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

Skills of Treatment Goal Setting in Physiotherapy Practices

This article is dedicated to all my little friends, my students who are the aspirant Physiotherapists of tomorrow and the constant source of our learning and motivation.

And also to all my teachers, professional colleagues and friends who have been working hard towards our professional enrichment, development and enhancement.

Have a happy friendships day.

The commonest dilemma we encounter in clinical practise as a physiotherapy student is planning the treatment concept for our patients. Although we know the general line of management, planning the detailed treatment sometimes becomes a challenge. Setting the treatment goal for the patient depends a lot on the patients’ assessment. But even here, the assessment has to be a physiotherapeutic assessment involving the patients’ functional diagnosis rather than purely the medical diagnosis. I don’t mean to say that the medical diagnosis of the patient is not important, but it does not lead us to the physiotherapy treatment. Rather, it helps us understand the red flags and the yellow flags for the patients’ treatment.

E.g., we routinely talk about OA knee, stroke, Grade III B fracture femur, PA shoulder, CABG, ACL reconstruction, TKR, Bronchitis, Spinal cord injury, GBS etc. But as Physios, we do not treat any of these problems. Rather we treat the functional impairments associated with these problems. In fact, many times, the diagnosis is purely functional based, e.g. Low back pain, neck pain, weakness etc. In short, Physiotherapy treatment is more functional impairment driven rather than structural impairment driven. Again, it’s not that we physios don’t manage any structural impairment at all. We do work on the tightness (stiffness) of the muscles, we do mobilise the joints (bread & butter of us manual therapists), we do help in clearing the chest of secretions or working on the consolidated/ fibrosed lungs to reduce the pathology, or reduce swelling (Oedema) or help in accelerating wound healing and in infection control by actinotherapy etc. But these are just a few examples of the application of physiotherapy in structural impairment. At least, to my knowledge, I have never heard of fracture healing, ACL repair, stroke management (of the infarct/ ischemia in the brain), coronary blockage clearance, articular degeneration treatment by physiotherapy.

Thus, the most crucial part is working on the functional aspect of the patient, working on the functional impairments as well as enhancing the activities and participation of the patient. This part cannot be understood without being clear in the International Classification of Functioning (ICF) aspect. ICF deals with a global, holistic approach to the patient. Rather than looking at the assessment on observation, palpation and examination in parts, it unites them together to understand the problems in totality.

E.g. Rather than observing chest movements or swelling, palpating for chest symmetry or type of swelling (pitting or non-pitting), examining for chest expansion or amount of swelling by measuring tape in isolated parts, ICF looks at the Impairment ‘reduced chest mobility’ (functional impairment) confirmed by observing chest movements, palpating for chest symmetry and examining for chest expansion by measuring tape or ‘presence of swelling/ oedema’ (structural impairment) confirmed by observing site of swelling, palpating for type of swelling (pitting or non-pitting) and examining for amount of swelling by measuring tape. This helps in identifying problems faster and planning the treatment goals with more accuracy.

Setting the treatment goals of the patients are often done looking at the patients’ short term goals. But this does not make sense as we need to know the final goal, the treatment end point. For this, the easiest method of treatment planning is the A B C D E method for goal setting:

A – Actor: Describes the patient

B – Behaviour: Describes the need of the patient. It is an important factor as it describes the level of involvement of the patient, whether the patient wants to or does not want to be compliant towards rehab.

C – Condition: Describes the need of the task the patient has to be involved in.

D – Demands of the task: Describes the demands of the task the patient has to be involved in.

E – Event time: Describes the times needed to complete the planned goal.

Example: I may have a 30 year old postman who is from a village and underwent a traumatic trans-tibial amputation on his right leg. Now the final treatment goal of this patient can be:

The patient, a 30 year old male (actor), wants to (behaviour) go back to his job as a postman (condition) and should be able to deliver the letters to all the houses by riding his cycle on the rough village roads (demands of the task) in a period of 4 months (16 weeks) (event time).

HOW????

Treatment Options can be multiple but always rationalise and choose the best possible option including the details of the therapy, dosage etc. Always have an evidence backing for your management with recent literatures from reputed journals. Best possible option means the best and most effective treatment that we can give to our patients in the given possible situation. It may or may not be the most ideal treatment. But it has to be the most practicable and realistic option being offered to the patient.

A] Short term OR Phase I/ Maximum protection phase/ (0 – 4 weeks):

1) Wound care – wound healing by IR (luminous) for 15 minutes x 2times/ day [1-2 weeks cryotherapy for controlling inflammation and pain]

2) Pain relief (VAS was 8/10) – GOAL: Pain should be VAS 2/10 in 4 weeks: TENS at 150 Hz, 4 electrodes, 2 over sciatic nerve course & 2 over L4 – S1 nerve roots on right side [Even a IFT can be used with same arrangement]

3) Strengthening (Strength was grade 3 on MMT) – GOAL: Strength should be grade 4 in 4 weeks: Active resistive exercises [Here calculating the 1RM or the RPE would be very important rather than just 10 reps x 10 count holds which is non-specific to treatment. Also rather than only strength, training for ENDURANCE is more important.]

Left lower limb closed chain strengthening (squats by holding the bed end/ railing) till RPE 6/10 on modified Borg scale.

Bilateral upper limb closed strengthening by scooting/ push ups on the bed till RPE 6/10 on modified Borg scale.

[Initiation of the strength/ endurance training can be done by open chain PRE by calculating the 1RM by dynamometer/ spring balance or calculating RPE and train the patient to 50-60% of it]

4) Range of Motion (Knee flexion was 15 – 65 degrees) – GOAL: ROM should be 0 – 90 in 4 weeks: Active ROM exercises for the knee [in intra articular stiffness/ hypo mobility, manual therapy concept with dosage (grade of mobilisation) and direction of glide to be mentioned]

5) Gait training – with axillary crutches 3 point NWB gait. Start with standing and swing-to gait progressed to swing-through gait.

B] Long term OR Phase II/ Moderate Protection phase (4 – 8 weeks)

1) Stump shaping and conditioning – Weight bearing on the stump, pressure bandaging/ shrinker for compression, bridging exercises for gluteal and back extensor strengthening.

2) Strengthening – GOAL: Strength should be grade 5 in 8 weeks by closed chain exercises till RPE 6/10 on modified Borg scale.

3) Range of motion – GOAL: Full ROM should be obtained. Active ROM exercises for the knee to be done 3-4 times in the day.

4) Pre prosthetic training – GOAL: Should be able to use PTB prosthesis with a SACH foot.

5) Gait training – with temporary prosthesis using a pylon and walker/ crutches

C] Phase III/ Minimum Protection phase (8-12 weeks)

1) Prosthetic training – Gait training with PTB prosthesis for all functional activities

2) Strengthening – Maintenance of strength by closed chain exercises till RPE 6/10 on modified Borg scale. Also focus on endurance training.

3) Proprioception training – For lower limb by single leg stance, eyes closed standing for 10 sec x 5 sets

4) Gait training – walking on even surface in controlled environment. Begin ambulation as per patients’ needs. E.g. Begin with 10 meters progressing to 100 meters in 12 weeks.

D] Return to the work training phase (12-16 weeks)

1) Gait training – uneven surface in real environment

2) Training for cycling on static cycle (12 – 14 weeks) – cycling for ½ hour x 4 times/ day x 5 days/ week

3) Training for cycling on moving cycle on controlled surface (14 – 16 weeks) – cycling for ½ hour x 4 times/ day x 5 days/ week

The treatment goal of being able to ride the cycle on the rough village roads for 8 hours/ day (intermittent) to deliver the letters should be achieved by the end of the 16 weeks. This is only an outline which can be hindered with factors like patient landing with infection/ fever due to reasons other than infection/ got transferred etc. But the minimum time frame and treatment plan is extremely important.

Also treatment has to be realistic in relation to the pathology. E.g. Instead of a Trans tibial, if this patient had a Trans femoral amputation, this above mentioned final outcome will not be possible (considering the limited technology and resources) and alternative treatment options have to be realised by both the therapist and the patient in the final goal and return to work phase.

Similar treatment plan can be done for any condition considering the pathology, healing phase, patients’ age and requirements. The part B, C & D should be based on re-assessment ensuring that the patient participates equally and is well informed of the goals of the treatment and also of the expectations from them in the rehab process. Details of the phase II, III and IV can be based on these re-assessments, but the treatment outline, goals and plan should definitely be ready even before initiation of the 1^st treatment session.

In our professional training we are typically taught the problem solving approach. We are trained to look at what is wrong with the patient and patch it up. Typically like patching the roads with tar which has developed potholes rather than focussing on making a stronger and better road right at the beginning. In ICF, the functional impairments help us formulate our short term goals which are definitely important to make the patient normal again to his pre injury status. I always like to give example of the movies ‘Koi Mil Gaya’ and ‘Krishh’. In KMG, the mentally challenged hero becomes a powerful hero at the movie end. This is typically what we do for our patients. It’s like the patient has become a zero and you are making the patient hero again. But just stopping at this phase is not good as the patient is at a risk of re-injury once again going back to his zero status, maybe with a higher level of disability. In Krishh, the lead actor becomes a superhero from his hero state. This should be the objective from our Phase III treatment onwards. Along with the problem solving approach, we should also perform something called as ‘appreciate enquiry’. We need to know what is good in the patient as well and should enhance these qualities. This will help us take the patient to a level where he learns not just to compensate for his weakness (for which we are treating and training them) but also to reach such a level of fitness and health by which he is never at a risk of landing with the injury again. This can only be obtained by knowing and focussing on the structural and functional integrity of the patient and also on the activities and participation levels of the patient. This can be further enhanced by knowing the contextual factors of the patients, especially the environmental facilitators including the architectural, technological, support systems, family and policies available for health.

We are many times ruled by the treatment protocol in patient treatment. Every protocol is extremely important in patient care as it help us keep in line each and every part of the treatment spectrum. In absence of a protocol, there is always a risk of missing out a crucial treatment link. In the example cited above, it is very important to follow the steps and sequences of the treatment. But we cannot forget the individualisation in the patients’ needs and requirements considering the patients goals. Thus protocols should form the basis of patient treatment, but it should also be individualised using the therapists’ knowledge of the patient, the condition, the pathology, and the sciences of tissue healing and the needs of the patient.

Again, in the example cited above, nowhere are we treating the structural or medical pathologies. We are looking and treating the movement dysfunction, dyskinesia’s, abnormal muscle recruitments, sensory dysfunction, functional loss and loss of involvement in daily life’s situations. Thus, as physiotherapists, we should be more trained in understanding and assessing these problems and managing them rather than conditions and medical diagnosis. There may be surely other views and opinions on the same and they all are respected and welcomed. No way is medical diagnosis lesser important to be learnt and understood. It, many times, helps us in re-assessment or understanding the problem being treated. It also helps us all to speak the same common language of patient care between all the care giving professionals. But as physiotherapists, we should also be focussing more on physiotherapeutic assessment and diagnosis and treatment as well.

Thus, I would again like to say that planning the clients treatment plan is an art, a science and also a commerce as it involves not only the skills of treatments, the evidences and the logics behind it backed by an efficient research methodology and publications but also involves the financial management of treatment expenses, of learning to have a proper documentation of the treatment procedures and also of the financial transactions, payment receipts and bills, legal knowledge of the laws and legislature of the state in relation to Physiotherapy practices, partnering with the professional councils and associations governing profession and the professionals and very important, being accountable and answerable to your clients, your own self and finally to GOD who blessed us all in this noble and honourable profession.