|HOW TO WRITE PROTOCOL
|Year : 2021 | Volume
| Issue : 1 | Page : 53-61
Guidelines for writing research protocol
Satish Saluja, Manoj Modi
Department of Neonatology, Sir Ganga Ram Hospital, New Delhi, India
|Date of Submission||07-Jan-2021|
|Date of Decision||16-Jan-2021|
|Date of Acceptance||20-Jan-2021|
|Date of Web Publication||19-Feb-2021|
Prof. Satish Saluja
Department of Neonatology, Sir Ganga Ram Hospital, New Delhi
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Saluja S, Modi M. Guidelines for writing research protocol. Curr Med Res Pract 2021;11:53-61
As a part of their training, the postgraduate students have to conduct a research project and submit a thesis 6 months before their final examination. The purpose of writing the Thesis Protocol is to help the candidate, explore gaps in knowledge about the subject and create a methodology to meet the objectives of the proposed research study. It provides an opportunity to have practical exposure to various aspects of research methods. The responsibility for improving the quality of the protocol lies with the Student, ‘Thesis Guide’ and ‘Co-Guides'. They should guide the student at each step of writing the draft and proofread the protocol for its content and format. A critical review of each aspect of the protocol is the key to writing a good protocol. The protocol should have been discussed in the department. The candidate shall submit a letter signed by the ‘Head of the Department', stating that the protocol has been discussed within the department. The candidate shall submit the checklist provided at the end of this document.
The first step in writing the protocol is to frame a ‘Research Question'. This should be based on the on-going issues in the clinical practice of the concerned speciality. The question should be feasible, interesting, novel, ethical and relevant (FINER). The key components of the research question should be in PICO format, which includes the population, intervention/exposure, comparison group and outcome of the proposed study. Based on the question, a detailed review of literature should be performed after developing a search strategy with identified keywords. The essential components of a research protocol are described in subsequent sections. All the protocols have to be approved by the research and ethics committees of the hospital. The key to writing a good research protocol is to write in your own and simple language, revise your draft and proofread before submission.
| Title Page|| |
The essential elements of Title page should be:
- A good title should be short, accurate, informative and concise; it should avoid abbreviations. It should also reflect the details of the study undertaken, e.g., whether a prospective or a retrospective study/whether a cross-sectional or a randomised trial/whether an equivalence or superiority or inferiority trial, etc.? (Titles such as ‘A study on prevalence on asthma in North India [hospital based]’ should not be encouraged)
- The name and title of the investigator who is responsible for conducting the research. Mention the duration of your course
- The address and telephone numbers of the site.
- On the title page in the middle section, the text for award of degree should be written as DNB (Diplomate of National Board) for broad specialties and DrNB (Doctorate of National Board) for superspecialities.
| Investigators Page|| |
Title at the top, followed by names of Student, Guide and Co-guides along with their designations and affiliation.
| Table of Contents|| |
| Abbreviations|| |
Give all the abbreviations used in the protocol in ‘Alphabetical order'.
| Project Summary|| |
The summary should include a brief introduction of the subject, research question and the justification for the proposed study. It should state the hypothesis (if applicable) and the objectives. Give a brief description of methods and the expected number of subjects to be enrolled. Mention anticipated outcomes of the study. Do not include references in this section. The project summary shall be brief and not more than three-fourth of a page.
| Introduction and Background|| |
Introduction: 1–2 pages
This section gives the background of the research question and the burden of the problem. Mention the relevance and importance of the subject to be researched. Give a brief description of what is already known on the subject globally and in local settings. End this section with the main objectives of the study.
- Start introduction by clearly identifying the subject or area of interest
- Give brief description and burden of problem/disease/condition
- Briefly discuss ‘What is already known as per the published literature’ and ‘What are the gaps'
- Write about the research question and its importance
- How answering this research question is likely to modify the current state of knowledge?
- Conclude this section by stating what is the proposed plan to answer the question by stating objectives.
| Review of Literature|| |
Review of literature is a very crucial section of the protocol. Create a structure of the topics to be included in the review. Identify keywords, develop a search strategy and search common databases. Avoid old reference. It may be a good idea to review articles which have been published in the preceding 20 years. To learn a search strategy, go through tutorials in PubMed. The review must be precise and concise. Do not include unrelated articles. Avoid starting each paragraph with the author's name. Do not write information from the abstracts of the research articles. It is a good idea to go through the whole articles and provide a description of key methodological aspects and important findings in the results. Include studies ‘For’ and ‘Against’ the topic in question. A good review should be able to identify lacunae in the literature.
Review of literature 3–5 pages
Structure your review
- Definitions of your problem/area of interest, in general
- Burden of problem globally and in India
- Define specific problem you are going to research on
- Decide on key components of Review
- Estimation of prevalence of a disease
- Risk factors to assessed
- Outcomes you are going to assess
- Tools used to assess outcomes
- Create a structure of your review clearly stating all sections and components
- Use Keywords and all databases to review literature
- Club publications chronologically related to each of your components
- For each publication included the review of literature, identify following issues:
- Question or problem addressed.
- The key concepts and their definitions
- Methods used to carry out the research study
- Key findings of the results, conclusions, strengths and limitations of the study
- Whether the findings of this study are in confirmation or contradictory to other published studies?
- What arguments are given to explain their findings which are in contrast with others?
Conclude review of literature with a short summaryGive ‘Gaps in knowledge’ in the ‘Lacunae section’ and provide justification for the proposed study.
Organising review of literature
- Organise you review thematically or chronologically
- Give headings of each section you are going to review
- Avoid beginning the paragraph with Authors name and year of publication
- Introduce each section before citing references
- Summarise review in the last paragraph
- Give lacunae in literature with justification of your study.
- Provide information regarding a component of the review in a chronological order, as the understanding of the topic evolved over a period of time
- Include a comparison and contrast of different studies. This helps to identify the main gaps in the existing knowledge. This will provide the justification and the purpose of study. The researcher shall try to include some novelty in the proposed study.
| Lacunae in Literature|| |
This is the most important section of the protocol which is stated after a detailed review of the literature. This indicates that the candidate has performed a detailed review of the literature and has been able to identify the gaps in existing knowledge regarding the topic to be researched. The lacunae related to the topic shall be highlighted; this provides a justification for the study. Few examples could be: Some aspect of a topic has not been researched or limited data available on the topic either globally or in local settings or To the best of our knowledge, no data available … etc.
| Research Question|| |
The first step in writing a research protocol is to frame a valid research question, based on an existing problem. It should be feasible, interesting, novel, ethical and relevant (FINER). The question shall be framed in a PICO format, including population to be studied, intervention if any, comparison group and the main outcomes. The candidate shall clearly state what question the proposed study is likely to answer. Example: Does zinc supplementation to infants as compared to placebo reduce the duration of diarrhoea in infants?
| Aims and Objectives|| |
The ‘Aims’ of the study are broad based and describe what would be achieved by this study.
The ‘Objectives’ of the research study are specific and are drawn from the research question. It should include participants, intervention, comparison group and outcomes. A primary objective shall include the outcome, which is the main focus of the research proposal. The sample size calculation is usually done based on the outcome in the primary objective. The title, research question, primary objective and sample size calculation shall be in sync. The secondary objectives are the other aspects to be evaluated in the study. These may include the adverse effects or outcomes that are deemed less important by the researcher.
- The objectives should be written in PICO format mentioning population intervention or exposure or risk factors or predictors to be evaluated, comparison group if applicable and clearly mentioning the outcomes along with effect size if applicable
- The objectives are written as: To assess…, To estimate…., To correlate…, To evaluate… or To compare….
| Materials and Methods|| |
This section should include the following:
- Study area: The patient recruitment area (outpatient and/or inpatient of a department in the hospital)
- Study design: Mention the study design of your proposed study. The common study designs are descriptive, analytical or experimental. The experimental study designs are randomised controlled studies which could be an open-label/single-blind/double-blind study. Please mention if it is an active or placebo controlled and whether it is a cross-over or parallel design. Also include if it is superiority, inferiority or equivalence study design.
The commonly used study designs in medical research are displayed in [Figure 1]. There are some other study designs that can be used.
- Study duration: Provide the duration of the proposed study, e.g., from the date of ethics clearance to the proposed end date of the study. Mention the last date of recruitment, keeping in mind the duration of follow-up. Describe the duration of subject participation including follow-up. The discontinuation criteria should also be mentioned.
- Study population: Give a detailed description of the study population to be enrolled in the study. Provide a list of inclusion and exclusion criteria
- Study intervention: Provide a list of interventions to be given in the study. If applicable, give details how intervention will be prepared and administered
- Randomisation, allocation, concealment and blinding: A description of the measures taken to minimise/avoid bias including randomisation and blinding, allocation concealment, masking of intervention, maintenance of randomisation codes and procedures for breaking codes must also be listed out
- Blinding: The patient who is receiving treatment or intervention/person conducting the research or assessing the outcome or analysing the data can be blinded. Thus, the studies can be single, double or triple blinded
- Masking: The interventions are masked, e.g., the intervention of administering two drugs is such that the care provider is not able to differentiate which drug is being given. The preparations are similar looking, same volume, same smell/taste and same mode and rate of administration
- Allocation concealment means that the person randomising the patient does not know what the next treatment allocation will be. Example: The randomisation sequence is stored in serially numbered sealed opaque envelopes. It is intended to prevent the selection bias
Outcome measures: Give a list of primary and secondary outcome measures as per primary and secondary objectives.
You may divide outcome measures as:
- Independent: Exposures/Risk factors/Predictors
- Dependent: Outcome variables
- Study methodology: It includes a brief description of how the study will be conducted along with time lines
- Method of measurement of outcome of interest: Describe detailed methods of measurements of each of the outcome variables both primary and secondary. Provide details of the sample techniques, equipment to be used, units of measurement and how the result of a particular outcome will be recorded. Clearly define methods to avoid biases in recording outcomes. Give details of the visits at which these measurements will be assessed and recorded, along with the timeline for each outcome measure
Data collection methods: Mention all definitions of all the terms and variables to be used during the conduct of the studyData collection forms: Prepare pro forma based on your objectives, outcome measures and tools to be used to assess outcomes. Include only those variables which are part of the study. Do not include irrelevant data variablesStatistical methods
- Sample size: Provide information regarding the number of subjects to be recruited into the study. Give basis of calculation of sample size (along with reference) with formula being used. Provide reasons for convenience sample if there are time constraints for a postgraduate thesis
- Statistical analytical methods: Mention how the data variables will be recorded in the electronic format, e.g., MS Excel or MS Access. Give the name of the statistical package to be used for analysis. Provide methods of description of continuous and categorical variables. Give a scheme for statistical analysis including the names of statistical tests for comparison and assessing the association of variables. Describe any statistical tests, e.g., correlation analysis and regression. Give a detailed description how each of the variables concerning primary and secondary objectives will be handled during analysis. Give a level of statistical significance, e.g., P < 0.05 will be considered significant.
Study flowchart: Give a flow diagram as per the design. Examples are displayed in [Figure 2] and [Figure 3].
| Ethical Consideration|| |
All the research proposals must obtain clearance from the Ethics Committee. The researcher shall highlight the ethical issues related to the research proposal. Provide details seeking permission for access to medical records, exemption of consent for retrospective studies or assent for children. State any financial implications, if applicable.
| Plagiarism Check|| |
All manuscripts should be checked for plagiarism. Avoid ‘Copy and Paste’ from the published literature. Write text in your own language. The plagiarism should not be >20% in introduction and review. You can use online sites to check for plagiarism.
| References|| |
Relevant references must be listed out in Vancouver style. Avoid references older than 20 years from the current date. Few examples are listed below.
| How to Cite References|| |
Citing references in ‘Manuscript’ and ‘Bibliography’ is done differently.
1. Citing references in ‘Bibliography'
- Learn to write references in Vancouver style.
- Check references in PubMed or Google Scholar
- Check for Duplicate references
- It is important to learn to write number of authors in a reference
- Up to ‘Six’ authors, write names of ALL the authors
- If there are more than Six authors
- Write names of six authors followed by ‘comma (,)’ followed by et al.
- Gao SR, McGarry M, Ferrier TL, Pallante B, Gasparrini B, Fletcher JR, Harkness L, De Sousa P, McWhir J, Wilmut I. Effect of cell confluence on production of cloned mice using an inbred embryonic stem cell line. Biol Reprod. 2003;68:595-603.
- There are 10 authors in the above reference. Above method is INCORRECT
- Correct method is
- Gao SR, McGarry M, Ferrier TL, Pallante B, Gasparrini B, Fletcher JR, et al. Effect of cell confluence on production of cloned mice using an inbred embryonic stem cell line. Biol Reprod. 2003;68:595-603.
- Do not write the Month, day and issues
- Only write Year; Volume: pages
- E.g. 2015;40:128-129
Reference from a book:
- Author/Editor (if it is an editor always put [ed.] after the name)
- Series title and number (if part of a series)
- Edition (if not the first edition)
- Place of publication (if there is more than one place listed, use the first named)
- Year of publication
- Example: Brooks A, Mahoney P, Rowlands B, (eds). ABC of tubes, drains, lines and frames. Malden, Mass.: BMJ Books, Blackwell Pub.; 2008.
Reference from a book:
- Author(s) of chapter
- Title of chapter.
- In: Editor(s) of book
- Title of book.
- Edition (if not first).
- Place of publication: Publisher name;
- Year of publication.
- p. [page numbers of chapter].
- Example: Rowlands TE, Haine LS. Acute limb ischaemia. In: Donnelly R, London NJM, editors. ABC of arterial and venous disease. 2nd ed. West Sussex: Blackwell Publishing; 2009. p. 123-140.
Reference from internet site
- Title site.
- Place of publication:
- [Updated year month date; cited year month date].
- Available from: URL.
- Last accessed on: Give date
- Example: Diabetes Australia. Gestational diabetes [Internet]. Canberra (ACT): Diabetes Australia; 2015 [updated 2015; cited 2017 Nov 23]. Available from: https://www.diabetesaustralia.com.au/gestational-diabetes. Last accessed on 2nd December, 2020.
2. Citing references in ‘Manuscript'
- While you are citing reference in the text of your manuscript, ONLY write LAST name
- Do not write initials of MIDDLE or FIRST Name
- If there is only one author in an article, cite as
- E.g. Brown JG. Asphyxiation. Med J Aust. 2003;432:120-124.
- Write as Brown in a study on asphyxiated neonates reported….
- If there are two authors to an article, cite as
- E.g. Smith SD, Jones, AD. Organ donation. N Engl J Med. 2001;657:230-235.
- Smit and Jones in a review article on organ donation reported ….
- If there are three authors to an article, cite as
- E.g. Smithline HA, Mader TJ, Ali FM. Determining pretest probability of DVT: clinical intuition vs. validated scoring systems. N Engl J Med. 2003 Apr 4;21 (2):161-2.
- Smithline, Mader and Ali validated scoring system for deep vein thrombosis….
- If there are more than three authors to an article, cite as
- E.g. Gao SR, McGarry M, Ferrier TL, Pallante B, Gasparrini B, Fletcher JR, Harkness L, De Sousa P, McWhir J, Wilmut I. Effect of cell confluence on production of cloned mice using an inbred embryonic stem cell line. Biol Reprod. 2003;68:595-603.
- Gao et al. in a retrospective study reported the effect of cell confluence on production of ….
| Annexures|| |
It include: The Patient Information Sheet (PIS) and the Informed Consent Form (ICF) in English and Vernacular Languages, Questionnaires, Measurement tools and Data Collection Forms.
| Protocol Size|| |
The thesis protocol should be of 12–15 pages. The suggested format is:
- Font size: 12
- A4 size paper
- Line spacing: Double space
- Margins: At least 2.5 cm on both sides
- Margins: Justified
- Title and details: 1 page
- Synopsis: ½–1 page
- Introduction and Background: 1–2 pages
- Review of literature and lacunae: 3–5 pages
- Research question and Aims and Objectives: 1 page
- Material and Methods: 2–3 pages
- References: 2–3 pages
- Data collection forms
- PIS, ICF and mandatory: 4–6 pages. These should be separate page numbers, not merged with the main protocol.
| Sample Title Page|| |
Title xxx……(Title case, Font Size = 16, Bold)
Protocol for submission of thesis for the
Award of DNB (Specialty)
Session 20xx-20xx (Font Size = 14)
Dr. Name xxxxx
Department of xxxxxxx
Ganga Ram Institute of Postgraduate Medical Education and Research (GRIPMER),
New Delhi – 110060
Phone number -xxxxxxxxx
Roll No. xxxxxxxxxx
| Sample Investigator Page|| |
Name of the candidate: Dr. xxxxxxxxxxxxxx
Name of Guide: Dr. xxxxxxxxxxxx
Name of the Department
Name of the Hospital
Name of Co-guide: Dr. xxxxxxxxxxxx
Name of the Department
Name of the Hospital
○ Title page
○ List of DNB trainee, Guides and Co-guides
○ Table of Contents
○ Project summary
○ Ends with objective
○ Review of literature
○ Researh Question and Hypothesis (if any)
○ Objectives (in PICO Format)
○ Follow the sequence as given below
○ Study area
○ Study design
○ Study duration
○ Study population with inclusion and exclusion criteria
○ Study intervention if any
○ Allocation concealment
○ Blinding (if applicable, if not write: Not applicable)
○ Outcome measures
○ Primary outcome measures
○ Secondary outcome measures
○ Study methodology
○ Method of measurement of outcome of interest
○ Data Collection Methods
○ Data Collection Forms
○ Statistical Methods
○ Sample size
○ Statistical Analytical methods
○ Study Flow Chart: Give a flow diagram as per the design
○ Ethical Consideration
○ Plagiarism Check
[Figure 1], [Figure 2], [Figure 3]