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Br J Sports Med: first published as 10.1136/bjsports-2014-094389 on 12 February 2015. Downloaded from http://bjsm.bmj.com/ on 12 April 2019 by guest. Protected by copyright.
interventions and therefore constitutes
Death by effectiveness: exercise as phase IV research. However, all too often
resultant data relate largely or exclusively to
medicine caught in the efficacy trap! exercise behaviour, providing evidence of
behavioural or implementation effectiveness
Chris Beedie,1,2 Steven Mann,2 Alfonso Jimenez,2,3 Lynne Kennedy,2,4 but little evidence of clinical or treatment
effectiveness.7 In all exercise interventions,
Andrew M Lane,5 Sarah Domone,2 Stephen Wilson,2 Greg Whyte2,6 exercise behaviour is the throughput, with
health status the output. Outputs are more
Sport and Exercise Medicine (SEM) has It is often argued that the major chal- important to stakeholders.
had a good run. For a while it was the lenge to the effectiveness of exercise is Furthermore, a recent review8 identified
low-cost magic bullet. With efficacy adherence. Adherence to exercise, vari- that many studies examining the treatment
demonstrated in study after study, the con- ously reported at between 40% and 50%3 effectiveness of exercise in the real world
clusion was clear: ‘Exercise is Medicine’, a is no lower than that reported for drugs.4 adopt laboratory style methods and con-
potential public health panacea. However, while there is general confi- trols that would be impractical and uneco-
Sadly, the early promise waned. While dence that licensed drugs are effective nomic in real-world interventions. Data
we continue to be bombarded by original when taken, reports cited above1 2 suggest resulting from such studies merely add to
research and reviews extoling the efficacy that this confidence does not currently the efficacy data set.
of exercise, there is an apparent dearth of extend to exercise. We argue that despite metaphorically
evidence of its effectiveness. This fact is Confidence in drugs results from their drowning in evidence of efficacy and
highlighted in 2014 reports from the UK demonstrating efficacy and effectiveness in implementation effectiveness, SEM is yet
Government1 and Public Health England.2 clinical trials. Efficacy, demonstrated in to provide sufficient evidence of treatment
phases I–III of a trial, refers to “the extent effectiveness. Furthermore, while it is a
to which a drug has the ability to bring mistake to confuse efficacy with effective-
about its intended effect under ideal cir- ness,9 in lobbying for exercise as a public
Department of Psychology, Aberystwyth University, cumstances”.5 Effectiveness, demonstrated health tool, we often do just that.
Ceredigion, Wales, UK; 2ukactive Research Institute,
London, UK; 3Faculty of Health, Exercise & Sport
in phase IV studies, refers to “the extent to On the basis of the above we believe
Sciences, Universidad Europea, Madrid, Spain; which a drug achieves its intended effect in that SEM risks being side-lined in public
Department of Clinical Sciences & Nutrition, University the usual clinical setting”.5 Effectiveness health. If we are to provide critical life
of Chester, Chester, UK; 5University of Wolverhampton, is what matters to commissioners and support to SEM—and arguably to belea-
Walsall, UK; 6Research Institute for Sport and Exercise patients. guered health services—that lifeline is the
Science, Liverpool John Moores University, Liverpool,
UK The requirement for effectiveness (ie, production of high-quality phase IV/
Correspondence to Dr Chris Beedie, Department of
phase IV) studies is well recognised.6 A sub- effectiveness research.
Psychology, Aberystwyth University, Aberystwyth, stantial volume of social science research A phase IV methodology applicable to a
Ceredigion, Wales SY23 3UX, UK; chb44@aber.ac.uk has examined real-world exercise wide range of exercise interventions is the
Br J Sports Med March 2016 Vol 50 No 6 323

Br J Sports Med: first published as 10.1136/bjsports-2014-094389 on 12 February 2015. Downloaded from http://bjsm.bmj.com/ on 12 April 2019 by guest. Protected by copyright.
large simple trial (LST).10 LSTs are embed- that it cannot meet the rigorous methodo- original work is properly cited and the use is non-
ded in the delivery of treatment, make use logical standards of laboratory work. Public commercial. See: http://creativecommons.org/licenses/
of existing data and service infrastructure, health commissioners should not only insist
demand little extra effort of practitioners on evidence-based practice, but should insist
and patients, and can be conducted at that ongoing data capture is a feature of all
relatively modest costs (this factor being commissioned interventions. Accordingly,
critical at a time when commissioners legit- practitioners and providers must become
imately question the allocation to research adept at embedding data capture and ana- To cite Beedie C, Mann S, Jimenez A, et al. Br J
Sports Med 2016;50:323–324.
of funds better spent on care).10 While a lysis into all relevant activity. Representative Accepted 21 January 2015
randomised controlled trial maximises val- bodies must lobby government, health agen- Published Online First 12 February 2015
idity but has limited generalisability, and cies and research councils to provide greater Br J Sports Med 2016;50:323–324.
an observational study has limited validity funding for effectiveness research. doi:10.1136/bjsports-2014-094389
but maximises generalisability, a well- However, while the contributions above
conducted LST maximises validity and are important, it is SEM researchers who
generalisability.10 In fact, LSTs represent a must play the leading role. A commitment 1 Tackling physical inactivity—a coordinated approach
combination of a process evaluation, to conducting rigorous effectiveness All Party Commission on Physical Activity. 2014.
important to stakeholders, and a research studies might be critical if SEM is to avoid http://parliamentarycommissiononphysicalactivity.files.
study, important to science ( perhaps ‘con- the inexorable decline into an early grave! wordpress.com/2014/04/apcopa-final.pdf
2 Public Health England. Identifying what works for
trolled evaluation’ would in fact be an
local physical inactivity interventions. Public Health
appropriate alternative descriptor). Contributors CB wrote substantial sections and takes
England, 2014. http://researchinstitute.ukactive.com/
responsibility for all content. SM wrote substantial
No matter how efficacious an interven- downloads/managed/Identifying_what_works.pdf
sections. GW, LK, AL, AJ, SD and SW contributed
tion during phases I–III of a clinical trial, directly and substantially to the intellectual content of
3 Hallal PC, Andersen LB, Bull FC, et al; Lancet
if patients do not take it, or it does not Physical Activity Series Working Group. Global
the paper.
physical activity levels: surveillance progress, pitfalls,
demonstrate its effectiveness among those Competing interests None. and prospects. Lancet 2012;380:247–57.
who do, it should not be commissioned. 4 Sabaté E. Adherence to long-term therapies: evidence
Provenance and peer review Not commissioned;
If the SEM community fails to provide externally peer reviewed. for action. World Health Organization, 2003.
evidence for the effectiveness of exercise, 5 Hill TP. Conducting phase IV clinical studies: a moral
imperative? Ecancermedicalscience 2012;6:276.
we could condemn subsequent genera-
6 Mackay FJ. Post-marketing studies: the work of the
tions of the population to increasingly Drug Safety Research Unit. Drug Saf 1998;19:343–53.
complex and expensive biomedical inter- 7 Flay BR. Efficacy and effectiveness trials (and other
ventions, with the associated likelihoods phases of research) in the development of health
of poorer public health and greater health promotion programs. Prev Med 1986;15:451–74.
8 Beedie C, Mann S, Jimenez A. Community fitness
inequalities. We might also condemn our Open Access
center-based physical activity interventions: a brief
Scan to access more
discipline to the status of a side show to free content review. Curr Sports Med Rep 2014;13:267–74.
the main event. 9 Glasgow RE, Lichtenstein E, Marcus AC. Why don’t
The ‘SEM community’ extends to journal Open Access This is an Open Access article we see more translation of health promotion
distributed in accordance with the Creative Commons research to practice? Rethinking the efficacy-to-
editors, commissioners, practitioners and
Attribution Non Commercial (CC BY-NC 4.0) license, effectiveness transition. Am J Public Health
representative bodies, all of whom have a which permits others to distribute, remix, adapt, build 2003;93:1261–7.
part to play. Journal editors must recognise upon this work non-commercially, and license their 10 Suvarna V. Phase IV of drug development. Perspect
the value of real-world research, and accept derivative works on different terms, provided the Clin Res 2010;1:57–60.

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