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    Strategies to increase the ownership and use of insecticide

    treated bednets to prevent malaria (Protocol)

    Augustincic Polec L, Ueffing E, Welch V, Tanjong Ghogomu E, Pardo Pardo J, Grabowsky M,

    Attaran A, Tugwell P

    This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The CochraneLibrary2011, Issue 6

    http://www.thecochranelibrary.com

    Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol)

    Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

    http://www.thecochranelibrary.com/http://www.thecochranelibrary.com/
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    T A B L E O F C O N T E N T S

    1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    3OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    3METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

    Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

    8ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    9REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    10APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    12HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    12CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    12DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    12SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

    iStrategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol)

    Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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    [Intervention Protocol]

    Strategies to increase the ownership and use of insecticidetreated bednets to prevent malaria

    Lana Augustincic Polec1, Erin Ueffing1, Vivian Welch1, Elizabeth Tanjong Ghogomu1, Jordi Pardo Pardo1, Mark Grabowsky2, Amir

    Attaran1, Peter Tugwell3

    1Centre for Global Health, Institute of Population Health, University of Ottawa, Ottawa, Canada. 2 National Vaccine Program Office,

    Washington, D.C., USA. 3 Department of Medicine, University of Ottawa, Ottawa, Canada

    Contact address: Lana Augustincic Polec, Centre for Global Health, Institute of Population Health, University of Ottawa, 1 Stewart

    Street, Ottawa, Ontario, K1N 6N5, Canada. [email protected].

    Editorial group:Cochrane Effective Practice and Organisation of Care Group.

    Publication status and date: New, published in Issue 6, 2011.

    Citation: Augustincic Polec L, Ueffing E, Welch V, Tanjong Ghogomu E, Pardo Pardo J, Grabowsky M, Attaran A, Tugwell P. Strategies

    to increase the ownership and use of insecticide treated bednets to prevent malaria.Cochrane Database of Systematic Reviews2011, Issue6. Art. No.: CD009186. DOI: 10.1002/14651858.CD009186.

    Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

    A B S T R A C T

    This is the protocol for a review and there is no abstract. The objectives are as follows:

    To assess the evidence on the effectiveness and equity of available strategies that focus on delivery and the proper use of ITNs.

    To assess the impact of different strategies on equity ratio of household ownership and proper use.

    1Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol)

    Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

    mailto:[email protected]:[email protected]
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    B A C K G R O U N D

    Description of the condition

    Malaria is a life-threatening parasitic disease transmitted by female

    Anophelesmosquitoes. Approximately 40% of the worlds popula-tion is at risk of malaria; those at risk are primarily in the worlds

    poorest countries. The geographic spread of malaria used to be

    much broader, but it was eradicated successfully in many coun-

    tries with temperateclimatesduring themid-20th century (WHO

    2010a).

    Malaria can cause a significant economic burden at both the in-

    dividual and the regional level; it can have an enormous and

    long-lasting effect on economic growth and development. Malaria

    also contributes to localized differences in gross domestic product(GDP) between countries with and without malaria, especially in

    Africa. According to the World Health Organization (WHO), in

    some countries personal and public spending on costs related to

    malaria accounts for up to 40% of public health expenditures,

    30% to 50% of inpatient hospital admissions, [and] up to 60% of

    outpatient health clinic visits. The costs of malaria are borne dis-

    proportionately by those who can afford them the least; the poor

    who cannot afford treatment and those who have limited access

    to health services are burdened the most (WHO 2010b).

    According to the WHO World Malaria Report 2010, global esti-

    mates of the malaria disease burden for 2009 indicated that there

    were 225 million cases of malaria. The increase in international

    funding for malaria has resulted in better access to malaria pre-ventive measures (WHO 2010c). Efficacious malaria prevention

    strategies include insecticide-treated bed nets (ITNs) (Lengeler

    2004), indoor residual spraying andscreens (Morel 2005). Malaria

    has the highest impact on young children who have not devel-

    oped acquired immunity. In pregnant women, malaria is associ-

    ated with increased risk of severe anaemia, low birth weight, as

    well as with an increase in miscarriages and maternal deaths (Desai

    2007;WHO 2010b). However, the proportion of children under

    five years and pregnant women sleeping under ITNs is still too

    low (Alaii 2003; Eisele 2009a). According to surveys conducted in

    Africa between 1999 and 2004, with the median survey year 2001,

    the medianproportion of children under five sleeping under ITNs

    was only 3%. In countries with subsidized or free-of-charge ITNdistribution, use has been scaled up successfully (WHO 2005a).

    By mid-2010, ITN ownership increased in Africa; 42% of house-

    holds owned at least one ITN and 35% of children slept under

    one (WHO 2010c).

    One of the barriers to the effective use of ITNs is the associated

    cost. Populations affected by malaria are among the poorest in

    the world and they may not be able to afford them. For example,

    one Kenyan study found that although rural residents wanted to

    use ITNs, they could not afford them; it was estimated that ITNs

    for an entire household would cost about the same as paying for

    three children to attendone year of primary school (Guyatt 2002).

    Another barrier is that people are often unfamiliarwith ITNs, or do

    nothaveahabitofusingthem,sotheyneedtobeconvincedoftheir

    usefulness and persuaded to use them on a regular basis (WHO2010a). The culture of ITN use is more developed among some

    ethnic groups and it has a significant impact on ITN coverage.

    Wealth, living in an urban rather than rural area and higher levels

    of education are other important factors positively associated with

    ITN ownership and use, and their impacts on coverage need to be

    assessed (Belay 2008;Eisele 2009b;Monasch 2004).

    Description of the intervention

    WHO defines an insecticide-treated net as a mosquito net that

    repels, disables and/or kills mosquitoes coming into contact with

    insecticide on the netting material (WHO 2007). Large increasesin funding and attention to malaria have accelerated malaria con-

    trol activities in many countries, in particular those associated with

    ITNs. The production of ITNs has increased worldwide from 30

    million in 2004 to 95 million in 2007. Increased funding con-

    tributed to the rapid rise in the number of ITNs procured and dis-

    tributed within countries. For example, the United Nations Chil-

    drens Fund (UNICEF) increased its procurement from 7 million

    in 2004 to nearly 20 million in 2007, and the Global Fund in-

    creased its distribution from 1.35 million in 2004 to 18 million

    in 2006.In two of four African countries where repeated national surveys

    were conducted, household ownership decreased by 13% and 37%

    within 24 to 36 months of mass ITN distribution campaigns.After free ITN distribution in Kenya, the adherence was lower

    than desired and 30% of ITNs remained unused (Alaii 2003).

    Therefore, it is important to identify strategies that will increase

    the ownership of ITNs and encourage proper use. Proper use of

    ITNs requires that they are hanging properly and that they are

    used consistently (Eisele 2009b). ITNs should also be in good

    condition, contain an active and sufficient dose of insecticide, and

    not be torn or otherwise damaged. Strategies to increase the use

    of ITNs include social marketing, health education campaigns by

    multidisciplinary teams, developing a net culture through pro-

    motion and publicity, increased availability (e.g. local production

    of high-quality ITNs), free ITN distribution campaigns and cost

    reduction (e.g. reduced taxes imposed on ITNs) (WHO 2010a).Identified effective strategies should be used to scale-up ITNs and

    to achieve universal coverage. Strengthening healthcare systems is

    very important in this process, but it cannot be done quickly. In

    order to reach high national coverage, lessons learned from ongo-

    ing ITN programs and reviews should be applied. According to

    Roll Back Malaria, the initial step in scaling up should integrate

    short-term strategies to increase ITN coverage rapidly by offer-

    ing subsidized ITNs to the most vulnerable populations (WHO

    2005b). The second step should include long-term strategies that

    focus on sustainability and systems that sustain high ITNs cover-

    age and appropriate use by the most vulnerable groups. A national

    ITN partners committee should co-ordinate efforts of public, pri-

    2Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol)

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    vate and non-governmental partners and facilitate ITN scale-up

    (WHO 2005b).The WHO Global Malaria Programme (WHO/GMP) empha-

    sizes that the sustainability of high ITN coverage and scaling-

    up access to and use of long-lasting insecticidal nets (LLINs) are

    some of the key issues in malaria prevention (WHO 2007). Incor-

    porating ITN campaigns into existing successful campaigns (e.g.

    measlesvaccinationcampaigns) may be a good approachto achieve

    a rapid catch-up and keep-up (Grabowsky 2007a). The focus of

    malaria prevention campaigns should be on properand regular use

    of ITNs, continuing access to ITNs for newborns and pregnant

    women, and ensuring an affordable cost of ITNs for the rest of

    the population (Grabowsky 2007b). In many sub-Saharan African

    countries, rapid progress in malaria control has been observed,

    and higher and more widely applied ITN coverage is expected.Current challenges to equitable distribution of ITNs appear to be

    linked to the policies and intervention delivery strategies (Kilian

    2010;Steketee 2009).

    The effectiveness, sustainability and equity of these strategies to

    increase the use of ITNs, especially ITN scale-up strategies, are

    unclear.Consequently, thereis a lackof guidance for policy-makers

    on effective strategies related to the use of ITNs. This review will

    assesscurrent evidence on such strategies andit will provide policy-

    makers with guidance on how ITNs can be used effectivelyto help

    roll back malaria.

    Why it is important to do this review

    This review addresses one of the emerging global health issues that

    is a core part of the United Nations Millennium Development

    Goal(MDG) #6, Combat HIV/AIDS, Malariaand otherdiseases

    (UN 2008). By identifying effective ITN delivery mechanisms,

    the strategies aiming at proper ITN use, and the contexts and

    populations in which theyare effective, this reviewcan helppolicy-

    makers and practitioners to make appropriate and evidence-based

    decisions. The use of rigorous research methods will ensure high-

    quality evidence for effective strategies to increase the proper use

    of ITNs.

    O B J E C T I V E S

    To assess the evidence on the effectiveness and equity of

    available strategies that focus on delivery and the proper use of

    ITNs.

    To assess the impact of different strategies on equity ratio of

    household ownership and proper use.

    M E T H O D S

    Criteria for considering studies for this review

    Types of studies

    We will include studies that report on strategies that may increase

    the ownership and the proper use of ITNs. It may be difficult

    and inappropriate to evaluate these interventions using random-

    ized controlled trials (RCTs), because scale-up strategies are deliv-

    ered at a population level and are the standard of care in at-risk

    populations (WHO 2010c). Thus, we will include non-random-

    ized studies in our review. Studies to be included are: randomized

    and quasi-randomized controlled trials (RCTs, controlled clinical

    trials (CCTs), cluster-RCTs); controlled before and after studies

    (CBAs) with contemporaneous data collection and with two or

    more control and intervention sites; and interrupted time series

    studies (ITSs) with a clearly defined point in time when the in-

    tervention occurred and at least three data points before and after

    implementation of the intervention. We will include any other

    study design that meets EPOC study design criteria, regardless of

    the name (e.g. stepped wedge design, controlled interrupted time

    series). We will exclude studies focusing solely on the effectiveness

    of ITNs as this research question is addressed in anotherCochrane

    systematic review (Lengeler 2004). We will exclude study designs

    that do not meet the EPOC criteria from meta-analyses or nar-

    rative syntheses as applicable, but may use them to inform the

    discussion and the background for the review.

    Types of participants

    We will include children and adults with permanent residence in

    malarious areas in ourstudy. We will exclude military populations,

    travelers, students, those who live in transient refugee camps for

    less than one malaria season, and others not permanently residing

    in the study area.

    Types of interventions

    Our systematic review will include both unifaceted and multi-

    faceted interventions that may increase the ownership and proper

    use of ITNs. To clarify the relationship between the interventions

    and the outcomes, we developed a logic model (Tugwell 2010)

    (Figure 1 and Figure 2). Interventions are grouped into three main

    categories depending on their focus: interventions focusing on

    ITN delivery strategies, interventions focusing on proper use of

    ITNs and combinations of these interventions.

    3Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol)

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    Figure 1. LOGIC MODEL: Strategies to increase the use of insecticide-treated bed nets in households and

    vulnerable populations to reduce morbidity and mortality from malaria in endemic settings

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    Figure 2. Types of interventions to increase the use of ITNs

    Theframework forITN delivery mechanismstrategies by Kilian et

    al was adapted and incorporated into our logic model. Categories

    that are defined by this framework include ITN delivery channel,

    duration of distribution, cost to user, choices of a net in terms

    of net preference and accessibility, and sectors involved in the

    distribution (Kilian 2010).

    Interventions focusing on proper ITN use strategies after ITN

    distribution are mapped similarly as previously described for ITN

    delivery mechanisms. Examples for these interventions are: cam-

    paigns to increase ITN hang-up and volunteer home visits to ed-

    ucate populations about the proper use of ITNs. Interventions to

    encourage proper use can be delivered through different channels(community, outreach, routine services and at retail points). These

    interventions can be provided during limited periods of time (sin-

    gle or repeated) or they can be ongoing (continuous). Proper use

    interventions can be delivered by the public sector (e.g. govern-

    ment) or private sector (civil society: non-governmental organi-

    zations (NGOs), faith and community-based organizations; and

    commercial sector). Interventions are further categorized as those

    focusing on education, peer monitoring (e.g. volunteer home vis-

    its) or publicity (e.g. media). We decided not to use the categories

    Cost to user and Choice of type and time in our logic model.

    We will report relevant context information that may impact the

    proper use of ITNs (e.g. national/regional culture, ITN stock-out

    periods, nomadic lifestyle).

    Comparison groups will include no intervention and other strate-

    gies aiming to increase ITN use (e.g. comparing two different in-

    terventions that are aiming to increase ITN use).

    Types of outcome measures

    Primary outcomes

    Proportion of households with at least one ITN.

    Proportion of existing ITNs used (the previous night and

    when a time frame is not reported).

    Proportion of population sleeping under ITNs (the

    previous night and when a time frame is not reported).

    Proportion of pregnant women sleeping under ITNs (the

    previous night and when a time frame is not reported).

    Proportion of children under five sleeping under ITNs (the

    previous night and when a time frame is not reported).

    Proportion of households with all children under five

    sleeping under ITNs (the previous night and when a time frame

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    is not reported).

    Proportion of households with people/ITN ratio 2.0among households with any nets.

    Equity ratio of household ownership with ITNs calculated

    across household income.

    Secondary outcomes

    Child all-cause mortality.

    Child malaria-specific mortality.

    Child malaria morbidity.

    All-cause mortality.

    Malaria-specific mortality.

    Malaria-specific morbidity.

    Anemia in pregnant women. Low birth weight.

    The focus of our review is the use of ITNs measured with the

    coverage outcomes that are defined as ITN ownership or the use

    of ITNs. Coverage outcomes are sometimes reported in an in-

    consistent manner. In order to reduce bias when reporting study

    findings, we will report coverage-related outcomes that do not fall

    under any of the above outlined categories as published in the

    original paper (e.g. if time frame of use is not specified). If iden-

    tified studies report on ITNs existing prior to the intervention,

    we will account for them in our analysis. We will record clinical

    indicators and those focusing on morbidity and mortality as sec-

    ondary outcomes. The outcome measures that we selected for ourreview overlap to a great extent with Roll Back Malaria Monitor-

    ing & Evaluation Reference Group (MERG) minimum standards

    recommended for assessing malaria impact in countries in Sub-

    Saharan Africa (Kilian 2011).

    We will also include measures of population knowledge, attitudes

    andsatisfaction in ourdiscussion. If anyadverse or any unintended

    effects are reported (e.g. unable to afford other necessities due to

    money use by households to purchase ITNs) we will record them.

    Search methods for identification of studies

    The Cochrane EPOC Group Trials Search Co-ordinator (TSC)

    designed a search strategy for the OVID MEDLINE database(seeAppendix 1). The TSC will translate this strategy for the databases

    listed below and will apply methodological filters to identify ac-

    ceptable study designs (see Types of studies) as necessary. However,

    given that a search of OVID MEDLINE(1948 forward) identified

    fewer than 2000 citations before the application of filters, we may

    decide to screen all search results(i.e. non-filtered search results).

    We will delineate this process clearly in the review manuscript.

    Electronic searches

    We will search the following databases.

    a) MEDLINE

    b) The Cochrane Central Register of Controlled Trials (CEN-

    TRAL) (The Cochrane Library, latest issue)c) The Cochrane Effective Practice and Organization of Care

    Group (EPOC) Specialized Register and the database of studies

    awaiting assessment

    d) The Cochrane Infectious Diseases Groups Specialized Register

    e) EMBASE

    f ) Latin American and Caribbean Health Sciences Literature

    database (LILACS)

    g) ISI Web of Knowledge Cited Reference Search

    h) African Index Medicus

    i)The Abdul Latif Jameel Poverty Action Lab

    j)The Malaria in Pregnancy Library

    k) A selection of low and middle-income countries databases

    chosen from the compilation of the Norwegian satellite of theCochrane EPOC Group as being potentially relevant for malaria

    and ITNs: 3ie Database of Impact Evaluations, British Library

    for Development Studies (BLDS), WHO Global Health Library,

    IEAS Economic and Finance database (RePEc), JOLIS library cat-

    alogue, PAHO Library Catalogue, WHOLIS, World Bank Doc-

    uments & Reports, AFROLIB Database, IndMED, MedCarib,

    South African Medical Database (SAMED), African Journals On-

    Line (AJOL) and Bioline International.

    Searching other resources

    We will search the reference lists of all included studies and rele-vant reviews. We will contact authors of relevant papers regarding

    any further published or unpublished work. We will search for

    papers that cite studies included in the review. We will contact

    authors of other reviews in the field of malaria control and preven-

    tion regarding relevant studies of which they may be aware. We

    will contact agencies that conduct studies or provide funding for

    malaria interventions with a request for data from unpublished

    and ongoing studies. These agencies mayinclude the World Bank,

    the Rockefeller Foundation, UNICEF, the World Health Organi-

    zation, the Pan American Health Organization, the International

    Federation of Red Cross and Red Crescent Societies, USAID and

    the Alliance for Malaria Prevention.

    We will attempt to identify all relevant studies regardless of lan-guage or publication status (published, unpublished, in press and

    in progress). We will search the following grey literature sources:

    Google Scholar, Open SIGLE, British Library Catalogue, New

    York Academy of Medicine Grey Literature Collection, AEGIS,

    and ProQuest Dissertation & Theses Database. We will report the

    results of the search using the PRISMA flow diagram (Higgins

    2011).

    Data collection and analysis

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    Selection of studies

    Two review authors will independently screen all titles and ab-stracts for potentially relevant studies. Two independent review

    authors will retrieve and screen against the inclusion criteria full-

    text copies of all papers that are deemed potentially eligible by

    consensus. Any disagreement about the eligibility will be resolved

    by discussion between the two review authors and by consulting

    a third review author as necessary.

    Data extraction and management

    Two review authors will independently undertake data extraction

    from the full text of each eligible study based on the EPOC Data

    Collection Checklist (EPOC 2010a). Any disagreement will be

    resolved by discussion between the review authors and consulta-tion with a third author if required. If any data are missing, we

    will contact the relevant corresponding authors. We will collect

    data for specific populations and address these data in subgroup

    analysis.

    Assessment of risk of bias in included studies

    Two review authors will independently assess the methodological

    quality of included studies. For RCTs, we will assess the risk of bias

    using the Cochrane Collaborations Risk of bias tool ( Higgins

    2011), which assesses the following domains: generation of ran-

    domization sequence, allocation concealment, blinding (popula-

    tion, provider, outcome assessor), selective outcome reporting, in-complete outcome data and other sources of bias (e.g. major base-

    line differences, early stopping, etc.). Due to the characteristics of

    interventions that we will be exploring in our review, blinding of

    study participants and providers may not be possible, however this

    will still present a risk of bias.

    For other study designs, we will use the risk of bias criteria sug-

    gested by EPOC:

    generation of allocation sequence;

    concealment of allocation;

    baseline outcome measurements;

    baseline characteristics;

    incomplete outcome data;

    blinding of outcome assessor;

    protection against contamination;

    independence of intervention from other changes;

    pre-specified shape of the intervention;

    intervention unlikely to affect data collection;

    selective outcome reporting; and

    other risks of bias (EPOC 2010b).

    Any disagreements will be resolved by discussion, and with a third

    review author when necessary. We will assess the quality of evidence

    for each main outcome using the Grading of Recommendations

    Assessment, Development and Evaluation (GRADE) approach

    and the GradePro software (Guyatt 2008).

    Measures of treatment effect

    We will report pre-intervention and post-intervention means or

    proportions for both study andcontrol groups and calculateunad-

    justed and adjusted (for any baseline imbalance) absolute change

    from baseline with 95% confidence intervals, where baseline re-

    sults are available from RCTs, CCTs and CBAs. We will account

    for existing ITNs when reported by authors.

    For ITS studies, we will report the main outcomes and two effect

    sizes: the change in the level of outcome immediately after the

    introduction of the intervention and the change in the slopes of

    the regression lines.

    We will report findings from each study design (RCTs, CCTs and

    CBAs) separately. We will report median effect size across included

    studies, inter-quartile ranges of effect sizes across included studiesand range of effect sizes across included studies. Where studies

    report more than one measure for each endpoint, we will abstract

    the primary measure (as defined by the authors of the study).

    Unit of analysis issues

    Wewill attempt to re-analyze studies with potential unit of analysis

    errors where possible. If a comparison is re-analyzed, then we will

    quote the P value and annotate it with re-analyzed. If this is not

    possible, we will report only the point estimate.

    In cluster-randomized trials, a cluster is the unit of allocation. The

    cluster refers to a group of individuals enrolled in the study suchas medical practices, villages or families. The individuals within

    a cluster may be more similar in their characteristics, therefore it

    would be incorrect to analyze the data as if the individual par-

    ticipants are the unit of allocation. For cluster-randomized trials

    with unit-of-analysis errors, we will use statistical methods to per-

    form the analysis at the individual level while accounting for inter-

    cluster correlation. We will use the Cochrane Handbook for Sys-tematic Reviews of Interventionsmethods to calculate the varianceinflation factor (Higgins 2011). We will search for appropriate

    intraclass correlation coefficients (ICC) from studies or authors.

    We will compare these ICCs with those used by the Lengeler et

    al Cochrane Review on ITNs (Lengeler 2004). If a comparison

    is reanalyzed, we will annotate it as reanalyzed. We will use timeseries regression to reanalyze each comparison when accounting

    for unit of analysis errors in ITS designs, in consultation with a

    statistician.

    Dealing with missing data

    We will attempt to obtain missing data from the authors of the

    included studies. When this is not possible, we will perform the

    analysis using only the available data. We will explore the impact

    of missing data on the review findings in the Discussion section

    of our review.

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    Assessment of heterogeneity

    We will initially describe the variability of interventions identifiedin our review using a logic model described inFigure 1andFigure

    2. If meta-analysis is possible, we will explore heterogeneity using

    forest plots and the I2 statistic. We will perform Chi2 tests and

    evaluate P values using 0.10 as a cut-off point. The importance

    of I2 will depend on the strength of evidence of heterogeneity (P

    value from Chi2 test or a confidence interval for I2) and on the

    magnitude and direction of effects.

    Assessment of reporting biases

    We will use funnel plots to explore the possibility of publication

    bias. They will be used if 10 or more studies are included in meta-

    analysis andif studies areof a differentsize.We will visually inspect

    funnel plots for asymmetry and explore reasons for asymmetry.

    Data synthesis

    We will carry out meta-analysis only if we are able to identify a

    sufficient number of studies that are homogeneous regarding pop-

    ulations, interventions and comparisons. We will use a random-

    effects model for meta-analyses. If meta-analyses are not possible,

    we will provide a narrative summary.

    We will perform data synthesis using Review Manager 5.1

    (RevMan) (RevMan 5.1). We will present the main findings in

    a Summary of findings table using the GradePro software. Wewill synthesize information about study methods (e.g. study de-

    sign, duration of intervention, follow up), participants (e.g. sex,

    age, country, setting), intervention (e.g. intervention description

    and its components, means of delivery, methods of communica-

    tion), setting (for both control and intervention group if avail-

    able), outcomes (list of outcomes and time points reported), and

    notes (other details of the study that do not fall under mentioned

    categories).

    We will report the outcomes of interest as published in the original

    paper. Due to inconsistency in reporting of outcomes, we may not

    be able to pool them, but for similar outcomes we will report the

    direction of the effect (e.g. we will view households with at least

    one ITN versus households with properly hanging ITN as simi-lar outcomes). Some outcome measurements could be considered

    more reliable than others (e.g. inspection of the ITN in the house

    versus self-reporting of the use of the ITN) so we will also report

    the outcomes grouped by the way in which the outcome was as-

    sessed, if appropriate.

    We will include the magnitude of the effects of the interventions

    and the quality of evidence, and summarize available data on each

    of the main outcomes of interest. We will include both relative

    and absolute measures of effect when possible.

    If the number of studies is insufficient for meta-analysis and data

    are heterogeneous in respect to populations, interventions, com-

    parisons and outcomes, we will report the review as a descriptive

    narrative only. We will categorize and describe data according to

    population, intervention, setting and outcome as described above.We will report the overall number of studies included in the re-

    view andthe main research questions addressed. We will comment

    on study designs, analytical methods used, methodological qual-

    ity, generalizability and relevance of study results as well as other

    important study characteristics. We will explore differences and

    similarities between included studies with the emphasis on expla-

    nation for potential differences between study results, taking into

    account the context where the intervention was implemented. We

    will accompany the descriptive narrative with a table that summa-

    rizes characteristics and findings of included studies in a consistent

    and systematic manner, following our logic model (Figure 1and

    Figure 2).

    Subgroup analysis and investigation of heterogeneity

    We will conduct subgroup analysis to explore heterogeneity, ac-

    cording to the following study characteristics: the type of inter-

    vention as per logic model (Figure 1and Figure 2) (e.g. cost to

    end user), specific population characteristics (e.g. gender/sex, eth-

    nicity, geographic areas, rural/urban, socioeconomic status, ed-

    ucation, age/subgroup (children under five years and pregnant

    women)), and the number and type of interventions in each strat-

    egy (unifaceted interventions versus multifaceted interventions).

    Unifaceted interventions are interventions with only one compo-

    nent (e.g. ITN distribution only), whereas multifaceted interven-

    tions consist of two or more components (e.g. free ITNs bundledwith education about proper ITN use).

    Sensitivity analysis

    If meta-analysis is conducted, we will perform sensitivity analysis

    considering the relevant issues identified during the review pro-

    cess. For example, we will perform a sensitivity analysis to assess

    whether a difference in parameters used for reporting the use of

    ITNs impacts our findings (e.g. ITN usage reported with the time

    frame the previous night and without specifying the time frame).

    We plan to investigate the following study characteristics: fixed-

    effect versus random-effects; odds ratios versus risk ratios; studies

    with versus without imputation for standard deviations; and RCTsversus non-RCTs.

    A C K N O W L E D G E M E N T S

    We would like to thank UNICEF and the African Leaders Malaria

    Alliance (ALMA), the organizers of the Enhancing Mosquito Net

    Utilization Meeting, Geneva 2011 and the meeting participants

    fortheirsupport anduseful comments on thedraftof theprotocol.

    We would also like to thank Don de Savigny and Kara Hanson

    who encouraged us when we applied for the funding and provided

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    letters of collaboration. We would like to express our gratitude to

    Michelle Fiander, Trials Search Co-ordinatory, EPOC Group, forher help with search strategy development and Elizabeth Paulsen,

    Susan Munabi-Babigumira, Jenny Hill and Jan Odgaard-Jensen

    for their support and guidance.

    R E F E R E N C E S

    Additional references

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    Alaii JA, Hawley WA, Kolczak MS, ter Kuile FO, Gimnig

    JE, Vulule JM, et al.Factors affecting use of permethrin-

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    Hygiene2003;68(Suppl 4):13741.

    Belay 2008

    Belay M, Deressa W. Use of insecticide treated nets by

    pregnant women and associated factors in a pre-dominantly

    rural population in northern Ethiopia. Tropical Medicine

    and International Health2008;13(10):130313.

    Desai 2007

    Desai M, ter Kuile FO, Nosten F, McGready R, Asamoa

    K, Brabin B, et al.Epidemiology and burden of malaria in

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    Eisele 2009a

    Eisele TP, Keating J, Littrell M, Larsen D, Macintyre K.

    Assessment of insecticide-treated bednet use among children

    and pregnant women across 15 countries using standardized

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    Eisele 2009b

    Eisele T, Root B. Insecticide-treated net use among children

    and pregnant women in sub-Saharan Africa: systematic

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    Review Group (EPOC). Data Collection Checklist.

    Available from: http://epoc.cochrane.org/sites/

    epoc.cochrane.org/files/uploads/datacollectionchecklist.pdf

    (accessed July 2010).

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    Cochrane Effective Practice and Organisation of Care

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    resources-review-authors (accessed July 2010).

    Grabowsky 2007a

    Grabowsky M, Nobiya T, Selanikio J. Sustained high

    coverage of insecticide-treated bednets through combined

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    Lengeler C, Grabowsky M, Mcguire D, de Savigny D.

    Quick wins versus sustainability: options for the upscaling

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    Guyatt 2002

    Guyatt HL, Ochola SA, Snow RW. Too poor to pay:

    charging for insecticide-treated bednets in highland Kenya.

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    Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y,

    Alonso-Coello P, et al.GRADE Working Group. GRADE:

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    Higgins JPT, Green S (editors). Cochrane Handbook for

    Systematic Reviews of Interventions Version 5.1.0 [updatedMarch 2011]. The Cochrane Collaboration, 2011.

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    Kilian A, Wijayanandana N, Ssekitoleeko J. Review of

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    Monasch R, Reinisch A, Steketee RW, Korenromp EL,

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    countries. BMJ2005;331(7528):1299. [DOI: 10.1136/

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    evaluation. Massachusetts Institute of Technology.

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    A P P E N D I C E S

    Appendix 1. Search strategy

    MEDLINE

    Database: Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R)

    1 Plasmodium.ti,ab. (29283)

    2 exp malaria/ (42886)

    3 Plasmodium/ or Plasmodium falciparum/ or Plasmodium malariae/ or Plasmodium ovale/ or Plasmodium vivax/ [related to malaria]

    (26963)

    4 culicidae/ or exp anopheles/ [Mosquitos] (16478)

    5 (culicidae or anopheles).ti,ab. (10590)

    6 malaria$.ti,ab. (47331)

    7 mosquito$.ti,ab. (21972)

    8 (marsh fever or blackwater fever or paludism?).ti,ab. [synonyms for malaria] (186)

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    9 Mosquito Control/ (5425)

    10 or/1-9[Malaria/Mosquitos](86458)11 Insecticide-Treated Bednets/ or Mosquito Nets/ (161)

    12 (net? or netting or bednet$ or bed net$ or ITN? or LLIN?).ti,ab. (65749)

    13 (bed$ adj2 screen$).ti,ab. (137)

    14 curtain?.ti,ab. (807)

    15 or/11-14[Nets](66658)

    Results before filters:

    16 10 and 15[Malaria/Mosquito Control & Nets](1990)

    Results with filters

    39 16 and (or/19,38) (650)

    Filters

    Cochrane RCT Filter - MEDLINE: sensitivity & precision maximizing (Handbook 6.4.d) (Higgins 2011)

    17 (randomized controlled trial or controlled clinical trial).pt. or randomized.ab. or placebo.ab. or clinical trials as topic.sh. or ran-

    domly.ab. or trial.ti. (729425)

    18 exp animals/ not humans.sh. (3567219)

    19 17 not 18[Cochrane RCT Filter 6.4.d Sens/Precision Maximizing](675254)

    EPOC filter MEDLINE (v. 2.3) (to identify non RCT designs)

    20 intervention?.ti. or (intervention? adj6 (clinician? or collaborat$ or community or complex or DESIGN$ or doctor? or educational

    or family doctor? or family physician? or family practitioner? orfinancial or GP or general practice? or hospital? or impact? or improv$ or individuali?e? or individuali?ing or interdisciplin$ or

    multicomponent or multi-component or multidisciplin$ or multi-

    disciplin$ or multifacet$ or multi-facet$ or multimodal$ or multi-modal$ or personali?e? or personali?ing or pharmacies or pharmacist?

    or pharmacy or physician? or practitioner? or prescrib$ or prescription? or primary care or professional$ or provider? or regulatory or

    regulatory or tailor$ or target$ or team$ or usual care)).ab. (112659)

    21 (hospital$ or patient?).hw. and (study or studies or care or health$ or practitioner? or provider? or physician? or nurse? or nursing

    or doctor?).ti,hw. (609702)

    22 demonstration project?.ti,ab. (1692)

    23 (pre-post or pre test$ or pretest$ or posttest$ or post test$ or (pre adj5 post)).ti,ab. (47137)

    24 (pre-workshop or post-workshop or (before adj3 workshop) or (after adj3 workshop)).ti,ab. (429)

    25 trial.ti. or ((study adj3 aim?) or our study).ab. (438991)

    26 (before adj10 (after or during)).ti,ab. (296123)

    27 (quasi-experiment$ or quasiexperiment$ or quasi random$ or quasirandom$ or quasi control$ or quasicontrol$ or ((quasi$or experimental) adj3 (method$ or study or trial or design$))).ti,ab,hw. [ML] (81245)

    28 (time series adj2 interrupt $).ti,ab,hw. [ML] (584)

    29 (time points adj3 (over or multiple or three or four or five or six or seven or eight or nine or ten or eleven or twelve or month$ or

    hour? or day? or more than)).ab. (6022)

    30 pilot.ti. (28825)

    31 Pilot projects/ [ML] (64947)

    32 (clinical trial or controlled clinical trial or multicenter study).pt. [ML] (555681)

    33 (multicentre or multicenter or multi-centre or multi-center).ti. (21771)

    34 random$.ti,ab. or controlled.ti. (581955)

    35 (control adj3 (area or cohort? or compare? or condition or design or group? or intervention? or participant? or study)).ab. not

    (controlled clinical trial or randomized controlled trial).pt. [ML] (318012)

    36 comment on.cm. or review.ti,pt. or randomized controlled trial.pt. [ML] (2428765)

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    37 exp animals/ not humans.sh. (3567219)

    38 (or/20-35) not (or/36-37)[EPOC Filter 2.3](1709254)

    H I S T O R Y

    Protocol first published: Issue 6, 2011

    C O N T R I B U T I O N S O F A U T H O R S

    PT conceived the idea for the systematic review. LAP drafted and revised the protocol with suggestions from EU, VW, ETG, JPP, PT,

    AA and MG who extensively reviewed the protocol and provided feedback on the draft.

    D E C L A R A T I O N S O F I N T E R E S T

    AA has published papers on malaria drug quality in Africa and India. MG has been engaged in studies potentially eligible for our

    Cochrane Review. LAP, EU, VW, ETG, JPP and PT have no known conflicts of interest.

    S O U R C E S O F S U P P O R T

    Internal sources

    No sources of support supplied

    External sources

    Knowledge Synthesis Grant, CIHR, Canada.

    12Strategies to increase the ownership and use of insecticide treated bednets to prevent malaria (Protocol)

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