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The Journal of the Canadian Chiropractic Association

The Canadian Chiropractic Association

What is your research question? An introduction to the PICOT format for clinicians

John J. Riva, BA, DC, Keshena M.P. Malik, BSc,

DC, [...], and Jason W. Busse, DC, PhD

Additional article information

Introduction Clinicians often witness impressive treatment

results in practice and may wish to pursue

research to formally explore 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

question?” With limited understanding of how to

respond, this interaction may result in the first

and last experience these 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 research. Arguably, this low engagement

could be the result of practitioners’ perceived

importance of research and levels of research

literacy and capacity. However, increasing

demands for evidence-based approaches across

the health system puts pressure on all clinicians to

base their decisions on the best available

scientific evidence. Lack of clinician

representation in research has the probable effect

of limiting growth and new developments for the

profession. Furthermore, lack of clinician

involvement in research complicates the transfer

of study findings into practical settings.

The Canadian Institutes of Health Research

describes integrated knowledge translation as a

process that involves collaboration between

researchers and knowledge users at all stages of a

research project. This necessitates involvement

of clinicians to help in forming a research

question, interpreting the results, and moving

research findings into practice. This shared effort

between clinicians and researchers increases the

likelihood that research initiatives will be relevant

to practice. Conversely, it has been reported that

there is a growing communication gap between

clinicians and academics in chiropractic.

Clinicians have important practice-related

questions to ask, but many may lack the ability to

map out their research strategy, specifically in

communicating their question in a manner

required to develop a research protocol.

David L. Sackett, Officer of the Order of Canada

and the founding Chair of Canada’s first

Department of Clinical Epidemiology &

Biostatistics at McMaster University, 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 its publication in the New England

Journal of Medicine should be spent fighting

about the research question.” (personal

communication, November 30, 2011) We

describe a randomized controlled trial (RCT)

example to highlight how clinicians may use

existing literature and the PICOT format to

formulate a research question on treatment

efficacy.

PICOT Defined The PICOT format is a helpful approach for

summarizing research questions that explore the

effect of therapy:

(P) – Population refers to the sample of

subjects you wish to recruit for your study.

There may be a fine balance between

defining a sample that is most likely to

respond to your intervention (e.g. no co-

morbidity) and one that can be generalized

to patients that are likely to be seen in actual

practice.

(I) – Intervention refers to the treatment that

will be provided to subjects enrolled in your

study.

(C) – Comparison identifies what you plan

on using as a reference group to compare

with your treatment intervention. 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 intervention. Familiar

and validated outcome measurement tools

relevant to common chiropractic patient

populations may include the Neck Disability

Index or Roland-Morris Questionnaire.

There are, typically, a multitude of outcome

tools available for different clinical

populations, each having strengths and

weaknesses.

(T) – Time describes the duration for your

data collection.

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.

Chronic neck pain (i.e. neck pain lasting longer

than 90 days) is a common reason for presenting

to a chiropractor’s office, and such patients often

receive spinal manipulation or mobilization.

Recent systematic reviews of RCTs and prior

observational studies have shown increases in

cervical range of motion, and decreases in

self-rated neck pain following cervical spine

manipulation. In 2010, the Cochrane systematic

review concluded, “Optimal technique and dose

need to be determined.”

Despite evidence of benefit, there is a limited

understanding of the optimal dose for neck

manipulation; as such, frequency and duration of

this treatment varies greatly between clinicians.

Although patient characteristics and clinicians’

beliefs likely account for some of this variation, it

seems likely that many cases of mechanical neck

pain will require a minimal number of spinal

manipulative therapy (SMT) treatments to derive

benefit and that no further benefit will result after

a certain upper threshold is reached. To properly

examine the dose effects of manipulation for neck

pain, it is necessary to consider three treatment

factors:

1. frequency

2. intensity

3. total number of manipulations

A factorial design RCT allows investigators to

consider more than one treatment factor at a time

and examine possible 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 provide a

certain number of manipulations over shorter or

longer durations (i.e. an interaction between the

two factors). Considering a 3x4 factorial design,

patients would attend 1, 2, or 3 sessions per week

(i.e. the first ’factor’ of frequency) with

manipulation provided over a duration of 2

weeks, 4 weeks, 6 weeks, or not at all (i.e. the

second ‘factor’ of duration). To improve

generalizability of findings, neck manipulation

could be performed using standard rotary or

lateral break diversified technique, which 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

important change in intensity for patients with

chronic pain.

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?

(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 manipulation would receive standard

rotary or lateral break diversified technique

once, twice, or three times per week over a

period of 2, 4, or 6 weeks (see Table 1).

These subjects would also receive the same

exercise regimen given to the control group

to eliminate exercise as a second variable

affecting outcomes.

Table 1

Frequency and Duration of

SMT

(C) – Comparison: A standardized supervised

exercise regimen would be used as an active

control group. All subjects, regardless of

group assignment, would perform a

standardized exercise regime at each session

over a period of 6 weeks. Using this

strategy, we will be able to minimize the

non-specific effects due to attending a clinic.

(O) – Outcome: Changes in neck pain,

measured using the 100mm VAS for pain.

(T) – Time: The outcome would be measured

weekly for 6 weeks.

Clinician input, assuming expertise in the ‘gold

standard’ standard rotary or lateral break

diversified technique and an ability to teach it,

would be helpful during the planning of patient

recruitment. Specifically, in leading 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 structured training

sessions for those rendering treatment, will help

ensure no additional interventions were

inadvertently applied (i.e. education, extra

advice).

Other Study Designs Amenable to PICOT The PICOT format example described above

represents 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 efficacy, they are

typically costly, time-consuming and 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 applicable to other study designs.

The clinical research question being asked ideally

determines the best research design for a study. A

prospective 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 methodology,

used to look for associations between respondent

characteristics and outcomes of interest, is a

cross-sectional survey. This methodology is faster

and less expensive 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.

While these study designs are common in clinical

research today, they are not exhaustive of all

designs available. 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, also exist which are amenable to

the PICOT format depending on the research

question that is being posed.

Discussion 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 best fits the research question?

Should the patient population include very similar

types of patients or will there be more of a real-

world wide variety of participants? Will the

intervention be very specific and rendered by a

clinical expert or will there be a combination of

tailored interventions 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 important 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 outcomes 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 investigation and the current

literature that exists. As highlighted by the

example above, it is necessary to review the type

and quality of research that has already been

performed 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 field?

what has been found?

what areas need further exploration?

would the proposed study fill a gap and

better an understanding?

In our example design, the literature search

identified existing knowledge in the respective

area. A recent high-quality Cochrane review

reported on previously completed RCTs in the

area, strengths and weaknesses of these studies

and offered direction as to gaps in current

understanding that would benefit from further

research exploration. As research is a time

consuming and often costly endeavour, building

on the best available existing knowledge rather

than “re-inventing the wheel” is favourable.

Only after a thorough literature synthesis and

investigation into these answers should a research

question be formulated – in some instances a

systematic review methodology may actually

align best with the PICOT framework for your

research question. Turning an idea into a good

research question requires it to be feasible,

interesting, novel, ethical and relevant. 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 results. 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 are not harmed

by the study. Finally, reflection is required 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 benefit? There should be a definitive and

strong rationale for the purpose of the research. A

well-thought-out focused research question leads

directly into hypotheses; the predictions 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 research 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.

Similarly, researchers often find that clinicians

have difficulty distilling the important concepts

they would like investigated in a way that can be

feasibly researched.

To support both clinical and academic interests,

an important clinical research question should

therefore be one that is developed in conjunction

with a diverse team. This expertise should align

with the best research methodology 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. An opportunity exists to

engage these researchers, as well as those from

chiropractic schools, in helping to formulate

important clinical research questions.

Conclusion 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.

Key Points

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

studies

Framing of a research question offers a

common language between clinician

and researcher discourse

Footnotes

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