Design of Infectious Disease Studies



Design of Infectious Disease Studies

SPRING 2002

9 weeks (Feb 28 – May 2) 2 credits

Thursday evenings 5:30-7:30pm

Faculty: Maureen Miller and Crystal Fuller

Requirements:

Principals of Epidemiology (P6400)

Introduction to Biostatistical Methods (P6104)

Concurrent or past:

Epi II: Design and Conduct of Observational Epidemiologic Studies (P8438)

Applied Regression Analysis (P8100)

Infectious Disease Epidemiology I (P8406)

Recommended:

Selected Problems of Measurement in Epidemiology (P8417)

Seminar Leaders:

Allison Aeillo

Farzana Kapadia

Purpose:

The purpose of this class is to introduce students to the design of epidemiologic studies focused on all facets and types of infectious disease. Students will be presented with a wide array of studies and study designs that address research questions concerning infectious disease. Students are expected to familiarize themselves with the National Institutes of Health grant proposal guidelines. No data are required for participation in the class.

Organization:

Each lecturer will present a research project focusing on the ways in which research questions were developed and studies were designed. Each week, a student presentation will focus on the studies that were part of the class reading assignments. Students will summarize the study design, review the strengths and weakness of the design, and identify the types of questions for which the study design is suitable, as well as questions that could not be answered given the particular study design under discussion.

Over the course of the semester, students will be expected to develop a research question, identify specific aims to explore the research question, and design a research study. Study designs will include the identification of a suitable population, sampling, data collection procedures, and the selection of appropriate methods and analyses that address the specific aims. Study designs will be based on the National Institutes of Health grant proposal guidelines (Form 398) and will not exceed 10 pages (single-spaced).

Grading:

Class attendance and discussion (10%)

Student presentation (20%)

Final paper (70%)

2/28 Designing Social Network Studies

Maureen Miller

Aral SO, Hughes JP, Stoner B, Whittington W, Handsfield HH, Anderson RM, & Holmes KK. (1999). Sexual mixing patterns in the spread of gonococcal and chlamydial infections. American Journal of Public Health, 89(6), 825-833.

Neaigus A, Friedman SR, Curtis R, Des Jarlais DC, Furst RT, Jose B, Mota P, Stepherson B, Sufian M, Ward T, & Wright JW. (1994). The relevance of drug injectors social and risk networks for understanding and preventing HIV infection. Social Science and Medicine, 38 (1), 67-78.

Neaigus A, Miller M, Friedman SR, Des Jarlais DC. Sexual transmission risk among noninjecting heroin users infected with human immunodeficiency virus or hepatitis C virus. Journal of Infectious Diseases 2001;184(3):359-63.

Rothenberg RB, Potterat JJ, Woodhouse DE, Muth SQ, Darrow WW, & Klovdahl AS. (1998). Social network dynamics and HIV transmission. AIDS, 12, 1529-1536.

Optional reading:

Hoffmann JP, Su SS, & Pach A. (1997). Changes in network characteristics and HIV risk behavior among injection drug users. Drug and Alcohol Dependence, 46(1-2), 41-51.

Schwartz S, & Carpenter KM . (1999). The right answer for the wrong question: Consequences of type III error for public health research. American Journal of Public Health, 89(8), 1175-1180.

3/7 Data Collection Methodology among High Risk Populations

Crystal Fuller

Latkin CA, Vlahov D, Anthony JC. Socially desirable responding and self-reported HIV infection risk behaviors among intravenous drug users. Addiction 1993; 88:517-526.

Goldstein MF, Friedman SR, Neaigus A et al. Self-reports of HIV risk behavior by injecting drug users: are they reliable: Addiction 1995; 90:1097-1104.

McElrath K, Chitwood DD, Griffin DK et al. The consistency of self-reported HIV risk behavior among injection drug users. Am J Public Health 1994; 84:1965-1970.

Samuels JC, Vlahov D, Anthony JA, et al. Measurement of HIV risk behaviors among intravenous drug users. Br J Addict 1992;87:417-428.

Greenfield L, Bigelow GE, Brooner RK. Valididy of intravenous drug abusers’ self-reported changes in HIV high-risk use behaviors. Drug and Alcohol Dependence 1995; 39:91-98.

Kissinger P, Rice J, Farley T, Trim S, Jewitt K, Margavio V. Application of computer-assisted interviews to sexual behavior research. Am J Epidemiol 1999;149:950-954.

Metzger D, Koblin B, Turner C, Navaline H, Valenti F, Holte W, Gross M, Sheon A, Miller H, Cooley P, Seage G. Randomized controlled trial of audia computer-assisted self-interviewing: utility and acceptability in longitudinal studies. Am J Epidemiol 2000;152:99-106.

Turner FC, Ku L, Rogers SM et al. Adolescent sexual behavior, drug use, and violence: increased reporting with computer survey technology. Science 1998: 280:867-873.

3/14 Design of clinical trials to prevent nosocomial infections

Elaine Larson

Larson E. Skin hygiene and infection prevention: More of the same or different approaches? Clin Infec Dis 1999; 29: 1287-1294.

Larson E, Silberger M, Jakob K, Whittier S, Lai L, DellaLatta P, Saiman L. Assessment of alternative hand hygiene regimens to improve skin health among neonatal intensive care unit nurses. Heart and Lung 2000; 29:136-142.

Larson EL, Aiello A, Heilman J, Lyle C, Cronquist A, Stahl J, Della-Latta P. Comparison of different regimens for surgical hand preparation. AORN J 2001; 73:412-432.

Larson E. Hygiene and the skin: When is clean too clean? Emerg Infec Dis 2001; 7:225-230.

Larson EL, Aiello AE, Bastyr J, Lyle C, Stahl J, Cronquist A, Lai L, Della-Latta P.

Assessment of two hand hygiene regimens for intensive care unit personnel. Crit Care Med 2001; 29:944-951.

Elaine Larson (Principal Investigator) 1RO1 NR05197, “Staff Hand Hygiene and Nosocomial Infections in Neonates,” Grant proposal to NIH.

3/28 Models of Transmission Dynamics: Tuberculosis and Malaria

Sally Blower

Blower SM, Small PM, Hopewell PC. Control strategies for tuberculosis epidemics: new models for old problems. Science 1996; 273:497-500

Blower SM, McLean AR, Porco TC, Small PM, Hopewell PC, Sanchez MA, Moss AR. The intrinsic transmission dynamics of tuberculosis epidemics. Nat Med. 1995 8:815-21.

Koella JC. On the use of mathematical models of malaria transmission. Acta Tropica 1991; 49:1-25.

Lindsay SW. and Birley MH. Climate change and malaria transmission. Annals of Tropical Medicine and Parasitology 1996; 90: 573-588.

4/4 Modeling the Spread of Infectious Disease among Refugees

Ron Waldman

Moore PS, Toole MJ, Nieburg P, Waldman RJ, Broome CV. Surveillance and control of meningococcal meningitis epidemics in refugee populations. Bull World Health Organ. 1990;68(5):587-96.

Roberts L, Chartier Y, Chartier O, Malenga G, Toole M, Rodka H. Keeping clean water clean in a Malawi refugee camp: a randomized intervention trial. Bull World Health Organ. 2001;79(4):280-7.

Boss LP, Toole MJ, Yip R. Assessments of mortality, morbidity, and nutritional status in Somalia during the 1991-1992 famine. Recommendations for standardization of methods. JAMA. 1994 Aug 3;272(5):371-6.

Mahalanabis D, Choudhuri AB, Bagchi NG, Bhattacharya AK, Simpson TW. Oral fluid therapy of cholera among Bangladesh refugees. 1973. Bull World Health Organ. 2001;79(5):473-9. No abstract available.

Legros D, Paquet C, Perea W, Marty I, Mugisha NK, Royer H, Neira M, Ivanoff B. Mass vaccination with a two-dose oral cholera vaccine in a refugee camp. Bull World Health Organ. 1999;77(10):837-42.

4/11 Randomized trials within the community (TB focus)

Wafaa El-Sadr

A review of efficacy studies of 6 months Short course therapy for TB among

Patietns infected with human immunodeficieny virus: differences in study

outcomes El-Sadr, Perlman, Denning, Matts and Cohn Clin Infect Dis 2001: 32: 6230632

Evaluation of new anti-infective drugs for the treatment and prevention of

TB. Hopewell, Cynamon, Starke, Iseman, O'Brien Clin Infect Dis 1992: 15 (suppl): S282-295

Tuberculosis Adherence Partnership Alliance Study (TAPAS).

NIH Grant Proposal.

4/18 International WHO studies looking at HIV among IDUs

Terry Perlis

Ball AL, Rana S, Dehne KLHIV prevention among injecting drug users: responses in developing and transitional countries. Public Health Reports. 1998;113 (Suppl 1):170-81.

Des Jarlais et al, In Stimson GV Des Jarlais DC Ball A. eds Drug injecting and HIV infection Global dimensions and local responses. London Taylor and Francis. 1999

Des Jarlais DC; Hagan H; Friedman SR; Friedmann P; Goldberg D; Frischer M; Green S; Tunvig K; Ljungberg B; Wodak A; Ross M; Purchase D; Millson M, and Myers T. Maintaining low HIV seroprevalence in populations of injecting drug users. Journal of the American Medical Association. 1995; 274(15):1226-1231.

4/25 Molecular and social epidemiology methods combined

Frank Lowy

Ward H, Ison CA, Day SE; Martin I, Ghani AC, Garnett GP, Bell G, Kinghorn G, Weber JN. A prospective social and molecular investigation of gonococcal transmission. Lancet. 2000; 356(9244):1812-7.

Binswanger et al. High prevalence of abscesses and cellulitis among community recruited injection drug users in San Francisco. Clinical Infectious Diseases. 2000; 30: 579-81

Fleisch F, Zbinden R, Vanoli C, Ruef C. Epidemic spread of a single clone of methicillin-resistant Staphylococcus aureus among injection drug users in Zurich, Switzerland. Clinical Infectious Diseases. 2001;32(4):581-6.

Klovdahl AS, Graviss EA, Yaganehdoost A, Ross MC, Wanger A, Adams GJ, Musser JM. Networks and tuberculosis: an undetected community outbreak involving public places. Social Science & Medicine. 2001; 52:681-694.

5/2 Randomized community trials (STI focus)

Ron Gray

Grosskurth H, Gray R, Hayes R, Mabey D, Wawer M. Control of sexually transmitted diseases for HIV-1 prevention: understanding the implications of Mwanza and Rakai trials. Lancet 2000 355(9219):1981-7.

Gray RH, Quinn TC, Serwadda D, Sewankambo NK, Wabwire-Mangen F, Wawer MJ. The ethics of research in developing countries. N Engl J Med 2000 343(5):361-2.

Gray RH, Kiwanuka N, Quinn TC, Sweankambo NK, Serwadda D, Mangen FW, Lutalo T, Nalugoda F, Kelly R, Meehan M, Chen MZ, Li C, Wawer MJ. Male circumcision and HIV acquisition and transmission: cohort studies in Rakai, Uganda. Rakai Project Team. AIDS 2000 14(15):2371-81.

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