ISSN: 2052-9368
Health Economics Working Paper Series
HEWPS Number: 201501
Microfinance, health and randomised trials
Neil McHugh, Olga Biosca and Cam Donaldson
April 2015
www.gcu.ac.uk/yunuscentre
Microfinance, health and randomised trials
Neil McHugh1*
* Corresponding author
Email: [email protected]
Olga Biosca1
Email: [email protected]
Cam Donaldson1
Email: [email protected]
1 Yunus Centre for Social Business and Health, Glasgow Caledonian University, Glasgow,
Scotland, UK
Contact information:
Yunus Centre for Social Business and Health
Glasgow Caledonian University
Level 3 - Buchanan House
58 Port Dundas Road
Glasgow
Scotland
United Kingdom
G4 0BA
1
Abstract
Background
There is a growing need to identify upstream public health interventions as an alternative
means of acting on health. Microfinance has been portrayed in this regard in public health
journals. Furthermore, microfinance has spread to more-advanced economies where it
offers potential as an alternative means of acting on persistent and growing health
inequalities. However recent considerations establish that randomised controlled trials
(RCTs) represent the ‘gold standard’ in impact evaluation of microcredit.
Discussion
In seeking to evidence ‘microcredit as a public health initiative’ in a Western context we
question the notion of trials as the apparent gold standard for microcredit evaluations by
comparing this approach to developments in thinking about study design for complex public
health interventions. This field has moved onto a more eclectic approach to study design for
complex interventions with recognition given to insights drawn from non-randomised study
designs and qualitative studies.
Furthermore, we consider ethical issues currently missing from the global debate on impact
assessment, raised by the notion of mounting microcredit RCTs in Western contexts. These
issues relate to equipoise and the screening devices used for randomisation and raise the
question of whether it would ethically be possible to conduct a microcredit RCT in a
Western context.
Summary
RCTs represent an attempt to improve the internal validity of microfinance impact
evaluations. However, questions remain regarding the appropriateness of adopting this
method to the exclusion of other important sources of evidence. Thus while microfinance
may hold potential in the field of public health, the sector may first have to heed
methodological lessons from public health to enhance its evidence base.
2
Background
The importance of identifying upstream public health interventions has heightened given
the general acceptance that there are limits to population health improvement through
traditional means [1, 2]. Microcredit, the provision of small loans to those excluded from
mainstream financial institutions, has been portrayed in this regard, with papers published
in public health journals [3, 4]. Furthermore, such initiatives have even been spreading to
more-advanced economies, due to, not only, being seen as an alternative means for
stimulating economic growth in deprived communities, but also for potentially, in the
longer-term, acting on persistent and growing health inequalities [5, 6]. This is a very
positive development, as microcredit can be seen as part of a set of initiatives which take us
beyond the mid-stream path of individual risk factor reduction and towards tackling the
genuine upstream ‘causes of the causes’ of illness. Ironically, this recognition comes when
randomised controlled trials (RCTs) have been adopted as somewhat of a ‘gold standard’ by
many academics in the microcredit field, and, moreover, trial evidence questions the
credibility of claims for the impact of microcredit. The aim of this paper is to call the
adoption of RCTs as a ‘gold standard’ into question, especially in the context of mounting
such studies in Western contexts, which is where our interest lies.
In seeking to evidence ‘microcredit as a public health initiative’ we have been contemplating
how the notion of trials, as the apparent gold standard for microcredit evaluations,
compares with developments in thinking about study design in public health. The basis of
our case is that, given developments in the evaluation of complex community based public
health initiatives, this field has moved onto a more eclectic approach to study design for
complex interventions [7]. Thus, as well as microcredit having a potential role as a public
health initiative, public health, in return, may provide methodological lessons to the
microcredit research sector where the pursuit of trial-based evidence alone, we contend,
may be hampering the production of relevant evidence on its public health (and other
wider) impacts.
Randomised trials of microfinance
The use of RCTs in development economics and, particularly in the microfinance arena,
continues to increase in popularity. As seen in Box 1 [8-10], recent initiatives such as the
Abdul Lateef Jameel Poverty Action Lab (J-PAL), Innovations for Poverty Action (IPA) and the
International Initiative for Impact Evaluation (3ie) have promoted the use of RCTs as the
best way of assessing impact in development. As a result, RCT-based impact evaluations on
microfinance programmes have multiplied; recently a full issue of the American Economic
Journal was dedicated to microfinance RCTs [11]. Since the first randomised evaluation of
microcredit took place [12], these have been applied to evaluate not only the impact of
microloans, but also several other related financial initiatives and credit-plus programmes
[3, 4, 13-25].
The growth of RCTs has, in part, been a reaction to concerns around the quality of initial
microcredit impact evaluations, specifically in disentangling causation from correlation [11,
26]. Further, the proliferation of RCTs reflects a growing trend in other areas of
development research where evaluations of social interventions seek to replicate methods
previously thought to be largely the domain of the medical field.
Critical papers have been written on the use of RCTs in development and microfinance [2734]. Most of these critiques focus on the lack of generalisability of RCT results [27], but
3
others reflect on flaws with respect to their internal validity and the difficulties of replicating
clinical-type experiments in a broader social context [8, 28]. It has also been recognised that
the economics literature on RCTs has, in the past, ignored reports on mistakes in the design,
conduct and reporting of medical trials [29], some of which is related to randomisation no
longer being considered the ‘gold standard’ in public health research [8, 30, 31]. Likewise
there are serious ethical implications to consider in RCTs of socio-economic interventions
[29, 30]. It is these issues, of the gold standard and ethics, that we wish to build upon in
reflecting on how best to generate evidence on the impacts of microcredit.
Discussion
Learning from public health: the move from RCTs as the gold standard
The clinical origins and application of RCTs guarantee their credibility and rigour amongst
the scientific community. The enthusiasm with which they have been adopted by social
scientists has contributed to the belief, particularly amongst development economists, that
this study design overrides any other. However, advocates for the use of RCTs in the social
sciences are formulating arguments that are very similar in nature to the claims that were
made when the evidence-based medicine movement began in the 1980s and 1990s. Since
RCTs started to be used in medicine around 60 years ago [29], their legitimacy as the ‘gold
standard’ has dissipated and the ‘weight’ assigned to this research method has been
rebalanced in favour of more epidemiological, or observational, approaches. This is
particularly so in the area of public health, where the causal chains that exist between the
intervention and the outcome are much more complex than in clinical interventions [32].
Context tends to matter more, and the results of RCTs cannot be easily extrapolated to
similar interventions in different areas. Additionally, the causal pathways for public health
interventions involve behavioural responses that go beyond the strictly biological ones that
exist in clinical research [30].
With causal pathways similar in complexity, microfinance could benefit from following the
evolution in public health research, as documented in the guidelines on ‘Developing and
evaluating complex interventions’ produced by prestigious UK funder, the MRC [7].
This new phase for public health research, reflected in the MRC guidelines, highlights the
need to go beyond scientific rationalism to tackle modern problems such as obesity and
mental health. A significant contribution to this debate identifies as a starting premise that
population health improvement is conditional on a health-promoting societal context
characterised by a culture in which healthy behaviours are the norm, with supportive
institutional, social, and physical environments [33]. This implies that environmental and
social factors play a determining role in understanding mediating mechanisms that underlie
the intervention-effect relationship. There is a general recognition that RCTs, on their own,
cannot achieve a full understanding of such relationships.
Research methods in epidemiology, the core science for public health, have been adapting
to these shifts in the nature and main purpose of public health and the limitations of the oftassumed linear pathway, generating new and wider frameworks [34]. In public health, as in
social interventions such as microfinance, research evaluation methods need to be able to
assess effects deriving from complex pathways. While RCTs can identify direct short-term
effects reasonably well, their efficacy falls when the routes from the intervention to the
effects are more indirect and circuitous. This makes other research methods equally
necessary and valid to evaluate a complex intervention, as these might identify subjective
4
and environmental correlates of behaviour that could inform the design of interventions in
different contexts. An example of this can be found in the public health literature with the
successful sudden infant death syndrome (SIDS) campaign ‘Back to Sleep’. The success of
this campaign was identified through observational evidence that highlighted behavioural
factors (position of baby) and poverty as risk factors for SIDS. Moreover, the success of this
campaign could have been established two decades earlier if non-trial evidence had been
synthesised in the same way that RCT evidence is [34]. Thus, microfinance researchers need
to be critical and aware of the limitations of RCTs, particularly in the area of complex
interventions, as well as of the fact that RCTs are not always feasible [11] or present severe
ethical dilemmas.
Ethical dilemmas in Western contexts
As well as considering whether an RCT approach is appropriate to answer a particular
research question in a given context, ethical issues associated with such a study must be
examined. Key issues to consider from an ethical standpoint are those of equipoise and
consent [35]. While literature has addressed the serious ethical implications that RCTs of
socio-economic interventions present in practice, we feel considering the issue of equipoise
in relation to the mounting of microcredit RCTs in Western contexts is illustrative and adds
to this debate.
Equipoise exists at the personal or clinical level and reflects uncertainty regarding the
outcome of an intervention. This uncertainty, within personal and clinical equipoise, has
been described as “the principle, moral and practical, required to justify ethically a
randomised controlled trial” [36]; it is key to the staging of an ethical RCT. Personal
equipoise is the uncertainty of an individual physician regarding the outcome of a trial [35].
Awareness of an inferior treatment option combined with the physician’s ethical obligation
to treat patients to the best of their ability would constitute a moral obligation for a
physician to prevent a patient from partaking in a RCT. Similarly, clinical, or collective,
equipoise reflects uncertainty or indifference regarding treatment types amongst the
profession as a whole – no consensus exists concerning a preferred mode of treatment [35,
37, 38].
This begs the question as to what this means for randomised trials of microcredit. Precisely
who is in equipoise and what is the relevance of this for policy? Of course, government and
donors may be in equipoise and require best evidence about what works best for lowincome communities. However, in policy terms, is it really the case that consideration could
be given to stopping financial services which, as indicated by demand, are taken up by lowincome groups? Furthermore, should at risk groups be denied access to credit-plus
programmes that offer a health intervention alongside a loan for income generating
activities until the end of a study period? On the ground, it is doubtful whether individual
credit officers (in many respects the corollary of the physician in the medical context) would
be in equipoise. Anyone would likely be judged as having the right to be considered for a
loan, and, also, to receive such a loan should the credit officer judge them to be
creditworthy.
This, in part, might explain why some individual RCT designs were typically implemented
using a form of randomisation connected to credit scoring in which randomly selected
applicants previously deemed marginal rejections were reconsidered; thus applicants
received a microloan who otherwise would have been rejected [4, 13, 14]. However, giving
5
loans to those who have failed to meet screening requirements could also be judged
ethically dubious, the medical parallel being to offer inappropriate treatment to a patient
for the sake of research. Likewise, cluster randomisation (e.g. randomising villages [12])
might be seen as a way of conducting a trial whilst avoiding the need to randomise at the
individual level. The problem with this becomes one of relevance – the need to look at
results at the cluster level when the uptake of microcredit at such a level might not even be
considered by many in the population, thus dampening any potential impacts observed.
Given the contextual nature of many RCTs of social and public health interventions, such as
microcredit, it is then doubtful whether results from RCTs will bring resolution to equipoise,
due to a lack of external validity [39, 40]. Thus serious questions remain around the ethics of
subjecting trial participants to research where the value of the results could be questioned,
especially given people’s rights to access such services and the possibility of error in
judgments arising from trial results. It is our belief that these considerations call into
question whether it would be ethically possible to conduct a microcredit RCT in a Western
context. These arguments are of course relevant to all forms of microcredit RCTs and thus a
further question is raised of why individuals in Western contexts are treated differently to
those in developing countries?
Summary
Recognition must be paid to the methodological development that RCTs represent in the
microcredit research sector in terms of seeking to improve the internal validity and so
quality of impact evaluations. However, as this article outlines, questions remain regarding
the appropriateness of adopting this method to the exclusion of other important sources of
evidence. Our purpose has been to draw attention to these questions by focusing on issues
preventing the implementation of RCTs in Western contexts rather than to argue against
rigour in impact evaluations. Accordingly, we reiterate the call for more rigorous microcredit
impact evaluation studies that are suitably designed to correspond to their particular setting
and see RCTs as an important part of that [41].
We also recognise that despite the arguments provided regarding the benefits of
implementing other (non-RCT) study designs identified in the public health research field,
concerns may still exist due to the higher face validity of RCT approaches. Therefore, we
conclude by highlighting methodological innovations which can enable researchers,
practitioners and policy-makers to better judge and identify rigorous studies conducted
using other research methods. For example, following developments in thinking within
public health research, outlined previously in this article, non-randomised study designs
have also achieved greater recognition within prestigious evidence-synthesis movements,
such as The Cochrane Collaboration [42]. Recognising the importance of moving beyond
RCTs, corresponding alternative synthesis approaches to the ‘specialist’ synthesis method of
meta-analysis have been developed, such as narrative synthesis [43, 44]. Furthermore, of
particular relevance to this article are the specialist tools available to assess the quality of
non-randomised study designs [45]. Specifically tools now exist in public health research,
such as that developed by the Effective Public Health Practice Project, which enable the
methodological quality of randomised and non-randomised study designs to be assessed
[46]. Such developments mean tools now exist whereby the quality of randomised and nonrandomised study designs can be compared. Thus the rigour and quality of non-randomised
study designs can be assessed in relation to RCTs to allow informed judgements about how
much weight to attach to the results of particular studies.
6
These developments stem from the notion of systematic reviews, commonly used in the
medical field to summarise the results of randomised trials in order to examine the
effectiveness of an intervention in attaining a particular impact. Ironically, although not
prevalent, their use has recently become more common within the microcredit research
sector [47-51] with increasing recognition given to the benefits of pooling studies and
undertaking formal synthesis [11]. This itself is a significant development given that
systematic reviews, in general, are noted for their ability to inform policy and practice [52].
In summary, we do recognise that use of RCTs in the microfinance sector may be suitable for
answering specific research questions, in specific contexts but importantly this method is
not suitable for examining all potential areas of impact. This view is beginning to be
acknowledged by others within the sector who are realising that for particular outcomes of
interest, such as health, RCTs may not be appropriate due to longer gestation periods
requiring longer study designs which may cause problems withholding participants’ access
to microcredit [11]. As such it is our belief that other study designs such as panel data
methods, observational studies and qualitative methods, which can form part of the
required preparatory work to an evaluation to determine adequacy or plausibility, should
also be seen as a necessary part of any subsequent main study. The lessons and tools
garnered from the public health research field, identified here, illustrate that the quality and
rigour of non-randomised study designs can be upheld and that the insights obtained from
their use mean they deserve the same level of attention as has been bestowed on RCTs.
Heeding such methodological lessons would enable the evidence base around microfinance
to be enhanced and increase its potential in the field of public health.
Authors’ contributions
NM, OB and CD contributed to the conception and writing of this article. Furthermore, NM,
OB and CD read and approved the final version.
Declaration of interest
All authors declare that there were no conflicts of interest in the writing of this article.
Role of funding source
The authors declare that there were no funding sources connected to the writing of this
article.
Acknowledgements
This article emerged from conversations with colleagues at the Yunus Centre for Social
Business and Health, Glasgow Caledonian University. We, the authorship team, thank these
colleagues for their insights and critical conversation.
7
Box 1
“Creating a culture in which rigorous randomized evaluations are promoted, encouraged,
and financed has the potential to revolutionize social policy during the 21st century, just as
randomized trials revolutionized medicine during the 20th“ (Duflo, The World Bank is finally
embracing science, 2004 Lancet editorial) (in Deaton 2010)5
“The cleanest way to answer these questions is to mimic the randomised trials that are used
in medicine to evaluate the effectiveness of new drugs” (Poor Economics, pg. 8, Banerjee and
Duflo)6
“IPA uses randomized evaluations to measure impact because they provide the most
credible and reliable way to learn what works and what does not. Randomized evaluations
use the same methods frequently used in high quality medical research and rely on the
random assignment of a program or policy to measure its impact.” (IPA’s website)7
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