Available via license: CC BY-NC-SA 4.0
Content may be subject to copyright.
CosmoDerma 2022 • 2(115) | 1
is is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-Share Alike 4.0 License, which allows others
to remix, transform, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
©2022 Published by Scientic Scholar on behalf of CosmoDerma
Perspective
FINER criteria – What does it mean?
Saritha Mohanan1, Narayanan Parameswaran2
1Department of Dermatology, Venereology and Leprology, Indira Gandhi Medical College and Research Institute, 2Department of Paediatrics, Jawaharlal
Institute of Postgraduate Medical Education and Research, Women and Children Hospital, JIPMER, Puducherry, India.
INTRODUCTION
Research is a systematic process of answering scientic questions to get an answer. e research
question is the unknown doubt/curiosity that the investigator is trying to answer with his
investigation.[1] e formulation of the research question in an “answerable” format is the rst
vital step in conducting research. It is said that the success of a research project can rely on how
well the investigators can convert a clinical problem into an “answerable” research question.[2]
ESSENTIAL ELEMENTS OF A RESEARCH QUESTION
For descriptive studies, questions start with an interrogative adjective, that is, which, how
much, who, etc. e essential elements of a research question in interventional and analytical
studies are represented by the PICO framework, that is, population, intervention, comparator,
and outcome.[3] Other elements such as time and eect size are sometimes added. For analytical
studies, the elements are PECO, that is, population, exposure, comparator, and outcome.
Population refers to the population that is being studied. Since there is no intervention done in
analytic studies, it is the exposure that forms an important element. e detailed description of
these elements is beyond the scope of this article.
A research question once framed should be assessed by the FINER criteria proposed by
Hulley et al.[4] FINER is an acronym that represents the essential attributes of a research
question. Careful consideration of these attributes will greatly enhance the possibility that the
research question being investigated translates into a well performed study that adds to the
knowledge used for clinical practice. FINER stands for feasible, interesting, novel, ethical, and
relevant.
ABSTRACT
e formulation of a research question in the appropriate scientic “syntax” is one of the vital steps in preparing
a research proposal. Every research question should ideally have certain essential attributes which are represented
by the FINER acronym. FINER stands for feasible, interesting, novel, ethical, and relevant. Ensuring that his/
her research question meets these attributes is useful to the investigator, especially for those starting out in their
research career. is article is a brief overview of these attributes which may assist an investigator to strengthen
his/her research plan or idea.
Keywords: Research question, FINER, Feasible, Ethical, Novel
www.cosmoderma.org
CosmoDerma
*Corresponding author:
Narayanan Parameswaran,
Department of Paediatrics,
Jawaharlal Institute of
Postgraduate Medical
Education and Research,
Women and Children Hospital,
JIPMER, Puducherry, India.
narayanan.p@jipmer.edu.in
Received : 19October 2022
Accepted : 07November 2022
Published : 19 November 2022
DOI
10.25259/CSDM_123_2022
Quick Response Code:
Mohanan and Parameswaran: FINER criteria
CosmoDerma 2022 • 2(115) | 2
Feasible
It is very important that a study that is planned is practically
easy to implement and is designed well. e study should
be equipped with an achievable sample size with easily
and reliably measurable outcome and exposure variables.[5]
ere should be sucient resources in terms of time, trained
manpower, and adequate funding.[6] e investigator should
have sucient expertise.[1] A well-designed study is more
likely to get good funding. It is more likely to optimize use
of human and technical resources. A robust methodology
would ensure high adherence to the intervention, in
interventional studies, and low rate of dropouts. e
investigators can do a pilot study, if in doubt, to assess
feasibility. If they feel that they would not get an adequate
sample to answer the question, they can consider modifying
the inclusion criteria. Other strategies that could be tried
include reducing the exclusion criteria, increasing the time
frame, planning multicentric studies, and changing the
study design and source of patients. It would be also prudent
to consult a biostatistician early to ensure that the study has
sucient power to answer the primary research question
and to plan the analysis using crisply dened exposures
and outcomes before data collection is commenced. Other
technical experts or consultants too can be involved to shore
up the expertise needed to conduct a study. It is important
to comprehensively assess the funds needed at the beginning
of the study, to avoid interruptions of the study for want of
funds later in the study process. e time needed too must
be estimated with a fair degree of accuracy. Investigators
trying to answer too many questions can also make the
data collection cumbersome. It would be wise to narrow
the scope of the study and to answer only the most relevant
questions.[4] For example, a study to compare the ecacy of
adalimumab to isotretinoin for the treatment of hidradenitis
suppurativa may be interesting to many investigators in
dermatology. However, it will throw up multiple challenges
with regard to feasibility if planned as a MD dissertation
or a single-center project with a limited time horizon. It
would be almost impossible to attain required sample size
if it was to be conducted in a single center and the drugs to
be used would be quite expensive, thus requiring substantial
resources both in terms of manpower and funding.
Interesting
e research question should kindle the interest of the
investigators primarily. Only if the question is interesting to
him or her, would the investigator expend the eort required
to overcome any potential challenges and bring the research
project to fruition.[4] e project should also be interesting to
collaborators in the case of multicentric studies. Sometimes,
the projects must be relevant to the public health sphere to
obtain funding from public health agencies. It falls on the
researcher to be familiar with existing literature to achieve
these goals. It is desirable to have a mentor and discuss with
them if the topic is interesting, before spending a lot of time
developing a project proposal that funding agencies may nd
dull.[2] One could also speak with representatives of funding
agencies such as NIH project ocers to ensure that funding
agencies nds the project interesting.[7] Last but not the least,
the proposed project should also be of interest to the readers of
the published research paper once it is completed. Otherwise,
the study results may never see the light of the day. For example,
a study of the antifungal susceptibility of dermatophytes from
a particular part of India would be of interest to all clinical
dermatologists in the area and will be an interesting area to
work on for a clinician researcher. Similarly, a study comparing
Universal Multidrug therapy to Rifampicin, Ooxacin, and
Minocycline for the treatment of single patch Hansen’s disease
would be of interest to policy makers and could easily attract
funding from public health agencies.
Novel
e point of conducting research is always to advance the
existing knowledge. It is imperative that the investigators
conduct a thorough literature review to assess the existing
knowledge about the research topic. Consulting with experts
in the eld and searching for abstracts in the eld of interest
that has been funded using the NIH Research Portfolio
OnlineReporting Tools (RePORT) website (http://report.
nih.gov/categorical_spending.aspx.) can also be done before
embarking on a new study.[7] e new study planned should
ideally provide new results. It is understandable that, in some
circumstances, research needs to be done to conrm pre-
existing knowledge. However, this should not be misused to
generate knowledge in each specic population subset when
there is already reasonably generalizable knowledge available
for the population. e project can instead attempt to
improve on the methodology of similar studies conducted in
the past and resolve a gap in the literature.[5] A conrmatory
study may be useful when it eliminates weaknesses of the
previous study.[4] For example, it has been established with
observational and analytical studies that dairy intake can
aggravate acne. However, since observational studies are
only indicative of a possible association and may be false,
the association needs to be proved by a controlled trial
which can generate new information. Hence, instead of just
repeating an observational study in more settings, to improve
on this knowledge, an interventional study can be planned
comparing standard treatment with dairy restriction to
standard treatment alone in patients with acne vulgaris.
Ethical
Research projects should follow well-established ethical
procedures as laid down by the Declaration of Helsinki.
Mohanan and Parameswaran: FINER criteria
CosmoDerma 2022 • 2(115) | 3
Other guidelines to be familiar with would be the good
clinical practices for clinical trials and the Tri-Council Policy
Statement.[2] Research of any kind should be approved by the
appropriate ethics committee constituted for that purpose. A
prudent step would be discussing the protocol with a member
of the ethics committee at the planning stage itself in case
there are concerns about the balance of risk versus benet for
the participants. For many conditions with standard therapy
available, it would not be ethical to administer only placebo
to the patients in control arm though it may result in a more
pronounced benecial eect of the trial drug. Administering
the placebo along with standard therapy would be needed.
For example, in pemphigus vulgaris, if a trial is planned to
study the eect of anticholinergic drugs, it would be advisable
to provide standard treatment to both arms to ensure safety
of the participants. Similarly, unnecessary investigations for
the sake of documentation are better avoided. For example,
for a condition that can be reliably recognized clinically such
as psoriasis, alopecia areata, or dermatophytosis, it would
be considered unethical to subject all patients to a biopsy
before being enrolled in a study. If a particular intervention
was found to be benecial, it would be advisable to give the
control arm the same benet at the end of the study. is
would be particularly relevant for split face studies as it would
be unethical to provide the benecial treatment to only one
side of the face by the end of the study.
Relevant
e knowledge that would be generated by the study should
be relevant to either current clinical practice or to current
laboratory research. e study should ideally generate potential
new avenues of research. In certain cases, it should be relevant
to the public health aspects of the region. In such instances, it
would be advisable to be familiar with the global and national
burden of the disease. Having questions related to local
problems would be more relevant than other questions. e
investigator would do well to imagine the possible outcomes
and think if each of them could change clinical practice,
advance scientic knowledge, and/or guide further research.
For example, for a practicing dermatologist, dermatophytosis
has grown to epidemic proportions in India. Any information
to address the issue will be highly relevant to the physicians.
Hence, even a simple observational study assessing host
and environmental factors that lead to chronic or resistant
dermatophytosis would be very relevant to dermatology
practitioners in India, so that they can have access to relevant
information to address this vexing condition.
Assessing the research question using the FINER criteria
and ensuring that it meets the criteria would instill ample
condence in the investigator to proceed with planning
the study. e next step aer this would be to make a study
proposal to answer the research question. e research
question developed based on the PICOT framework, and
vetted by the FINER criteria, would then be used by the
investigator to make the primary and secondary objectives.
Based on these objectives, the exposure and outcome
variables, previously judged to be feasible to measure (F of
FINER), would be standardized, the sample size calculated
(also judged earlier to be feasible to attain), and the statistical
analysis planned. All this together with the potential plans
for receiving funding would form a preliminary study plan,
which when ne-tuned, would set the investigator on the
path to successfully complete his or her project.
CONCLUSION
Assessing the research question by the FINER criteria is a
vital step in research planning, and if dispensed with can lead
to multiple challenges while executing a research project.
Declaration of patient consent
Patient’s consent not required as there are no patients in this
st u dy.
Financial support and sponsorship
Nil.
Conicts of interest
ere are no conicts of interest.
REFERENCES
1. Dhir SK, Gupta P. Formulation of research question and
composing study outcomes and objectives. Indian Pediatr
2021;58:584-8.
2. abane L, omas T, Ye C, Paul J. Posing the research
question: Not so simple. Can J Anaesth 2009;56:71-9.
3. Cañón M, Buitrago-Gómez Q. e research question in clinical
practice: Aguideline for its formulation. Rev Colomb Psiquiatr
(Engl Ed) 2018;47:193-200.
4. Hulley SB, Cummings SR, Browner WS. Conceiving the
Research Question Designing Clinical Research. 3rd ed.
Philadelphia, PA: Lippincott Williams and Wilkins; 2007.
p.17-26.
5. Fandino W. Formulating a good research question: Pearls and
pitfalls. Indian J Anaesth 2019;63:611-6.
6. Aslam S, Emmanuel P. Formulating a researchable question:
Acritical step for facilitating good clinical research. Indian J
Sex Transm Dis AIDS 2010;31:47-50.
7. Cummings SR, Browner WS, Hulley SB. Conceiving the
research question and developing the study plan. In: Designing
Clinical Research. 4thed. Philadelphia, PA: Lippincott Williams
and Wilkins; 2013. p.14-22.
How to cite this article: Mohanan S, Parameswaran N. FINER criteria –
What does it mean? CosmoDerma 2022;2:115.