Writing a Research Protocol

What is a Research Protocol?

A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical evaluation of the data, and organization of a clinical research project.

A well-written protocol will facilitate the process of obtaining institutional and ethical approval for your research and increase your chances of obtaining funding for your project.

A Good Research Protocol

- Forces the investigators to clarify their thoughts and to think about all aspects of the study, conduct, analysis of the data.

- Forms guidelines for a team working on research – help ensure study is performed similarly by different people over time

- is essential if study involves research on human subjects or on experimental animals, in order to get institution institution’s ethical approval

- is an essential component of a research proposal submitted for funding

- is used to start writing a manuscript when study completed

Developing a Research Protocol

Start with a good question - one for which the answer matters either to other researchers in the field, practicing clinicians, or patients

Convert the question to a hypothesis by asserting a position

Construct the protocol

Generate measures of exposure (treatments) and outcome

Test the hypothesis by making a comparison in two or more groups

Develop a plan for data collection and management

Determine the statistical methods for analysis, consult with statistician

Estimate the magnitude of expected difference between the two groups, as a basis for determining sample size (power calculation)

Assess feasibility of the study:

Can enough people be obtained for the study?

Can the outcome events be observed and suitably analyzed?

Research Protocol Format

Project title

Project summary

Project description

Rationale

Objectives

Subjects to study: Inclusion/ Exclusion criteria

Methodology

Data management and analysis

Sample size needed for the study

Ethical considerations

Risks and Benefits of the study

Recruitment plans, Compensation (if any)

Informed Consent, Approvals (DRB and IEC)

References

I] Project Title

Should be descriptive of the study, but concise

Clear, non-ambiguous

Arouse interest

Keep it short and Simple and Sweet

II] Project Summary

Why is the project necessary?

What do you aim to do?

What methods will you use for carrying out the project?

What will be the project outputs?

What is the projected impact of the project?

(An approximate word count: 500 words)

III] Project Rationale (Research Question)

Sets the stage for why the research project should be done. Cite appropriate references.

The condition to be studied

Treatments currently available, note gaps present

Specific treatment to be studied

Preliminary data for treatment in the condition to be studied

Purpose of the study

Discuss the anticipated results and potential pitfalls.

Describe the significance of the research including potential benefit for individual subjects or society at large.

IV] Research Objectives (Aims)

The purpose of the study (research questions and / or study objectives) should be clearly and precisely stated.

Objectives should be simple, specific, and stated in advance of performing the research.

In experimental designs, objectives will be stated as hypotheses to be tested.

Be short but complete and Be specific.

Objectives should be attainable, measurable and realistic

V] Procedures

A. Research Design

The research design should be identified and should be appropriate to answer the research question(s) under study.

Describe the type of research proposed (e.g. experimental, correlational, survey, qualitative) and specific study design that will be used (e.g. pre-test /post / test control group design, cross-sectional design; prospective longitudinal cohort design; phase III double-blind randomized control group design).

The research design, methods and procedures should help answer your research question(s) as written in your study objectives and aims

B. Sample/ Subjects/ Participants

Describe the sampling approach. For experimental designs, include justification for sample size determination.

Identify the procedures that will be used to recruit, screen, and follow study volunteers.

Specifically define the study sample (number of subjects to be enrolled, characteristics of subjects to be included in and excluded from the research).

In intervention studies, how will subjects be allocated to the treatment and comparison groups?

What are the criteria for discontinuation?

C. Measurement/ Instrumentation/ Intervention

Identify the variables of interest and study endpoints (where applicable).

Justify measurement techniques selected.

Provide validity and reliability data for selected measures.

If an intervention is performed, a description is given of the drugs available, or devices to be used, and whether they are already commercially available, or are in phases of development

D. Detailed study procedures

Methods for study data collection and for avoiding / minimizing subject risks should be included.

Include a timeline for subject evaluations and the duration of subject participation in the project.

Identify the plans the proposed safeguards for subject confidentiality (plans for coding data and for securing written and electronic subject records).

Indicate how long personal information will be stored once the study is completed.

Methods will vary with the research approach used (qualitative, quantitative).

The selected methods should be sufficiently described to justify the use of the approach for answering the defined research question.

Methods should also be described in adequate detail so that IEC members may assess the potential study risks and benefits.

Observations

What observations will be made, how they will be made, and how frequently will they be made.

Make a pilot study where required.

E. Internal Validity

Threats to internal / external validity should be considered.

Identify confounders.

Describe measures that have been taken to avoid study bias.

F. Data Analysis

Specify the analytic techniques the researcher will use to answer the study questions.

Indicate the statistical procedures (e.g. specific descriptive or inferential tests) that will be used and why the procedures are appropriate.

For qualitative data, specify the proposed analytic approaches.

VI] Sample Size

The protocol should provide information and justification on the sample size – the number of patients needed to be studied

A larger sample size than needed to test the research hypothesis Increases the cost and duration of the study and will be unethical if it exposes human subjects to any potential unnecessary risk without additional benefit

A smaller sample size than needed can also be unethical if it exposes human subjects to risk with no benefit to scientific knowledge

Calculation of sample size has been made easy by computer software programs. The principles underlying the estimation of the software sample size should be well understood

VII] Ethical considerations

Risks, Benefits of the study

Recruitment plans

Compensation for subjects in study

Informed Consent and procedure, IEC Approval

Conflict of Interest

Privacy

VIII] GCP Guidelines: https://gcp.nihtraining.com/

IX] Universal Guidelines:

CONSORT - CONsolidated Standards Of Reporting Trials

STROBE - STrengthening the Reporting of OBservational studies in Epidemiology.

X] Others:

Logistics – List of equipment/ tools required

Time Schedule – Gantt Chart

Action Plan – Procedural actions with durations

Budget – Self funded/ Sponsored

XI] Bibliography

Include a reference list of literature cited to support the protocol statement.

Vancouver Format/ APA format

XII] Registration

CTRI – Clinical Trials Registry of India

http://ctri.nic.in/

XIII] Forever Avoid Scientific Misconduct

Gift Authorship

Redundant Publication

Plagiarism

Fabrication

Falsification

References:

1. Fathalla MF. A Practical Guide for Health Researchers. WHO Regional Publications Eastern Mediterranean Series 30

2. Research Protocol. THE OHIO STATE UNIVERSITY Institutional Review Board

3. Parkman H. Writing a Research Protocol. WHO | Recommended format for a Research Protocol. http://www.who.int/rpc/research_ethics/format_rp/en/ [Viewed on Dec 14, 2015]

4. Guidelines on Writing a Research Protocol. Faculty of Health Sciences. University of Pretoria

My Louisville-age Fellowship in Physiotherapy Pilgrimage: An unusual realization

With my US mentor, Dr. John Nyland, 

Director of Athletic Training Program, Spalding University, 

President of Board of Directors, JOSPT

Someone has rightly said that we all are students for our whole life and that life itself is the best teacher. And what a wonderful teacher life really is! It gives us multiple opportunities to learn, grow and progress with all its unique and practical based experiences.

It has been 12 years now that I am facilitating Physiotherapy education at this wonderful institute. And these 12 years too have been unique learning experiences from seniors, colleagues and students alike. But one of my wonderful learning opportunities was recently presented to me when I got to do my fellowship in Physiotherapy in the US. But the process for this had already started more than 2 years back when my boss and mentor Dr. Parag Sancheti had invited Dr. John Nyland for a Continuous Physiotherapy Education (CPE) session right here at Sancheti Institute College of Physiotherapy around in 2013 when even I had an opportunity to take a session on Virtual Reality Training in Sports. Our interaction and the constant support by Dr. Parag finally led to the invitation by Dr. Nyland for my visit to the US for an advanced learning experience in Orthopedics and Sports Physical Therapy.

Kosair Charities College of Health and Natural Sciences, 

Spalding University, Louisville, KY, USA

But this, by itself, was not an easy step as my pre-preparation included multiple short certificate exams on HIPAA, Blood – borne pathogens, Fire safety, workplace emergencies etc. Also the tests and shots of Influenza, Montoux, MMR, and DPT were just amazingly painful. Not to mention that previous passport expired in Feb 2015 and I woke up only in July 2015 to get new passport issues. Fortunately (and surprisingly) the US visa issuance turned out as the quickest and hassle-free process. Well, everything seemed to be finally set. My fellowship dates were from 18^th October to 7^th November 2015, a whole 3 weeks. But going to US on tourist visa and no tour? That’s when the Niagara Falls trip just dropped in like a bomb. But hey, we aren’t talking about the Niagara and the helicopter ride and the awesome wonderful experience. Right now, it’s purely my fellowship!!

Orthopedic and Sports Physical Therapy, Louisville, KY

Advanced Orthopedic Physical Therapy, Louisville, KY

So finally I took off to look forth for a wonderful 3 weeks’ vacation (oops), 3 weeks of enhanced learning experience on 17^th Oct from Mumbai to reach Louisville. Dr. Nyland was extremely gracious to receive me on the airport. My learning started immediately from the next day and continued for the next 2 weeks. I got a chance to learn and observe eminent physical therapists like Dr. Bradley Wheeldon and Dr. Alex Kent from specialty clinics like the Orthopedics and Sports Physical Therapy, Dr. Julie Snowden, Dr. Robin McNeill and Dr. Katie Elder at the Advanced Orthopedics Physical Therapy and Dr. Janelle Caudill at the Kentucky Orthopedics Rehabilitation Team clinics. The purpose of the visit was not only to learn the advances in orthopedics and sports physical therapy but also to learn the aspects of PT department functioning, administrative responsibilities and to understand their perspective and rationale of Patient treatment approach and working on the needs and necessities of the PT department functioning. 

Kentucky Orthopedics Rehabilitation Team, Louisville, KY

My clinical learning also included 2 days each with Dr. David Caborn who is a Knee and Foot Surgeon at Kentucky One Health Jewish Hospital and with Dr. Ryan Krupp who is a Shoulder surgeon at Norton Brownsboro Hospital. And last but not the least, got to see Dr. John Nyland in action at his Return to Sports clinic at Spalding University as well as assist him in Inter-university Soccer matches for Men and women. 

Dr. Nyland Return to Sports Clinic, Spalding University

Inter-University Soccer Matches

My visit also comprised of giving an interactive lecture to the DPT students at Bellarmine University and to the MSAT students at Spalding University on my favorite topic of ‘Using Suryanamaskar (Sun-Salutation) as a Yogic way for a Community Based Exercise Program – A Physical Therapists Perspective’ which was a chance to represent my Institute, University, Culture and finally my Country and was highly appreciated by the students and the faculties at both the Universities.

Lecture on Suryanamaskar (Sun Salutation)

Practical Demo of Suryanamaskar with students and Faculty of Spalding

With Dr. Patricia Gillette, School of Physical Therapy, 

Bellarmine University, Louisville, KY, USA

Many of my friends and my colleagues have asked me about the different or new things I got to learn over there. Well, to start with, I would say that Physical Therapy education in India is in every way equivalent in standards to that in the US. Infact, our current education system has 4 years of Bachelors and 2-3 years of Masters Program in Physical Therapy while US has a general bachelors program and directly a 3 years DPT program. Ofcourse every education system has their own pros and cons and I definitely am not criticizing any one of it. What I feel is that we need to make special efforts at individual level to learn the best of every system. Even in India, we are very active in clinical research which will help our profession progress and grow. But we all yet need to take research publications more seriously. One basic learning part would be the multi-planar motions training, sports specific rehabilitation and the advanced functional rehabilitation concepts which I learned over there, probably due to the increased demands of their clients for a faster rehab to meet and match their active sports specific lifestyle. Also got to learn the utilisation and applicability of some different equipments like the 'Game-ready' and the 'Hivamat' which we typically do not use over here.

Game Ready Cryo Compress Packs

Hivamat Stimulator

But what I really liked and learned over there is their attitude and positivity. During my visits to the clinics or my lectures in Bellarmine and Spalding, I had asked Dr. Nyland about what were their expectations from me. His answer was simple. He just said, “Apurv, I want you to enjoy there. If you enjoy, people around you will enjoy and only then will you and others work more productively.” I was in love with this statement of his. We all are so much used to work under pressures that we know how to perform, but not how to excel. There, people laugh, play, joke and enjoy in their work also. This helps in creating a bonding between associates as well as your start liking what you do. Infact people want to be at work as it is not a place of stress, but a place to live your life too. (I am sure we know that US is amongst the most productive country in the world). 

Second, have a family life as well. We tend to work for our family and on this pretext get so much busy in that process that we don’t have any time left for our family. The next best thing I learned over there is their support system. Everyone has their own set of tasks and duties. But everyone is always eager and supportive towards their colleagues as well. This helps in building an extremely good team character and also facilitates a positive environment. We Indians are definitely extremely hardworking and intelligent breed of people and have the potential of exceeding in every aspect. I am sure, some change in our behavior and approach will get us far ahead. And it isn’t difficult either. Keeping the roads and our environment clean, following traffic laws and rules, loving and respecting others also is not so difficult. 

And most important what I learned is how to value people. Everyone around made me feel extremely special and cared for. Even in the public transport systems, hotel, and especially in the clinics I visited. We say “Atithi Deva Bhava” (Guests are Gods). I experienced it there. Ofcourse, staying away from my family for 3 weeks was painful. But I found another family over there in all the friends that I made. And that is how finally culminated my “Louisville Combined-Service Orthopaedic Surgery and Physiotherapy Fellowship”