Editorial

How to Write a Research Protocol: Tips and Tricks

The first drafting of the protocol for a new research project
Table 1: Main sections and subsections in a complete
should start from a solid idea with one or more of these goals:
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research protocol
1. Overcoming the limits of the current knowledge in a
Main investigator
determinate field with the aim of bridging a “knowledge gap”
Name
2. Bringing something new in a scarcely explored field
Address
3. Validating or nullifying previous results obtained in
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Phone/fax
limited records by studies on a wider population.
E‑mail
A research proposal born with the intent to convince the Number of involved centers (for multi‑centric studies)
others that your project is worthy and you are able to manage Indicate the reference center
it with a complete and specific work plan. With a strong Title of the study
idea in mind, it is time to write a document where all the Protocol ID (acronym)
aspects of the future research project must be explained in Keywords (up to 7 specific keywords)
a precise, understandable manner. This will successively Rationale of the study (describe current scientific evidence in support
of the research with a possible sub‑section for the references)
help the researcher to present it and process and elaborate
Study design
the obtained results.[1] The protocol manuscript should also
Monocentric/multicentric
underline both the pros and the potentialities of the idea to
Perspective/retrospective
put it under a new light.[2] Controlled/uncontrolled
Our paper will give the authors suggestions and advices Open‑label/single‑blinded or double‑blinded
regarding how to organize a research protocol, step by step Randomized/nonrandomized
[Table 1]. n parallel branches/n overlapped branches
Experimental/observational
First section: Description of the core center, contacts of Others
the investigator/s, quantification of the involved centers Primary objective
A research protocol must start from the definition of the Endpoints (main primary and secondary endpoints to be listed)
coordinator of the whole study: all the details of the main Expected results
investigator must be reported in the first paragraph. This Analyzed criteria
will allow each participant to know who ask for in case of Main variables/endpoints of the primary analysis
doubts or criticalities during the research. If the study will be Main variables/endpoints of the secondary analysis
multicentric, in the first section must be written also the number Safety variables
of the involved centers, each one possibly matched with the Quality of life (if applicable)
Health economy (if applicable)
corresponding reference investigator.
Visits and examinations
Second section: Specific features of the research study Therapeutic plan and goals
After completing the administrative details, the next step Visits/controls schedule (also with graphics)
is to provide and extend title of the study: This is made for Comparison to treatment products (if applicable)
identifying the field of research and the aim of the study itself Dose and dosage for the whole time period
in a sort of brief summary of the research; the title must be Formulation and power of the studied drugs
followed by a unique acronym, like an ID of the protocol. If Method of administration of the studied drugs
the protocol has been already exposed and approved by the Informed consent
Ethical Committee, it is appropriate to include also protocol Study population
number. Short description of the main inclusion and exclusion criteria
Sample size
A list of 3–7 keywords must be listed to simplify the Estimate of the duration of the study
collocation of the protocol in its field of research, including, Best supposed perspective
for example, disease, research tools, and analyzed parameters Safety advisory
(e.g. three‑dimensional echocardiography, right ventricle, Classification needed
end‑stage heart failure, and prognosis). Requested funds
Additional features
The protocol must continue stating the research background that On the main concept of the study
is the rational cause on the base on which the study is pursued.
This section is written to answer some of these questions: what current knowledge? Why we need to overcome that data? and
is the project about? What is already available in this field in the How will the community will from the present study?

© 2018 Journal of Cardiovascular Echography | Published by Wolters Kluwer - Medknow 151

 Cameli, et al.: How to write research protocols

As for an original research manuscript, the introduction the idea at the base on the project, the endpoints and the
to the project must include a brief review of the literature pre‑arranged objectives, the author can explain how its research
(with corresponding references). It is also fundamental to project will
support the premises of the study, to underline the importance • Contribute to optimize the scientific knowledge in that
of the project in that particular time period and above all, specific field
of the materials and methods that will be employed. The • Give real successive implications in clinical practice
rationale should accurately put in evidence the current lack • Pave the way for future scientific research in the same or
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in that field of scientific knowledge, following a precise, similar area of interest, etc.
logical thread with concrete solutions regarding how to
The study population must be specified in detail, starting from
overcome the gaps and to conclude with the hypothesis of the
inclusion criteria (including age and gender if it is planned to be
project. A distinct paragraph can be dedicated to references,
restricted) and exclusion criteria: the more precise are the lists,
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paying attention to select only the previous papers that can

the more accurate the enrollment of the subjects will be to avoid
help the reader to focus the attention on the topic and to not
selection biases. This will also help to raise the success rate of
excessively extend the list. In the references paragraph, the
the project and to reduce the risks of statistical error during
main studies regarding the object of the research but also
the successive analysis of the data. The sample size should
state‑of‑art reviews updating the most recent discoveries in
be planned and justified on the base of a statistic calculation
the field should be inserted.
considering the incidence and prevalence of the disease,
The section should successively expose the study design: frequency of use of a drug, etc., and possibly also indicating if
monocentric or multicentric, retrospective or prospective, the study considers a minimal or maximal number of subjects
controlled or uncontrolled, open‑label or blinded, randomized for each enrollment center (in case of multicentric studies).
or nonrandomized, and observational or experimental. It should
This section of the protocol should end with some indications
also be explained why that particular design has been chosen.
regarding timing and duration of the study: Starting and
At this point, the author must include the primary objective of end of enrollment date, starting and end of inclusion date,
the research, that is, the main goal of the study. This is a crucial potential frequency of control examinations, and timing of
part of the proposal and more than 4–5 aims should be avoided the analysis of the acquired data. If already settled, it can be
to do not reduce the accuracy of the project. Using verbs useful to indicate also the type of statistical analysis that the
as “to demonstrate,” “to assess,” “to verify,” “to improve,” investigators will apply to the data.
“to reduce,” and “to compare” help to give relevance to this
It is always necessary to prepare an informed consent to be
section. Add also a description of the general characteristics
proposed to the patient where premises, methods, and aims
of the population that will be enrolled in the study (if different
of the research together with advantages (e.g., some visits or
subgroups are planned, the criteria on the base of which they
diagnostic examinations for free) and possible risks derived
will be divided should be specified); primary and secondary
from the participation to the study.
end‑points, including all the variables that represent the
measure of the objective (e.g., all‑cause death, cardiovascular Section three: Additional features of the study
death, hospitalization, and side effects of a drug) follow in In this short section, various pieces of information regarding
this section. safety of the study must be added (a classification is
fundamental in case of studies that expect the use of invasive
All the single parameters and variables that will be assessed
procedures or drugs use). Usually, for nonobservational studies,
during the study must be accurately and precisely listed along
an insurance coverage must be considered.
with the tools, the methods, the process schedule timing, and
the technical details by which they will be acquired; Here, the If the investigators have requested or plan to request funding
author should explain how the Investigators who work in the other or financial support, all the obtained resources must be listed
involved centers have to sent their results and acquired data to the to avoid conflicts of interest.
Core Laboratory (e.g. by filled databases or by sending images).
A special attention must then be paid to clarify the planning Conclusion
of each examination the study patients will undergo: basal Writing a complete and detailed document is a paramount step
evaluation, potential follow‑up schedule, treatment strategy before starting a research projects. The protocol, as described
plan, comparison between new and already‑in‑use drugs, dose in this paper, should be simply and correctly written but must
and dosage of the treatment in case of a pharmacological study. clarify all the aspects of the protocol. The document could be
This part can be enhanced by flowcharts or algorithms that divided into three different sessions to give all the parts the
allow a more immediate comprehension and interpretation of appropriate attention.
the study strategy.
Matteo Cameli, Giuseppina Novo1, Maurizio Tusa2, Giulia Elena Mandoli,
This section may result more complete if one more subsection, Giovanni Corrado3, Frank Benedetto4, Francesco Antonini‑Canterin5,
illustrating the expected results, is included. Considering Rodolfo Citro6

152 Journal of Cardiovascular Echography ¦ Volume 28 ¦ Issue 3 ¦ July - September 2018

 Cameli, et al.: How to write research protocols

Department of Cardiovascular Diseases, University of Siena, Siena, 1Biomedical

This is an open access journal, and articles are distributed under the terms of the Creative
Department of Internal Medicine and Medical Specialties, Cardiology Unit, Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to
University of Palermo, Palermo, 2Division of Cardiology, IRCCS Policlinico remix, tweak, and build upon the work non-commercially, as long as appropriate credit
San Donato, 3Department of Cardiology, Valduce Hospital, Como, 4Division is given and the new creations are licensed under the identical terms.
of Cardiology, Bianchi‑Melacrino‑Morelli Hospital, Reggio Calabria, 5High
Specialization Rehabilitation Hospital, ORAS, Motta di Livenza, Treviso,
6
Heart Department, University Hospital “San Giovanni di Dio e Ruggi Access this article online
D’Aragona”, Salerno, Italy Quick Response Code:
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Website:
Address for correspondence: www.jcecho.org
Dr. Rodolfo Citro,
Heart Department, University Hospital “San Giovanni di Dio e Ruggi d’Aragona”,
Heart Tower Room 810, Largo Città D’ippocrate, 84131 Salerno, Italy. DOI:
10.4103/jcecho.jcecho_41_18
E‑mail: [email protected]
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References
1. Al‑Jundi A, Sakka S. Protocol writing in clinical research. J Clin Diagn How to cite this article: Cameli M, Novo G, Tusa M, Mandoli GE,
Res 2016;10:ZE10‑3. Corrado G, Benedetto F, et al. How to write a research protocol: Tips and
2. O’Brien K, Wright J. How to write a protocol. J Orthod 2002;29:58‑61. tricks. J Cardiovasc Echography 2018;28:151-3.

Journal of Cardiovascular Echography ¦ Volume 28 ¦ Issue 3 ¦ July - September 2018 153