What is your research question? An introduction to the PICOT format for clinicians
ABSTRACT Clinicians interested in research pursuits, related to patient care, should consider the use of a literature search and the PICOT format when engaging clinical researchers. This approach will provide clinicians and researchers an initial basis for mutual understanding, communication and direction to help answer clinical study questions of most relevance.
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ABSTRACT: In patients with acute respiratory distress syndrome (ARDS) fluid therapy might be necessary. The aim of this systematic review and meta-analysis is to determine the effects of colloid therapy compared to crystalloids on mortality and oxygenation in adults with ARDS. Randomized controlled trials (RCTs) identified through a systematic literature search of MEDLINE, EMBASE, CENTRAL and LILACS. Article published up to 15th February 2013 were independently screened, abstracted, and assessed (Cochrane Risk of Bias Tool) to provide evidence-based therapy recommendations. RCTs were eligible if they compared colloid versus crystalloid therapy on lung function, inflammation, damage or mortality in adults with ARDS. Primary outcome parameters were respiratory mechanics, gas exchange lung inflammation and damage as well as hospital mortality. Kidney function, need for renal replacement therapy, hemodynamic stabilization and intensive care unit (ICU) length of stay served as secondary outcomes. A total of 3 RCTs out of 4130 potential trials found in the databases were selected for qualitative and quantitative analysis totaling 206 patients who received either albumin or saline. Overall risk of bias was unclear to high in the identified trials. Calculated pooled risk of death was not statistically significant (albumin 34 of 100 (34.0%) versus 40 of 104 (38.5%), relative risk (RR) = 0.89, 95% confidence interval (CI) 0.62 to 1.28, P = 0.539). Weighted mean difference (WMD) in PaO2/FiO2 [mmHg] improved in the first 48 hours (WMD = 62, 95% CI 47 to 77, P <0.001, I2 = 0%) after therapy start and remained stable after 7 days (WMD = 20, 95% CI 4 to 36, P = 0.017, I2 = 0%). There is a high need for RCTs investigating the effects of colloids in ARDS patients. Based on the findings of this review, colloid therapy with albumin improved oxygenation but did not affect mortality.Critical care (London, England) 01/2014; 18(1):R10. · 4.72 Impact Factor
J Can Chiropr Assoc 2012; 56(3) 167
Clinicians often witness impressive treatment results in
practice and may wish to pursue research to formally ex-
plore their anecdotal experiences. The potential to further
new knowledge both within the profession and to the
greater healthcare system is compelling. An obvious next
step for a practitioner considering research is to connect
with experienced researchers to convey their idea for a
study, who may in turn ask, “What is your research ques-
tion?” With limited understanding of how to respond, this
clinicians will have with the research community.
It has been estimated that between 1% and 7% of
the chiropractic profession in Canada is engaged in re-
search.1,2 Arguably, this low engagement could be the
result of practitioners’ perceived importance of research
and levels of research literacy and capacity. However, in-
creasing demands for evidence-based approaches across
the health system puts pressure on all clinicians to base
Lack of clinician representation in research has the prob-
able effect of limiting growth and new developments for
the profession. Furthermore, lack of clinician involve-
ings into practical settings.
The Canadian Institutes of Health Research describes
integrated knowledge translation as a process that in-
volves collaboration between researchers and knowledge
users at all stages of a research project.3 This necessitates
involvement of clinicians to help in forming a research
question, interpreting the results, and moving research
icians and researchers increases the likelihood that re-
search initiatives will be relevant to practice.3 Conversely,
it has been reported that there is a growing communica-
tion gap between clinicians and academics in chiroprac-
tic.4 Clinicians have important practice-related questions
to ask, but many may lack the ability to map out their re-
tion in a manner required to develop a research protocol.
ical Epidemiology & Biostatistics at McMaster Univer-
sity, highlights the importance of mapping one’s research
strategy in exploration of the research question: “one-
third of a trial’s time between the germ of your idea and
What is your research question?
An introduction to the PICOT format for clinicians
John J. Riva, BA, DC†
Keshena M.P. Malik, BSc, DC¶
Stephen J. Burnie, BSc, DC, MSc‡
Andrea R. Endicott, LLB, MPPAL£
Jason W. Busse, DC, PhD§*
† Department of Family Medicine, McMaster University, Hamilton, Ontario.
¶ Graduate Student, Department of Rehabilitation Sciences, McMaster University, Hamilton, Ontario.
‡ Canadian Memorial Chiropractic College, Toronto, Ontario.
£ Senior Policy Analyst, Ontario Chiropractic Association, Toronto, Ontario.
§ Institute for Work & Health, Toronto, Ontario.
* Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario.
Funding: No funds were received for the preparation of this manuscript. Dr. Busse is funded by a New Investigator Award from the Canadian
Institutes of Health Research and Canadian Chiropractic Research Foundation. Dr. Riva is funded by an award from the NCMIC Foundation.
Drs. Burnie, Busse, Malik and Riva are members of the McMaster Chiropractic Working Group, which receives in-kind support from the
Canadian Chiropractic Association.
Competing Interests: None.
Correspondence: Dr. John J. Riva, Department of Family Medicine, McMaster University, McMaster Innovation Park, 175 Longwood Road
South, Hamilton, Ontario; email: firstname.lastname@example.org
168 J Can Chiropr Assoc 2012; 56(3)
its publication in the New England Journal of Medicine
should? be? spent? fighting? about? the? research? question.”?
(personal communication, November 30, 2011) We de-
scribe a randomized controlled trial (RCT) example to
highlight how clinicians may use existing literature and
the PICOT format to formulate a research question on
The PICOT format is a helpful approach for summarizing
research questions that explore the effect of therapy:5
(P) – Population refers to the sample of subjects you
to your intervention (e.g. no co-morbidity) and one that
can be generalized to patients that are likely to be seen in
(I) – Intervention refers to the treatment that will be
provided to subjects enrolled in your study.
a reference group to compare with your treatment inter-
vention. Many study designs refer to this as the control
group. If an existing treatment is considered the ‘gold
standard’, then this should be the comparison group.
(O) – Outcome represents what result you plan on
measuring to examine the effectiveness of your interven-
tion. Familiar and validated outcome measurement tools
relevant to common chiropractic patient populations may
include the Neck Disability Index6 or Roland-Morris
Questionnaire.7 There are, typically, a multitude of out-
come tools available for different clinical populations,
each having strengths and weaknesses.
(T) – Time describes the duration for your data collec-
RCT Design Example Using PICOT
Dosage effects of spinal manipulative therapy for
chronic neck pain
Neck pain is second in frequency only to low back pain
among musculoskeletal complaints reported in the general
population and among those presenting to manual therapy
providers.8,9 Chronic neck pain (i.e. neck pain lasting long-
er than 90 days) is a common reason for presenting to a
al manipulation or mobilization.10 Recent systematic re-
views of RCTs and prior observational studies have shown
increases in cervical range of motion,11,12 and decreases in
self-rated neck pain13,14 following cervical spine manipula-
tion. In 2010, the Cochrane systematic review concluded,
“Optimal technique and dose need to be determined.”14
standing of the optimal dose for neck manipulation; as
such, frequency and duration of this treatment varies
greatly between clinicians. Although patient character-
istics and clinicians’ beliefs likely account for some of
this variation, it seems likely that many cases of mech-
anical neck pain will require a minimal number of spinal
threshold is reached. To properly examine the dose effects
of manipulation for neck pain, it is necessary to consider
three treatment factors:
3) total number of manipulations
A factorial design RCT allows investigators to consider
more than one treatment factor at a time and examine pos-
sible interactions between them. This trial design allows
for determination of, not only, the effects of frequency
and duration, but also whether it is more effective to pro-
vide a certain number of manipulations over shorter or
longer durations (i.e. an interaction between the two fac-
tors). Considering a 3x4 factorial design, patients would
frequency) with manipulation provided over a duration of
2 weeks, 4 weeks, 6 weeks, or not at all (i.e. the second
ings, neck manipulation could be performed using stan-
is the most common manually applied neck manipulation
in chiropractic practice. Pain relief is a common concern
among patients presenting with neck pain and detection
of a resulting difference of 13 mm on the 100mm Visual
Analog Scale (VAS) line is considered a clinically import-
ant change in intensity for patients with chronic pain.15
Research Question: In adults with chronic neck pain,
what is the minimum dose of manipulation necessary to
produce a clinically important improvement in neck pain
compared to supervised exercise at 6 weeks?
J Can Chiropr Assoc 2012; 56(3) 169
JJ Riva, KMP Malik, SJ Burnie, AR Endicott, JW Busse
(P) – Population: Adults 18 to 60 years of age, with
a clinical diagnosis of chronic mechanical neck pain who
have not received cervical SMT in the past year. Patients
with non-mechanical neck pain or contraindications to
cervical manipulation will be excluded.
(I) – Intervention: Subjects randomized to have ma-
nipulation would receive standard rotary or lateral break
over a period of 2, 4, or 6 weeks (see Table 1). These sub-
jects would also receive the same exercise regimen given
to the control group to eliminate exercise as a second vari-
able affecting outcomes.
(C) – Comparison: A standardized supervised exer-
cise regimen would be used as an active control group.
All subjects, regardless of group assignment, would per-
form a standardized exercise regime at each session over
a period of 6 weeks. Using this strategy, we will be able
(O) – Outcome: Changes in neck pain, measured using
the 100mm VAS for pain.
(T) – Time: The outcome would be measured weekly
for 6 weeks.
Table 1 Frequency and Duration of SMT
Frequency of SMT
No SMT0 0 0
2 weeks SMT2 4 6
4 weeks SMT 4 8 12
6 weeks SMT612 18
Clinician input, assuming expertise in the ‘gold stan-
and an ability to teach it, would be helpful during the
training initiatives to calibrate each treating chiropractor
to deliver his/her manipulation in a similar way (i.e. load,
force, angle) and to assist in normalizing communication
with study subjects. This standardization, through struc-
tured training sessions for those rendering treatment, will
help ensure no additional interventions were inadvertent-
ly applied (i.e. education, extra advice).
Other Study Designs Amenable to PICOT
The PICOT format example described above repre-
sents a factorial RCT methodology that has been informed
by the existing literature. While a well-conducted RCT is
appropriate for answering many questions on treatment
challenging to conduct. Not all research questions that
clinicians wish answered are feasible using this research
methodology and the use of a PICOT format is also ap-
plicable to other study designs.
The clinical research question being asked ideally
determines the best research design for a study. A pro-
spective or retrospective cohort design may be an easier
methodology to administer in comparison to a RCT; but
study results can by affected by confounding due to the
comparison of non-randomized groups. Another meth-
odology, used to look for associations between respond-
ent characteristics and outcomes of interest, is a cross-
sectional survey. This methodology is faster and less ex-
pensive to do in comparison to a RCT since it considers
one time-point of individuals in various spectrums of the
variables of interest. However, this design can also can be
prone to recall problems by respondents who self-report
information if investigators ask about events in the past. A
case-control study is most appropriate when attempting to
identify associations between patient characteristics and
outcomes that take a long time to occur or are very rare.
For example, the study by Cassidy et al. (2008) looking at
risk of vertibrobasilar artery stroke following chiropractic
care, whilst more complex in the design approach, used
aspects of a case-control methodology.16
While these study designs are common in clinical re-
search today, they are not exhaustive of all designs avail-
able. Systematic reviews will be familiar to most as a
study design aimed at summarizing bodies of studies; but
other less familiar individual patient focus designs, such
as N-of-1 RCT,17 also exist which are amenable to the
PICOT format depending on the research question that is
Many considerations need to be contemplated in the
PICOT formulation: How detailed should the literature
search be in breadth and quality level? What study design
tion include very similar types of patients or will there be
170 J Can Chiropr Assoc 2012; 56(3)
more of a real-world wide variety of participants? Will the
expert or will there be a combination of tailored inter-
ventions rendered by a non-clinician with a more general
skill set? Will the comparison be against usual care (i.e.
‘gold standard’) or a sham placebo procedure? Will the
outcomes measured be from validated instruments on a
form or more from direct patient verbal communication
and will these results be presented in a way most import-
ant to clinicians, patients or policy-makers? And if so,
what amount of difference and how many patients would
be required to both statistically and clinically conclude
the intervention was effective? Will measurement of out-
comes occur at multiple times or once at 5 days, 6 months
or 10 years?
While these considerations are clearly complex and
not inclusive of the entire process, to develop a strong
research question framed in the PICOT format, it is an
important basis to understand both the clinical area of in-
vestigation and the current literature that exists. As high-
lighted by the example above, it is necessary to review
the type and quality of research that has already been per-
formed in the area of interest to guide development of a
question. When initially synthesizing the literature, some
key entry questions to examine include:
? •? ? what?are?the?important?research?questions?in?the?
? •? ? what?has?been?found?
? •? ? what?areas?need?further?exploration?
? •? ? would?the?proposed?study?fill?a?gap?and?better?an?
existing knowledge in the respective area. A recent high-
quality Cochrane review reported on previously complet-
ed RCTs in the area, strengths and weaknesses of these
studies and offered direction as to gaps in current under-
tion.14 As research is a time consuming and often costly
endeavour, building on the best available existing know-
ledge rather than “re-inventing the wheel” is favourable.
Only after a thorough literature synthesis and investi-
gation into these answers should a research question be
formulated – in some instances a systematic review meth-
odology may actually align best with the PICOT frame-
work for your research question. Turning an idea into a
good research question requires it to be feasible, interest-
ing, novel, ethical and relevant.18 This feasibility refers to,
not only, resources (time and money), but also to whether
there is agreement on the meaning of the research question
and to whether everything that needs to be measured can
be measured by the study design. The question should be
of interest to many in the clinical area to drive both team
momentum for the project and dissemination of the re-
sults. Generating new knowledge in large existing gaps of
healthcare provides the opportunity to help large volumes
of patients who previously may have had poorer clinical
outcomes. Practically, ethical considerations have to be
accounted for in related study designs to ensure subjects
on how well the study design will apply to the real world.
A strong research question should always pass the ‘so
what?’ test. Who will the research help? What is the bene-
the purpose of the research. A well-thought-out focused
research question leads directly into hypotheses; the pre-
dictions about the nature and direction of the relationship
between the variables under study. Hence, the question
acts as the foundation of the study.
The importance of moving from studies to empirically
supported treatments to evidence-based practices may
very well rest on whether or not a clinician views the re-
search as relevant to their daily practice. It is common for
clinicians to express frustration that researchers are not
asking questions that are of most relevance to practice.
investigated in a way that can be feasibly researched.
To support both clinical and academic interests, an im-
portant clinical research question should therefore be one
that is developed in conjunction with a diverse team. This
expertise should align with the best research methodol-
ogy available and propose a project feasible to complete
through study that will adequately answer the research
question asked. In Canada, the Canadian Chiropractic
Research Foundation has reported that there are currently
12 university-based research chairs, 15 PhD candidates
and 14 Masters students.19 An opportunity exists to en-
gage these researchers, as well as those from chiroprac-
tic schools, in helping to formulate important clinical re-
J Can Chiropr Assoc 2012; 56(3) 171
JJ Riva, KMP Malik, SJ Burnie, AR Endicott, JW Busse
Clinicians interested in research pursuits, related to pa-
tient care, should consider the use of a literature search
and the PICOT format when engaging clinical research-
ers. This approach will provide clinicians and researchers
an initial basis for mutual understanding, communication
and direction to help answer clinical study questions of
•? ? Clinicians should frame practice-based research
questions in the PICOT format
•? ? Look to existing literature for guidance in the
formulation of a research question
•? ? Clinicians have an important role in contributing
to the integrated knowledge translation of research
•? ? Framing of a research question offers a common
language between clinician and researcher
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