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Six steps in quality intervention development (6SQuID)
Article  in  Journal of epidemiology and community health · November 2015
DOI: 10.1136/jech-2015-205952
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Six steps in quality intervention development
(6SQuID)
Daniel Wight,1
Erica Wimbush,2
Ruth Jepson,3
Lawrence Doi3
1
MRC/CSO Social and Public
Health Sciences Unit,
University of Glasgow,
Glasgow, UK
2
Evaluation Team, NHS Health
Scotland, Edinburgh, UK
3
MRC/CSO Scottish
Collaboration for Public Health
Research and Policy,
University of Edinburgh,
Edinburgh, UK
Correspondence to
Professor Daniel Wight,
MRC/CSO Social and Public
Health Sciences Unit,
University of Glasgow,
200 Renfield Street, Glasgow
G2 3QB, UK;
d.wight@sphsu.mrc.ac.uk
Received 22 April 2015
Revised 18 September 2015
Accepted 11 October 2015
To cite: Wight D,
Wimbush E, Jepson R, et al.
J Epidemiol Community
Health Published Online
First: [please include Day
Month Year] doi:10.1136/
jech-2015-205952
ABSTRACT
Improving the effectiveness of public health interventions
relies as much on the attention paid to their design and
feasibility as to their evaluation. Yet, compared to the
vast literature on how to evaluate interventions, there is
little to guide researchers or practitioners on how best to
develop such interventions in practical, logical, evidence
based ways to maximise likely effectiveness. Existing
models for the development of public health
interventions tend to have a strong social-psychological,
individual behaviour change orientation and some take
years to implement. This paper presents a pragmatic
guide to six essential Steps for Quality Intervention
Development (6SQuID). The focus is on public health
interventions but the model should have wider
applicability. Once a problem has been identified as
needing intervention, the process of designing an
intervention can be broken down into six crucial steps:
(1) defining and understanding the problem and its
causes; (2) identifying which causal or contextual factors
are modifiable: which have the greatest scope for
change and who would benefit most; (3) deciding on
the mechanisms of change; (4) clarifying how these will
be delivered; (5) testing and adapting the intervention;
and (6) collecting sufficient evidence of effectiveness to
proceed to a rigorous evaluation. If each of these steps
is carefully addressed, better use will be made of scarce
public resources by avoiding the costly evaluation, or
implementation, of unpromising interventions.
INTRODUCTION
Improving the effectiveness of public health inter-
ventions depends as much on improving their
design as their evaluation.1
Yet, compared to the
vast literature on intervention evaluation,2–5
there
is little to guide researchers or practitioners on
developing interventions in logical, evidence-based
ways to maximise effectiveness. Poor intervention
design can waste public resources through expen-
sive evaluation or, worse, the implementation of
ineffective interventions unevaluated.
Existing frameworks and guidance for the devel-
opment of interventions3 4 6–10
are summarised in
table 1. These tend to be orientated towards
social-psychological, individual behaviour change
and either provide little specific detail on interven-
tion development or require great technical skills
and resources. Drawing on the strengths of these
existing frameworks and our own experiences, this
article outlines a pragmatic six-step guide to the
essential stages of intervention development to
assist public health practitioners and researchers.
The focus is on public health interventions,
although the model should have wider applicability.
A public health intervention is defined as
planned actions to prevent or reduce a particular
health problem, or the determinants of the
problem, in a defined population. Most require
some level of social interaction. They are rarely
simple, singular actions that can be easily replicated
but more often complicated (multicomponent) or
complex programmes (with feedback loops and
emergent outcomes)11
that are designed to affect
change at several levels of the socioecological
model12
(table 2). By and large, ‘upstream’ inter-
ventions ‘require less individual effort (from recipi-
ents) and have the greatest population impact’,13 14
whereas interventions requiring voluntary uptake
are more likely to exacerbate health inequalities.15
Interventions are best developed through colla-
borations between interdisciplinary teams of prac-
titioners, researchers, the effected population and
policymakers. Such coproduction maximises the
likelihood of intervention effectiveness by improv-
ing: the fit with the target group’s perceived
needs and thus acceptability; practicality;
evaluability, including the theorising of causal
pathways; and uptake by practitioners and
policymakers.
This paper sets out six crucial steps in the devel-
opment of public health interventions (box 1). For
an illustrative case study we use the early preven-
tion of gender-based violence (GBV) in Uganda
through a parenting intervention that addresses
familial predictors of GBV. However, we also draw
on other relevant examples to illustrate key
points.16 17
1. DEFINE AND UNDERSTAND THE PROBLEM
AND ITS CAUSES
Our starting point is that a public health problem
has already been identified as requiring interven-
tion. Often this results from a needs assessment,
for which there are several practical guides,8 18
or
from a political process such as a manifesto
commitment.
Clarifying the problem with stakeholders, using
the existing research evidence, is the first step in
intervention development. Some health problems
are relatively easily defined and measured, such as
the prevalence of a readily diagnosed disease, but
others have several dimensions and may be per-
ceived differently by different groups. For instance,
‘unhealthy housing’ could be attributed to poor
construction, antisocial behaviour, overcrowding or
lack of amenities. Definitions therefore need to be
sufficiently clear and detailed to avoid ambiguity or
confusion. Is ‘the problem’ a risk factor for a
disease/condition (eg, smoking) or the disease/con-
dition itself (eg, lung cancer)? If the former, it is
Wight D, et al. J Epidemiol Community Health 2015;0:1–6. doi:10.1136/jech-2015-205952 1
Theory and methods
JECH Online First, published on November 16, 2015 as 10.1136/jech-2015-205952
Copyright Article author (or their employer) 2015. Produced by BMJ Publishing Group Ltd under licence.
important to be aware of the factor’s importance relative to
other risk factors. If this is modest even a successful intervention
to change it might be insufficient to change the ultimate
outcome.
Once defined one should try to establish how the problem is
socially and spatially distributed, including who is currently
most/least likely to benefit from an intervention. It is also
important to consider what interventions or policies currently
exist and why they are not deemed adequate.
Having defined the problem, one needs to understand, as far
as possible, what are the immediate (proximal) and underlying
(distal) influences that give rise to it. These are often suggested
by the distribution of the problem, its history and relationship
to the life course. It is only by understanding what shapes and
perpetuates the problem (the causal pathways) that one can
identify possible ways to intervene. Case study step 1 applies
Funnell and Rogers’ useful questions for problem analysis to
GBV (ref. 19, p. 160). The main influences on the problem can
also be classified according to the socioecological model.12 20
It
can often be helpful to present the various causal pathways
affecting the problem diagrammatically: figure 1 attempts to do
this for GBV, distinguishing different levels of the socioeco-
logical model.
Case study step 1: Understanding the problem of GBV and its causes21–26
Questions Answers
Nature and extent of main problem
What is the nature and
extent of problem?
1 in 3 women likely to experience GBV
For whom and at what
levels does problem exist?
Predominantly affects girls and women. Problem
perpetuated at different socioecological levels
What is the history? Embedded in long-established patriarchal
institutions and norms but these are weakening
with improved education, employment and rights
for women
Continued
Table 1 Existing frameworks and guidance for public health intervention development
Guidance/framework Description Possible limitations
Intervention mapping6
Extremely rigorous and elaborate approach to intervention
development through six steps
Individual, social-psychological orientation. Highly
technical, prescriptive, can require years to implement,
difficult to operationalise
Conceptual framework for planning
intervention-related research7
Specifies nine steps in developing and evaluating public health
interventions
Insufficient detail in steps for operationalising
PRECEDE–PROCEED model8
Socioecological approach. Planning phase is PRECEDE; evaluation is
PROCEED. Extensively data driven and practical application
May require great technical skill, time and money. Little
detail on intervention development
Framework for design and evaluation of
complex interventions to improve health.9
Useful guide to development of interventions within the context of
healthcare services
Focus on healthcare not public health. Little detail on
intervention development
MRC guidance for the development and
evaluation of Complex interventions4
Identifies three broad stages of intervention development:
developing theory, modelling process and outcomes and assessing
feasibility
Does not break down three stages any further. Primarily
devoted to evaluation
Design for behaviour change framework10
For community development workers in low income countries.
Focuses on determinants, facilitators and barriers to intended
behaviour to plan behaviour change projects strategically
Sequence of steps advocated in part illogical and some of
the terminology confusing
Table 2 Examples of interventions, mechanisms and outcomes at different levels
Level Interventions Change mechanisms Outcomes
Individual Information provision; advertising Resonance; perceived relevance; reading
and reflection
Improving knowledge, motivation/intentions
Interpersonal Counselling; peer education Modelling; influence of reference group;
mentorship
Improving motivation/intentions; developing skills/
self-efficacy
Community Walking group; food co-operation; neighbourhood watch Solidarity; diffusion of innovation;
changing community norms
Improving motivation/intentions, physical activity,
diet, sense of security
Organisational Institutional policies; quality standards; partnership
working
Authorisation; inspection; enforcement;
increasing staff awareness
Reducing discrimination; improving services
Environmental Clean air legislation; piped water; housing regulations;
safe cycling and walking infrastructure
Legislation; enforcement; redesign of
services; ‘choice architecture’
Environmental improvements; healthier housing;
more physical activity
Macro policy Poverty reduction; redistribution of resources; education;
controlling corporations
Legislation and enforcement; economic
security and choices
Healthy lifestyles more affordable and given
higher priority
Box 1 Main steps in public health intervention
development
1. Define and understand the problem and its causes.
2. Clarify which causal or contextual factors are malleable and
have greatest scope for change.
3. Identify how to bring about change: the change mechanism.
4. Identify how to deliver the change mechanism.
5. Test and refine on small scale.
6. Collect sufficient evidence of effectiveness to justify rigorous
evaluation/implementation.
2 Wight D, et al. J Epidemiol Community Health 2015;0:1–6. doi:10.1136/jech-2015-205952
Theory and methods
Continued
Case study step 1: Understanding the problem of GBV and its causes21–26
Questions Answers
Causes and contributing factors
What are its causes? Individual: poor empathy and emotional
regulation, substance abuse. Interpersonal: as
child—poor attachment and parental bonding,
socialisation into gender roles and norms, harsh
parenting, witnessing parental conflict; as adult—
marital conflict, male control of wealth and
decision-making. Community: women’s isolation,
men’s peer group acceptance of violence.
Sociocultural: rigid gender roles and norms,
masculinity linked with toughness and honour,
men’s power enshrined in law
Which causes are most
important? (see case
study step 2)
Poor attachment and parental bonding; harsh
parenting; witnessing parental conflict
What has been effective in
addressing problem?
Early years parenting programmes; relationship
counselling; mediation; empowering women
educationally and economically; changed norms;
legislation
Consequences
What are the
consequences for those
directly affected?
Immediate: fear, injuries, sexually transmitted
infections, unintended pregnancies and death.
Long term: low self-esteem, depression and drug
abuse
What are the
consequences for those
indirectly affected?
Those witnessing more likely to become victims or
perpetrators; family break-up; burden on health
services; women unable to fulfil potential
2. CLARIFY WHICH CAUSAL OR CONTEXTUAL FACTORS ARE
MALLEABLE AND HAVE GREATEST SCOPE FOR CHANGE
The next step is to identify which of the immediate or under-
lying factors that shape a problem have the greatest scope to
be changed. These might be at any point along the causal
chain. For example, is it more promising to act on the factors
that encourage children to start smoking (primary preven-
tion), or to target existing smokers through smoking cessation
interventions (secondary prevention)? In general, ‘upstream’
structural factors take longer and are more challenging, to
modify than ‘downstream’ proximal factors, but if achieved
structural changes have greatest population impact, as noted
above.13
With complex problems the causal pathways can be very
diverse and interwoven. If they have been described diagram-
matically in step 1, it will be easier to identify where one might
intervene and, critically, whether it is necessary to intervene at
more than one point, or on more than one level, to interrupt
the most important causal pathways. One must also assess
which changes would have most effect. Most interventions take
place within systems (eg, healthcare, education, criminal justice)
and exert their influence by changing relationships, displacing
existing activities and redistributing and transforming
resources.27
It is necessary, therefore, to consider which system
an intervention would operate in, how the system is likely to
interact with the intervention and whether that system needs to
be/can be modified as well. For example, a school-based inter-
vention to improve pupils’ social and emotional well-being is
likely to be affected by existing school structures, relationships
and timetables and might require their modification.
Interventions that address complex problems through multilevel
actions are more likely to maximise synergy and long-term
success.13
The potential different levels of intervention are
shown in table 2.
In the case study of GBV, it was decided to focus on early pre-
vention in families since: this has the potential for widespread,
long-term change; it may improve other outcomes; and more
proximal factors were already being addressed.
Figure 1 Causal pathways perpetuating gender-based violence.21–26
Wight D, et al. J Epidemiol Community Health 2015;0:1–6. doi:10.1136/jech-2015-205952 3
Theory and methods
Case study step 2: Modifiable familial factors shaping GBV
Factor Evidence modifiable
1. Poor attachment and parental bonding Effective early years parenting
programmes; historical change
2. Harsh parenting ditto
3. Socialisation into inequitable gender
roles and norms
Historical change
4. Parental conflict Effective relationship counselling and
mediation; historical change
3. IDENTIFY HOW TO BRING ABOUT CHANGE: THE CHANGE
MECHANISM
Having identified the most promising modifiable causal factors
to address, the next step is to think through how to achieve that
change. All interventions have an implicit or explicit programme
theory19
about how they are intended to bring about the
desired outcomes. Central to this is the ‘change mechanism’ or
‘active ingredient’,2
the critical process that triggers change for
individuals, groups or communities (see table 2).
It is usually helpful to depict the programme theory diagram-
matically (see http://www.theoryofchange.org/). Many interven-
tions are not intended to achieve the final goal directly, but have
short-term and intermediate outcomes that are expected to lead
to the long-term outcomes. Ideally a range of stakeholders are
involved in formulating the programme theory A common
pitfall is that it is wildly optimistic, with little empirical evidence
to support each link in the causal chain. For instance, a short-
term change in health-related knowledge may be necessary, but
it is rarely sufficient to achieve behaviour change let alone
prevent the disease in question.
The best developed programme theories are based on forma-
lised theories of behaviour change (eg, Social Cognition
Theory28
or the Theory of Reasoned Action29
). This is not
essential, but can be very helpful if the theory has strong pre-
dictive and explanatory power. However, not many do,30 31
perhaps because they often only address one causal strand (cog-
nitions or motivation) and not socioenvironmental determi-
nants. Furthermore, few interventions said to be based on such
formalised theories clarify how the theory has been operationa-
lised. What is crucial in intervention development is that the
change mechanisms in the programme theory are clearly
articulated.
The interpersonal change mechanisms for the GBV case
study are shown below (there is not space to show those at
the community level). Critical to their effectiveness is who
delivers the intervention and their relationship with the target
group.
Case study step 3: Change mechanisms for early prevention of GBV
(interpersonal level only)
Modifiable factors Change mechanisms
Is this sufficient to
reduce the problem?
1. Poor attachment
and parental
bonding
Explaining infant development
and parent–child interactions
Probably
2. Harsh parenting Praising and reinforcing
parents’ techniques of positive
parenting
Not if poor attachment
Continued
Continued
Case study step 3: Change mechanisms for early prevention of GBV
(interpersonal level only)
Modifiable factors Change mechanisms
Is this sufficient to
reduce the problem?
3. Socialisation into
inequitable gender
roles and norms
Raising awareness of gender
issues and discussing between
couples
Not if poor attachment
and harsh parenting
impair emotional control
4. Parental conflict Understanding impact of
parental conflict on child
development and well-being
Developing parents’ skills to
sustain and improve
relationships with partner
Strengthening motivation to
reduce parental conflict
Mediating mothers’ and
fathers’ views on parenting
Probably
4. IDENTIFY HOW TO DELIVER THE CHANGE MECHANISMS
Having identified the change mechanisms, step 4 requires
working out how best to deliver them. As with other steps, it is
helpful to involve stakeholders with the relevant practical
expertise to develop the implementation plan. Sometimes
change mechanisms can only be brought about through a very
limited range of activities, for instance legal change is achieved
through legislation. However, other change mechanisms might
have several delivery options; for instance modelling new beha-
viours could be performed by teachers, peers or actors in TV/
radio soap operas. The choice is likely to be target group-
specific and context-specific.
The implementation plan requires clarifying the conditions
and resources necessary for successful implementation and the
related risks and assumptions. For example, if an intervention is
to be delivered by health visitors, are they available everywhere
and will their senior managers allow time for training and deliv-
ery? In low income countries resource constraints can seriously
restrict options for delivery, for instance the existence of suitably
skilled facilitators, or an ethos of voluntarism. In step 4 one
should also anticipate possible unintended effects of the inter-
vention and minimise any that might be harmful. These have
been categorised by Lorenc and Oliver32
as fivefold: direct, psy-
chological, equity, group/social and opportunity. ‘Equity harms’
Case study step 4: Delivering change mechanisms for early prevention of
GBV
1. Identify suitable villages or urban wards
2. Explain programme and offer it to community leadership: awareness raising
critical
3. Recruit existing groups or ‘opinion leaders’ and form parent groups
▸ initially single sex
▸ groups select facilitator
4. Deliver 2 weeks training to facilitators
5. Facilitators lead 10 weekly single sex sessions of about 2 h
6. Following five sessions facilitators recruit novice facilitator to mentor
7. After 10 sessions groups split in half and pair up with group of opposite sex
8. Facilitators lead 11 mixed sex sessions
▸ groups explore different understandings of parenting and GBV
9. Groups present recommendations for village/ward level to village/ward leaders
10. Trained facilitators start new groups and recruit others to be trained as
facilitators
4 Wight D, et al. J Epidemiol Community Health 2015;0:1–6. doi:10.1136/jech-2015-205952
Theory and methods
are currently of particular policy concern, the greatest benefi-
ciaries of many behaviour change interventions being the higher
educated or more affluent, thereby exacerbating inequalities in
health outcomes.15
The delivery of the change mechanisms for our case study of
GBV is set out below.
5. TEST AND REFINE ON SMALL SCALE
Once the initial intervention design has been resolved, in most
cases its feasibility needs to be tested and adaptations made.
This varies considerably according to the type of intervention.
For instance, national legislation or large-scale health protection
measures, such as water fluoridation, are difficult to pilot before
full implementation. Phased region by region implementation
might allow incremental adjustments, but the scope for adapta-
tion is primarily around implementation rather than the mech-
anism of change. With individual or community level
interventions a long process of repeated testing and adaptation
is often required, often called ‘formative evaluation’, especially
if the intervention is novel or highly innovative.
Testing the intervention can clarify fundamental issues such
as: acceptability to the target group, practitioners and delivery
organisations; optimum content (eg, how participatory), struc-
ture and duration; who should deliver it and where; what train-
ing is required; and how to maximise population reach.
Frequently this is the most hurried stage of intervention
development, due to lack of resources and time, but this often
compromises subsequent effectiveness. Ideally incremental adap-
tations would each be tested separately, but in practice adapta-
tions can be made simultaneously if sufficiently rich data are
collected to enable judgements about which are helpful and
which not. Practical constraints eventually force the decision
that the intervention is ‘good enough’ to go to the next step.
The testing and adapting of the GBV programme is set out
below.
Case study step 5: Testing and adapting programme for early prevention
of GBV
▸ Negotiate access to village and recruit one mothers and one fathers group
▸ Recruit and train two facilitators from each group
▸ Pilot draft manual with groups with observational research
▸ Revise problematic sessions as necessary and test again (if necessary several
times)
▸ Conduct group discussions with each group and in-depth interviews with
facilitators to explore views on intervention
▸ Finalise first draft of manual
▸ Repeat process in second village with two mothers and two fathers groups to
produce second draft of manual
6. COLLECT SUFFICIENT EVIDENCE OF EFFECTIVENESS TO
JUSTIFY RIGOROUS EVALUATION/IMPLEMENTATION
Before committing resources to a large scale rigorous evaluation
(typically a ‘phase III’ RCT), the final step is to establish suffi-
cient evidence of effectiveness to warrant such investment.
Beyond the research world, especially in third sector organisa-
tions, inadequate resources often mean practitioners move to
wide scale implementation without such rigorous evaluation.
This makes step 6 all the more critical.
What is being sought at this stage is some evidence that the
intervention is working as intended, it is achieving at least some
short-term outcomes, and it is not having any serious unin-
tended effects, for instance exacerbating social inequalities. It is
unlikely that the evaluation design will seek to prove causality
so theory-based evaluation approaches are likely to be most
appropriate. There are numerous guides on evaluation that
adequately cover step 6,4 33
but it is worth re-stating that often
the most practical way to collect evidence of effectiveness with
limited resources is through a before and after survey, or by
using routinely collected data. If possible, a control group
greatly increases the strength of evidence. If a phase III RCT is
planned, an ‘exploratory trial’ can provide valuable information
about the acceptability of evaluation designs, appropriate mea-
sures and likely effect sizes to inform subsequent trials. Plans for
this final step with our case study are set out below.
Case study step 6: Collecting evidence of effectiveness of programme for
early prevention of GBV.
▸ Baseline survey of parent and 10–14-year-old child dyads in two communities
to measure: attitudes to GBV, parent–child relationships, parent–parent
relationships, etc
▸ Implement intervention with 10 different groups
▸ Observe 10% of sessions to assess fidelity
▸ Group discussions and semistructured interviews with participants to assess
their characteristics, recruitment processes, group functioning and requirements
for facilitators
▸ Follow-up survey, ideally with the same respondents
CONCLUSION
In order to improve the effectiveness of public health interven-
tions, a systematic approach to intervention development is
required, as well as rigorous evaluation. However, little practical
guidance exists for public health practitioners and researchers
that explains the essential stages of intervention development.
We argue that this process can be broken down into six key
steps: defining and understanding the problem; identifying
modifiable determinants; deciding on the mechanisms of
change; clarifying how these will be delivered; testing and
adapting the intervention; and collecting initial evidence of
effectiveness. This model imposes somewhat arbitrary cut-offs
in the process of intervention development and suggests a linear
progression. In practice developers often return to an earlier
step in the sequence before reaching step 6, and subsequently
‘definitive trials’ can lead to further revisions of the
What this study adds?
This paper provides a pragmatic six-step guide to develop
interventions in a logical, evidence-based way to maximise likely
effectiveness. If each step is carefully addressed, better use will
be made of scarce public resources by avoiding the costly
evaluation, or implementation, of unpromising interventions.
What is already known on this subject?
There is little practical guidance for researchers or practitioners
on how best to develop public health interventions. Existing
models are generally orientated towards individual behaviour
change and some are highly technical and take years to
implement.
Wight D, et al. J Epidemiol Community Health 2015;0:1–6. doi:10.1136/jech-2015-205952 5
Theory and methods
intervention. However, we hope that if each of these six steps is
carefully addressed in the design of interventions better use will
be made of scarce public resources by avoiding the costly evalu-
ation, or implementation, of unpromising interventions.
Acknowledgements The authors are very grateful for seminal input from Sally
Wyke (Institute of Health and Wellbeing) in developing this model and for comments
on an earlier draft from Peter Craig (MRC/CSO Social and Public Health Sciences
Unit), both in the University of Glasgow. The authors’ salaries came through MRC
core funding (MR_UU_12017/9; 171332-01) and NHS Health Scotland. The
parenting intervention to address familial predictors of GBV in Uganda is led by
Godfrey Siu, Child Health and Development Centre, Makerere University and funded
by the Sexual Violence Research Initiative, South Africa, and Bernard van Leer
Foundation.
Contributors DW, RJ and EW shared the original idea to develop a model of
intervention development. All contributed to discussions to identify the six steps. DW
wrote the first draft of this paper and all revised successive drafts.
Funding Medical Research Council (grant no. MR UU 12017/9; 171332-01); NHS
Health Scotland.
Competing interests The authors declare that: the submitted work has been
supported, through funding of salaries, by the UK Medical Research Council (DW,
RJ, LD) and NHS Health Scotland (EW).
Provenance and peer review Not commissioned; externally peer reviewed.
Open Access This is an Open Access article distributed in accordance with the
terms of the Creative Commons Attribution (CC BY 4.0) license, which permits
others to distribute, remix, adapt and build upon this work, for commercial use,
provided the original work is properly cited. See: http://creativecommons.org/
licenses/by/4.0/
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Theory and methods
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6 steps

  • 1. See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/284165549 Six steps in quality intervention development (6SQuID) Article  in  Journal of epidemiology and community health · November 2015 DOI: 10.1136/jech-2015-205952 CITATIONS 117 READS 528 4 authors, including: Some of the authors of this publication are also working on these related projects: Personalised physical activity for people with dementia living in care homes View project Young People Health Behaviour Development & Change View project Daniel Wight University of Glasgow 147 PUBLICATIONS   5,676 CITATIONS    SEE PROFILE Ruth Jepson The University of Edinburgh 167 PUBLICATIONS   4,538 CITATIONS    SEE PROFILE All content following this page was uploaded by Ruth Jepson on 25 November 2015. The user has requested enhancement of the downloaded file.
  • 2. Six steps in quality intervention development (6SQuID) Daniel Wight,1 Erica Wimbush,2 Ruth Jepson,3 Lawrence Doi3 1 MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK 2 Evaluation Team, NHS Health Scotland, Edinburgh, UK 3 MRC/CSO Scottish Collaboration for Public Health Research and Policy, University of Edinburgh, Edinburgh, UK Correspondence to Professor Daniel Wight, MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, 200 Renfield Street, Glasgow G2 3QB, UK; d.wight@sphsu.mrc.ac.uk Received 22 April 2015 Revised 18 September 2015 Accepted 11 October 2015 To cite: Wight D, Wimbush E, Jepson R, et al. J Epidemiol Community Health Published Online First: [please include Day Month Year] doi:10.1136/ jech-2015-205952 ABSTRACT Improving the effectiveness of public health interventions relies as much on the attention paid to their design and feasibility as to their evaluation. Yet, compared to the vast literature on how to evaluate interventions, there is little to guide researchers or practitioners on how best to develop such interventions in practical, logical, evidence based ways to maximise likely effectiveness. Existing models for the development of public health interventions tend to have a strong social-psychological, individual behaviour change orientation and some take years to implement. This paper presents a pragmatic guide to six essential Steps for Quality Intervention Development (6SQuID). The focus is on public health interventions but the model should have wider applicability. Once a problem has been identified as needing intervention, the process of designing an intervention can be broken down into six crucial steps: (1) defining and understanding the problem and its causes; (2) identifying which causal or contextual factors are modifiable: which have the greatest scope for change and who would benefit most; (3) deciding on the mechanisms of change; (4) clarifying how these will be delivered; (5) testing and adapting the intervention; and (6) collecting sufficient evidence of effectiveness to proceed to a rigorous evaluation. If each of these steps is carefully addressed, better use will be made of scarce public resources by avoiding the costly evaluation, or implementation, of unpromising interventions. INTRODUCTION Improving the effectiveness of public health inter- ventions depends as much on improving their design as their evaluation.1 Yet, compared to the vast literature on intervention evaluation,2–5 there is little to guide researchers or practitioners on developing interventions in logical, evidence-based ways to maximise effectiveness. Poor intervention design can waste public resources through expen- sive evaluation or, worse, the implementation of ineffective interventions unevaluated. Existing frameworks and guidance for the devel- opment of interventions3 4 6–10 are summarised in table 1. These tend to be orientated towards social-psychological, individual behaviour change and either provide little specific detail on interven- tion development or require great technical skills and resources. Drawing on the strengths of these existing frameworks and our own experiences, this article outlines a pragmatic six-step guide to the essential stages of intervention development to assist public health practitioners and researchers. The focus is on public health interventions, although the model should have wider applicability. A public health intervention is defined as planned actions to prevent or reduce a particular health problem, or the determinants of the problem, in a defined population. Most require some level of social interaction. They are rarely simple, singular actions that can be easily replicated but more often complicated (multicomponent) or complex programmes (with feedback loops and emergent outcomes)11 that are designed to affect change at several levels of the socioecological model12 (table 2). By and large, ‘upstream’ inter- ventions ‘require less individual effort (from recipi- ents) and have the greatest population impact’,13 14 whereas interventions requiring voluntary uptake are more likely to exacerbate health inequalities.15 Interventions are best developed through colla- borations between interdisciplinary teams of prac- titioners, researchers, the effected population and policymakers. Such coproduction maximises the likelihood of intervention effectiveness by improv- ing: the fit with the target group’s perceived needs and thus acceptability; practicality; evaluability, including the theorising of causal pathways; and uptake by practitioners and policymakers. This paper sets out six crucial steps in the devel- opment of public health interventions (box 1). For an illustrative case study we use the early preven- tion of gender-based violence (GBV) in Uganda through a parenting intervention that addresses familial predictors of GBV. However, we also draw on other relevant examples to illustrate key points.16 17 1. DEFINE AND UNDERSTAND THE PROBLEM AND ITS CAUSES Our starting point is that a public health problem has already been identified as requiring interven- tion. Often this results from a needs assessment, for which there are several practical guides,8 18 or from a political process such as a manifesto commitment. Clarifying the problem with stakeholders, using the existing research evidence, is the first step in intervention development. Some health problems are relatively easily defined and measured, such as the prevalence of a readily diagnosed disease, but others have several dimensions and may be per- ceived differently by different groups. For instance, ‘unhealthy housing’ could be attributed to poor construction, antisocial behaviour, overcrowding or lack of amenities. Definitions therefore need to be sufficiently clear and detailed to avoid ambiguity or confusion. Is ‘the problem’ a risk factor for a disease/condition (eg, smoking) or the disease/con- dition itself (eg, lung cancer)? If the former, it is Wight D, et al. J Epidemiol Community Health 2015;0:1–6. doi:10.1136/jech-2015-205952 1 Theory and methods JECH Online First, published on November 16, 2015 as 10.1136/jech-2015-205952 Copyright Article author (or their employer) 2015. Produced by BMJ Publishing Group Ltd under licence.
  • 3. important to be aware of the factor’s importance relative to other risk factors. If this is modest even a successful intervention to change it might be insufficient to change the ultimate outcome. Once defined one should try to establish how the problem is socially and spatially distributed, including who is currently most/least likely to benefit from an intervention. It is also important to consider what interventions or policies currently exist and why they are not deemed adequate. Having defined the problem, one needs to understand, as far as possible, what are the immediate (proximal) and underlying (distal) influences that give rise to it. These are often suggested by the distribution of the problem, its history and relationship to the life course. It is only by understanding what shapes and perpetuates the problem (the causal pathways) that one can identify possible ways to intervene. Case study step 1 applies Funnell and Rogers’ useful questions for problem analysis to GBV (ref. 19, p. 160). The main influences on the problem can also be classified according to the socioecological model.12 20 It can often be helpful to present the various causal pathways affecting the problem diagrammatically: figure 1 attempts to do this for GBV, distinguishing different levels of the socioeco- logical model. Case study step 1: Understanding the problem of GBV and its causes21–26 Questions Answers Nature and extent of main problem What is the nature and extent of problem? 1 in 3 women likely to experience GBV For whom and at what levels does problem exist? Predominantly affects girls and women. Problem perpetuated at different socioecological levels What is the history? Embedded in long-established patriarchal institutions and norms but these are weakening with improved education, employment and rights for women Continued Table 1 Existing frameworks and guidance for public health intervention development Guidance/framework Description Possible limitations Intervention mapping6 Extremely rigorous and elaborate approach to intervention development through six steps Individual, social-psychological orientation. Highly technical, prescriptive, can require years to implement, difficult to operationalise Conceptual framework for planning intervention-related research7 Specifies nine steps in developing and evaluating public health interventions Insufficient detail in steps for operationalising PRECEDE–PROCEED model8 Socioecological approach. Planning phase is PRECEDE; evaluation is PROCEED. Extensively data driven and practical application May require great technical skill, time and money. Little detail on intervention development Framework for design and evaluation of complex interventions to improve health.9 Useful guide to development of interventions within the context of healthcare services Focus on healthcare not public health. Little detail on intervention development MRC guidance for the development and evaluation of Complex interventions4 Identifies three broad stages of intervention development: developing theory, modelling process and outcomes and assessing feasibility Does not break down three stages any further. Primarily devoted to evaluation Design for behaviour change framework10 For community development workers in low income countries. Focuses on determinants, facilitators and barriers to intended behaviour to plan behaviour change projects strategically Sequence of steps advocated in part illogical and some of the terminology confusing Table 2 Examples of interventions, mechanisms and outcomes at different levels Level Interventions Change mechanisms Outcomes Individual Information provision; advertising Resonance; perceived relevance; reading and reflection Improving knowledge, motivation/intentions Interpersonal Counselling; peer education Modelling; influence of reference group; mentorship Improving motivation/intentions; developing skills/ self-efficacy Community Walking group; food co-operation; neighbourhood watch Solidarity; diffusion of innovation; changing community norms Improving motivation/intentions, physical activity, diet, sense of security Organisational Institutional policies; quality standards; partnership working Authorisation; inspection; enforcement; increasing staff awareness Reducing discrimination; improving services Environmental Clean air legislation; piped water; housing regulations; safe cycling and walking infrastructure Legislation; enforcement; redesign of services; ‘choice architecture’ Environmental improvements; healthier housing; more physical activity Macro policy Poverty reduction; redistribution of resources; education; controlling corporations Legislation and enforcement; economic security and choices Healthy lifestyles more affordable and given higher priority Box 1 Main steps in public health intervention development 1. Define and understand the problem and its causes. 2. Clarify which causal or contextual factors are malleable and have greatest scope for change. 3. Identify how to bring about change: the change mechanism. 4. Identify how to deliver the change mechanism. 5. Test and refine on small scale. 6. Collect sufficient evidence of effectiveness to justify rigorous evaluation/implementation. 2 Wight D, et al. J Epidemiol Community Health 2015;0:1–6. doi:10.1136/jech-2015-205952 Theory and methods
  • 4. Continued Case study step 1: Understanding the problem of GBV and its causes21–26 Questions Answers Causes and contributing factors What are its causes? Individual: poor empathy and emotional regulation, substance abuse. Interpersonal: as child—poor attachment and parental bonding, socialisation into gender roles and norms, harsh parenting, witnessing parental conflict; as adult— marital conflict, male control of wealth and decision-making. Community: women’s isolation, men’s peer group acceptance of violence. Sociocultural: rigid gender roles and norms, masculinity linked with toughness and honour, men’s power enshrined in law Which causes are most important? (see case study step 2) Poor attachment and parental bonding; harsh parenting; witnessing parental conflict What has been effective in addressing problem? Early years parenting programmes; relationship counselling; mediation; empowering women educationally and economically; changed norms; legislation Consequences What are the consequences for those directly affected? Immediate: fear, injuries, sexually transmitted infections, unintended pregnancies and death. Long term: low self-esteem, depression and drug abuse What are the consequences for those indirectly affected? Those witnessing more likely to become victims or perpetrators; family break-up; burden on health services; women unable to fulfil potential 2. CLARIFY WHICH CAUSAL OR CONTEXTUAL FACTORS ARE MALLEABLE AND HAVE GREATEST SCOPE FOR CHANGE The next step is to identify which of the immediate or under- lying factors that shape a problem have the greatest scope to be changed. These might be at any point along the causal chain. For example, is it more promising to act on the factors that encourage children to start smoking (primary preven- tion), or to target existing smokers through smoking cessation interventions (secondary prevention)? In general, ‘upstream’ structural factors take longer and are more challenging, to modify than ‘downstream’ proximal factors, but if achieved structural changes have greatest population impact, as noted above.13 With complex problems the causal pathways can be very diverse and interwoven. If they have been described diagram- matically in step 1, it will be easier to identify where one might intervene and, critically, whether it is necessary to intervene at more than one point, or on more than one level, to interrupt the most important causal pathways. One must also assess which changes would have most effect. Most interventions take place within systems (eg, healthcare, education, criminal justice) and exert their influence by changing relationships, displacing existing activities and redistributing and transforming resources.27 It is necessary, therefore, to consider which system an intervention would operate in, how the system is likely to interact with the intervention and whether that system needs to be/can be modified as well. For example, a school-based inter- vention to improve pupils’ social and emotional well-being is likely to be affected by existing school structures, relationships and timetables and might require their modification. Interventions that address complex problems through multilevel actions are more likely to maximise synergy and long-term success.13 The potential different levels of intervention are shown in table 2. In the case study of GBV, it was decided to focus on early pre- vention in families since: this has the potential for widespread, long-term change; it may improve other outcomes; and more proximal factors were already being addressed. Figure 1 Causal pathways perpetuating gender-based violence.21–26 Wight D, et al. J Epidemiol Community Health 2015;0:1–6. doi:10.1136/jech-2015-205952 3 Theory and methods
  • 5. Case study step 2: Modifiable familial factors shaping GBV Factor Evidence modifiable 1. Poor attachment and parental bonding Effective early years parenting programmes; historical change 2. Harsh parenting ditto 3. Socialisation into inequitable gender roles and norms Historical change 4. Parental conflict Effective relationship counselling and mediation; historical change 3. IDENTIFY HOW TO BRING ABOUT CHANGE: THE CHANGE MECHANISM Having identified the most promising modifiable causal factors to address, the next step is to think through how to achieve that change. All interventions have an implicit or explicit programme theory19 about how they are intended to bring about the desired outcomes. Central to this is the ‘change mechanism’ or ‘active ingredient’,2 the critical process that triggers change for individuals, groups or communities (see table 2). It is usually helpful to depict the programme theory diagram- matically (see http://www.theoryofchange.org/). Many interven- tions are not intended to achieve the final goal directly, but have short-term and intermediate outcomes that are expected to lead to the long-term outcomes. Ideally a range of stakeholders are involved in formulating the programme theory A common pitfall is that it is wildly optimistic, with little empirical evidence to support each link in the causal chain. For instance, a short- term change in health-related knowledge may be necessary, but it is rarely sufficient to achieve behaviour change let alone prevent the disease in question. The best developed programme theories are based on forma- lised theories of behaviour change (eg, Social Cognition Theory28 or the Theory of Reasoned Action29 ). This is not essential, but can be very helpful if the theory has strong pre- dictive and explanatory power. However, not many do,30 31 perhaps because they often only address one causal strand (cog- nitions or motivation) and not socioenvironmental determi- nants. Furthermore, few interventions said to be based on such formalised theories clarify how the theory has been operationa- lised. What is crucial in intervention development is that the change mechanisms in the programme theory are clearly articulated. The interpersonal change mechanisms for the GBV case study are shown below (there is not space to show those at the community level). Critical to their effectiveness is who delivers the intervention and their relationship with the target group. Case study step 3: Change mechanisms for early prevention of GBV (interpersonal level only) Modifiable factors Change mechanisms Is this sufficient to reduce the problem? 1. Poor attachment and parental bonding Explaining infant development and parent–child interactions Probably 2. Harsh parenting Praising and reinforcing parents’ techniques of positive parenting Not if poor attachment Continued Continued Case study step 3: Change mechanisms for early prevention of GBV (interpersonal level only) Modifiable factors Change mechanisms Is this sufficient to reduce the problem? 3. Socialisation into inequitable gender roles and norms Raising awareness of gender issues and discussing between couples Not if poor attachment and harsh parenting impair emotional control 4. Parental conflict Understanding impact of parental conflict on child development and well-being Developing parents’ skills to sustain and improve relationships with partner Strengthening motivation to reduce parental conflict Mediating mothers’ and fathers’ views on parenting Probably 4. IDENTIFY HOW TO DELIVER THE CHANGE MECHANISMS Having identified the change mechanisms, step 4 requires working out how best to deliver them. As with other steps, it is helpful to involve stakeholders with the relevant practical expertise to develop the implementation plan. Sometimes change mechanisms can only be brought about through a very limited range of activities, for instance legal change is achieved through legislation. However, other change mechanisms might have several delivery options; for instance modelling new beha- viours could be performed by teachers, peers or actors in TV/ radio soap operas. The choice is likely to be target group- specific and context-specific. The implementation plan requires clarifying the conditions and resources necessary for successful implementation and the related risks and assumptions. For example, if an intervention is to be delivered by health visitors, are they available everywhere and will their senior managers allow time for training and deliv- ery? In low income countries resource constraints can seriously restrict options for delivery, for instance the existence of suitably skilled facilitators, or an ethos of voluntarism. In step 4 one should also anticipate possible unintended effects of the inter- vention and minimise any that might be harmful. These have been categorised by Lorenc and Oliver32 as fivefold: direct, psy- chological, equity, group/social and opportunity. ‘Equity harms’ Case study step 4: Delivering change mechanisms for early prevention of GBV 1. Identify suitable villages or urban wards 2. Explain programme and offer it to community leadership: awareness raising critical 3. Recruit existing groups or ‘opinion leaders’ and form parent groups ▸ initially single sex ▸ groups select facilitator 4. Deliver 2 weeks training to facilitators 5. Facilitators lead 10 weekly single sex sessions of about 2 h 6. Following five sessions facilitators recruit novice facilitator to mentor 7. After 10 sessions groups split in half and pair up with group of opposite sex 8. Facilitators lead 11 mixed sex sessions ▸ groups explore different understandings of parenting and GBV 9. Groups present recommendations for village/ward level to village/ward leaders 10. Trained facilitators start new groups and recruit others to be trained as facilitators 4 Wight D, et al. J Epidemiol Community Health 2015;0:1–6. doi:10.1136/jech-2015-205952 Theory and methods
  • 6. are currently of particular policy concern, the greatest benefi- ciaries of many behaviour change interventions being the higher educated or more affluent, thereby exacerbating inequalities in health outcomes.15 The delivery of the change mechanisms for our case study of GBV is set out below. 5. TEST AND REFINE ON SMALL SCALE Once the initial intervention design has been resolved, in most cases its feasibility needs to be tested and adaptations made. This varies considerably according to the type of intervention. For instance, national legislation or large-scale health protection measures, such as water fluoridation, are difficult to pilot before full implementation. Phased region by region implementation might allow incremental adjustments, but the scope for adapta- tion is primarily around implementation rather than the mech- anism of change. With individual or community level interventions a long process of repeated testing and adaptation is often required, often called ‘formative evaluation’, especially if the intervention is novel or highly innovative. Testing the intervention can clarify fundamental issues such as: acceptability to the target group, practitioners and delivery organisations; optimum content (eg, how participatory), struc- ture and duration; who should deliver it and where; what train- ing is required; and how to maximise population reach. Frequently this is the most hurried stage of intervention development, due to lack of resources and time, but this often compromises subsequent effectiveness. Ideally incremental adap- tations would each be tested separately, but in practice adapta- tions can be made simultaneously if sufficiently rich data are collected to enable judgements about which are helpful and which not. Practical constraints eventually force the decision that the intervention is ‘good enough’ to go to the next step. The testing and adapting of the GBV programme is set out below. Case study step 5: Testing and adapting programme for early prevention of GBV ▸ Negotiate access to village and recruit one mothers and one fathers group ▸ Recruit and train two facilitators from each group ▸ Pilot draft manual with groups with observational research ▸ Revise problematic sessions as necessary and test again (if necessary several times) ▸ Conduct group discussions with each group and in-depth interviews with facilitators to explore views on intervention ▸ Finalise first draft of manual ▸ Repeat process in second village with two mothers and two fathers groups to produce second draft of manual 6. COLLECT SUFFICIENT EVIDENCE OF EFFECTIVENESS TO JUSTIFY RIGOROUS EVALUATION/IMPLEMENTATION Before committing resources to a large scale rigorous evaluation (typically a ‘phase III’ RCT), the final step is to establish suffi- cient evidence of effectiveness to warrant such investment. Beyond the research world, especially in third sector organisa- tions, inadequate resources often mean practitioners move to wide scale implementation without such rigorous evaluation. This makes step 6 all the more critical. What is being sought at this stage is some evidence that the intervention is working as intended, it is achieving at least some short-term outcomes, and it is not having any serious unin- tended effects, for instance exacerbating social inequalities. It is unlikely that the evaluation design will seek to prove causality so theory-based evaluation approaches are likely to be most appropriate. There are numerous guides on evaluation that adequately cover step 6,4 33 but it is worth re-stating that often the most practical way to collect evidence of effectiveness with limited resources is through a before and after survey, or by using routinely collected data. If possible, a control group greatly increases the strength of evidence. If a phase III RCT is planned, an ‘exploratory trial’ can provide valuable information about the acceptability of evaluation designs, appropriate mea- sures and likely effect sizes to inform subsequent trials. Plans for this final step with our case study are set out below. Case study step 6: Collecting evidence of effectiveness of programme for early prevention of GBV. ▸ Baseline survey of parent and 10–14-year-old child dyads in two communities to measure: attitudes to GBV, parent–child relationships, parent–parent relationships, etc ▸ Implement intervention with 10 different groups ▸ Observe 10% of sessions to assess fidelity ▸ Group discussions and semistructured interviews with participants to assess their characteristics, recruitment processes, group functioning and requirements for facilitators ▸ Follow-up survey, ideally with the same respondents CONCLUSION In order to improve the effectiveness of public health interven- tions, a systematic approach to intervention development is required, as well as rigorous evaluation. However, little practical guidance exists for public health practitioners and researchers that explains the essential stages of intervention development. We argue that this process can be broken down into six key steps: defining and understanding the problem; identifying modifiable determinants; deciding on the mechanisms of change; clarifying how these will be delivered; testing and adapting the intervention; and collecting initial evidence of effectiveness. This model imposes somewhat arbitrary cut-offs in the process of intervention development and suggests a linear progression. In practice developers often return to an earlier step in the sequence before reaching step 6, and subsequently ‘definitive trials’ can lead to further revisions of the What this study adds? This paper provides a pragmatic six-step guide to develop interventions in a logical, evidence-based way to maximise likely effectiveness. If each step is carefully addressed, better use will be made of scarce public resources by avoiding the costly evaluation, or implementation, of unpromising interventions. What is already known on this subject? There is little practical guidance for researchers or practitioners on how best to develop public health interventions. Existing models are generally orientated towards individual behaviour change and some are highly technical and take years to implement. Wight D, et al. J Epidemiol Community Health 2015;0:1–6. doi:10.1136/jech-2015-205952 5 Theory and methods
  • 7. intervention. However, we hope that if each of these six steps is carefully addressed in the design of interventions better use will be made of scarce public resources by avoiding the costly evalu- ation, or implementation, of unpromising interventions. Acknowledgements The authors are very grateful for seminal input from Sally Wyke (Institute of Health and Wellbeing) in developing this model and for comments on an earlier draft from Peter Craig (MRC/CSO Social and Public Health Sciences Unit), both in the University of Glasgow. The authors’ salaries came through MRC core funding (MR_UU_12017/9; 171332-01) and NHS Health Scotland. The parenting intervention to address familial predictors of GBV in Uganda is led by Godfrey Siu, Child Health and Development Centre, Makerere University and funded by the Sexual Violence Research Initiative, South Africa, and Bernard van Leer Foundation. Contributors DW, RJ and EW shared the original idea to develop a model of intervention development. All contributed to discussions to identify the six steps. DW wrote the first draft of this paper and all revised successive drafts. Funding Medical Research Council (grant no. MR UU 12017/9; 171332-01); NHS Health Scotland. Competing interests The authors declare that: the submitted work has been supported, through funding of salaries, by the UK Medical Research Council (DW, RJ, LD) and NHS Health Scotland (EW). Provenance and peer review Not commissioned; externally peer reviewed. Open Access This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/ licenses/by/4.0/ REFERENCES 1 Speller V, Learmonth A, Harrison D. 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