1921
Volume 101, Issue 1
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

Abstract

Abstract.

To explore the consistency in impact evaluation based on reported diarrhea, we compared diarrhea data collected through two different surveys and with observed diarrhea-associated hospitalization for children aged ≤ 5 years from a non-blinded cluster-randomized trial conducted over 2 years in urban Dhaka. We have previously reported that the interventions did not reduce diarrhea-associated hospitalization for children aged ≤ 5 years in this trial. We randomly allocated 90 geographic clusters comprising > 60,000 low-income households into three groups: cholera vaccine only, vaccine plus behavior change (cholera vaccine and handwashing plus drinking water chlorination promotion), and control. We calculated reported diarrhea prevalence within the last 2 days using data collected from two different survey methods. The “census” data were collected from each household every 6 months for updating household demographic information. The “monthly survey” data were collected every month from a subset of randomly selected study households for monitoring the uptake of behavior change interventions. We used binomial regression with a logarithmic link accounting for clustering to compare diarrhea prevalence across intervention and control groups separately for both census and monthly survey data. No intervention impact was detected in the census (vaccine only versus control: 2.32% versus 2.53%; = 0.49; vaccine plus behavior change versus control: 2.44% versus 2.53%; = 0.78) or in the vaccine only versus control in the monthly survey (3.39% versus 3.80%; = 0.69). However, diarrhea prevalence was lower in the vaccine-plus-behavior-change group than control in the monthly survey (2.08% versus 3.80%; = 0.02). Although the reasons for different observed treatment effects in the census and monthly survey data in this study are unclear, these findings emphasize the importance of assessing objective outcomes along with reported outcomes from non-blinded trials.

[open-access] This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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References

  1. GBD 2017 Causes of Death Collaborators, 2018. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet 392: 17361788. [Google Scholar]
  2. Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE, , 2015. Global, regional, and national causes of child mortality in 2000–13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet 385: 430440. [Google Scholar]
  3. Walker CL, Perin J, Aryee MJ, Boschi-Pinto C, Black RE, , 2012. Diarrhea incidence in low-and middle-income countries in 1990 and 2010: a systematic review. BMC Public Health 12: 220. [Google Scholar]
  4. Black RE, Cousens S, Johnson HL, Lawn JE, Rudan I, Bassani DG, Jha P, Campbell H, Walker CF, Cibulskis R, , 2010. Global, regional, and national causes of child mortality in 2008: a systematic analysis. Lancet 375: 19691987. [Google Scholar]
  5. Boschi-Pinto C, Velebit L, Shibuya K, , 2008. Estimating child mortality due to diarrhoea in developing countries. Bull World Health Organ 86: 710717. [Google Scholar]
  6. Cairncross S, Feachem R, , 1993. Environmental Health Engineering in the Tropics: an Introductory Text. Chichester, UK: John Wiley & Sons Ltd. [Google Scholar]
  7. Emerson PM, Lindsay SW, Walraven GE, Faal H, Bøgh C, Lowe K, Bailey RL, , 1999. Effect of fly control on trachoma and diarrhoea. Lancet 353: 14011403. [Google Scholar]
  8. Fewtrell L, Kaufmann RB, Kay D, Enanoria W, Haller L, Colford JM, Jr., 2005. Water, sanitation, and hygiene interventions to reduce diarrhoea in less developed countries: a systematic review and meta-analysis. Lancet Infect Dis 5: 4252. [Google Scholar]
  9. Ejemot-Nwadiaro RI, Ehiri JE, Meremikwu MM, Critchley JA, , 2008. Hand washing for preventing diarrhoea. Cochrane Database Syst Rev 1: CD004265. [Google Scholar]
  10. Clasen T, Schmidt W-P, Rabie T, Roberts I, Cairncross S, , 2007. Interventions to improve water quality for preventing diarrhoea: systematic review and meta-analysis. BMJ 334: 782. [Google Scholar]
  11. Ejemot RI, Ehiri JE, Meremikwu MM, Critchley JA, , 2009. Cochrane review: hand washing for preventing diarrhoea. Evid Based Child Health 4: 893939. [Google Scholar]
  12. Clasen TF, Alexander KT, Sinclair D, Boisson S, Peletz R, Chang HH, Majorin F, Cairncross S, , 2015. Interventions to improve water quality for preventing diarrhoea. Cochrane Database Syst Rev 10: CD004794. [Google Scholar]
  13. Blum D, Feachem RG, , 1983. Measuring the impact of water supply and sanitation investments on diarrhoeal diseases: problems of methodology. Int J Epidemiol 12: 357365. [Google Scholar]
  14. Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA, , 2008. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ 336: 601605. [Google Scholar]
  15. Clemens JD, 1990. Field trial of oral cholera vaccines in Bangladesh: results from three-year follow-up. Lancet 335: 270273. [Google Scholar]
  16. Ali M, Emch M, von Seidlein L, Yunus M, Sack DA, Rao M, Holmgren J, Clemens JD, , 2005. Herd immunity conferred by killed oral cholera vaccines in Bangladesh: a reanalysis. Lancet 366: 4449. [Google Scholar]
  17. Clemens J, Harris J, Khan M, Ali M, Yunus M, Khan M, Svennerholm A-M, Sack D, Chakraborty J, Stanton B, , 1988. Impact of B subunit killed whole-cell and killed whole-cell-only oral vaccines against cholera upon treated diarrhoeal illness and mortality in an area endemic for cholera. Lancet 331: 13751379. [Google Scholar]
  18. McFarland LV, , 2006. Meta-analysis of probiotics for the prevention of antibiotic associated diarrhea and the treatment of Clostridium difficile disease. Am J Gastroenterol 101: 812822. [Google Scholar]
  19. Zar FA, Bakkanagari SR, Moorthi KMLST, Davis MB, , 2007. A Comparison of vancomycin and metronidazole for the treatment of Clostridium difficile–associated diarrhea, stratified by disease severity. Clin Infect Dis 45: 302307. [Google Scholar]
  20. Schmidt W-P, Arnold BF, Boisson S, Genser B, Luby SP, Barreto ML, Clasen T, Cairncross S, , 2011. Epidemiological methods in diarrhoea studies—an update. Int J Epidemiol 40: 16781692. [Google Scholar]
  21. Ercumen A, Naser AM, Unicomb L, Arnold BF, Colford JM, Jr. Luby SP, , 2015. Effects of source-versus household contamination of tubewell water on child diarrhea in rural Bangladesh: a randomized controlled trial. PLoS One 10: e0121907. [Google Scholar]
  22. Melo MC, Taddei JA, Diniz-Santos DR, May DS, Carneiro NB, Silva LR, , 2007. Incidence of diarrhea: poor parental recall ability. Braz J Infect Dis 11: 571579. [Google Scholar]
  23. Alam N, Henry FJ, Rahman MM, , 1989. Reporting errors in one-week diarrhoea recall surveys: experience from a prospective study in rural Bangladesh. Int J Epidemiol 18: 697700. [Google Scholar]
  24. Boerma JT, Black RE, Sommerfelt AE, Rustein SO, Bicego GT, , 1991. Accuracy and completeness of mothers’ recall of diarrhoea occurrence in pre-school children in demographic and health surveys. Int J Epidemiol 20: 10731080. [Google Scholar]
  25. Feikin DR, Audi A, Olack B, Bigogo GM, Polyak C, Burke H, Williamson J, Breiman RF, , 2010. Evaluation of the optimal recall period for disease symptoms in home-based morbidity surveillance in rural and urban Kenya. Int J Epidemiol 39: 450458. [Google Scholar]
  26. Ramakrishnan R, Venkatarao T, Koya P, Kamaraj P, , 1998. Influence of recall period on estimates of diarrhoea morbidity in infants in rural Tamilnadu. Indian J Public Health 43: 136139. [Google Scholar]
  27. Zafar SN, Luby S, Mendoza C, , 2010. Recall errors in a weekly survey of diarrhoea in Guatemala: determining the optimal length of recall. Epidemiol Infect 138: 264269. [Google Scholar]
  28. Colford JM, 2005. A randomized, controlled trial of in-home drinking water intervention to reduce gastrointestinal illness. Am J Epidemiol 161: 472482. [Google Scholar]
  29. Hellard ME, Sinclair MI, Forbes AB, Fairley CK, , 2001. A randomized, blinded, controlled trial investigating the gastrointestinal health effects of drinking water quality. Environ Health Perspect 109: 773778. [Google Scholar]
  30. Genser B, Strina A, Teles CA, Prado MS, Barreto ML, , 2006. Risk factors for childhood diarrhea incidence: dynamic analysis of a longitudinal study. Epidemiology 17: 658667. [Google Scholar]
  31. Hróbjartsson A, Thomsen AS, Emanuelsson F, Tendal B, Hilden J, Boutron I, Ravaud P, Brorson S, , 2013. Observer bias in randomized clinical trials with measurement scale outcomes: a systematic review of trials with both blinded and nonblinded assessors. CMAJ 185: E201E211. [Google Scholar]
  32. Hróbjartsson A, Thomsen AS, Emanuelsson F, Tendal B, Hilden J, Boutron I, Ravaud P, Brorson S, , 2012. Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors. BMJ 344: e1119. [Google Scholar]
  33. Schmidt W-P, Cairncross S, , 2009. Household water treatment in poor populations: is there enough evidence for scaling up now? Environ Sci Technol 43: 986992. [Google Scholar]
  34. Arnold BF, Colford JM, , 2007. Treating water with chlorine at point-of-use to improve water quality and reduce child diarrhea in developing countries: a systematic review and meta-analysis. Am J Trop Med Hyg 76: 354364. [Google Scholar]
  35. Qadri F, 2015. Feasibility and effectiveness of oral cholera vaccine in an urban endemic setting in Bangladesh: a cluster randomised open-label trial. Lancet 386: 13621371. [Google Scholar]
  36. Najnin N, 2017. Impact of adding hand-washing and water disinfection promotion to oral cholera vaccination on diarrhoea-associated hospitalization in Dhaka, Bangladesh: evidence from a cluster randomized control trial. Int J Epidemiol 46: 20562066. [Google Scholar]
  37. Amin N, Pickering AJ, Ram PK, Unicomb L, Najnin N, Homaira N, Ashraf S, Abedin J, Islam MS, Luby SP, , 2014. Microbiological evaluation of the efficacy of soapy water to clean hands: a randomized, non-inferiority field trial. Am J Trop Med Hyg 91: 415423. [Google Scholar]
  38. Dreibelbis R, Winch PJ, Leontsini E, Hulland KR, Ram PK, Unicomb L, Luby SP, , 2013. The integrated behavioural model for water, sanitation, and hygiene: a systematic review of behavioural models and a framework for designing and evaluating behaviour change interventions in infrastructure-restricted settings. BMC Public Health 13: 1015. [Google Scholar]
  39. Platts-Mills JA, 2015. Pathogen-specific burdens of community diarrhoea in developing countries: a multisite birth cohort study (MAL-ED). Lancet Glob Health 3: e564e575. [Google Scholar]
  40. Ruxton GD, , 2017. Allocation concealment as a potentially useful aspect of randomised experiments. Behav Ecol Sociobiol 71: 31. [Google Scholar]
  41. Nederhof AJ, , 1985. Methods of coping with social desirability bias: a review. Eur J Soc Psychol 15: 263280. [Google Scholar]
  42. Van de Mortel TF, , 2008. Faking it: social desirability response bias in self-report research. Aust J Adv Nurs 25: 40. [Google Scholar]
  43. Zwane AP, Zinman J, Van Dusen E, Pariente W, Null C, Miguel E, Kremer M, Karlan DS, Hornbeck R, Giné X, , 2011. Being surveyed can change later behavior and related parameter estimates. Proc Natl Acad Sci 108: 18211826. [Google Scholar]
  44. Schmidt W-P, Luby SP, Genser B, Barreto ML, Clasen T, , 2007. Estimating the longitudinal prevalence of diarrhea and other episodic diseases: continuous versus intermittent surveillance. Epidemiology 18: 537543. [Google Scholar]
  45. WHO, 2005. The Treatment of Diarrhoea: A Manual for Physicians and Other Senior Health Workers. Geneva, Switzerland: World Health Organization. [Google Scholar]
  46. Diniz-Santos DR, Santana JS, Barretto JR, Andrade MG, Silva LR, , 2005. Epidemiological and microbiological aspects of acute bacterial diarrhea in children from Salvador, Bahia, Brazil. Braz J Infect Dis 9: 7783. [Google Scholar]
  47. Newman RD, Sears CL, Moore SR, Nataro JP, Wuhib T, Agnew DA, Guerrant RL, Lima AA, , 1999. Longitudinal study of Cryptosporidium infection in children in northeastern Brazil. J Infect Dis 180: 167175. [Google Scholar]
  48. Lima A, Moore S, Barboza M, Soares A, Schleupner M, Newman R, Sears C, Nataro J, Fedorko D, Wuhib T, , 2000. Persistent diarrhea signals a critical period of increased diarrhea burdens and nutritional shortfalls: a prospective cohort study among children in northeastern Brazil. J Infect Dis 181: 16431651. [Google Scholar]
  49. Haque R, Mondal D, Kirkpatrick BD, Akther S, Farr BM, Sack RB, Petri WA, , 2003. Epidemiologic and clinical characteristics of acute diarrhea with emphasis on Entamoeba histolytica infections in preschool children in an urban slum of Dhaka, Bangladesh. Am J Trop Med Hyg 69: 398405. [Google Scholar]
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  • Received : 01 Nov 2018
  • Accepted : 16 Apr 2019
  • Published online : 03 Jul 2019

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