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What is the problem?

The concern is that there is a difficulty in implementing best evidence interventions
found under optimal conditions into real-life clinical practice, thereby prompting the use of
therapies that have not been put through the same rigour but can achieve favourable results.
What information do I need to gather/understand to better appreciate the scope and
impact of the concern?
Since there is currently no first-line therapy for Back-related leg pain (BRLP) that is
clearly supported by a strong evidence base, it is important that the clinician becomes
transparent enough to realise that a degree of diagnostic focus should be placed on pragmatic
interventions that measure a broad spectrum of outcomes and are mostly patient-centred. A
pragmatic trial is a trial designed to help choose between care options, as opposed to an
explanatory trial which is used to test causal research hypotheses. These interventions usually
maximise applicability and generalizability and can provide the most significant benefit
relative to risk, treatment wise, for their patient, especially in a real-life scenario. While these
interventions may not have the clinical backing of an RCT, systematic review or clinical
guidelines, they tend to give real-world results, not results that have been gained under
optimal situations. Therefore I must verify with my client, why these pragmatic studies are
very useful and can be used as published clinical evidence when developing evidence-based
management strategies for her patients’ active requirements.
How can I critically evaluate the information as it relates to the central concern?
Evidence-based practice recommends that I critique the information presented in the
study by Bronfort et al.1 by using evaluating tools such as critical appraisal tools that assess
the study on its reliability, validity, accuracy, authenticity, timeliness, point of view or bias to
conclude whether or not the article is a relevant and reliable source of information to use as a
foundation for my research and outcome.
I have utilised the PRECIS-2 tool to assess the value of the literature presented in the
pragmatic study by Bronfort et al.1 to see if I can use this study as evidence to answer the
clinical question posed to me by my client. Based on PRECIS-2 ratings, the trial was
relatively pragmatic during the planning phase, apart from the recruitment domain which was
done via newspaper advertisements, direct mail, and community posters which tends to be
more of the explanatory approach. The ratings from the remaining of the PRECIS-2 tool
domains were consistent in indicating more of a pragmatic study approach was utilised rather
than an explanatory study. See appendix for results.
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Upon reflection, what concerns may become an impediment to the implementation of

this new synthesis, and how may this be communicated in a patient-centred setting?
Since pragmatic trials are based around a real-world setting means that I will have to
be prepared to be able to combat more possible issues that may eventuate if I try and
implement the pragmatic recommendations as opposed to explanatory trial recommendations
which usually has stringent guidelines that must be adhered to. My main concern here is my
patients and their willingness to try to incorporate a more active lifestyle into their regime
whilst on their own, and even if they say they will follow the recommendations, will they
actually though? To overcome these issues I need to use a sensitive approach and prove that
by incorporating active care into their daily regime will accelerate the healing process and
their quality of life will improve vastly since multiple research projects found that being
stationary during rehab is actually more detrimental to overall health than remaining active. I
would also do my best to hold them accountable with regular check-ins to see if any progress
is being made. Another aspect worth mentioning and one I will have to be on the lookout for
is the 'Hawthorne Effect'. This phenomenon refers to the tendency that some people work
harder and perform better when they are aware they are participants in an experiment.
Therefore, I need to be mindful of this phenomenon as it can potentially affect the patients
outcomes.
How can I apply this new synthesis research in an ideal patient-centred approach?
By using the pragmatic study by Bronfort et al.1 as a benchmark, I can illustrate to my
client that adding additional interventions to her patients’ treatment plans is a feasible, real-
world clinical option that may help aid her patients’ chances of recovery. Bronfort et al.1
states that although evidence is limited, certain conservative approaches can be effective and
if it has a possibility of improving a patients quality of life, it should be at the forefront of a
clinicians mind. While acknowledging that evidence is limited about some of the possible
conservative care methods that we chiropractors may implement for our patients, I can
highlight the fact that there are growing concerns about the safety of commonly used
conventional western medical treatments and the possible adverse effects which may present,
seeing that individuals differ in their response to therapies.
Can I summarise the newly relevant issues?
Since no single trial, pragmatic or otherwise, is likely to answer all potential questions
about the value of any health care option, features from pragmatic trials should be adopted by
the practitioner whenever feasible and sensible to do so and has the ability to answer the
clinical question of interest and improve quality of life. In addition to the arguments made
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above, a literature review has demonstrated that outcomes in patients who receive care in
real-world (or pragmatic) circumstances are neither better nor worse than in patients who
receive care in the context of an explanatory RCT (ideal circumstances).
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References:
1. Bronfort G, Hondras M, Schulz C, Evans R, Long C, Grimm R. Spinal manipulation
and home exercise with advice for subacute and chronic back-related leg pain. Annals
of Internal Medicine [Internet]. 2014 [cited 2020 Aug 13];161(6):381. Available
from: doi:10.7326/m14-0006
Appendix:
Domain
1 Eligibility Criteria
2 Recruitment Path
3 Setting
4 Organisation intervention
5 Flex of experimental
intervention – Delivery
6 Flex of experimental
intervention – Adherence
7 Follow up
8 Outcome
9 Analysis
Score Rationale
4 Some participants were excluded who
met the criteria for the condition of
interest.
3 Patients were recruited through
newspaper advertisements, direct mail,
and community posters. Interested
patients were initially screened by
telephone interviews, followed by 2 in-
person baseline evaluation visits.
4 Setting was different to a usual care
setting.
5 The best alternative treatments were
used for comparison with no restrictions
on their application. Both interventions
were intended to be pragmatic in nature
(for example, modified to patient
presentation and needs) and were
informed by commonly recommended
clinical practices, patient preferences, and
promising research evidence
5 Treatment fidelity was facilitated through
standardized training, manuals of
operation, while the comparison group
had available alternative interventions.
5 To facilitate adherence to HEA, providers
called or e-mailed patients 3 times (at 1,
4, and 9 weeks) to reaffirm main
messages and answer exercise-related
questions.
5 Overall global satisfaction at the 52-week
follow-up.
5 The outcome was objectively measured,
has clinical significance, and is one that
can be assessed under usual conditions
and is very relevant to participants.
5 All participants were included in the
analyses regardless of compliance
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