Molly F Franke1, J Gregory Jerome2, Wilfredo R Matias3, Ralph Ternier2, Isabelle J Hilaire2, Jason B Harris4, Louise C Ivers5. 1. Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA. Electronic address: molly_franke@hms.harvard.edu. 2. Zanmi Lasante/Partners In Health, Port au Prince, Haiti. 3. Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA. 4. Division of Infectious Diseases, Massachusetts General Hospital, Boston, MA, USA. 5. Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA; Division of Global Health Equity, Brigham and Women's Hospital, Boston, MA, USA.
Abstract
BACKGROUND: Case-control studies to quantify oral cholera vaccine effectiveness (VE) often rely on neighbors without diarrhea as community controls. Test-negative controls can be easily recruited and may minimize bias due to differential health-seeking behavior and recall. We compared VE estimates derived from community and test-negative controls and conducted bias-indicator analyses to assess potential bias with community controls. METHODS: From October 2012 through November 2016, patients with acute watery diarrhea were recruited from cholera treatment centers in rural Haiti. Cholera cases had a positive stool culture. Non-cholera diarrhea cases (test-negative controls and non-cholera diarrhea cases for bias-indicator analyses) had a negative culture and rapid test. Up to four community controls were matched to diarrhea cases by age group, time, and neighborhood. RESULTS: Primary analyses included 181 cholera cases, 157 non-cholera diarrhea cases, 716 VE community controls and 625 bias-indicator community controls. VE for self-reported vaccination with two doses was consistent across the two control groups, with statistically significant VE estimates ranging from 72 to 74%. Sensitivity analyses revealed similar, though somewhat attenuated estimates for self-reported two dose VE. Bias-indicator estimates were consistently less than one, with VE estimates ranging from 19 to 43%, some of which were statistically significant. CONCLUSIONS: OCV estimates from case-control analyses using community and test-negative controls were similar. While bias-indicator analyses suggested possible over-estimation of VE estimates using community controls, test-negative analyses suggested this bias, if present, was minimal. Test-negative controls can be a valid low-cost and time-efficient alternative to community controls for OCV effectiveness estimation and may be especially relevant in emergency situations.
BACKGROUND: Case-control studies to quantify oral cholera vaccine effectiveness (VE) often rely on neighbors without diarrhea as community controls. Test-negative controls can be easily recruited and may minimize bias due to differential health-seeking behavior and recall. We compared VE estimates derived from community and test-negative controls and conducted bias-indicator analyses to assess potential bias with community controls. METHODS: From October 2012 through November 2016, patients with acute watery diarrhea were recruited from cholera treatment centers in rural Haiti. Cholera cases had a positive stool culture. Non-cholera diarrhea cases (test-negative controls and non-cholera diarrhea cases for bias-indicator analyses) had a negative culture and rapid test. Up to four community controls were matched to diarrhea cases by age group, time, and neighborhood. RESULTS: Primary analyses included 181 cholera cases, 157 non-cholera diarrhea cases, 716 VE community controls and 625 bias-indicator community controls. VE for self-reported vaccination with two doses was consistent across the two control groups, with statistically significant VE estimates ranging from 72 to 74%. Sensitivity analyses revealed similar, though somewhat attenuated estimates for self-reported two dose VE. Bias-indicator estimates were consistently less than one, with VE estimates ranging from 19 to 43%, some of which were statistically significant. CONCLUSIONS:OCV estimates from case-control analyses using community and test-negative controls were similar. While bias-indicator analyses suggested possible over-estimation of VE estimates using community controls, test-negative analyses suggested this bias, if present, was minimal. Test-negative controls can be a valid low-cost and time-efficient alternative to community controls for OCV effectiveness estimation and may be especially relevant in emergency situations.
Authors: Vu Dinh Thiem; Jacqueline L Deen; Lorenz von Seidlein; Do Gia Canh; Dang Duc Anh; Jin-Kyung Park; Mohammad Ali; M Carolina Danovaro-Holliday; Nguyen Dinh Son; Nguyen Thai Hoa; Jan Holmgren; John D Clemens Journal: Vaccine Date: 2006-03-20 Impact factor: 3.641
Authors: Marcelino E S Lucas; Jacqueline L Deen; Lorenz von Seidlein; Xuan-Yi Wang; Julia Ampuero; Mahesh Puri; Mohammad Ali; M Ansaruzzaman; Juvenaldo Amos; Arminda Macuamule; Philippe Cavailler; Philippe J Guerin; Claude Mahoudeau; Pierre Kahozi-Sangwa; Claire-Lise Chaignat; Avertino Barreto; Francisco F Songane; John D Clemens Journal: N Engl J Med Date: 2005-02-24 Impact factor: 91.245
Authors: Edward A Belongia; Melissa D Simpson; Jennifer P King; Maria E Sundaram; Nicholas S Kelley; Michael T Osterholm; Huong Q McLean Journal: Lancet Infect Dis Date: 2016-04-06 Impact factor: 25.071
Authors: Andrew S Azman; Lucy A Parker; John Rumunu; Fisseha Tadesse; Francesco Grandesso; Lul L Deng; Richard Laku Lino; Bior K Bior; Michael Lasuba; Anne-Laure Page; Lameck Ontweka; Augusto E Llosa; Sandra Cohuet; Lorenzo Pezzoli; Dossou Vincent Sodjinou; Abdinasir Abubakar; Amanda K Debes; Allan M Mpairwe; Joseph F Wamala; Christine Jamet; Justin Lessler; David A Sack; Marie-Laure Quilici; Iza Ciglenecki; Francisco J Luquero Journal: Lancet Glob Health Date: 2016-11 Impact factor: 26.763
Authors: Anne-Laure Page; Iza Ciglenecki; Ernest Robert Jasmin; Laurence Desvignes; Francesco Grandesso; Jonathan Polonsky; Sarala Nicholas; Kathryn P Alberti; Klaudia Porten; Francisco J Luquero Journal: PLoS Negl Trop Dis Date: 2015-03-26
Authors: Huiying Chua; Shuo Feng; Joseph A Lewnard; Sheena G Sullivan; Christopher C Blyth; Marc Lipsitch; Benjamin J Cowling Journal: Epidemiology Date: 2020-01 Impact factor: 4.822
Authors: E Ferreras; A Blake; O Chewe; J Mwaba; G Zulu; M Poncin; A Rakesh; A L Page; M L Quilici; A S Azman; S Cohuet; I Ciglenecki; K Malama; E Chizema-Kawesha; F J Luquero Journal: Epidemiol Infect Date: 2020-03-13 Impact factor: 2.451
Authors: Molly F Franke; Ralph Ternier; J Gregory Jerome; Wilfredo R Matias; Jason B Harris; Louise C Ivers Journal: Lancet Glob Health Date: 2018-09 Impact factor: 26.763
Authors: Monika A Roy; Jean M Arnaud; Paul M Jasmin; Steve Hamner; Nur A Hasan; Rita R Colwell; Timothy E Ford Journal: Int J Environ Res Public Health Date: 2018-10-10 Impact factor: 3.390