riboli sasco communication protocol
TRANSCRIPT
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Effectiveness ofcommunication strategiesembedded in socialmarketing programmes onhealth behaviours andrelated health and welfare
outcomes in Low and MiddleIncome Countries (LMICs)
Eva Riboli-Sasco, Jacqueline Leslie, Lambert Felix, RoyHead, Josip Car, Laura H. Gunn
PROTOCOL
Publication date: 02 March, 2015
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2 The Campbell Collaboration | www.campbellcollaboration.org
Table of contents
TABLE OF CONTENTS 3
1 BACKGROUND 3
1.1 Description of the problem 3
1.2 Description of the intervention 5
1.3
How the intervention might work 6
1.4 Why it is important to do this review 11
2 OBJECTIVE OF THE REVIEW 14
3 METHODS 16
3.1 Criteria for including studies in the review [PICOS] 16
3.2 Search methods for identification of studies 21
3.3 Data collection and analysis 26
3.4 Data synthesis 31
4 TIMELINE 35
5 ACKNOWLEDGEMENTS 36
6 REFERENCES 37
7 APPENDIX 46
8 CONTRIBUTION OF AUTHORS 52
9 DECLARATIONS OF INTEREST 53
10 SOURCES OF SUPPORT 54
10.1 Internal sources 54
10.2 External sources 54
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1
Background
1.1 DESCRIPTION OF THE PROBLEM
Human behaviour plays a significant role in the leading causes of disease, disability,
and death (Marteau, Hollands, & Fletcher, 2012). In developed countries, health
programmes use behaviour change communication to provide tailored messages and
a supportive environment that persuades individuals and encourages communities to
make better health changes (Glanz & Bishop, 2010; Gordon et al. 2006). For example,
many studies have examined behaviours like smoking cessation, dieting and exercise,
since these are important contributors to urgent health issues in developed countries
(Glanz & Bishop, 2010; Gordon et al., 2006; Hastings et al. 2006). However, in the
developing world it is becoming increasingly critical to address health issues and to
find new methods of promoting behaviours that might prevent illness. Based on this
reality, health communication campaigns have been developed to inform and
promote the adoption of preventive practices, health products and services and to
fight harmful cultural beliefs and behaviours, among groups and individuals (Snyder,
Linkov, & Laporte, 2007).
Health related communication strategies have changed significantly in the last 15
years from top down public service announcements to a wider approach which draws
on behaviour models and methods used in marketing and adapted for the purposes of
"social marketing" (Figueroa et al., 2008; Lefebvre & Flora, 1988).
Social marketing uses a consumer-focused approach based on behaviour, not
awareness or attitude, change and/or maintenance to maximise sale and use of the
product (for example, insecticide treated nets) or service (for example, peercounsellors) by segmented target groups, and uses a marketing mix or ‘‘4 Ps’’
(product, price, place, promotion) (Perez-Escamilla, 2012) to provide products
differentiated by brand, relevance, and positioning. The 4 ‘Ps’ are mostly used with
tangible products, however for non-tangible products or services (for example, hand
washing, exclusive breast feeding, regular exercise), a more appropriate marketing
mix to use would include the “4 Cs” (consumer need/want/desire, cost, convenience,
and communication) of Integrated Marketing Communication for Behavioural
Impact (IMC/COMBI) (Hosein, Parks, & Schiavo, 2009). The UK National Social
Marketing Centre (NSMC) has identified eight benchmark criteria defining key
characteristics of social marketing programmes (see Section 3.1.3 for these criteria)
(National Social Marketing Centre, 2010).
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However the evidence on the effectiveness of social marketing and/or behaviour
change communication strategies in the health and public health context is not always
well synthesised, and often scattered across a number of subsectors in water and
sanitation, family planning, mother and child health, malaria, and epidemic diseases
such as HIV, polio, and avian influenza (Hornik, 2002; Bertrand et al., 2006). The
effectiveness of the communication strategies reported can also be confounded by
issues related to health product or service characteristics such as price, access, and
ease of use.
Early use of health communication relied on top-down one-way messages (Thackeray
& Neiger, 2009). They did not take account of motivational factors and constraints,
and as a result, these campaigns had limited impact (Pfeiffer, 2004). However,
communication approaches continuously evolve. Behaviour change communication
(BCC) is a more recent approach, which makes strategic use of communication to
promote positive health outcomes. It is based on proven theories and models of
behaviour change (and maintenance) and market segmentation. Segmentation is a
group-level, or community/population, marketing approach, whereas behaviour
change focuses primarily on individual actions. Both models of behaviour change and
market segmentation are often used for community mobilisation, health and
environmental education, and various public outreach programmes (Maibach et al.,
2007; Grier and Bryant, 2005). However in some cases, the effectiveness of BCC can
be constrained by other factors relating to product or service characteristics,
availability, and cost (Price, 2001). In India, the National Family Planning
programme uses BCC, however in selected areas, social marketing approaches were
added in order to improve access to products and services (Gurgaon, 2012).
Strategic communication is an important component of social marketing programmes
(UNICEF, 2005). The purpose of any social marketing campaign is to change people’s
behaviour (Andreasen, 1995), or maintain positive behaviour adoption (Hosein, et al.,
2009). Social marketing is distinguished from other health and education campaigns
by its adoption of commercial marketing principles, consumer orientated focus, and
its use of integrated market analysis, segmentation, and marketing strategies (Noble
& Camit, 2005). These are endorsed by the UK National Social Marketing Centre
(NSMC) who recognises these as benchmarks of what is needed for a successful socialmarketing programme (NSMC, 2010).
This review will assess the evidence on “what works” and the impact of BCC strategies
in a social marketing environment on health behaviour and other health and welfare
outcomes among individuals and their carers and communities. The review will draw
on a wide range of public health programmes implemented in low- and middle-
income countries (LMICs).
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1.2 DESCRIPTION OF THE INTERVENTION
Health communication is concerned with “informing, influencing and motivating
individual, institutional [including community] and public audiences about
important health issues” (needs citation with page number) and engaging people
through three principal approaches: individual messaging, social networks, and thepopulation or a community (Maibach, Abroms, & Marosits, 2007).
A communication strategy has been defined by the Food and Agriculture Organization
of the United Nations as “a systematic, well-planned series of actions, combining
different methods, techniques and tools, to achieve an intended change or objective
utilising the available resources within a specific time frame” (Mefalopulos &
Kamlongera, 2004, p. xx).
Various communication strategies may be used within a campaign to change the
behaviour of the target population (Snyder, 2007). Whether acting as an individual
component or multi-component programme(s), single- or multi- media can be used
at various levels, including locally, regionally, and nationally (Noar et al., 2009).
Communication strategies can involve a range of complimentary components
delivered by various channels and in different interventional forms, including public
advocacy and public relations; awareness; mobilisation; education; and advertising,
promotion, and incentivisation.
Interventions can use a range of delivery channels including: mass media (for
example, television, radio, newspapers, leaflets, and posters); educationalentertainment (that is “edutainment”; for example, songs and dances, road shows,
dramas); interpersonal communication/counselling (for example, home visits,
discussion groups and point-of-service); and digital or electronic communications
(including individual mobile phone messaging and electronic social networks).
Although “traditional” mass media such as television and radio remain common, so-
called “new media” are increasingly being used in public communication campaigns
(Parker and Thorson, 2009), including health behaviour change interventions (Edgar,
Noar and Freimuth, 2008). This new field is referred to as eHealth. New media
includes emerging digital technologies and platforms (for example, video games,
virtual worlds, software, mobile devices), online communication (for example,
Internet, blogs, chat rooms, wikis, e-mail, online newsletters) and electronic and
multimedia publishing—multimedia CD-ROMs and hypertext (Shapiro et al., 2007) .
Their increasing success in health communication can be explained by the several
additional features brought by such technologies, including:
- the use of multimedia applications, combining text, audio, video, graphics,
and animation;
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the possibility of an interactive process, as opposed to the passivity of watching
TV or listening to the radio;
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- the tailoring of information which pushes further the broader targeting of
traditional campaigns by individualizing the message conveyed; and
- the use of hypertext which allows linkage of information with other related
content (Pavlik, 2001).
An important factor in this development has been the widespread usage of the
Internet, on which health promoters are increasingly capitalizing (Webb et al., 2010).
Examples of interventions include the setting up of an Internet-Based Peer
Community dedicated to health information in Dakar, Senegal (Massey et al., 2009),
Despite several successful experiences, in the general context of LMICs, the individual
access to most new media, and particularly the Internet, often remains limited by
several socioeconomic, political and geographical barriers (Edejer, 2000). While the
World Bank estimated that 75.3% of the population in high-income countries had
access to the Internet in 2012, the figures dropped to 29.8% in middle-income
countries and 6.9% in low-income countries (World Bank, 2013a). As a result, thisusage limitation highly restricts the potential reach and impact of digital health
communication campaigns utilising the Internet in LMICs.
Whereas television, computers and landline phones tend to remain scarce in LMICs,
mobile phones constitute a noticeable exception. With 41.5 mobile subscriptions for
100 habitants in low-income countries and more than 80% in middle-income
countries (World Bank, 2013a), this technology is becoming ubiquitous, including in
the most deprived settings. Mobile phones, therefore, hold promising opportunities
for delivering health related messages to a wide audience, in the form of text messages
(Cole-Lewis and Kershaw, 2010) or apps (Cohn et al., 2011; Cowan et al., 2013).
However, the effectiveness of such interventions is still debated, dependent on a
multitude of internal and external factors, thus calling for high quality evidence-based
evaluations (Noar and Harrington, 2012; Sood et al., 2014). This is even more true for
LMICs where specific and often stronger social, economic and cultural constraints
might arise, compromising the success of these eHealth interventions (Kaplan, 2006).
Sood et al. (2014) conducted a review of health communication campaigns in
developing countries; however a major difference between their review and ours is
that our review will specifically address communication strategies embedded in social
marketing programmes.
1.3 HOW THE INTERVENTION MIGHT WORK
Figure 1 (below) presents an example of a logic model we created which shows the
connections between the possible variables identified in various theoretical models as
determinants of behaviour change and/or maintenance and potential health and
welfare outcomes, whether short term or intermediate-to-long term (Knowlton and
Phillips, 2009; Patton, 2008).
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Figure 1. Example of a logic model of possible variables considered in communication interventions and the inputs and
channels used to affect short and intermediate-to-long term outcomes within a framework of social marketing health
programmes
Model
Socialmarketingframework
Behaviourmodels
McGuire'scommunication
stages
Audience
Individuals
Social & othernetworks
Communities
or
populations
Input
Public advocacy& publicrelations
Awareness
Mobilisation
Information &education
Promotion,advertising, &incentivisation
Channel
Mass media
Educationalentertainment
Digital orelectronic
communications
Interpersonal
Short Term
Outcomes
Communication& channel
contact rates
Cognitiveoutcomes
Behaviourchange
Changes indemand forservice orproduct
Intermediate-to-Long
TermOutcomes
Health outcomes
Welfareoutcomes
Social outcomes
Behaviour changeand/or
maintenance
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Figure 1 portrays the theoretical models from a number of areas including behaviour
change and/or maintenance, communication theory, and social marketing.
Commonly used behaviour change (including maintenance) models include (though
are not limited to): Health Belief Model (Janz & Becker, 1984), Theory of Planned
Behaviour (Ajzen, 1991), and the Transtheoretical Model-Stages of Change
(Prochaska & Velicer, 1997). These three models are associated with behaviour change
at the individual level, whereas theories of mobilization and diffusion (for example,
Community Mobilisation Theory (Rothman & Tropman, 1987) and Diffusions of
Innovation Theory (Rogers, 2010)) are associated with the community level. The
social marketing framework considers both individual and community levels.
These models assume that any health or illness outcome is the consequence of the
complex interaction between social, economic, psychological and biomedical factors
(Edelman, 2000; Kelly et al., 2009). Essential components of these models and
theories are the set of mediators and other variables on which they rely. A mediator
is an intervening variable necessary to complete a cause-effect link between an
intervention programme and the targeted health behaviour. Common mediators
include, but are not restricted to: self-efficacy; attitudes towards the behaviour; fear;
perceived barriers and benefits; subjective norms; knowledge; and so forth (World
Bank, 2013b).
Furthermore, McGuire (McGuire, 1984) identifies five communication components
for successful communication. These include: credibility of the message source;
message design; delivery channel; intended audience; and intended behaviour (see
also (Clarke, 1999)).
We are interested to identify communication interventions, targeted at individuals,
groups (including social and other networks), or communities/populations, which
involve strategies (that is, inputs) with single or multiple media delivery channels.
For example, the health objective may be to reduce infant mortality (e.g., an
intermediate to long term health outcome), where messages are directed at mothers
and are delivered using different communication strategies in different programmes.
One strategy may involve interpersonal messaging only; another may involve
interpersonal messaging and a poster campaign; a third may include the same
elements plus advocacy through key networks. Such communication strategies have
been studied, particularly in relation to reviewing alternative strategies to improve the
performance of health workers (Rowe, 2011, 2013).1
1.4 WHY IT IS IMPORTANT TO DO THIS REVIEW
There is a lack of clear synthesised evidence on the effectiveness of communication
strategies of social marketing health programmes. It is unclear which communication
strategies are most effective as assessed by changes in health and welfare outcomes,
1http://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/DI2011/res
ources/4B%20Rowe%20Reviews%20of%20Emerging%20Issues%20[Compatibility%20Mode].pdf
http://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/DI2011/resources/4B%20Rowe%20Reviews%20of%20Emerging%20Issues%20%5bCompatibility%20Mode%5d.pdfhttp://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/DI2011/resources/4B%20Rowe%20Reviews%20of%20Emerging%20Issues%20%5bCompatibility%20Mode%5d.pdfhttp://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/DI2011/resources/4B%20Rowe%20Reviews%20of%20Emerging%20Issues%20%5bCompatibility%20Mode%5d.pdfhttp://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/DI2011/resources/4B%20Rowe%20Reviews%20of%20Emerging%20Issues%20%5bCompatibility%20Mode%5d.pdfhttp://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/DI2011/resources/4B%20Rowe%20Reviews%20of%20Emerging%20Issues%20%5bCompatibility%20Mode%5d.pdfhttp://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/DI2011/resources/4B%20Rowe%20Reviews%20of%20Emerging%20Issues%20%5bCompatibility%20Mode%5d.pdf
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as well as behaviour change and/or maintenance. There is a need to provide evidence
on what facilitates effective and persuasive messaging in different communication
interventions, which often brings together a mix of strategies (such as public advocacy
and public relations; awareness; mobilisation; information and education; and
advertising, promotion, and incentivisation) across a range of public health
programmes in LMICs (Noar et al., 2009).
Previous reviews to date conducted specifically on behaviour change communication
(BCC) interventions, and their outcomes, have several limitations. First, they have
focused on very specific topics such as: condom use (Sweat et al., 2012); HIV/AIDS
(Noar et al., 2009); uptake of HIV/STI testing in men who have sex with men (Wei et
al., 2011); alcohol (Moreira, Smith, & Foxcroft, 2009); hand hygiene (Mah et al.,
2008); bicycle helmet use (Spinks et al., 2005; Royal et al., 2007); and preventive
cardiology, sexual health, and substance use (Jepson et al., 2010). Second, previous
reviews have examined a single, specific type of communication channel, particularly
mass media (Bala, Strzeszynski, & Cahill, 2008; Bertrand et al., 2006; Grilli, Ramsay,
& Minozzi, 2002; Leavy et al., 2011; Lecouturier et al., 2010; Marcus et al., 1998; Noar
et al., 2009) and campaigns (Evans et al., 2008; Snyder, 2007). Third, some prior
reviews have restricted their search to the highest quality study designs such as
randomised controlled trials (RCTs) and cluster randomised controlled trials
(Moreira et al., 2009). Fourth, although many of these reviews did not exclude LMICs,
they nonetheless did not focus on LMICs. Fifth, previous reviews have neither
explored the theoretical basis nor the mechanism of action of the interventions,
whereas this review seeks to understand mechanisms of action by exploring potential
mediators of behaviour such as knowledge, intention, self-efficacy and attitudes.Finally, there are a couple of protocols registered with the Cochrane Public Health
Group that may overlap, to some degree, with this review but these reviews are
focussed on specific topics such as oral health in children (de Silva-Sanigorski et al.,
2012) and dietary behaviour in children and adolescents (Ganann et al., 2010).
A review was undertaken in 2003 by PSI (Population Services International) of health
based social marketing research (Department for International Development, 2003).
The evidence base was defined through systematic review methodological procedures
of the published literature documenting the effectiveness of social marketing availableon PubMed as well as unpublished PSI papers. The review resulted in the
identification of 87 studies, which almost exclusively were related to HIV/AIDS,
maternal and child health (including malaria interventions), and family planning and
reproductive health. The review evaluated the effectiveness, efficiency and equity of
social marketing programmes presented in the papers. Effectiveness of social
marketing appeared clear based on strong evidence of a positive relationship between
social marketing interventions and changes in product and service use as well as non-
product related behaviours. The underlying process of such changes involves the areas
of opportunity, ability and motivation as key determinants of health behaviours. On
the other hand, recurrent observation of substitution as well as halo effects supported
the claim of efficiency of social marketing interventions. Only in terms of equity, the
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evidence base is more mixed, due mainly to differences in the statistical choices of
study authors. More data is therefore required for it to be assessed properly.
Despite these encouraging results, the review also demonstrated the gaps in the
knowledge base about social marketing, and in particular in terms of:
Guidance on the design of interventions, projects, and programmes; Evidence of the rates of change at which targeted behaviour practices occur;
Effectiveness of different levels of intensity/frequency;
Effectiveness and efficiency of different marketing mixes as behaviour
changes within a population;
Long term effect on health behaviours; and
Role of the price as a potential barrier to continued use of products and
services.
The major investment made by the international community in the communicationcomponent of global public health and development programmes, along with an
increasing scientific literature, illustrate the importance accorded to this component
– and hope in its effectiveness (Obregon & Waisbord, 2012). However, more evidence
on its processes and best practices is needed.
This review will address the gaps identified in the earlier PSI study and Department
for International Development (DFID) review discussed above and will focus
specifically on evidence from studies that have used BCC strategies in an intervention
underpinned by social marketing principles.
There is an increasing demand from policy-makers and funders for rigorous evidence
for the impact of BCC projects on health behaviours and health outcomes and on
market efficiency (Dhaliwal & Tulloch, 2012). This is driven by several factors:
A significantly increased emphasis on evidence-based policy and funding
within the international development sector as a whole, and thus on the
importance of rigorous impact evaluation (UNICEF, 2005);
A linked increase in the importance placed by donors (such as DFID and
USAID, United States Agency for International Development) as well as
NGOs on cost-effectiveness and value for money in the context of increased
public scrutiny of funding for overseas aid and pressure on philanthropic
budgets (Fowler, 2013);
Scepticism in some quarters about the effectiveness of mass media behaviour
change campaigns, given the lack of robust evidence, exacerbated by an
impression that some BCC campaigns (for example, promoting condom use)
have not always been effective; and
Increased interest and funding in markets for the poor and underserved
(Heierli, 2009; Bloom et al., 2014).
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This review will focus on those studies that have specifically used single and multi-
channel communication strategies in social marketing health programmes as defined
by at least five of the eight underlying NSMC criteria mentioned in Section 1.1 above.
The review will consider social marketing programmes from all LMIC health related
sectors.
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Objective of the review
The overall objectives of the review are to assess the effectiveness of communication
strategies incorporated in social marketing, on behaviour changes and/or
maintenance, and health and welfare outcomes in LMICs.
Primary objectives
1) To assess the effectiveness of communication strategies and the impact of such
“messages’’ that are most used to underpin communication strategies through
theoretical models of behaviour change and/or maintenance and social marketing
strategies (that is, message impact); and
2) To assess the effectiveness of such communication strategies on health outcomes
(prevalence, morbidity and mortality).
Secondary objectives
The following secondary objectives will be addressed, when available among includedstudies, in a narrative review:
3) To assess the barriers, mediators and moderators which significantly influence the
impact of communication strategies on health behaviour change and/or
maintenance;
4) To review the convergence of tools/technologies and channels which have been
most used in communications for social marketing programmes. What evidence
and potentially on-going research is available to support what is the best
combination of tools and how and when should these be used (while keeping inmind that it may not always be evident for authors of studies involving complex
interventions to identify exactly which tool, or combination of tools, yields the
most favourable outcomes);
5) To review the principles and approaches used in communication design and
evaluation, particularly the methods or theories used for: effective messaging;
persuasiveness and information processing; credibility of programme and spokes
people; and message design; and
6)
To identify important evidence gaps in communication strategies.
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to): statistical matching (for example, propensity score matching); and regression
adjustment (for example, difference-in-differences, estimation, and variable selection
models) (Waddington et al., 2012).
With the breadth of different study designs within the inclusion criteria, any meta-
analysis to evaluate the effect size(s) will be appropriately sub-grouped by study
design (in addition to other PICO components – participants, interventions,
comparisons, outcomes, including by health condition) in order to minimise biases
that could occur from combining studies of multiple types; further explanation of
analyses are presented in Sections 3.3 and 3.4.
3.1.2 Participants
Participants will include targeted populations or communities, including social
networks, and/or individuals in low- and middle-income countries (LMICs) of any
age, gender, education, socio-economic status, or health conditions, who are eitherthe direct recipient of the health treatment product or service, the carer, or those in
positions to administer or provide a treatment, product or service.
3.1.3 Interventions
Interventions would include all communication strategies in social marketing health
behaviour change and maintenance programmes (which could also include those
among the private sector) which agree with a modified version of at least five of the
eight NSMC criteria that use communication inputs and channels designed to
influence voluntary behaviour of target audiences (NSMC, 2010). The strategiescould relate to any product and/or service, or variation of these, promoted as part of
the health programme.
These criteria include:
1) Behaviour change and/or maintenance: the intervention seeks to change (or
maintain, in the case of positive behaviour adoption at baseline; for example,
exclusive breast feeding may be an initial behaviour adoption but then it is often not
always sustained for the recommended period) behaviour and has specific measurable
behavioural objectives;
2) Consumer research: formative research is conducted to identify consumer
characteristics and needs, including their view of the recommended behaviour and
what they see as constraining and facilitating factors in terms of implementing the
behaviour. Interventions are pre-tested with the target group;
3) Segmentation and targeting: different segmentation variables are used and a
strategy is tailored to the segments;
4) Marketing communication mix: the intervention must consist of communications
(for example, mass media, personal selling, advertising, community mobilisation, or
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public relations) plus at least one ‘P’ (from product, price, place, or promotion) or ‘C’
(from consumer need/want/desire, cost, convenience, and communication);
5) Exchange: the intervention considers what will motivate people to engage
voluntarily with the intervention and offers them something beneficial in return,
whether that is intangible or tangible, and whether the benefits are of value to the
consumer (for example, insecticide treated bed nets are beneficial, but are these
benefits perceived by the consumer as of value to them?);
6) Competition: the intervention considers the appeal of competing behaviours
(including the current behaviour) and uses strategies to decrease competition;
7) Theory: the intervention uses behavioural theories to understand human behaviour
and to build programmes around this understanding; and
8) Customer orientation: the intervention attaches importance to understanding from
where the customers are starting, their knowledge, attitudes and beliefs, and the social
context in which they work.
The intervention setting should be a developing country defined as a country bearing
the World Bank designation of a low income, lower middle income, or upper middle
income economy (World Bank, 2012).
3.1.4 Comparisons
Any comparisons will be included, both inactive and active controls including
comparisons between different types of medium of communications.
Comparisons would include:
Baseline or adjusted baseline;
Communication strategies, which can be comprised of at least one different
type of communication method/channel;
Use of different communication channels and their attributes including
persuasiveness and information processing and message design and
interactivity; and
Different characteristics of social marketing policy as identified through the
four “P”s (including, for example, differentiation in pricing, place of
delivery and organisational provider, products and promotion), or the four
“C”s (including, for example, differences in consumer
needs/wants/desires, costs, conveniences to obtain the product or service,
and communications).
With the possible comparisons that could exist in evaluating effect sizes among
studies of the same study design, further sub-groups will be defined to meta-analyse
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those studies with similar comparisons in order to minimise biases that could occur
from combining studies containing varying comparisons; further explanation of
analyses are presented in Sections 3.3 and 3.4.
3.1.5 Outcomes
Due to the nature of the interventions, only the primary outcome will form part of theeligibility criteria. As seen in Figure 1, outcomes can occur in the short term, as well
as in the more intermediate to long term. In some cases, outcomes can be both short
and intermediate-to-long term in nature.
Primary
A change in behaviour, and/or sustained behaviour change over time, targeted by the
intervention, which could also include the adoption or sale of a service or product
(that is, change in, or maintenance/uptake of, demand of a service or product). This
may be objectively measured/observed or self-reported. In order to measure
sustainability, or maintenance, of a behaviour change (or an initial positive behaviour
adoption), the outcome would need to be measured for at least 6 months or longer
(Prochaska & Velicer, 1997).
Secondary
Any of the following health, welfare, and cognitive outcomes will be identified from
included studies, when available, and assessed narratively.
Health outcomes:
Prevalence and/or incidence;
Indicators of morbidity and/or severity of morbidity; and
Indicators of transmission, including change in transmission rate (for
example, change in infected vectors).
Welfare outcomes:
Economic
o Income (change in monetary income);
o Labour productivity (for example, change in working hours, ability
to work a “standard work day”, or to undertake more demanding
work e.g. heavier work or increased production, including
agricultural production for the same hours of work); and
o Voluntary leisure time;
Social
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o Change in social relations (for example, measures of community
inclusion/exclusion, measures of stigma e.g. earnings,
employment, marriage status as compared with “health y people”);
and
Environmental
o Water and air quality.
There are also intermediaries that assist the assessment of progress toward achieving
a primary outcome of behaviour change, or a secondary health and welfare outcome.
Intermediaries will be considered only if the aforementioned primary outcome is
identified within a study. Intermediaries include the following:
Cognitive outcomes:
o Knowledge (for example, awareness of the disease, knowledge of
disease risk and realism of risk perception, and knowledge ofprivate and public benefits of the health intervention);
o Attitudes and intentions to change; and
o Self-efficacy (that is, a person’s belief in their capacity to carry out
a specific action).
Adverse outcomes may also be reported throughout the studies, which we will include
in this review.
Intermediate outcomes will be collected along the causal chain and may form part of
the contextual and background information of the study.
Based on the PICOS components defined above, an example of a study that meets the
eligibility criteria for inclusion is Pattanayak et al. (2009). The intervention reported
by the authors consisted in a community-led total sanitation approach aiming to
empower local inhabitants by not simply providing latrines but also fostering
discussions and reflexions to change knowledge, attitudes and practices. The
development of the campaign was informed by in-depth interviews and focus groups
with the targeted audience and key informants. Such formative research suggested
the importance of key notions such as privacy, dignity and safety benefits, thus going beyond a simply medical approach and encompassing social and cultural dimensions.
Social mobilization was fostered through a variety of intervention tools and channels,
including three community-based activities: a community walk, a participatory
mapping exercise, and group discussions. The planning and evaluation of the
intervention makes use of other key social marketing concepts including the
marketing mix approach: price, product, placement and promotion.
On the contrary, Khan et al. (2012) is an example of a study that does not meet
inclusion criteria. Although this study assesses a behaviour change communication,
it does not meet any of the following social marketing criteria: consumer research,
customer orientation, exchange, segmentation and targeting and therefore does not
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reach the minimum five out of the eight criteria listed previously. Furthermore, the
communication is limited to a single booklet, which is not accessible to illiterate
women, thus reducing the reachable audience.
3.2 SEARCH METHODS FOR IDENTIFICATION OF STUDIES
3.2.1 Electronic searches
The search will be performed in the following electronic databases:
i. CENTRAL, The Cochrane Central Register of Controlled Trials (latest
issue);
ii. MEDLINE (Ovid SP) (1960 to date);
iii. EMBASE (Ovid SP) (1960 to date);
iv. PubMed;
v. PsycINFO (Ovid SP) (1960 to date);
vi. ERIC (Ovid) (1960 to date);
vii. CINAHL (Ovid) (1960 to date);
viii. Chinese Social Science Citation Index;
ix. Indian Citation Index;
x. Interred educational search engine;
xi. Global Health (Ovid) (1960 to date);
xii. WHOLIS (1960 to date);
xiii. LILACS (1960 to date);
xiv.
SCIRUS (1960 to date);
xv. Web of Science (1960 to date);
xvi. ASSIA (ProQuest) (1960 to date);
xvii. HMIC (Health Management Information Consortium)
xviii. WHO nutrition databases
(http://www.who.int/nutrition/databases/en/)
xix. Social Science Index
http://en.wikipedia.org/wiki/Chinese_Social_Science_Citation_Indexhttp://en.wikipedia.org/wiki/Indian_Citation_Indexhttp://en.wikipedia.org/wiki/Interred_educational_search_enginehttp://www.who.int/nutrition/databases/en/http://www.who.int/nutrition/databases/en/http://www.who.int/nutrition/databases/en/http://www.who.int/nutrition/databases/en/http://en.wikipedia.org/wiki/Interred_educational_search_enginehttp://en.wikipedia.org/wiki/Indian_Citation_Indexhttp://en.wikipedia.org/wiki/Chinese_Social_Science_Citation_Index
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xx. OVID HealthStar
xxi. Open Grey
xxii. Sociofiles
xxiii.
HINARI
xxiv. Scopus
xxv. Social Care Online
3.2.2 Searching other resources
We will also search reference lists of included studies and related reviews.
In addition, we will search the grey literature using Google Scholar.
The following document repositories of organisations will also be searched,
throughout which we will use broad search terms such as ‘social marketing’ and
‘communication’:
i. Population Service International (http://www.psi.org);
ii. U.K. Department for International Development
(http://www.dfid.gov.uk);
iii.
U.S. Agency for International Development (http://www.usaid.gov);
iv. IDEAS/RePEc (http://ideas.repec.org);
v. 3ie impact evaluation (http://www.3ieimpact.org);
vi. JHPIEGO (http://www.jhpiego.org/en);
vii. Family Health International (FHI) (http://www.fhi.org/en/index.htm);
viii.
Population Council (http://www.popcouncil.org);
ix. The British Library for Development Studies;
(http://www.blds.ids.ac.uk);
x. Asian Development Bank (http://www.adb.org);
xi. Australian Aid Agency (http://www.ausaid.gov.au/Pages/home.aspx);
xii. Canadian International Development Agency
(http://www.acdi-cida.gc.ca/home);
http://www.psi.org/http://www.dfid.gov.uk/http://www.usaid.gov/http://www.3ieimpact.org/http://www.jhpiego.org/enhttp://www.fhi.org/en/index.htmhttp://www.popcouncil.org/http://www.blds.ids.ac.uk/http://www.blds.ids.ac.uk/http://www.popcouncil.org/http://www.fhi.org/en/index.htmhttp://www.jhpiego.org/enhttp://www.3ieimpact.org/http://www.usaid.gov/http://www.dfid.gov.uk/http://www.psi.org/
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xiii. Swedish Development Agency (http://www.sida.se/English);
xiv. Danish Development Agency (http://um.dk/en/danida-en);
xv. Japan International Cooperation Agency (http://www.jica.go.jp/english);
xvi.
Japan Bank for International Cooperation (http://www.jbic.go.jp/en);
xvii. World Bank (Office of Evaluation and Development)
(http://go.worldbank.org/1F1W42VYV0);
xviii. Pan American Health Organization (http://www.paho.org);
xix. World Health Organization (http://www.who.int/en);
xx. United Nations (UNAIDS (http://www.unaids.org/en), UNICEF
(http://www.unicef.org), UNEP (http://www.unep.org), UNDP(http://www.undp.org), UN-HABITAT (http://www.unhabitat.org), and
UNRISD (http://www.unrisd.org));
xxi. Inter-American Development Bank (http://www.iadb.org);
xxii. African Development Bank (http://www.afdb.org);
xxiii. Red Cross (http://www.redcross.org);
xxiv. Christian Aid (http://www.christianaid.org.uk);
xxv. Oxfam (http://www.oxfam.org.uk);
xxvi. African Medical and Research Control (http://www.amref.org);
xxvii. Centers for Disease Control and Prevention (http://www.cdc.gov);
xxviii. Futures Group (http://futuresgroup.com);
xxix. Manoff Group (http://manoffgroup.com);
xxx. Centre of Excellence for Public Sector Marketing (CEPSM)
(http://cepsm.ca.home);
xxxi. Rescue Social Change Group (http://rescuescg.com);
xxxii. Strategic Social Marketing Ltd. (http://www.strategic-social-
marketing.vpweb.co.uk);
xxxiii. Social Marketing Services Inc. (http://www.socialmarketing
servive.com);
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xxxiv. National Social Marketing Centre (NSMC) (http://www.thensmc.com);
and
xxxv. DKT International (http://www.dkinternational.org/about-dkt).
We will search the following theses and conference proceedings databases:
i. Index to Theses (http://www.theses.com); and
ii. Dissertation Abstracts
(http://library.dialog.com/bluesheets/html/bl0035.html).
We will search the following trial registers for on-going and recently completed trials:
i. WHO International Clinical Trials Registry Platform
(http://www.who.int/ictrp/en/);
ii. Current Controlled Trials (www.controlled-trials.com);
iii. Clinical Trials (www.clinicaltrials.gov);
iv. Trials Register of Promoting Health Interventions (TRoPHI)
(http://eppi.ioe.ac.uk/webdatabases/Intro.aspx?ID=5); and
v. Database of promoting health effectiveness reviews (DoPHER)
(http://eppi.ioe.ac.uk/webdatabases/Intro.aspx?ID=2).
We will also search the EPPI-Centre database of health promotion (Bibliomap)
(http://eppi.ioe.ac.uk/webdatabases/Intro.aspx?ID=7).
Given the focus of the review and the potential for studies to have been conducted and
reported in other countries and languages, studies will not be excluded based on
language of publication, and a translation will be performed when necessary.
3.2.3 Search terms
The following search terms will be used across marketing, communication, and
setting domains:
Marketing
1 exp Marketing
2 exp Social Marketing
3 marketing.ab.ti
4 (social adj3 market$).ab,ti.
http://www.dkinternational.org/about-dkthttp://www.dkinternational.org/about-dkthttp://www.dkinternational.org/about-dkthttp://eppi.ioe.ac.uk/webdatabases/Intro.aspx?ID=2http://eppi.ioe.ac.uk/webdatabases/Intro.aspx?ID=2http://www.dkinternational.org/about-dkt
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5 behavio?r change.ab,ti.
6 consumer research.ab,ti.
7 audience segment$.ab,ti.
8 market$ mix.ab,ti.
9 customer orient$.ab,ti.
Communication
1 exp communication
2 exp advocacy
3 exp Consumer Advocacy/ or exp Patient Advocacy
4 exp information dissemination
5 information adj3 disseminat$.ab,ti.
6 exp health promotion
7 exp Education
8 exp advertising
9 adverti$.ab,ti.
10 exp mass media
11 mass media.ab.ti
12 exp multimedia
13 exp communications media
14 exp information technology
15 exp information
16 drama?.ab,ti.
17 "home visit*".ab,ti.
18 play$.ab,ti.
19 internet.ab,ti.
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Setting
43 exp Developing Countries
44 low income countr$.ab,ti.
45 low middle income countr$.ab,ti.
46 developing countr$.ab,ti.
47 middle income countr$.ab,ti.
48 sub-saharan africa.ab,ti.
49 southeast asia.ab,ti.
50 latin america.ab,ti.
51 south america.ab,ti.
52 Exp Africa south of the Sahara
53 Exp Asia, Southeastern
54 Exp Latin America
55 exp South America
3.3 DATA COLLECTION AND ANALYSIS
We will follow a three-stage approach to data collection and analysis. Using the
aforementioned search strategy, Stage 1 will consist of identifying peer-reviewed and
grey literature from databases and other sources listed in the previous section. These
will be screened, first using titles and abstracts and then the full texts of potentially
eligible studies, to ensure that articles meet the study inclusion criteria. In the full text
screening, we will apply a restriction to include only those articles published after
1960, as although “social marketing” was coined in 1971 (Kotler & Zaltman, 1971) the
term and approach had already started being applied to health interventions by the
1960s, especially in developing countries (Manoff, 1985; Walsh et al., 1993). However,
we will not apply this restriction at the time of searching or initial screening of titles
and abstracts due to the possibility of incorrect indexing of an article, particularly the
date of publication.
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In Stage 2, we will develop a matrix to facilitate the identification and categorisation
of relevant social marketing communication strategies. The columns in the matrix will
consist of common health conditions in LMICs that contribute to the global burden of
disease while the rows will consist of the different strategies of the alternative
communication strategies. These strategies relate to the inputs and channels outlined
in Figure 1.
In Stage 3, the definition and understanding of communication strategies will be
informed by the matrix and refined as necessary.
3.3.1 Selection of studies
We will merge search results across databases and other resources, using the
reference management software EndNote X5 (Thomson Reuters Corporation, 2010),
and remove duplicate records of the same report. Two authors (ERS and LF) will
independently examine titles and abstracts of records retrieved from the search. We will retrieve the full text of the potentially-relevant studies and assess their eligibility
against the inclusion criteria. Multiple reports of the same study will be reviewed in
order to determine if the study is eligible for inclusion, since oftentimes multiple
publications regarding a single study may not always provide the study design and
analysis information in each publication for that study. Authors will compare their
inclusion and exclusion decisions and discuss any differing results, with unresolved
disagreements about study eligibility evaluated by a third review author (LHG or JL),
who will serve as a mediator.
If any disagreements are not resolved, then we will place the article with those
'awaiting assessment' and will contact the author(s) for clarification. We will also
include any on-going trials if a study author(s) provides interim outcome data, or the
final data, ahead of publication of their report. We will describe all the potentially-
relevant excluded studies in the ‘Characteristics for Excluded Studies’ table along with
reasons for exclusion. We will use an adapted PRISMA (Preferred Reporting Items for
Systematic Reviews and Meta-Analyses) flow-chart to describe the study selection
process (Schünemann et al., 2011).
3.3.2
Data extraction and management
For studies meeting the inclusion criteria, we will extract the PICOS characteristics
(information on participants, interventions, comparisons, outcomes, and study
designs) and present them in a table. The Appendix (in Section 7) provides a draft
codebook of key constructs of interest for the data extraction. Two authors (ERS and
LF) will independently extract relevant PICOS characteristics of all the included
studies using a structured data collection/extraction form approved by the other team
members; any disagreements will be resolved by referencing the original article or
consulting, when necessary, with a third author (LHG). Any relevant missing
information on the study(s) will be sought from the original author(s) of the article, if
required. ERS will transfer the data from the extraction form to the Review Manager
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software (The Cochrane Collaboration, 2012) while LF will confirm the accuracy of
the entered data. We will summarise extracted data in a ‘Characteristics of Included
Studies’ table.
3.3.3 Assessment of risk of bias in included studies
Two authors (ERS and LF) will perform independent assessments of the risks of biases within each study. For studies with a separate control group such as
randomised controlled trials, non-randomised controlled trials, and controlled
before-after studies, we will use the risk of bias criteria as suggested by the Cochrane
Collaboration’s Effective Practice and Organisation of Care (EPOC) review group
(Effective Practice and Organisation of Care Group, 2009). This judges the study
against nine criteria related to: sequence generation; allocation concealment; baseline
outcome measurements; baseline characteristics; incomplete outcome data; blinding
of outcome assessments; contamination; selective outcome reporting; and other
biases. For judging other biases, we will consider the following two criteria: use of valid and reliable outcome measurements; and funding sources. For each criterion,
the risk of bias will be judged as low, unclear, or high.
For studies that use an interrupted time series (ITS) design, we will assess the risk of
bias using the following domains as recommended by EPOC (Effective Practice and
Organisation of Care Group, 2009): 1) the intervention being independent of other
changes; 2) sufficient data points to enable statistical inference; 3) the intervention
being unlikely to affect data collection; 4) blinding of outcome assessors to
intervention allocation; 5) incomplete outcome data being adequately addressed; 6)
selective reporting of outcomes; and 7) other risk of bias related to validity and
reliability of outcome measures and funding sources.
We will seek guidance from the IDCG (International Development Coordinating
Group) secretariat to assess the risk of bias in studies that have used multiple
statistical analyses (IDCG, 2012).
In all cases, two authors (ERS and LF) will independently assess the risk of bias of
included studies, with any disagreements resolved by discussion, and with
consultation of a third review author (LHG) as a mediator. As necessary and wherepossible, we will contact study authors for additional information about the included
studies, or for clarification of the study methods. We will incorporate the results of
the risk of bias assessment into the review through a ‘Risk of Bias’ table, and a
systematic narrative description and commentary about each of the elements, leading
to an overall assessment of the risk of bias of included studies and a judgment about
the overall internal validity of the review’s results.
The correlation between these risks of bias measures and the effect sizes will be
examined. And a sensitivity analysis will be conducted using one or more risk of bias
scores as a moderator.
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3.3.4 Assessment of statistical power of included studies
For any included study that is not eligible for a meta-analytic synthesis of estimating
pooled effects, we will obtain the statistical power of the study to detect pre-
established significant effect magnitudes from the published report (IDCG, 2012). If
this is not available, then we will calculate the power of the study (post-hoc) for the
point estimate of the effect based on the primary outcome. This will be based on the
assumption that the sample size is sufficient to detect an optimal difference in
behaviour change outcome with 90% power at the 0.05 significance level.
3.3.5 Measures of treatment effect
We will compare characteristics of included studies to assess the feasibility of
conducting a meta-analysis. Only those studies that are deemed homogeneous based
on similar PICOS elements, including cultural and population-specific characteristics
(that is, it may be unrealistic to conclude that the effectiveness of the sameintervention strategy/mix of strategies is equivalent among varying cultures), will be
meta-analysed. For dichotomous outcomes of included studies, we will report risk
ratios and corresponding 95% confidence intervals. For continuous data among
studies that assess the same outcome measure, we will estimate mean differences (for
studies using the same scale) and standardised mean differences (for differences in
scale) between groups, along with their corresponding 95% confidence intervals.
Since included studies are likely to come from heterogeneous epidemiological and
socioeconomic settings, and true effect sizes are expected to vary, a random effects
meta-analysis will be employed, if feasible to combine similar studies by subgroups.
For controlled before and after studies, we will report the relative percentage change
post intervention and standardised mean differences, along with their associated 95%
confidence intervals.
Where follow-up data were collected at different time periods, we will report results
taken from the furthest points in time relative to the intervention (Deeks et al., 2011).
For interrupted time series studies, we will report the following estimates, and their
95% confidence intervals, from regression analyses which adjust for autocorrelation:
(i) change in level of the outcome at the first point after the introduction of the
intervention (immediate effect of the intervention); and (ii) post-intervention slope
minus the pre-intervention slope (long term effect of the intervention) (Brennan et
al., 2009).
3.3.6 Unit of analysis issues
If a study has multiple intervention arms, but only one that would fulfil our inclusion
criteria, then we would compare this arm with the least active or inactive arm. We
will, however, list all other arm(s) that were not used for comparison in the report.
Where a study has more than one active intervention arm, data from the appropriate
arms for each of the main comparisons will be extracted. If more than one treatment
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arm is relevant for a single comparison, then data from all appropriate arms will be
included in that comparison.
In studies where the effects of clustering have not been taken into account (for
example, by using multilevel modelling), we will correct for this unit of analysis error
by adjusting the studies’ corresponding standard errors and confidence intervals, by
a factor including the intra-class correlation coefficient (ICC), if provided in papers,
or using a published estimate of the ICC for different interventions and outcomes
(Ukoumunne et al., 1999) as suggested by (Higgins et al., 2011).
3.3.7 Dealing with missing data and incomplete data
For any missing data within included studies, we will contact the study authors in an
effort to obtain this missing information (for example, number of participants in each
group, outcomes, and summary statistics). If the standard deviations (SDs) of
continuous outcome data are missing, then we will attempt to calculate them usingother reported statistics, such as 95% confidence intervals, standard errors, or p-
values. If these are unavailable, then we will contact the author(s) in an effort to obtain
them. We will use an intention-to-treat (ITT) analysis (Higgins et al., 2011).
3.4 DATA SYNTHESIS
3.4.1 Quantitative Synthesis
The studies’ characteristics based on the PICOS components will be compared to
determine whether studies can be combined with a meta-analysis based on relatively
little or moderate clinical heterogeneity, as determined by experts with knowledge of
communication strategies embedded within social marketing programmes. First,
studies will be grouped according to health condition and primary outcome(s) within
that condition. Next, studies will be assessed on the criteria of intervention(s),
comparison(s), and participants within a given health condition to determine whether
(or which) studies can be combined based on relatively low or moderate clinical
heterogeneity of these criteria (e.g., see Section 3.4.1.2 for some of the intervention
components that will be assessed). Experts with knowledge of communication
strategies embedded within social marketing programmes (for example, one of our
co-authors at Development Media International, some of the Key Influencers as
identified in our Policy Influence Plan) will be contacted to review these criteria to
assess the level of clinical heterogeneity, hence advising whether to combine
potentially similar studies in a meta-analysis. Grouped studies will then be assessed
by study design and only those with the same study design will be combined into a
meta-analysis. Thus, only those studies that are deemed by the experts as
homogeneous based on similar PICOS elements, including cultural and population-
specific characteristics (that is, it may be unrealistic to conclude that the effectiveness
of the same intervention strategy/mix of strategies is equivalent among varying
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cultures), will be meta-analysed. Where appropriate, effects will be synthesized for
short, intermediate, and long term outcomes along the causal chain (IDCG, 2012).
If suitable numerical data are not available and/or if a meta-analysis is not
appropriate, as in cases where the included studies are too clinically heterogeneous to
combine, we will perform a narrative synthesis. We will refer to the narrative
synthesis framework to guide this process (Rodgers et al., 2009). In particular, we will
use the following steps:
Develop a preliminary synthesis by grouping the included studies by the type
of health condition;
Describe Participants, Interventions, Comparisons, and Outcomes (PICO
elements) along with the reported findings for each of the included studies;
Explore the relationships between characteristics of individual studies and
their reported findings, as well as those between the findings of different
studies;
Describe the moderators as well as the mediators that would have an impact
on the intervention effects. Depending on the availability of data from
included studies, we will also explore and report the impact of the
interventions on specific population groups such as those belonging to low
socioeconomic status, children, women, or older people; and
Use the summary of the risk of bias of an outcome across studies to judge therobustness of the evidence.
We will perform the statistical analysis using RevMan version 5.2 (The Cochrane
Collaboration, 2012). We will adhere to the statistical guidelines in (Higgins et al.,
2011).
We will use the GRADE system to assess the quality of the overall evidence. We will
construct a ‘Summary of Findings’ table that will include the magnitude of the effect
of the interventions, and a summary of available data for primary and secondary
outcomes (Schünemann et al., 2011).
3.4.1.1 Assessment of heterogeneity
When a meta-analysis is possible, we will assess statistical heterogeneity through
visual inspection of forest plots, by assessing the overlap of 95% confidence intervals
for estimated intervention effects across studies (i.e., with poor overlap indicative of
statistical heterogeneity), and through assessment of heterogeneity statistics, such as
I2 and the Chi-square significance test for heterogeneity. Since the Chi-square test
may have lower statistical power for a smaller number of combined studies or with
studies of small sample sizes, a 0.1 significance level will be used rather than the
standard 0.05 level, with significant results indicative of statistical heterogeneity
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(Deeks et al., 2011). As we will be using a random effects meta-analytic model, we will
also report the between study variability, tau-squared (τ 2).
3.4.1.2 Investigation of Heterogeneity
We will investigate whether findings differ according to key intervention components
or potential contextual mediators as listed below (Baron & Kenny, 1986; Bauman etal., 2002):
Theoretical models used;
Mono or multi intervention and intervention combinations;
Duration of intervention, its frequency and intensity;
Channel(s) of delivery (fore example, media, face-to-face, electronic, and so
forth);
Level of interaction allowed by intervention;
Audience health status; Product or service type;
Level and attributes of segmentation;
Country income level (that is, ‘lower middle income countries’, ‘higher middle
income countries’ and ‘low income countries’); and
Source of funding and/or implementation (that is, industry, aid, national).
In addition, we will collect information on sub-groups of interest, including
vulnerable groups, according to PROGRESS-plus (place of residence, race/ethnicity,
occupation, gender, religion, education, socioeconomic status, social capital, age,
disability, and sexual orientation) categories (Kavanagh et al., 2009).
If sufficient studies are available for a given outcome and potentially important
moderators are identified in the review through a sub-group meta-analysis, then we
will perform meta-regression to estimate the independent effects of these covariates
on effect (IDCG, 2012). This would be performed in the statistical software package R
(R Core Team, 2013).
3.4.1.3 Sensitivity Analysis
We will perform sensitivity analyses (using the criteria discussed in the ‘Assessment
of Risk of Bias in Included Studies’ section, and as recommended by Effective Practice
and Organisation of Care Group, (2009)) including:
Exclusion of studies with a high risk of attrition bias, that is, incomplete
outcome data; and
Exclusion of potentially influential outliers (that is, large studies with
excessively large or small effect sizes that may heavily influence the mean
effect size).
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At the end we will apply 3ie’s quality appraisal of systematic reviews checklist2 to
check for the completeness of all the review methods and to improve clarity in the
final report.
3.4.1.4 Assessment of Publication Bias
We will evaluate funnel plots for asymmetry (provided there are at least ten includedstudies in the meta-analysis). Funnel plots will be used as a means of investigating
small study effects that may have occurred due to the potential existence of reporting
biases (for example, small study bias). Tests of funnel plot asymmetry may also be
used to examine whether the association between estimated intervention effects and
a measure of study size is greater than might be expected to occur by chance, and to
add further consideration to the visual inspection of the funnel plot (Sterne et al.,
2011). We will also consider other reasons for possible funnel plot asymmetry such as
true heterogeneity or the methodological quality of included studies.
3.4.2 External Validity
In order to explore external validity of the review, we will present results in terms of
relative and/or absolute effects and discuss the implications of differences in absolute
or relative effects for different contexts such as related to moderators and PROGRESS
plus categories as listed under the Assessment of Heterogeneity section. In addition,
we will use the GRADE system to assess the quality of the evidence, the magnitude of
effect of the interventions, and the available information on the primary and
secondary outcomes. Results will be presented in a ‘Summary of Findings’ table
(Schünemann et al., 2011).
2http://www.3ieimpact.org/media/filer/2012/05/07/quality_appraisal_checklist_srdatabas
e.pdf
http://www.3ieimpact.org/media/filer/2012/05/07/quality_appraisal_checklist_srdatabase.pdfhttp://www.3ieimpact.org/media/filer/2012/05/07/quality_appraisal_checklist_srdatabase.pdfhttp://www.3ieimpact.org/media/filer/2012/05/07/quality_appraisal_checklist_srdatabase.pdfhttp://www.3ieimpact.org/media/filer/2012/05/07/quality_appraisal_checklist_srdatabase.pdfhttp://www.3ieimpact.org/media/filer/2012/05/07/quality_appraisal_checklist_srdatabase.pdfhttp://www.3ieimpact.org/media/filer/2012/05/07/quality_appraisal_checklist_srdatabase.pdf
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4
Timeline
Date Event
1 March 2013 Preliminary Protocol submitted to Campbell Collaboration
14 April 2013 Comments received from Campbell Collaboration
21 May 2013 Final Protocol submitted to Campbell Collaboration
15 October 2013 Submission of draft report to Campbell Collaboration
15 November 2013 Comments received from Campbell Collaboration
31 December 2013 Submission of final paper to Campbell Collaboration
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5
Acknowledgements
We would like to acknowledge support and assistance from:
International Initiative for Impact Evaluation (3ie) who are funding this
review;
Tim Reeves, Medical Research Support Librarian at Imperial College
London, for his advice on devising the search strategies;
The review Advisory Group members for their feedback on a draft of this
document; and
Campbell peer review groups.
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6
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