Campbell International Development Group Title Registration Form Please complete this form to outline your proposal for a Campbell International Development Group systematic review. Email the completed form to Martina Vojtkova, Coordinator, Campbell International Development Group: mvojtkova@3ieimpact.org. Tel: +44 20 7958 8351. Before completing this form: Make sure that your proposal falls within our scope, and that it has not already been covered in another Campbell or Cochrane review. Check existing registered titles at: www.campbellcollaboration.org/library.php and www.cochrane.org/reviews/en/topics. Authors are advised to use the Cochrane Handbook for Systematic Reviews of Interventions (see www.cochrane-handbook.org). Be aware that preparing a Campbell review requires a significant, long-term commitment. At least two authors are required before a title can be registered. 1. Title of review Suggested format: [intervention/s] for [outcome/s] in [problem/population] in [location/situation] Example: Water and sanitation interventions for reducing child diarrhoea in low and middle income countries. Concurrent deworming of soil-transmitted helminths and schistosomiasis for improving school attendance and cognition in school-aged children in low and middle income countries: a systematic review International Development Group title registration form revised 11 th April 2011 1
2. Background and objective(s) of review Briefly describe the problem, the intervention(s), the relevance to policy and practice, and the objective(s) of the review, including important sub-questions. Will you develop a logic model (theory of change) to illustrate the hypothesized mechanism of action (that is, how the intervention is expected to work)? Is there potential for differences in relative effects between advantaged and disadvantaged populations? The burden of disease of soil-transmitted helminths and schistosomiasis was estimated at almost 3 million DALYS (disability adjusted life years) globally in 2004 according to the WHO s Global Burden of Disease. Most of the burden of disease is due to morbidity not mortality since soil-transmitted helminths and schistosomiasis cause chronic morbidity. Soil transmitted helminths (e.g. hookworms) and Schistosomiasis infections act through one or more of five mechanisms on the nutritional status of their host: 1) feeding on the host s gut contents; 2) feeding on host tissues (e.g. blood serum); 3) causing maldigestion or malabsorption; 4) inflammatory responses; and 5) responses to infection that affect use of nutrients (Hall 2008). In school-aged children, STH and schistosomiasis infections are hypothesized to lead to poor attendance at school due to illness and fatigue. The World Health Assembly resolution 54.19 (May 2001) endorsed a strategy for control of schistosomiasis and soil-transmitted helminths in high-transmission areas. Several international organizations are involved in deworming schoolchildren including the World Health Organization (WHO), Deworm the World, the World Food Programme and UNICEF. The WHO recommends deworming for soil transmitted helminths when prevalence is above 20% and for any prevalence of schistosomiasis. Despite the focus on concurrent deworming of both STH and shistosomiasis, there is no systematic review which assesses the impact of this combination treatment on human important outcomes of child nutritional status, stunting and school attendance. We will construct a logic model to elucidate the causal chain from infection to nutritional status to educational effects including attendance and academic performance. Mediating factors will be considered such as baseline prevalence of infection, hygiene habits, poverty, under-nutrition and sanitation. International Development Group title registration form revised 11 th April 2011 2
3. Existing reviews Briefly describe any existing systematic reviews on the topic, and justify the need for this review if existing reviews exist or are in progress. Three systematic reviews have been identified. A Cochrane review (Taylor- Robinson 2007) assessed the effectiveness of geohelminth treatment on health and cognition. Schistosomiasis treatment was excluded if it was given to only the treatment but not the control group. This review concluded that deworming may be effective on weight gain, but there was no improvement in school performance demonstrated. This review has addressed two criticisms of an earlier review (Dickson 2000) by assessing the role of longer follow-up and assessing the role of prevalence of infection (Engels and Savioli 2009). However, this Cochrane review does not address the possibility of treatment externalities that deworming children has an effect on infection and reinfection rates in control communities and untreated individuals, including household members (Bundy 2009). Furthermore, the lack of effect on cognitive outcomes needs to be interpreted in the context of poverty, health status and the learning environment provided. Secondly, effects on school attendance need to be assessed with consideration to the validity of school attendance records compared to on-site checks. (Bundy 2009). Furthermore, this systematic review does not assess the effect of combination treatment for both schistosomiasis and soil transmitted helminths. Concurrent treatment for soil transmitted helminths and schistosomiasis has been shown in another systematic review to be more effective at reducing anaemia than albendazole or praziquantel alone (Smith 2010). This review did not assess school attendance or cognition. Concurrent treatment is also the recommended strategy of the World Health Organization (WHO 2004) and others active in deworming such as the Poverty Action Lab. Combination therapy has been postulated to improve adherence (Namwanje 2011). A second review by Hall et al 2008 of treatment for soil transmitted helminths only (schistosomiasis concurrent treatment was excluded) found statistically significant effects on height (0.06 Z score of height for age, 95% confidence interval 0.03 to 0.08) and weight for age (Z score 0.09, 95% confidence interval of 0.06 to 0.11) (Hall 2008). Both of the above systematic reviews found statistically significant heterogeneity that was not explained by subgroup and sensitivity analyses to assess the role of prevalence of infection, frequency of dosing or risk of bias. Hall 2008 hypothesizes that some of the heterogeneity may be explained by variation in effects according to intensity of worm infection. The children with very intense worm infections are likely to benefit the most, whilst others may not benefit at International Development Group title registration form revised 11 th April 2011 3
all. Thus, the mean effect may be diluted by the average children. A third systematic review assessed the effects of deworming on anaemia (Smith 2010). This review did not assess attendance and cognitive outcomes. The objective of this current review is to evaluate the effects of concurrent deworming for both schistosomiasis and soil transmitted helminths on school attendance and cognition. The rationale for assessing the effects of concurrent treatment is that the most current WHO guidelines recommend concurrent treatment whenever worm prevalence is over 50% (WHO 2006), and that evidence suggests the effect on hemoglobin and anaemia is larger for concurrent than single therapy (Smith 2010). References Taylor-Robinson DC, Jones AP, Garner P. Deworming drugs for treating soiltransmitted intestinal worms in children: effects on growth and school performance. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD000371. DOI: 10.1002/14651858.CD000371.pub3. Dickson R.,Williamson P., Awasthi S. & Demellweek C. Anthelmintic drugs for treating worms in children: effects on growth and cognitive performance.cochrane Database of Systematic Reviews 2000,CD000371. Namwanje H, Kabatereine, Olsen A. A randomised controlled clinical trial on the safety of co-administration of albendazole, ivermectin and praziquantel in infected schoolchildren in Uganda Transactions of the Royal Society of Tropical Medicine and Hygiene. 2011: 105 (4); 181-188. Hall A, Hewitt G, Tuffrey V, de Silva N. A review and meta-analysis of the impact of intestinal worms on child growth and nutrition. Matern Child Nutr. 2008 Apr;4 Suppl 1:118-236. Miguel E, Kremer M (2004) Worms: identifying impacts on education and health in the presence of treatment externalities. Econometrica 72: 159 217 Smith JL, Brooker S. Impact of hookworm infection and deworming on anaemia in non-pregnant populations: a systematic review. Trop Med Int Health. 2010 July; 15(7): 776 795. http://www.ncbi.nlm.nih.gov/pmc/articles/pmc2916221/ World Health Organisation. Report of the third global meeting of the partners for parasite control: Deworming for health and development, World Health Organization, Geneva, 2005. http://whqlibdoc.who.int/hq/2005/who_cds_cpe_pvc_2005.14.pdf International Development Group title registration form revised 11 th April 2011 4
4. Define the population Who is included and who is excluded? Are disadvantaged populations included, defined across PROGRESS-Plus categories? 1 All children in low and middle income countries will be included, up to 16 years of age. We will describe characteristics of populations across categories of disadvantage including socioeconomic status, place of residence (rural/urban), and country. 5. Define the intervention(s) What is given, by whom, to whom, and for how long? What are the comparison conditions (what is usually provided to control/comparison groups who don t receive the intervention)? Are interventions aimed at the disadvantaged? We will include studies of combined treatment of geohelminth and schistosomiasis deworming. We will include any dose and frequency of deworming. We will include combination of albendazole (piperazine) as well as other drugs used for soil transmitted infection (e.g. ivermectin, pyrantel, levamisole, mebendazole) combined with schistosomiasis treatment (praziquantel). Concurrent interventions such as nutritional supplements and hygiene promotion will be allowed, only if given to both treatment and control groups. Comparator We will include comparison of concurrent treatment to single treatment of either STH or schistosomiasis, to attention-control, to placebo and to no treatment. 1 Disadvantage can be measured across categories of social differentiation, using the mnemonic PROGRESS-Plus. PROGRESS is an acronym for Place of Residence, Race/Ethnicity, Occupation, Gender, Religion, Education, Socioeconomic Status, and Social Capital, and Plus represents additional categories such as Age, Disability, and Sexual Orientation. International Development Group title registration form revised 11 th April 2011 5
6. Outcome(s) What are the intended effects of the intervention? What are the potential or unintended effects of the intervention? Primary and secondary (intermediate) outcomes for the review should all be mentioned, together with beneficial and, if applicable, adverse effects. Note relevant and important outcomes for the appropriate disadvantaged groups. The major outcomes are school achievement, attendance, nutritional status, fatigue, diarrhoea and serious adverse events. We will also extract resource use and cost data, if available, from included studies. This systematic review will not synthesize cost-effectiveness studies. 7. Methodology What types of studies are to be included and excluded: please describe eligible study designs, measures, and duration of follow-ups. Briefly describe proposed data sources, search strategies and methods of synthesis. Where the review aims to include quantitative and qualitative evidence, specify which of the review questions noted in section 2 will be addressed using each type of evidence. We will include randomized controlled trials, interrupted time series designs and controlled before after designs as well as non-randomized studies that meet the design criteria of the Campbell International Development Review Group, including regression discontinuity designs, instrumental variables analysis, studies that use matching on propensity scores or covariates and difference in differences regression analysis. Data sources: We will search electronic databases (including health, nutrition and international development databases such as LILACS, IDEAS, MEDLINE, CINAHL), search the references of included studies, conduct a SCOPUS search for citations of included studies, and search relevant specialized registers (e.g. Cochrane infectious diseases, Campbell international development review group). We will also conduct a grey literature search using databases (eg SIGLE and Graylit), and websites. We will assess the methodological quality of studies using appropriate tools. For randomized trials, we will use the Cochrane risk of bias tool. For other study designs, we will use validated tools appropriate to the design of the study. International Development Group title registration form revised 11 th April 2011 6
METHODS We will conduct a meta-analysis using Campbell and Cochrane Collaboration methods, if possible. We will consider potential effect modifiers and assumptions on the causal chain in the quantitative and qualitative analysis. 8. Review team List names of those who will be cited as authors on the final publication. Lead reviewer Name: Vivian Andrea Welch This is the person who Title: Deputy director develops and coordinates the review team, discusses and assigns roles for individual members of the review team, liaises Affiliation: Centre for Global Health, University of Ottawa Address: 1 Stewart Street, Ottawa State, Province or County: Ontario Postal Code:k1n-6n5 Country: Canada with the editorial base Phone: 6135625800 ext 2921 and takes responsibility Email: vivian.welch@uottawa.ca for the on-going updates of the review Co-author There should be at least one co-author Name: Peter Tugwell Affiliation:Faculty of Medicine, University of Ottawa Country:Canada Email:tugwellb@uottawa.ca Co-author If applicable Co-author If applicable Co-author If applicable Name: Tamara Rader Affiliation: University of Ottawa Country:Canada Email:trader@uottawa.ca Name: Affiliation: Country: Email: Name: Affiliation: International Development Group title registration form revised 11 th April 2011 7
Country: Email: 9. Roles and responsibilities Please give brief description of content and methodological expertise within the review team. It is recommended to have at least one person on the review team who has content expertise, at least one person who has methodological expertise and at least one person who has statistical expertise. It is also recommended to have one person with information retrieval expertise. Please note that this is the recommended optimal review team composition. Content: Vivian Welch and Peter Tugwell Methodology: VW and PT Statistics: VW and PT. Search: TR, librarian scientist 10. Potential conflicts of interest For example, have any of the authors been involved in the development of relevant interventions, primary research, or prior published reviews on the topic? None known 11. Support Do you need support in any of these areas: methodology and causal inference, systematic searches, coding, statistical analysis (meta-analysis)? We would appreciate help from the librarian scientist of IDCG. 12. Funding Do you receive any financial support? If so, where from? If not, are you planning to apply for funding? Where? No International Development Group title registration form revised 11 th April 2011 8
13. Proposed deadlines Note, if the protocol or review are not submitted within 6 months and 18 months of title registration, respectively, the review area is opened up for other reviewers. Date you plan to submit a draft Aug 1, 2011 protocol: Date you plan to submit a draft Jul 1, 2012 review: 14. Declaration Authors responsibilities By completing this form, you accept responsibility for preparing, maintaining and updating the review in accordance with Campbell Collaboration policy. The Campbell International Development Group will provide as much support as possible to assist with the preparation of the review. A draft protocol must be submitted to the Group within six months. If drafts are not submitted before the agreed deadlines, or if we are unable to contact you for an extended period, the Group has the right to de-register the title or transfer the title to alternative authors. The Group also has the right to de-register or transfer the title if it does not meet the standards of the Group and/or the Campbell Collaboration. You accept responsibility for maintaining the review in light of new evidence, comments and criticisms, and other developments, and updating the review at least once every three years, or, if requested, transferring responsibility for maintaining the review to others as agreed with the Group. Publication in the Campbell Library The support of the International Development Group in preparing your review is conditional upon your agreement to publish the protocol, finished review and subsequent updates in the Campbell Library. Concurrent publication in other journals is encouraged. However, a Campbell systematic review should be published either before, or at the same time as, its publication in other journals. Authors should not publish Campbell reviews in journals before they are ready for publication in CL. Authors should remember to include the statement: This is a version of a Campbell review, which is available in The Campbell Library. I understand the commitment required to undertake a Campbell review, and agree to publish in the Campbell Library. Signed on behalf of the authors: Form completed by: Date: International Development Group title registration form revised 11 th April 2011 9
For Campbell use: Title registration submission date: Title registration approval date: International Development Group title registration form revised 11 th April 2011 10