ArticlePDF Available

Costing the implementation of public health interventions in resource-limited settings: a conceptual framework

Authors:

Abstract and Figures

Background Failing to account for the resources required to successfully implement public health interventions can lead to an underestimation of costs and budget impact, optimistic cost-effectiveness estimates, and ultimately a disconnect between published evidence and public health decision-making. Methods We developed a conceptual framework for assessing implementation costs. We illustrate the use of this framework with case studies involving interventions for tuberculosis and HIV/AIDS in resource-limited settings. Results Costs of implementing public health interventions may be conceptualized as occurring across three phases: design, initiation, and maintenance. In the design phase, activities include developing intervention components and establishing necessary infrastructure (e.g., technology, standard operating procedures). Initiation phase activities include training, initiation of supply chains and quality assurance procedures, and installation of equipment. Implementation costs in the maintenance phase include ongoing technical support, monitoring and evaluation, and troubleshooting unexpected obstacles. Within each phase, implementation costs can be incurred at the site of delivery (“site-specific” costs) or more centrally (“above-service” or “central” costs). For interventions evaluated in the context of research studies, implementation costs should be classified as programmatic, research-related, or shared research/program costs. Purely research-related costs are often excluded from analysis of programmatic implementation. Conclusions In evaluating public health interventions in resource-limited settings, accounting for implementation costs enables more realistic estimates of budget impact and cost-effectiveness and provides important insights into program feasibility, scale-up, and sustainability. Assessment of implementation costs should be planned prospectively and performed in a standardized manner to ensure generalizability.
Content may be subject to copyright.
C O M M E N T A R Y Open Access
Costing the implementation of public
health interventions in resource-limited
settings: a conceptual framework
Hojoon Sohn
*
, Austin Tucker
, Olivia Ferguson
, Isabella Gomes
and David Dowdy
Abstract
Background: Failing to account for the resources required to successfully implement public health interventions
can lead to an underestimation of costs and budget impact, optimistic cost-effectiveness estimates, and ultimately
a disconnect between published evidence and public health decision-making.
Methods: We developed a conceptual framework for assessing implementation costs. We illustrate the use of this
framework with case studies involving interventions for tuberculosis and HIV/AIDS in resource-limited settings.
Results: Costs of implementing public health interventions may be conceptualized as occurring across three
phases: design, initiation, and maintenance. In the design phase, activities include developing intervention
components and establishing necessary infrastructure (e.g., technology, standard operating procedures). Initiation
phase activities include training, initiation of supply chains and quality assurance procedures, and installation of
equipment. Implementation costs in the maintenance phase include ongoing technical support, monitoring and
evaluation, and troubleshooting unexpected obstacles. Within each phase, implementation costs can be incurred at
the site of delivery (site-specificcosts) or more centrally (above-serviceor centralcosts). For interventions
evaluated in the context of research studies, implementation costs should be classified as programmatic, research-
related, or shared research/program costs. Purely research-related costs are often excluded from analysis of
programmatic implementation.
Conclusions: In evaluating public health interventions in resource-limited settings, accounting for implementation
costs enables more realistic estimates of budget impact and cost-effectiveness and provides important insights into
program feasibility, scale-up, and sustainability. Assessment of implementation costs should be planned
prospectively and performed in a standardized manner to ensure generalizability.
Keywords: Implementation strategies, Costs of implementation, Economic evaluation, Decision-making, Tuberculosis
© The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License,
which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give
appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if
changes were made. The images or other third party material in this article are included in the article's Creative Commons
licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons
licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain
permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the
data made available in this article, unless otherwise stated in a credit line to the data.
* Correspondence: hsohn6@jhu.edu
Hojoon Sohn, Austin Tucker, Olivia Ferguson, Isabella Gomes and David
Dowdy contributed equally to this work.
Department of Epidemiology, Johns Hopkins Bloomberg School of Public
Health, 615 N. Wolfe Street E6531, Baltimore, MD 21205, USA
Sohn et al. Implementation Science (2020) 15:86
https://doi.org/10.1186/s13012-020-01047-2
Introduction
Economic evaluations are frequently used to inform
prioritization of health interventions and resource alloca-
tion for public health [1]. Unfortunately, most existing
economic evaluations of public health interventions have
done so retrospectively [2], thereby limiting their ability to
fully assess the costs of implementation, especially during
the early stages of design and initiation. A growing num-
ber of studies are exploring these implementation costs,
but many continue to do so in retrospective fashion, and
interventions in resource-limited settingswhere imple-
mentation costs may represent a disproportionate fraction
of total intervention costsaresorelyunder-represented
[2]. As such, most published economic evaluations may
have greatly underestimated the costs of public health in-
terventions, particularly those studied in resource-limited
settings. A framework for considering and prospectively
collecting implementation costs could therefore greatly
improve economic evaluations of public health interven-
tions in the coming years.
To illustrate, the Avahan initiative was a complex inter-
vention to prevent HIV transmission across six Indian
states that included peer outreach, clinical services, condom
distribution, safe needle exchange, and community
mobilization [3]. A cost-effectiveness analysis estimated that
Avahan cost $46 per disability-adjusted life year (DALY)
averted [4]. However, approximately two thirds of overall
costs were incurred at the above-servicelevelinvolving
institutions above or ancillary to the provision of care (e.g.,
government, non-governmental organization (NGO), or
multilateral institution support or infrastructure for facili-
tating provision of care). Had these costs of implementation
not been counterbalanced by four years of service delivery,
the cost per person reached could have been four times
higherwith qualitatively important cost-effectiveness im-
plications [5]. Such implementation costs are frequently
neglected in economic evaluations, leading to underesti-
mated costs, optimistic cost-effectiveness estimates, and a
disconnect between published evidence and public health
decision-making. This disconnect is particularly stark in
settings where resources are most constrained.
Another illustration of the importance of implementation
costing is the recently published PopART (HPTN 071) trial
of universal testing and treatment for HIV in South Africa
and Zambia [6]. This trial, conducted over 5 years, mobi-
lized 740 community HIV care providers working in pairs
(each pair covering approximately 500 households) to
provide comprehensive health servicesfrom HIV
counseling and rapid testing to screening for tuberculosis
(TB) and sexually transmitted infectionsduring annual
household visits. This multifaceted intervention reduced
HIV infection by 30% but required extensive programmatic
coordination and administrative management, including
rigorous re-training and human resource management,
planning of daily household visits and periodic community
engagement campaigns, HIV testing drives, and centralized
coordination of study activities (e.g., obtaining regulatory
approvals, provision of security, and maintenance of a
stable procurement and supply chain) [7]. Costs associated
with the implementation of these complex and compre-
hensive activitiesoften neglected in cost-effectiveness
analysesmay make the start-up of health interventions
unaffordable or infeasible. This, in turn, would result in
substantial waste of resources if interventions are poorly
maintained or not sustained.
To provide decision-makers with an honest appraisal
of the potential costs and benefits of any health inter-
vention, it is critical to document the full range of costs
required for programmatic implementation, including
the costs of intervention design and local adaptation,
initiation and scale-up, and maintenance/sustainability.
While consideration of implementation costs is universally
relevant, these costs may be proportionally more import-
ant in settings where resources are highly constrained.
Here, we use the example of peripheral diagnostic testing
for TB as a case study to illustrate the importance of
evaluating costs throughout the implementation process
Contributions to the literature
Economic evaluations have long been used to prioritize
health interventions in resource-limited settings. However,
these analyses often fail to capture the resources required to
successfully implement interventions and thus may greatly
underestimate the actual economic costs of the intervention.
Most existing studies in the health economics literature in
the context of implementation science are retrospective or
ex-postin nature; methods and examples of evaluating
these costs prospectively are limited, particularly in resource
limited settings.
Using recent examples from the literature, we highlight the
importance and potential magnitude of costs associated
with implementation of public health interventions in
resource constrained settings.
We also provide a conceptual framework that details the
types of economic resources utilized during the design,
initiation, and maintenance phases of implementation and
the implications of neglecting implementation costs in
evaluating the cost-effectiveness of interventions in resource-
limited settings.
Such a framework provides greater insight into the need for
implementation costing practices for more accurate
economic evaluation and budget impact analysis as well as
insights into program feasibility, scale up and sustainability.
Sohn et al. Implementation Science (2020) 15:86 Page 2 of 8
and to propose a structured method for investigating these
costs.
Peripheral diagnostic testing for TB: a case study of
implementing a novel health intervention in settings of
severe resource constraints
An estimated 1318% of patients diagnosed with TB in
Africa and Asia are lost to follow-up before starting
treatment [8]. The current standard of care for TB diag-
nosis involves molecular testing requiring equipment
(e.g., four-module GeneXpert® instruments) that often
cannot be maintained at the point of care [9]. Novel
testsincluding more portable devices (e.g., GeneXpert®
Edge) and simpler assays (e.g., lateral-flow detection of
urine lipoarabinomannan [LF-LAM])that can diagnose
TB at the point of treatment have been prioritized as a
means of reducing diagnostic delays and losses to fol-
low-up [10]. Cost-effectiveness analyses of peripherally
implemented TB diagnostic tests are emerging [11]; how-
ever, existing analyses may not fully account for the costs
required to implement these novel assays in practice.
Costing the implementation process: a framework
Similar to many consumer products, public health inter-
ventions can be conceptualized as having a product life
cycle,with well-defined stagesdesign, launch, growth,
maturity, and declinefrom introduction to removal
from the market[12]. Considering each of these stages
is critical to the financial success of consumer prod-
uctsand this is equally true for public health interven-
tions. Although the systems required for each product
life cycle phase differ, the costing of systems for launch
often overlaps with those for design (preparation for
launch) or growth (which starts immediately after
launch)and the decline phase acknowledges that every
product (or intervention) has a finite time horizon. Thus,
in mapping the structure of the product life cycle to the
costing of public health interventions, one can delineate
three stages: design and adaptation to the local context
(design phaseincluding preparation for launch), initial
implementation and scale-up (initiation phasecorre-
sponding to launch and growth), and ongoing activities
to ensure intervention sustainability (maintenance
phasecorresponding to maturity and forestalling of
decline) [13].
As illustrated in Fig. 1a, the implementation process is
not necessarily unidirectional. Rather, the various phases
of implementation inform one another, especially as
interventions are adapted from one context to another
or expanded in size or scope. For example, experiential
knowledge attained during the initiation phase in one
setting may inform the re-design of protocols for the
design phase in a different cultural context. Similarly,
the maintenance phase of an intervention in an early
adoptercountry may inform policymakers and re-
searchers about the potential sustainability of the inter-
vention and influence considerations about design and
initiation in other regions or countries. As such, it is
important to individually estimate the cost of each stage
of the implementation processand to illustrate how
those estimates depend on key assumptions (e.g., scale
of implementation, local market rates for human re-
sources and other costs)so that those estimates can be
generalized to other contexts where existing knowledge
and infrastructure may be more or less complete.
In addition to the costs incurred at different phases of
implementation, costs can be incurred at the site of
delivery (site-specificcosts; containing administrative
efforts from the service delivery facilitye.g., clinic or
hospital administration) or more centrally (above-ser-
viceor centralcosts; services such as support from a
district health office [DHO], NGO, or Ministry of Health
[MOH]). Furthermore, health interventions are often
evaluated in the context of research studies or evaluation
programs, necessitating a differentiation between costs
required for programmatic implementation and those
incurred purely for the purposes of research or evaluation
(the latter being less relevant to the cost-effectiveness of the
intervention itself). Importantly, some degree of monitoring
and evaluation is necessary for effective implementation
and should therefore be included as a programmatic cost;
however, the costs incurred by research studies and other
knowledge generation activities often exceed this baseline
requirement and may vary depending on the type of
intervention being considered. As such, it is important to
prospectively monitor and categorize costs as purely
research-related (i.e., likely not to be incurred during subse-
quent implementation in other settings) versus necessary
for programmatic implementation (even if those costs rep-
resent researchactivities) to facilitate subsequent analyses.
Table 1provides examples of costs that may be incurred
acrossthethreephasesofimplementation, site-specific ver-
sus central locations, and programmatic versus research
purposesusing the example of an ongoing cluster
randomized trial of peripheral versus central molecular TB
testing(theXpertPerformanceEvaluationforLinkageto
Tuberculosis Care [XPEL TB] trial) [14]. As illustrated in
panel b of Fig. 1,above-servicecosts in the design and
initiation phases tend to represent a greater proportion of
total costs. Thus, consideration of these costswhile always
importantis most critical when the costs of design and
initiation are greater relative to the costs of delivery (e.g., in-
terventions that are scaled-up to a smaller population),
when interventions are being considered by decision-
makers (e.g., politicians) with shorter time horizons, when
interventions are expected to change in scope or cost with
time (e.g., through price reductions or release of new
competing interventions), or when interventions are not
Sohn et al. Implementation Science (2020) 15:86 Page 3 of 8
immediately affordable. These situations account for a large
fraction of health interventions being considered for imple-
mentation in resource-limited settings. Furthermore, most
public health interventions in resource-limited settings are
not sustained indefinitely. Thus, rigorously measuring the
costs of design and implementation and weighing those
against the expected duration of the maintenance phase
can improve our understanding of the costs and sustain-
ability of public health interventions in terms of their life
cycles. We now provide examples of costs that might be
incurred at each phase of the implementation process
(summarized in Table 2).
Design phase
Implementation costs incurred during the design and
adaptation of health interventions may include crafting
of appropriate policies and algorithms, obtaining polit-
ical and administrative approvals, developing necessary
infrastructure, engagement of relevant stakeholders, and
pilot testing in the local context. Where these costs are
large and must be incurred before scale-up is certain,
they may represent a majority of the total cost of the
intervention. For example, in a trial of mobile Health-
facilitated home-based contact investigation for TB in
Uganda, a software package was required to generate
short messaging service (SMS) reminders to facilitate
home-based screening, incurring large up-front costs for
an initial service contract and adaptation to the Ugandan
telecommunications infrastructure [15]. While this inter-
vention was only delivered to 372 households (919 con-
tacts screened), the cost of designing and developing the
intervention ($137 per contact screened, of which $90
Fig. 1 Simplified illustration of stages, activities, resource classification, and assessment of costs of public health intervention implementation
process. aA description of the implementation process listing key components of each phase that may carry additional resource requirements is
provided. Light blue arrows represent potential feedback loops between phases. bAn illustration of resource and cost classification of the public
health intervention implementation process. At each phase, resource-use for relevant activities is classified based on the location (above site vs.
site-specific) of activity and degree to which activities are programmatic versus research specific. Sizes of each square (different shades of
blue)arbitrarily assigned for the purposes of demonstrationrepresent the corresponding size of each activity category. The increasing size of
light-shaded boxes to the right indicate an increasing programmatic component as the study progresses into the maintenance phase
Sohn et al. Implementation Science (2020) 15:86 Page 4 of 8
Table 1 Descriptions of key activities by study phases (XPEL study example)
Classification of activities Research or knowledge generation costs
a
Programmatic costs Shared research/program costs
Design phase
Central Ministry of Health (MoH), provincial,
and district level approvals for the
research study
Institutional Review Board approvals
Development of study CRFs (clinical
outcomes)
Development of research database
(RedCap* program)
Development of study protocols
International collaborator site visits
and periodic study calls
Central procurement of GeneXpert
machines, related equipment (e.g.,
solar panels and external batteries),
Xpert Ultra cartridges, and
associated supplies
Development of SOPs* for Xpert
testing, troubleshooting and QA/
QC manuals, and management of
testing equipment
Recruitment of study staff
Focus group discussions
Site-specific Site visits for site selection
Review of clinical and laboratory
data
N/A Sensitization meetings at district
health office and potential study
sites
Pilot studies conducted at select
potential study sites
Initiation phase
Central Establish clinical and laboratory data
monitoring (including National TB
Reference Laboratory)
Management of regulatory
processes with MoH
Development of data collection
plans for health economics study
International collaborator site visits
and periodic study calls
Development of plans and
organization of site visit and
training
Stock management (medical and
laboratory consumables and Xpert
cartridges)
Study database management
(clinical and programmatic)
Data quality checks
Weekly study call
(implementation issues, study
data checks, etc.)
Site-specific Management of provincial, district
level regulatory processes
Installation of solar panel and
GeneXpert equipment (including
GX Alert system)
Distribution of Xpert cartridges and
laboratory consumables
Training of laboratory personnel
and technical support for Xpert
testing
Site sensitization meetings (w/
routine clinic staff) at both
intervention and control sites
Initial participant enrolment
Establishment of data collection
and follow-up plans
Interim adjustments in
implementation plans (including
addition or exclusion of sites)
Recruitment of study contact
persons at each site (for data
monitoring and study logistics
purposes)
Maintenance phase
Central Management and monitoring of
study data
International collaborator site
visits and periodic study calls
Data analyses and reporting
Stock management (medical and
laboratory consumables and Xpert
cartridges)
Site visit organizations and
communications
Study database management
(clinical and programmatic)
Central database data review
and quality checks
Weekly study call
(implementation issues, study
data checks, etc.)
Central study team human
resource management
Site-specific Site-specific data issue
troubleshooting
Ongoing technical support and
troubleshooting (for GeneXpert and
Solar panel equipment)
Distribution of Xpert cartridges and
laboratory consumables
Procurement and replacement of
key equipment (if broken)
QA/QC of Xpert testing
Review of GX Alert data
Periodic EQA and re-training for
Xpert testing
Quarterly site visit
Participant enrolment
Adjustments in site-specific
operations
Ongoing human resource
management at study sites
Data monitoring and quality
checks
a
Research or knowledge generation costs that would be required for programmatic implementation in other settings (for example, ongoing monitoring
and evaluation) should be clearly delineated and considered as programmatic costs in most analyses
SOP Standard operation procedure, QA Quality assurance, QC Quality control, EQA External quality control, GX Alert System software system to centrally
report site-specific Xpert testing statistics, equipment and testing troubleshooting, and testing operations
Sohn et al. Implementation Science (2020) 15:86 Page 5 of 8
was for software development) overshadowed the cost of
intervention delivery ($54 per contact screened) [16].
This initial outlay for intervention design could be
partially counterbalanced by scale-up to a broader popu-
lation but would probably be incurred again if the inter-
vention were implemented in a different country with a
different telecommunications system. Importantly, these
costs might vary considerably across countries, regions,
and facilities with different levels of underlying infrastruc-
tureand these differences would need to be considered by
both researchers (aiming to produce generalizable know-
ledge) and implementers (aiming to accurately estimate
design costs in their unique contexts). Failure to consider
the cost of designing the intervention and adapting it to the
local context would have resulted in both a dramatic
overestimation of cost-effectiveness and an incomplete
understanding of the generalizability of cost and cost-
effectiveness estimates for implementation of the interven-
tion in other settings.
Initiation phase
As interventions are initially rolled out and scaled-up,
many types of implementation costs (e.g., training mate-
rials and personnel, infrastructure necessary to launch
implementing teams) are incurred up-front. These fixed
costs often do not vary with the level of service output.
The contribution of up-front costs to the overall cost
and cost-effectiveness of a program may vary consider-
ably across implementation sites depending on each
sites operational and infrastructural capacity and imple-
mentation outcomes such as program reach (i.e., the
number and representativeness of people engaged by the
program) [17]. These costs are often not adequately con-
sidered in traditional cost-effectiveness estimates. This is
particularly problematic when variable costs (e.g., med-
ical consumables, test kits, and unit staffing costs) to
deliver the intervention are low, but the intervention has
high implementation and operating costs. For example,
the Alere Determine
TM
TB LAM Ag assay (LF-LAM) is
a simple dipstick-based diagnostic test for TB that costs
less than $2 per test kit and requires minimal operator
time [18]. Cost-effectiveness analyses have therefore
considered the unit cost of LF-LAM to be between $3
and $4 per test [11]. However, this estimate fails to
account for the above-service(and service-level) costs
required to implement LAMincluding building costs,
staff salaries, utilities, and supplies necessary for such
activities as preparing clinics and training clinical staff,
coordinating logistics during implementation, assuring
fidelity to (often complex) policy guidance, and estab-
lishing a reliable supply chain [10]. After incorporating
these costs, the unit cost of LF-LAM in South Africa
was estimated at over $23 per patient testedapproxi-
mately seven-fold higher than the simple estimate based
primarily on consumable costs alone [19]. Such underesti-
mates of intervention costs (when costs of implementation
and scale-up are not incorporated) are unfortunately very
common in the scientific literature and lead to reported
cost estimates that do not reflect programmatic realities
on the ground.
Maintenance phase
Although implementation costs are often proportionally
lower during the maintenance phase (Fig. 1b), they
should not be ignored entirelyparticularly for interven-
tions that require infrastructure and/or procedures that
require ongoing upkeep or quality assurance. For
example, in the XPEL trial, single-module GeneXpert
devices were installed to enable point-of-treatment
diagnosis at 10 peripheral health centers in Uganda.
Maintaining these devices requires assurance of a stable
electrical supply (e.g., installation and maintenance of
solar panels), backup testing systems for when devices
temporarily fail (which occurred at 6 sites over a 14-
month period), security to prevent theft of computers
and other electronics, service contracts to perform
repairs, routine monitoring and evaluation, maintenance
of a reliable supply chain of diagnostic cartridges, and
external quality assurance to ensure ongoing high-
quality testing by mid-level staff. Corresponding costs
varied from one site to another and when considered in
full, costs associated with the maintenance operations
accounted for > 12% of the total unit cost of peripheral
Xpert testing, even when only considering costs beyond
the initiation phase (unpublished data). As the level of
technology incorporated in new health interventions often
Table 2 Interventions for peripheral diagnosis of tuberculosis (TB) likely to incur large costs in each phase of implementation
Implementation
phase
Application Example
Design phase Interventions needing large capital outlay for
design and adaptation with uncertain scale-up
Implementation of mHealth-facilitated contact investigation for TB requiring
procurement and tailoring of software packages
Initiation phase Simple interventions with low consumable costs
that require changes in policy and workflow
Low-cost lateral-flow LAM assay for TB that necessitates a new supply chain,
clinical algorithms, and training of personnel
Maintenance
phase
Interventions that require continued infrastructure
support and quality control
Molecular diagnosis of TB with equipment (e.g., Xpert MTB/RIF®) that
necessitates service contracts for equipment failure and external quality
assurance of test results
Sohn et al. Implementation Science (2020) 15:86 Page 6 of 8
outpaces the establishment of corresponding infrastruc-
ture in many global settings, explicitly estimating the costs
of maintaining those interventions and ensuring their
sustainability will become increasingly important [20].
A way forward
The examples above help illustrate the importance of
considering costs at each stage of the implementation
process. This structured approach to costing of the imple-
mentation process suggests three priorities for improving
cost-effectiveness analyses of health interventions in
resource-limited settings.
First, cost-effectiveness analyses should not rely entirely
on budgetary information but should explicitly consider
activities and resources required for successful implemen-
tation. Examples of approaches for such implementation
costing include collection of routine activity logs of imple-
menting staff, structured discussions with field personnel
to enable health economists to understand the extent of
resources required for major implementation activities
(e.g., trainings, site initiation), and ongoing documentation
of specific challenges in implementation (e.g., sites in
which implementation failed, staff leaving).
Second, implementation cost data should be classified
by resource type, key activities, phase of implementation
(e.g., as described in Fig. 1), site level (site-specific vs
above-service), and as programmatic versus non-
programmatic (research) so that implementation costs
can be generalized to other settings and key drivers of
implementation costs can be identified. In costing the
implementation process, assumptions can often be made
when empiric data are not immediately availablebut
appropriate documentation and categorization of data
and assumptions are critical if generalizable knowledge
is to be generated.
Third, costing activities should generally be planned
prospectively before implementation begins (so the process
of implementation can be costed). While retrospective
estimation of implementation costs is often feasible, such
estimates are often subject to recall bias and difficult to
appropriately classify retroactively. Early involvement of
health economists (with experience in empiric costing ac-
tivities) can therefore be very useful in evaluating the costs
of implementation.
One final consideration is whether detailed measure-
ment of implementation costs is justified for a particu-
lar implementation research study. In making this
assessment, investigators should consider two ques-
tions. First, if the intervention is found to be effective,
is implementation likely to be influenced by consider-
ations of cost-effectiveness and/or budget impact?
Second, are there sufficient uncertainties in the costs of
implementing the intervention that an empiric estima-
tionofcostsiswarranted(asopposedtosimplyusing
pre-existing cost estimates from the literature)? In most
cases, the answer to the first question will be yes, and
the answer to the second question will be no, meaning
that an empiric estimation of costs is scientifically justi-
fied. When this is the case, investigators must then
evaluate whether the budget exists to measure these
costs and (given limited financial resources) whether
otherscientificquestionsaremorepressing.
Conclusions
In summary, we argue that the costs of implementing
health interventions in resource-limited settings are often
very substantial, but generally neglected in economic
evaluation. We provide a framework for effectively
conceptualizing and prospectively measuring these costs,
whichif incorporated appropriatelycan improve the
linkage between published results of cost-effectiveness
analyses and the realities of implementation in the field.
Acknowledgements
We gratefully acknowledge the teams of the XPEL trial and mHealth TB
contact investigation trial of TB diagnosis in Uganda, as well as the REDART
trial and SNaP trial of interventions to improve delivery of antiretroviral
therapy in Vietnam, from which many of these lessons were distilled.
Authorscontributions
HS and DD conceived the idea of the topic of this manuscript. All authors
contributed equally in writing the initial draft and revising this manuscript.
The author(s) read and approved the final manuscript.
Funding
This work was supported in part by the National Heart, Lung, and Blood
Institute (NHLBI), grant number R01HL138728, to Dr. Dowdy.
Availability of data and materials
Not applicable
Ethics approval and consent to participate
Not applicable
Consent for publication
Not applicable
Competing interests
All authors do not have any interests to declare.
Received: 6 April 2020 Accepted: 16 September 2020
References
1. Hoomans T, Severens JL. Economic evaluation of implementation strategies
in health care. Implement Sci. 2014;9(1):168. Available from: http://doi.wiley.
com/10.1002/9781118525975.ch23.
2. Roberts SL, Healey A, Sevdalis N. Use of health economic evaluation in the
implementation and improvement science fieldsa systematic literature
review. Implementation Sci. 2019;14(1):72.
3. Ng M, Gakidou E, Levin-Rector A, Khera A, Murray CJ, Dandona L.
Assessment of population-level effect of Avahan, an HIV-prevention
initiative in India. Lancet. 2011;378(9803):164352.
4. Vassall A, Pickles M, Chandrashekar S, Boily MC, Shetty G, Guinness L,
Lowndes CM, Bradley J, Moses S, Alary M, Group CI. Cost-effectiveness of
HIV prevention for high-risk groups at scale: an economic evaluation of the
Avahan programme in south India. Lancet Glob Health. 2014;2(9):e53140.
5. Chandrashekar S, Guinness L, Pickles M, Shetty GY, Alary M, Vickerman
P, Vassall A. The costs of scaling up HIV prevention for high risk
Sohn et al. Implementation Science (2020) 15:86 Page 7 of 8
groups: lessons learned from the Avahan Programme in India. PloS one.
2014;9(9):e106582.
6. Hayes RJ, Donnell D, Floyd S, Mandla N, Bwalya J, Sabapathy K, Yang B, Phiri
M, Schaap A, Eshleman SH, Piwowar-Manning E. Effect of universal testing
and treatment on HIV incidenceHPTN 071 (PopART). N Engl J Med. 2019;
381(3):20718.
7. Vermund SH, Fidler SJ, Ayles H, Beyers N, Hayes RJ, HPTN 071 Study
Team. Can combination prevention strategies reduce HIV transmission
in generalized epidemic settings in Africa? The HPTN 071 (PopART)
study plan in South Africa and Zambia. J Acquir Immune Defic Syndr.
2013;63(0 2):S221.
8. MacPherson P, Houben RM, Glynn JR, Corbett EL, Kranzer K. Pre-treatment
loss to follow-up in tuberculosis patients in low-and lower-middle-income
countries and high-burden countries: a systematic review and meta-analysis.
Bull World Health Organ. 2013;92:12638.
9. Clouse K, Page-Shipp L, Dansey H, Moatlhodi B, Scott L, Bassett J, Stevens
W, Sanne I. Implementation of Xpert MTB/RIF for routine point-of-care
diagnosis of tuberculosis at the primary care level. S Afri Med J. 2012;
102(10):8057.
10. World Health Organization. The use of lateral flow urine lipoarabinomannan
assay (LF-LAM) for the diagnosis and screening of active tuberculosis in
people living with HIV: policy guidance. Geneva: World Health Organization;
2015. ISBN: 978 92 4 150963 3. WHO reference number: WHO/HTM/TB/2015.
25.
11. Reddy KP, Gupta-Wright A, Fielding KL, Costantini S, Zheng A, Corbett EL,
Yu L, Van Oosterhout JJ, Resch SC, Wilson DP, Horsburgh CR Jr. Cost-
effectiveness of urine-based tuberculosis screening in hospitalised patients
with HIV in Africa: a microsimulation modelling study. Lancet Glob Health.
2019;7(2):e2008.
12. Rink DR, Swan JE. Product life cycle research: a literature review. J Bus Res.
1979;7(3):21942.
13. Scheirer MA, Dearing JW. An agenda for research on the sustainability of
public health programs. Am J Public Health. 2011;101(11):205967.
14. Shete PB, Nalugwa T, Farr K, Ojok C, Nantale M, Howlett P, Haguma P,
Ochom E, Mugabe F, Joloba M, Chaisson LH. Feasibility of a streamlined
tuberculosis diagnosis and treatment initiation strategy. Int J Tuberc Lung
Dis. 2017;21(7):74652.
15. Davis JL, Turimumahoro P, Meyer AJ, Ayakaka I, Ochom E, Ggita J, Mark D,
Babirye D, Okello DA, Mugabe F, Fair E. Home-based tuberculosis contact
investigation in Uganda: a household randomised trial. ERJ Open Res. 2019;
5(3):001122019.
16. Turimumahoro P, Tucker A, Meyer A, Tampi R, Ayakaka I, Dowdy D, Katamba
A, Davis JL. But at what cost? The cost of implementing mobile-health
facilitated tuberculosis contact investigation. The Hague, The Netherlands:
Oral presentation (OA12-281-26), 49th Union World Conference on Lung
Health; 2018.
17. Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG,
Estabrooks PA. RE-AIM planning and evaluation framework: adapting to new
science and practice with a 20-year review. Front Public Health. 2019;7:64.
18. Shah M, Hanrahan C, Wang ZY, Dendukuri N, Lawn SD, Denkinger
CM, Steingart KR. Lateral flow urine lipoarabinomannan assay for
detecting active tuberculosis in HIV-positive adults. Cochrane
Database Syst Rev. 2016;2016(5):CD011420. https://doi.org/10.1002/
14651858.CD011420.pub2.
19. Mukora R, Tlali M, Monkwe S, Charalambous S, Karat AS, Fielding KL, Grant
AD, Vassall A. Cost of point-of-care lateral flow urine lipoarabinomannan
antigen testing in HIV-positive adults in South Africa. Int J Tuberc Lung Dis.
2018;22(9):10827.
20. Packard RM. A history of global health: interventions into the lives of other
peoples: JHU Press; 2016.
PublishersNote
Springer Nature remains neutral with regard to jurisdictional claims in
published maps and institutional affiliations.
Sohn et al. Implementation Science (2020) 15:86 Page 8 of 8
... Similarly, in other settings where new interventions are being implemented, it is commendable to integrate cost effectiveness analysis studies from the planning phase so that appropriate cost and effectiveness data can be captured throughout the program implementation [30]. This will generate robust evidence for program feasibility, scale up and sustainability [31]. A costing framework proposed by Sohn et al can be used to help inform the design of costing the implementation of public health interventions [31]. ...
... This will generate robust evidence for program feasibility, scale up and sustainability [31]. A costing framework proposed by Sohn et al can be used to help inform the design of costing the implementation of public health interventions [31]. ...
... This does directly reflect effectiveness in terms of health outcomes and therefore, efforts to scale-up the intervention should consider adding more strong measures of outcome such as DALYs or QALYs. Retrospective analysis of cost data could have resulted in the underestimation of the cost for implementing the EmTS intervention [31]. Despite the limitations, this is the first study in Tanzania to examine cost effectiveness of a community-based innovative intervention aiming at combating the second maternal delay, an important cause of maternal mortality in Tanzania, and other areas with similar context. ...
Article
Full-text available
In achieving the sustainable development goal 3.1, Tanzania needs substantial investment to address the three delays which responsible for most of maternal deaths. To this end, the government of Tanzania piloted a community-based emergency transport intervention to address the second delay through m-mama program. This study examined secondary data to determine the cost-effectiveness of this intervention in comparison to the standard ambulance system alone. The m-mama program was implemented in six councils of Shinyanga region. The m-mama program data analyzed included costs of referral services using the Emergency Transportation System (EmTS) compared with the standard ambulance system. Analysis was conducted using Microsoft Excel, whose data was fed into a TreeAge Pro Healthcare 2022 model. The cost and effectiveness data were discounted at 5% to make a fair comparison between the two systems. During m-mama program implementation a total of 989 referrals were completed. Of them, 30.1% used the standard referral system using ambulance, while 69.9% used the EmTS. The Emergency transport system costed USD 170.4 per a completed referral compared to USD 472 per one complete referral using ambulance system alone. The introduction of m-mama emergency transportation system is more cost effective compared to standard ambulance system alone in the context of Shinyanga region. Scaling up of similar intervention to other regions with similar context and burden of maternal mortality may save cost of otherwise normal emergency ambulance system. Through lessons learned while scaling up, the intervention may be improved and tailored to local challenges and further improve its effectiveness.
... These costs entail expenses for acquiring capital equipment, training medical and other staff, supplying medical consumables and reagents, and initiating and maintaining quality control measures. This oversight can result in an underestimation of costs, potentially leading to overly optimistic cost-effectiveness estimates [57]. Existing frameworks [57] offer a valuable means to assess essential implementation costs, and pertinent data can be collected through related cost-of-illness studies [58] and qualitative interviews with stakeholders [59]. ...
... This oversight can result in an underestimation of costs, potentially leading to overly optimistic cost-effectiveness estimates [57]. Existing frameworks [57] offer a valuable means to assess essential implementation costs, and pertinent data can be collected through related cost-of-illness studies [58] and qualitative interviews with stakeholders [59]. ...
Article
Full-text available
Background The increasing global prevalence of atrial fibrillation (AF) has led to a growing demand for stroke prevention strategies, resulting in higher healthcare costs. High-quality economic evaluations of stroke prevention strategies can play a crucial role in maximising efficient allocation of resources. In this systematic review, we assessed the methodological quality of such economic evaluations. Methods We searched electronic databases of PubMed, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, and Econ Lit to identify model-based economic evaluations comparing the left atrial appendage closure procedure (LAAC) and oral anticoagulants published in English since 2000. Data on study characteristics, model-based details, and analyses were collected. The methodological quality was evaluated using the modified Economic Evaluations Bias (ECOBIAS) checklist. For each of the 22 biases listed in this checklist, studies were categorised into one of four groups: low risk, partial risk, high risk due to inadequate reporting, or high risk. To gauge the overall quality of each study, we computed a composite score by assigning + 2, 0, − 1 and − 2 to each risk category, respectively. Results In our analysis of 12 studies, majority adopted a healthcare provider or payer perspective and employed Markov Models with the number of health states varying from 6 to 16. Cost-effectiveness results varied across studies. LAAC displayed a probability exceeding 50% of being the cost-effective option in six out of nine evaluations compared to warfarin, six out of eight evaluations when compared to dabigatran, in three out of five evaluations against apixaban, and in two out of three studies compared to rivaroxaban. The methodological quality scores for individual studies ranged from 10 to − 12 out of a possible 24. Most high-risk ratings were due to inadequate reporting, which was prevalent across various biases, including those related to data identification, baseline data, treatment effects, and data incorporation. Cost measurement omission bias and inefficient comparator bias were also common. Conclusions While most studies concluded LAAC to be the cost-effective strategy for stroke prevention in AF, shortcomings in methodological quality raise concerns about reliability and validity of results. Future evaluations, free of these shortcomings, can yield stronger policy evidence.
... Similarly, frameworks developed for complex interventions have also not sufficiently addressed program cost estimation [17][18][19][20]. Methodological guidance is emerging for specific cost components, such as implementation costs of public health programs [21,22], but this cannot account for the full breadth of program costs of DHIs. Therefore, the existing scientific literature is insufficient to help standardize the estimation and reporting of program costs of DHIs. ...
Article
Full-text available
The rate of development and complexity of digital health interventions (DHIs) in recent years has to some extent outpaced the methodological development in economic evaluation and costing. Particularly, the choice of cost components included in intervention or program costs of DHIs have received scant attention. The aim of this study was to build a literature-informed checklist of program cost components of DHIs. The checklist was next tested by applying it to an empirical case, Mamma Mia, a DHI developed to prevent perinatal depression. A scoping review with a structured literature search identified peer-reviewed literature from 2010 to 2022 that offers guidance on program costs of DHIs. Relevant guidance was summarized and extracted elements were organized into categories of main cost components and their associated activities following the standard three-step approach, that is, activities, resource use and unit costs. Of the 3448 records reviewed, 12 studies met the criteria for data extraction. The main cost categories identified were development, research, maintenance, implementation and health personnel involvement (HPI). Costs are largely considered to be context-specific, may decrease as the DHI matures and vary with number of users. The five categories and their associated activities constitute the checklist. This was applied to estimate program costs per user for Mamma Mia Self-Guided and Blended, the latter including additional guidance from public health nurses during standard maternal check-ups. Excluding research, the program cost per mother was more than double for Blended compared with Self-Guided (€140.5 versus €56.6, 2022 Euros) due to increased implementation and HPI costs. Including research increased the program costs to €190.8 and €106.9, respectively. One-way sensitivity analyses showed sensitivity to changes in number of users, lifespan of the app, salaries and license fee. The checklist can help increase transparency of cost calculation and improve future comparison across studies.
... The cost of implementation-that is, financial resources needed across the design, initiation and maintenance stages of DIPH-would have been helpful information for health system stakeholders, especially policymakers, when embedding the strategy. 36 It is important to note that the intervention is not resource-intensive, as it is about streamlining the decision-making process of the district health administration within an existing routine platform and with existing resources. The key costing element for scaling up would be the training of district administration staff and of supportive supervision, which would be 0.3-0.25 full-time equivalent for each district, particularly during the first months of implementation. ...
Article
Full-text available
Background Use of local data for health system planning and decision-making in maternal, newborn and child health services is limited in low-income and middle-income countries, despite decentralisation and advances in data gathering. An improved culture of data-sharing and collaborative planning is needed. The Data-Informed Platform for Health is a system-strengthening strategy which promotes structured decision-making by district health officials using local data. Here, we describe implementation including process evaluation at district level in Ethiopia, and evaluation through a cluster-randomised trial. Methods We supported district health teams in 4-month cycles of data-driven decision-making by: (a) defining problems using a health system framework; (b) reviewing data; (c) considering possible solutions; (d) value-based prioritising; and (e) a consultative process to develop, commit to and follow up on action plans. 12 districts were randomly selected from 24 in the North Shewa zone of Ethiopia between October 2020 and June 2022. The remaining districts formed the trial’s comparison arm. Outcomes included health information system performance and governance of data-driven decision-making. Analysis was conducted using difference-in-differences. Results 58 4-month cycles were implemented, four or five in each district. Each focused on a health service delivery challenge at district level. Administrators’ practice of, and competence in, data-driven decision-making showed a net increase of 77% (95% CI: 40%, 114%) in the regularity of monthly reviews of service performance, and 48% (95% CI: 9%, 87%) in data-based feedback to health facilities. Statistically significant improvement was also found in administrators’ use of information to appraise services. Qualitative findings also suggested that district health staff reported enhanced data use and collaborative decision-making. Conclusions This study generated robust evidence that 20 months’ implementation of the Data-Informed Platform for Health strengthened health management through better data use and appraisal practices, systemised problem analysis to follow up on action points and improved stakeholder engagement. Trial registration number NCT05310682 .
... In addition, the extent of translation and impact of EBIs to specifically address a wide range of social inequities and how impact from an equity perspective could best be defined and operationalized both remain understudied. Building from existing implementation science evaluation frameworks (106), researchers and practitioners also need to consider and examine how implementation outcomes should be operationalized and evaluated appropriately, in a way that is feasible in global contexts and that captures aspects of equity and impact that are relevant and meaningful to local partners in global resource-limited settings (111). ...
Article
Implementation science focuses on enhancing the widespread uptake of evidence-based interventions into routine practice to improve population health. However, optimizing implementation science to promote health equity in domestic and global resource-limited settings requires considering historical and sociopolitical processes (e.g., colonization, structural racism) and centering in local sociocultural and indigenous cultures and values. This review weaves together principles of decolonization and antiracism to inform critical and reflexive perspectives on partnerships that incorporate a focus on implementation science, with the goal of making progress toward global health equity. From an implementation science perspective, we synthesize examples of public health evidence-based interventions, strategies, and outcomes applied in global settings that are promising for health equity, alongside a critical examination of partnerships, context, and frameworks operationalized in these studies. We conclude with key future directions to optimize the application of implementation science with a justice orientation to promote global health equity. Expected final online publication date for the Annual Review of Public Health, Volume 45 is April 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.
... This information not only improves budget predictions but also enhances future calculations of cost-effectiveness. 45 We will use activity-based costing to estimate the cost of implementing the LAUNCH intervention in a real-world setting, from the provider's perspective, to help the FMOH in planning whether and how to incorporate the LAUNCH intervention into their national health agenda. ...
Article
Full-text available
Introduction Child mortality rates remain high in sub-Saharan Africa, including Ethiopia. We are conducting a cluster randomised control trial in the Gondar zone of the Amhara region to determine the impact of pairing Orthodox priests with community health workers, known locally as the Health Development Army (HDA), on newborns’ nutritional status, early illness identification and treatment, and vaccination completeness. Ensuring intervention efficacy with scientific rigour is essential, but there are often delays in adopting evidence into policy and programmes. Here, we present a protocol for conducting parallel implementation research alongside an efficacy study to understand intervention implementability and scalability. This will help develop a scale-up strategy for effective elements of the intervention to ensure rapid implementation at scale. Methods and analysis We will conduct a stakeholder analysis of key implementation stakeholders and readiness surveys to assess their readiness to scale up the intervention. We will conduct semistructured interviews and focus group discussions with stakeholders, including HDA members, health workers, Orthodox priests, and caregivers, to determine the core intervention elements that need to be scaled, barriers and facilitators to scaling up the intervention in diverse sociocultural settings, as well as the human and technical requirements for national and regional implementation. Finally, to determine the financial resources necessary for sustaining and scaling the intervention, we will conduct activity-based costing to estimate implementation costs from the provider’s perspective. Ethics and dissemination The study received approval from the University of Gondar Institutional Review Board (approval no: VP/RTT/05/1030/2022) and the University of Washington Human Subjects Division (approval no: STUDY00015369). Participants will consent to participate. Results will be disseminated through workshops with stakeholders, local community meetings, presentations at local and international conferences, and journal publications. The study will provide evidence for factors to consider in developing a scale-up strategy to integrate the intervention into routine health system practices.
... Costeffectiveness analysis (CEA) is intended to evaluate costs to produce a specific, nonmonetary outcome by a given intervention (Honeycutt et al., 2006), such as the associated costs of providing care compared to client outcomes. However, there is less information on the detailed costs that inform CEA, such as those captured through bottomup micro-costing, or activity-based costing, and which can offer precise cost estimates and reflect actual resources used in implementation beyond that of a traditional program budget (O'Malley et al., 2013;Sohn et al., 2020). Similarly, there are a limited number of studies that look at the costs associated with competency-based education, or tactics related to competency-based methods, of which are mainly in high-income settings (Brown et al., 2015;Taylor & Green, 2013;van Rossum et al., 2018). ...
Article
Full-text available
We estimated incremental costs of a competency-based Problem Management Plus (PM+) training of trainers (ToT) and training of helpers (TOH), guided by the World Health Organization (WHO)/United Nations International Children's Emergency Fund (UNICEF) Ensuring Quality in Psychological Support (EQUIP) platform compared to a standard PM+ training. Activity based cost analysis was conducted in Kathmandu, Nepal from July to October 2021. Organisational perspectives were assessed on resources required to implement one PM+ ToT, one EQUIP training for trainers and six PM+ ToH. For PM+ trainers, a standard PM+ ToT costs NPR 63,800.06 (US$510.40), with additional training on EQUIP competency-based approaches and digital platform costing an incremental NPR 45,111.15 (US$360.89). A standard PM+ helper training costs an average of NPR 207,906.35 (US$1,663.25) compared to an EQUIP-based PM+ ToH costing NPR 211,122.71 (US$1,688.98), for an incre-mental NPR 3,216 (US$25.73) per ToH. An EQUIP competency-based approach requires initial investment through training of PM+ trainers; thenceforth, differences in time and costs are negligible for training PM+ helpers when using an EQUIP approach compared to a standard approach. Given minimal cost differences and potential benefits for improving provider compe-tency and client safety and outcomes, we recommend greater use of EQUIP. Stakeholders may use this study as a guide for costing competency-based approaches.
Chapter
This chapter highlights the crucial role of teaching and learning in today's rapidly evolving world. It explores the significance of effective instructional strategies, pedagogical and andragogical approaches integration, and the implications for research and practice. The chapter emphasizes the need for engaging and inclusive learning environments, using technology in education, and promoting critical thinking and problem-solving skills. It underscores the importance of assessment and feedback, equity and inclusion, and lifelong learning. The implications for future research and practice are discussed, highlighting the importance of collaboration, innovation, and continuous improvement in teaching methods. Overall, this chapter underscores the essentiality of teaching and learning in equipping individuals with the knowledge, skills, and values necessary to succeed in a rapidly changing world.
Article
Aim Optimising preconception health increases the likelihood of conception, positively influences short‐ and long‐term pregnancy outcomes and reduces intergenerational chronic disease risk. Our aim was to synthesise study characteristics and maternal outcomes of digital or blended (combining face to face and digital modalities) interventions in the preconception period. Methods We searched six databases (PubMed, Cochrane, Embase, Web of Science, CINHAL and PsycINFO) from 1990 to November 2022 according to the PRISMA guidelines for randomised control trials, quasi‐experimental trials, observation studies with historical control group. Studies were included if they targeted women of childbearing age, older than 18 years, who were not currently pregnant and were between pregnancies or/and actively trying to conceive. Interventions had to be delivered digitally or via digital health in combination with face‐to‐face delivery and aimed to improve modifiable behaviours, including dietary intake, physical activity, weight and supplementation. Studies that included women diagnosed with type 1 or 2 diabetes were excluded. Risk of bias was assessed using the Academy of Nutrition and Dietetics quality criteria checklist. Study characteristics, intervention characteristics and outcome data were extracted. Results Ten studies (total participants n=4,461) were included, consisting of nine randomised control trials and one pre–post cohort study. Seven studies received a low risk of bias and two received a neutral risk of bias. Four were digitally delivered and six were delivered using blended modalities. A wide range of digital delivery modalities were employed, with the most common being email and text messaging. Other digital delivery methods included web‐based educational materials, social media, phone applications, online forums and online conversational agents. Studies with longer engagement that utilised blended delivery showed greater weight loss. Conclusion More effective interventions appear to combine both traditional and digital delivery methods. More research is needed to adequately test effective delivery modalities across a diverse range of digital delivery methods, as high heterogeneity was observed across the small number of included studies.
Article
Introduction: The COVID pandemic prompted a significant increase in the utilization of telemedicine (TM) for substance use disorder (SUD) treatment. As we transition towards a "new normal" policy, it is crucial to comprehensively understand the evidence of TM in SUD treatment. This scoping review aims to summarize existing evidence regarding TM's acceptability, quality, effectiveness, access/utilization, and cost in the context of SUD treatment in order to identify knowledge gaps and inform policy decisions regarding TM for SUDs. Method: We searched studies published in 2012-2022 from PubMed, Cochrane Library, Embase, Web of Science, and other sources. Findings were synthesized using thematic analysis. Results: A total of 856 relevant articles were screened, with a final total of 42 articles included in the review. TM in SUD treatment was perceived to be generally beneficial and acceptable. TM was as effective as in-person SUD care in terms of substance use reduction and treatment retention; however, most studies lacked rigorous designs and follow-up durations were brief (≤3 months). Telephone-based TM platforms (vs video) were positively associated with older age, lower education, and no prior overdose. Providers generally consider TM to be affordable for patients, but no relevant studies were available from patient perspectives. Conclusions: TM in SUD treatment is generally perceived to be beneficial and acceptable and as effective as in-person care, although more rigorously designed studies on effectiveness are still lacking. Access and utilization of TM may vary by platform. TM service quality and costs are the least studied and warrant further investigations.
Article
Full-text available
Introduction The World Health Organization (WHO) recommends household tuberculosis (TB) contact investigation in low-income countries, but most contacts do not complete a full clinical and laboratory evaluation. Methods We performed a randomised trial of home-based, SMS-facilitated, household TB contact investigation in Kampala, Uganda. Community health workers (CHWs) visited homes of index patients with pulmonary TB to screen household contacts for TB. Entire households were randomly allocated to clinic (standard-of-care) or home (intervention) evaluation. In the intervention arm, CHWs offered HIV testing to adults; collected sputum from symptomatic contacts and persons living with HIV (PLWHs) if ≥5 years; and transported sputum for microbiologic testing. CHWs referred PLWHs, children <5 years, and anyone unable to complete sputum testing to clinic. Sputum testing results and/or follow-up instructions were returned by automated SMS texts. The primary outcome was completion of a full TB evaluation within 14 days; secondary outcomes were TB and HIV diagnoses and treatments among screened contacts. Results There were 471 contacts of 190 index patients allocated to the intervention and 448 contacts of 182 index patients allocated to the standard-of-care. CHWs identified 190/471 (40%) intervention and 213/448 (48%) standard-of-care contacts requiring TB evaluation. In the intervention arm, CHWs obtained sputum from 35/91 (39%) of sputum-eligible contacts and SMSs were sent to 95/190 (50%). Completion of TB evaluation in the intervention and standard-of-care arms at 14 days (14% versus 15%; difference −1%, 95% CI −9% to 7%, p=0.81) and yields of confirmed TB (1.5% versus 1.1%, p=0.62) and new HIV (2.0% versus 1.8%, p=0.90) diagnoses were similar. Conclusions Home-based, SMS-facilitated evaluation did not improve completion or yield of household TB contact investigation, likely due to challenges delivering the intervention components.
Article
Full-text available
Background: Economic evaluation can inform whether strategies designed to improve the quality of health care delivery and the uptake of evidence-based practices represent a cost-effective use of limited resources. We report a systematic review and critical appraisal of the application of health economic methods in improvement/implementation research. Method: A systematic literature search identified 1668 papers across the Agris, Embase, Global Health, HMIC, PsycINFO, Social Policy and Practice, MEDLINE and EconLit databases between 2004 and 2016. Abstracts were screened in Rayyan database, and key data extracted into Microsoft Excel. Evidence was critically appraised using the Quality of Health Economic Studies (QHES) framework. Results: Thirty studies were included-all health economic studies that included implementation or improvement as a part of the evaluation. Studies were conducted mostly in Europe (62%) or North America (23%) and were largely hospital-based (70%). The field was split between improvement (N = 16) and implementation (N = 14) studies. The most common intervention evaluated (43%) was staffing reconfiguration, specifically changing from physician-led to nurse-led care delivery. Most studies (N = 19) were ex-post economic evaluations carried out empirically-of those, 17 were cost effectiveness analyses. We found four cost utility analyses that used economic modelling rather than empirical methods. Two cost-consequence analyses were also found. Specific implementation costs considered included costs associated with staff training in new care delivery pathways, the impacts of new processes on patient and carer costs and the costs of developing new care processes/pathways. Over half (55%) of the included studies were rated 'good' on QHES. Study quality was boosted through inclusion of appropriate comparators and reporting of incremental analysis (where relevant); and diminished through use of post-hoc subgroup analysis, limited reporting of the handling of uncertainty and justification for choice of discount rates. Conclusions: The quantity of published economic evaluations applied to the field of improvement and implementation research remains modest; however, quality is overall good. Implementation and improvement scientists should work closely with health economists to consider costs associated with improvement interventions and their associated implementation strategies. We offer a set of concrete recommendations to facilitate this endeavour.
Article
Full-text available
The RE-AIM planning and evaluation framework was conceptualized two decades ago. As one of the most frequently applied implementation frameworks, RE-AIM has now been cited in over 2,800 publications. This paper describes the application and evolution of RE-AIM as well as lessons learned from its use. RE-AIM has been applied most often in public health and health behavior change research, but increasingly in more diverse content areas and within clinical, community, and corporate settings. We discuss challenges of using RE-AIM while encouraging a more pragmatic use of key dimensions rather than comprehensive applications of all elements. Current foci of RE-AIM include increasing the emphasis on cost and adaptations to programs and expanding the use of qualitative methods to understand “how” and “why” results came about. The framework will continue to evolve to focus on contextual and explanatory factors related to RE-AIM outcomes, package RE-AIM for use by non-researchers, and integrate RE-AIM with other pragmatic and reporting frameworks.
Article
Full-text available
Background Testing urine improves the number of tuberculosis diagnoses made among patients in hospital with HIV. In conjunction with the two-country randomised Rapid Urine-based Screening for Tuberculosis to Reduce AIDS-related Mortality in Hospitalised Patients in Africa (STAMP) trial, we used a microsimulation model to estimate the effects on clinical outcomes and the cost-effectiveness of adding urine-based tuberculosis screening to sputum screening for hospitalised patients with HIV. Methods We compared two tuberculosis screening strategies used irrespective of symptoms among hospitalised patients with HIV in Malawi and South Africa: a GeneXpert assay (Cepheid, Sunnyvale, CA, USA) for Mycobacterium tuberculosis and rifampicin resistance (Xpert) in sputum samples (standard of care) versus sputum Xpert combined with a lateral flow assay for M tuberculosis lipoarabinomannan in urine (Determine TB-LAM Ag test, Abbott, Waltham, MA, USA [formerly Alere]; TB-LAM) and concentrated urine Xpert (intervention). A cohort of simulated patients was modelled using selected characteristics of participants, tuberculosis diagnostic yields, and use of hospital resources in the STAMP trial. We calibrated 2-month model outputs to the STAMP trial results and projected clinical and economic outcomes at 2 years, 5 years, and over a lifetime. We judged the intervention to be cost-effective if the incremental cost-effectiveness ratio (ICER) was less than US$750/year of life saved (YLS) in Malawi and $940/YLS in South Africa. A modified intervention of adding only TB-LAM to the standard of care was also evaluated. We did a budget impact analysis of countrywide implementation of the intervention. Findings The intervention increased life expectancy by 0·5–1·2 years and was cost-effective, with an ICER of $450/YLS in Malawi and $840/YLS in South Africa. The ICERs decreased over time. At lifetime horizon, the intervention remained cost-effective under nearly all modelled assumptions. The modified intervention was at least as cost-effective as the intervention (ICERs $420/YLS in Malawi and $810/YLS in South Africa). Over 5 years, the intervention would save around 51 000 years of life in Malawi and around 171 000 years of life in South Africa. Health-care expenditure for screened individuals was estimated to increase by $37 million (10·8%) and $261 million (2·8%), respectively. Interpretation Urine-based tuberculosis screening of all hospitalised patients with HIV could increase life expectancy and be cost-effective in resource-limited settings. Urine TB-LAM is especially attractive because of high incremental diagnostic yield and low additional cost compared with sputum Xpert, making a compelling case for expanding its use to all hospitalised patients with HIV in areas with high HIV burden and endemic tuberculosis. Funding UK Medical Research Council, UK Department for International Development, Wellcome Trust, US National Institutes of Health, Royal College of Physicians, Massachusetts General Hospital.
Article
Full-text available
Introduction: The World Health Organization recommends point-of-care (POC) lateral flow urine lipoarabinomannan (LF-LAM) for tuberculosis (TB) diagnosis in selected human immunodeficiency virus (HIV) positive people. South Africa had 438 000 new TB episodes in 2016, 58.9% of which were contributed by HIV-positive people. LF-LAM is being considered for scale-up in South Africa. Methods: We estimated the costs of using LF-LAM in HIV-positive adults with CD4 counts  150 cells/μl enrolled in the TB Fast Track Trial in South Africa. We also estimated costs of POC haemoglobin (Hb), as this was used in the study algorithm. Data on clinic-level (10 intervention clinics) and above-clinic-level costs were collected. Results: A total of 1307 LF-LAM tests were performed at 10 clinics over 24 months. The mean clinic-level costs were US$12.80 per patient for LF-LAM and POC Hb; LF-LAM costs were US$11.49 per patient. The mean above-clinic-level unit costs for LF-LAM were US$12.06 for clinic preparation, training, coordination and mentoring. The mean total cost of LF-LAM was US$23.55 per patient. Conclusion: At clinic level, the cost of LF-LAM was comparable to other TB diagnostics in South Africa. It is important to consider above-clinic-level costs for POC tests, as these may be required to support roll-out and ensure successful implementation.
Article
Full-text available
OBJECTIVE To assess the feasibility of a streamlined strategy for improving tuberculosis (TB) diagnostic evaluation and treatment initiation among patients with presumed TB. DESIGN Single-arm interventional pilot study at five primary care health centers of a streamlined, SIngle-saMPLE (SIMPLE) TB diagnostic evaluation strategy: 1) examination of two smear results from a single spot sputum specimen using light-emitting diode fluorescence microscopy, and 2) daily transportation of smear-negative sputum samples to Xpert® MTB/RIF testing sites. RESULTS Of 1212 adults who underwent sputum testing for TB, 99.6% had two smears examined from the spot sputum specimen. Sputum was transported for Xpert testing within 1 clinic day for 83% (907/1091) of the smear-negative patients. Of 157 (13%) patients with bacteriologically positive TB, 116 (74%) were identified using sputum smear microscopy and 41 (26%) using Xpert testing of smear-negative samples. Anti-tuberculosis treatment was initiated in 142 (90%) patients with bacteriologically positive TB, with a median time to treatment of 1 day for smear-positive patients and 6 days for smear-negative, Xpert-positive patients. CONCLUSION The SIMPLE TB strategy led to successful incorporation of Xpert testing and rapid treatment initiation in the majority of patients with bacteriologically confirmed TB in a resource-limited setting.
Article
Full-text available
Background: Rapid detection of tuberculosis (TB) among people living with human immunodeficiency virus (HIV) is a global health priority. HIV-associated TB may have different clinical presentations and is challenging to diagnose. Conventional sputum tests have reduced sensitivity in HIV-positive individuals, who have higher rates of extrapulmonary TB compared with HIV-negative individuals. The lateral flow urine lipoarabinomannan assay (LF-LAM) is a new, commercially available point-of-care test that detects lipoarabinomannan (LAM), a lipopolysaccharide present in mycobacterial cell walls, in people with active TB disease. Objectives: To assess the accuracy of LF-LAM for the diagnosis of active TB disease in HIV-positive adults who have signs and symptoms suggestive of TB (TB diagnosis).To assess the accuracy of LF-LAM as a screening test for active TB disease in HIV-positive adults irrespective of signs and symptoms suggestive of TB (TB screening). Search methods: We searched the following databases without language restriction on 5 February 2015: the Cochrane Infectious Diseases Group Specialized Register; MEDLINE (PubMed,1966); EMBASE (OVID, from 1980); Science Citation Index Expanded (SCI-EXPANDED, from 1900), Conference Proceedings Citation Index-Science (CPCI-S, from 1900), and BIOSIS Previews (from 1926) (all three using the Web of Science platform; MEDION; LILACS (BIREME, from 1982); SCOPUS (from 1995); the metaRegister of Controlled Trials (mRCT); the search portal of the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP); and ProQuest Dissertations & Theses A&l (from 1861). Selection criteria: Eligible study types included randomized controlled trials, cross-sectional studies, and cohort studies that determined LF-LAM accuracy for TB against a microbiological reference standard (culture or nucleic acid amplification test from any body site). A higher quality reference standard was one in which two or more specimen types were evaluated for TB, and a lower quality reference standard was one in which only one specimen type was evaluated for TB. Participants were HIV-positive people aged 15 years and older. Data collection and analysis: Two review authors independently extracted data from each included study using a standardized form. We appraised the quality of studies using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. We evaluated the test at two different cut-offs: (grade 1 or 2, based on the reference card scale of five intensity bands). Most analyses used grade 2, the manufacturer's currently recommended cut-off for positivity. We carried out meta-analyses to estimate pooled sensitivity and specificity using a bivariate random-effects model and estimated the models using a Bayesian approach. We determined accuracy of LF-LAM combined with sputum microscopy or Xpert® MTB/RIF. In addition, we explored the influence of CD4 count on the accuracy estimates. We assessed the quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Main results: We included 12 studies: six studies evaluated LF-LAM for TB diagnosis and six studies evaluated the test for TB screening. All studies were cross-sectional or cohort studies. Studies for TB diagnosis were largely conducted among inpatients (median CD4 range 71 to 210 cells per µL) and studies for TB screening were largely conducted among outpatients (median CD4 range 127 to 437 cells per µL). All studies were conducted in low- or middle-income countries. Only two studies for TB diagnosis (33%) and one study for TB screening (17%) used a higher quality reference standard.LF-LAM for TB diagnosis (grade 2 cut-off): meta-analyses showed median pooled sensitivity and specificity (95% credible interval (CrI)) of 45% (29% to 63%) and 92% (80% to 97%), (five studies, 2313 participants, 35% with TB, low quality evidence). The pooled sensitivity of a combination of LF-LAM and sputum microscopy (either test positive) was 59% (47% to 70%), which represented a 19% (4% to 36%) increase over sputum microscopy alone, while the pooled specificity was 92% (73% to 97%), which represented a 6% (1% to 24%) decrease from sputum microscopy alone (four studies, 1876 participants, 38% with TB). The pooled sensitivity of a combination of LF-LAM and sputum Xpert® MTB/RIF (either test positive) was 75% (61% to 87%) and represented a 13% (1% to 37%) increase over Xpert® MTB/RIF alone. The pooled specificity was 93% (81% to 97%) and represented a 4% (1% to 16%) decrease from Xpert® MTB/RIF alone (three studies, 909 participants, 36% with TB). Pooled sensitivity and specificity of LF-LAM were 56% (41% to 70%) and 90% (81% to 95%) in participants with a CD4 count of less than or equal to 100 cells per µL (five studies, 859 participants, 47% with TB) versus 26% (16% to 46%) and 92% (78% to 97%) in participants with a CD4 count greater than 100 cells per µL (five studies, 1410 participants, 30% with TB).LF-LAM for TB screening (grade 2 cut-off): for individual studies, sensitivity estimates (95% CrI) were 44% (30% to 58%), 28% (16% to 42%), and 0% (0% to 71%) and corresponding specificity estimates were 95% (92% to 97%), 94% (90% to 97%), and 95% (92% to 97%) (three studies, 1055 participants, 11% with TB, very low quality evidence). There were limited data for additional analyses.The main limitations of the review were the use of a lower quality reference standard in most included studies, and the small number of studies and participants included in the analyses. The results should, therefore, be interpreted with caution. Authors' conclusions: We found that LF-LAM has low sensitivity to detect TB in adults living with HIV whether the test is used for diagnosis or screening. For TB diagnosis, the combination of LF-LAM with sputum microscopy suggests an increase in sensitivity for TB compared to either test alone, but with a decrease in specificity. In HIV-positive individuals with low CD4 counts who are seriously ill, LF-LAM may help with the diagnosis of TB.
Article
Background Universal testing and treatment (UTT) is a potential strategy to reduce HIV incidence, yet prior trial results are inconsistent. We report results from HPTN 071 (PopART), the largest HIV prevention trial to date. Methods In this community-randomized trial (2013-18), 21 communities in Zambia and South Africa were randomized to Arm A (PopART intervention, universal antiretroviral therapy [ART]), Arm B (PopART intervention, ART per local guidelines), and Arm C (standard-of-care). The PopART intervention included home-based HIV-testing delivered by community workers who supported linkage-to-care, ART adherence, and other services. The primary outcome, HIV incidence between months 12-36, was measured in a Population Cohort (PC) of ~2,000 randomly-sampled adults/community aged 18-44y. Viral suppression (VS, <400 copies HIV RNA/ml) was measured in all HIV-positive PC participants at 24m. Results The PC included 48,301 participants. Baseline HIV prevalence was similar across study arms (21%-22%). Between months 12-36, 553 incident HIV infections were observed over 39,702 person-years (py; 1.4/100py; women: 1.7/100py; men: 0.8/100py). Adjusted rate-ratios were A vs. C: 0.93 (95%CI: 0.74-1.18, p=0.51); B vs. C: 0.70 (95%CI: 0.55-0.88, p=0.006). At 24m, VS was 71.9% in Arm A; 67.5% in Arm B; and 60.2% in Arm C. ART coverage after 36m was 81% in Arm A and 80% in Arm B. Conclusions The PopART intervention with ART per local guidelines reduced HIV incidence by 30%. The lack of effect with universal ART was surprising and inconsistent with VS data. This study provides evidence that UTT can reduce HIV incidence at population level. Trial registration ClinicalTrials.gov NCT01900977
Article
Economic evaluations can inform decisions about the efficiency and allocation of resources to implementation strategies-strategies explicitly designed to inform care providers and patients about the best available research evidence and to enhance its use in their practices. These strategies are increasingly popular in health care, especially in light of growing concerns about quality of care and limits on resources. But such concerns have hardly motivated health authorities and other decision-makers to spend on some form of economic evaluation in their assessments of implementation strategies. This editorial addresses the importance of economic evaluation in the context of implementation science-particularly, how these analyses can be most efficiently incorporated into decision-making processes about implementation strategies.
Article
The HIV Prevention Trials Network (HPTN) is conducting the HPTN 071 (PopART) study in 21 communities in Zambia and South Africa with support from a consortium of funders. HPTN 071 (PopART) is a community-randomized trial of a combination prevention strategy to reduce HIV incidence in the context of the generalized epidemic of southern Africa. The full PopART intervention strategy is anchored in home-based HIV testing and facilitated linkage of HIV-infected persons to care through community health workers and universal antiretroviral therapy for seropositive persons regardless of CD4+ cell count or HIV viral load. To further reduce the risk of HIV acquisition among uninfected individuals, the study aims to expand voluntary medical male circumcision, diagnosis and treatment of sexually transmitted infections, behavioral counseling, and condom distribution. The full PopART intervention strategy also incorporates promotion of other interventions designed to reduce HIV and tuberculosis transmission, including optimization of the prevention of mother-to-child HIV transmission and enhanced individual and public health tuberculosis services. Success for the PopART strategy depends on the ability to increase coverage for the study interventions whose uptake is a necessary antecedent to a prevention effect. Processes will be measured to assess the degree of penetration of the interventions into the communities. A randomly sampled population cohort from each community will be used to measure the impact of the PopART strategy on HIV incidence over 3 years. We describe the strategy being tested and progress to date in the HPTN 071 (PopART) study.