Key Elements of a Study

Protocol Michelle Krahe

Research Development Officer, Research Office

Ph. 5678 0663

E. gchresearchdevelopment@health.qld.gov.au

Del Siegle, Ph.D. Neag School of Education - University of Connecticut

What is a Study Protocol?

A research protocol is a roadmap – it describes every step of the study

Identification of the problem

Application of the results

In order to have a clear roadmap, it is important to have a succinct and

relevant protocol that others can review for a general sense of direction.

When Should you Write a Study Protocol?

For every research project, no matter how small or seemingly insignificant.

It is the key document in study planning, conduct, interpretation, oversight

and review

Before doing anything else!

Why Should you Write a Study Protocol?

To organise your thinking - Can the objectives be achieved?

To reduce the risk of digressions during a project – Lays down the rules

For submissions to HREC & governance

To compete for funding

Makes it much easier to write an article

How Should you Write a Study Protocol?

Get some good examples

Engage with a multidisciplinary team

Give yourself adequate time!

Deadlines within deadlines (i.e. Institutional requirements)

Be prepared to draft and redraft!

Begin at the Beginning…

Then go until you reach the end. Then stop.”

Preliminary Planning

Start with a clear research question

The research question should be interesting, novel and relevant

Investigators should check the literature to ensure the question has not

already been answered – You should be the expert!

Once the question is defined, a systematic approach is followed

The Research Question

1. Specify the research question using PICO

Population, patient, problem

Intervention, prognostic factor or exposure

Comparisons/s

Outcome

Riva et al., 2012, J Can Chiropr Assoc; 56(3);

http://delib.qatar-med.cornell.edu/index.php?page=EBMquestion&pagetype=How

P high blood pressure, elderly

I ACE inhibitors

C beta-blockers

O reduce blood pressure, minimize

adverse effects

In elderly patients, are ACE inhibitors more effective

than beta-blockers in controlling high blood pressure

and minimizing adverse effects?

P

C

I

O

P

The Research Team

2. Identify your research team / collaborators

Expertise: statistics, health economics, behavioural sciences, qualitative

research, trialists (for RCTs), scientific / clinical / methodological areas

Add them as a co-investigators or collaborator

Engage partner organisations (i.e. academic, health service providers,

governments, NGOs)

The Research Team

Adds to Complexity, but synergistic for Quality

Key Elements of a Study Protocol

Protocol Outline

1. Presentation

2. Introduction / Background

3. Objectives

4. Study Methodology

5. Population & Participants

6. Statistical Analysis

7. Ethical Considerations

8. Budget

9. References

Use the Study

Protocol

Template

www.equator-network.org

Presentation

Study Title

This should be concise and descriptive, identifying the main objective and

study population

Protocol Version

Starting at 1.0

Version Date

Date version was finalised or submitted to HREC

Statement of Compliance

Presentation

Study Investigators

Sponsor

Glossary of abbreviations

Study sites

Synopsis

Stands on its own, with no reference to the protocol

Summarises the key elements of the protocol

Introduction / Background

This is a comprehensive review of the literature

State the issue!

Identify and summarise previous knowledge / research

Identify gaps in current knowledge – What can you contribute?

Include relevant literature only

Seek assistance and input

How to Structure Your LR

Broad introduction to topic

Level of

detail

Your research question

Broad issues

Overlap with your

research

Directly related to

your research

General Content

Gaps

My Research

At the end of your literature

review, the reader must

have only one thought in

their head…

This question must be

answered

Objective/s

Aim

Statement of the questions/s to be answered (use action verbs)

Should be: logical, coherent, feasible, realistic, measurable

Formulating study aims will help to:

Focus the study (help define the scope)

Avoid the collection of data which is not strictly necessary

Organise the study in clearly defined parts or phases

describe determine examine analyse

Objective/s

Define measurable objectives that directly answer the research question

A common mistake is to overload the protocol with too many objectives or

they are too vague

It is best to focus on a main/primary objective

Must be achieved

Dictates the design and methods

Objectives

Hypothesis/es

Statement of the Hypothsis/es to be tested

Null hypothesis – There is no difference

Alternative hypothesis – There is a difference

Effect: The result of

what happens

Cause: The reason

something happens

Hypothesis: Predicts a

cause and effect

Dependent Variable

Outcome

Independent Variable

Risk or predisposing

factor – Exposure

Determines

the type of

study

design,

data and

analysis

Methodology

The description of the study design

should be capable of meeting the

study objectives

Study Design

What design will be used?

http://www.cebm.net/study-designs/

Study Population

Know your study population

What are the criteria for inclusion and exclusion?

Demographics: age, gender, occupational, ethnicity, geographic area

Biological: specific parameters/ranges

Diagnostic: criteria for recruitment, define cut-off points

Why are criteria important?

Enhance the quality of subject selection

Simplify and expedite enrolment process

Minimise protocol violations

Study Population

Recruitment issues

Know your incidence and prevalence data

Feasibility – Organisation of recruitment

Duration – How long will it take?

Participant information – Consent issues?

Response rate – Adjustments?

Non-participants / refusals – Characteristics?

Compliance – Drop-outs or loss to follow-up?

Impact on endpoints – Data analysis?

Describe the recruitment process in detail: consent and randomisation

Website www.liverlife.org.au

QR Code Connect your device to

the study website

SMS Text to get involved

Call to Action GET A LIVER SCAN

Site Contact Speak with someone

at the clinic

Get Tested Here Details of the next

campaign day

Data Collection

How?

Interview, observation, record review, electronic

By Whom?

Researcher

Clinic staff

Interviewer

Tools & Resources?

Questionnaire: Attach it to your protocol

Type of interview: Describe the structure of the interview (guideline)

Laboratory tests: Refer to literature if it is a validated test

Clinical examination: Describe the device or procedure

Selection?

Training?

Supervision?

Anything that

the patient

receives,

needs to be

included

Sampling Methods

Probability Samples

Simple random, Systematic, Stratified, Cluster

Non-Probability Samples

Convenience, Judgement, Snowball, Quota

Sample Size Estimation

For almost every type of study

Sample size and power calculations are based on

the principal objective

Get help!

Data Handling

Describe the measures of data quality control:

Double data entry

Consistency checking

Verification procedures

Software, hardware, manually, electronic

Standardise procedures to

reduce measurement error and ensure

researchers are trained in specific measurements

Develop SOPs appropriate for

the study

Use validated or pre-tested

instruments

Statistical Analysis

Most Researchers…

Know they should write a Study Protocol before starting a project

Can guess the key elements of a Study Protocol even without a template

Really don’t think much about the data required

What data is collected?

Where to get / collect the required data?

How to collect the required data?

What to do with it once collected?

Data analysis plan

Prevents collection of data that will not be used

Prevents failure to collect crucial information

Ethical Considerations

One of the most important aspects of research

Important aspects to consider:

Informed consent

Confidentiality, anonymity?

Data storage and protection

References

Use a standard referencing system

Make use of reference management software

Methodological appendices

Questionnaires

Appendices

Common Mistakes

Not enough detail: Including too little detail and insufficient justification for

the significance of the problem

Too ambitious: Proposing far more work than can be reasonably done

Poor justification: No consideration for ethical implications and patient

safety/confidentiality

The protocol is unclear: Full or jargon, large gaps in the methodology

Errors: Typographical and formatting errors

Reporting Guidelines

EQUATOR-Network Enhancing the QUAlity and Transparency Of health Research (EQUATOR)

collects and provides links to all of the reporting guidelines

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

SPIRIT 2013 explanation and elaboration: Guidance for protocols of clinical trials

CONSORT Statement (Clinical Trials)

CONSORT 2010 Statement: Updated Guidelines for Parallel Group Clinical Trials

GRACE Principles: Good ReseArch for Comparative Effectiveness

GRACE Principles Checklist: For observational comparative effectiveness research

STROBE Statement (Observational Studies)

STARD 2015 (Diagnostic Studies, updated)

The TRIPOD Statement: Transparent Reporting of a multivariable prediction model for Individual

Prognosis Or Diagnosis

TRIPOD: Explanation and Elaboration

PICO Framework

"EBM - Question Formulation". Retrieved 2010-05-18

Huang X, Lin J, Demner-Fushman D (2006). "Evaluation of PICO as a

knowledge representation for clinical questions". AMIA Annu Symp Proc:

359–63

Schardt C, Adams MB, Owens T, Keitz S, Fontelo P (2007). "Utilization of

the PICO framework to improve searching PubMed for clinical questions".

BMC Med Inform Decis Mak. 7: 16. doi:10.1186/1472-6947-7-16.