 12:30
STUDENT PRESENTATIONS 2: SURVEYS
Monday, November 10, 9:00 – 10:30
LECTURE 8: CRITICAL ASSESSMENT OF EXPERIMENTAL STUDIES
Topics covered:
Bias: selection, information, confounding, contamination, Hawthorne effect
Randomization methods
Blinding, placebo
Intention to treat analysis
CONSORT criteria and other checklists
Required readings
Schulz KF, Chalmers I, Hayes RJ et al. Empirical evidence of bias: Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995; 273(5):408-12.
Guyatt G, Sackett D, Cook D. Users' guides to the medical literature II. How to use an article about therapy or prevention B. What were the results and will they help me in caring for my patients? JAMA 1994; 271(1):59-63
Moher D, Schulz KF, Altman D. The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001; 285(15):1987-91
Additional readings
Shapiro S. The revised CONSORT statement: Honing the cutting edge of the randomized controlled trial. Can Med Assoc J 2001; 164(8):1157-58
Monday, November 10, 11:00 – 12:30
MID-TERM EXAM
Friday, November 14, 9:00 – 10:30
LECTURE 9: ANALYSIS OF INTERVENTION STUDIES
Topics covered:
Measures of effect for categorical outcomes:
Risk difference
Risk ratio
Relative risk reduction
Number needed to treat
Measures of effect for continuous outcomes
Applications to experimental and observational studies
Required readings
Sinclair JC, Bracken MB Clinically useful measures of effects in binary analyses of randomized trials. J Clin Epidemiol 1994; 47(8):881-9.
Monday, November 17, 9:00 – 10:30
LECTURE 10: META-ANALYSIS OF INTERVENTION STUDIES
Topics covered:
Selection of studies, data abstraction, quality scales
Sources of bias: publication, selection, information
Presentation of results: traditional vs cumulative meta-analysis
Analysis: fixed and random effects models, explaining heterogeneity
Readings
L'Abbe K, Detsky A, O'Rourke K. Meta-analysis in clinical research. Ann Intern Med 1987; 107:224-33.
Cook DJ, Sackett DL, Spitzer WO. Methodologic guidelines for systematic reviews of randomized control trials in health care from the Potsdam consultation on meta-analysis. J Clin Epidemiol 1995; 48(1):167-71.
Moher D, Pham B, Jones A et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses. Lancet 1998; 352:609-13.
Additional readings
Cappelleri J, Ioannidis J, Schmid C et al. Large trials vs meta-analysis of smaller trials: How do their results compare? JAMA 1996; 276(16):1332-8.
LeLorier J, Gregoire G, Benhaddad A et al. Discrepancies between meta-analyses and subsequent large randomized, controlled trials. N Engl J Med 1997; 337:536-42.
Benson K, Hartz 9:00 - 10:25 A comparison of observational studies and randomized, controlled trials. N Engl J Med 2000; 342:1878-86.
Monday, November 17, 11:00 – 12:30
SMALL GROUP EXERCISE 3: RCT
Required readings
Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. JAMA 2002; 288(3):321-33.
Friday, November 21, 9:00 – 10:30
GUEST LECTURE: CRITICAL ASSESSMENT OF META-ANALYSES OF INTERVENTION STUDIES
Ritsuko Kakuma, MSc, PhD cand.
Topics covered:
QUOROM criteria, Cochrane collaboration criteria
Required readings
Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF, QUOROM Group. Improving the quality of reports of meta-analyses of randomised controlled trials: The QUOROM statement. Lancet 1999; 354:1896-900
Additional readings
*Fletcher SW, Black W, Harris R, Rimer BK, Shapiro S. Report of the international workshop on screening for breast cancer. J Natl Cancer Inst 1993; 85(20):1644-56
*Kerlikowske K, Grady D, Rubin S, Sandrock C, Ernster V. Efficacy of screening mammography: A meta-analysis. JAMA 1995; 273(2):149-54
*Shea B, Dube C, Moher D. Assessing the quality of reports of systematic reviewes: the QUOROM statement compared to other tools. In: Systematic Reviews in Health Care: Meta-analysis in context. BMJ books, eds Egger M et al.
**Jadad AR, Cook DJ, Browman GP. A guide to interpreting discordant systematic reviews. Can Med Assoc J 1997; 156(10)
**Jadad AR, Cook DJ, Jones A, Klassen TP, Tugwell P, Moher M, Moher D. Methodology and reports of systematic reviews and meta-analyses. JAMA 1998; 280(3):278-80
**Klassen TP , Jadad AR, Moher D. Guides for reading and interpreting systematic reviews. 1 Getting started. Arch Pediatr Adolesc Med 1998; 152:700-4
**Jadad AR, Moher D, Klassen TP. Guides for reading and interpreting systematic reviews. II. How did the authors find the studies and assess their quality? Arch Pediatr Adolesc Med 1998(152)
**Moher D, Jadad AR, Klassen TP. Guides for reading and interpreting systematic reviews. III. How did the authors synthesize the data and make their conclusions? Arch Pediatr Adolesc Med 1998; 152:915-20
**Gotzsche PC. Is screening for breast cancer with mammography justifiable? Lancet 2000; 355:129-34
Monday, November 24, 9:00 – 10:30
To be announced
Monday, November 24, 11:00 – 12:30
SMALL GROUP EXERCISE 4: METAANALYSIS
Required reading:
*Linde K, Ramirez G, Mulrow CD, Pauls A, Weidenhammer W, Melchart D. St John's wort for depression - an overview and meta-analysis of randomised clinical trials. BMJ 1996; 313 (August):253-8
Friday, November 28, 9:00 – 10:30
LECTURE 11: COMMUNITY AND CLUSTER RANDOMIZED TRIALS
Topics covered:
Individual vs cluster randomization
Rationale
Study designs
Analysis
Required readings
Campbell M, Grimshaw J. Cluster randomised trials: time for improvement. Br Med J 1998; 317:1171-2
Koepsell TD. Chapter 6: Epidemiologic issues in the design of community intervention trials. In: Brownson RC, Petitti DB Applied Epidemiology: Theory to practice. New York: Oxford University Press, 1998: 177-211.