Correction: Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols (PLoS ONE (2017) 12:7 (e0180220) DOI: 10.1371/journal.pone.0180220);Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols

PLoS ONE

Volumn 12, Issue 7, 2017, Pages

  Reveiz, Ludovic ^a   Haby, Michelle M ^b   Martínez Vega, Ruth ^c   Pinzón Flores, Carlos E ^d,e   Elias, Vanessa ^a   Smith, Emma ^a,f   Pinart, Mariona ^g   Broutet, Nathalie ^h   Becerra Posada, Francisco ^a   Aldighieri, Sylvain ^a   Van Kerkhove, Maria D ^h,i  

^a PAN AMERICAN HEALTH ORGANIZATION   (United States)

^b UNIVERSIDAD DE SONORA   (Mexico)

^c UNIVERSIDAD DE SANTANDER   (Colombia)

^d UNIVERSIDAD DE LA SABANA   (Colombia)

^e Instituto de Evaluación Tecnológica en Salud IETS   (Colombia)

^f YALE UNIVERSITY   (United States)

^g UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^h WORLD HEALTH ORGANIZATION   (Switzerland)

ⁱ INSTITUT PASTEUR   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CASE CONTROL STUDY; CLINICAL PROTOCOL; CLINICAL RESEARCH; CONFOUNDING VARIABLE; CONGENITAL MALFORMATION; FOLLOW UP; GUILLAIN BARRE SYNDROME; HUMAN; MICROCEPHALY; OBSERVATIONAL STUDY; SELECTION BIAS; SYSTEMATIC ERROR; ZIKA FEVER; COHORT ANALYSIS; COMPLICATION; EPIDEMIC; FEMALE; GUILLAIN-BARRE SYNDROME; PATHOGENICITY; PATHOLOGY; PATHOPHYSIOLOGY; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PUBLIC HEALTH; RISK FACTOR; VIROLOGY; WORLD HEALTH ORGANIZATION; ZIKA VIRUS; ZIKA VIRUS INFECTION;

CASE-CONTROL STUDIES; COHORT STUDIES; DISEASE OUTBREAKS; FEMALE; GUILLAIN-BARRE SYNDROME; HUMANS; MICROCEPHALY; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PUBLIC HEALTH; RISK FACTORS; WORLD HEALTH ORGANIZATION; ZIKA VIRUS; ZIKA VIRUS INFECTION;

EID: 85022182656     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0189027     Document Type: Erratum

References (66)

1. Duffy MR, Chen TH, Hancock WT, Powers AM, Kool JL, Lanciotti RS, et al. Zika virus outbreak on Yap Island, Federated States of Micronesia. N Engl J Med. 2009; 360(24):2536-43. https://doi.org/10.1056/NEJMoa0805715 PMID: 19516034.
2. Cao-Lormeau VM, Roche C, Teissier A, Robin E, Berry AL, Mallet HP, et al. Zika virus, French polyne-sia, South pacific, 2013 [Letter]. Emerg Infect Dis. 2014; 20(6):1085-6. https://doi.org/10.3201/eid2006.140138 PMID: 24856001;
3. WHO. Zika Situation Report: Zika virus, Microcephaly and Guillain-Barré syndrome-27 October 2016: World Health Organization; 2016 [31 October 2016]. http://www.who.int/emergencies/zika-virus/situation-report/27-october-2016/en/.
4. WHO Director-General summarizes the outcome of the Emergency Committee regarding clusters of microcephaly and Guillain–Barré syndrome [Internet]. World Health Organization; 2016; February 1, [cited February 2, 2016]. http://www.who.int/mediacentre/news/statements/2016/emergencycommittee-zika-microcephaly/en/
5. CDC. Revised diagnostic testing for Zika, chikungunya, and dengue viruses in US Public Health Laboratories Centers for Disease Control, Division of Vector-Borne Diseases, 2016 7 February 2016. Report No.
6. Barreto de Araujo TV, Rodrigues LC, de Alencar Ximenes RA, de Barros Miranda-Filho D, Montarroyos UR, de Melo AP, et al. Association between Zika virus infection and microcephaly in Brazil, January to May, 2016: preliminary report of a case-control study. Lancet Infect Dis. 2016; 16(12):1356–63. https://doi.org/10.1016/S1473-3099(16)30318-8 PMID: 27641777.
7. Brasil P, Pereira JP Jr., Moreira ME, Ribeiro Nogueira RM, Damasceno L, Wakimoto M, et al. Zika Virus Infection in Pregnant Women in Rio de Janeiro. N Engl J Med. 2016; 375(24):2321–34. https://doi.org/10.1056/NEJMoa1602412 PMID: 26943629.
8. Cauchemez S, Besnard M, Bompard P, Dub T, Guillemette-Artur P, Eyrolle-Guignot D, et al. Association between Zika virus and microcephaly in French Polynesia, 2013–15: a retrospective study. Lancet. 2016; 387(10033):2125–32. https://doi.org/10.1016/S0140-6736(16)00651-6 PMID: 26993883;
9. Cuevas EL, Tong VT, Rozo N, Valencia D, Pacheco O, Gilboa SM, et al. Preliminary Report of Microcephaly Potentially Associated with Zika Virus Infection During Pregnancy—Colombia, January-November 2016. MMWR Morb Mortal Wkly Rep. 2016; 65(49):1409–13. https://doi.org/10.15585/mmwr.mm6549e1 PMID: 27977645.
10. Cao-Lormeau VM, Blake A, Mons S, Lastere S, Roche C, Vanhomwegen J, et al. Guillain-Barre Syndrome outbreak associated with Zika virus infection in French Polynesia: a case-control study. Lancet. 2016; 387(10027):1531–9. https://doi.org/10.1016/S0140-6736(16)00562-6 PMID: 26948433.
11. Dos Santos T, Rodriguez A, Almiron M, Sanhueza A, Ramon P, de Oliveira WK, et al. Zika Virus and the Guillain-Barre Syndrome—Case Series from Seven Countries. N Engl J Med. 2016; 375(16):1598–601. https://doi.org/10.1056/NEJMc1609015 PMID: 27579558.
12. Krauer F, Riesen M, Reveiz L, Oladapo OT, Martinez-Vega R, Porgo TV, et al. Zika Virus Infection as a Cause of Congenital Brain Abnormalities and Guillain-Barre Syndrome: Systematic Review. PLoS Med. 2017; 14(1):e1002203. https://doi.org/10.1371/journal.pmed.1002203 PMID: 28045901.
13. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000; 342(25):1887–92. https://doi.org/10.1056/NEJM200006223422507 PMID: 10861325
14. Grimes DA, Schulz KF. Bias and causal associations in observational research. The Lancet. 2002; 359 (9302):248–52.
15. Gonzalez U, Pinart M, Reveiz L, Rengifo-Pardo M, Tweed J, Macaya A, et al. Designing and reporting clinical trials on treatments for cutaneous leishmaniasis. Clin Infect Dis. 2010; 51(4):409–19. https://doi.org/10.1086/655134 PMID: 20624067.
16. Van Kerkhove MD, Reveiz L, Souza JP, Jaenisch T, Carson G, Broutet N, et al. Harmonisation of Zika virus research protocols to address key public health concerns. Lancet Glob Health. 2016. https://doi.org/10.1016/S2214-109X(16)30255-8 PMID: 27815145.
17. WHO, Institut Pasteur. Standardized Protocol: Case-control study to assess potential risk factors related to microcephaly caused by Zika virus infection during pregnancy: World Health Organization and Institut Pasteur; 2016. http://origin.who.int/reproductivehealth/zika/zika-virus-research-agenda/en/.
18. WHO, Institut Pasteur. Standardized Protocol: Case-control study to assess potential risk factors related to Guillan-Barré Syndrome caused by Zika virus infection: World Health Organization and Institut Pasteur; 2016. http://origin.who.int/reproductivehealth/zika/zika-virus-research-agenda/en/.
19. WHO, Institut Pasteur. Standardized Protocol: Prospective longitudinal cohort study of newborns and infants born to mothers exposed to ZIKV during pregnancy: World Health Organization and Institut Pasteur; 2016. http://origin.who.int/reproductivehealth/zika/zika-virus-research-agenda/en/.
20. WHO, Institut Pasteur. Standardized Protocol: Prospective longitudinal cohort study of women and newborns exposed to ZIKV during the course of pregnancy: World Health Organization and Institut Pasteur; 2016. http://origin.who.int/reproductivehealth/zika/zika-virus-research-agenda/en/.
21. WHO, Institut Pasteur. Standardized Protocol: Prospective longitudinal cohort study of Zika-infected patients to measure the persistence of Zika virus in body fluids: World Health Organization and Institut Pasteur; 2016. http://origin.who.int/reproductivehealth/zika/zika-virus-research-agenda/en/.
22. WHO, Institut Pasteur. Standardized Protocol: Cross-sectional seroprevalence study of Zika virus infection in the general population: World Health Organization and Institut Pasteur; 2016. http://origin.who.int/reproductivehealth/zika/zika-virus-research-agenda/en/.
23. Benchimol EI, Smeeth L, Guttmann A, Harron K, Hemkens LG, Moher D, et al. [The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement]. Z Evid For-tbild Qual Gesundhwes. 2016; 115–116:33–48. PMID: 27837958;
24. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, et al. STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies. Clin Chem. 2015; 61(12):1446–52. https://doi.org/10.1373/clinchem.2015.246280 PMID: 26510957.
25. Fitchett EJ, Seale AC, Vergnano S, Sharland M, Heath PT, Saha SK, et al. Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE-NI): an extension of the STROBE statement for neonatal infection research. Lancet Infect Dis. 2016; 16(10):e202–13. https://doi.org/10.1016/S1473-3099(16)30082-2 PMID: 27633910.
26. von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med. 2007; 4(10):e296. https://doi.org/10.1371/journal.pmed.0040296PMID: 17941714;
27. Porta M, Greenland S, Hernán M, Silva IdS, Last JM, for the International Epidemiological Association, editors. A dictionary of epidemiology. 6th ed. New York, NY: Oxford University Press; 2014.
28. Bonita R, Beaglehole R, Kjellstrom T. Basic epidemiology. 2nd ed. Geneva: World Health Organization; 2006. 212 p.
29. MAGIC. Tool to Assess Risk of Bias in Cohort Studies [January 22, 2017]. http://help.magicapp.org/knowledgebase/articles/327941-tool-to-assess-risk-of-bias-in-cohort-studies.
30. Viswanathan M, Berkman ND, Dryden DM, Hartling L. Assessing risk of bias and confounding in observational studies of interventions or exposures: Further development of the RTI item bank. Methods research report. (Prepared by RTI–UNC Evidence-based Practice Center under Contract No. 290-2007-10056-I). AHRQ Publication No. 13-EHC106-EF. Rockville, MD: Agency for Healthcare Research and Quality, 2013.
31. Paixao ES, Barreto F, Teixeira Mda G, Costa Mda C, Rodrigues LC. History, epidemiology, and clinical manifestations of Zika: a systematic review. Am J Public Health. 2016; 106(4):606–12. https://doi.org/10.2105/AJPH.2016.303112 PMID: 26959260;
32. Haug CJ, Kieny MP, Murgue B. The Zika Challenge. N Engl J Med. 2016; 374(19):1801–3. https://doi.org/10.1056/NEJMp1603734 PMID: 27028782.
33. Priyamvada L, Quicke KM, Hudson WH, Onlamoon N, Sewatanon J, Edupuganti S, et al. Human antibody responses after dengue virus infection are highly cross-reactive to Zika virus. Proc Natl Acad Sci U S A. 2016; 113(28):7852–7. https://doi.org/10.1073/pnas.1607931113 PMID: 27354515;
34. Steinhagen K, Probst C, Radzimski C, Schmidt-Chanasit J, Emmerich P, van Esbroeck M, et al. Sero-diagnosis of Zika virus (ZIKV) infections by a novel NS1-based ELISA devoid of cross-reactivity with dengue virus antibodies: a multicohort study of assay performance, 2015 to 2016. Euro Surveill. 2016; 21(50):30426. https://doi.org/10.2807/1560-7917.ES.2016.21.50.30426 PMID: 28006649;
35. PAHO. Case definitions: Pan American Health Organization; 2016 [28 October 2016]. http://www.paho.org/hq/index.php?option=com_content&view=article&id=11117:2015-zika-case-definitions-&Itemid= 41532&lang=en.
36. WHO, Institut Pasteur. Harmonization of ZIKV research protocols to address key public health concerns: World Health Organization and Institut Pasteur; 2016. http://origin.who.int/reproductivehealth/zika/zika-virus-research-agenda/en/.
37. Corman VM, Rasche A, Baronti C, Aldabbagh S, Cadar D, Reusken CB, et al. Assay optimization for molecular detection of Zika virus. Bulletin World Health Organization. 2016; 94(12):880–92. https://doi.org/10.2471/BLT.16.175950 PMID: 27994281;
38. Goebel S, Snyder B, Sellati T, Saeed M, Ptak R, Murray M, et al. A sensitive virus yield assay for evaluation of Antivirals against Zika Virus. J Virol Methods. 2016; 238:13–20. https://doi.org/10.1016/j.jviromet.2016.09.015 PMID: 27678028.
39. WHO. Laboratory testing for Zika virus infection. Interim guidance. 23 March 2016. WHO/ZIKV/LAB/ 16.1. World Health Organization, 2016.
40. WHO. Zika virus research agenda. October 2016 2016 [cited 2017 10 January]. http://www.who.int/reproductivehealth/zika/zika-virus-research-agenda/en/.
41. Landry ML, St George K. Laboratory diagnosis of zika virus infection. Arch Pathol Lab Med. 2017; 141 (1):60–7. https://doi.org/10.5858/arpa.2016-0406-SA PMID: 27763787.
42. Mayeux R. Biomarkers: Potential Uses and Limitations. NeuroRx. 2004; 1(2):182–8. https://doi.org/10.1602/neurorx.1.2.182 PMID: 15717018
43. WHO, Institut Pasteur. Screening, assessment and management of neonates and infants with complications associated with Zika virus exposure in utero. Interim Guidance Update. World Health Organization, 2016.
44. Russell K, Oliver SE, Lewis L, Barfield WD, Cragan J, Meaney-Delman D, et al. Update: Interim Guidance for the Evaluation and Management of Infants with Possible Congenital Zika Virus Infection—United States, August 2016. MMWR Morb Mortal Wkly Rep. 2016; 65(33):870–8. https://doi.org/10.15585/mmwr.mm6533e2 PMID: 27559830.
45. Sejvar JJ, Kohl KS, Gidudu J, Amato A, Bakshi N, Baxter R, et al. Guillain-Barre syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data. Vaccine. 2011; 29(3):599–612. https://doi.org/10.1016/j.vaccine.2010.06.003 PMID: 20600491.
46. WHO. Identification and management of Guillain-Barré syndrome in the context of Zika virus. Interim guidance update. 22 August 2016. WHO/ZIKV/MOC/16.4 Rev.1. World Health Organization, 2016.
47. WHO. Case Definitions: Pan American Health Organization/World Health Organization; 2016 [updated 18 April 20161 July 2016]. http://www.paho.org/hq/index.php?option=com_content&view=article&id=11117&Itemid=41532&lang=en.
48. Stegmann BJ, Carey JC. TORCH Infections. Toxoplasmosis, Other (syphilis, varicella-zoster, parvovirus B19), Rubella, Cytomegalovirus (CMV), and Herpes infections. Curr Womens Health Rep. 2002; 2 (4):253–8. Epub 2002/08/02. PMID: 12150751.
49. Cragan JD, Isenburg JL, Parker SE, Alverson CJ, Meyer RE, Stallings EB, et al. Population-based microcephaly surveillance in the United States, 2009 to 2013: An analysis of potential sources of variation. Birth Defects Res A Clin Mol Teratol. 2016; 106(11):972–82. https://doi.org/10.1002/bdra.23587PMID: 27891783.
50. Krauss MJ, Morrissey AE, Winn HN, Amon E, Leet TL. Microcephaly: an epidemiologic analysis. Am J Obstet Gynecol. 2003; 188(6):1484–9; discussion 9–90. PMID: 12824982.
51. Malone RW, Homan J, Callahan MV, Glasspool-Malone J, Damodaran L, Schneider Ade B, et al. Zika virus: medical countermeasure development challenges. PLoS Negl Trop Dis. 2016; 10(3):e0004530. https://doi.org/10.1371/journal.pntd.0004530 PMID: 26934531;
52. Grimes DA, Schulz KF. Cohort studies: marching towards outcomes. Lancet. 2002; 359(9303):341–5. https://doi.org/10.1016/S0140-6736(02)07500-1 PMID: 11830217
53. Mann CJ. Observational research methods. Research design II: cohort, cross sectional, and case-control studies. Emerg Med J. 2003; 20(1):54–60. https://doi.org/10.1136/emj.20.1.54 PMID: 12533370
54. White E, Hunt JR, Casso D. Exposure measurement in cohort studies: the challenges of prospective data collection. Epidemiol Rev. 1998; 20(1):43–56. Epub 1998/10/08. PMID: 9762508.
55. Hill AB. The Environment and Disease: Association or Causation? Proc R Soc Med. 1965; 58(5):295–300.
56. Sedgwick P. Prospective cohort studies: advantages and disadvantages. BMJ. 2013; 347:f6726.
57. Kristman V, Manno M, Cote P. Loss to follow-up in cohort studies: how much is too much? Eur J Epidemiol. 2004; 19(8):751–60. Epub 2004/10/08. PMID: 15469032.
58. Aiken AR, Scott JG, Gomperts R, Trussell J, Worrell M, Aiken CE. Requests for abortion in Latin America related to concern about zika virus exposure. N Engl J Med. 2016; 375(4):396–8. https://doi.org/10.1056/NEJMc1605389 PMID: 27331661;
59. Diniz D, Gumieri S, Bevilacqua BG, Cook RJ, Dickens BM. Zika virus infection in Brazil and human rights obligations. Int J Gynaecol Obstet. 2017; 136(1):105–10. PMID: 28099714.
60. Harville EW, Althabe FA, Breart G, Buekens P. The Difficult Design of Epidemiologic Studies on Zika Virus and Pregnancy. Paediatr Perinat Epidemiol. 2016. https://doi.org/10.1111/ppe.12312 PMID: 27766638.
61. The Center for Reproductive Rights. The World’s Abortion Laws: 2016 2016 [updated 20166 July 2016]. http://worldabortionlaws.com/map/.
62. Wacholder S, McLaughlin JK, Silverman DT, Mandel JS. Selection of controls in case-control studies: I. Principles. Am J Epidemiol. 1992; 135(9):1019–28. PMID: 1595688
63. Wacholder S, Silverman DT, McLaughlin JK, Mandel JS. Selection of controls in case-control studies: II. Types of controls. Am J Epidemiol. 1992; 135(9):1029–41. PMID: 1595689
64. Ury HK. Efficiency of case-control studies with multiple controls per case: continuous or dichotomous data. Biometrics. 1975; 31(3):643–9. PMID: 1100136
65. Woodward M. Epidemiology: Study Design and Data Analysis. 2nd ed. London: Chapman & Hall/ CRC; 2005.
66. Wacholder S, Silverman DT, McLaughlin JK, Mandel JS. Selection of controls in case-control studies: III. Design options. Am J Epidemiol. 1992; 135(9):1042–50. PMID: 1595690